Tillkännagivande • 53m
Actinium Pharmaceuticals, Inc. Amends Its Investigational New Drug Actinium Pharmaceuticals, Inc. amended its Investigational New Drug (IND) application to add an additional manufacturer. The additional manufacturer will supply studies conducted under the Company's Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), together with additional Company-sponsored studies, which carry clinical milestones expected from the second half of 2026 and throughout 2027. Establishing an additional manufacturing source is intended to expand capacity and supply flexibility as Actimab-A advances into a broader set of studies across hematologic malignancies and solid tumors. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds approximately 250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. Tillkännagivande • Aug 16
Actinium Pharmaceuticals, Inc. Receives Notice of Non-Compliance and NYSE Regulation and Granted Extension to Regain Compliance Actinium Pharmaceuticals, Inc. received notice from NYSE American LLC that the Company was not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and (iii) of the NYSE American Company Guide. The Company submitted a compliance plan to NYSE American on June 18, 2026. On August 12, 2026, the Company received a letter from NYSE Regulation stating that it had reviewed and accepted the Company's compliance plan submitted on June 18, 2026 and granted the Company a plan period through November 27, 2027 to regain compliance with the applicable continued listing standards. During the plan period, while the Company is not in compliance with the continued listing standards set forth in Sections 1003(a)(ii) and (iii) of the Company Guide, the Company's common stock will continue to be listed and traded on NYSE American pursuant to an extension, subject to the Company's compliance with the other continued listing requirements of NYSE American and periodic review by NYSE Regulation of the Company's compliance with the initiatives outlined in the compliance plan. If the Company does not regain compliance with the applicable continued listing standards by the end of the Plan Period or does not make progress consistent with the compliance plan during the Plan Period, NYSE Regulation may initiate delisting proceedings. Valuation Update With 7 Day Price Move • Aug 14
Investor sentiment improves as stock rises 30% After last week's 30% share price gain to US$1.04, the stock trades at a trailing P/E ratio of 2.9x. Average trailing P/E is 16x in the Biotechs industry in the US. Total loss to shareholders of 83% over the past three years. Tillkännagivande • Jun 01
Actinium Pharmaceuticals Receives Patent Allowances for Actimab-A and Iomab-Act Programs in Canada Actinium Pharmaceuticals, Inc. has received Notices of Allowance from the Canadian Intellectual Property Office for two patent applications spanning the Actimab-A and Iomab-ACT programs. The allowances broaden Actinium's intellectual property protection across both hematologic malignancies and next-generation conditioning for gene-edited cell-based therapies in Canada. These Canadian allowances build on protection already secured in other major markets, including a previously granted Japanese patent for the Actimab-A program and an issued U.S. patent for the Iomab-ACT program, with additional applications pending in the United States, Europe and China. The Notices of Allowance follow examination by CIPO, with issuance of the patents expected in the ordinary course. The allowances deepen Actinium's intellectual property protection across two of its priority franchises and reinforce a global patent estate of approximately 250 issued and pending patents and patent applications. The allowed application covers the use of Actimab-A in combination with the CLAG-M chemotherapy regimen for the treatment of AML. Actimab-A is one of Actinium's most advanced clinical-stage candidates and may serve as a therapeutic backbone for myeloid malignancies. The Canadian allowance complements a counterpart patent already granted in Japan, with applications pending in the United States and Europe. The Canadian patent issuing from Application No. 3,087,346 titled "Combination Immunotherapy and Chemotherapy for the Treatment of a Hematological Malignancy" will have a patent term running into January 2039. The allowed application covers Actinium's targeted CD45 conditioning approach used to prepare patients for gene-edited cell-based therapies. Iomab-ACT is designed as a targeted conditioning agent intended to enable adoptive cell therapies. The Canadian allowance builds on a patent already granted in the United States, with additional applications pending in the United States, Europe and China. The Canadian patent issuing from Application No. 3,078,963 titled "Anti-CD45-Based Conditioning Methods and Uses Thereof in Conjunction with Gene-Edited Cell-Based Therapies" will have a patent term running into October 2038. Tillkännagivande • May 31
Actinium Pharmaceuticals, Inc. Receives Notice of Non-Compliance with NYSE Listing Standards On May 27, 2026, Actinium Pharmaceuticals, Inc. (the Company) received a notice from NYSE American LLC indicating that the Company is not in compliance with the continued listing standards set in Section 1003(a)(ii) of the NYSE American Company Guide, which requires a listed company to maintain stockholders’ equity of $4.0 million or more if it has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. As of March 31, 2026, the Company reported stockholders’ equity of approximately $2.3 million, and had net losses in its last five fiscal years ended December 31, 2025. In connection with its non-compliance with Sections 1003(a)(ii) and (iii) of the Company Guide, the Company must submit a plan by June 26, 2026, advising of actions it has taken or will take to regain compliance with the continued listing standards by November 27, 2027 (“Plan Period Deadline”). If NYSE Regulation determines to accept the plan, the Company will be notified in writing and will be subject to periodic reviews including quarterly monitoring for compliance with the plan. If the Company does not submit a plan or if the plan is not accepted, delisting proceedings will commence. Furthermore, if the plan is accepted but the Company is not in compliance with the continued listing standards by the Plan Period Deadline, or if the Company does not make progress consistent with the plan during the plan period, NYSE American staff will initiate delisting proceedings as appropriate. The Company may appeal a staff delisting determination in accordance with Section 1010 and Part 12 of the Company Guide. The Notice has no immediate effect on the listing or trading of the Company’s common stock, which will continue to trade on NYSE American under the symbol “ATNM,” subject to the Company’s compliance with the other continued listing requirements of NYSE American, and will continue to trade with a “.BC” indicator to denote that the Company is below compliance. The Company intends to submit a plan to NYSE American within the required timeframe. There can be no assurance that the Company will be able to regain compliance with the applicable continued listing standards, that the Company will submit a plan that is accepted by NYSE American, that the Company will be able to comply with the terms of any accepted Plan, or that the Company will be able to maintain the listing of its common stock on NYSE American. Tillkännagivande • May 08
Actinium Pharmaceuticals Announces Three SNMMI 2026 Presentations Highlighting Differentiated Profile of Atnm-400 Across Lung and Prostate Cancer and Radioconjugate Optimization Actinium Pharmaceuticals, Inc. announced the upcoming presentation of three abstracts at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, taking place May 30-June 2, 2026, in Los Angeles, California. The presentations include two posters on ATNM-400, Actinium's first-in-class Actinium-225 (225Ac) antibody radioconjugate, demonstrating its potential in prostate cancer and non-small cell lung cancer (NSCLC), as well as a third poster presenting preclinical radiochemistry data on chelator-to-antibody ratio (CAR) optimization that underpins ATNM-400 development. Together, the data underscore Actinium's scientific leadership in next-generation alpha-emitting radioconjugates. Tillkännagivande • Apr 07
Actinium Pharmaceuticals Announces New Pan-Tumor Preclinical Data for Atnm-400 in Solid Tumors and Differentiated Mechanism for Actimab-A in Aml Actinium Pharmaceuticals, Inc. announced the publication of two abstracts that will be presented at the American Association for Cancer Research Annual Meeting 2026, taking place April 17–22, 2026, in San Diego, California. The Company will present previously undisclosed data demonstrating the expanding potential of its Ac-225 radiotherapy platform across both solid tumors and hematologic malignancies. Both presentations will occur on April 21, 2026 in the session Radiopharmaceutical Platforms for Theranostic Precision Oncology. ATNM-400 AACR 2026 Presentation Details Poster Number: 5824 Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology Date & Time: April 21, 2026 – 2:00 PM – 5:00 PM PT | Poster Section 16, Board #18 Actimab-A AACR 2026 Presentation Details Poster Number: 5827 Session: Radiopharmaceutical Platforms for Theranostic Precision Oncology Date & Time: April 21, 2026 – 2:00 PM – 5:00 PM PT | Poster Section 16, Board #21 ATNM-400 targets a novel antigen distinct from PSMA and has demonstrated preclinical activity across metastatic castration-resistant prostate cancer (mCRPC), non-small cell lung cancer (NSCLC), and breast cancer. Actimab-A has shown improved survival in relapsed/refractory AML with CLAG-M and is advancing toward a Phase 2/3 trial, with additional development ongoing through a CRADA with the NCI. Actinium is also advancing preclinical solid tumor programs and holds ~250 patents and patent applications, including intellectual property related to cyclotron-based production of Ac-225. Tillkännagivande • Dec 12
