AIM ImmunoTech（0A4Y）株式概要イムノファーマであるAIMイムノテック社は、米国で複数の種類の癌、ウイルス性疾患、免疫不全症を治療する治療薬の研究開発に従事している。 詳細0A4Y ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長2/6過去の実績0/6財務の健全性5/6配当金0/6報酬収益は年間78.68%増加すると予測されています 過去5年間の収益は年間0.7%増加しました。 リスク分析過去1年間で株主の希薄化は大幅に進んだ 収益が 100 万ドル未満 ( $94K )UK市場と比較して、過去 3 か月間の株価の変動が非常に大きい意味のある時価総額がありません ( $6M )+1 さらなるリスクすべてのリスクチェックを見る0A4Y Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.NEW488,589 membersJoin community and earn perksGain real feedbackFrom our editorial team, personally. Not silence.Grow your followingReal investors. The kind who actually invest, not scroll past.Unlock free accessFree premium subscription for consistent and quality authors.Learn moreCreate NarrativeINBLROAG488,589 investors already sharing narrativesYour Fair ValueUS$Current PriceUS$0.30355.4% 割高 内在価値ディスカウントEst. Revenue$PastFuture-31m2m2016201920222025202620282031Revenue US$1.7mEarnings US$315.3kAdvancedSet Fair ValueView all narrativesAIM ImmunoTech Inc. 競合他社CardiogeniSymbol: OFEX:CGNIMarket cap: UK£6.7mTheracryfSymbol: AIM:TCFMarket cap: UK£4.6mOptiBiotix HealthSymbol: AIM:OPTIMarket cap: UK£6.7mAptamer GroupSymbol: AIM:APTAMarket cap: UK£16.4m価格と性能株価の高値、安値、推移の概要AIM ImmunoTech過去の株価現在の株価US$0.3052週高値US$34.1452週安値US$0.22ベータ1.171ヶ月の変化-66.13%3ヶ月変化-49.67%1年変化-96.96%3年間の変化-99.57%5年間の変化-99.85%IPOからの変化-99.90%最新ニュースお知らせ • Jun 25Aim Immunotech Highlights Clinical Progress and Key Milestones in Ampligen Pancreatic Cancer ProgramAIM ImmunoTech Inc. highlighted the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones. At the center of AIM's strategy is Ampligen (rintatolimod), the Company's proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. AIM believes Ampligen's unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease. Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development: Completed Phase 2 DURIPANC enrollment ahead of schedule; Achieved the important clinical milestone of dosing the final patient in the study; Reported positive interim clinical updates from the ongoing trial; Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates; Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center; Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations; Maintained orphan drug designation for pancreatic cancer in major markets; Regained compliance with NYSE American continued listing standards; Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities. Ampligen's pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations. Recent interim updates from DURIPANC have continued to support management's confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition. The combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment. With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company's recent history. Key anticipated milestones include: Additional clinical updates from the ongoing DURIPANC study; Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027; Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027; Continued immune monitoring and biomarker analyses; Regulatory interactions supporting future development planning; Further expansion of the Company's global intellectual property portfolio; Advancement of Phase 3 planning activities; Potential design and initiation activities associated with a registration-focused pivotal study. AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value. The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority. With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period. As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment.お知らせ • Jun 19Aim Immunotech Achieves Clinical Milestone as Final Subject Receives First Dose in Phase 2 Duripanc Study in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in the First Quarter 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate, defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy. Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial. DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications: Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in Progression-Free Survival. Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Overall Survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in Overall Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Progression-Free Survival of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in Progression-Free Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Overall Survival of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in Overall Survival. These results were accompanied by consistent reports of improved quality of life. DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.お知らせ • Jun 16AIM ImmunoTech Inc Regains NYSE American Compliance, Company Resolves Stockholder Equity DeficiencyAIM ImmunoTech Inc. announced that it has received written notice from the NYSE American that AIM has regained compliance with NYSE American's continued listing standards related to stockholders' equity. On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with certain a holder of existing warrants, pursuant to which the holders agreed to exercise their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.5 million in consideration of the Company's agreement to issue new warrants upon such exercise. On May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $0.001 per share, to certain investors for aggregate gross proceeds of approximately $2.4 million. On June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million. Following the closing of these transactions, the Company believes it currently has stockholders' equity in excess of the $6.0 million minimum requirement. The NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. As a result, the “below compliance” (“.BC”) indicator will be removed from the Company's trading symbol for its common stock, and the Company will be removed from NYSE American's list of noncompliant issuers on its website. The Company will remain subject to NYSE American's continued listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward.お知らせ • Jun 09+ 1 more updateAIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,554,119 Price\Range: $0.5189 Transaction Features: Registered Direct Offeringお知らせ • Jun 02AIM ImmunoTech Inc. Completes Enrollment in Phase 2 DURIPANC Clinical Trial for Ampligen Combined with Imfinzi in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company's original enrollment target of July 2026 in the Phase 2 clinical trial of AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the DURIPANC study). The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study's primary endpoint, Clinical Benefit Rate (CBR), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers. AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks. AIM remains on track to complete Ampligen dosing for all subjects in August, which should allow evaluation of the study's critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy. The enrollment milestone further advances AIM's broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company's strategy of advancing Ampligen toward pivotal-stage development. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life. Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients.お知らせ • May 22AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 7,519,351 Price\Range: $0.325 Transaction Features: Registered Direct Offering最新情報をもっと見るRecent updatesお知らせ • Jun 25Aim Immunotech Highlights Clinical Progress and Key Milestones in Ampligen Pancreatic Cancer ProgramAIM ImmunoTech Inc. highlighted the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones. At the center of AIM's strategy is Ampligen (rintatolimod), the Company's proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. AIM believes Ampligen's unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease. Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development: Completed Phase 2 DURIPANC enrollment ahead of schedule; Achieved the important clinical milestone of dosing the final patient in the study; Reported positive interim clinical updates from the ongoing trial; Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates; Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center; Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations; Maintained orphan drug designation for pancreatic cancer in major markets; Regained compliance with NYSE American continued listing standards; Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities. Ampligen's pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations. Recent interim updates from DURIPANC have continued to support management's confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition. The combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment. With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company's recent history. Key anticipated milestones include: Additional clinical updates from the ongoing DURIPANC study; Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027; Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027; Continued immune monitoring and biomarker analyses; Regulatory interactions supporting future development planning; Further expansion of the Company's global intellectual property portfolio; Advancement of Phase 3 planning activities; Potential design and initiation activities associated with a registration-focused pivotal study. AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value. The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority. With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period. As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment.お知らせ • Jun 19Aim Immunotech Achieves Clinical Milestone as Final Subject Receives First Dose in Phase 2 Duripanc Study in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in the First Quarter 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate, defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy. Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial. DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications: Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in Progression-Free Survival. Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Overall Survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in Overall Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Progression-Free Survival of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in Progression-Free Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Overall Survival of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in Overall Survival. These results were accompanied by consistent reports of improved quality of life. DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.お知らせ • Jun 16AIM ImmunoTech Inc Regains NYSE American Compliance, Company Resolves Stockholder Equity DeficiencyAIM ImmunoTech Inc. announced that it has received written notice from the NYSE American that AIM has regained compliance with NYSE American's continued listing standards related to stockholders' equity. On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with certain a holder of existing warrants, pursuant to which the holders agreed to exercise their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.5 million in consideration of the Company's agreement to issue new warrants upon such exercise. On May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $0.001 per share, to certain investors for aggregate gross proceeds of approximately $2.4 million. On June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million. Following the closing of these transactions, the Company believes it currently has stockholders' equity in excess of the $6.0 million minimum requirement. The NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. As a result, the “below compliance” (“.BC”) indicator will be removed from the Company's trading symbol for its common stock, and the Company will be removed from NYSE American's list of noncompliant issuers on its website. The Company will remain subject to NYSE American's continued listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward.お知らせ • Jun 09+ 1 more updateAIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,554,119 Price\Range: $0.5189 Transaction Features: Registered Direct Offeringお知らせ • Jun 02AIM ImmunoTech Inc. Completes Enrollment in Phase 2 DURIPANC Clinical Trial for Ampligen Combined with Imfinzi in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company's original enrollment target of July 2026 in the Phase 2 clinical trial of AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the DURIPANC study). The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study's primary endpoint, Clinical Benefit Rate (CBR), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers. AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks. AIM remains on track to complete Ampligen dosing for all subjects in August, which should allow evaluation of the study's critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy. The enrollment milestone further advances AIM's broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company's strategy of advancing Ampligen toward pivotal-stage development. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life. Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients.お知らせ • May 22AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 7,519,351 Price\Range: $0.325 Transaction Features: Registered Direct Offeringお知らせ • May 20AIM ImmunoTech Inc. has completed a Follow-on Equity Offering in the amount of $2.846758 million.AIM ImmunoTech Inc. has completed a Follow-on Equity Offering in the amount of $2.846758 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 155,874 Price\Range: $1.445796 Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,025,292 Price\Range: $1.018814 Security Name: Common Stock Security Type: Common Stock Securities Offered: 1,019,570 Price\Range: $0.54729 Transaction Features: At the Market Offeringお知らせ • May 10Aim Immunotech Inc Announces 50% Objective Response Rate in Upmc Recurrent Ovarian Cancer Phase 2 Clinical TrialAIM ImmunoTech Inc. announced the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme are collaborators – evaluating Ampligen (rintatolimod) in combination with checkpoint inhibition and chemotherapy in recurrent ovarian cancer—data that may signal a major step forward in overcoming resistance to immunotherapy. The study aimed to improve clinical outcomes by overcoming the immunosuppressive tumor microenvironment characteristic of ovarian cancer through locoregional and systemic immune activation strategies. This clinical trial was financially supported by a Merck grant. Topline results included: 50% Objective Response Rate (ORR), including 21% complete responses; 79% Clinical Benefit Rate; Median Overall Survival of 32.5 months; Durable responses exceeding 70+ months in select patients; No Grade 4 or 5 toxicities observed. Collection of additional secondary endpoint data including progression-free survival, time to disease progression and overall survival is expected to be completed in January 2027.お知らせ • Apr 17AIM ImmunoTech Enters Pivotal Value Inflection Phase with Planned Phase 3 Study of Ampligen in Pancreatic Cancer, Backed by Positive Clinical Signals, Orphan Drug Status, and Global IPAIM ImmunoTech Inc. highlighted accelerating momentum in its pancreatic cancer program, underscored by Phase 3 trial planning underway, encouraging Phase 2 clinical signals, and a rapidly strengthening global regulatory and intellectual property position. The Company recently announced a strategic agreement with the PPD clinical research business of Thermo Fisher Scientific to design its planned Phase 3 clinical trial of Ampligen in late-stage pancreatic cancer. This collaboration brings world-class clinical development expertise to support trial design and positions AIM to efficiently advance Ampligen into late-stage development. The planned Phase 3 program is supported by very positive published data from a Dutch government-approved Named Patient Program with Ampligen as a monotherapy in late-stage pancreatic ductal adenocarcinoma and reported encouraging data from the ongoing Phase 2 DURIPANC study, which is evaluating Ampligen in combination with AstraZeneca’s durvalumab. That ongoing study is showing promising improvement in progression-free survival and overall survival, as well as a favorable safety profile. Conducted in collaboration with AstraZeneca and Erasmus Medical Center, the study is expected to complete enrollment later this year and represents a key clinical validation step for our upcoming pivotal trial. As mentioned above, similar positive data was observed in the NPP, where Ampligen as a monotherapy was administered to 82 total patients and which had a significant positive findings on both progression-free and overall survival compared to historical controls. Pancreatic cancer represents a large and rapidly growing global market opportunity, with incidence rising and limited innovation over several decades. It is projected to become the second leading cause of cancer-related deaths in the United States, underscoring both the urgency and the commercial potential for new therapeutic options. Ampligen, a selective TLR3 agonist, is designed to activate innate immunity and improve tumor responsiveness, making it a strong candidate for use as both a monotherapy and in combination with checkpoint inhibitors in multiple solid tumor types, and specifically with positive Phase 1/2 safety and efficacy data in combination with AstraZeneca’s durvalumab and Merck’s pembrolizumab in pancreatic cancer. The Company continues to expand its global IP portfolio. AIM recently obtained final approval of a Japanese patent covering Ampligen in combination with checkpoint inhibitors, which is set to expire in 2039. Existing patents in the United States and Europe also extend to 2039, with broad claims supporting combination use across multiple oncology indications. This IP estate positions Ampligen for long-term commercial protection across major markets. AIM’s IP portfolio includes orphan drug designations for pancreatic cancer in both the United States and Europe, and the Company announced in March 2026 that it would seek similar status in Japan. These designations provide potential market exclusivity upon approval, regulatory incentives, reduced development costs, and opportunities for accelerated development pathways, reinforcing the Company’s strategy and enhancing long-term value creation. AIM anticipates several near-term milestones that may serve as significant value drivers. These include the completion of Phase 2 DURIPANC enrollment and additional data updates; continued clinical data readouts; further IP expansion and regulatory progress; the potential for new developments from existing strategic collaborations; and the design, IND approval and commencement of a Phase 3 pivotal study in pancreatic cancer.お知らせ • Mar 18AIM ImmunoTech Inc Announces Final Approval Of Novel Cancer Therapy Patent In Japan Combining Ampligen With Checkpoint InhibitorsAIM ImmunoTech Inc. announced that the Japan Patent Office has fully approved a Japanese patent covering the Company’s proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The patent was granted in September 2025, but had to then pass a 6-month opposition period. Japan is one of the largest health markets in the world, with Japan and the United States expected to experience the greatest increase in global pancreatic cancer burden by 2030. The Japan patent expires December 20, 2039. The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad and encompass multiple cancer types – including pancreatic cancer. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving the use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). AIM also intends to expand its intellectual property portfolio by pursuing orphan drug designation in Japan for Ampligen in the treatment of pancreatic cancer. The Company already holds Orphan Drug designations for pancreatic cancer in the United States and the European Union. While the details of the designations vary by region, the purpose is to incentivize the development of therapies for unmet health needs, by providing various benefits and market exclusivity after a drug receives market approval.お知らせ • Mar 05AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $12 million.AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $12 million. Security Name: Units Security Type: Preferred Equity/Derivative Unit Securities Offered: 12,000 Price\Range: $1000 Discount Per Security: $80 Transaction Features: Rights Offeringお知らせ • Mar 03AIM ImmunoTech Signs Agreement for Planning of A Proposed Phase 3 Clinical Trial of Ampligen in the Treatment of Late-Stage Pancreatic CancerAIM ImmunoTech Inc. announced an agreement with the PPD™? clinical research business of Thermo Fisher Scientific to design AIM's anticipated Phase 3 clinical trial in the use of the Company's drug Ampligen in the treatment of late-stage pancreatic cancer. AIM recently published an updated corporate presentation that emphasizes the Company's priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM's research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic Cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM's stockholders. AIM has thus far reported positive progress in Progression-Free Survival ("PFS"), Overall Survival ("OS") and safety in the DURIPANC study, which is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands.お知らせ • Feb 24Aim Immunotech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and Astrazeneca's Durvalumab in the Treatment of Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced milestones in the expected timeline for the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study). DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands. Planned DURIPANC milestones: July 2026 - Complete subject enrollment. Reporting of Quality of life (EORTC QLQ-C30) based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy. AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study - which supported advancement to the ongoing Phase 2 portion of the study - continue to be seen and that enrollment is ongoing. According to Erasmus MC, there has also been no significant toxicity - an encouraging safety profile for a post-chemo setting - and Ampligen subjects are consistently reporting "high quality of life" during treatment. Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company's priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM's research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials are clinical trials, the Company is currently being conducted in the United States.