Panbela Therapeutics（PBLA）株式概要臨床段階のバイオ医薬品企業であるパンベラ・セラピューティクス社は、アンメット・メディカル・ニーズの高い患者の治療に向けた破壊的治療薬の開発に取り組んでいます。 詳細PBLA ファンダメンタル分析スノーフレーク・スコア評価0/6将来の成長0/6過去の実績0/6財務の健全性0/6配当金0/6リスク分析最新の財務報告は1年以上前のものである 株式の流動性は非常に低い 意味のある時価総額がありません ( $53K )すべてのリスクチェックを見るPBLA Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair ValueUS$Current PriceUS$0.011該当なし内在価値ディスカウントEst. Revenue$PastFuture-37m12016201920222025202620282031Revenue US$1.0Earnings US$0.2AdvancedSet Fair ValueView all narrativesPanbela Therapeutics, Inc. 競合他社Vincerx PharmaSymbol: OTCPK:VINCMarket cap: US$66.5kOnconetixSymbol: NasdaqCM:ONCOMarket cap: US$83.2kSynairgenSymbol: OTCPK:SYGG.FMarket cap: US$110.3kBeroni GroupSymbol: OTCPK:BNIG.FMarket cap: US$217.5k価格と性能株価の高値、安値、推移の概要Panbela Therapeutics過去の株価現在の株価US$0.01152週高値US$2.5052週安値US$0.000001ベータ01ヶ月の変化-0.90%3ヶ月変化-78.00%1年変化-95.74%3年間の変化-99.90%5年間の変化-99.90%IPOからの変化-99.90%最新ニュースお知らせ • Oct 30Nant Capital Engages in Discussions with Panbela TherapeuticsOn October 29, 2024, Nant Capital, LLC announced that it has been and may continue to be in contact with members of Panbela Therapeutics, Inc.’s management, the Company’s board of directors, other significant shareholders, and others regarding alternatives that the Company could employ to maximize shareholder value.お知らせ • Jun 24Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial ModificationPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The DSMB recommended study continuation without modification, marking the third consecutive positive safety review. The safety database now includes 395 patients, compared to 214 patients on November 29, 2023. Key Takeaways: The DSMB's recommendation to proceed without modification affirms support for ivospemin’s safety profile. The safety database has expanded to 395 patients, providing a robust foundation for evaluating ivospemin's safety. The lower-than-expected event rate suggests the potential for prolonged survival among ASPIRE trial participants. Rapid enrollment positions Panbela to remain on path to complete enrollment in First Quarter 2025, earlier than initially anticipated. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin, and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years, with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9-month survival benefit compared to the approval of gemcitabine and nab-paclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela remains committed to advancing the ASPIRE trial and evaluating ivospemin's potential to improve outcomes for patients with mPDAC. Despite recent advancements in treatment, the median overall survival for patients with mPDAC remains less than 12 months. The company looks forward to the interim survival analysis in early 2025, which will provide important insights into ivospemin's potential to address this significant unmet medical need.お知らせ • Apr 27Panbela Therapeutics, Inc. Announces Nasdaq Files A Form 25 Notification of Removal from ListingOn April 25, 2024, The Nasdaq Stock Market LLC (Nasdaq") filed a Form 25 Notification of Removal from Listing indicating that the delisting will become effective ten days after the Form 25 was filed. As a result, Panbela Therapeutics, Inc. no longer intends to file its own Form 25. The Company has applied to list its common stock on the US Equity Listings Tier II of the Chicago Board of Options Exchange (CBOE"). No assurances can be given that the application will be approved or that a trading market will develop on the CBOE. In the interim, the Company intends to maintain the existing eligibility for quotation of its common stock on the OTCQB under its current symbol, PBLA".お知らせ • Apr 24Panbela Therapeutics, Inc. Announces Interim Data Analysis for its Ongoing ASPIRE Trial Pushed to First Quarter of 2025Panbela Therapeutics, Inc. announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as first quarter of 2025. This delay in the projected date for analysis comes as a result of the trial's current event rate, which is lower than initially anticipated, indicating that patients have lived longer than expected. The ASPIRE trial, which is evaluating the efficacy and safety of Panbela's lead product candidate, ivospemin (SBP-101), in combination with gemcitabine and nab-paclitaxel (Abraxane) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), requires 33% of the total expected events to occur before the interim analysis can be conducted. As of the latest assessment, less than half of the required events for the interim analysis have occurred. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9 month survival benefit compared to the approval of gemcitabine and nab-paclitaxel which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela will continue to monitor the progress of the ASPIRE trial and provide updates as appropriate.お知らせ • Apr 20Panbela Announces Poster Presentation At American Association for Cancer ResearchPanbela Therapeutics, Inc. announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024. The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine. The poster highlights the efficacy of SBP-101 in combination with doxorubicin which is used to treat platinum-resistant ovarian cancer. Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. SBP-101 and doxorubicin cooperatively increase polyamine catabolism and decrease overall cell survival in vitro. Utilizing the immunocompetent VDID8+ murine ovarian cancer model (ID8+ C57Bl/6 ovarian cells overexpressing both VEGF and Defensin), the combination of SBP-101 and doxorubicin was evaluated significantly increased median mouse survival time. Cotreatment also results in delayed ascites formation and decreased overall tumor burden. The combination treatment cooperatively decreases overall ascitic polyamine content.Immunodeficient NSG mice injected with VDID8+ ovarian cancer cells do not receive a survival benefit from ivospemin, doxorubicin, or a combination treatment, indicating that an intact immune system is required for the efficacy of this therapy. The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP-101 in combination with other polyamine metabolism modulators as well as with immune modulators.お知らせ • Apr 19+ 1 more updatePanbela Therapeutics, Inc. has filed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has filed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 29,069,768 Security Name: Class G Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Class H Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 29,069,768最新情報をもっと見るRecent updatesお知らせ • Oct 30Nant Capital Engages in Discussions with Panbela TherapeuticsOn October 29, 2024, Nant Capital, LLC announced that it has been and may continue to be in contact with members of Panbela Therapeutics, Inc.’s management, the Company’s board of directors, other significant shareholders, and others regarding alternatives that the Company could employ to maximize shareholder value.お知らせ • Jun 24Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial ModificationPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The DSMB recommended study continuation without modification, marking the third consecutive positive safety review. The safety database now includes 395 patients, compared to 214 patients on November 29, 2023. Key Takeaways: The DSMB's recommendation to proceed without modification affirms support for ivospemin’s safety profile. The safety database has expanded to 395 patients, providing a robust foundation for evaluating ivospemin's safety. The lower-than-expected event rate suggests the potential for prolonged survival among ASPIRE trial participants. Rapid enrollment positions Panbela to remain on path to complete enrollment in First Quarter 2025, earlier than initially anticipated. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin, and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years, with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9-month survival benefit compared to the approval of gemcitabine and nab-paclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela remains committed to advancing the ASPIRE trial and evaluating ivospemin's potential to improve outcomes for patients with mPDAC. Despite recent advancements in treatment, the median overall survival for patients with mPDAC remains less than 12 months. The company looks forward to the interim survival analysis in early 2025, which will provide important insights into ivospemin's potential to address this significant unmet medical need.お知らせ • Apr 27Panbela Therapeutics, Inc. Announces Nasdaq Files A Form 25 Notification of Removal from ListingOn April 25, 2024, The Nasdaq Stock Market LLC (Nasdaq") filed a Form 25 Notification of Removal from Listing indicating that the delisting will become effective ten days after the Form 25 was filed. As a result, Panbela Therapeutics, Inc. no longer intends to file its own Form 25. The Company has applied to list its common stock on the US Equity Listings Tier II of the Chicago Board of Options Exchange (CBOE"). No assurances can be given that the application will be approved or that a trading market will develop on the CBOE. In the interim, the Company intends to maintain the existing eligibility for quotation of its common stock on the OTCQB under its current symbol, PBLA".お知らせ • Apr 24Panbela Therapeutics, Inc. Announces Interim Data Analysis for its Ongoing ASPIRE Trial Pushed to First Quarter of 2025Panbela Therapeutics, Inc. announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as first quarter of 2025. This delay in the projected date for analysis comes as a result of the trial's current event rate, which is lower than initially anticipated, indicating that patients have lived longer than expected. The ASPIRE trial, which is evaluating the efficacy and safety of Panbela's lead product candidate, ivospemin (SBP-101), in combination with gemcitabine and nab-paclitaxel (Abraxane) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), requires 33% of the total expected events to occur before the interim analysis can be conducted. As of the latest assessment, less than half of the required events for the interim analysis have occurred. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9 month survival benefit compared to the approval of gemcitabine and nab-paclitaxel which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela will continue to monitor the progress of the ASPIRE trial and provide updates as appropriate.お知らせ • Apr 20Panbela Announces Poster Presentation At American Association for Cancer ResearchPanbela Therapeutics, Inc. announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024. The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine. The poster highlights the efficacy of SBP-101 in combination with doxorubicin which is used to treat platinum-resistant ovarian cancer. Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. SBP-101 and doxorubicin cooperatively increase polyamine catabolism and decrease overall cell survival in vitro. Utilizing the immunocompetent VDID8+ murine ovarian cancer model (ID8+ C57Bl/6 ovarian cells overexpressing both VEGF and Defensin), the combination of SBP-101 and doxorubicin was evaluated significantly increased median mouse survival time. Cotreatment also results in delayed ascites formation and decreased overall tumor burden. The combination treatment cooperatively decreases overall ascitic polyamine content.Immunodeficient NSG mice injected with VDID8+ ovarian cancer cells do not receive a survival benefit from ivospemin, doxorubicin, or a combination treatment, indicating that an intact immune system is required for the efficacy of this therapy. The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP-101 in combination with other polyamine metabolism modulators as well as with immune modulators.お知らせ • Apr 19+ 1 more updatePanbela Therapeutics, Inc. has filed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has filed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 29,069,768 Security Name: Class G Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Class H Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 29,069,768お知らせ • Mar 07+ 1 more updateThe Nasdaq Stock Market Notifies Panbela Therapeutics That the Nasdaq Hearings Panel Has Determined to Delist the Company’s Common StockOn March 5, 2024, The Nasdaq Stock Market LLC notified Panbela Therapeutics, Inc. that the Nasdaq Hearings Panel has determined to delist the Company’s common stock and that trading of the Company’s securities will be suspended at the open of trading on March 7, 2024. Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the U.S. Securities and Exchange Commission after applicable appeal periods have lapsed. In the interim, the Company expects its common stock will be eligible for quotation on the OTC Pink Market under its existing symbol, “PBLA.” The Panel reached its decision because the Company is in violation of the minimum $2.5 million stockholders equity requirement in Listing Rule 5550(b)(1) and unable to comply with any of the alternative requirements in Listing Rule 5550(b). The Company has 15 days after the date it received notice of the Panel’s decision to request that the Nasdaq Listing and Hearing Review Council review the decision, or the Council may, on its own motion, determine to review the Panel’s decision within 45 calendar days after the Company was notified of the decision. The Company plans to continue to file its required periodic reports and other filings with the SEC.お知らせ • Feb 02Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 4,375,000 Price\Range: $2.06 Discount Per Security: $0.1442 Security Name: Class E Common Warrants Security Type: Equity Warrant Securities Offered: 4,375,000 Security Name: Class F Common Warrants Security Type: Equity Warrant Securities Offered: 4,375,000 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 4,375,000 Price\Range: $2.059 Discount Per Security: $0.1441お知らせ • Jan 26Panbela Therapeutics, Inc. Exceeds 50% Enrollment for Aspire Trial in Pancreatic Cancer, Exceeding Anticipated Timelines with Accelerated MomentumPanbela Therapeutics, Inc. announced it has reached 50% enrollment for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Panbela is committed to delivering a more effective treatment for pancreatic cancer, a deadly disease with few treatment options. The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies.Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenac and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase III trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), showed statistically significant benefit compared to both single agents (p=0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP. CPP-1X (eflornithine) is being developed as a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.お知らせ • Jan 25Panbela Therapeutics Receives Notice from the Listing Qualifications Department of the Nasdaq Regarding Listing Rule 5550(a)(4)On January 22, 2024, Panbela Therapeutics, Inc. (the ‘Company’) received a notice from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) indicating that, as of effective date of the previously reported 1-for-20 reverse stock split on January 18, 2024, the Company was no longer in compliance with Nasdaq Listing Rule 5550(a)(4) (the ‘Minimum Float Requirement’), which requires a minimum of 500,000 publicly held shares. The Staff informed the Company that this matter serves as an additional basis for delisting the Company’s common stock and that the Nasdaq Hearings Panel will consider this matter in rendering a determination regarding the Company’s continued listing on The Nasdaq Capital Market. As previously reported, the Company has requested and has been granted a hearing to present its plan to regain compliance with the bid price of $1.00 per share requirement as outlined in Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’) and the minimum stockholders’ equity requirement as required by Nasdaq Listing Rule 5550(b) (the ‘Minimum Stockholders’ Equity Requirement’). Any delisting of the Company’s common stock has been stayed pending the conclusion of the hearing process. Consequently, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market at least until the panel renders a decision following the hearing. There can be no assurance that the panel will grant the Company’s appeal for continued listing. If the Company is unable to regain compliance with the Minimum Bid Price Requirement, the Minimum Stockholders’ Equity Requirement, or the Minimum Float Requirement, then it is likely that its common stock will be delisted from the Nasdaq Capital Market. The Company intends to continue to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and continues to evaluate various alternative courses of action to regain compliance with the Rules. However, there can be no assurance that the Company will be able to maintain compliance with the Nasdaq Capital Market’s continued listing requirements or regain compliance with the Rules.お知らせ • Jan 18Panbela Therapeutics, Inc. Announces Publication of Clinical Data Titled: Phase 1 Study of High-Dose DFMO, Celecoxib, Cyclophosphamide and Topotecan for Patients with Relapsed NeuroblastomaPanbela Therapeutics, Inc. announces the publication of clinical data from studies of CPP-1X (also known as a-Difluoromethylornithine (DFMO) or Eflornithine) in neuroblastoma. According to Hogarty et al, children with relapsed refractory neuroblastoma have dismal outcomes and new therapeutic options are needed. Data published in the British Journal of Cancer investigated the tolerability and activity of depleting polyamines by high dose CPP-1X and celecoxib in combination with standard of care chemotherapy in heavily pretreated neuroblastoma patients. Results showed that DFMO treatment was well tolerated, and the median time-to-progression was 19.8 months. From the Phase 1 dose range finding study of CPP-1X in heavily pretreated neuroblastoma patients, CPP-1X was well tolerated. The best overall response included 2 partial responses (PR), 4 minor responses (MR), 10 Stable disease (SD), 7 progressive disease (PD) and 1 unevaluable. All patients with an overall response of PR or MR sustained this response until stopping or completing protocol therapy. The overall objective response rate (CR+PR) was 9% and rate of any response (CR+PR+MR) was 26%. At 2 years, PFS (progression free survival) for the entire cohort was 29.5%. Notably, three patients completed protocol therapy and remain without disease progression or event at >4 years from treatment end in the absence of additional therapy. These results build upon the recent FDA approval of CPP-1X or DFMO to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. Results from these studies suggest that CPP-1X is a safe, oral treatment option that may improve response rates in heavily pretreated relapsed refractory neuroblastoma patients and are the basis for the ongoing ANBL-1821 Phase 2 trial.お知らせ • Nov 29Panbela Therapeutics, Inc. Announces second Independent Safety Review of the ASPIRE Registration Clinical TrialPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 ASPIRE clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients which included 214 patients in the trial. The DSMB has recommended that the study continue without modification. The ASPIRE Trial is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, ovarian cancer and diabetes. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.New Risk • Nov 11New major risk - Negative shareholders equityThe company has negative equity. Total equity: -US$2.5m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-US$2.5m). Shareholders have been substantially diluted in the past year (over 110x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.72m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$42m net loss in 3 years).お知らせ • Nov 04Panbela Announces Publication of Preclinical and Clinical Data Titled: Inhibition of Polyamine Biosynthesis Preserves B Cell Function in Type 1 DiabetesPanbela Therapeutics, Inc. announced the publication of preclinical and clinical data from studies of CPP-1X (also known as a-Difluoromethylornithine (DFMO) or Eflornithine) in recent onset type 1 diabetes (T1D). According to Sims et al, although therapy of T1D has improved, the morbidity, mortality and cost continue to impact the quality of life for those affected highlighting the need for safe and effective therapies that address the underlying pathology. Data published in the journal Cell Reports Medicine investigated the mechanism of polyamines and polyamine inhibition by CPP-1X on ß cell stress that plays a role in the onset of type 1 diabetes in vitro and ex vivo models. Results showed that DFMO treatment may preserve ß cell function, reflected by C-peptide levels in patients with T1D through the modulation of urinary polyamines, in particular putrescine. The work reflects the Company’s ongoing collaboration with Indiana University School of Medicine. The research is part of a multi-site clinical trial led by Indiana University (IU) School of Medicine, supported by funding from JDRF, the leading global T1D research and advocacy organization. The preclinical data were generated by Raghavendra Mirmira's laboratory at the University of Chicago. Panbela Therapeutics is providing the drug at no cost to researchers and was not involved in the design and analysis of these studies. From the Phase 1 dose range finding study of CPP-1X in patients with recent onset T1D, CPP-1X was well tolerated and a dose dependent inhibition of ODC was observed. An exploratory secondary analysis showed that at the two highest dose levels, treatment with CPP-1X stabilized C-peptide areas under the curve compared to placebo. When assessing immune cell populations, there were no differences between the placebo and CPP-1X patients. Results from these studies suggest that CPP-1X is a safe, oral treatment option that may improve ß cell function and/or survival in recent onset T1D.New Risk • Nov 03New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Earnings are forecast to decline by an average of 0.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 126x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.36m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$40m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change).お知らせ • Oct 26Panbela Therapeutics, Inc. Announces Acceptance of Polyamine Inhibitor Car-T Combination Abstract for Online PublicationPanbela Therapeutics, Inc. announced that an abstract about SBP-101 and CPP-1X (also known as DFMO or Eflornithine) research in multiple myeloma (cell lines), has been accepted for an online publication on the American Society of Hematology (ASH) meeting site in the November supplemental issue of the journal Blood. The work reflects the company's on-going collaboration with researchers from The University of Texas MD Anderson Cancer Center and will become part of the permanent ASH and Blood abstracts archive.New Risk • Aug 13New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 0.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings are forecast to decline by an average of 0.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 65x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.85m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$44m net loss in 3 years).お知らせ • Jul 25Panbela Therapeutics, Inc. Opens Enrollment in UK and Germany for Aspire Trial in Pancreatic CancerPanbela Therapeutics, Inc. announced it has opened enrollment in the UK and Germany for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. There are approximately 95 sites planned for throughout the United States, Europe, Australia, and South Korea, in the global Aspire trial. Panbela is committed to delivering a more effective treatment for pancreatic cancer, a deadly disease with few treatment options.お知らせ • Jul 11Panbela Announces Preliminary Safety Analysis for ASPIRE TrialPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) of the Phase III ASPIRE clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients in the trial. The DSMB has recommended that the study continue without modification. The ASPIRE Trial is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal Adenocarcinoma.お知らせ • Jun 29Panbela Therapeutics, Inc. Announces PACES S0820 Phase III Trial Passes Pre-Planned Futility AnalysisPanbela Therapeutics, Inc. announced the SWOG Cancer Research Network's PACES S0820 Phase III trial passed a single planned futility analysis and will continue. The trial entitled: "A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or rectal cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and sulindac (PACES)" is designed to evaluate the combination of eflornithine and sulINDac in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colorectal cancer or rectal cancer. The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies.Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events.お知らせ • Jun 22Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $8.510816 million.