Actinium Pharmaceuticals, Inc. Presents New Preclinical Data Demonstrating Potent Anti-Tumor Activity of Atnm-400 Actinium Pharmaceuticals, Inc. announced the presentation of new preclinical data for ATNM-400, its first-in-class Actinium-225 (Ac-225) based antibody radioconjugate, at the 2025 San Antonio Breast Cancer Symposium (SABCS). The data highlight robust anti-tumor activity and a favorable tolerability profile across a broad panel of preclinical breast cancer models, including hormone receptor-positive (HR+), triple-negative breast cancer (TNBC), and tamoxifen- and trastuzumab-resistant tumors. The data presented at SABCS show that ATNM-400 generates potent, targeted DNA damage even in highly resistant breast cancer models, while maintaining a favorable tolerability profile. This therapeutic approach has the potential to address some of the most pressing unmet needs in breast cancer care, particularly for those who have exhausted established modalities", said Dr. Bardia. The breadth of activity seen in both endocrine-resistant and HER2-resistant breast cancer reinforces ATNM-400's potential to become a differentiated, first-in-class therapy. Beyond breast cancer, have presented compelling ATNM-400 data in prostate cancer and lung cancer that demonstrate its pan-tumor potential. These data further support excitement for ATNM-400 and plans to accelerate development of ATNM-400 as advance toward clinical readiness. In addition, Actinium is engaged with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA®? and OPDIVO®? by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. Tillkännagivande • Nov 07
Actinium Pharmaceuticals, Inc., Annual General Meeting, Nov 26, 2025 Actinium Pharmaceuticals, Inc., Annual General Meeting, Nov 26, 2025. Location: the garden city hotel, 45 seventh st, garden city, ny 11530., United States Tillkännagivande • Nov 05
Actinium Pharmaceuticals, Inc. to Highlight ATNM-400 Data in Hormone-Resistant and HER2-Resistant Breast Cancer At the 2025 San Antonio Breast Cancer Symposium, Expanding Pan-Tumor Profile Across Three Solid Tumor Indications Actinium Pharmaceuticals, Inc. announced that new preclinical data for its lead antibody radioconjugate program, ATNM-400, will be presented at the 2025 San Antonio Breast Cancer Symposium (SABCS) taking place December 10-14, 2025 in San Antonio, Texas. ATNM-400: Program and Multi-Indication Opportunity Overview: ATNM-400 is a first-in-class antibody-radioconjugate powered by Actinium-225 (Ac-225), designed to deliver potent alpha-particle radiation directly to tumor cells. Non-Small Cell lung Cancer: Superior anti-tumor activity compared to the leading first, second and third-Line approved EGFR mutant therapies that generated sales of over $7.0 billion in 2024 and mechanistic synergy with first-line therapy osimertinib, which accounted for approximately $6.6 billion in sales in 2024. The strong single-agent efficacy of ATNM-400 and its ability to overcome resistance when coupled with enzalutamide (Xtandi®?) in prostate cancer and osimertinib (TAGRISSO®?) in lung cancer showcases Actinium's capability for innovation by exploiting the power of a radiotherapeutic directed to a target linked to resistance and poor prognosis. In breast cancer, Actinium has been studied in hormone and HER-2 resistant settings with data to be presented at the San Antonio Breast Cancer Symposium in December 2025. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actinium-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on the Securities and Exchange Commission, including without limitation its most recent report on the Company's Bcl-400 data presented at the SABCS. Tillkännagivande • Oct 27
Actinium Pharmaceuticals, Inc. Announces Superior Anti-Tumor Activity of ATNM-400 in Lung Cancer Compared to Leading First, Second and Third-Line Approved EGFR Mutant Therapies and Mechanistic Synergy with Osimertinib at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Actinium Pharmaceuticals, Inc. announced the presentation of the first ever preclinical data of ATNM-400 in non-small cell lung cancer (NSCLC). ATNM-400 a novel, multi-indication first-in-class antibody radioconjugate armed with the potent alpha-emitter Actinium-225 (Ac-225) is Actinium's lead solid tumor program, which is also being studied in prostate cancer. The data presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics studied ATNM-400 in Epithelial Growth Factor Receptor (EGFR)-mutant NSCLC models. ATNM-400 demonstrated superior efficacy with 3-5x greater tumor growth inhibition compared to standard-of-care therapies across EGFR-mutant NSCLC including: Frontline: Osimertinib (TARGRISSO®?, AstraZeneca) an EGFR tyrosine kinase inhibitor (TKI); Second line: Dato-DXd (DATROWAY®?, AstraZenec/Daiichi Sankyo) a Trop-2 antibody drug conjugate (ADC); Third line: Amivantamab (RYBREVANT®?, J&J), an EGFR-cMET bispecific antibody ATNM-400 also demonstrated synergistic activity in combination with osimertinib with complete tumor regression in 100% of tumor-bearing animals. ATNM-400 represents a novel and differentiated development candidate for non-small cell lung cancer with EGFR mutations. The positive clinical results with EBRT and osimertinib provide strong support for combining targeted alpha-therapy via ATNM-400 and EGFR therapies to effectively deliver radiation to the target tumors and leverage mechanistic synergies while minimizing off-target effects. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time to time in Actinium's filings with the Securities and Exchange Commission (the "SECSEC") (the "SEC") (the "SEC"). ATNM-400 is the first first-in-class drug in the second half of 2025. Tillkännagivande • Jul 31
Actinium Pharmaceuticals, Inc. Presents Data Supporting Paradigm Changing Potential of ATNM-400 in Prostate Cancer Demonstrating Its Superior Efficacy and Improved Survival in Treatment Resistant Tumor Models versus Pluvicto and ARPI Therapy Actinium Pharmaceuticals, Inc. reported additional preclinical data supporting its ATNM-400 radiotherapy prostate cancer candidate at the 4th Annual Targeted Radiopharmaceuticals Summit (TRP) being held July 29 - 31, 2025 in San Diego, CA. ATNM-400 is a novel, first-in-class targeted radiotherapy designed to deliver potent Actinium-225 (Ac-225), an alpha-emitter radioisotope, to prostate cancer cells by targeting a non-Prostate Specific Membrane Antigen (PSMA), disease-driving protein overexpressed in advanced and treatment-resistant disease. Unlike PSMA-targeted agents that primarily serve as imaging and targeting tools, the ATNM-400 target is directly implicated in tumor progression, survival signaling, and resistance to androgen receptor (AR) pathway inhibitor (ARPI) therapy. The new data presented at TRP highlight the utility of the differentiated mechanism of action of ATNM-400 via the Ac-225 alpha-emitter payload evidenced by durable tumor control, improved survival rates compared to Pluvicto, and efficacy in enzalutamide andluVicto resistant models. The company believe ATNM-400 has the potential to redefine the treatment paradigm in the high-value, advanced disease, and metastatic castrate-resistant prostate cancer settings, which impact tens of thousands of patients annually. In addition, Actinium is engaged with the National Cancer Institute (NCI) under a Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA and OPDIVO by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. New Risk • Jun 25
New major risk - Revenue and earnings growth Earnings have declined by 19% 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 Earnings have declined by 19% per year over the past 5 years. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$5.2m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$53.0m market cap). Tillkännagivande • Jun 24
Actinium Pharmaceuticals, Inc. Highlights Expanded Data Set for ATNM-400 in Prostate Cancer Demonstrating Superior Efficacy to Enzalutamide and Ability to Overcome Resistance to ARPI Therapy and PSMA-Ac-225/Lu-225/Lu-177 Labelled Radiotherapy at the Society of Nuclear Medicine & Molecular Imaging Annual Meeting Actinium Pharmaceuticals, Inc. reported new preclinical data from its first-in-class, non-PSMA targeting radiotherapy prostate cancer candidate ATNM-400, that leverages the potent alpha-particle emitter Actinium-225 (Ac-225) isotope, at the Society of Nuclear Medicine & Molecular Imaging (SNMMI) annual meeting being held June 21st - 24th, 2025, in New Orleans, Louisiana. The data presented at SNMMI showed ATNM-400 has superior potency compared Xtandi (enzalutamide) and is highly efficacious in Xtandi resistant prostate models. Xtandi is an androgen receptor inhibitor (ARPI) therapy developed and marketed by Astellas and Pfizer that is approved for three stages of prostate cancer and generated sales of $5.9 billion in 2024. Actinium also presented additional new data showing ATNM-400 is more efficacious than PSMA-617labeled with both Lutetium-177 (Lu-177) and Ac-225 and that ATNM-400 also overcomes resistance to Pluvicto®? (Lu-177-PSMA-617). Pluvicto®? is developed and marketed by Novartis and generated sales of $1.4 billion in 2024. ATNM-400 exhibited potent killing of all Xtandi®? resistant prostate cancer cells that remained following treatment with Xtandi®?, with Xtandi®? only killing 50% of the resistant prostate cancer cells. ATNM-400 monotherapy and in combination with Xtandi®? had superior anti-tumor efficacy in vivo compared to Xtandi alone in a prostate cancer model; all treatments were well-tolerated with no change in body weight; ATNM-400 inhibited tumor growth of Xtandi®? resistant tumors whereas re-treatment with Pluvicto®? or additional zalutamide did not ATNM-400 Compared to PSMA targeted Radiotherapy; ATNM-400 was more potent than both Pluvicto®? ("177Lu-PSMA-617) and 225Ac-PSMA-617 in prostate cancer cell killing; At therapeutically relevant doses, ATNM-400 exhibited more efficacious tumor growth inhibition compared to both Pluvicto®®? and 225Ac-PSMA -617 in prostate cancer in vivo model; As previously reported, ATNM-400 was able to overcome Pluvicto®? resistance, halting tumor growth in prostate cancer tumors that failed Pluvicto therapy and producing potent tumor cell killing. As previously reported, ATNM -400 was able to overcome Plvicto®? resistance, stopping tumor growth in prostate cancer tumors That failed Pluvicto therapy. As previously reported, AT NM-400 was able to overcome pluvicto®? resistance. As previously reported, ATnm-400 was able to overcome Puvicto®? resistance., halting tumor growth in prostate cancer tumor that failed Pluvicto®? therapy and producing potent tumor cell kill. As previously reported, ATMC-400 was able to overcomePluvicto®? and 225 Ac-PSMA-617 in Pro cancer in vivo model. As previously reported, ATNF-400 was able to overcome PLuvicto®? and225Ac-PSMA-617 In prostate cancer in vivo model. Tillkännagivande • May 06