お知らせ • Feb 06Aim Immunotech Reports Positive Year-End Interim Clinical Progress from Phase 2 Study Evaluating Ampligen®? (Rintatolimod) in Combination with Astrazeneca's Imfinzi®? (Durvalumab) for the Treatment of Pancreatic CancerAIM ImmunoTech Inc. reported positive data in a year-end update from the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen®? (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi®? (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care. This is a follow-up Phase 2 to a 57-subject early access program ("EAP") of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life. The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. Eighteen patients have been enrolled in the study. According to Erasmus MC, there has also been no significant toxicity - an encouraging safety profile for a post-chemo setting - and Ampligen subjects are consistently reporting "high quality of life" during treatment.お知らせ • Nov 19AIM ImmunoTech Inc. announced that it has received $2.5 million in fundingAIM ImmunoTech Inc. entered into a note purchase agreement with returning lender Streeterville Capital, LLC, and announced that it has issued non-convertible unsecured promissory note with an original principal amount of $3,301,250 on November 18, 2024. The note carries an original issuance discount of $781,250 and the company agreed to pay $20,000 to the Investor to cover the Investor’s legal and administrative transaction costs, each of which were included in the original principal amount and deducted from the proceeds of the note received by the company which resulted in a purchase price received by the company of $2,500,000. The note bears interest at 10% per annum compounded daily. The maturity date of the note is 24 months from the date of its issuance. Beginning on the date that is six months after the Purchase Price Date, Investor shall have the right, exercisable at any time in its sole and absolute discretion, to redeem any amount of the Note up to $250,000 per calendar month by providing written notice to the Company provided, however, that if the Investor does not exercise any Monthly Redemption Amount in its corresponding month then such Monthly Redemption Amount shall be available for the Investor to redeem in any future month in addition to such future month’s Redemption Amount. Upon receipt of any Monthly Redemption Notice, the Company shall pay the applicable Monthly Redemption Amount in cash to the Investor within three business days of the Company’s receipt of such Monthly Redemption Notice.お知らせ • Nov 18AIM ImmunoTech Inc. announced delayed 10-Q filingOn 11/17/2025, AIM ImmunoTech Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.お知らせ • Nov 11Aim Immunotech Details New Upmc Abstract on Completed Clinical Trial Involving Ampligen's Synergistic Potential in the Treatment of Advanced Recurrent Ovarian CancerAIM ImmunoTech Inc. detailed a recent abstract containing data from the completed Phase 2 advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod), which was presented at the 40th Annual SITC Meeting on November 7, 2025, at National Harbor, MD. Platinum-sensitive patients with measurable peritoneal disease were eligible for combination therapy with up to six treatment cycles at 3-week intervals of intraperitoneal cisplatin, intravenous pembrolizumab (also known as Merck's Keytruda) and intraperitoneal Ampligen. Of the 27 patients included in the trial, 24 were evaluable for response and of those 24 there were 5 patients with complete response and 7 patients with partial response, for an Objective Response Rate ("ORR") of 50%. In contrast, a previous study titled Keynote-100 found ORRs of 7.4% and 9.9% in two arms of a pembrolizumab-only study in advanced recurrent ovarian cancer. These new ovarian cancer study results are consistent with AIM's belief that Ampligen can act as a synergistic agent when combined with checkpoint inhibitors. This could be especially encouraging for refractory patients whose cancers do not respond to checkpoint inhibitors alone, such as in the Keynote-189 study in non-small cell lung cancer, which found that approximately 52% of study subjects did not respond in the pembrolizumab -combination group.お知らせ • Oct 31AIM ImmunoTech Inc., Annual General Meeting, Dec 16, 2025AIM ImmunoTech Inc., Annual General Meeting, Dec 16, 2025.お知らせ • Sep 26AIM ImmunoTech Secures Patent in Japan Through 2039 for Novel Cancer Therapy Combining Ampligen (Rintatolimod) with Checkpoint InhibitorsAIM ImmunoTech Inc. announced that the Japan Patent Office has issued a patent covering the Company's proprietary use of Ampligen (Rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad, encompassing multiple cancer types, including pancreatic cancer, skin cancer, colorectal cancer, ovarian cancer, melanoma, breast cancer/triple negative breast cancer, head and neck tumors, bladder cancer, renal cell carcinoma, and lung cancer. The claims also capture specific dosing regimens, administration routes, and synergistic therapeutic effects observed when Ampligen is combined with checkpoint inhibitors. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. AIM believes this novel approach could revolutionize the treatment landscape for cancers that have historically been challenging to treat, such as pancreatic cancer and advanced recurrent ovarian cancer. In fact, in collaboration with AstraZeneca, Ampligen is in a Phase 2 clinical trial combined with AstraZeneca's durvalumab (an anti-PD-L1) for the treatment of metastatic pancreatic cancer. AIM recently released a DURIPANC Mid-Year Interim Clinical Progress Update showing promising signs of superior Progression-Free Survival and Overall Survival, as well as no significant toxicity. Similarly, a Phase 2 study in collaboration with Merck Sharp & Dohme LLC in advanced recurrent ovarian cancer combing Ampligen with Keytruda has been completed and expect the final data report within the next two months.お知らせ • Sep 23AIM ImmunoTech Announces Publication of Journal Article on the Positive Effect of Ampligen and Interferon-Alpha on Tumor GrowthAIM ImmunoTech Inc. announced that the Journal for ImmunoTherapy of Cancer (JITC) has published a new peer-reviewed article providing evidence of a positive combination effect of AIM's drug Ampligen and interferon- Alpha on tumor growth and subsequent subject survival. The paper concluded that the ability of systemic chemokine modulation to eliminate the PD-1-resistance of cold tumors indicates that intratumoral cytotoxic t-lymphocyte accumulation, rather than tumor immunogenicity, is the key factor limiting the therapeutic effectiveness of immune checkpoint inhibitors. These data suggest a broad therapeutic potential of tumor microenvironment reprogramming strategies.お知らせ • Aug 07AIM ImmunoTech Inc.'s Oncology Drug Ampligen to Be Featured in Key Presentations and Abstract at the International 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and CareAIM ImmunoTech Inc. announced that the strong clinical successes in oncology of its drug Ampligen will be presented in four separate aspects at the upcoming 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care in Warsaw, Poland. This will include a presentation by AIM regarding its ongoing lead clinical program in late-stage pancreatic cancer; a presentation by Pawel Kalinski, MD, PhD, a world-renowned research oncologist and senior investigator for multiple oncology clinical studies involving Ampligen, outlining his clinical research with Ampligen in multiple other solid tumor types; a presentation of Kathleen Kokolus, PhD, a senior scientist in Dr. Kalinski' laboratory, who will discuss cellular and molecular mechanisms of action of Ampligen; and finally a presentation and abstract on positive data strongly suggesting Ampligen's potential as a therapy in the treatment of endometriosis. An AIM representative will present data from AIM's pancreatic cancer Early Access Program and advances in the Phase 2 pancreatic cancer clinical trial currently underway at Erasmus Medical Center in the Netherlands. Among the expected highlights will be recent data from the DURIPANC study, an ongoing Phase 2 clinical study evaluating the combination therapy of Ampligen and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor durvalumab in the treatment of late-stage metastatic pancreatic cancer patients. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Preliminary data from DURIPANC suggests that Ampligen may prove to change that equation for the better. Last week, the Company released a DURIPANC Mid-Year Interim Clinical Progress Update showing that the therapy is, thus far, well-tolerated with positive preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Compared to historical data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS: No significant toxicity, an encouraging safety profile for a post-chemo setting; ~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and OS >6 months in the majority (64%) of eligible patients-better than expected in this setting. Dr. Kokolus will discuss cellular and molecular mechanisms the Ampligen-based chemokine-modulatory regimen's activity in enhancing the effectiveness of PD1 blockade in "cold" tumors. All of the late-stage cancers being challenged by Ampligen therapy whose results will be discussed are lethal malignancies and constitute serious and unmet global health care issues. The endometriosis abstract and presentation will be based on an analysis of data from AIM's Phase 2 and Phase 3 clinical trials of Ampligen for the treatment of Chronic Fatigue Syndrome ("CFS"), which showed that a large percentage of female participants had significant comorbidity with endometriosis. Approximately 80% of subjects experienced improvement in symptoms in the analyzed data. The Company's lead product is a first-in-class investigational drug called Ampligen, a first-in-class Investigational drug called Ampligen in multiple other solid tumors.お知らせ • Jul 31AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $8 million.AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $8 million. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 2,000,000 Price\Range: $4 Discount Per Security: $0.28お知らせ • Jul 30AIM ImmunoTech Reports Positive Mid-Year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen®? (rintatolimod) in Combination with AstraZeneca's Imfinzi®? (durvalumab) for the Treatment of Pancreatic CancerAIM ImmunoTech Inc. reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen®? (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi®? (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the "DURIPANC" study). The DURIPANC study -- which is a joint collaboration with AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands - is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling. Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: "Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRinoX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes".ancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS: No significant toxicity, an encouraging safety profile for a post-chemo setting; ~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and OS >6 months in the majority (64%) of eligible patients--better than expected in this setting. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need thatills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide. The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses. Based on these strong results suggesting Ampligen's potential effectiveness as a pancreatic cancer monotherapy, in January 2023 the Company entered into Clinical Agreements with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor. The Company's lead product is expected to enroll up to 25 patients in the Phase 2 portion of the Phase 2 portion of the study. The DURIPANC, the Phase 2 portion of the DURIPANC study is expected to enroll up to25 subjects in the Phase 2 portion of 25 subjects in the Phase 2 part of the Phase 2 portion. AURIPANC study. A total of the Phase 2 portion of DURIPANC study is a total of the Phase 2 portion.お知らせ • Jun 23AIM ImmunoTech Announces NYSE American Notice of Noncompliance With Minimum Stockholders’ Equity RequirementsAIM ImmunoTech Inc. announced the receipt of a warning notification (the “Letter”) from the NYSE American LLC (the “NYSE American”) stating that the Company is not in compliance with the minimum stockholders’ equity requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (the “Company Guide”) requiring stockholders’ equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years and $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years, respectively. As of March 31, 2025, the Company had a stockholders’ deficit of negative $3.9 million and has had losses in the most recent five fiscal years ended December 31, 2024. The NYSE American previously issued a warning on December 17, 2024 for the same reasons and has issued the Letter because the deficiency remains as of March 31, 2025, when the Company filed its quarterly report on Form 10-Q for the first quarter of fiscal 2025. On February 26, 2025, the NYSE American accepted a plan submitted by the Company to regain compliance by June 11, 2026. Accordingly, the Company still has until June 11, 2026 to regain compliance. The Company’s common stock recommenced trading on the NYSE American on June 17, 2025 under the symbol “AIM”. The Letter in no way has any effect on such trading and does not affect the Company’s business, operations or reporting requirements with the U.S. Securities and Exchange Commission.お知らせ • Jun 13AIM Immunotech Regains Compliance with Section 1003(f)(v) of the NYSE AmericanOn June 11, 2025, AIM ImmunoTech Inc. (the “Company”) was notified by The NYSE American (the “Exchange”) that the Company has regained compliance with Section 1003(f)(v) of the NYSE American Company Guide (low selling price) and that trading in the Company’s Common Stock is expected to be reinstated on the Exchange on June 17, 2025 and the ticker symbol will be “AIM” upon reinstatement. The Company’s Common Stock currently trades on the OTC Pink under the symbol “AIMID”. The new CUSIP is 00901B303.New Risk • Jun 05New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 34% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (46% average weekly change). Negative equity (-US$3.9m). Earnings are forecast to decline by an average of 20% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Revenue is less than US$1m (US$146k revenue). Market cap is less than US$10m (US$5.96m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$23m net loss next year).Reported Earnings • May 17First quarter 2025 earnings released: US$0.053 loss per share (vs US$0.12 loss in 1Q 2024)First quarter 2025 results: US$0.053 loss per share (improved from US$0.12 loss in 1Q 2024). Net loss: US$3.71m (loss narrowed 36% from 1Q 2024). Revenue is forecast to grow 16% p.a. on average during the next 2 years, compared to a 9.4% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 55% per year, which means it is significantly lagging earnings.お知らせ • May 08AIM ImmunoTech Inc. Announces the Presentation of Ampligen Oncology Data at the Recent Annual Meeting of the American Association of ImmunologistsAIM ImmunoTech Inc. announced the presentation of clinical trial data involving AIM's drug Ampligen by Pawel Kalinski, MD, PhD, at the recent Annual Meeting of the American Association of Immunologists held May 3-7, 2025, in Honolulu, HI.お知らせ • Apr 10AIM ImmunoTech Inc.(OTCPK:AIMI) dropped from S&P TMI IndexAIM ImmunoTech Inc.(OTCPK:AIMI) dropped from S&P TMI IndexNew Risk • Apr 07New major risk - Revenue and earnings growthEarnings have declined by 17% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (27% average weekly change). Negative equity (-US$1.3m). Earnings have declined by 17% per year over the past 5 years. Shareholders have been substantially diluted in the past year (45% increase in shares outstanding). Revenue is less than US$1m (US$170k revenue). Market cap is less than US$10m (US$3.01m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$23m net loss next year).お知らせ • Apr 05AIM ImmunoTech Announces NYSE American Notice of Delisting and AppealAIM ImmunoTech Inc. reported that on April 4, 2025, it received notification from NYSE Regulation of the NYSE American LLC that it had suspended trading of the Company’s common stock and of its determination to commence delisting proceedings of the Company’s common stock from the Exchange pursuant to Section 1003(f)(v) of the NYSE American Company Guide due to the low selling price of the Company’s common stock. The Company plans to appeal the determination to the Exchange’s Listing Qualifications Panel, although there can be no assurance that any such appeal will be successful. The Company’s common stock is expected to begin trading on the Pink Open Market on April 7, 2025.お知らせ • Apr 02AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $0.663329 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $0.663329 million. Security Name: Common Stock Security Type: Common Stock Transaction Features: At the Market OfferingReported Earnings • Mar 28Full year 2024 earnings released: US$0.31 loss per share (vs US$0.60 loss in FY 2023)Full year 2024 results: US$0.31 loss per share (improved from US$0.60 loss in FY 2023). Net loss: US$17.3m (loss narrowed 40% from FY 2023). Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 51% per year, which means it is performing significantly worse than earnings.お知らせ • Feb 27AIM ImmunoTech Announces NYSE American Acceptance of Plan to Regain Listing ComplianceAIM ImmunoTech Inc. (“AIM” or the “Company”) announced that it received notice from the NYSE American (the “American”) that the American has accepted the Company’s Plan to regain compliance with the minimum stockholders’ equity requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the American Company Guide. AIM has until June 11, 2026 to regain compliance with the NYSE’s Continued Listings Standards. AIM CEO Thomas K. Equels stated: “We are pleased that the NYSE American has approved our plan and look forward to executing the strategy over the coming months as we also continue to make advancements in our oncology and antiviral pipelines".お知らせ • Feb 26AIM ImmunoTech Appoints David Chemerow to Board of Directors as an Independent DirectorAIM ImmunoTech Inc. announced that the Company’s Board of Directors has, by unanimous vote, appointed David Chemerow as an Independent Director to the Board, effective immediately. Mr. Chemerow brings more than 40 years of finance, accounting and operations leadership experience across multiple industries. He previously served as the Chief Financial Officer and Treasurer, and prior to that as Chief Revenue Officer, of Comscore Inc., an American-based global media measurement and analytics company. Prior to his tenure at Comscore, Mr. Chemerow served as the Chief Operating Officer and Chief Financial Officer of Rentrak Corporation through its merger with Comscore Inc. in January 2016. Prior to 2009, Mr. Chemerow held senior executive roles leveraging his financial, business and operational expertise across multiple companies. Mr. Chemerow currently serves on the Board of Directors for Dunham’s Athleisure Corporation, a sporting goods retailer, and on the Advisory Board of Huntington Outdoor, LLC, an outdoor advertising company. Additionally, Mr. Chemerow serves on the Board of non-profit theater, The Martha’s Vineyard Playhouse, and is President of the Board of the Pilot Hill Farm Association. Previously, Mr. Chemerow served as a member of the Board of Directors of RiceBran Technologies Inc., a Nasdaq and OTC company, and served 15 years as a Board member of Playboy Enterprises. Mr. Chemerow is a graduate of Dartmouth College and holds a Master of Business Administration degree from The Amos Tuck School at Dartmouth College.お知らせ • Feb 25AIM Doses First New Subject in Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic CancerAIM ImmunoTech Inc. announced that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”). Several subjects from Phase 1 who received the highest dose will also be included in Phase 2. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center. Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC.お知らせ • Feb 07AIM ImmunoTech Inc. Announces Planned Follow-Up Clinical Study Evaluating A Combination Treatment of AIM's Ampligen and AstraZeneca's FluMist to Address the Recent Avian Influenza OutbreaksAIM ImmunoTech Inc. announced its initiation of a plan to advance Ampligen as a vaccine adjuvant for avian influenza as part of the Company's antiviral priority development pipeline. AIM has engaged Amarex Clinical Research ("Amarex"), its Clinical Research Organization ("CRO"), with the application and eventual management of a follow-up Investigational New Drug ("IND") application for the study of a potential avian influenza combination therapy of AIM's Ampligen and AstraZeneca's FluMist, a nasal spray vaccine that helps prevent seasonal influenza. AIM is seeking collaborative grants from government and industry to defray the cost of the study. The new proposed clinical trial would expand upon previous Company-sponsored clinical research at the University of Alabama-Birmingham ("UAB") (Overton 2014), which indicated that intranasal delivery of Ampligen after the intranasal delivery of the FluMist seasonal influenza vaccine not only increased the immune response to seasonal variants in the vaccine by greater than four-fold, but most importantly induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3. This Company's belief stems directly from the pre-clinical and clinical work performed with Ampligen and multiple influenza variants, some of which supported the conception of the original UAB study. Previous pre-clinical work showed that when Ampligen was administered with the then-standard seasonal triple flu vaccine -- which included influenza A H1N1, influenza A H3N2 and influenza B Shanghai strain -- intranasally to laboratory mice, it manifested cross-reactivity of mucosal and serum antibodies against H5N1. An AIM-sponsored study to assess the safety, tolerability and biological activity of intranasal Ampligen in humans found that repeated administration in four cohorts of 10 subjects each was generally well-tolerated with no serious treatment-related adverse events. AIM believes that the totality of this pre-clinical and clinical work to date -- combined with the ever-growing threat of Avian influenza -- strongly supports its decision to move forward with this second Ampligen and FluMist study in humans.New Risk • Feb 06New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: US$9.09m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Revenue is less than US$1m (US$190k revenue). Market cap is less than US$10m (US$9.09m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years).