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $8.510816 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 586,000 Price\Range: $3.75 Discount Per Security: $0.2625 Security Name: Class A Common Warrants Security Type: Equity Warrant Securities Offered: 2,270,000 Security Name: Class B Common Warrants Security Type: Equity Warrant Securities Offered: 2,270,000 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 1,684,000 Price\Range: $3.749 Discount Per Security: $0.2624お知らせ • Jun 18Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,270,000 Price\Range: $3.75 Discount Per Security: $0.2625 Security Name: Class A Common Warrants Security Type: Equity Warrant Securities Offered: 4,540,000 Security Name: Class B Common Warrants Security Type: Equity Warrant Securities Offered: 4,540,000 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 2,270,000お知らせ • Jun 02Panbela Announces 1-For-30 Reverse Stock Split Effective June 1, 2023 to Regain Compliance with the Continued Listing Requirements of the Nasdaq Capital MarketPanbela Therapeutics, Inc. announced that it will implement the previously announced and stockholder approved 1-for-30 reverse split of its common stock. The reverse stock split will be effective as of the morning of June 1, 2023, and the company’s common stock will trade on a post-split basis at the beginning of trading on the same date under the existing trading symbol “PBLA.” The CUSIP number for the common stock following the reverse stock split will be 69833W305. The reverse stock split is primarily intended to increase the market price per share of the company’s common stock to regain compliance with the continued listing requirements of The Nasdaq Capital Market. The company intends to continue to pursue additional actions to satisfy the exchange’s other continued listing requirements. The reverse stock split will reduce the number of shares of the company’s common stock currently outstanding to an estimated 559,560 shares. Proportionate adjustments will be made to the conversion and exercise prices of the company’s outstanding stock purchase warrants, stock options and to the number of shares issued and issuable under the company’s equity incentive plans. The number of shares authorized for issuance by the company will not decrease as a result of the reverse stock split.Breakeven Date Change • Mar 18Forecast to breakeven in 2025The 2 analysts covering Panbela Therapeutics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 4.8% per year to 2024. The company is expected to make a profit of US$6.98m in 2025. Average annual earnings growth of 67% is required to achieve expected profit on schedule.お知らせ • Feb 14Panbela Therapeutics Regains Compliance with Nasdaq Listing StandardsPanbela Therapeutics, Inc. announced that, primarily as a result of the January 30, 2023 closing of its public offering of approximately $15 million of common stock and warrants, Panbela has regained compliance with applicable listing standards of The Nasdaq Stock Market. Nasdaq has issued notice that Panbela has regained compliance for continued listing of its common stock. On February 9, 2023, Panbela received a letter from Nasdaq confirming that Panbela has cured the previously identified minimum bid price and stockholders’ equity deficiencies under Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively, and that Panbela is in compliance with all applicable listing standards. Panbela’s previously scheduled delisting determination appeal hearing has been canceled, and its common stock will continue to be listed and traded on Nasdaq.Breakeven Date Change • Feb 01Forecast to breakeven in 2025The 2 analysts covering Panbela Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$6.98m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule.お知らせ • Jan 27Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $15.01875 million.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $15.01875 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 6,675,000 Price\Range: $2.25 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 13,350,000お知らせ • Jan 12Panbela Therapeutics, Inc. Starts Phase II Trial of CPP-1X-T for Recent Onset Type I Diabetes, in Collaboration with Indiana University School of Medicine and JDRFPanbela Therapeutics, Inc. announced that it has commenced a Phase II double-blind, randomized study to evaluate CPP-1X-T (Eflornithine tablets) for recent onset type 1 diabetes, in collaboration with Indiana University School of Medicine and funded by JDRF, the leading global type 1 diabetes research and advocacy organization. Indiana University expects to enroll 70 patients in the Phase II clinical trial at approximately 6 centers in the United States. Study eligibility will be for patients with recent onset type 1 diabetes. Participants will be randomized 2:1 to CPP-1X-T, administered orally with food, twice daily, at a 1000 mg/m2 dose, or placebo over 6 months followed by a 6 month wash out period to assess durability of response. The primary objective will be to determine the difference between the treated and placebo 2-hour Area Under the Curve (AUC)-mean using the log (mean C-peptide+1) at the 6-month end of treatment period. Secondary objectives will include C-peptide AUC, fasting and stimulated proinsulin/c-peptide ratios a biomarker of ß cell stress, and the urine polyamine content at 3, 9, and 12 months timepoints.Price Target Changed • Nov 16Price target decreased to US$6.00Down from US$6.67, the current price target is provided by 1 analyst. New target price is 3,674% above last closing price of US$0.16. Stock is down 93% over the past year. The company is forecast to post a net loss per share of US$1.52 next year compared to a net loss per share of US$0.87 last year.Seeking Alpha • Sep 30Panbela Therapeutics dips 24% on pricing $6M public offeringPanbela Therapeutics (NASDAQ:PBLA) prices a public offering of (i) 20.1M shares of stock, warrants to purchase up to 30.15M shares at a purchase price of $0.30. Warrants will have an exercise price of $0.30 per share, are exercisable upon issuance, and will expire five years following the date of issuance. Offering is expected to close on or about October 4, 2022. Gross proceeds of $6M. Net proceeds to be deployed for the continued clinical development of its product candidates ivospemin (SBP-101) and eflornithine (CPP-1X), working capital, business development and other general corporate purposes, which may include repayment of debt. Stock drops 24% pre-marketSeeking Alpha • Aug 15Panbela Therapeutics GAAP EPS of -$1.51Panbela Therapeutics press release (NASDAQ:PBLA): Q2 GAAP EPS of -$1.51. Total cash was $2.5M as of June 30, 2022.Board Change • Jun 22Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Art Fratamico was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.お知らせ • May 02Panbela Therapeutics, Inc., Annual General Meeting, Jun 08, 2022Panbela Therapeutics, Inc., Annual General Meeting, Jun 08, 2022, at 14:30 Eastern Daylight. Location: Element Bloomington, 2400 East 82nd Street, Bloomington, Minnesota 55425, Bloomington United States Agenda: To Elect directors; to Ratify the selection of Cherry Bekaert LLP as independent registered public accounting firm; to Approve the issuance of shares of common stock as partial consideration for acquisition of Cancer Prevention Pharmaceuticals, Inc; and Approve the adjournment or postponement of the Annual Meeting to solicit additional proxies if there are insufficient votes at the time of the Annual Meeting to approve acquisition of Cancer Prevention Pharmaceuticals, Inc.Price Target Changed • Apr 27Price target increased to US$8.00Up from US$6.67, the current price target is an average from 3 analysts. New target price is 373% above last closing price of US$1.69. Stock is down 64% over the past year. The company is forecast to post a net loss per share of US$0.93 next year compared to a net loss per share of US$0.87 last year.お知らせ • Feb 24Panbela Therapeutics, Inc. (NasdaqCM:PBLA) entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc.Panbela Therapeutics, Inc. (NasdaqCM:PBLA) entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc. on February 21, 2022. The consideration will be paid through stock at closing. The potential Post-Closing Contingent Payments are eligible to be paid in connection with the future satisfaction of three milestones after netting out applicable expenses and setoff amounts: (1) 50% of milestone payments and royalties received pursuant to the existing North American license agreement, up to a maximum payout of $25.0 million; (2) 50% of royalty payments received for U.S. sales of Flynpovi in excess of $400.0 million, up to a maximum payout of $15.0 million; and (3) either 35% of any cash amounts originating from the European Union and received pursuant to partnerships involving Flynpovi or 10% of any cash amounts received from efforts to self-market Flynpovi in the European Union; up to an aggregate maximum payout of $20.0 million. The combined company will be led by Jennifer Simpson, Chief Executive Officer of Panbela and will remain headquartered in Waconia, Minnesota. The board of the combined company is expected to optimize the value of this transaction and beyond and will include at least two members initially designated by CPP, CPP Chief Executive Officer, Jeff Jacob, and CPP Director, Dan Donovan. The proposed mergers have been unanimously approved by the boards of directors of each company and the stockholders of CPP. A closing is expected to occur by the second quarter of 2022, subject to approval of the issuance of securities in the transactions by Panbela’s stockholders, and satisfaction of other customary closing conditions. Canaccord Genuity LLC is acting as the exclusive financial advisor to Panbela, and W. Morgan Burns and Joshua L. Colburn of Faegre Drinker Biddle & Reath LLP is acting as its legal counsel. The Sage Group is acting as the exclusive financial advisor to CPP, and Leslie Marlow of Blank Rome LLP is acting as its legal counsel.分析記事 • Feb 18Companies Like Panbela Therapeutics (NASDAQ:PBLA) Are In A Position To Invest In GrowthEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...お知らせ • Jan 25Panbela Presents Clinical Data on Phase 1B Clinical Trial of Sbp-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pda At 2022 Asco Gi MeetingPanbela Therapeutics, Inc. announced the presentation of interim clinical data from its Phase 1b combination therapy study of SBP-101, a proprietary polyamine analogue, with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA), at the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Meeting that took place January 20-22, 2022. At the Phase 1b dose and schedule (N=30), CA19-9 levels decreased 60-99% in 70% of evaluable patients, with 1/29 (3%) achieving a complete remission, 13/29 evaluable patients achieving partial responses (45%) and 10/29 achieving stable disease at 8 weeks (34%). PFS was 6.0 months. While PFS may be confounded by SBP-101 dosing holds implemented to investigate potential toxicity, the rates for 6-month PFS was 52% and for 12 month PFS was 10%. Nine subjects are in survival follow up as of the date the poster was presented at the ASCO GI meeting. Median OS is 12.0 months and is not final. The safety population includes all subjects who received at least one dose of SBP-101 (N=50). The most common Grade =3 adverse events (AEs) related to any study medication were neutropenia in 20 subjects (19 attributed to G+A and 1 attributed to all 3) and elevated liver function tests in 14 subjects (5 attributed to SBP-101 and 9 attributed to all 3). SBP-101-related increases in LFTs were asymptomatic in all but 2 subjects and reversed in all subjects when SBP-101 administration was interrupted and dose-reduced or discontinued. Additionally, seven subjects experienced serious vision adverse events (4 possibly related to SBP-101, 1 related to gemcitabine and 2 related to all 3 based on PI assessment). All were considered by the sponsor to be possibly related to SBP-101; 5 had findings consistent with retinopathy. The company has just begun a randomized trial to study SBP-101, as an addition to first-line treatment for metastatic PDA, will begin a neoadjuvant pancreatic trial this quarter and will begin an Ovarian Cancer program mid-year. SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown potential signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, if SPB-101 receives approval in the US. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events observed in the Company’s recently completed Phase 1a/1b clinical trial have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.Seeking Alpha • Jan 06Panbela: Biotech With Updated Patent Protection And Unmet Market Target IndicationData from phase 1b study using SBP-101 for patients with pancreatic cancer will be shown at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium on January 20- 22, 2022. Pancreatic cancer patients in cohort 2 given SBP-101 + chemotherapies achieved ORR of 71%; Cohort 4 patients achieved ORR of 48% but median overall survival has not yet been reached. The global pancreatic cancer market is expected to reach $4.5 billion by 2025. A phase 1 study using SBP-101 for the treatment of patients with ovarian cancer is expected to start in the 1st half of 2022.お知らせ • Dec 15Panbela Therapeutics, Inc. Announces Positive Preclinical Data Strongly Supporting the Activity of SBP-101 in Ovarian Cancer Cell LinesPanbela Therapeutics, Inc. announced positive preclinical data supporting the activity of SBP-101 in ovarian cancer cell lines. Panbela expects to launch a development effort for SBP-101 in ovarian cancer in the first half of 2022 and will host a virtual R&D day to discuss the new ovarian cancer program early in the new year. As stated by the European Society for Medical Oncology (ESMO), ovarian cancer represents a significant unmet need in gynecological cancers, with the absence of well-defined screening programs and inconsistent initial symptoms leading to late diagnosis in most patients. Considered largely incurable, ovarian cancer typically relapses within 3 years in 80% of women, with subsequent recurrences arising sooner each time as resistance to chemotherapy develops. About SBP-101: SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.分析記事 • Nov 02Will Panbela Therapeutics (NASDAQ:PBLA) Spend Its Cash Wisely?We can readily understand why investors are attracted to unprofitable companies. For example, although...Director Overboarding • Aug 05Director Jennifer Simpson has joined 3rd company boardCEO, President & Director Jennifer Simpson has been appointed to the board of CytRx Corporation (OTCPK:CYTR). Simpson now sits on a total of 3 company boards. With 3 board positions including the role of CEO at Panbela Therapeutics, Inc. (NasdaqCM:PBLA), the director is at risk of having too many board obligations according to the Simply Wall St Risk Model.分析記事 • Jul 15Companies Like Panbela Therapeutics (NASDAQ:PBLA) Are In A Position To Invest In GrowthEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...お知らせ • Jun 05Panbela Therapeutics, Inc. Presents Clinical Data on Phase 1b Clinical Trial of SBP-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic PDA at 2021 ASCO Annual MeetingPanbela Therapeutics, Inc. announced the presentation of interim clinical data from its Phase 1b combination therapy study of SBP-101, a proprietary polyamine analogue, with gemcitabine and nab-paclitaxel (G+A) in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDA), at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4-8, 2021. In the response-evaluable subjects in cohort 4 + Phase 1b (N=29), 11 had treatment with SBP-101 interrupted to evaluate retinal toxicity; this may impact final efficacy results. In cohort 2 (N=7) the objective response rate (ORR) was 71%, and the disease control rate (DCR) was 100% by RECIST criteria (stable disease (SD) or better for = 16 weeks). Median progression free survival (PFS) in cohort 2 was 5.63 months and median overall survival (OS) was 10.3 months compared with ORR of 48%, DCR of 70%, PFS of 5.2 months and median OS, not yet reached, in cohort 4 + 1b. SBP-101 was well-tolerated when administered at doses and schedules tested in combination with G+A in subjects with previously untreated metastatic pancreatic adenocarcinoma. The most common Grade =3 adverse events (AEs) related to any study medication were neutropenia in 20 subjects (19 attributed to G+A and 1 attributed to all 3) and elevated liver function tests in 15 subjects (5 attributed to SBP-101 and 10 attributed to all 3). SBP-101-related increases in LFTs were asymptomatic in all but 2 subjects and reversed in all subjects when SBP-101 administration was interrupted and dose-reduced or discontinued. Additionally, six subjects experienced serious vision adverse events (3 possibly related to SBP-101, 1 related to gemcitabine and 2 related to all 3 based on PI assessment). All were considered by the sponsor to be possibly related to SBP-101; 5 had findings consistent with retinopathy. All future studies will exclude patients with a history of retinopathy or at risk of retinal detachment and scheduled ophthalmologic monitoring for all patients. Additionally, in future dose-finding studies screening for retinal toxicity will be included. The company continues to plan for the initiation of a randomized trial to study SBP-101, as an addition to first-line treatment for metastatic PDA, in the middle of this year and releasing preclinical data across tumors outside of pancreatic cancer by year-end.Breakeven Date Change • May 18Forecast to breakeven in 2025The analyst covering Panbela Therapeutics expects the company to break even for the first time. New forecast suggests the company will make a profit of US$14.3m in 2025. Average annual earnings growth of 5.6% is required to achieve expected profit on schedule.分析記事 • Mar 29We Think Panbela Therapeutics (NASDAQ:PBLA) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...お知らせ • Feb 11+ 1 more updatePanbela Therapeutics Inc. Provides Update on Current Clinical Trial: Decision to Hold Administration of SBP-101Panbela Therapeutics Inc. has been evaluating the safety and tolerability of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA). SBP-101 has received Fast Track and Orphan Drug designation from FDA and Panbela has been working closely with the FDA to advance its development studies of SBP-101 for patients with metastatic PDA. Panbela continues to be in communication with the trial investigators regarding the recommendation from the independent data safety monitoring board (DSMB) of the ongoing Phase 1 clinical trial to hold administration of SBP-101 pending further investigation of visual disturbance adverse events. Some patients in the trial were noted to have complaints of visual changes, although visual changes were not seen in the SBP-101 monotherapy study. Company have consulted with the DSMB and SBP-101 will not be administered to ongoing patients in the current trial while additional safety information is analyzed. Patients will continue with the standard drug regimen. All other trial activities continue. Panbela has conferred with FDA regarding the plan to continue the trial but hold dosing of SBP-101 in ongoing patients until company can learn more. Withholding SBP-101 constitutes a “partial clinical hold”. There is no impact on enrollment, as enrollment of the trial completed in December 2020, and the study is ongoing. Panbela is working to finalize a visual screening program in order to understand the significance of reported visual changes and to inform future studies. Company will also seek to evaluate the exact cause of these recent visual reports and to determine whether serial eye exams during treatment can identify potential toxicity or risk before symptoms develop. While company evaluate supplementary data, company remain confident in the potential benefits of SBP-101 including its potential benefits for patients with pancreatic cancer. Company are thankful to the patients who have, or are, participating in company clinical trials. Company are committed to objectively evaluating the data from those clinical studies to confirm both the therapeutic benefits and safety profile of company polyamine inhibitor in metastatic pancreatic cancer patients. Panbela is planning to submit interim results at a major cancer conference and looks forward to publication of final efficacy and safety data, when available. Additionally, all other research and manufacturing activities related to future SBP-101 indications are continuing, including working with the FDA to initiate a randomized trial mid-year. SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved standard chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides support for continued evaluation of the compound in a randomized clinical trial subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold.Is New 90 Day High Low • Jan 28New 90-day high: US$4.93The company is up 72% from its price of US$2.86 on 29 October 2020. The American market is up 21% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 28% over the same period.お知らせ • Dec 10Panbela Therapeutics, Inc. Completes Enrollment in Its Phase 1B Trial Investigating SBP-101 Combination Therapy for First Line Metastatic Pancreatic CancerPanbela Therapeutics Inc. disruptive therapeutics for the treatment of patients with cancer, has completed patient enrollment in its Phase 1 trial evaluating the safety and tolerability of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma. The trial, which included a dose escalation phase and an expansion phase, enrolled 50 patients, 30 of whom were treated using the dose and schedule that will advance to a randomized trial of the combination versus gemcitabine and nab-paclitaxel alone planned to begin in the first half of 2021. In total, the safety of SBP-101 has been evaluated in 79 patients in two clinical trials. SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial of patients with previously untreated metastatic PDA at sites in the United States and Australia. SBP -101 has received Fast Track and orphan drug designation from FDA.Is New 90 Day High Low • Dec 10New 90-day high: US$4.37The company is up 52% from its price of US$2.87 on 10 September 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 21% over the same period.お知らせ • Aug 29Sun BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $10.5 million.Sun BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $10.5 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,545,454 Price\Range: $4.125 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 2,545,454お知らせ • Jul 18Sun Biopharma, Inc. Announces Appointment of Jennifer K. Simpson, Ph.D., as Chief Executive OfficerSun BioPharma, Inc. announced the appointment of Jennifer K. Simpson, Ph.D., as Chief Executive Officer. Dr. Simpson brings more than two decades of public company executive and fundraising experience in oncology drug development and commercialization to Sun BioPharma, most recently having served as CEO of Delcath Systems, Inc.株主還元PBLAUS BiotechsUS 市場7D1,000.0%1.2%1.6%1Y-95.7%35.9%28.5%株主還元を見る業界別リターン: PBLA過去 1 年間で35.9 % の収益を上げたUS Biotechs業界を下回りました。リターン対市場: PBLAは、過去 1 年間で28.5 % のリターンを上げたUS市場を下回りました。価格変動Is PBLA's price volatile compared to industry and market?PBLA volatilityPBLA Average Weekly Movementn/aBiotechs Industry Average Movement10.8%Market Average Movement7.2%10% most volatile stocks in US Market16.8%10% least volatile stocks in US Market3.0%安定した株価: PBLAの株価は、 US市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のPBLAのボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト2011n/aJennifer Simpsonwww.panbela.comPanbela Therapeutics, Inc.は臨床段階にあるバイオ医薬品企業で、アンメット・メディカル・ニーズの高い患者を対象とした破壊的治療薬の開発に取り組んでいる。同社の主要製品候補は、転移性膵管腺癌患者を対象とした第Ia/Ib相臨床試験を完了した独自のポリアミンアナログであるIvospemin（SBP-101）である；エフロルニチン（CPP-1X）とスリンダックの配合剤であるFlynpovi（臨床第III相試験中）、酵素活性化オルニチン脱炭酸酵素の非可逆的阻害剤であるEflornithine（臨床第I/II相試験中）。また、ジョンズ・ホプキンス大学医学部とivospeminの開発に関する研究契約を結んでいる。旧社名はサン・バイオファーマ・インクで、2020年12月にパンベラ・セラピューティクス・インクに社名変更。Panbela Therapeutics, Inc.は2011年に法人化され、ミネソタ州ワコニアに本社を置いている。もっと見るPanbela Therapeutics, Inc. 基礎のまとめPanbela Therapeutics の収益と売上を時価総額と比較するとどうか。PBLA 基礎統計学時価総額US$53.40k収益（TTM）-US$37.05m売上高(TTM)n/a0.0xP/Sレシオ0.0xPER（株価収益率PBLA は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計PBLA 損益計算書（TTM）収益US$0売上原価US$0売上総利益US$0その他の費用US$37.05m収益-US$37.05m直近の収益報告Sep 30, 2024次回決算日該当なし一株当たり利益（EPS）0グロス・マージン0.00%純利益率0.00%有利子負債／自己資本比率0.0%PBLA の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/05/31 09:36終値2026/05/29 00:00収益2024/09/30年間収益2023/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Panbela Therapeutics, Inc. 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。4 アナリスト機関Robin Garner KalleyCraig-Hallum Capital Group LLCJoseph PantginisH.C. Wainwright & Co.Jason McCarthyMaxim Group1 その他のアナリストを表示
お知らせ • Oct 30Nant Capital Engages in Discussions with Panbela TherapeuticsOn October 29, 2024, Nant Capital, LLC announced that it has been and may continue to be in contact with members of Panbela Therapeutics, Inc.’s management, the Company’s board of directors, other significant shareholders, and others regarding alternatives that the Company could employ to maximize shareholder value.