Actinium Pharmaceuticals, Inc. Announces Enrollment of First Patient in the Iomab-ACT Commercial CAR-T Trial at the University of Texas Southwestern Medical Center Actinium Pharmaceuticals, Inc. announced that the first patient was enrolled on the trial studying Iomab-ACT targeted conditioning with a commercial CAR-T therapy at the University of Texas Southwestern Medical Center (UTSW) (NCT06768905). Initial clinical data from this trial is expected in the second half of 2025. Actinium is developing Iomab-ACT as a targeted radiotherapy conditioning agent intended to replace non-targeted chemotherapeutic conditioning agents such as Fludarabine and Cyclophosphamide (Flu/Cy) to address serious CAR-T related toxicities including immune effector cell-associated neurotoxicity (ICANS) and cytokine release syndrome (CRS), to potentially improve patient access and outcomes. This data supported the first clinical trial of Iomab-ACT with a novel CD19 CAR-T therapy in collaboration with Memorial Sloan Kettering Cancer Center (MSK) in patients heavily pretreated with relapsed and refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL). In this study, no patients (0/4) developed ICANS of any grade, and minimal CRS. Iomab-ACT also demonstrated transient depletion of peripheral blood lymphocytes and monocytes, persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities. A multi-billion-dollar market opportunity exists for better conditioning in other areas of cellular therapy, such as CAR-T. Currently, there are seven CAR T-cell therapies targeting CD19 for lymphoma and leukemia and BCMA for multiple myeloma that are approved by the FDA with total sales of over $4.0 billion in 2024. The pipeline of CAR-T therapies in development has rapidly expanded, with the addressable patient population expected to nearly double and reach approximately 93,000 patients in the U.S. by 2030 based on the current pipeline of cellular therapies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Major Estimate Revision • May 01
Consensus EPS estimates upgraded to US$0.95 loss The consensus outlook for fiscal year 2025 has been updated. 2025 losses forecast to reduce from -US$1.23 to -US$0.954 per share. Revenue forecast unchanged from US$7.74m at last update. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target of US$5.00 unchanged from last update. Share price rose 17% to US$1.49 over the past week. New Risk • Apr 29
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.2% 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 Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$48m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$40.6m market cap). Tillkännagivande • Apr 28
Actinium Pharmaceuticals, Inc. Announces Preclinical Results with ATNM-400 in Prostate Cancer Models Presented at the American Association for Cancer Research Annual Meeting Actinium Pharmaceuticals, Inc. announced preclinical results with ATNM-400 in prostate cancer models presented at the American Association for Cancer Research (AACR) Annual Meeting. ATNM-400 is a novel, non-PSMA targeting, first in class targeted radiotherapy utilizing the Actinium-225 (Ac-225) radioisotope that Actinium is evaluating in prostate cancer models prior to and following treatment with Pluvicto. PluVicto (Lu-177-PSMA-617) is a prostate-specific membrane antigen (PSMA) directed radiotherapy radiolabeled with the beta-particle emitter, Lutetitium-177 (Lu-177) is approved for patients with metastatic castration-resistant prostate cancer. Actinium has demonstrated potential activity in relapsed and refractory acute myeloid leukemia (r/r AML) patients in combination with the chemotherapy CLAG-M including high rates of Complete Remissions (CR) and measurable residual disease (MRD) Negativity leading to improved survival outcomes and is being advanced to a pivotal Phase 2/3 trial. In addition, Actinium is engaged with the National Cancer Institute (NCI) under the Cooperative Research and Development Agreement (CRADA) for development of Actimab-A in AML and other myeloid malignancies. The first clinical trial under the CRADA will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Additionally, Actinium is developing Actimab-A as a potential pan tumor therapy in combination with PD-1 checkpoint inhibitors including KEYTRUDA®? and OPDIVO®? by depleting myeloid derived suppressor cells (MDSCs), which represents a potential multi-billion-dollar addressable market. ATNM-400 is Actinium's novel non-PSMA targeting Ac-225 radiotherapy for prostate cancer, which is supported by preclinical data demonstrating higher efficacy than Pluvicto (PSMA-617-Lutetium-177) and potent efficacy in Pluvicto resistant prostate cancer models. Tillkännagivande • Mar 28
Scott+Scott Attorneys at Law LLP Files Securities Class Action Against Actinium Pharmaceuticals, Inc Scott+Scott Attorneys at Law LLP has filed a securities class action lawsuit in the United States District Court for the Southern District of New York against Actinium Pharmaceuticals, Inc. (“Actinium” or the “Company”), and certain of its former and current officers and/or directors (collectively, “Defendants”). The Class Action asserts claims under §§10(b) and 20(a) of the Securities Exchange Act of 1934 (15 U.S.C. and 78t(a)) and U.S. Securities and Exchange Commission Rule 10b-5 promulgated thereunder (17 C.F.R. §240.10b-5) on behalf of all persons other than Defendants who purchased or otherwise acquired Actinium securities between October 31, 2022, and August 2, 2024, inclusive (the “Class Period”), and were damaged thereby (the “Class”). The Class Action filed by Scott+Scott is captioned: Kohil v. Actinium Pharmaceuticals, Inc., et al., Case No. 1:25-cv-02553. Actinium is a late-stage biopharmaceutical company that develops targeted radiotherapies, such as Iomab-B, to treat people who have failed existing oncology therapies. Iomab-B is an induction-and-conditioning agent used before bone marrow transplants and has the potential to treat elderly relapsed or refractory acute myeloid leukemia. Actinium evaluated Iomab-B in the pivotal Phase 3 Sierra trial (the “Sierra Trial”), where the drug met the primary endpoint of durable Complete Remission with statistical significance (p<0.0001). The Class Action alleges that, during the Class Period, Defendants made misleading statements and omissions regarding the Company’s business, financial condition, and prospects. Specifically, Defendants misled the market to believe the data submitted in support of its Biologics License Application (“BLA”) was likely to satisfy the U.S. Food and Drug Administration’s guidelines for acceptance and approval of Actinium’s BLA. As the truth about Actinium’s business reached the market, the price of Actinium’s stock suffered significant declines, harming investors. For example, on the morning of August 5, 2024, before the market opened, when Actinium issued a press release providing, among other things, a regulatory update on the planned BLA filing and the future plans for Iomab-B in the U.S. Specifically, the press release revealed the Company would need to conduct an additional clinical trial to further support the Company’s BLA filing. On this news, the price of Actinium’s common stock plummeted $3.69, or nearly 60%, to close at $2.48, on unusually high trading volume. Tillkännagivande • Mar 18
Actinium Pharmaceuticals, Inc. Announces Clinical Trial Program in Solid Tumors Combining Actimab-A with PD-1 Checkpoint Inhibitors KEYTRUDA® and OPDIVO® Actinium Pharmaceuticals, Inc. announced a clinical program comprising of trials studying Actimab-A in combination with either KEYTRUDA (pembrolizumab) or OPDIVO(nivolumab) which are blockbuster immunotherapies known as PD-1 inhibitors which are approved in multiple solid tumor indications. KEYTRUDA developed and commercialized by Merck & Co. and OPDIVOdeveloped and commercialized by Bristol Myers Squibb, collectively generated $38.8 billion in sales in 2024 across several solid tumor cancer indications. However, the efficacy of these drugs has shown to be limited by a certain type of cell known as MDSCs or Myeloid Derived Suppressor Cells which accumulate in the tumor microenvironment. MDSCs express the CD33 antigen which is targeted by Actimab-A. The rationale for studying Actimab-A in combination with either KEYTRUDA or OPDIVOis based on the premise that depleting MDSCs with Actimab-A will improve the efficacy of these drugs. MDSCs are immune-suppressive cells that help tumors evade immune detection and promote disease progression. They are overexpressed in the tumor microenvironment in several different solid tumors and associated with poor outcomes. They work by multiple mechanisms but most relevant to PD-1 inhibitors which work by keeping T-cells active is that MDSCs prevent T-cells from recognizing and attacking cancer cells. There is considerable preclinical scientific evidence in the literature that depleting MDSCs could be a viable strategy in improving the outcomes of PD-1 directed immunotherapy, however, there have been no viable clinical approaches that have been tried successfully to once knowledge. MDSCs are known to express the CD33 antigen which is the target of Actimab-A. Actinium has also generated published and unpublished preclinical data showing that Actimab-A can selectively deplete MDSCs in solid tumors. Actinium believes that in the clinic Actimab-A can deplete CD33 expressing MDSCs and hence improve the outcomes with PD-1 inhibitors such as KEYTRUDA and OPDIVO.Actimab-A is Actinium's lead radiotherapeutic that delivers Actinium-225, a potent alpha-emitter radioisotope payload that can produce lethal double strand DNA breaks to kill targeted cells. Actimab-A has been studied in over 150 patients in several clinical trials in Acute Myeloid Leukemia or AML. Based on its safety and tolerability, Actimab-A is under clinical development via an NCI CRADA in the front-line AML setting with an expected registrational study in combination with CLAG-M in relapsed/refractory AML expected to initiate in 2025. The Actimab-A solid tumor program is comprised of several controlled, head-to-head clinical trials that will evaluate the combination of Actimab-A with KEYTRUDA versus KEYTRUDA alone, and Actimab-A with OPDIVO versus OPDIVO alone. The initial tumors that are being targeted are HNSCC or Head and Neck Squamous Cell Carcinoma and NSCLC or Non-Small Cell Lung Cancer with a separate trial for each indication. The patient population for these trials will be adults with PD-L1 expression and locally advanced metastatic HNSCC or NSCLC randomized to either Actimab-A alone or Actimab-A with a specific checkpoint inhibitor. The objective of each trial would be to evaluate the safety and tolerability as well as following endpoints including ORR – Overall Response Rate, PFS – Progression Free Survival and OS – Overall Survival. Further, the following biomarker data would be collected including the pattern of depletion of CD33+ MDSCs and T-Cell activity in peripheral blood. Actinium expects to present initial proof of concept clinical data from the first of these trials in the second half of 2025 as well as provide an update on the outlook for the rest of the trials in the Actimab-A solid tumor program. Tillkännagivande • Mar 12