お知らせ • Jan 23AIM ImmunoTech Announces Publication of Final Clinical Study Results for AMP-518 Clinical Trial on Ampligen as a Therapeutic for Post-COVID ConditionsAIM ImmunoTech Inc. announced that the final Clinical Study Results for the “Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions” (“AMP-518”) was posted January 22, 2025 to ClinicalTrials.gov (See: NCT05592418). AIM had previously reported positive topline results from its AMP-518 Phase 2 clinical trial. In further analyzing the results of AMP-518, AIM determined that, in this study, Ampligen-treated patients with Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo. The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks. A clear signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than 205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group who received the placebo. AIM therefore believes that any future trial design should focus on Ampligen’s therapeutic potential for subjects whose COVID-related fatigue or ME/CFS symptoms can be categorized as moderate or worse.New Risk • Jan 16New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 31% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Revenue is less than US$1m (US$190k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Market cap is less than US$100m (US$12.1m market cap).Board Change • Dec 26Less than half of directors are independentThere are 6 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 6 new directors. 3 experienced directors. 2 highly experienced directors. 3 independent directors (4 non-independent directors). Independent Chairman of the Board & Member of Scientific Advisory Board William Mitchell is the most experienced director on the board, commencing their role in 1998. Independent Director Rob Chioini was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors.お知らせ • Dec 18+ 1 more updateAIM ImmunoTech Receives Non-Compliance Letter from NYSE AmericanOn December 11, 2024, AIM ImmunoTech Inc. (the Company") received a warning notification (the Letter") from the NYSE American LLC (the NYSE American") stating that the Company is not in compliance with the minimum stockholders' equity requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (the Company Guide") requiring stockholders' equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years and $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years, respectively. As of September 30, 2024, the Company had a stockholders' deficit of $2.9 million and has had losses in the most recent five fiscal years ended December 31, 2023. The Company is now subject to the procedures and requirements of Section 1009 of the Company Guide. The Company has until January 10, 2025, to submit a plan (the Plan") of actions it has taken or will take to regain compliance with the continued listing standards by June 11, 2026. The Company intends to submit a plan to regain compliance with NYSE American listing standards. If the NYSE American accepts the Plan, the Company will be able to continue its listing during the Plan period and will be subject to periodic reviews including quarterly monitoring for compliance with the Plan until it has regained compliance. If the Plan is not accepted by the NYSE American, the Letter stated that delisting proceedings will commence. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide. The Letter has no immediate effect on the listing or trading of the Company's common stock on the NYSE American. The Company's receipt of the Letter from the NYSE American does not affect the Company's business, operations or reporting requirements with the U.S. Securities and Exchange Commission.お知らせ • Dec 17Ted Kellner Provides Information to the ShareholdersOn December 14, 2024, Ted Kellner, as the nominating stockholder and a nominee, together with his other nominees, Todd Deutsch, Robert L. Chioini and Paul W. Sweeney (collectively, the Kellner Group), issued an urgent statement in response to baseless, deceptive rumors and in connection with Kellner Group efforts to bring accountability to the entrenched, incumbent Board of Directors of AIM Immunotech Inc. Kellner Group denounced the false rumors about the Company short selling and demands immediate accountability from incumbent board. In addition, Kellner Group urged the vote ‘FOR’ all 4 Kellner Group nominees on gold card for urgently needed change.お知らせ • Dec 11Ted D. Kellner Files Definitive Proxy Statement with Securities and Exchange CommissionOn December 10, 2024, Ted D. Kellner, Todd Deutsch, Robert L. Chioini and Paul W. Sweeney have filed a definitive proxy statement with the Securities and Exchange Commission to be used to solicit votes for their election to the Board of Directors of AIM Immunotech Inc, and pleased to announce that Dr. William A. Carter, the founder and former CEO of the Company and inventor of Ampligen, has agreed to become Chairman of AIM’s Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting. In addition, Kellner Group urged the shareholders of the Company to vote for its board nominees Ted D. Kellner, Todd Deutsch, Robert L. Chioini and Paul Sweeney, at the annual meeting of shareholders scheduled to be held on December 17, 2024.お知らせ • Dec 10AIM Immunotech Inc. Appoints William A. Carter as Chairman of Scientific Advisory BoardThe Kellner Group announced that Dr. William A. Carter, MD, F.A.C.P., the founder and former CEO of AIM and inventor of Ampligen, has agreed to become Chairman of AIM Immunotech Inc.’s Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting. After meeting with Dr. Carter recently, Mr. Ted Kellner remains convinced that Ampligen has great potential but only with a new AIM Board of Directors, and he asked Dr. Carter if he would be willing to serve on the intended Scientific Advisory Board, to which Dr. Carter agreed. Dr. Carter is the co-inventor of Ampligen, joined AIM (f/k/a Hemispherx) in 1978, and served as: Chief Scientific Officer from 1989-2016; the Chairman of the Board of Directors from 1992-2016; Chief Executive Officer from 1993-2016; President from 1995 to 2006; and a Director from 1987-2016. Dr. Carter was a leading innovator in the development of human interferon for a variety of treatment indications including various viral diseases and cancer. Dr. Carter received the first FDA approval to initiate clinical trials on a beta interferon product manufactured in the U.S. under his supervision. He received his M.D. degree from Duke University (with high honors) and underwent his post-doctoral training at the National Institutes of Health and Johns Hopkins University. Dr. Carter also served as Professor of Neoplastic Diseases at Hahnemann Medical University, a position he held from 1980 to 1998. Dr. Carter served as Professor and Director of Clinical Research for Hahnemann Medical University's Institute for Cancer and Blood Diseases, and as a member of the faculty at Johns Hopkins School of Medicine and the State University of New York at Buffalo. Dr. Carter is a Board-certified physician and author of more than 200 scientific articles, including the editing of various textbooks on anti-viral and immune therapy.お知らせ • Dec 03Kellner Group Issues Press Release to Urge AIM Immunotech Stockholders to Vote the Gold CardOn December 2, 2024, Ted Kellner, as the nominating stockholder and a nominee, together with his other nominees, Todd Deutsch, Robert L. Chioini and Paul W. Sweeney issued a press release in connection with their efforts to bring accountability to the entrenched, incumbent Board of Directors of AIM Immunotech Inc. The Kellner Group, which owns 5.04% of AIM's outstanding shares, emphasizes its alignment with stockholders and its commitment to providing the financial resources AIM requires. The Kellner Group criticizes the current AIM Board for their inadequate cash conservation plan, describing it as a "too little, too late" effort that underscores the company's financial situation. They highlight the decline in AIM's stock price, which has dropped over 99%, attributing this to the mismanagement by the incumbent Board and accused the Board of franticly doubling down on their attempts to deceive stockholders. In light of these issues, the Kellner Group urged the stockholders to vote for change by supporting their nominees and using the Gold Card in the upcoming vote.New Risk • Nov 23New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 0.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Revenue is less than US$1m (US$190k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Shareholders have been diluted in the past year (30% increase in shares outstanding). Market cap is less than US$100m (US$13.4m market cap).Reported Earnings • Nov 17Third quarter 2024 earnings released: US$0.064 loss per share (vs US$0.16 loss in 3Q 2023)Third quarter 2024 results: US$0.064 loss per share (improved from US$0.16 loss in 3Q 2023). Net loss: US$3.70m (loss narrowed 53% from 3Q 2023). Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 45% per year, which means it is performing significantly worse than earnings.お知らせ • Nov 15Kellner Group Urges Immediate Change at AIM Immunotech IncOn November 14, 2024, Ted Kellner, along with nominees Todd Deutsch, Robert L. Chioini, and Paul W. Sweeney, issued a statement advocating for immediate change in the AIM Immunotech Inc. Board of Directors. Kellner emphasized the need for stockholders to vote for the Kellner Group Nominees using the Gold Card, highlighting the Delaware Supreme Court ruling that found the incumbent Board had breached its fiduciary duties and wasted millions of dollars for improper purposes. The statement argued that the current Board's self-interested actions are damaging the company and urged stockholders to act before irreversible harm is done. The Kellner Group asserted that their nominees possess the skills, experience, and credibility necessary to bring accountability and create value for AIM, countering the misleading statements by the incumbent Board.お知らせ • Nov 06AIM ImmunoTech Inc., Annual General Meeting, Dec 17, 2024AIM ImmunoTech Inc., Annual General Meeting, Dec 17, 2024.お知らせ • Oct 02AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.25632 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.25632 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 4,653,036 Price\Range: $0.27 Discount Per Security: $0.0216 Transaction Features: Registered Direct Offeringお知らせ • Sep 19AIM ImmunoTech Reports Positive Preliminary Data in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic CancerAIM ImmunoTech Inc. announced positive preliminary data from the Phase 1b/2 study evaluating the combination of AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center (“Erasmus MC”) in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM announced that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival (“PFS”) requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS. Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.お知らせ • Sep 04Ted D. Kellner Sends a Notice to AIM ImmunoTechOn September 4, 2024, Ted D. Kellner announced that in accordance with the requirements of the Company’s bylaws, on September 3, 2024, Kellner submitted to AIM ImmunoTech Inc notice of his intent to nominate himself, Deutsch and Chioini for election to the Company’s board of directors at the 2024 annual meeting of stockholders. Kellner also notified the Company that he would supplement the Notice no later than September 13, 2024, to identify an additional highly qualified and independent nominee. The Notice, together with this Schedule 13D, the proxy statement filed by the Reporting Persons and Chioini last year and the extensive factual record gained through discovery and trial in the Delaware Court of Chancery last year, provides the board with all information it could possibly desire in connection with Kellner’s nominations. The Company’s stockholders expressed their clear will in connection with last year’s annual meeting, delivering proxies sufficient to elect the Reporting Persons (despite the fact that the Company did not even include Kellner, Deutsch and Chioini on its proxy card).Against this backdrop, any rejection of the Notice by the board this year would be a clear and obvious bad faith act and continuation of its improper purpose and breach of duty of loyalty. In addition, on August 27, 2024, Kellner made a demand to inspect certain books and records of the Company pursuant to Section 220 of the Delaware General Corporation Law. The demand seeks materials related to the advancement or indemnification of fees and expenses, any repayment of any advanced or indemnified fees and expenses and related D&O insurance information related to the Delaware litigation in which certain directors were found by the Delaware Supreme Court to have breached their fiduciary duty of loyalty. Customary stockholder records required for a proxy solicitation were also included in the demand. In a separate letter, Kellner requested that the Company reimburse him for expenses incurred in conferring the corporate benefit that resulted when the Company amended its bylaws to remove provisions found invalid or unenforceable by the Delaware Supreme Court.お知らせ • Aug 20AIM ImmunoTech Announces Print Publication and Further Positive Findings from a Study Evaluating Ampligen® in the Treatment of Pancreatic Cancer in the Journal Clinical Cancer ResearchAIM ImmunoTech Inc. announced the official print publication of the data analysis from a long-term Early Access Program (“EAP”) studying the company’s drug Ampligen® (rintatolimod) for the treatment of advanced pancreatic ductal adenocarcinoma (“PDAC”). The manuscript titled “Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses,” appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals. Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and tumors. Researchers at the Erasmus University Medical Center (“Erasmus MC”) found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients. In addition to the published manuscript, further commentary discussing the potential of Ampligen and two other drugs, referencing findings from the journal article, were published. Key highlights from the additional commentary include: Ampligen has been found to be also safely used through a systemic route. Interesting increases in cDC1 numbers and cytokines governing T-cell activation and migration are found to be upregulated. Researchers detected an important enrichment of B-cell numbers in peripheral blood from patients treated with Ampligen. B-cells correlated with long-term (>1 year) survival in a previous study. AIM is currently evaluating Ampligen as a therapy for metastatic pancreatic ductal adenocarcinoma in the Phase 1b/2 DURIPANC clinical study (NCT05927142) and as a therapy for locally advanced pancreatic adenocarcinoma in the Phase 2 AMP-270 clinical study (NCT05494697).Reported Earnings • Aug 16Second quarter 2024 earnings released: US$0.035 loss per share (vs US$0.10 loss in 2Q 2023)Second quarter 2024 results: US$0.035 loss per share (improved from US$0.10 loss in 2Q 2023). Net loss: US$1.84m (loss narrowed 63% from 2Q 2023). Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 48% per year, which means it is performing significantly worse than earnings.お知らせ • Aug 15Todd Deutsch Sends Notice of Intent to Nominate Candidates to AIM ImmunoTech BoardOn August 14, 2024, Todd Deutsch and Ted D. Kellner announced that they have submitted to the Company notice of their intent to nominate Ted D. Kellner, Todd Deutsch and Robert L Chioini for election to the Company’s board of directors at the 2024 annual meeting of stockholders. In addition, Ted D. Kellner stated that he also continues to review legal options that may be available to them as a result of the board’s improper purpose and breach of the duty of loyalty.お知らせ • Jul 24AIM ImmunoTech Inc. Announces New Positive Data on Ampligen’s Anti-Tumor Potential When Used as Part of A Combination TherapyAIM ImmunoTech Inc. announced the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor cell growth and improved survival in a mouse model.お知らせ • Jun 01AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.047668 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.047668 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 5,640,958 Price\Range: $0.363 Transaction Features: Registered Direct OfferingNew Risk • May 17New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$23m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$23m free cash flow). Shares are highly illiquid. Revenue is less than US$1m (US$193k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$23m net loss in 3 years). Shareholders have been diluted in the past year (5.1% increase in shares outstanding). Market cap is less than US$100m (US$19.8m market cap).Reported Earnings • May 17First quarter 2024 earnings released: US$0.12 loss per share (vs US$0.076 loss in 1Q 2023)First quarter 2024 results: US$0.12 loss per share (further deteriorated from US$0.076 loss in 1Q 2023). Net loss: US$5.82m (loss widened 59% from 1Q 2023). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 42% per year, which means it is performing significantly worse than earnings.お知らせ • Apr 10AIM Immunotech Announces Positive Top-Line, Protocol-Planned Interim Report Data from the Study of Ampligen Combined with Pembrolizumab for the Treatment of Recurrent Ovarian CancerAIM ImmunoTech Inc. announced top-line interim data indicating that combining Ampligen (rintatolimod) with Keytruda (pembrolizumab) in the treatment of recurrent ovarian cancer may have a powerful synergistic effect, leading the investigator to conclude that the combination therapy could be far more effective than pembrolizumab alone as a therapy for the disease. See further details on the study “Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer” at ClinicalTrials.gov: NCT03734692. Additionally, the immunological signature supporting this synergistic enhancement has been seen in other clinical trials, including with pancreatic cancer metastatic triple-negative breast cancer and colorectal cancer metastatic to the liver. Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and most solid tumors. In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate of 45% when combining Ampligen, pembrolizumab and cisplatin in platinum-sensitive subjects with recurrent ovarian cancer. ORR includes complete response and partial response to treatment. There was a total Clinical Benefit Rate of 55% when including patients who experienced stable disease. Researchers also reported a median Progression-Free Survival of 7.8 months.New Risk • Apr 08New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m (US$202k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Shareholders have been diluted in the past year (3.1% increase in shares outstanding). Market cap is less than US$100m (US$24.6m market cap).Reported Earnings • Apr 03Full year 2023 earnings released: US$0.60 loss per share (vs US$0.41 loss in FY 2022)Full year 2023 results: US$0.60 loss per share (further deteriorated from US$0.41 loss in FY 2022). Net loss: US$29.0m (loss widened 49% from FY 2022). Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 40% per year, which means it is performing significantly worse than earnings.お知らせ • Mar 27AIM ImmunoTech Inc. to Report Q4, 2023 Results on Apr 02, 2024AIM ImmunoTech Inc. announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Apr 02, 2024お知らせ • Feb 21AIM ImmunoTech Inc. announced that it has received $3.30125 million in fundingOn February 20, 2024, AIM ImmunoTech Inc. closed the transaction. The transaction included participation from a single investor. The company has paid sales commissions of $1,300,000? in the transaction.お知らせ • Feb 08Aim Immunotech Reports Positive Topline Results from Phase 2 Study Evaluating Ampligen for the Treatment of Post-COVID ConditionsAIM ImmunoTech Inc. announced positive topline results from the Company's Phase 2 study evaluating the efficacy and safety of Ampligen®? as a potential therapeutic for people with the Post-COVID condition of fatigue ("AMP-518"). The AMP-518 clinical trial was a two-arm, randomized, double-blind, placebo-controlled, multicenter study. The primary outcome measure is change from baseline to week 13 in PROMIS®? Fatigue Score. Although the reduction in that measure did not show a significant difference at the 13-week time point, initial analysis revealed that subjects in the Ampligen group had experienced lower levels of fatigue at multiple time points during the treatment phase when compared to the placebo group. An analysis of secondary and ad hoc endpoints found that the difference in change from baseline in PROMIS®? fatigue Score between the Ampligen and placebo groups reached or approached statistical significance at several timepoints during the treatment phase. Demographics and baseline characteristics were generally comparable between the Ampligen and placebo group. Additionally, the analysis of safety parameters demonstrated that Ampligen was generally well-tolerated with no severe adverse events, no treatment-emergent adverse events (TEAEs) leading to death, and no severe TEAEs reported during the study. There were six subjects (15.0%) in the Ampligen group with TEAEs considered related to the study treatment, the majority of which were mild in severity. More subjects in the Ampligen group compared to the placebo group reported TEAE (10 subjects, 25.0% vs. four subjects, 10.0%), however the majority of these were mild.お知らせ • Nov 29AIM ImmunoTech Inc., Annual General Meeting, Dec 29, 2023AIM ImmunoTech Inc., Annual General Meeting, Dec 29, 2023.