お知らせ • Jun 24Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial ModificationPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The DSMB recommended study continuation without modification, marking the third consecutive positive safety review. The safety database now includes 395 patients, compared to 214 patients on November 29, 2023. Key Takeaways: The DSMB's recommendation to proceed without modification affirms support for ivospemin’s safety profile. The safety database has expanded to 395 patients, providing a robust foundation for evaluating ivospemin's safety. The lower-than-expected event rate suggests the potential for prolonged survival among ASPIRE trial participants. Rapid enrollment positions Panbela to remain on path to complete enrollment in First Quarter 2025, earlier than initially anticipated. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin, and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years, with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9-month survival benefit compared to the approval of gemcitabine and nab-paclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela remains committed to advancing the ASPIRE trial and evaluating ivospemin's potential to improve outcomes for patients with mPDAC. Despite recent advancements in treatment, the median overall survival for patients with mPDAC remains less than 12 months. The company looks forward to the interim survival analysis in early 2025, which will provide important insights into ivospemin's potential to address this significant unmet medical need.
お知らせ • Apr 27Panbela Therapeutics, Inc. Announces Nasdaq Files A Form 25 Notification of Removal from ListingOn April 25, 2024, The Nasdaq Stock Market LLC (Nasdaq") filed a Form 25 Notification of Removal from Listing indicating that the delisting will become effective ten days after the Form 25 was filed. As a result, Panbela Therapeutics, Inc. no longer intends to file its own Form 25. The Company has applied to list its common stock on the US Equity Listings Tier II of the Chicago Board of Options Exchange (CBOE"). No assurances can be given that the application will be approved or that a trading market will develop on the CBOE. In the interim, the Company intends to maintain the existing eligibility for quotation of its common stock on the OTCQB under its current symbol, PBLA".
お知らせ • Apr 24Panbela Therapeutics, Inc. Announces Interim Data Analysis for its Ongoing ASPIRE Trial Pushed to First Quarter of 2025Panbela Therapeutics, Inc. announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as first quarter of 2025. This delay in the projected date for analysis comes as a result of the trial's current event rate, which is lower than initially anticipated, indicating that patients have lived longer than expected. The ASPIRE trial, which is evaluating the efficacy and safety of Panbela's lead product candidate, ivospemin (SBP-101), in combination with gemcitabine and nab-paclitaxel (Abraxane) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), requires 33% of the total expected events to occur before the interim analysis can be conducted. As of the latest assessment, less than half of the required events for the interim analysis have occurred. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9 month survival benefit compared to the approval of gemcitabine and nab-paclitaxel which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela will continue to monitor the progress of the ASPIRE trial and provide updates as appropriate.
お知らせ • Apr 20Panbela Announces Poster Presentation At American Association for Cancer ResearchPanbela Therapeutics, Inc. announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024. The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine. The poster highlights the efficacy of SBP-101 in combination with doxorubicin which is used to treat platinum-resistant ovarian cancer. Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. SBP-101 and doxorubicin cooperatively increase polyamine catabolism and decrease overall cell survival in vitro. Utilizing the immunocompetent VDID8+ murine ovarian cancer model (ID8+ C57Bl/6 ovarian cells overexpressing both VEGF and Defensin), the combination of SBP-101 and doxorubicin was evaluated significantly increased median mouse survival time. Cotreatment also results in delayed ascites formation and decreased overall tumor burden. The combination treatment cooperatively decreases overall ascitic polyamine content.Immunodeficient NSG mice injected with VDID8+ ovarian cancer cells do not receive a survival benefit from ivospemin, doxorubicin, or a combination treatment, indicating that an intact immune system is required for the efficacy of this therapy. The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP-101 in combination with other polyamine metabolism modulators as well as with immune modulators.
お知らせ • Apr 19+ 1 more updatePanbela Therapeutics, Inc. has filed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has filed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 29,069,768 Security Name: Class G Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Class H Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 29,069,768
お知らせ • Oct 30Nant Capital Engages in Discussions with Panbela TherapeuticsOn October 29, 2024, Nant Capital, LLC announced that it has been and may continue to be in contact with members of Panbela Therapeutics, Inc.’s management, the Company’s board of directors, other significant shareholders, and others regarding alternatives that the Company could employ to maximize shareholder value.
お知らせ • Jun 24Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial ModificationPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) has completed its third pre-specified safety review of the ongoing Phase 3 ASPIRE clinical trial evaluating ivospemin in combination with gemcitabine and nab-Paclitaxel for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The DSMB recommended study continuation without modification, marking the third consecutive positive safety review. The safety database now includes 395 patients, compared to 214 patients on November 29, 2023. Key Takeaways: The DSMB's recommendation to proceed without modification affirms support for ivospemin’s safety profile. The safety database has expanded to 395 patients, providing a robust foundation for evaluating ivospemin's safety. The lower-than-expected event rate suggests the potential for prolonged survival among ASPIRE trial participants. Rapid enrollment positions Panbela to remain on path to complete enrollment in First Quarter 2025, earlier than initially anticipated. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin, and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years, with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9-month survival benefit compared to the approval of gemcitabine and nab-paclitaxel, which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela remains committed to advancing the ASPIRE trial and evaluating ivospemin's potential to improve outcomes for patients with mPDAC. Despite recent advancements in treatment, the median overall survival for patients with mPDAC remains less than 12 months. The company looks forward to the interim survival analysis in early 2025, which will provide important insights into ivospemin's potential to address this significant unmet medical need.
お知らせ • Apr 27Panbela Therapeutics, Inc. Announces Nasdaq Files A Form 25 Notification of Removal from ListingOn April 25, 2024, The Nasdaq Stock Market LLC (Nasdaq") filed a Form 25 Notification of Removal from Listing indicating that the delisting will become effective ten days after the Form 25 was filed. As a result, Panbela Therapeutics, Inc. no longer intends to file its own Form 25. The Company has applied to list its common stock on the US Equity Listings Tier II of the Chicago Board of Options Exchange (CBOE"). No assurances can be given that the application will be approved or that a trading market will develop on the CBOE. In the interim, the Company intends to maintain the existing eligibility for quotation of its common stock on the OTCQB under its current symbol, PBLA".
お知らせ • Apr 24Panbela Therapeutics, Inc. Announces Interim Data Analysis for its Ongoing ASPIRE Trial Pushed to First Quarter of 2025Panbela Therapeutics, Inc. announced that the interim data analysis for its ongoing ASPIRE trial is now expected to be available as soon as first quarter of 2025. This delay in the projected date for analysis comes as a result of the trial's current event rate, which is lower than initially anticipated, indicating that patients have lived longer than expected. The ASPIRE trial, which is evaluating the efficacy and safety of Panbela's lead product candidate, ivospemin (SBP-101), in combination with gemcitabine and nab-paclitaxel (Abraxane) in patients with metastatic pancreatic ductal adenocarcinoma (mPDAC), requires 33% of the total expected events to occur before the interim analysis can be conducted. As of the latest assessment, less than half of the required events for the interim analysis have occurred. Panbela also highlighted the significance of the ASPIRE trial in the context of recent advancements in mPDAC treatment, such as the Napoli 3 trial, which led to the approval of liposomal irinotecan (Onivyde) in combination with fluorouracil, oxaliplatin and leucovorin (NALIRIFOX). Despite this approval, which was based on a median overall survival benefit of 1.9 months compared to gemcitabine and nab-paclitaxel, the prognosis for patients with mPDAC remains poor, with median overall survival still less than 12 months. The incremental benefits in median survival have been modest in the past 11 years with the recent approval of Onivyde in the NALIRIFOX regimen demonstrating a 1.9 month survival benefit compared to the approval of gemcitabine and nab-paclitaxel which was based on a median overall survival benefit of 1.8 months over gemcitabine alone. Panbela will continue to monitor the progress of the ASPIRE trial and provide updates as appropriate.
お知らせ • Apr 20Panbela Announces Poster Presentation At American Association for Cancer ResearchPanbela Therapeutics, Inc. announces a poster presentation highlighting the results for ivospemin (SBP-101) as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR), which took place April 10, 2024. The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine. The poster highlights the efficacy of SBP-101 in combination with doxorubicin which is used to treat platinum-resistant ovarian cancer. Treatment with doxorubicin significantly increases the in vitro toxicity of SBP-101 in both cisplatin-sensitive and cisplatin-resistant ovarian cancer cell lines. SBP-101 and doxorubicin cooperatively increase polyamine catabolism and decrease overall cell survival in vitro. Utilizing the immunocompetent VDID8+ murine ovarian cancer model (ID8+ C57Bl/6 ovarian cells overexpressing both VEGF and Defensin), the combination of SBP-101 and doxorubicin was evaluated significantly increased median mouse survival time. Cotreatment also results in delayed ascites formation and decreased overall tumor burden. The combination treatment cooperatively decreases overall ascitic polyamine content.Immunodeficient NSG mice injected with VDID8+ ovarian cancer cells do not receive a survival benefit from ivospemin, doxorubicin, or a combination treatment, indicating that an intact immune system is required for the efficacy of this therapy. The poster concludes that the treatment of C57Bl/6 mice containing VDID8+ ovarian cancer with SBP-101 in combination with doxorubicin significantly prolonged survival and decreased overall tumor burden. Future studies will be designed to evaluate the effects of SBP-101 in combination with other polyamine metabolism modulators as well as with immune modulators.
お知らせ • Apr 19+ 1 more updatePanbela Therapeutics, Inc. has filed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has filed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 29,069,768 Security Name: Class G Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Class H Common Warrants Security Type: Equity Warrant Securities Offered: 29,069,768 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 29,069,768
お知らせ • Mar 07+ 1 more updateThe Nasdaq Stock Market Notifies Panbela Therapeutics That the Nasdaq Hearings Panel Has Determined to Delist the Company’s Common StockOn March 5, 2024, The Nasdaq Stock Market LLC notified Panbela Therapeutics, Inc. that the Nasdaq Hearings Panel has determined to delist the Company’s common stock and that trading of the Company’s securities will be suspended at the open of trading on March 7, 2024. Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the U.S. Securities and Exchange Commission after applicable appeal periods have lapsed. In the interim, the Company expects its common stock will be eligible for quotation on the OTC Pink Market under its existing symbol, “PBLA.” The Panel reached its decision because the Company is in violation of the minimum $2.5 million stockholders equity requirement in Listing Rule 5550(b)(1) and unable to comply with any of the alternative requirements in Listing Rule 5550(b). The Company has 15 days after the date it received notice of the Panel’s decision to request that the Nasdaq Listing and Hearing Review Council review the decision, or the Council may, on its own motion, determine to review the Panel’s decision within 45 calendar days after the Company was notified of the decision. The Company plans to continue to file its required periodic reports and other filings with the SEC.