Actinium Pharmaceuticals Announces Initiation of Actimab-A Triplet Combination Frontline Trial Under NCI CRADA with Venetoclax and Taiho Oncology's Hypomethylating Agent ASTX-727 in Patients with Newly Diagnosed AML Actinium Pharmaceuticals, Inc. announced that the first clinical trial under its previously announced Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) for Actimab-A has been initiated. The trial (NCT06802523) will evaluate the triplet combination comprised of Actimab-A, Venetoclax (Abbvie/Roche) an oral Bcl-2 inhibitor and ASTX-727 (Taiho Oncology, an Otsuka holdings company) a novel oral hypomethylating agent (HMA) in frontline acute myeloid leukemia (AML) patients. Venetoclax in combination with HMAs (Ven-HMA) is approved for patients with newly diagnosed AML. New Risk • Nov 25
New major risk - Revenue and earnings growth Earnings 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 Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Revenue is less than US$1m (US$81k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$52m net loss in 3 years). Shareholders have been diluted in the past year (14% increase in shares outstanding). Market cap is less than US$100m (US$45.2m market cap). Tillkännagivande • Nov 06
Actinium Pharmaceuticals, Inc., Annual General Meeting, Nov 27, 2024 Actinium Pharmaceuticals, Inc., Annual General Meeting, Nov 27, 2024. Location: the garden city hotel, 45 seventh st, garden city, ny 11530, United States Tillkännagivande • Nov 05
Actinium Pharmaceuticals, Inc. Appoints June Almenoff to its Board Actinium Pharmaceuticals, Inc. announced the appointment of June Almenoff, M.D., Ph.D. to its Board of Directors. Dr. Almenoff is an accomplished biopharma executive with over 25 years of senior leadership and drug development experience. She currently serves as a Board Director and advisor to numerous biopharma companies. Dr. Almenoff served as President and Chief Medical Officer of Furiex Pharmaceuticals, which was acquired by Actavis plc (now AbbVie). Furiex developed eluxadoline (Viberzi®), which was approved both in the United States and Europe. She also served as Chief Medical Officer of RedHill Biopharma Ltd. leading a team whose work led to the recognition of Talicia® as a first-line therapy for H. pylori. Earlier in her career, Dr. Almenoff was at GlaxoSmithKline (GSK) for 12 years, where she held various positions of increasing responsibility. She was a Vice President in the Clinical Safety Organization, chaired a PhRMA-FDA working group, and worked in the area of scientific licensing. She also led the development of pioneering data analytics systems, which have been widely adopted by industry and regulators to minimize clinical risk for pharmaceutical products. Dr. Almenoff has strong expertise in translational medicine, clinical development, commercial strategy, and business development across many therapeutic areas, and has led or contributed to numerous regulatory submissions, product approvals and launches. She is a member of the investment advisory board of the Harrington Discovery Institute, a director on the board of Avalo Therapeutics, Inc. and Tenax Therapeutics. Dr. Almenoff received her B.A. cum laude from Smith College and graduated with Alpha Omega Alpha honors from the M.D.-Ph.D. program at the Icahn (Mt. Sinai) School of Medicine. She completed post-graduate medical training at Stanford University Medical Center and served on the faculty of Duke University School of Medicine. She is an adjunct professor at Duke, a Fellow of the American College of Physicians (FACP) and has authored over 70 publications. Price Target Changed • Aug 05
Price target decreased by 18% to US$19.56 Down from US$23.80, the current price target is an average from 7 analysts. New target price is 689% above last closing price of US$2.48. Stock is down 63% over the past year. The company is forecast to post a net loss per share of US$1.45 next year compared to a net loss per share of US$1.83 last year. Breakeven Date Change • Aug 05
No longer forecast to breakeven The 7 analysts covering Actinium Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$34.8m in 2026. New consensus forecast suggests the company will make a loss of US$3.17m in 2026. Tillkännagivande • Aug 05
Actinium Pharmaceuticals, Inc. Provides Regulatory Update on Planned BLA Filing and Future Plans for Iomab-B in the U.S Actinium Pharmaceuticals, Inc. announced a regulatory update on the Company's planned Biologics License Application ("BLA") filing for Iomab-B in patients with active relapsed or refractory acute myeloid leukemia ("r/r AML"). Iomab-B is an induction and conditioning targeted radiotherapy agent comprised of an anti-CD45 monoclonal antibody and Iodine-131 radioisotope payload. The Company announced that it has now concluded both its clinical and Chemistry, Manufacturing and Controls ("CMC") interactions with the FDA regarding the BLA pathway for Iomab-B. Despite the SIERRA trial meeting the primary endpoint of durable Complete Remission ("dCR") with statistical significance (p-value<0.0001) and other positive secondary endpoints including Event Free Survival ("EFS") and safety, the FDA has now determined that demonstrating an overall survival benefit in a randomized head-to-head trial is required for a BLA filing. The FDA has advised Actinium to conduct a study to evaluate allogeneic bone marrow transplant ("BMT") using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation ("Flu/TBI") versus allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI, a difference from the SIERRA trial, which had allowed physician's choice of salvage therapies and heterogenous conditioning regimens in the control arm. Additionally, the proposed new study will not allow patients to crossover from the control arm which was allowed in the SIERRA trial and confounded the overall survival analysis in the intent to treat ("ITT") patient population, as nearly 60% of patients crossed over from the control arm. The Phase 3 SIERRA trial enrolled 153 patients with r/r AML and compared outcomes of patients receiving Iomab-B and BMT to patients receiving physician's choice of care with salvage chemotherapy and standard allogeneic BMT in the control arm. In February 2023, Actinium announced that the SIERRA trial met the primary endpoint with statistical significance as 22% of patients (13/76) on the Iomab-B arm achieved dCR compared to 0% of patients (0/77) on the control arm resulting in a p-value of <0.0001. The SIERRA trial was conducted in accordance with guidance from the End of Phase 2 meeting with the FDA, which stated that positive results for dCR as the primary endpoint would be an acceptable endpoint to support an Iomab-B BLA filing. SIERRA did not meet the secondary endpoint of overall survival on an intent to treat basis analysis due to the high crossover rate with nearly 60% of control arm patients receiving Iomab-B followed by a BMT. Over the last several years, a majority of therapies for patients with AML have been approved based on achieving a positive overall survival endpoint. Actinium presented several additional analyses from the SIERRA study to the FDA including long-term follow-up that demonstrated a trend towards improved overall survival and evidence of survival benefit in patients with high-risk TP53 mutations to support Iomab-B's impact on overall survival. The SIERRA trial data were presented in 12 oral presentations at several leading bone marrow transplant, hematology and nuclear medicine conferences in both the U.S. and Europe, which Actinium believes demonstrates the high unmet medical need and scientific importance of Iomab-B's ability to provide improved access and outcomes for patients with active r/r AML to the transplant community. However, the FDA has now determined that the analyses from the SIERRA trial do not adequately support a BLA filing for Iomab-B and requires an additional clinical study. Actinium expects the safety and efficacy data from the SIERRA trial will provide supportive evidence for a future Iomab-B BLA filing. Key Outcomes and Implications of FDA Interactions: Phase 3 SIERRA trial results are not adequate to support a BLA filing for Iomab-B in patients with active r/r AML; FDA is requiring an additional randomized head-to-head trial to demonstrate an overall survival benefit evaluating allogeneic BMT using Iomab-B plus a reduced intensity conditioning regimen of fludarabine and total body irradiation (Flu/TBI) to allogeneic BMT using reduced intensity conditioning comprised of cyclophosphamide plus Flu/TBI; Proposed additional clinical trial to evaluate Iomab-B plus Flu/TBI compared to a single regimen comprised of cyclophosphamide plus Flu/TBI which differs from the SIERRA trial that allowed physician's choice of salvage therapy and heterogenous conditioning regimens in the control arm; The proposed additional clinical trial will not allow crossover, which was allowed in SIERRA, and confounded the overall survival analysis in the intent to treat (ITT) patient population as nearly 60% of patients crossed over from the control arm; Actinium intends to further discuss the specifics of the additional clinical trial including the patient population, which the FDA has suggested could include all adult AML patients; Upon conclusion of its interactions with the FDA, Actinium will seek a strategic partner for Iomab-B for the U.S. Tillkännagivande • Jul 25