お知らせ • Nov 22AIM ImmunoTech Inc. Completes Treatment of Last Subject in Phase 2 Study Evaluating Ampligen for the Treatment of Post-COVID ConditionsAIM ImmunoTech Inc. announced the last subject has completed treatment in the company's Phase 2 study evaluating Ampligen®? as a potential therapeutic for people with the Post-COVID condition of fatigue (AMP-518). As previously announced, the Company completed enrollment in the AMP-518 study in August 2023. Approximately 80 subjects, ages 18 to 60 years, were enrolled and randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. To date, no severe adverse events have been reported. The company remains on track to report topline data as early as first quarter 2024. The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in subjects experiencing the post-COVID condition of fatigue. The primary protocol planned outcome measure of the study is change from baseline to week 13 in PROMIS® Fatigue Score. Other protocol planned study outcomes include: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to weeks 6 and 13 in distance traveled during a Six-Minute Walk Test; proportion of subjects that surpass 54 meters in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to weeks 6 and 13 in PROMIS® Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS® Sleep Disturbance Score.Reported Earnings • Nov 17Third quarter 2023 earnings released: US$0.16 loss per share (vs US$0.13 loss in 3Q 2022)Third quarter 2023 results: US$0.16 loss per share (further deteriorated from US$0.13 loss in 3Q 2022). Net loss: US$7.82m (loss widened 22% from 3Q 2022). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the United Kingdom.お知らせ • Nov 15AIM ImmunoTech Announces Publication of Data from Roswell Park Comprehensive Cancer Center Phase 1 Study Evaluating AmpligenAIM ImmunoTech Inc. announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.'s drug candidate Ampligen (also known as rintatolimod), interferon a-2b and celecoxib, followed by pembrolizumab. The data were published in a manuscript titled, "Systemic Infusion of TLR3-Ligand and IFNa in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx," in The Journal for ImmunoTherapy of Cancer. The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon a- 2b and celecoxib, and the combination's ability to promote local CTL influx to mTNBC lesions. Principal investigator and first author Shipra Gandhi, MD, of the Department of Medicine at Roswell Park, led the study under the scientific leadership of Pawel Kalinski, MD, PhD, senior author of the paper, Chair of Immunology and Senior Vice President for Team Science at Roswell Park.お知らせ • Nov 09AIM ImmunoTech Inc. Announces Encouraging Translational Data from Phase 2 Study Evaluating Ampligen for the Treatment of Advanced Recurrent Ovarian CancerAIM ImmunoTech Inc. announced encouraging translational data from an ongoing Phase 2 clinical trial utilizing AIM’s drug Ampligen in patients with platinum-sensitive advanced recurrent ovarian cancer. The abstract with data illustrations, titled Combination intraperitoneal chemoimmunotherapy triggers a T-cell chemotactic locoregional response in patients with recurrent platinum-sensitive ovarian cancer, was presented by collaborators from the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine (UPMC) — one of the world’s top centers for the treatment of gynecological cancers — at the recent Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, in San Diego, Calif. Data highlighted in the abstract were collected by UPMC through translational studies focused on the immune tumor microenvironment (TME), using a longitudinal collection of biospecimens, including plasma, PBMC, IP washes and tumor tissue collected from patients treated in a Phase 2, efficacy/safety trial (NCT03734692) combining intraperitoneal (IP) chemotherapy (cisplatin) with dual agent immunotherapy using intravenous (IV) pembrolizumab (anti-PD1, Keytruda®, provided by Merck) and IP rintatolimod (Ampligen, a dsRNA acting as toll-like receptor 3 -TLR-3- agonist, provided by AIM). Sequential sampling of the IP cavity showed an increase in cellularity immediately after treatment consistent with an “acute” pro-inflammatory reaction. Mesoscale Delivery (MSD) measurements in IP washes revealed an acute increase in granzyme B, perforin, TNF alpha, CXCL9, CXCL10, and CXCL11 after treatment (p<0.05). Longitudinal data revealed a progressive increase in some biomarkers (p<0.05). RNA sequencing data showed a significant upregulation acutely in STAT1 and downstream targets, CXCL9, 10, 11 and TH1 type response genes (p<0.05).お知らせ • Nov 08AIM ImmunoTech Inc., Annual General Meeting, Dec 01, 2023AIM ImmunoTech Inc., Annual General Meeting, Dec 01, 2023.お知らせ • Aug 29Kellner Group to Proceed with AIM Director Nominations and Proxy SolicitationOn August 28, 2023, Ted D. Kellner announced that as previously disclosed, in accordance with the requirements of the Company’s bylaws, on August 4, 2023, Kellner delivered notice to the Company of his intent to nominate himself, Chioini and Deutsch for election to the Company’s board of directors at the 2023 annual meeting of stockholders. On August 23, 2023, the Company notified Kellner of the rejection of the Notice. On August 25, 2023, Kellner filed a complaint in the Delaware Court of Chancery seeking declarations that the bylaw amendments are unlawful, that the application of the bylaw amendments by the Board to reject the Notice is unlawful and/or inequitable and that the applicable directors breached their fiduciary duties in adopting the bylaw amendments and rejecting the Notice. Kellner also filed a motion for expedited proceedings and will seek a trial on the merits prior to the 2023 Annual Meeting of Stockholders. In addition, the Kellner Group stated that it intends to file a proxy statement with the Securities and Exchange Commission to be used to solicit votes for the election of its slate of qualified director nominees at the upcoming annual meeting of stockholders of the Company.Reported Earnings • Aug 16Second quarter 2023 earnings released: US$0.10 loss per share (vs US$0.10 loss in 2Q 2022)Second quarter 2023 results: US$0.10 loss per share (in line with 2Q 2022). Net loss: US$4.91m (loss widened 1.2% from 2Q 2022). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in the United Kingdom.お知らせ • Aug 09AIM Immunotech Announces Completion of Enrollment in Phase 2 Study Evaluating Ampligen(R) for the Treatment of Post-Covid ConditionsAIM ImmunoTech Inc. announced the completion of enrollment in the company's Phase 2 study evaluating Ampligen(R) as a potential therapeutic for people with post-COVID conditions ("AMP-518"). The study has met the planned enrollment of 80 AMP-518 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. The ompany expects to complete dosing of the last study patient in Fourth Quarter 2023.お知らせ • Jul 12AIM ImmunoTech Enrolls and Doses First Subject in Phase 2 Study Evaluating Ampligen(R) for the Treatment of Post-COVID ConditionsAIM ImmunoTech Inc. announced it has enrolled and dosed the first subject in the company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions. This important study milestone follows on the heels of the company having recently opened multiple clinical study sites and having screened numerous subjects. Study screening is ongoing and AIM expects to dose additional new subjects in the coming weeks. For more information about AMP-518, please visit ClinicalTrials.gov and reference identifier NCT05592418. The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in subjects experiencing the post-COVID condition of fatigue. The primary protocol planned outcome measure of the study is change from baseline to week 13 in PROMIS® Fatigue Score. Other protocol planned study outcomes include: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to weeks 6 and 13 in distance traveled during a Six-Minute Walk Test; proportion of subjects that surpass 54 meters in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to weeks 6 and 13 in PROMIS® Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS® Sleep Disturbance Score. AMP-518 is expected to enroll approximately 80 subjects between the ages of 18 to 60 years across up to 10 centers in the United States. Subjects will be randomized 1:1 to receive twice weekly IV infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks.お知らせ • Jun 28AIM ImmunoTech Inc. Announces Authorizations from Competent Authority and Ethics Board in the Netherlands to Begin Phase 1B/2 Study Evaluating Ampligen®? (Rintatolimod) in Combination with Astrazeneca's Imfinzi (Durvalumab) for the Treatment of Pancreatic CancerAIM ImmunoTech Inc. announced the required approvals from the Netherlands for Erasmus Medical Center to begin a Phase 1b/2 study under the previously announced external sponsored collaborative clinical research agreement with AstraZeneca and Erasmus MC. The authorizations are from the Central Committee on Research Involving Human Subjects, which is the Competent Authority for the review of clinical trials in the Netherlands, and the Medical Ethics Review Committee Erasmus MC, which is the governing ethics board. The investigator-initiated clinical study, entitled "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect" (the "DURIPANC Study"), is an exploratory, open-label, single center, Phase 1b/2 study which will use Study Drug provided by AstraZeneca and AIM ImmunoTech. The primary objective of the Phase 1b portion of the study is to determine the safety of combination therapy with durvalumab and Ampligen. The primary objective of the phase 2 portion of the trial is to determine the clinical benefit rate of combination therapy with durvalUMab and Ampligen. The DURIPANC Study is expected to enroll between 9 and 18 subjects in the Phase 1b portion and between 13 and 25 patients in the Phase 2 portion of the study. All included patients will receive combination therapy with Ampligen and durvalumab. Patients will start with Ampligen 200mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to 400mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500mg via IV infusion will be introduced in week 2. Patients will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks (up to 12 doses/cycles) with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST 1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.お知らせ • Jun 13AIM ImmunoTech Inc. Outlines Recent Significant Progress Across Clinical Development Pipeline and Provides Update on Positive Pre-Clinical and IP DevelopmentsAIM ImmunoTech Inc. provided an update on its ongoing clinical development programs evaluating Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immune-modulator with broad spectrum activity. The AMP-270 clinical trial is the Company’s randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The Company is recruiting patients for its AMP-270 Phase 2 study of Ampligen as a therapy for LAPC. The lead site at the University of Nebraska Medical Center is now open and actively working to enroll patients. The Gabrail Cancer & Research Center in Canton, Ohio is also recruiting patients. AIM continues its efforts to open additional clinical sites at premier cancer centers across the United States and Europe. The Company remains optimistic for first patient enrollment in the second quarter of this year.Reported Earnings • May 17First quarter 2023 earnings released: US$0.076 loss per share (vs US$0.08 loss in 1Q 2022)First quarter 2023 results: US$0.076 loss per share (improved from US$0.08 loss in 1Q 2022). Net loss: US$3.66m (loss narrowed 4.2% from 1Q 2022). Revenue is forecast to grow 75% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in the United Kingdom.Board Change • Mar 02Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Feb 11Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.お知らせ • Jan 10AIM ImmunoTech Inc. Announces the Netherlands Patent Office (Octrooicentrum Nederland) Grants A Utility Patent Covering Rugged dsRNA, A Double-Stranded RNA Product Related to Ampligen® (Rintatolimod)AIM ImmunoTech Inc. announced that the Netherlands Patent Office (Octrooicentrum Nederland) granted a utility patent covering rugged dsRNA, a double-stranded RNA product related to Ampligen(R) (rintatolimod), which claims cover, among other aspects, compositions and compositions for use in the prevention or treatment of COVID-19. The new patent broadens AIM's existing portfolio for COVID-19 treatments to include rugged dsRNA. Data from in vitro, pre-clinical and clinical experiments strongly suggest that Ampligen has a broad-spectrum early-onset antiviral effect by stimulating a powerful innate immune response. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication.Recent Insider Transactions • Jan 06Executive Vice Chairman recently bought US$50k worth of stockOn the 3rd of January, Thomas Equels bought around 161k shares on-market at roughly US$0.31 per share. This transaction amounted to 42% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Thomas' only on-market trade for the last 12 months.Board Change • Jan 04Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Nov 22Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.Board Change • Jun 22Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.株主還元0A4YGB BiotechsGB 市場7D-16.4%1.5%0.2%1Y-97.0%23.4%18.1%株主還元を見る業界別リターン: 0A4Y過去 1 年間で23.4 % の収益を上げたUK Biotechs業界を下回りました。リターン対市場: 0A4Yは、過去 1 年間で18.1 % のリターンを上げたUK市場を下回りました。価格変動Is 0A4Y's price volatile compared to industry and market?0A4Y volatility0A4Y Average Weekly Movement50.9%Biotechs Industry Average Movement7.9%Market Average Movement5.4%10% most volatile stocks in GB Market10.8%10% least volatile stocks in GB Market2.9%安定した株価: 0A4Yの株価は、 UK市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 0A4Yの 週次ボラティリティ は、過去 1 年間で34%から51%に増加しました。会社概要設立従業員CEO（最高経営責任者ウェブサイト196620Thomas Equelsaimimmuno.com免疫製薬会社であるAIMイミュノテック社は、米国で複数の種類の癌、ウイルス性疾患、免疫不全障害を治療する治療薬の研究開発に従事している。同社の主力製品は、慢性疲労症候群治療用の高分子二本鎖リボ核酸製剤であるアンプリジェン（リンタトリモド）と、性器疣贅治療用の精製天然由来糖鎖多種αインターフェロン製剤であるアルフェロンN注（インターフェロン・アルファ）である。また、膵臓がん、腎細胞がん、悪性黒色腫、非小細胞肺がん、卵巣がん、乳がん、大腸がん、前立腺がん、筋痛性脳脊髄炎、B型肝炎、HIV、COVID-19、COVID後遺症の治療薬としてアンプリジェンを開発中である。同社は以前Hemispherx Biopharma, Inc.として知られていたが、2019年8月にAIM ImmunoTech Inc.に社名を変更した。AIM ImmunoTech Inc.は1966年に設立され、フロリダ州オカラに本社を置いている。もっと見るAIM ImmunoTech Inc. 基礎のまとめAIM ImmunoTech の収益と売上を時価総額と比較するとどうか。0A4Y 基礎統計学時価総額US$6.27m収益（TTM）-US$13.28m売上高(TTM)US$94.00k69.5xP/Sレシオ-0.5xPER（株価収益率0A4Y は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計0A4Y 損益計算書（TTM）収益US$94.00k売上原価US$122.00k売上総利益-US$28.00kその他の費用US$13.25m収益-US$13.28m直近の収益報告Mar 31, 2026次回決算日該当なし一株当たり利益（EPS）-0.60グロス・マージン-29.79%純利益率-14,123.40%有利子負債／自己資本比率198.3%0A4Y の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/07/01 06:15終値2026/07/01 00:00収益2026/03/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレークこのレポートを生成するために使用した分析モデルの詳細は、当社の Github ページ でご覧いただけます。また、レポートの使い方に関する ガイド や YouTube の チュートリアル もご用意しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋AIM ImmunoTech Inc. 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Edward WooAscendiant Capital Markets LLCLing WangChardan Capital Markets, LLC
お知らせ • Jun 25Aim Immunotech Highlights Clinical Progress and Key Milestones in Ampligen Pancreatic Cancer ProgramAIM ImmunoTech Inc. highlighted the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones. At the center of AIM's strategy is Ampligen (rintatolimod), the Company's proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. AIM believes Ampligen's unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease. Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development: Completed Phase 2 DURIPANC enrollment ahead of schedule; Achieved the important clinical milestone of dosing the final patient in the study; Reported positive interim clinical updates from the ongoing trial; Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates; Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center; Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations; Maintained orphan drug designation for pancreatic cancer in major markets; Regained compliance with NYSE American continued listing standards; Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities. Ampligen's pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations. Recent interim updates from DURIPANC have continued to support management's confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition. The combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment. With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company's recent history. Key anticipated milestones include: Additional clinical updates from the ongoing DURIPANC study; Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027; Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027; Continued immune monitoring and biomarker analyses; Regulatory interactions supporting future development planning; Further expansion of the Company's global intellectual property portfolio; Advancement of Phase 3 planning activities; Potential design and initiation activities associated with a registration-focused pivotal study. AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value. The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority. With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period. As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment.
お知らせ • Jun 19Aim Immunotech Achieves Clinical Milestone as Final Subject Receives First Dose in Phase 2 Duripanc Study in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in the First Quarter 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate, defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy. Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial. DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications: Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in Progression-Free Survival. Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Overall Survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in Overall Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Progression-Free Survival of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in Progression-Free Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Overall Survival of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in Overall Survival. These results were accompanied by consistent reports of improved quality of life. DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.
お知らせ • Jun 16AIM ImmunoTech Inc Regains NYSE American Compliance, Company Resolves Stockholder Equity DeficiencyAIM ImmunoTech Inc. announced that it has received written notice from the NYSE American that AIM has regained compliance with NYSE American's continued listing standards related to stockholders' equity. On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with certain a holder of existing warrants, pursuant to which the holders agreed to exercise their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.5 million in consideration of the Company's agreement to issue new warrants upon such exercise. On May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $0.001 per share, to certain investors for aggregate gross proceeds of approximately $2.4 million. On June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million. Following the closing of these transactions, the Company believes it currently has stockholders' equity in excess of the $6.0 million minimum requirement. The NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. As a result, the “below compliance” (“.BC”) indicator will be removed from the Company's trading symbol for its common stock, and the Company will be removed from NYSE American's list of noncompliant issuers on its website. The Company will remain subject to NYSE American's continued listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward.
お知らせ • Jun 09+ 1 more updateAIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,554,119 Price\Range: $0.5189 Transaction Features: Registered Direct Offering
お知らせ • Jun 02AIM ImmunoTech Inc. Completes Enrollment in Phase 2 DURIPANC Clinical Trial for Ampligen Combined with Imfinzi in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company's original enrollment target of July 2026 in the Phase 2 clinical trial of AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the DURIPANC study). The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study's primary endpoint, Clinical Benefit Rate (CBR), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers. AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks. AIM remains on track to complete Ampligen dosing for all subjects in August, which should allow evaluation of the study's critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy. The enrollment milestone further advances AIM's broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company's strategy of advancing Ampligen toward pivotal-stage development. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life. Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients.
お知らせ • May 22AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 7,519,351 Price\Range: $0.325 Transaction Features: Registered Direct Offering
お知らせ • Jun 25Aim Immunotech Highlights Clinical Progress and Key Milestones in Ampligen Pancreatic Cancer ProgramAIM ImmunoTech Inc. highlighted the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones. At the center of AIM's strategy is Ampligen (rintatolimod), the Company's proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca's PD-L1 inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. AIM believes Ampligen's unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease. Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development: Completed Phase 2 DURIPANC enrollment ahead of schedule; Achieved the important clinical milestone of dosing the final patient in the study; Reported positive interim clinical updates from the ongoing trial; Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates; Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center; Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations; Maintained orphan drug designation for pancreatic cancer in major markets; Regained compliance with NYSE American continued listing standards; Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities. Ampligen's pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations. Recent interim updates from DURIPANC have continued to support management's confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition. The combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment. With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company's recent history. Key anticipated milestones include: Additional clinical updates from the ongoing DURIPANC study; Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027; Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027; Continued immune monitoring and biomarker analyses; Regulatory interactions supporting future development planning; Further expansion of the Company's global intellectual property portfolio; Advancement of Phase 3 planning activities; Potential design and initiation activities associated with a registration-focused pivotal study. AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value. The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority. With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period. As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment.