お知らせ • Feb 02Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 4,375,000 Price\Range: $2.06 Discount Per Security: $0.1442 Security Name: Class E Common Warrants Security Type: Equity Warrant Securities Offered: 4,375,000 Security Name: Class F Common Warrants Security Type: Equity Warrant Securities Offered: 4,375,000 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 4,375,000 Price\Range: $2.059 Discount Per Security: $0.1441
お知らせ • Jan 26Panbela Therapeutics, Inc. Exceeds 50% Enrollment for Aspire Trial in Pancreatic Cancer, Exceeding Anticipated Timelines with Accelerated MomentumPanbela Therapeutics, Inc. announced it has reached 50% enrollment for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. Panbela is committed to delivering a more effective treatment for pancreatic cancer, a deadly disease with few treatment options. The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies.Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenac and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the previous Panbela-sponsored clinical trials provide support for continued evaluation of ivospemin in the ASPIRE trial. Flynpovi is a combination of CPP-1X (eflornithine) and sulindac with a dual mechanism inhibiting polyamine synthesis and increasing polyamine export and catabolism. In a Phase III clinical trial in patients with sporadic large bowel polyps, the combination prevented > 90% subsequent pre-cancerous sporadic adenomas versus placebo. Focusing on FAP patients with lower gastrointestinal tract anatomy in the recent Phase III trial comparing Flynpovi to single agent eflornithine and single agent sulindac, FAP patients with lower GI anatomy (patients with an intact colon, retained rectum or surgical pouch), showed statistically significant benefit compared to both single agents (p=0.02) in delaying surgical events in the lower GI for up to four years. The safety profile for Flynpovi did not significantly differ from the single agents and supports the continued evaluation of Flynpovi for FAP. CPP-1X (eflornithine) is being developed as a single agent tablet or high dose powder sachet for several indications including prevention of gastric cancer, treatment of neuroblastoma and recent onset Type 1 diabetes. Preclinical studies as well as Phase I or Phase II investigator-initiated trials suggest that CPP-1X treatment may be well-tolerated and has potential activity.
お知らせ • Jan 25Panbela Therapeutics Receives Notice from the Listing Qualifications Department of the Nasdaq Regarding Listing Rule 5550(a)(4)On January 22, 2024, Panbela Therapeutics, Inc. (the ‘Company’) received a notice from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market LLC (‘Nasdaq’) indicating that, as of effective date of the previously reported 1-for-20 reverse stock split on January 18, 2024, the Company was no longer in compliance with Nasdaq Listing Rule 5550(a)(4) (the ‘Minimum Float Requirement’), which requires a minimum of 500,000 publicly held shares. The Staff informed the Company that this matter serves as an additional basis for delisting the Company’s common stock and that the Nasdaq Hearings Panel will consider this matter in rendering a determination regarding the Company’s continued listing on The Nasdaq Capital Market. As previously reported, the Company has requested and has been granted a hearing to present its plan to regain compliance with the bid price of $1.00 per share requirement as outlined in Nasdaq Listing Rule 5550(a)(2) (the ‘Minimum Bid Price Requirement’) and the minimum stockholders’ equity requirement as required by Nasdaq Listing Rule 5550(b) (the ‘Minimum Stockholders’ Equity Requirement’). Any delisting of the Company’s common stock has been stayed pending the conclusion of the hearing process. Consequently, the Company’s common stock is expected to remain listed on the Nasdaq Capital Market at least until the panel renders a decision following the hearing. There can be no assurance that the panel will grant the Company’s appeal for continued listing. If the Company is unable to regain compliance with the Minimum Bid Price Requirement, the Minimum Stockholders’ Equity Requirement, or the Minimum Float Requirement, then it is likely that its common stock will be delisted from the Nasdaq Capital Market. The Company intends to continue to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and continues to evaluate various alternative courses of action to regain compliance with the Rules. However, there can be no assurance that the Company will be able to maintain compliance with the Nasdaq Capital Market’s continued listing requirements or regain compliance with the Rules.
お知らせ • Jan 18Panbela Therapeutics, Inc. Announces Publication of Clinical Data Titled: Phase 1 Study of High-Dose DFMO, Celecoxib, Cyclophosphamide and Topotecan for Patients with Relapsed NeuroblastomaPanbela Therapeutics, Inc. announces the publication of clinical data from studies of CPP-1X (also known as a-Difluoromethylornithine (DFMO) or Eflornithine) in neuroblastoma. According to Hogarty et al, children with relapsed refractory neuroblastoma have dismal outcomes and new therapeutic options are needed. Data published in the British Journal of Cancer investigated the tolerability and activity of depleting polyamines by high dose CPP-1X and celecoxib in combination with standard of care chemotherapy in heavily pretreated neuroblastoma patients. Results showed that DFMO treatment was well tolerated, and the median time-to-progression was 19.8 months. From the Phase 1 dose range finding study of CPP-1X in heavily pretreated neuroblastoma patients, CPP-1X was well tolerated. The best overall response included 2 partial responses (PR), 4 minor responses (MR), 10 Stable disease (SD), 7 progressive disease (PD) and 1 unevaluable. All patients with an overall response of PR or MR sustained this response until stopping or completing protocol therapy. The overall objective response rate (CR+PR) was 9% and rate of any response (CR+PR+MR) was 26%. At 2 years, PFS (progression free survival) for the entire cohort was 29.5%. Notably, three patients completed protocol therapy and remain without disease progression or event at >4 years from treatment end in the absence of additional therapy. These results build upon the recent FDA approval of CPP-1X or DFMO to reduce the risk of relapse in adult and pediatric patients with high-risk neuroblastoma (HRNB) who have demonstrated at least a partial response to prior multiagent, multimodality therapy including anti-GD2 immunotherapy. Results from these studies suggest that CPP-1X is a safe, oral treatment option that may improve response rates in heavily pretreated relapsed refractory neuroblastoma patients and are the basis for the ongoing ANBL-1821 Phase 2 trial.
お知らせ • Nov 29Panbela Therapeutics, Inc. Announces second Independent Safety Review of the ASPIRE Registration Clinical TrialPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) of the Phase 3 ASPIRE clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients which included 214 patients in the trial. The DSMB has recommended that the study continue without modification. The ASPIRE Trial is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, ovarian cancer and diabetes. The combined development programs have a steady cadence of catalysts with programs ranging from pre-clinical to registration studies.
New Risk • Nov 11New major risk - Negative shareholders equityThe company has negative equity. Total equity: -US$2.5m This is considered a major risk. Being in negative equity means that the company's liabilities exceed its assets, meaning it owes more to creditors than it has in owned assets. While this doesn't mean the company is about to collapse, in the long-term, this is unsustainable. The company may have issues meeting financial obligations, is at risk of becoming insolvent and may have difficulty raising capital, especially more debt, if needed. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$27m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Negative equity (-US$2.5m). Shareholders have been substantially diluted in the past year (over 110x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.72m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$42m net loss in 3 years).
お知らせ • Nov 04Panbela Announces Publication of Preclinical and Clinical Data Titled: Inhibition of Polyamine Biosynthesis Preserves B Cell Function in Type 1 DiabetesPanbela Therapeutics, Inc. announced the publication of preclinical and clinical data from studies of CPP-1X (also known as a-Difluoromethylornithine (DFMO) or Eflornithine) in recent onset type 1 diabetes (T1D). According to Sims et al, although therapy of T1D has improved, the morbidity, mortality and cost continue to impact the quality of life for those affected highlighting the need for safe and effective therapies that address the underlying pathology. Data published in the journal Cell Reports Medicine investigated the mechanism of polyamines and polyamine inhibition by CPP-1X on ß cell stress that plays a role in the onset of type 1 diabetes in vitro and ex vivo models. Results showed that DFMO treatment may preserve ß cell function, reflected by C-peptide levels in patients with T1D through the modulation of urinary polyamines, in particular putrescine. The work reflects the Company’s ongoing collaboration with Indiana University School of Medicine. The research is part of a multi-site clinical trial led by Indiana University (IU) School of Medicine, supported by funding from JDRF, the leading global T1D research and advocacy organization. The preclinical data were generated by Raghavendra Mirmira's laboratory at the University of Chicago. Panbela Therapeutics is providing the drug at no cost to researchers and was not involved in the design and analysis of these studies. From the Phase 1 dose range finding study of CPP-1X in patients with recent onset T1D, CPP-1X was well tolerated and a dose dependent inhibition of ODC was observed. An exploratory secondary analysis showed that at the two highest dose levels, treatment with CPP-1X stabilized C-peptide areas under the curve compared to placebo. When assessing immune cell populations, there were no differences between the placebo and CPP-1X patients. Results from these studies suggest that CPP-1X is a safe, oral treatment option that may improve ß cell function and/or survival in recent onset T1D.
New Risk • Nov 03New minor risk - Share price stabilityThe company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Earnings are forecast to decline by an average of 0.4% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 126x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.36m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$40m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change).
お知らせ • Oct 26Panbela Therapeutics, Inc. Announces Acceptance of Polyamine Inhibitor Car-T Combination Abstract for Online PublicationPanbela Therapeutics, Inc. announced that an abstract about SBP-101 and CPP-1X (also known as DFMO or Eflornithine) research in multiple myeloma (cell lines), has been accepted for an online publication on the American Society of Hematology (ASH) meeting site in the November supplemental issue of the journal Blood. The work reflects the company's on-going collaboration with researchers from The University of Texas MD Anderson Cancer Center and will become part of the permanent ASH and Blood abstracts archive.
New Risk • Aug 13New major risk - Revenue and earnings growthEarnings are forecast to decline by an average of 0.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$22m free cash flow). Share price has been highly volatile over the past 3 months (23% average weekly change). Earnings are forecast to decline by an average of 0.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 65x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.85m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$44m net loss in 3 years).
お知らせ • Jul 25Panbela Therapeutics, Inc. Opens Enrollment in UK and Germany for Aspire Trial in Pancreatic CancerPanbela Therapeutics, Inc. announced it has opened enrollment in the UK and Germany for its ASPIRE global clinical trial in the first-line treatment of metastatic pancreatic cancer. ASPIRE is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma. There are approximately 95 sites planned for throughout the United States, Europe, Australia, and South Korea, in the global Aspire trial. Panbela is committed to delivering a more effective treatment for pancreatic cancer, a deadly disease with few treatment options.