Actinium Pharmaceuticals, Inc. Announces FDA Clearance of Iomab-ACT Targeted Conditioning IND Application for Sickle Cell Disease Actinium Pharmaceuticals, Inc. announced the FDA clearance of an Investigational New Drug (IND) application to study Iomab-ACT for targeted conditioning prior to a bone marrow transplant (BMT), in patients with sickle cell disease. The study will be conducted in collaboration with the Columbia University and led by Markus Mapara, M.D., Ph.D., Professor of Medicine, Columbia University Irving Medical Center, Director, Bone Marrow Transplantation and Cell Therapy Program, Vagelos College of Physicians and Surgeons. This trial will evaluate the safety of Iomab-ACT in patients with sickle cell Disease who are to receive an allogeneic BMT. If successful, the trial is expected to inform a clinical trial to evaluate Iomab-ACT as a targeted conditioning agent prior to gene therapy for which there are two approved agents for patients with sickle cell disease, Casgevy (Vertex Pharmaceuticals, Inc.) and Lyfgenia (Bluebird Bio, Inc.). This collaboration with Dr. Mapara is intended to enable patients with sickle cell disease broader access to allogeneic BMT and gene therapy, potentially curable cellular therapies, via Iomab-ACT. Iomab-ACT is an ARC that targets CD45, a marker expressed on blood cancer cells and immune cells that is intended to enable conditioning prior to cell and gene therapies replacing the non-targeted chemotherapy and total body irradiation that is currently used for conditioning. The CAR-T market size in terms of revenue is estimated to grow at a CAGR of approximately 11% over the next 5 plus years. Currently, there are six CAR T-cell therapies approved by the FDA that are used to treat patients with lymphomas, leukemia, and multiple myeloma, which collectively had total sales of over $3.5 billion in 2023 and two gene therapies approved by the FDA for patients with sickle cell Disease. The addressable market for Iomab-ACT is in line with the patient population for cell and gene therapies as all patients must receive some type of conditioning prior to these treatments. The company will continue to develop Iomab-ACT, next-generation conditioning program for rapidly growing cell and gene therapies based on early promising results, ultimately with the value proposition of improving overall access and outcomes for patients who need cellular or gene therapies. A potential blockbuster revenue opportunity exists for Iomab-ACT assuming it can provide one or more clinical benefits related to lower cytokine release syndrome (CRS), less immune effector cell-associated neurotoxicity syndrome (ICANS), longer duration of response with selective lymphodepletion or a higher overall success rate of cell and gene therapies due to benefits of targeted conditioning. Tillkännagivande • Jun 15
Actinium Pharmaceuticals, Inc. Highlights Oral Presentation at EHA 2024 Annual Congress Featuring Improved Outcomes in TP53 Positive Patients Receiving Iomab-B in the Phase 3 SIERRA Trial Actinium Pharmaceuticals, Inc. announced that results from the Phase 3 SIERRA trial of Iomab-B were presented at the 2024 European Hematology Association (EHA) Hybrid Congress being held June 13 - 16, 2024, in Madrid, Spain. The two presentations at EHA highlighted outcomes in patients with active relapsed or refractory acute myeloid leukemia (r/r AML) enrolled in the SIERRA trial who had a TP53 mutation and long-term efficacy results in this older patient population. The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active r/r AML and compared outcomes of patients receiving an Iomab-B led bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm. Across all patients in SIERRA study, only patients receiving an Iomab the trial's primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival. The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents. Highlights from Oral Presentation of Outcomes in Patients with a TP53 Mutation: In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is usually associated with limited treatment options and poor outcomes; For patients with TP53 mutation only those receiving Iomab-B (either at randomization or via cross-over) achieved complete remission or achieve a durable complete remission (dCR), the primary endpoint of the SIERRA trial. Median Overall Survival (OS) of 5.49 months observed in patients with a TP53 mutation receiving an Iomab- B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002); Median OS was 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B's ability to overcome TP53 gene mutations. Presentation Title: 131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RES results in IMPROVED SURVIVALOUTCOMES in R/R AML PATIENTS with high-RISK TP53 MUTATIONS in the SIERRA trial. Of the patients achieving dCR after an Iomab-B lead BMT, there was 92% 1-year survival. Tillkännagivande • May 16
Actinium Announces Oral Presentation Detailing Improved Survival Outcomes in Tp53 Positive Patients At the Eha 2024 Annual Congress and Presentation of Long-Term Efficacy Results in Older Patients Receiving an Iomab-B Led Bone Marrow Transplant in the Phase 3 Sierra Trial Actinium Pharmaceuticals, Inc. announced that results from the Phase 3 SIERRA trial of Iomab-B have been accepted for an oral presentation and poster presentation at the 2024 European Hematology Association (EHA) Hybrid Congress being held June 13 – 16, 2024, in Madrid, Spain. The Phase 3 SIERRA trial enrolled 153 patients ages 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving an Iomab-B led bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm. Across all patients in SIERRA study, only patients receiving an Iomab-B led BMT achieved the trial's primary endpoint of durable complete remission with these patients having 92% 1-year survival and 69% 2-year survival with statistically significant higher event free survival. The SIERRA trial enrolled high-risk patients including those with one or more of the following: a TP53 mutation, advanced age up to 77 years old, complex cytogenetics and prior therapy including venetoclax and other targeted agents. In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is usually associated with limited treatment options and poor outcomes. Median Overall Survival of 5.49 months observed in patients with a TP53 mutation receiving an Iomab-B led allogeneic bone marrow transplant compared to 1.66 months in patients that did not receive Iomab-B (hazard ratio=0.23, p=0.0002). Iomab-B EHA presentations titles are as follows: Oral Presentation: 131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANT RESULTS IN IMPROVED SURVIVAL OUTCOMES IN R/R AML PATIENTS WITH HIGH-RISK TP53 MUTATIONS IN THE RANDOMIZED PHASE III SIERRA TRIAL. Poster Presentation: LONG TERM EFFICACY RESULTS OF THE SIERRA TRIAL: A PHASE 3 STUDY OF 131I-APAMISTAMAB-LED ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION VERSUS CONVENTIONAL CARE IN OLDER PATIENTS WITH ACTIVE, R/R AML. Tillkännagivande • May 08
Actinium Pharmaceuticals, Inc. Announces KOL Webinar to Highlight Recently Announced Iomab-ACT Trial with Leading FDA Approved Commercial CAR T-Cell Therapy Being Led by the University of Texas Southwestern Actinium Pharmaceuticals, Inc. announced it will host a KOL call on May 20, 2024, at 8:00 AM ET to provide updates and highlight its recently announced clinical trial to study Iomab-ACT with a leading FDA approved CAR-T cell therapy at the University of Texas Southwestern (UTSW). Iomab-ACT is an ARC that targets CD45, a marker expressed on blood cancer cells and immune cells that is intended to enable conditioning prior to cell and gene therapies such as CAR T-cell therapy and replace the non-targeted chemotherapy that is currently used for conditioning. There are six CAR-T cell therapies approved to treat patients with leukemias, lymphomas and multiple myeloma that collectively reached sales in 2023 exceeding $3.5 billion. Dr. Farrukh Awan specializes in the treatment of patients with leukemia and lymphoma including CAR-T therapy and bone marrow transplantation. Dr. Awan will serve as principal investigator for this study that will be led by UTSW. To date, Iomab-ACT has been studied in a clinical trial with an investigational CD19 targeting CAR-T cell therapy developed by Memorial Sloan Kettering Cancer Center (MSKCC) under a National Institutes of Health funded grant. The trial at UTSW will be the first trial to study Iomab-ACT or any targeted radiotherapy conditioning agent with an FDA approved CAR-T therapy. Actinium presented results from its ongoing phase 1 trial using Iomab-ACT as conditioning prior to CD19 CAR-T therapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) at the Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) in February 2024. Importantly, no patients (0/4) developed immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, a major safety measure of the study and minimal Cytokine Release Syndrome (CRS). ICANS is observed in 25% or more of pts w/R/R B-ALL and DLBCL treated with various currently approved CAR T-cell products. Iomab-ACT demonstrated transient depletion of peripheral blood lymphocytes and monocytes. Persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities have been observed to date. The opportunity exists for better conditioning in other areas of cellular therapy, such as CAR-T as well as gene therapies. The pipeline of CAR-T and gene therapies has rapidly expanded, with the addressable patient population expected to nearly double and reach approximately 93,000 patients in the U.S. by 2030 based on the current pipeline of cellular therapies. The CAR-T market size in terms of revenue is estimated to grow at a CAGR of approximately 11% over the next 5 plus years. Currently, there are six CAR T-cell therapies approved by the FDA that are used to treat patients with lymphomas, leukemia, and multiple myeloma, which collectively had total sales of over $3.5 billion in 2023. The addressable market for Iomab-ACT is in line with the patient population for cell and gene therapies as all patients must receive some type of conditioning prior to these treatments. Breakeven Date Change • Apr 23
Forecast breakeven date pushed back to 2026 The 6 analysts covering Actinium Pharmaceuticals previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 79% per year to 2025. The company is expected to make a profit of US$44.4m in 2026. Average annual earnings growth of 66% is required to achieve expected profit on schedule. Tillkännagivande • Apr 19