お知らせ • Jun 19Aim Immunotech Achieves Clinical Milestone as Final Subject Receives First Dose in Phase 2 Duripanc Study in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced that the final subject has received their first dose in the Phase 2 DURIPANC clinical trial evaluating Ampligen (rintatolimod) in combination with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) for the treatment of metastatic pancreatic cancer. With this final subject, Primary Endpoint analysis is anticipated to begin in December 2026 and topline results are anticipated in the First Quarter 2027. DURIPANC’s primary endpoint is Clinical Benefit Rate, defined as the proportion of patients achieving stable disease, partial response or complete response at 24 weeks following initiation of combination therapy. Analysis of Secondary Endpoints is expected to begin in June 2027, or 49 weeks after this final subject received their first dose. DURIPANC’s Secondary Endpoints include Overall Survival – the gold standard in oncology trials – as well as progression-free survival and immune profiling analysis that could potentially help identify subsets of future pancreatic cancer patients likely to experience the best survival results, which could be critical to the design of a pivotal Phase 3 clinical trial. DURIPANC is a follow-up to the AIM/Erasmus Medical Center Named Patient Program utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival, particularly when broken down by biomarker stratifications: Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Progression-Free Survival of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in Progression-Free Survival. Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, Overall Survival of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in Overall Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Progression-Free Survival of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in Progression-Free Survival. Based upon stratification for immune marker CA 19-9 less than 1000, Overall Survival of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in Overall Survival. These results were accompanied by consistent reports of improved quality of life. DURIPANC is an investigator-initiated, exploratory, open-label, single-center Phase 2 study. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center in the Netherlands. In addition to the Primary Endpoint of clinical benefit rate, the secondary/exploratory objectives include assessing overall survival and progression-free survival; exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.
お知らせ • Jun 16AIM ImmunoTech Inc Regains NYSE American Compliance, Company Resolves Stockholder Equity DeficiencyAIM ImmunoTech Inc. announced that it has received written notice from the NYSE American that AIM has regained compliance with NYSE American's continued listing standards related to stockholders' equity. On May 7, 2026, the Company entered into a warrant exercise inducement offer letter agreement with certain a holder of existing warrants, pursuant to which the holders agreed to exercise their warrants in cash at a reduced exercise price for aggregate gross proceeds of approximately $3.5 million in consideration of the Company's agreement to issue new warrants upon such exercise. On May 21, 2026, the Company issued and sold 7,519,351 shares of common stock, par value $0.001 per share, to certain investors for aggregate gross proceeds of approximately $2.4 million. On June 10, 2026, the Company issued and sold 2,554,119 shares of common stock and, in a concurrent private placement, 771,503 shares of common stock, pre-funded warrants to purchase up to 1,782,616 shares of common stock, and Class J warrants to purchase up to 10,216,476 shares of common stock to certain investors for aggregate gross proceeds of approximately $2.6 million. Following the closing of these transactions, the Company believes it currently has stockholders' equity in excess of the $6.0 million minimum requirement. The NYSE American formally notified the Company on June 12, 2026, confirming that the Company had successfully addressed and resolved all deficiencies related to Sections 1003(a)(i), (ii), and (iii) of the NYSE American Company Guide. As a result, the “below compliance” (“.BC”) indicator will be removed from the Company's trading symbol for its common stock, and the Company will be removed from NYSE American's list of noncompliant issuers on its website. The Company will remain subject to NYSE American's continued listing monitoring procedures and remains committed to maintaining strong financial discipline and governance going forward.
お知らせ • Jun 09+ 1 more updateAIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.325332 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,554,119 Price\Range: $0.5189 Transaction Features: Registered Direct Offering
お知らせ • Jun 02AIM ImmunoTech Inc. Completes Enrollment in Phase 2 DURIPANC Clinical Trial for Ampligen Combined with Imfinzi in Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced a significant milestone in its pancreatic cancer development program, with enrollment of the final subject, barring disqualifying pre-treatment circumstances. The final planned subject is scheduled for treatment in mid-June, surpassing the Company's original enrollment target of July 2026 in the Phase 2 clinical trial of AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the DURIPANC study). The ahead-of-schedule enrollment milestone reinforces AIM’s emphasis on accelerating momentum and keeps the Company on track for a planned December 2026 evaluation of the study's primary endpoint, Clinical Benefit Rate (CBR), a key measure of treatment effectiveness in one of the deadliest and most difficult-to-treat cancers. AIM previously reported positive year-end interim results in DURIPANC and intends to publish its next interim report in the next two to three weeks. AIM remains on track to complete Ampligen dosing for all subjects in August, which should allow evaluation of the study's critical primary endpoint of Clinical Benefit Rate in December 2026. Clinical Benefit Rate is defined as stable disease, partial response, or complete response six months after initiation of combination therapy. The enrollment milestone further advances AIM's broader pancreatic cancer strategy, which includes ongoing Phase 3 clinical trial planning and continued expansion of its global regulatory and intellectual property position. The planned Phase 3 program is supported by positive published data from a Dutch government-approved Named Patient Program involving Ampligen-treated pancreatic cancer patients, as well as encouraging findings from the ongoing DURIPANC study. Collectively, these programs have generated clinical experience in more than 100 pancreatic cancer patients treated with Ampligen and continue to support the Company's strategy of advancing Ampligen toward pivotal-stage development. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study conducted through a collaboration among AIM ImmunoTech, AstraZeneca, and Erasmus Medical Center in the Netherlands. The primary objective of the study is to evaluate the CBR of the combination therapy. Secondary and exploratory objectives include assessing overall survival and progression-free survival, evaluating immune-monitoring through tissue biopsies and peripheral immune profiling, and measuring patient quality of life. Pancreatic cancer remains one of the most lethal malignancies worldwide and is projected to become the second leading cause of cancer-related deaths in the United States. Despite decades of research, treatment options remain limited, highlighting the urgent need for innovative therapeutic approaches that can improve survival and quality of life for patients.
お知らせ • May 22AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.443789 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 7,519,351 Price\Range: $0.325 Transaction Features: Registered Direct Offering
お知らせ • May 20AIM ImmunoTech Inc. has completed a Follow-on Equity Offering in the amount of $2.846758 million.AIM ImmunoTech Inc. has completed a Follow-on Equity Offering in the amount of $2.846758 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 155,874 Price\Range: $1.445796 Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,025,292 Price\Range: $1.018814 Security Name: Common Stock Security Type: Common Stock Securities Offered: 1,019,570 Price\Range: $0.54729 Transaction Features: At the Market Offering
お知らせ • May 10Aim Immunotech Inc Announces 50% Objective Response Rate in Upmc Recurrent Ovarian Cancer Phase 2 Clinical TrialAIM ImmunoTech Inc. announced the Final Primary Endpoint Report on Objective Response Rate data from a University of Pittsburgh Medical Center Phase 2 clinical trial – in which AIM and Merck Sharp & Dohme are collaborators – evaluating Ampligen (rintatolimod) in combination with checkpoint inhibition and chemotherapy in recurrent ovarian cancer—data that may signal a major step forward in overcoming resistance to immunotherapy. The study aimed to improve clinical outcomes by overcoming the immunosuppressive tumor microenvironment characteristic of ovarian cancer through locoregional and systemic immune activation strategies. This clinical trial was financially supported by a Merck grant. Topline results included: 50% Objective Response Rate (ORR), including 21% complete responses; 79% Clinical Benefit Rate; Median Overall Survival of 32.5 months; Durable responses exceeding 70+ months in select patients; No Grade 4 or 5 toxicities observed. Collection of additional secondary endpoint data including progression-free survival, time to disease progression and overall survival is expected to be completed in January 2027.
お知らせ • Apr 17AIM ImmunoTech Enters Pivotal Value Inflection Phase with Planned Phase 3 Study of Ampligen in Pancreatic Cancer, Backed by Positive Clinical Signals, Orphan Drug Status, and Global IPAIM ImmunoTech Inc. highlighted accelerating momentum in its pancreatic cancer program, underscored by Phase 3 trial planning underway, encouraging Phase 2 clinical signals, and a rapidly strengthening global regulatory and intellectual property position. The Company recently announced a strategic agreement with the PPD clinical research business of Thermo Fisher Scientific to design its planned Phase 3 clinical trial of Ampligen in late-stage pancreatic cancer. This collaboration brings world-class clinical development expertise to support trial design and positions AIM to efficiently advance Ampligen into late-stage development. The planned Phase 3 program is supported by very positive published data from a Dutch government-approved Named Patient Program with Ampligen as a monotherapy in late-stage pancreatic ductal adenocarcinoma and reported encouraging data from the ongoing Phase 2 DURIPANC study, which is evaluating Ampligen in combination with AstraZeneca’s durvalumab. That ongoing study is showing promising improvement in progression-free survival and overall survival, as well as a favorable safety profile. Conducted in collaboration with AstraZeneca and Erasmus Medical Center, the study is expected to complete enrollment later this year and represents a key clinical validation step for our upcoming pivotal trial. As mentioned above, similar positive data was observed in the NPP, where Ampligen as a monotherapy was administered to 82 total patients and which had a significant positive findings on both progression-free and overall survival compared to historical controls. Pancreatic cancer represents a large and rapidly growing global market opportunity, with incidence rising and limited innovation over several decades. It is projected to become the second leading cause of cancer-related deaths in the United States, underscoring both the urgency and the commercial potential for new therapeutic options. Ampligen, a selective TLR3 agonist, is designed to activate innate immunity and improve tumor responsiveness, making it a strong candidate for use as both a monotherapy and in combination with checkpoint inhibitors in multiple solid tumor types, and specifically with positive Phase 1/2 safety and efficacy data in combination with AstraZeneca’s durvalumab and Merck’s pembrolizumab in pancreatic cancer. The Company continues to expand its global IP portfolio. AIM recently obtained final approval of a Japanese patent covering Ampligen in combination with checkpoint inhibitors, which is set to expire in 2039. Existing patents in the United States and Europe also extend to 2039, with broad claims supporting combination use across multiple oncology indications. This IP estate positions Ampligen for long-term commercial protection across major markets. AIM’s IP portfolio includes orphan drug designations for pancreatic cancer in both the United States and Europe, and the Company announced in March 2026 that it would seek similar status in Japan. These designations provide potential market exclusivity upon approval, regulatory incentives, reduced development costs, and opportunities for accelerated development pathways, reinforcing the Company’s strategy and enhancing long-term value creation. AIM anticipates several near-term milestones that may serve as significant value drivers. These include the completion of Phase 2 DURIPANC enrollment and additional data updates; continued clinical data readouts; further IP expansion and regulatory progress; the potential for new developments from existing strategic collaborations; and the design, IND approval and commencement of a Phase 3 pivotal study in pancreatic cancer.
お知らせ • Mar 18AIM ImmunoTech Inc Announces Final Approval Of Novel Cancer Therapy Patent In Japan Combining Ampligen With Checkpoint InhibitorsAIM ImmunoTech Inc. announced that the Japan Patent Office has fully approved a Japanese patent covering the Company’s proprietary use of Ampligen (rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The patent was granted in September 2025, but had to then pass a 6-month opposition period. Japan is one of the largest health markets in the world, with Japan and the United States expected to experience the greatest increase in global pancreatic cancer burden by 2030. The Japan patent expires December 20, 2039. The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad and encompass multiple cancer types – including pancreatic cancer. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving the use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). AIM also intends to expand its intellectual property portfolio by pursuing orphan drug designation in Japan for Ampligen in the treatment of pancreatic cancer. The Company already holds Orphan Drug designations for pancreatic cancer in the United States and the European Union. While the details of the designations vary by region, the purpose is to incentivize the development of therapies for unmet health needs, by providing various benefits and market exclusivity after a drug receives market approval.
お知らせ • Mar 05AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $12 million.AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $12 million. Security Name: Units Security Type: Preferred Equity/Derivative Unit Securities Offered: 12,000 Price\Range: $1000 Discount Per Security: $80 Transaction Features: Rights Offering
お知らせ • Mar 03AIM ImmunoTech Signs Agreement for Planning of A Proposed Phase 3 Clinical Trial of Ampligen in the Treatment of Late-Stage Pancreatic CancerAIM ImmunoTech Inc. announced an agreement with the PPD™? clinical research business of Thermo Fisher Scientific to design AIM's anticipated Phase 3 clinical trial in the use of the Company's drug Ampligen in the treatment of late-stage pancreatic cancer. AIM recently published an updated corporate presentation that emphasizes the Company's priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM's research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic Cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM's stockholders. AIM has thus far reported positive progress in Progression-Free Survival ("PFS"), Overall Survival ("OS") and safety in the DURIPANC study, which is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands.
お知らせ • Feb 24Aim Immunotech Announces Planned Milestones in the Ongoing Phase 2 Trial of Ampligen and Astrazeneca's Durvalumab in the Treatment of Metastatic Pancreatic CancerAIM ImmunoTech Inc. announced milestones in the expected timeline for the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care (the "DURIPANC" study). DURIPANC is an investigator-initiated, exploratory, open-label, single-center study, and 18 subjects have enrolled in the study so far. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands. Planned DURIPANC milestones: July 2026 - Complete subject enrollment. Reporting of Quality of life (EORTC QLQ-C30) based upon evaluations at baseline, 6 weeks, 3 months, 9 months and 1 year after the start of immunotherapy. AIM is committed to releasing mid-year and year-end interim progress reports on DURIPANC, with the most recent update released at the beginning of February. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study - which supported advancement to the ongoing Phase 2 portion of the study - continue to be seen and that enrollment is ongoing. According to Erasmus MC, there has also been no significant toxicity - an encouraging safety profile for a post-chemo setting - and Ampligen subjects are consistently reporting "high quality of life" during treatment. Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company's priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM's research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen will be efficacious in humans. No assurance can be given as to whether current or planned clinical trials will be successful or yield favorable data and the trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials are clinical trials, the Company is currently being conducted in the United States.
お知らせ • Feb 06Aim Immunotech Reports Positive Year-End Interim Clinical Progress from Phase 2 Study Evaluating Ampligen®? (Rintatolimod) in Combination with Astrazeneca's Imfinzi®? (Durvalumab) for the Treatment of Pancreatic CancerAIM ImmunoTech Inc. reported positive data in a year-end update from the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen®? (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi®? (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX standard of care. This is a follow-up Phase 2 to a 57-subject early access program ("EAP") of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life. The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life. Eighteen patients have been enrolled in the study. According to Erasmus MC, there has also been no significant toxicity - an encouraging safety profile for a post-chemo setting - and Ampligen subjects are consistently reporting "high quality of life" during treatment.
お知らせ • Nov 19AIM ImmunoTech Inc. announced that it has received $2.5 million in fundingAIM ImmunoTech Inc. entered into a note purchase agreement with returning lender Streeterville Capital, LLC, and announced that it has issued non-convertible unsecured promissory note with an original principal amount of $3,301,250 on November 18, 2024. The note carries an original issuance discount of $781,250 and the company agreed to pay $20,000 to the Investor to cover the Investor’s legal and administrative transaction costs, each of which were included in the original principal amount and deducted from the proceeds of the note received by the company which resulted in a purchase price received by the company of $2,500,000. The note bears interest at 10% per annum compounded daily. The maturity date of the note is 24 months from the date of its issuance. Beginning on the date that is six months after the Purchase Price Date, Investor shall have the right, exercisable at any time in its sole and absolute discretion, to redeem any amount of the Note up to $250,000 per calendar month by providing written notice to the Company provided, however, that if the Investor does not exercise any Monthly Redemption Amount in its corresponding month then such Monthly Redemption Amount shall be available for the Investor to redeem in any future month in addition to such future month’s Redemption Amount. Upon receipt of any Monthly Redemption Notice, the Company shall pay the applicable Monthly Redemption Amount in cash to the Investor within three business days of the Company’s receipt of such Monthly Redemption Notice.
お知らせ • Nov 18AIM ImmunoTech Inc. announced delayed 10-Q filingOn 11/17/2025, AIM ImmunoTech Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.
お知らせ • Nov 11Aim Immunotech Details New Upmc Abstract on Completed Clinical Trial Involving Ampligen's Synergistic Potential in the Treatment of Advanced Recurrent Ovarian CancerAIM ImmunoTech Inc. detailed a recent abstract containing data from the completed Phase 2 advanced recurrent ovarian cancer clinical study utilizing Ampligen (rintatolimod), which was presented at the 40th Annual SITC Meeting on November 7, 2025, at National Harbor, MD. Platinum-sensitive patients with measurable peritoneal disease were eligible for combination therapy with up to six treatment cycles at 3-week intervals of intraperitoneal cisplatin, intravenous pembrolizumab (also known as Merck's Keytruda) and intraperitoneal Ampligen. Of the 27 patients included in the trial, 24 were evaluable for response and of those 24 there were 5 patients with complete response and 7 patients with partial response, for an Objective Response Rate ("ORR") of 50%. In contrast, a previous study titled Keynote-100 found ORRs of 7.4% and 9.9% in two arms of a pembrolizumab-only study in advanced recurrent ovarian cancer. These new ovarian cancer study results are consistent with AIM's belief that Ampligen can act as a synergistic agent when combined with checkpoint inhibitors. This could be especially encouraging for refractory patients whose cancers do not respond to checkpoint inhibitors alone, such as in the Keynote-189 study in non-small cell lung cancer, which found that approximately 52% of study subjects did not respond in the pembrolizumab -combination group.
お知らせ • Oct 31AIM ImmunoTech Inc., Annual General Meeting, Dec 16, 2025AIM ImmunoTech Inc., Annual General Meeting, Dec 16, 2025.