お知らせ • Jul 11Panbela Announces Preliminary Safety Analysis for ASPIRE TrialPanbela Therapeutics, Inc. announced that the independent Data Safety Monitoring Board (DSMB) of the Phase III ASPIRE clinical trial for patients with untreated metastatic pancreatic ductal adenocarcinoma has completed its pre-specified review of safety data for treated patients in the trial. The DSMB has recommended that the study continue without modification. The ASPIRE Trial is a global randomized, double-blind placebo-controlled clinical trial to evaluate ivospemin in combination with gemcitabine and nab-Paclitaxel in patients with metastatic pancreatic ductal Adenocarcinoma.
お知らせ • Jun 29Panbela Therapeutics, Inc. Announces PACES S0820 Phase III Trial Passes Pre-Planned Futility AnalysisPanbela Therapeutics, Inc. announced the SWOG Cancer Research Network's PACES S0820 Phase III trial passed a single planned futility analysis and will continue. The trial entitled: "A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients With Stage 0-III Colon or rectal cancer, Phase III - Preventing Adenomas of the Colon With Eflornithine and sulindac (PACES)" is designed to evaluate the combination of eflornithine and sulINDac in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colorectal cancer or rectal cancer. The pipeline consists of assets currently in clinical trials with an initial focus on familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention and ovarian cancer. The combined development programs have a steady cadence of anticipated catalysts with programs ranging from pre-clinical to registration studies.Ivospemin is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. It has shown signals of tumor growth inhibition in clinical studies of metastatic pancreatic cancer patients, demonstrating a median overall survival (OS) of 14.6 months and an objective response rate (ORR) of 48%, both exceeding what is typical for the standard of care of gemcitabine + nab-paclitaxel suggesting potential complementary activity with the existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, ivospemin has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events.
お知らせ • Jun 22Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $8.510816 million.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $8.510816 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 586,000 Price\Range: $3.75 Discount Per Security: $0.2625 Security Name: Class A Common Warrants Security Type: Equity Warrant Securities Offered: 2,270,000 Security Name: Class B Common Warrants Security Type: Equity Warrant Securities Offered: 2,270,000 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 1,684,000 Price\Range: $3.749 Discount Per Security: $0.2624
お知らせ • Jun 18Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,270,000 Price\Range: $3.75 Discount Per Security: $0.2625 Security Name: Class A Common Warrants Security Type: Equity Warrant Securities Offered: 4,540,000 Security Name: Class B Common Warrants Security Type: Equity Warrant Securities Offered: 4,540,000 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 2,270,000
お知らせ • Jun 02Panbela Announces 1-For-30 Reverse Stock Split Effective June 1, 2023 to Regain Compliance with the Continued Listing Requirements of the Nasdaq Capital MarketPanbela Therapeutics, Inc. announced that it will implement the previously announced and stockholder approved 1-for-30 reverse split of its common stock. The reverse stock split will be effective as of the morning of June 1, 2023, and the company’s common stock will trade on a post-split basis at the beginning of trading on the same date under the existing trading symbol “PBLA.” The CUSIP number for the common stock following the reverse stock split will be 69833W305. The reverse stock split is primarily intended to increase the market price per share of the company’s common stock to regain compliance with the continued listing requirements of The Nasdaq Capital Market. The company intends to continue to pursue additional actions to satisfy the exchange’s other continued listing requirements. The reverse stock split will reduce the number of shares of the company’s common stock currently outstanding to an estimated 559,560 shares. Proportionate adjustments will be made to the conversion and exercise prices of the company’s outstanding stock purchase warrants, stock options and to the number of shares issued and issuable under the company’s equity incentive plans. The number of shares authorized for issuance by the company will not decrease as a result of the reverse stock split.
Breakeven Date Change • Mar 18Forecast to breakeven in 2025The 2 analysts covering Panbela Therapeutics expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 4.8% per year to 2024. The company is expected to make a profit of US$6.98m in 2025. Average annual earnings growth of 67% is required to achieve expected profit on schedule.
お知らせ • Feb 14Panbela Therapeutics Regains Compliance with Nasdaq Listing StandardsPanbela Therapeutics, Inc. announced that, primarily as a result of the January 30, 2023 closing of its public offering of approximately $15 million of common stock and warrants, Panbela has regained compliance with applicable listing standards of The Nasdaq Stock Market. Nasdaq has issued notice that Panbela has regained compliance for continued listing of its common stock. On February 9, 2023, Panbela received a letter from Nasdaq confirming that Panbela has cured the previously identified minimum bid price and stockholders’ equity deficiencies under Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively, and that Panbela is in compliance with all applicable listing standards. Panbela’s previously scheduled delisting determination appeal hearing has been canceled, and its common stock will continue to be listed and traded on Nasdaq.
Breakeven Date Change • Feb 01Forecast to breakeven in 2025The 2 analysts covering Panbela Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$6.98m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule.
お知らせ • Jan 27Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $15.01875 million.Panbela Therapeutics, Inc. has completed a Follow-on Equity Offering in the amount of $15.01875 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 6,675,000 Price\Range: $2.25 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 13,350,000
お知らせ • Jan 12Panbela Therapeutics, Inc. Starts Phase II Trial of CPP-1X-T for Recent Onset Type I Diabetes, in Collaboration with Indiana University School of Medicine and JDRFPanbela Therapeutics, Inc. announced that it has commenced a Phase II double-blind, randomized study to evaluate CPP-1X-T (Eflornithine tablets) for recent onset type 1 diabetes, in collaboration with Indiana University School of Medicine and funded by JDRF, the leading global type 1 diabetes research and advocacy organization. Indiana University expects to enroll 70 patients in the Phase II clinical trial at approximately 6 centers in the United States. Study eligibility will be for patients with recent onset type 1 diabetes. Participants will be randomized 2:1 to CPP-1X-T, administered orally with food, twice daily, at a 1000 mg/m2 dose, or placebo over 6 months followed by a 6 month wash out period to assess durability of response. The primary objective will be to determine the difference between the treated and placebo 2-hour Area Under the Curve (AUC)-mean using the log (mean C-peptide+1) at the 6-month end of treatment period. Secondary objectives will include C-peptide AUC, fasting and stimulated proinsulin/c-peptide ratios a biomarker of ß cell stress, and the urine polyamine content at 3, 9, and 12 months timepoints.
Price Target Changed • Nov 16Price target decreased to US$6.00Down from US$6.67, the current price target is provided by 1 analyst. New target price is 3,674% above last closing price of US$0.16. Stock is down 93% over the past year. The company is forecast to post a net loss per share of US$1.52 next year compared to a net loss per share of US$0.87 last year.
Seeking Alpha • Sep 30Panbela Therapeutics dips 24% on pricing $6M public offeringPanbela Therapeutics (NASDAQ:PBLA) prices a public offering of (i) 20.1M shares of stock, warrants to purchase up to 30.15M shares at a purchase price of $0.30. Warrants will have an exercise price of $0.30 per share, are exercisable upon issuance, and will expire five years following the date of issuance. Offering is expected to close on or about October 4, 2022. Gross proceeds of $6M. Net proceeds to be deployed for the continued clinical development of its product candidates ivospemin (SBP-101) and eflornithine (CPP-1X), working capital, business development and other general corporate purposes, which may include repayment of debt. Stock drops 24% pre-market
Seeking Alpha • Aug 15Panbela Therapeutics GAAP EPS of -$1.51Panbela Therapeutics press release (NASDAQ:PBLA): Q2 GAAP EPS of -$1.51. Total cash was $2.5M as of June 30, 2022.
Board Change • Jun 22Less than half of directors are independentFollowing the recent departure of a director, there are only 3 independent directors on the board. The company's board is composed of: 3 independent directors. 4 non-independent directors. Independent Director Art Fratamico was the last independent director to join the board, commencing their role in 2019. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.
お知らせ • May 02Panbela Therapeutics, Inc., Annual General Meeting, Jun 08, 2022Panbela Therapeutics, Inc., Annual General Meeting, Jun 08, 2022, at 14:30 Eastern Daylight. Location: Element Bloomington, 2400 East 82nd Street, Bloomington, Minnesota 55425, Bloomington United States Agenda: To Elect directors; to Ratify the selection of Cherry Bekaert LLP as independent registered public accounting firm; to Approve the issuance of shares of common stock as partial consideration for acquisition of Cancer Prevention Pharmaceuticals, Inc; and Approve the adjournment or postponement of the Annual Meeting to solicit additional proxies if there are insufficient votes at the time of the Annual Meeting to approve acquisition of Cancer Prevention Pharmaceuticals, Inc.
Price Target Changed • Apr 27Price target increased to US$8.00Up from US$6.67, the current price target is an average from 3 analysts. New target price is 373% above last closing price of US$1.69. Stock is down 64% over the past year. The company is forecast to post a net loss per share of US$0.93 next year compared to a net loss per share of US$0.87 last year.
お知らせ • Feb 24Panbela Therapeutics, Inc. (NasdaqCM:PBLA) entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc.Panbela Therapeutics, Inc. (NasdaqCM:PBLA) entered into a definitive agreement to acquire Cancer Prevention Pharmaceuticals, Inc. on February 21, 2022. The consideration will be paid through stock at closing. The potential Post-Closing Contingent Payments are eligible to be paid in connection with the future satisfaction of three milestones after netting out applicable expenses and setoff amounts: (1) 50% of milestone payments and royalties received pursuant to the existing North American license agreement, up to a maximum payout of $25.0 million; (2) 50% of royalty payments received for U.S. sales of Flynpovi in excess of $400.0 million, up to a maximum payout of $15.0 million; and (3) either 35% of any cash amounts originating from the European Union and received pursuant to partnerships involving Flynpovi or 10% of any cash amounts received from efforts to self-market Flynpovi in the European Union; up to an aggregate maximum payout of $20.0 million. The combined company will be led by Jennifer Simpson, Chief Executive Officer of Panbela and will remain headquartered in Waconia, Minnesota. The board of the combined company is expected to optimize the value of this transaction and beyond and will include at least two members initially designated by CPP, CPP Chief Executive Officer, Jeff Jacob, and CPP Director, Dan Donovan. The proposed mergers have been unanimously approved by the boards of directors of each company and the stockholders of CPP. A closing is expected to occur by the second quarter of 2022, subject to approval of the issuance of securities in the transactions by Panbela’s stockholders, and satisfaction of other customary closing conditions. Canaccord Genuity LLC is acting as the exclusive financial advisor to Panbela, and W. Morgan Burns and Joshua L. Colburn of Faegre Drinker Biddle & Reath LLP is acting as its legal counsel. The Sage Group is acting as the exclusive financial advisor to CPP, and Leslie Marlow of Blank Rome LLP is acting as its legal counsel.