Actinium Pharmaceuticals, Inc. Highlights Ability of Iomab-B to Overcome High-Risk TP53 Mutation Resulting in Significant Improvement in Overall Survival in Patients with Active Relapsed Refractory AML at the European Bone Marrow Transplant Annual Meeting Actinium Pharmaceuticals, Inc. announced that results from the Phase 3 SIERRA trial of Iomab-B were presented in an oral presentation at the 50th Annual European Bone Marrow Transplant Society Meeting (EBMT) held in Glasgow, Scotland on April 14-17. The results showed that an Ibomab-B led bone marrow transplant (BMT) results in higher rates of remissions and durable Complete Remission (dCR), which is the primary endpoint of the SIERRA trial, as well as significant improvement in overall survival in TP53 positive patients. Iomab-B is a targeted radiotherapeutic comprised of an anti-CD45 monoclonal antibody with the Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients age 55 and above with active relapsed or refractory acute myeloid leukemia (AML) and compared outcomes of patients receiving Iomab-B BMT to those of patients receiving physician's choice of care in the control arm. In total, 24% (37/153) of the patients enrolled on SIERRA had a TP53 mutation, which is associated with limited treatment options and poor outcomes. Median OS was 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B's ability to overcome TP53 gene mutations. Tillkännagivande • Apr 02
Actinium Pharmaceuticals, Inc. Announces Iomab-B Phase 3 Sierra Trial Results Demonstrating Survival Benefit in High-Risk Relapsed or Refractory Acute Myeloid Leukemia Patients with TP53 Mutations Accepted for Oral Presentation At the 50Th European Bone Marrow Transplant Annual Meeting Actinium Pharmaceuticals, Inc. announced that results from the Phase 3 SIERRA trial of Iomab-B in patients with a TP53 mutation have been accepted for oral presentation at the 50th Annual meeting of the European Bone Marrow Transplant Society (EBMT) being held April 14 – 17, 2024, in Glasgow, Scotland. Iomab-B is a targeted radiotherapy conditioning agent comprised of an anti-CD45 monoclonal antibody and Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients with active relapsed or refractory acute myeloid leukemia (r/r AML) and compared outcomes of patients receiving Iomab-B and a bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm. In total, 24% of patients (37/153) in the SIERRA trial had a TP53 mutation, which is associated with poor outcomes, and 27 of the TP53 positive patients received Iomab-B. Iomab-B met the primary endpoint of durable Complete Remission (dCR) in the SIERRA trial with high-statistical significance (p<0.0001) and 100% of patients receiving a therapeutic dose of Iomab-B achieved BMT access and engagement. Tillkännagivande • Mar 26
Actinium Pharmaceuticals Announces Clinical Trial to Study Iomab-ACT Targeted Radiotherapy Conditioning with FDA Approved Commercial CAR T-Cell Therapy Actinium Pharmaceuticals, Inc. announced that the University of Texas Southwestern Medical Center (UT Southwestern) will lead a clinical trial studying Actinium's Iomab-ACT, a targeted radiotherapy conditioning agent prior to patients receiving an FDA approved commercial CAR T-cell therapy. UT Southwestern will start recruiting patients following FDA's review and clearance of the study. CAR T-cell therapy utilizes patients' own immune cells called T-cells, which are engineered to include a chimeric antigen receptor and then reinfused into the patient to recognize and destroy cancer cells. Currently, there are six CAR-T therapies approved to treat patients with leukemias, lymphomas and multiple myeloma that collectively reached sales in 2023 exceeding $3.5 billion. Actinium developed Iomab-ACT with the goal of replacing the chemotherapy conditioning regimens currently used prior to cell and gene therapies. Early clinical data with Iomab-ACT conditioning prior to CAR-T demonstrates its ability to produce targeted lymphodepletion along with negligible incidences of immune effector cell-associated neurotoxicity syndrome (ICANS) or cytokine release syndrome (CRS), which are the major toxicities observed with the current chemotherapy based conditioning regimens, which are suboptimal and can limit patients from CAR-T access and may result in poor outcomes. Ongoing Iomab-ACT Phase 1 CAR-T Conditioning Results: Actinium presented results from its ongoing phase 1 trial using Iomab-ACT as conditioning prior to CD19 CAR-T therapy for patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL) or Diffuse Large B-cell Lymphoma (DLBCL) at the Tandem Meetings I Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR the combined annual meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) in February 2024. Importantly, no patients (0/4) developed immune effector cell-associated neurotoxicity syndrome (ICANS) of any grade, a major safety measure of the study, as ICANS is observed in 25% or more of pts w/R/R B-ALL and DLBCL treated with various CAR T-cell products and minimal CRS. Iomab-ACT demonstrated transient depletion of peripheral blood lymphocytes and monocytes. Persistence of CAR T-cells up to 8 weeks and minimal non-hematologic toxicities have been observed to date. Targeted Radiotherapy Conditioning Opportunity: The opportunity exists for better conditioning in other areas of cellular therapy, such as CAR-T as well as gene therapies. The pipeline of CAR-T and gene therapies has rapidly expanded, with the addressable patient population expected to nearly double and reach approximately 93,000 patients in the U.S. by 2030 based on the current pipeline of cellular therapies. The CAR-T market size in terms of revenue is estimated to grow at a CAGR of approximately 11% over the next 5 plus years. Currently, there are six CAR T-cell therapies approved by the FDA that are used to treat patients with lymphomas, leukemia, and multiple myeloma, which collectively had total sales of over $3.5 billion in 2023. The addressable market for Iomab-ACT is in line with the patient population for cell and gene therapies as all patients receive conditioning of some type prior to these treatments. The company will continue to develop Iomab-ACT, its next-generation conditioning program for rapidly growing cell and gene therapies based on early promising results, ultimately with the value proposition of improving overall access and outcomes for patients who need cellular or gene therapies. A potential blockbuster revenue opportunity exists for Iomab-ACT assuming it can provide one or more clinical benefits related to lower CRS, less ICANS, longer duration of response or a higher overall success rate of cellular therapy due to benefits of targeted conditioning. Price Target Changed • Mar 19
Price target increased by 8.4% to US$25.36 Up from US$23.40, the current price target is an average from 5 analysts. New target price is 209% above last closing price of US$8.21. Stock is down 13% over the past year. The company is forecast to post a net loss per share of US$2.04 next year compared to a net loss per share of US$1.37 last year. Price Target Changed • Dec 12
Price target increased by 32% to US$23.40 Up from US$17.75, the current price target is an average from 5 analysts. New target price is 376% above last closing price of US$4.92. Stock is down 56% over the past year. The company is forecast to post a net loss per share of US$2.04 next year compared to a net loss per share of US$1.37 last year. Tillkännagivande • Dec 12
Actinium Pharmaceuticals, Inc. Announces Results from the Phase 3 SIERRA Trial of Iomab-B Were Presents in an Oral Presentation At the 65th Annual American Society of Hematology Meeting & Exposition Actinium Pharmaceuticals, Inc. announced that results from the Phase 3 SIERRA trial of Iomab-B were presented in an oral presentation at the 65th Annual American Society of Hematology Meeting & Exposition (ASH). The oral presentation highlighted significantly improved survival in patients with a TP53 mutation receiving Iomab-B. Iomab-B is a targeted radiotherapeutic comprised of an anti-CD45 monoclonal antibody with the Iodine-131 radioisotope payload. The Phase 3 SIERRA trial enrolled 153 patients with active relapsed or refractory acute myeloid leukemia (AML) and compared outcomes of patients receiving Iomab-B and a bone marrow transplant (BMT) to those of patients receiving physician's choice of care in the control arm, which was intended to reflect current best practices. Patients not achieving a Complete Remission (CR) in the control arm who were unable to proceed to a BMT were offered to crossover to receive an Iomab-B led BMT. Iomab-B achieved the primary endpoint in the SIERRA trial of durable Complete Remission (dCR) of at least 6 months with high statistical significance (p<0.0001), with 22% of patients randomized to the Iomab-B arm achieving dCR and 0% of patients in the control arm achieving dCR, irrespective of TP53 mutational status. In addition, Iomab-B significantly improved event-free survival, a secondary endpoint, with a hazard ratio of 0.22 and median overall survival (mOS) was doubled. Median OS was 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B's ability to overcome TP53 gene mutations. Overall, 24% (37/153) of patients enrolled on SIERRA had a TP53 mutation. In total, 27 patients with a TP53 mutation received Iomab-B and accessed BMT on the SIERRA trial either after initial randomization or following crossover after not being able to access a BMT on the control arm. Only 1 patient with a TP53 mutation was able to access a BMT on the control arm via conventional care. Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. Iomab-B met the primary endpoint of durable Complete Remission (dCR) of 6 months after initial remission post-BMT in the pivotal Phase 3 SIERRA trial with high statistical significance (p<0.0001). Iomab-B produced a 75% post-BMT CR rate (44/59 patients), which is 12-times greater than the post-BMT rate of 6.3% (4/64 patients) in the control arm. Patients receiving Iomab-B had a 78% lower probability of an event, defined as not achieving a CR/CRp, crossover, not receiving a BMT, relapse or death, with a Hazard Ratio of 0.22 (p<0.0001). Iomab-B doubled 1-year overall survival with 26.1% compared to 13.1% in the control arm for patients who did not crossover as well as median overall survival with 6.4 months vs 3.2 months. Overall survival statistics are confounded by the crossover arm. Crossover patients had a 35.8% 1-year overall survival rate. Due to its targeted nature, Iomab-B was well tolerated with four times lower rates of sepsis compared to the control arm (6.1% vs. 28.6%) and lower rates of BMT associated adverse events including febrile neutropenia, mucositis and graft versus host disease (GVHD). Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B in 2024 to address patients age 55+ with r/r AML who cannot access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037. Tillkännagivande • Nov 10