お知らせ • Sep 26AIM ImmunoTech Secures Patent in Japan Through 2039 for Novel Cancer Therapy Combining Ampligen (Rintatolimod) with Checkpoint InhibitorsAIM ImmunoTech Inc. announced that the Japan Patent Office has issued a patent covering the Company's proprietary use of Ampligen (Rintatolimod) in combination with checkpoint inhibitors (anti-PD-1 or anti-PD-L1 antibodies) for the treatment of cancer. The allowed claims in Japan cover an agent for treating cancer consisting of Ampligen in combination with a checkpoint inhibitor. The claims are broad, encompassing multiple cancer types, including pancreatic cancer, skin cancer, colorectal cancer, ovarian cancer, melanoma, breast cancer/triple negative breast cancer, head and neck tumors, bladder cancer, renal cell carcinoma, and lung cancer. The claims also capture specific dosing regimens, administration routes, and synergistic therapeutic effects observed when Ampligen is combined with checkpoint inhibitors. AIM also holds a U.S. patent (expires August 9, 2039) for methods involving use of Ampligen as part of a combination oncology therapy when paired with an anti-PD-L1 antibody and a patent in the Netherlands (expires December 19, 2039) for the use of Ampligen as a combination cancer therapy with checkpoint blockade inhibitors, such as Keytruda (pembrolizumab), Opdivo (nivolumab) and Imfinzi (durvalumab). The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. AIM believes this novel approach could revolutionize the treatment landscape for cancers that have historically been challenging to treat, such as pancreatic cancer and advanced recurrent ovarian cancer. In fact, in collaboration with AstraZeneca, Ampligen is in a Phase 2 clinical trial combined with AstraZeneca's durvalumab (an anti-PD-L1) for the treatment of metastatic pancreatic cancer. AIM recently released a DURIPANC Mid-Year Interim Clinical Progress Update showing promising signs of superior Progression-Free Survival and Overall Survival, as well as no significant toxicity. Similarly, a Phase 2 study in collaboration with Merck Sharp & Dohme LLC in advanced recurrent ovarian cancer combing Ampligen with Keytruda has been completed and expect the final data report within the next two months.
お知らせ • Sep 23AIM ImmunoTech Announces Publication of Journal Article on the Positive Effect of Ampligen and Interferon-Alpha on Tumor GrowthAIM ImmunoTech Inc. announced that the Journal for ImmunoTherapy of Cancer (JITC) has published a new peer-reviewed article providing evidence of a positive combination effect of AIM's drug Ampligen and interferon- Alpha on tumor growth and subsequent subject survival. The paper concluded that the ability of systemic chemokine modulation to eliminate the PD-1-resistance of cold tumors indicates that intratumoral cytotoxic t-lymphocyte accumulation, rather than tumor immunogenicity, is the key factor limiting the therapeutic effectiveness of immune checkpoint inhibitors. These data suggest a broad therapeutic potential of tumor microenvironment reprogramming strategies.
お知らせ • Aug 07AIM ImmunoTech Inc.'s Oncology Drug Ampligen to Be Featured in Key Presentations and Abstract at the International 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and CareAIM ImmunoTech Inc. announced that the strong clinical successes in oncology of its drug Ampligen will be presented in four separate aspects at the upcoming 5th Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care in Warsaw, Poland. This will include a presentation by AIM regarding its ongoing lead clinical program in late-stage pancreatic cancer; a presentation by Pawel Kalinski, MD, PhD, a world-renowned research oncologist and senior investigator for multiple oncology clinical studies involving Ampligen, outlining his clinical research with Ampligen in multiple other solid tumor types; a presentation of Kathleen Kokolus, PhD, a senior scientist in Dr. Kalinski' laboratory, who will discuss cellular and molecular mechanisms of action of Ampligen; and finally a presentation and abstract on positive data strongly suggesting Ampligen's potential as a therapy in the treatment of endometriosis. An AIM representative will present data from AIM's pancreatic cancer Early Access Program and advances in the Phase 2 pancreatic cancer clinical trial currently underway at Erasmus Medical Center in the Netherlands. Among the expected highlights will be recent data from the DURIPANC study, an ongoing Phase 2 clinical study evaluating the combination therapy of Ampligen and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor durvalumab in the treatment of late-stage metastatic pancreatic cancer patients. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Preliminary data from DURIPANC suggests that Ampligen may prove to change that equation for the better. Last week, the Company released a DURIPANC Mid-Year Interim Clinical Progress Update showing that the therapy is, thus far, well-tolerated with positive preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. Compared to historical data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS: No significant toxicity, an encouraging safety profile for a post-chemo setting; ~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and OS >6 months in the majority (64%) of eligible patients-better than expected in this setting. Dr. Kokolus will discuss cellular and molecular mechanisms the Ampligen-based chemokine-modulatory regimen's activity in enhancing the effectiveness of PD1 blockade in "cold" tumors. All of the late-stage cancers being challenged by Ampligen therapy whose results will be discussed are lethal malignancies and constitute serious and unmet global health care issues. The endometriosis abstract and presentation will be based on an analysis of data from AIM's Phase 2 and Phase 3 clinical trials of Ampligen for the treatment of Chronic Fatigue Syndrome ("CFS"), which showed that a large percentage of female participants had significant comorbidity with endometriosis. Approximately 80% of subjects experienced improvement in symptoms in the analyzed data. The Company's lead product is a first-in-class investigational drug called Ampligen, a first-in-class Investigational drug called Ampligen in multiple other solid tumors.
お知らせ • Jul 31AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $8 million.AIM ImmunoTech Inc. has completed a Composite Units Offering in the amount of $8 million. Security Name: Units Security Type: Equity/Derivative Unit Securities Offered: 2,000,000 Price\Range: $4 Discount Per Security: $0.28
お知らせ • Jul 30AIM ImmunoTech Reports Positive Mid-Year Safety and Efficacy Data from Phase 2 Study Evaluating Ampligen®? (rintatolimod) in Combination with AstraZeneca's Imfinzi®? (durvalumab) for the Treatment of Pancreatic CancerAIM ImmunoTech Inc. reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM's drug Ampligen®? (rintatolimod) combined with AstraZeneca's anti-PD-L1 immune checkpoint inhibitor Imfinzi®? (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the "DURIPANC" study). The DURIPANC study -- which is a joint collaboration with AstraZeneca and Erasmus Medical Center ("Erasmus MC") in the Netherlands - is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. A total of 14 subjects have been enrolled in DURIPANC as of the mid-year report. The primary objective of the study is the clinical benefit rate of the combination therapy; the secondary/exploratory objectives include assessing overall survival (OS), progression-free survival (PFS) and initiating immune-monitoring using available tissue biopsies and peripheral immune profiling. Prof. Casper van Eijck, MD, PhD, of Erasmus MC, stated: "Our preliminary data suggests that the combination of Ampligen and durvalumab is well-tolerated in post-FOLFIRinoX pancreatic cancer patients, with encouraging preliminary survival data, especially given the historical difficulty of improving outcomes in this setting. In addition, it will be important to identify which patients are most likely to benefit from the combination treatment, thereby personalizing therapy better and maximizing clinical outcomes".ancreatic cancer has limited immunotherapy responsiveness, particularly in unselected populations. Following FOLFIRINOX, maintenance or second-line immunotherapies have historically shown limited survival benefit in comparison trials. Compared to these data, the DURIPANC study mid-year report shows continuing promising early signs of both no significant toxicity and superior PFS and OS: No significant toxicity, an encouraging safety profile for a post-chemo setting; ~21% of patients have PFS >6 months (3/14), with an additional 21% not yet progressed; and OS >6 months in the majority (64%) of eligible patients--better than expected in this setting. DURIPANC builds on that foundation and these results suggest a clear path forward and identify a promising potential benefit of combining the selective innate immune activation of Ampligen with the checkpoint inhibition of durvalumab in pancreatic cancer maintenance therapy. I am hopeful that pending immune-monitoring data analysis by Prof. van Eijck and the team at Erasmus Medical Center will identify additional mechanistic insights or predictive biomarkers in this potentially clinical trial, bringing hope for a future therapy for this highly lethal and clearly unmet medical need thatills more than 100,000 people in the American and European Union markets each year, and more than 500,000 worldwide. The DURIPANC study is the culmination of several years of focus by AIM on the development of Ampligen for the treatment of pancreatic cancer. Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses. Based on these strong results suggesting Ampligen's potential effectiveness as a pancreatic cancer monotherapy, in January 2023 the Company entered into Clinical Agreements with AstraZeneca and Erasmus MC for the investigator-initiated DURIPANC clinical trial to study the potential combination therapy of Ampligen and Durvalumab, a PD-L1 checkpoint inhibitor. The Company's lead product is expected to enroll up to 25 patients in the Phase 2 portion of the Phase 2 portion of the study. The DURIPANC, the Phase 2 portion of the DURIPANC study is expected to enroll up to25 subjects in the Phase 2 portion of 25 subjects in the Phase 2 part of the Phase 2 portion. AURIPANC study. A total of the Phase 2 portion of DURIPANC study is a total of the Phase 2 portion.
お知らせ • Jun 23AIM ImmunoTech Announces NYSE American Notice of Noncompliance With Minimum Stockholders’ Equity RequirementsAIM ImmunoTech Inc. announced the receipt of a warning notification (the “Letter”) from the NYSE American LLC (the “NYSE American”) stating that the Company is not in compliance with the minimum stockholders’ equity requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (the “Company Guide”) requiring stockholders’ equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years and $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years, respectively. As of March 31, 2025, the Company had a stockholders’ deficit of negative $3.9 million and has had losses in the most recent five fiscal years ended December 31, 2024. The NYSE American previously issued a warning on December 17, 2024 for the same reasons and has issued the Letter because the deficiency remains as of March 31, 2025, when the Company filed its quarterly report on Form 10-Q for the first quarter of fiscal 2025. On February 26, 2025, the NYSE American accepted a plan submitted by the Company to regain compliance by June 11, 2026. Accordingly, the Company still has until June 11, 2026 to regain compliance. The Company’s common stock recommenced trading on the NYSE American on June 17, 2025 under the symbol “AIM”. The Letter in no way has any effect on such trading and does not affect the Company’s business, operations or reporting requirements with the U.S. Securities and Exchange Commission.
お知らせ • Jun 13AIM Immunotech Regains Compliance with Section 1003(f)(v) of the NYSE AmericanOn June 11, 2025, AIM ImmunoTech Inc. (the “Company”) was notified by The NYSE American (the “Exchange”) that the Company has regained compliance with Section 1003(f)(v) of the NYSE American Company Guide (low selling price) and that trading in the Company’s Common Stock is expected to be reinstated on the Exchange on June 17, 2025 and the ticker symbol will be “AIM” upon reinstatement. The Company’s Common Stock currently trades on the OTC Pink under the symbol “AIMID”. The new CUSIP is 00901B303.
New Risk • Jun 05New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 34% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (46% average weekly change). Negative equity (-US$3.9m). Earnings are forecast to decline by an average of 20% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (34% increase in shares outstanding). Revenue is less than US$1m (US$146k revenue). Market cap is less than US$10m (US$5.96m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$23m net loss next year).
Reported Earnings • May 17First quarter 2025 earnings released: US$0.053 loss per share (vs US$0.12 loss in 1Q 2024)First quarter 2025 results: US$0.053 loss per share (improved from US$0.12 loss in 1Q 2024). Net loss: US$3.71m (loss narrowed 36% from 1Q 2024). Revenue is forecast to grow 16% p.a. on average during the next 2 years, compared to a 9.4% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has remained flat but the company’s share price has fallen by 55% per year, which means it is significantly lagging earnings.
お知らせ • May 08AIM ImmunoTech Inc. Announces the Presentation of Ampligen Oncology Data at the Recent Annual Meeting of the American Association of ImmunologistsAIM ImmunoTech Inc. announced the presentation of clinical trial data involving AIM's drug Ampligen by Pawel Kalinski, MD, PhD, at the recent Annual Meeting of the American Association of Immunologists held May 3-7, 2025, in Honolulu, HI.
お知らせ • Apr 10AIM ImmunoTech Inc.(OTCPK:AIMI) dropped from S&P TMI IndexAIM ImmunoTech Inc.(OTCPK:AIMI) dropped from S&P TMI Index
New Risk • Apr 07New major risk - Revenue and earnings growthEarnings have declined by 17% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (27% average weekly change). Negative equity (-US$1.3m). Earnings have declined by 17% per year over the past 5 years. Shareholders have been substantially diluted in the past year (45% increase in shares outstanding). Revenue is less than US$1m (US$170k revenue). Market cap is less than US$10m (US$3.01m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$23m net loss next year).
お知らせ • Apr 05AIM ImmunoTech Announces NYSE American Notice of Delisting and AppealAIM ImmunoTech Inc. reported that on April 4, 2025, it received notification from NYSE Regulation of the NYSE American LLC that it had suspended trading of the Company’s common stock and of its determination to commence delisting proceedings of the Company’s common stock from the Exchange pursuant to Section 1003(f)(v) of the NYSE American Company Guide due to the low selling price of the Company’s common stock. The Company plans to appeal the determination to the Exchange’s Listing Qualifications Panel, although there can be no assurance that any such appeal will be successful. The Company’s common stock is expected to begin trading on the Pink Open Market on April 7, 2025.
お知らせ • Apr 02AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $0.663329 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $0.663329 million. Security Name: Common Stock Security Type: Common Stock Transaction Features: At the Market Offering
Reported Earnings • Mar 28Full year 2024 earnings released: US$0.31 loss per share (vs US$0.60 loss in FY 2023)Full year 2024 results: US$0.31 loss per share (improved from US$0.60 loss in FY 2023). Net loss: US$17.3m (loss narrowed 40% from FY 2023). Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 11% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 7% per year but the company’s share price has fallen by 51% per year, which means it is performing significantly worse than earnings.
お知らせ • Feb 27AIM ImmunoTech Announces NYSE American Acceptance of Plan to Regain Listing ComplianceAIM ImmunoTech Inc. (“AIM” or the “Company”) announced that it received notice from the NYSE American (the “American”) that the American has accepted the Company’s Plan to regain compliance with the minimum stockholders’ equity requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the American Company Guide. AIM has until June 11, 2026 to regain compliance with the NYSE’s Continued Listings Standards. AIM CEO Thomas K. Equels stated: “We are pleased that the NYSE American has approved our plan and look forward to executing the strategy over the coming months as we also continue to make advancements in our oncology and antiviral pipelines".
お知らせ • Feb 26AIM ImmunoTech Appoints David Chemerow to Board of Directors as an Independent DirectorAIM ImmunoTech Inc. announced that the Company’s Board of Directors has, by unanimous vote, appointed David Chemerow as an Independent Director to the Board, effective immediately. Mr. Chemerow brings more than 40 years of finance, accounting and operations leadership experience across multiple industries. He previously served as the Chief Financial Officer and Treasurer, and prior to that as Chief Revenue Officer, of Comscore Inc., an American-based global media measurement and analytics company. Prior to his tenure at Comscore, Mr. Chemerow served as the Chief Operating Officer and Chief Financial Officer of Rentrak Corporation through its merger with Comscore Inc. in January 2016. Prior to 2009, Mr. Chemerow held senior executive roles leveraging his financial, business and operational expertise across multiple companies. Mr. Chemerow currently serves on the Board of Directors for Dunham’s Athleisure Corporation, a sporting goods retailer, and on the Advisory Board of Huntington Outdoor, LLC, an outdoor advertising company. Additionally, Mr. Chemerow serves on the Board of non-profit theater, The Martha’s Vineyard Playhouse, and is President of the Board of the Pilot Hill Farm Association. Previously, Mr. Chemerow served as a member of the Board of Directors of RiceBran Technologies Inc., a Nasdaq and OTC company, and served 15 years as a Board member of Playboy Enterprises. Mr. Chemerow is a graduate of Dartmouth College and holds a Master of Business Administration degree from The Amos Tuck School at Dartmouth College.
お知らせ • Feb 25AIM Doses First New Subject in Phase 2 Study of Ampligen and Imfinzi as a Potential Combination Therapy for Late-Stage Pancreatic CancerAIM ImmunoTech Inc. announced that the first new subject has been dosed in Phase 2 of the Phase 1b/2 clinical trial involving AIM’s Ampligen (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”). Several subjects from Phase 1 who received the highest dose will also be included in Phase 2. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at the Erasmus Medical Center. Up to 25 patients are expected to be enrolled in the Phase 2 portion of DURIPANC.
お知らせ • Feb 07AIM ImmunoTech Inc. Announces Planned Follow-Up Clinical Study Evaluating A Combination Treatment of AIM's Ampligen and AstraZeneca's FluMist to Address the Recent Avian Influenza OutbreaksAIM ImmunoTech Inc. announced its initiation of a plan to advance Ampligen as a vaccine adjuvant for avian influenza as part of the Company's antiviral priority development pipeline. AIM has engaged Amarex Clinical Research ("Amarex"), its Clinical Research Organization ("CRO"), with the application and eventual management of a follow-up Investigational New Drug ("IND") application for the study of a potential avian influenza combination therapy of AIM's Ampligen and AstraZeneca's FluMist, a nasal spray vaccine that helps prevent seasonal influenza. AIM is seeking collaborative grants from government and industry to defray the cost of the study. The new proposed clinical trial would expand upon previous Company-sponsored clinical research at the University of Alabama-Birmingham ("UAB") (Overton 2014), which indicated that intranasal delivery of Ampligen after the intranasal delivery of the FluMist seasonal influenza vaccine not only increased the immune response to seasonal variants in the vaccine by greater than four-fold, but most importantly induced cross-reactive secretory Immunoglobulin A against highly pathogenic avian influenza virus strains H5N1, H7N9 and H7N3. This Company's belief stems directly from the pre-clinical and clinical work performed with Ampligen and multiple influenza variants, some of which supported the conception of the original UAB study. Previous pre-clinical work showed that when Ampligen was administered with the then-standard seasonal triple flu vaccine -- which included influenza A H1N1, influenza A H3N2 and influenza B Shanghai strain -- intranasally to laboratory mice, it manifested cross-reactivity of mucosal and serum antibodies against H5N1. An AIM-sponsored study to assess the safety, tolerability and biological activity of intranasal Ampligen in humans found that repeated administration in four cohorts of 10 subjects each was generally well-tolerated with no serious treatment-related adverse events. AIM believes that the totality of this pre-clinical and clinical work to date -- combined with the ever-growing threat of Avian influenza -- strongly supports its decision to move forward with this second Ampligen and FluMist study in humans.