Actinium Pharmaceuticals, Inc., Annual General Meeting, Nov 30, 2023 Actinium Pharmaceuticals, Inc., Annual General Meeting, Nov 30, 2023, at 09:30 US Eastern Standard Time. Location: The Garden City Hotel, 45 Seventh St, Garden City NY 11530 New York United States Agenda: To elect each of David Nicholson and Richard I. Steinhart as a Class I director to serve for a three-year term that expires at the 2026 Annual Meeting of Stockholders, or until his successor is elected and qualified or until his earlier resignation or removal; and to ratify the appointment of Marcum LLP as company independent registered public accounting firm for the fiscal year ending December 31, 2023. Major Estimate Revision • Nov 09
Consensus revenue estimates fall by 85% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$1.20m to US$180.0k. Forecast losses increased from -US$1.84 to -US$2.04 per share. Biotechs industry in the US expected to see average net income growth of 0.9% next year. Consensus price target down from US$24.78 to US$18.61. Share price fell 11% to US$4.84 over the past week. Price Target Changed • Nov 06
Price target decreased by 25% to US$18.61 Down from US$24.78, the current price target is an average from 5 analysts. New target price is 309% above last closing price of US$4.55. Stock is down 63% over the past year. The company is forecast to post a net loss per share of US$2.04 next year compared to a net loss per share of US$1.37 last year. Tillkännagivande • Nov 04
Actinium Pharmaceuticals, Inc. Appoints Lynn Bodarky as Chief Business Officer Actinium Pharmaceuticals, Inc. announced that Lynn Bodarky has been named Chief Business Officer to lead the Company's business development, licensing, and collaboration activities. Ms. Bodarky joins Actinium with over 25 years of proven business development and licensing experience at large global pharmaceutical and innovative biotechnology companies including Pfizer, Merck, Progenics and HiFiBiO. Over her career, she has executed a wide array of business transactions totaling over $5 billion in value across oncology, autoimmune and neurological indications. Ms. Bodarky joins Actinium from HiFiBiO Therapeutics, a clinical-stage biotechnology company developing immunotherapies for oncology and autoimmune diseases, where she was Senior Vice President, Global Head of Business Development & Operations. At HiFiBiO, she advanced strategic initiatives with Novartis and Kite Pharma. Prior to HiFiBiO, she was Vice President, Business Development at Geron Corporation, a company focused on developing treatments for hematologic malignancies and Intrexon Corporation, which focused on developing therapies for oncology, rare diseases, and neuroscience. Ms. Bodarky held senior roles focused on vaccines and corporate affairs Wyeth and then Pfizer, following Pfizer's acquisition of Wyeth. Previously, she was Vice President of Marketing at Progenics Pharmaceuticals, Inc. where she focused on the launch of Relistor, a first-in-class product that Progenics licensed to Wyeth in a transaction totaling more than $400 million. Earlier at Progenics, she served as Vice President, Business Development & Licensing, and led the acquisition of a PSMA targeting antibody for prostate cancer and secured a license for related linker and toxin technology from Seattle Genetics to create a PSMA antibody-drug conjugate. Earlier in her career she held roles at Pharmacia Corporation and Merck & Co. Ms. Bodarky holds an MBA in finance and international business from Columbia Business School and a BS in accounting from the University of Pennsylvania, Wharton School of Business. Tillkännagivande • Nov 03
Actinium Pharmaceuticals, Inc. Announces Oral Presentation at ASH Annual Meeting Actinium Pharmaceuticals, Inc. announced that three abstracts detailing results from the completed Phase 3 SIERRA trial of Iomab-B in patients age 55 and above with active relapsed or refractory acute myeloid leukemia (r/r AML) have been accepted for presentation at the 65(th) Annual American Society of Hematology Annual Meeting & Exposition (ASH) being held in San Diego on December 9-12, 2023. Outcomes of patients with a TP53 gene mutation enrolled in the SIERRA trial have been accepted for an oral presentation and results detailed in the abstract include the following: Medn OvOverall Survival (OS) of TP53 positive patients receiving Iob-B and a bone marrow transplant (BMT) w was 5.49 months compared to 1.66 months in patients who did not receive Iomab-B; Iomab-B produced a statistically significant improvement in median OS in TP53 positive patients with a hazard ratio of 0.23 and p-value of 0.0002; Median OS of 6.37 months in TP53 negative patients receiving Iomab-B and 5.72 months for TP53 positive patients demonstrating Iomab-B's mutation agnostic mechanism and ability to overcome TP53 gene mutations; 24% of patients (37/153) enrolled on the SIERRA trial had a TP53 mutation, with 17 being randomized to the Iomab-B arm and 20 randomized to the control arm. Tillkännagivande • Oct 06
National Institutes of Health Awards Actinium A Small Business Technology Transfer Grant Extension to Actinium Pharmaceuticals, Inc Actinium Pharmaceuticals, Inc. announced the National Institutes of Health (NIH) awarded Actinium a Small Business Technology Transfer grant extension to support its clinical collaboration with Memorial Sloan Kettering Cancer Center (MSK) to study Iomab-ACT, Actinium's CD45-targeting radiotherapeutic, for targeted conditioning to achieve lymphodepletion therapy along with the reduction of cytokine release syndrome and neurotoxicity prior to administration of a CD19-targeted CAR-T cell therapy developed at MSK. Iomab-ACT is a next-generation, CD45-targeted conditioning agent intended to enable either lymphodepletion or reduced intensity conditioning prior to CAR-T and gene therapies with multi-indication potential. Iomab-ACT has the potential to reduce toxicities and improve patient outcomes when paired with MSK's CD19 CAR-T cell therapy in difficult to treat relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and diffuse large B cell lymphoma (DLBCL). This grant will advance the ongoing study of Iomab-ACT for patients with relapsed or refractory B-ALL or DLBCL. Price Target Changed • Sep 07
Price target decreased by 13% to US$24.78 Down from US$28.41, the current price target is an average from 6 analysts. New target price is 274% above last closing price of US$6.62. Stock is down 12% over the past year. The company is forecast to post a net loss per share of US$1.83 next year compared to a net loss per share of US$1.37 last year. Major Estimate Revision • Aug 21
Consensus EPS estimates fall by 10% The consensus outlook for fiscal year 2023 has been updated. 2023 expected loss increased from -US$1.71 to -US$1.89 per share. Revenue forecast of US$1.22m unchanged since last update. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target down from US$28.41 to US$27.41. Share price fell 2.2% to US$6.19 over the past week. Price Target Changed • Aug 15
Price target decreased by 8.9% to US$27.41 Down from US$30.09, the current price target is an average from 5 analysts. New target price is 323% above last closing price of US$6.48. Stock is up 9.5% over the past year. The company is forecast to post a net loss per share of US$1.89 next year compared to a net loss per share of US$1.37 last year. Major Estimate Revision • May 22
Consensus revenue estimates decrease by 52%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$2.56m to US$1.22m. EPS estimate increased from -US$1.72 to -US$1.70 per share. Biotechs industry in the US expected to see average net income decline 81% next year. Consensus price target of US$28.41 unchanged from last update. Share price fell 2.9% to US$8.68 over the past week. Major Estimate Revision • Mar 02
Consensus revenue estimates increase by 13% The consensus outlook for fiscal year 2022 has been updated. 2022 revenue forecast increased from US$2.05m to US$2.32m. EPS estimate unchanged from -US$1.27 at last update. Biotechs industry in the US expected to see average net income decline 53% next year. Consensus price target down from US$32.62 to US$30.09. Share price rose 3.5% to US$10.06 over the past week. Price Target Changed • Feb 21
Price target increased by 15% to US$32.62 Up from US$28.43, the current price target is an average from 4 analysts. New target price is 185% above last closing price of US$11.44. Stock is up 127% over the past year. The company is forecast to post a net loss per share of US$1.27 next year compared to a net loss per share of US$1.20 last year. Tillkännagivande • Feb 15