New Risk • Feb 06New major risk - Market cap sizeThe company's market capitalization is less than US$10m. Market cap: US$9.09m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Revenue is less than US$1m (US$190k revenue). Market cap is less than US$10m (US$9.09m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years).
お知らせ • Jan 23AIM ImmunoTech Announces Publication of Final Clinical Study Results for AMP-518 Clinical Trial on Ampligen as a Therapeutic for Post-COVID ConditionsAIM ImmunoTech Inc. announced that the final Clinical Study Results for the “Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions” (“AMP-518”) was posted January 22, 2025 to ClinicalTrials.gov (See: NCT05592418). AIM had previously reported positive topline results from its AMP-518 Phase 2 clinical trial. In further analyzing the results of AMP-518, AIM determined that, in this study, Ampligen-treated patients with Long COVID were, on average, able to walk farther in a Six-Minute Walk Test (“6MWT”) when compared to subjects who received a placebo. The 6MWT measured the distance a subject was able to walk in six minutes as a baseline and then again at 13 weeks. A clear signal of significant potential (p <0.02, two-tailed T-test) was observed in Ampligen-treated subjects with a baseline 6MWT less than 205 meters, who saw a mean improvement of 139 meters, compared to a mean improvement of 91 meters in the corresponding part of the group who received the placebo. AIM therefore believes that any future trial design should focus on Ampligen’s therapeutic potential for subjects whose COVID-related fatigue or ME/CFS symptoms can be categorized as moderate or worse.
New Risk • Jan 16New major risk - Shareholder dilutionThe company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 31% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (31% increase in shares outstanding). Revenue is less than US$1m (US$190k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Market cap is less than US$100m (US$12.1m market cap).
Board Change • Dec 26Less than half of directors are independentThere are 6 new directors who have joined the board in the last 3 years. Of these new board members, 2 were independent directors. The company's board is composed of: 6 new directors. 3 experienced directors. 2 highly experienced directors. 3 independent directors (4 non-independent directors). Independent Chairman of the Board & Member of Scientific Advisory Board William Mitchell is the most experienced director on the board, commencing their role in 1998. Independent Director Rob Chioini was the last independent director to join the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors.
お知らせ • Dec 18+ 1 more updateAIM ImmunoTech Receives Non-Compliance Letter from NYSE AmericanOn December 11, 2024, AIM ImmunoTech Inc. (the Company") received a warning notification (the Letter") from the NYSE American LLC (the NYSE American") stating that the Company is not in compliance with the minimum stockholders' equity requirements of Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide (the Company Guide") requiring stockholders' equity of $4.0 million or more if the Company has reported losses from continuing operations and/or net losses in three of the four most recent fiscal years and $6.0 million or more if the Company has reported losses from continuing operations and/or net losses in its five most recent fiscal years, respectively. As of September 30, 2024, the Company had a stockholders' deficit of $2.9 million and has had losses in the most recent five fiscal years ended December 31, 2023. The Company is now subject to the procedures and requirements of Section 1009 of the Company Guide. The Company has until January 10, 2025, to submit a plan (the Plan") of actions it has taken or will take to regain compliance with the continued listing standards by June 11, 2026. The Company intends to submit a plan to regain compliance with NYSE American listing standards. If the NYSE American accepts the Plan, the Company will be able to continue its listing during the Plan period and will be subject to periodic reviews including quarterly monitoring for compliance with the Plan until it has regained compliance. If the Plan is not accepted by the NYSE American, the Letter stated that delisting proceedings will commence. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide. The Letter has no immediate effect on the listing or trading of the Company's common stock on the NYSE American. The Company's receipt of the Letter from the NYSE American does not affect the Company's business, operations or reporting requirements with the U.S. Securities and Exchange Commission.
お知らせ • Dec 17Ted Kellner Provides Information to the ShareholdersOn December 14, 2024, Ted Kellner, as the nominating stockholder and a nominee, together with his other nominees, Todd Deutsch, Robert L. Chioini and Paul W. Sweeney (collectively, the Kellner Group), issued an urgent statement in response to baseless, deceptive rumors and in connection with Kellner Group efforts to bring accountability to the entrenched, incumbent Board of Directors of AIM Immunotech Inc. Kellner Group denounced the false rumors about the Company short selling and demands immediate accountability from incumbent board. In addition, Kellner Group urged the vote ‘FOR’ all 4 Kellner Group nominees on gold card for urgently needed change.
お知らせ • Dec 11Ted D. Kellner Files Definitive Proxy Statement with Securities and Exchange CommissionOn December 10, 2024, Ted D. Kellner, Todd Deutsch, Robert L. Chioini and Paul W. Sweeney have filed a definitive proxy statement with the Securities and Exchange Commission to be used to solicit votes for their election to the Board of Directors of AIM Immunotech Inc, and pleased to announce that Dr. William A. Carter, the founder and former CEO of the Company and inventor of Ampligen, has agreed to become Chairman of AIM’s Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting. In addition, Kellner Group urged the shareholders of the Company to vote for its board nominees Ted D. Kellner, Todd Deutsch, Robert L. Chioini and Paul Sweeney, at the annual meeting of shareholders scheduled to be held on December 17, 2024.
お知らせ • Dec 10AIM Immunotech Inc. Appoints William A. Carter as Chairman of Scientific Advisory BoardThe Kellner Group announced that Dr. William A. Carter, MD, F.A.C.P., the founder and former CEO of AIM and inventor of Ampligen, has agreed to become Chairman of AIM Immunotech Inc.’s Scientific Advisory Board in the event that the Kellner Group Nominees control the Board of Directors of AIM following the upcoming annual meeting. After meeting with Dr. Carter recently, Mr. Ted Kellner remains convinced that Ampligen has great potential but only with a new AIM Board of Directors, and he asked Dr. Carter if he would be willing to serve on the intended Scientific Advisory Board, to which Dr. Carter agreed. Dr. Carter is the co-inventor of Ampligen, joined AIM (f/k/a Hemispherx) in 1978, and served as: Chief Scientific Officer from 1989-2016; the Chairman of the Board of Directors from 1992-2016; Chief Executive Officer from 1993-2016; President from 1995 to 2006; and a Director from 1987-2016. Dr. Carter was a leading innovator in the development of human interferon for a variety of treatment indications including various viral diseases and cancer. Dr. Carter received the first FDA approval to initiate clinical trials on a beta interferon product manufactured in the U.S. under his supervision. He received his M.D. degree from Duke University (with high honors) and underwent his post-doctoral training at the National Institutes of Health and Johns Hopkins University. Dr. Carter also served as Professor of Neoplastic Diseases at Hahnemann Medical University, a position he held from 1980 to 1998. Dr. Carter served as Professor and Director of Clinical Research for Hahnemann Medical University's Institute for Cancer and Blood Diseases, and as a member of the faculty at Johns Hopkins School of Medicine and the State University of New York at Buffalo. Dr. Carter is a Board-certified physician and author of more than 200 scientific articles, including the editing of various textbooks on anti-viral and immune therapy.
お知らせ • Dec 03Kellner Group Issues Press Release to Urge AIM Immunotech Stockholders to Vote the Gold CardOn December 2, 2024, Ted Kellner, as the nominating stockholder and a nominee, together with his other nominees, Todd Deutsch, Robert L. Chioini and Paul W. Sweeney issued a press release in connection with their efforts to bring accountability to the entrenched, incumbent Board of Directors of AIM Immunotech Inc. The Kellner Group, which owns 5.04% of AIM's outstanding shares, emphasizes its alignment with stockholders and its commitment to providing the financial resources AIM requires. The Kellner Group criticizes the current AIM Board for their inadequate cash conservation plan, describing it as a "too little, too late" effort that underscores the company's financial situation. They highlight the decline in AIM's stock price, which has dropped over 99%, attributing this to the mismanagement by the incumbent Board and accused the Board of franticly doubling down on their attempts to deceive stockholders. In light of these issues, the Kellner Group urged the stockholders to vote for change by supporting their nominees and using the Gold Card in the upcoming vote.
New Risk • Nov 23New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 0.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$21m free cash flow). Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Revenue is less than US$1m (US$190k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$37m net loss in 3 years). Shareholders have been diluted in the past year (30% increase in shares outstanding). Market cap is less than US$100m (US$13.4m market cap).
Reported Earnings • Nov 17Third quarter 2024 earnings released: US$0.064 loss per share (vs US$0.16 loss in 3Q 2023)Third quarter 2024 results: US$0.064 loss per share (improved from US$0.16 loss in 3Q 2023). Net loss: US$3.70m (loss narrowed 53% from 3Q 2023). Revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 45% per year, which means it is performing significantly worse than earnings.
お知らせ • Nov 15Kellner Group Urges Immediate Change at AIM Immunotech IncOn November 14, 2024, Ted Kellner, along with nominees Todd Deutsch, Robert L. Chioini, and Paul W. Sweeney, issued a statement advocating for immediate change in the AIM Immunotech Inc. Board of Directors. Kellner emphasized the need for stockholders to vote for the Kellner Group Nominees using the Gold Card, highlighting the Delaware Supreme Court ruling that found the incumbent Board had breached its fiduciary duties and wasted millions of dollars for improper purposes. The statement argued that the current Board's self-interested actions are damaging the company and urged stockholders to act before irreversible harm is done. The Kellner Group asserted that their nominees possess the skills, experience, and credibility necessary to bring accountability and create value for AIM, countering the misleading statements by the incumbent Board.
お知らせ • Nov 06AIM ImmunoTech Inc., Annual General Meeting, Dec 17, 2024AIM ImmunoTech Inc., Annual General Meeting, Dec 17, 2024.
お知らせ • Oct 02AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.25632 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $1.25632 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 4,653,036 Price\Range: $0.27 Discount Per Security: $0.0216 Transaction Features: Registered Direct Offering
お知らせ • Sep 19AIM ImmunoTech Reports Positive Preliminary Data in Phase 1b/2 Study of Ampligen and Imfinzi as a Combination Therapy for Late-Stage Pancreatic CancerAIM ImmunoTech Inc. announced positive preliminary data from the Phase 1b/2 study evaluating the combination of AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study. AIM previously announced that investigators at Erasmus Medical Center (“Erasmus MC”) in the Netherlands had completed the safety evaluation of subjects enrolled in the first dose level of the dose escalation design, finding the combination therapy to be generally well-tolerated with no severe adverse events or dose-limiting toxicities. That first cohort has now reached the pre-determined 6-month stability assessment timepoint and AIM announced that two of the three subjects remain stable. The subjects will continue to be treated and receive formal assessment of progression every three months. The standard for calculating median progression-free survival (“PFS”) requires that 50% or more of the subjects have seen disease progression. Because 67% of the patients in the cohort evaluated at 6 months have remained stable, AIM cannot yet report on PFS. Two of the three subjects in the higher-dose second cohort of subjects also have stable disease, although they have not yet reached the 6-month stability assessment timepoint. Investigators continue to treat and monitor these subjects.
お知らせ • Sep 04Ted D. Kellner Sends a Notice to AIM ImmunoTechOn September 4, 2024, Ted D. Kellner announced that in accordance with the requirements of the Company’s bylaws, on September 3, 2024, Kellner submitted to AIM ImmunoTech Inc notice of his intent to nominate himself, Deutsch and Chioini for election to the Company’s board of directors at the 2024 annual meeting of stockholders. Kellner also notified the Company that he would supplement the Notice no later than September 13, 2024, to identify an additional highly qualified and independent nominee. The Notice, together with this Schedule 13D, the proxy statement filed by the Reporting Persons and Chioini last year and the extensive factual record gained through discovery and trial in the Delaware Court of Chancery last year, provides the board with all information it could possibly desire in connection with Kellner’s nominations. The Company’s stockholders expressed their clear will in connection with last year’s annual meeting, delivering proxies sufficient to elect the Reporting Persons (despite the fact that the Company did not even include Kellner, Deutsch and Chioini on its proxy card).Against this backdrop, any rejection of the Notice by the board this year would be a clear and obvious bad faith act and continuation of its improper purpose and breach of duty of loyalty. In addition, on August 27, 2024, Kellner made a demand to inspect certain books and records of the Company pursuant to Section 220 of the Delaware General Corporation Law. The demand seeks materials related to the advancement or indemnification of fees and expenses, any repayment of any advanced or indemnified fees and expenses and related D&O insurance information related to the Delaware litigation in which certain directors were found by the Delaware Supreme Court to have breached their fiduciary duty of loyalty. Customary stockholder records required for a proxy solicitation were also included in the demand. In a separate letter, Kellner requested that the Company reimburse him for expenses incurred in conferring the corporate benefit that resulted when the Company amended its bylaws to remove provisions found invalid or unenforceable by the Delaware Supreme Court.
お知らせ • Aug 20AIM ImmunoTech Announces Print Publication and Further Positive Findings from a Study Evaluating Ampligen® in the Treatment of Pancreatic Cancer in the Journal Clinical Cancer ResearchAIM ImmunoTech Inc. announced the official print publication of the data analysis from a long-term Early Access Program (“EAP”) studying the company’s drug Ampligen® (rintatolimod) for the treatment of advanced pancreatic ductal adenocarcinoma (“PDAC”). The manuscript titled “Rintatolimod in Advanced Pancreatic Cancer enhances Anti-Tumor Immunity through Dendritic Cell-Mediated T Cell Responses,” appears in the journal Clinical Cancer Research, one of oncology’s most prestigious journals. Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and tumors. Researchers at the Erasmus University Medical Center (“Erasmus MC”) found that Ampligen treatment in pancreatic cancer patients enhances peripheral immune activity at the transcriptomic and proteomic levels, particularly involving type 1 conventional dendritic cells (cDC1s) and T cells. Post-Ampligen, the increased peripheral abundance of BTLA+XCR1+ cDC1s and CD4+SELL+ T cells correlated with improved clinical outcomes. Patients with stable disease exhibited pronounced overexpression of genes related to DC and T cell activation. Notably, the expression of immune checkpoints PD-L1 and PD-L2 decreased post-Ampligen across all patients. In addition to the published manuscript, further commentary discussing the potential of Ampligen and two other drugs, referencing findings from the journal article, were published. Key highlights from the additional commentary include: Ampligen has been found to be also safely used through a systemic route. Interesting increases in cDC1 numbers and cytokines governing T-cell activation and migration are found to be upregulated. Researchers detected an important enrichment of B-cell numbers in peripheral blood from patients treated with Ampligen. B-cells correlated with long-term (>1 year) survival in a previous study. AIM is currently evaluating Ampligen as a therapy for metastatic pancreatic ductal adenocarcinoma in the Phase 1b/2 DURIPANC clinical study (NCT05927142) and as a therapy for locally advanced pancreatic adenocarcinoma in the Phase 2 AMP-270 clinical study (NCT05494697).
Reported Earnings • Aug 16Second quarter 2024 earnings released: US$0.035 loss per share (vs US$0.10 loss in 2Q 2023)Second quarter 2024 results: US$0.035 loss per share (improved from US$0.10 loss in 2Q 2023). Net loss: US$1.84m (loss narrowed 63% from 2Q 2023). Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 48% per year, which means it is performing significantly worse than earnings.
お知らせ • Aug 15Todd Deutsch Sends Notice of Intent to Nominate Candidates to AIM ImmunoTech BoardOn August 14, 2024, Todd Deutsch and Ted D. Kellner announced that they have submitted to the Company notice of their intent to nominate Ted D. Kellner, Todd Deutsch and Robert L Chioini for election to the Company’s board of directors at the 2024 annual meeting of stockholders. In addition, Ted D. Kellner stated that he also continues to review legal options that may be available to them as a result of the board’s improper purpose and breach of the duty of loyalty.
お知らせ • Jul 24AIM ImmunoTech Inc. Announces New Positive Data on Ampligen’s Anti-Tumor Potential When Used as Part of A Combination TherapyAIM ImmunoTech Inc. announced the publication of new pre-clinical data concerning the company’s drug Ampligen as part of a combinational therapy in the treatment of melanoma, showing that combination dendritic cell-based vaccines including anti-PD-L1 checkpoint inhibitors and Ampligen-containing chemokine modulation helped slow tumor cell growth and improved survival in a mouse model.
お知らせ • Jun 01AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.047668 million.AIM ImmunoTech Inc. has filed a Follow-on Equity Offering in the amount of $2.047668 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 5,640,958 Price\Range: $0.363 Transaction Features: Registered Direct Offering
New Risk • May 17New major risk - Financial positionThe company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$23m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$23m free cash flow). Shares are highly illiquid. Revenue is less than US$1m (US$193k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$23m net loss in 3 years). Shareholders have been diluted in the past year (5.1% increase in shares outstanding). Market cap is less than US$100m (US$19.8m market cap).
Reported Earnings • May 17First quarter 2024 earnings released: US$0.12 loss per share (vs US$0.076 loss in 1Q 2023)First quarter 2024 results: US$0.12 loss per share (further deteriorated from US$0.076 loss in 1Q 2023). Net loss: US$5.82m (loss widened 59% from 1Q 2023). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 19% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 42% per year, which means it is performing significantly worse than earnings.
お知らせ • Apr 10AIM Immunotech Announces Positive Top-Line, Protocol-Planned Interim Report Data from the Study of Ampligen Combined with Pembrolizumab for the Treatment of Recurrent Ovarian CancerAIM ImmunoTech Inc. announced top-line interim data indicating that combining Ampligen (rintatolimod) with Keytruda (pembrolizumab) in the treatment of recurrent ovarian cancer may have a powerful synergistic effect, leading the investigator to conclude that the combination therapy could be far more effective than pembrolizumab alone as a therapy for the disease. See further details on the study “Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer” at ClinicalTrials.gov: NCT03734692. Additionally, the immunological signature supporting this synergistic enhancement has been seen in other clinical trials, including with pancreatic cancer metastatic triple-negative breast cancer and colorectal cancer metastatic to the liver. Ampligen is a dsRNA product candidate that acts via the TLR-3 receptor present on several immune cells, epithelial cells and most solid tumors. In the ongoing, investigator-initiated Phase 2, single-arm efficacy/safety trial, University of Pittsburgh Medical Center researchers saw an Objective Response Rate of 45% when combining Ampligen, pembrolizumab and cisplatin in platinum-sensitive subjects with recurrent ovarian cancer. ORR includes complete response and partial response to treatment. There was a total Clinical Benefit Rate of 55% when including patients who experienced stable disease. Researchers also reported a median Progression-Free Survival of 7.8 months.
New Risk • Apr 08New minor risk - Shareholder dilutionThe company's shareholders have been diluted in the past year. Increase in shares outstanding: 3.1% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Revenue is less than US$1m (US$202k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$17m net loss in 3 years). Shareholders have been diluted in the past year (3.1% increase in shares outstanding). Market cap is less than US$100m (US$24.6m market cap).
Reported Earnings • Apr 03Full year 2023 earnings released: US$0.60 loss per share (vs US$0.41 loss in FY 2022)Full year 2023 results: US$0.60 loss per share (further deteriorated from US$0.41 loss in FY 2022). Net loss: US$29.0m (loss widened 49% from FY 2022). Revenue is forecast to grow 61% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the United Kingdom. Over the last 3 years on average, earnings per share has fallen by 6% per year but the company’s share price has fallen by 40% per year, which means it is performing significantly worse than earnings.
お知らせ • Mar 27AIM ImmunoTech Inc. to Report Q4, 2023 Results on Apr 02, 2024AIM ImmunoTech Inc. announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Apr 02, 2024
お知らせ • Feb 21AIM ImmunoTech Inc. announced that it has received $3.30125 million in fundingOn February 20, 2024, AIM ImmunoTech Inc. closed the transaction. The transaction included participation from a single investor. The company has paid sales commissions of $1,300,000? in the transaction.
お知らせ • Feb 08Aim Immunotech Reports Positive Topline Results from Phase 2 Study Evaluating Ampligen for the Treatment of Post-COVID ConditionsAIM ImmunoTech Inc. announced positive topline results from the Company's Phase 2 study evaluating the efficacy and safety of Ampligen®? as a potential therapeutic for people with the Post-COVID condition of fatigue ("AMP-518"). The AMP-518 clinical trial was a two-arm, randomized, double-blind, placebo-controlled, multicenter study. The primary outcome measure is change from baseline to week 13 in PROMIS®? Fatigue Score. Although the reduction in that measure did not show a significant difference at the 13-week time point, initial analysis revealed that subjects in the Ampligen group had experienced lower levels of fatigue at multiple time points during the treatment phase when compared to the placebo group. An analysis of secondary and ad hoc endpoints found that the difference in change from baseline in PROMIS®? fatigue Score between the Ampligen and placebo groups reached or approached statistical significance at several timepoints during the treatment phase. Demographics and baseline characteristics were generally comparable between the Ampligen and placebo group. Additionally, the analysis of safety parameters demonstrated that Ampligen was generally well-tolerated with no severe adverse events, no treatment-emergent adverse events (TEAEs) leading to death, and no severe TEAEs reported during the study. There were six subjects (15.0%) in the Ampligen group with TEAEs considered related to the study treatment, the majority of which were mild in severity. More subjects in the Ampligen group compared to the placebo group reported TEAE (10 subjects, 25.0% vs. four subjects, 10.0%), however the majority of these were mild.
お知らせ • Nov 29AIM ImmunoTech Inc., Annual General Meeting, Dec 29, 2023AIM ImmunoTech Inc., Annual General Meeting, Dec 29, 2023.
お知らせ • Nov 22AIM ImmunoTech Inc. Completes Treatment of Last Subject in Phase 2 Study Evaluating Ampligen for the Treatment of Post-COVID ConditionsAIM ImmunoTech Inc. announced the last subject has completed treatment in the company's Phase 2 study evaluating Ampligen®? as a potential therapeutic for people with the Post-COVID condition of fatigue (AMP-518). As previously announced, the Company completed enrollment in the AMP-518 study in August 2023. Approximately 80 subjects, ages 18 to 60 years, were enrolled and randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. To date, no severe adverse events have been reported. The company remains on track to report topline data as early as first quarter 2024. The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in subjects experiencing the post-COVID condition of fatigue. The primary protocol planned outcome measure of the study is change from baseline to week 13 in PROMIS® Fatigue Score. Other protocol planned study outcomes include: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to weeks 6 and 13 in distance traveled during a Six-Minute Walk Test; proportion of subjects that surpass 54 meters in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to weeks 6 and 13 in PROMIS® Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS® Sleep Disturbance Score.
Reported Earnings • Nov 17Third quarter 2023 earnings released: US$0.16 loss per share (vs US$0.13 loss in 3Q 2022)Third quarter 2023 results: US$0.16 loss per share (further deteriorated from US$0.13 loss in 3Q 2022). Net loss: US$7.82m (loss widened 22% from 3Q 2022). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the United Kingdom.
お知らせ • Nov 15AIM ImmunoTech Announces Publication of Data from Roswell Park Comprehensive Cancer Center Phase 1 Study Evaluating AmpligenAIM ImmunoTech Inc. announced the publication of results from the Phase 1 study at Roswell Park Comprehensive Cancer Center in patients with metastatic triple-negative breast cancer using chemokine modulation therapy, including AIM ImmunoTech Inc.'s drug candidate Ampligen (also known as rintatolimod), interferon a-2b and celecoxib, followed by pembrolizumab. The data were published in a manuscript titled, "Systemic Infusion of TLR3-Ligand and IFNa in Breast Cancer Patients Reprograms Local Tumor Microenvironment for Selective CTL Influx," in The Journal for ImmunoTherapy of Cancer. The pilot study evaluated the safety of systemic CKM composed of intravenous rintatolimod (Ampligen; selective TLR3 ligand), interferon a- 2b and celecoxib, and the combination's ability to promote local CTL influx to mTNBC lesions. Principal investigator and first author Shipra Gandhi, MD, of the Department of Medicine at Roswell Park, led the study under the scientific leadership of Pawel Kalinski, MD, PhD, senior author of the paper, Chair of Immunology and Senior Vice President for Team Science at Roswell Park.
お知らせ • Nov 09AIM ImmunoTech Inc. Announces Encouraging Translational Data from Phase 2 Study Evaluating Ampligen for the Treatment of Advanced Recurrent Ovarian CancerAIM ImmunoTech Inc. announced encouraging translational data from an ongoing Phase 2 clinical trial utilizing AIM’s drug Ampligen in patients with platinum-sensitive advanced recurrent ovarian cancer. The abstract with data illustrations, titled Combination intraperitoneal chemoimmunotherapy triggers a T-cell chemotactic locoregional response in patients with recurrent platinum-sensitive ovarian cancer, was presented by collaborators from the Magee-Womens Research Institute at the University of Pittsburgh School of Medicine (UPMC) — one of the world’s top centers for the treatment of gynecological cancers — at the recent Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, in San Diego, Calif. Data highlighted in the abstract were collected by UPMC through translational studies focused on the immune tumor microenvironment (TME), using a longitudinal collection of biospecimens, including plasma, PBMC, IP washes and tumor tissue collected from patients treated in a Phase 2, efficacy/safety trial (NCT03734692) combining intraperitoneal (IP) chemotherapy (cisplatin) with dual agent immunotherapy using intravenous (IV) pembrolizumab (anti-PD1, Keytruda®, provided by Merck) and IP rintatolimod (Ampligen, a dsRNA acting as toll-like receptor 3 -TLR-3- agonist, provided by AIM). Sequential sampling of the IP cavity showed an increase in cellularity immediately after treatment consistent with an “acute” pro-inflammatory reaction. Mesoscale Delivery (MSD) measurements in IP washes revealed an acute increase in granzyme B, perforin, TNF alpha, CXCL9, CXCL10, and CXCL11 after treatment (p<0.05). Longitudinal data revealed a progressive increase in some biomarkers (p<0.05). RNA sequencing data showed a significant upregulation acutely in STAT1 and downstream targets, CXCL9, 10, 11 and TH1 type response genes (p<0.05).
お知らせ • Nov 08AIM ImmunoTech Inc., Annual General Meeting, Dec 01, 2023AIM ImmunoTech Inc., Annual General Meeting, Dec 01, 2023.
お知らせ • Aug 29Kellner Group to Proceed with AIM Director Nominations and Proxy SolicitationOn August 28, 2023, Ted D. Kellner announced that as previously disclosed, in accordance with the requirements of the Company’s bylaws, on August 4, 2023, Kellner delivered notice to the Company of his intent to nominate himself, Chioini and Deutsch for election to the Company’s board of directors at the 2023 annual meeting of stockholders. On August 23, 2023, the Company notified Kellner of the rejection of the Notice. On August 25, 2023, Kellner filed a complaint in the Delaware Court of Chancery seeking declarations that the bylaw amendments are unlawful, that the application of the bylaw amendments by the Board to reject the Notice is unlawful and/or inequitable and that the applicable directors breached their fiduciary duties in adopting the bylaw amendments and rejecting the Notice. Kellner also filed a motion for expedited proceedings and will seek a trial on the merits prior to the 2023 Annual Meeting of Stockholders. In addition, the Kellner Group stated that it intends to file a proxy statement with the Securities and Exchange Commission to be used to solicit votes for the election of its slate of qualified director nominees at the upcoming annual meeting of stockholders of the Company.
Reported Earnings • Aug 16Second quarter 2023 earnings released: US$0.10 loss per share (vs US$0.10 loss in 2Q 2022)Second quarter 2023 results: US$0.10 loss per share (in line with 2Q 2022). Net loss: US$4.91m (loss widened 1.2% from 2Q 2022). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in the United Kingdom.
お知らせ • Aug 09AIM Immunotech Announces Completion of Enrollment in Phase 2 Study Evaluating Ampligen(R) for the Treatment of Post-Covid ConditionsAIM ImmunoTech Inc. announced the completion of enrollment in the company's Phase 2 study evaluating Ampligen(R) as a potential therapeutic for people with post-COVID conditions ("AMP-518"). The study has met the planned enrollment of 80 AMP-518 subjects ages 18 to 60 years who have been randomized 1:1 to receive twice-weekly intravenous infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks. The ompany expects to complete dosing of the last study patient in Fourth Quarter 2023.
お知らせ • Jul 12AIM ImmunoTech Enrolls and Doses First Subject in Phase 2 Study Evaluating Ampligen(R) for the Treatment of Post-COVID ConditionsAIM ImmunoTech Inc. announced it has enrolled and dosed the first subject in the company’s Phase 2 study evaluating Ampligen® as a potential therapeutic for people with post-COVID conditions. This important study milestone follows on the heels of the company having recently opened multiple clinical study sites and having screened numerous subjects. Study screening is ongoing and AIM expects to dose additional new subjects in the coming weeks. For more information about AMP-518, please visit ClinicalTrials.gov and reference identifier NCT05592418. The AMP-518 clinical trial is a two-arm, randomized, double-blind, placebo-controlled, multicenter study to evaluate efficacy and safety of Ampligen in subjects experiencing the post-COVID condition of fatigue. The primary protocol planned outcome measure of the study is change from baseline to week 13 in PROMIS® Fatigue Score. Other protocol planned study outcomes include: change from baseline to week 6 in PROMIS® Fatigue Score; change from baseline to weeks 6 and 13 in distance traveled during a Six-Minute Walk Test; proportion of subjects that surpass 54 meters in the Six-Minute Walk Test at the end of 12-week treatment phase; change from baseline to weeks 6 and 13 in PROMIS® Cognitive Function Score; and change from baseline to weeks 6 and 13 in PROMIS® Sleep Disturbance Score. AMP-518 is expected to enroll approximately 80 subjects between the ages of 18 to 60 years across up to 10 centers in the United States. Subjects will be randomized 1:1 to receive twice weekly IV infusions of Ampligen or placebo for 12 weeks, with a follow-up phase of two weeks.
お知らせ • Jun 28AIM ImmunoTech Inc. Announces Authorizations from Competent Authority and Ethics Board in the Netherlands to Begin Phase 1B/2 Study Evaluating Ampligen®? (Rintatolimod) in Combination with Astrazeneca's Imfinzi (Durvalumab) for the Treatment of Pancreatic CancerAIM ImmunoTech Inc. announced the required approvals from the Netherlands for Erasmus Medical Center to begin a Phase 1b/2 study under the previously announced external sponsored collaborative clinical research agreement with AstraZeneca and Erasmus MC. The authorizations are from the Central Committee on Research Involving Human Subjects, which is the Competent Authority for the review of clinical trials in the Netherlands, and the Medical Ethics Review Committee Erasmus MC, which is the governing ethics board. The investigator-initiated clinical study, entitled "Combining anti-PD-L1 immune checkpoint inhibitor durvalumab with TLR-3 agonist rintatolimod in patients with metastatic pancreatic ductal adenocarcinoma for therapy effect" (the "DURIPANC Study"), is an exploratory, open-label, single center, Phase 1b/2 study which will use Study Drug provided by AstraZeneca and AIM ImmunoTech. The primary objective of the Phase 1b portion of the study is to determine the safety of combination therapy with durvalumab and Ampligen. The primary objective of the phase 2 portion of the trial is to determine the clinical benefit rate of combination therapy with durvalUMab and Ampligen. The DURIPANC Study is expected to enroll between 9 and 18 subjects in the Phase 1b portion and between 13 and 25 patients in the Phase 2 portion of the study. All included patients will receive combination therapy with Ampligen and durvalumab. Patients will start with Ampligen 200mg via IV infusion twice per week for a total of 6 weeks (12 doses). Ampligen dose will be escalated to 400mg according to a 3+3 DLT design. The first dose of Ampligen will be administered preferably 4-6 weeks after the last chemotherapy FOLFIRINOX dose. After two doses of Ampligen, the first dose of durvalumab 1500mg via IV infusion will be introduced in week 2. Patients will continue to receive 1500 mg durvalumab via IV infusion every 4 weeks for up to a maximum of 48 weeks (up to 12 doses/cycles) with the last administration on week 48 or until confirmed disease progression according to Response Evaluation Criteria in solid Tumors (RECIST 1.1), unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
お知らせ • Jun 13AIM ImmunoTech Inc. Outlines Recent Significant Progress Across Clinical Development Pipeline and Provides Update on Positive Pre-Clinical and IP DevelopmentsAIM ImmunoTech Inc. provided an update on its ongoing clinical development programs evaluating Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immune-modulator with broad spectrum activity. The AMP-270 clinical trial is the Company’s randomized, open-label, controlled, parallel-arm study with the primary objective of comparing the efficacy of Ampligen versus a no treatment control group following FOLFIRINOX for subjects with locally advanced pancreatic adenocarcinoma. Secondary objectives include comparing safety and tolerability. AMP-270 is expected to enroll approximately 90 subjects in up to 30 centers across the United States and Europe. The Company is recruiting patients for its AMP-270 Phase 2 study of Ampligen as a therapy for LAPC. The lead site at the University of Nebraska Medical Center is now open and actively working to enroll patients. The Gabrail Cancer & Research Center in Canton, Ohio is also recruiting patients. AIM continues its efforts to open additional clinical sites at premier cancer centers across the United States and Europe. The Company remains optimistic for first patient enrollment in the second quarter of this year.
Reported Earnings • May 17First quarter 2023 earnings released: US$0.076 loss per share (vs US$0.08 loss in 1Q 2022)First quarter 2023 results: US$0.076 loss per share (improved from US$0.08 loss in 1Q 2022). Net loss: US$3.66m (loss narrowed 4.2% from 1Q 2022). Revenue is forecast to grow 75% p.a. on average during the next 3 years, compared to a 10% growth forecast for the Biotechs industry in the United Kingdom.
Board Change • Mar 02Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Feb 11Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
お知らせ • Jan 10AIM ImmunoTech Inc. Announces the Netherlands Patent Office (Octrooicentrum Nederland) Grants A Utility Patent Covering Rugged dsRNA, A Double-Stranded RNA Product Related to Ampligen® (Rintatolimod)AIM ImmunoTech Inc. announced that the Netherlands Patent Office (Octrooicentrum Nederland) granted a utility patent covering rugged dsRNA, a double-stranded RNA product related to Ampligen(R) (rintatolimod), which claims cover, among other aspects, compositions and compositions for use in the prevention or treatment of COVID-19. The new patent broadens AIM's existing portfolio for COVID-19 treatments to include rugged dsRNA. Data from in vitro, pre-clinical and clinical experiments strongly suggest that Ampligen has a broad-spectrum early-onset antiviral effect by stimulating a powerful innate immune response. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a powerful impact on viral replication.
Recent Insider Transactions • Jan 06Executive Vice Chairman recently bought US$50k worth of stockOn the 3rd of January, Thomas Equels bought around 161k shares on-market at roughly US$0.31 per share. This transaction amounted to 42% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was Thomas' only on-market trade for the last 12 months.
Board Change • Jan 04Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Nov 22Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
Board Change • Jun 22Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. 2 highly experienced directors. Independent Director Stewart Appelrouth was the last director to join the board, commencing their role in 2016. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model.