Actinium Pharmaceuticals, Inc. to Present Full Results from Pivotal Phase 3 Iomab-B SIERRA Trial on Investor Call Following the Late-Breaker Presentation at the 2023 Transplantation & Cellular Therapy Tandem Meetings Actinium Pharmaceuticals, Inc. announced its presence at the upcoming Tandem Meetings: Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) being held February 15 – 19, 2023 at the World Center Marriott in Orlando, Florida. Actinium will host an investor conference call and webcast to present full topline results from its pivotal Phase 3 SIERRA trial of Iomab-B at 6:00 PM EST on Saturday, February 18, 2023. The investor conference call will follow the late-breaker presentation of the full Phase 3 SIERRA trial results. In addition, Iomab-B will be highlighted in a CME Event titled, "The Convergence of Innovative Therapy and AlloHCT in AML: Applying Current Evidence to Improve Outcomes Across Patient Populations. Iomab-B is a first-in-class targeted radiotherapy intended to improve patient access to potentially curative BMT by simultaneously and rapidly depleting blood cancer, immune and bone marrow stem cells that uniquely express CD45. Multiple studies have demonstrated increased survival in patients receiving BMT, however, an overwhelming majority of patients with blood cancers do not receive BMT as current approaches do not produce a remission, which is needed to advance to BMT, or are too toxic. Studied in over 400 patients, prior studies with Iomab-B have demonstrated nearly universal access to BMT, increased survival and tolerability in multiple clinical trials including the recently completed pivotal Phase 3 SIERRA trial in patients with active (leukemic blasts >5%), relapsed or refractory acute myeloid leukemia (r/r AML) age 55 and above. The SIERRA trial produced positive topline results, meeting its primary endpoint of durable Complete Remission (dCR) of 6 months with statistical significance (p<0.0001). Actinium intends to submit a Biologics License Application (BLA) seeking approval for Iomab-B to address patients age 55+ with r/r AML who cannot access BMT with currently available therapies. Iomab-B has been granted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) and has patent protection into 2037. The pivotal Phase 3 SIERRA (Study of Iomab-B in Elderly relapsed or refractory AML) is a 153-patient, randomized, multi-center clinical trial, studying Iomab-B compared to the control arm of physician's choice of salvage therapy. Control arm options included chemotherapies like cytarabine and daunorubicin and targeted agents such as a Bcl-2 inhibitor (Venetoclax), FLT3 inhibitors and IDH 1/2 inhibitors. The SIERRA control arm reflects real-world treatment of r/r AML patients with over 20 single agents or combination of agents as no standard of care exists for this patient population. Data from full patient enrollment presented at the Transplantation & Cellular Therapy Tandem Meetings in April 2022 showed that 100% of patients receiving Iomab-B accessed BMT and engrafted without delay. Iomab-B was also shown to be well tolerated given its targeted nature, consistent with its previous clinical data. The SIERRA trial enrolled patients at 24 leading transplant centers in the United States and Canada that perform over 30% of AML BMTs. Developed at the Fred Hutchinson Cancer Research Center, a pioneer in the field of BMT, Iomab-B is supported by data in six disease indications including leukemias, lymphomas and multiple myeloma, which afflict over 100,000 patients annually. Actinium intends to pursue additional indications for Iomab-B beyond AML. Actinium also intends to pursue international regulatory approvals independently and through partnerships. In April 2022, Actinium licensed the European, Middle East and North African commercial rights for Iomab-B to Immedica AB, a fully-fledged independent pharmaceutical company headquartered in Sweden. In exchange, Actinium received an upfront payment of $35 million USD with the potential for an additional $417 million USD in regulatory and sales milestones and mid-twenty percent royalties. Europe represents a commercial opportunity double the size of the United States by number of patients with AML receiving BMT. Iomab-B has been granted Orphan Drug Designation by the European Medicines Agency (EMA) and has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the EMA indicating that the Phase 3 SIERRA trial design, primary endpoint and planned statistical analysis are acceptable as the basis for a Marketing Authorization Application. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 5 analysts covering Actinium Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$60.9m in 2025. Average annual earnings growth of 67% is required to achieve expected profit on schedule. Major Estimate Revision • Dec 10
Consensus revenue estimates fall by 16% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$2.74m to US$2.31m. Forecast losses increased from -US$1.17 to -US$1.22 per share. Biotechs industry in the US expected to see average net income decline 93% next year. Consensus price target of US$30.15 unchanged from last update. Share price fell 4.4% to US$10.77 over the past week. Major Estimate Revision • Nov 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$1.83m to US$2.74m. EPS estimate unchanged at -US$1.17. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target of US$28.43 unchanged from last update. Share price fell 5.8% to US$11.78 over the past week. Breakeven Date Change • Nov 16
Forecast to breakeven in 2024 The 5 analysts covering Actinium Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$4.35m in 2024. Average annual earnings growth of 81% is required to achieve expected profit on schedule. Price Target Changed • Nov 16
Price target increased to US$28.43 Up from US$23.23, the current price target is an average from 5 analysts. New target price is 132% above last closing price of US$12.27. Stock is up 54% over the past year. The company is forecast to post a net loss per share of US$1.17 next year compared to a net loss per share of US$1.20 last year. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 4 highly experienced directors. Independent Director Ajit Shetty was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Nov 01
Price target increased to US$27.23 Up from US$23.23, the current price target is an average from 5 analysts. New target price is 106% above last closing price of US$13.25. Stock is up 56% over the past year. The company is forecast to post a net loss per share of US$1.17 next year compared to a net loss per share of US$1.20 last year. Breakeven Date Change • Sep 09
No longer forecast to breakeven The 5 analysts covering Actinium Pharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$22.5m in 2024. New consensus forecast suggests the company will make a loss of US$887.3k in 2024. Price Target Changed • Aug 25
Price target decreased to US$24.04 Down from US$27.28, the current price target is an average from 3 analysts. New target price is 271% above last closing price of US$6.48. Stock is up 6.8% over the past year. The company is forecast to post a net loss per share of US$1.06 next year compared to a net loss per share of US$1.20 last year. Major Estimate Revision • Aug 19
Consensus revenue estimates fall by 22% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$3.47m to US$2.72m. Forecast losses increased from -US$0.92 to -US$1.06 per share. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target down from US$27.28 to US$26.72. Share price was steady at US$5.88 over the past week. Major Estimate Revision • Jul 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$21.0m to US$6.00m. EPS estimate unchanged from -US$0.92 per share at last update. Biotechs industry in the US expected to see average net income decline 61% next year. Consensus price target of US$27.28 unchanged from last update. Share price was steady at US$5.10 over the past week. Major Estimate Revision • May 20
Consensus revenue estimates increase by 193% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$8.75m to US$25.7m. Forecast losses expected to reduce from -US$0.83 to -US$0.63 per share. Biotechs industry in the US expected to see average net income decline 52% next year. Consensus price target of US$26.71 unchanged from last update. Share price rose 5.2% to US$6.05 over the past week. Price Target Changed • May 17
Price target decreased to US$26.71 Down from US$30.00, the current price target is an average from 4 analysts. New target price is 331% above last closing price of US$6.20. Stock is down 19% over the past year. The company is forecast to post a net loss per share of US$0.63 next year compared to a net loss per share of US$1.20 last year. Board Change • Apr 27
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Independent Director Ajit Shetty was the last director to join the board, commencing their role in 2017. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Breakeven Date Change • Jan 01
Forecast to breakeven in 2024 The 4 analysts covering Actinium Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$56.4m in 2024. Average annual earnings growth of 73% is required to achieve expected profit on schedule. Breakeven Date Change • Dec 16
Forecast to breakeven in 2023 The 4 analysts covering Actinium Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 11% per year to 2022. The company is expected to make a profit of US$5.21m in 2023. Average annual earnings growth of 88% is required to achieve expected profit on schedule. Breakeven Date Change • Nov 18
Forecast to breakeven in 2023 The 3 analysts covering Actinium Pharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$9.30m in 2023. Average annual earnings growth of 92% is required to achieve expected profit on schedule. Executive Departure • Oct 01
Chief Medical Officer Mark Berger has left the company On the 24th of September, Mark Berger's tenure as Chief Medical Officer ended after 4.7 years in the role. As of June 2021, Mark still personally held only 750.00 shares (US$5.9k worth at the time). Mark is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 3.63 years. Executive Departure • Sep 24
Chief Medical Officer Mark Berger has left the company On the 24th of September, Mark Berger's tenure as Chief Medical Officer ended after 4.7 years in the role. As of June 2021, Mark still personally held only 750.00 shares (US$5.9k worth at the time). Mark is the only executive to leave the company over the last 12 months. The current median tenure of the management team is 4.29 years. Major Estimate Revision • Aug 06
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$622.0k to US$1.14m. EPS estimate fell from -US$1.01 to -US$1.14 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$41.00 to US$35.00. Share price rose 3.9% to US$6.92 over the past week. Price Target Changed • Aug 04
Price target decreased to US$35.00 Down from US$38.33, the current price target is an average from 3 analysts. New target price is 407% above last closing price of US$6.91. Stock is down 61% over the past year. Is New 90 Day High Low • Mar 06
New 90-day low: US$7.75 The company is down 29% from its price of US$10.84 on 04 December 2020. The American market is up 5.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 1.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$390 per share. Is New 90 Day High Low • Dec 30
New 90-day low: US$8.08 The company is down 17% from its price of US$9.69 on 30 September 2020. The American market is up 15% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 16% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$420 per share. Is New 90 Day High Low • Nov 14
New 90-day high: US$12.01 The company is up 22% from its price of US$9.82 on 14 August 2020. The American market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is US$357 per share. 