分析記事 • Feb 18Companies Like Panbela Therapeutics (NASDAQ:PBLA) Are In A Position To Invest In GrowthEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
お知らせ • Jan 25Panbela Presents Clinical Data on Phase 1B Clinical Trial of Sbp-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pda At 2022 Asco Gi MeetingPanbela Therapeutics, Inc. announced the presentation of interim clinical data from its Phase 1b combination therapy study of SBP-101, a proprietary polyamine analogue, with gemcitabine and nab-paclitaxel in patients with metastatic pancreatic ductal adenocarcinoma (PDA), at the American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Meeting that took place January 20-22, 2022. At the Phase 1b dose and schedule (N=30), CA19-9 levels decreased 60-99% in 70% of evaluable patients, with 1/29 (3%) achieving a complete remission, 13/29 evaluable patients achieving partial responses (45%) and 10/29 achieving stable disease at 8 weeks (34%). PFS was 6.0 months. While PFS may be confounded by SBP-101 dosing holds implemented to investigate potential toxicity, the rates for 6-month PFS was 52% and for 12 month PFS was 10%. Nine subjects are in survival follow up as of the date the poster was presented at the ASCO GI meeting. Median OS is 12.0 months and is not final. The safety population includes all subjects who received at least one dose of SBP-101 (N=50). The most common Grade =3 adverse events (AEs) related to any study medication were neutropenia in 20 subjects (19 attributed to G+A and 1 attributed to all 3) and elevated liver function tests in 14 subjects (5 attributed to SBP-101 and 9 attributed to all 3). SBP-101-related increases in LFTs were asymptomatic in all but 2 subjects and reversed in all subjects when SBP-101 administration was interrupted and dose-reduced or discontinued. Additionally, seven subjects experienced serious vision adverse events (4 possibly related to SBP-101, 1 related to gemcitabine and 2 related to all 3 based on PI assessment). All were considered by the sponsor to be possibly related to SBP-101; 5 had findings consistent with retinopathy. The company has just begun a randomized trial to study SBP-101, as an addition to first-line treatment for metastatic PDA, will begin a neoadjuvant pancreatic trial this quarter and will begin an Ovarian Cancer program mid-year. SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown potential signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen, if SPB-101 receives approval in the US. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events observed in the Company’s recently completed Phase 1a/1b clinical trial have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.
Seeking Alpha • Jan 06Panbela: Biotech With Updated Patent Protection And Unmet Market Target IndicationData from phase 1b study using SBP-101 for patients with pancreatic cancer will be shown at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium on January 20- 22, 2022. Pancreatic cancer patients in cohort 2 given SBP-101 + chemotherapies achieved ORR of 71%; Cohort 4 patients achieved ORR of 48% but median overall survival has not yet been reached. The global pancreatic cancer market is expected to reach $4.5 billion by 2025. A phase 1 study using SBP-101 for the treatment of patients with ovarian cancer is expected to start in the 1st half of 2022.
お知らせ • Dec 15Panbela Therapeutics, Inc. Announces Positive Preclinical Data Strongly Supporting the Activity of SBP-101 in Ovarian Cancer Cell LinesPanbela Therapeutics, Inc. announced positive preclinical data supporting the activity of SBP-101 in ovarian cancer cell lines. Panbela expects to launch a development effort for SBP-101 in ovarian cancer in the first half of 2022 and will host a virtual R&D day to discuss the new ovarian cancer program early in the new year. As stated by the European Society for Medical Oncology (ESMO), ovarian cancer represents a significant unmet need in gynecological cancers, with the absence of well-defined screening programs and inconsistent initial symptoms leading to late diagnosis in most patients. Considered largely incurable, ovarian cancer typically relapses within 3 years in 80% of women, with subsequent recurrences arising sooner each time as resistance to chemotherapy develops. About SBP-101: SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial.
分析記事 • Nov 02Will Panbela Therapeutics (NASDAQ:PBLA) Spend Its Cash Wisely?We can readily understand why investors are attracted to unprofitable companies. For example, although...
Director Overboarding • Aug 05Director Jennifer Simpson has joined 3rd company boardCEO, President & Director Jennifer Simpson has been appointed to the board of CytRx Corporation (OTCPK:CYTR). Simpson now sits on a total of 3 company boards. With 3 board positions including the role of CEO at Panbela Therapeutics, Inc. (NasdaqCM:PBLA), the director is at risk of having too many board obligations according to the Simply Wall St Risk Model.
分析記事 • Jul 15Companies Like Panbela Therapeutics (NASDAQ:PBLA) Are In A Position To Invest In GrowthEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
お知らせ • Jun 05Panbela Therapeutics, Inc. Presents Clinical Data on Phase 1b Clinical Trial of SBP-101 in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic PDA at 2021 ASCO Annual MeetingPanbela Therapeutics, Inc. announced the presentation of interim clinical data from its Phase 1b combination therapy study of SBP-101, a proprietary polyamine analogue, with gemcitabine and nab-paclitaxel (G+A) in patients with metastatic Pancreatic Ductal Adenocarcinoma (PDA), at the American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4-8, 2021. In the response-evaluable subjects in cohort 4 + Phase 1b (N=29), 11 had treatment with SBP-101 interrupted to evaluate retinal toxicity; this may impact final efficacy results. In cohort 2 (N=7) the objective response rate (ORR) was 71%, and the disease control rate (DCR) was 100% by RECIST criteria (stable disease (SD) or better for = 16 weeks). Median progression free survival (PFS) in cohort 2 was 5.63 months and median overall survival (OS) was 10.3 months compared with ORR of 48%, DCR of 70%, PFS of 5.2 months and median OS, not yet reached, in cohort 4 + 1b. SBP-101 was well-tolerated when administered at doses and schedules tested in combination with G+A in subjects with previously untreated metastatic pancreatic adenocarcinoma. The most common Grade =3 adverse events (AEs) related to any study medication were neutropenia in 20 subjects (19 attributed to G+A and 1 attributed to all 3) and elevated liver function tests in 15 subjects (5 attributed to SBP-101 and 10 attributed to all 3). SBP-101-related increases in LFTs were asymptomatic in all but 2 subjects and reversed in all subjects when SBP-101 administration was interrupted and dose-reduced or discontinued. Additionally, six subjects experienced serious vision adverse events (3 possibly related to SBP-101, 1 related to gemcitabine and 2 related to all 3 based on PI assessment). All were considered by the sponsor to be possibly related to SBP-101; 5 had findings consistent with retinopathy. All future studies will exclude patients with a history of retinopathy or at risk of retinal detachment and scheduled ophthalmologic monitoring for all patients. Additionally, in future dose-finding studies screening for retinal toxicity will be included. The company continues to plan for the initiation of a randomized trial to study SBP-101, as an addition to first-line treatment for metastatic PDA, in the middle of this year and releasing preclinical data across tumors outside of pancreatic cancer by year-end.
Breakeven Date Change • May 18Forecast to breakeven in 2025The analyst covering Panbela Therapeutics expects the company to break even for the first time. New forecast suggests the company will make a profit of US$14.3m in 2025. Average annual earnings growth of 5.6% is required to achieve expected profit on schedule.
分析記事 • Mar 29We Think Panbela Therapeutics (NASDAQ:PBLA) Can Afford To Drive Business GrowthThere's no doubt that money can be made by owning shares of unprofitable businesses. For example, although Amazon.com...
お知らせ • Feb 11+ 1 more updatePanbela Therapeutics Inc. Provides Update on Current Clinical Trial: Decision to Hold Administration of SBP-101Panbela Therapeutics Inc. has been evaluating the safety and tolerability of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma (PDA). SBP-101 has received Fast Track and Orphan Drug designation from FDA and Panbela has been working closely with the FDA to advance its development studies of SBP-101 for patients with metastatic PDA. Panbela continues to be in communication with the trial investigators regarding the recommendation from the independent data safety monitoring board (DSMB) of the ongoing Phase 1 clinical trial to hold administration of SBP-101 pending further investigation of visual disturbance adverse events. Some patients in the trial were noted to have complaints of visual changes, although visual changes were not seen in the SBP-101 monotherapy study. Company have consulted with the DSMB and SBP-101 will not be administered to ongoing patients in the current trial while additional safety information is analyzed. Patients will continue with the standard drug regimen. All other trial activities continue. Panbela has conferred with FDA regarding the plan to continue the trial but hold dosing of SBP-101 in ongoing patients until company can learn more. Withholding SBP-101 constitutes a “partial clinical hold”. There is no impact on enrollment, as enrollment of the trial completed in December 2020, and the study is ongoing. Panbela is working to finalize a visual screening program in order to understand the significance of reported visual changes and to inform future studies. Company will also seek to evaluate the exact cause of these recent visual reports and to determine whether serial eye exams during treatment can identify potential toxicity or risk before symptoms develop. While company evaluate supplementary data, company remain confident in the potential benefits of SBP-101 including its potential benefits for patients with pancreatic cancer. Company are thankful to the patients who have, or are, participating in company clinical trials. Company are committed to objectively evaluating the data from those clinical studies to confirm both the therapeutic benefits and safety profile of company polyamine inhibitor in metastatic pancreatic cancer patients. Panbela is planning to submit interim results at a major cancer conference and looks forward to publication of final efficacy and safety data, when available. Additionally, all other research and manufacturing activities related to future SBP-101 indications are continuing, including working with the FDA to initiate a randomized trial mid-year. SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved standard chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides support for continued evaluation of the compound in a randomized clinical trial subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold.
Is New 90 Day High Low • Jan 28New 90-day high: US$4.93The company is up 72% from its price of US$2.86 on 29 October 2020. The American market is up 21% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 28% over the same period.
お知らせ • Dec 10Panbela Therapeutics, Inc. Completes Enrollment in Its Phase 1B Trial Investigating SBP-101 Combination Therapy for First Line Metastatic Pancreatic CancerPanbela Therapeutics Inc. disruptive therapeutics for the treatment of patients with cancer, has completed patient enrollment in its Phase 1 trial evaluating the safety and tolerability of SBP-101 when used in combination with standard of care agents gemcitabine and nab-paclitaxel for first-line treatment of patients with metastatic pancreatic ductal adenocarcinoma. The trial, which included a dose escalation phase and an expansion phase, enrolled 50 patients, 30 of whom were treated using the dose and schedule that will advance to a randomized trial of the combination versus gemcitabine and nab-paclitaxel alone planned to begin in the first half of 2021. In total, the safety of SBP-101 has been evaluated in 79 patients in two clinical trials. SBP-101 is currently being evaluated in a Phase 1a/1b clinical trial of patients with previously untreated metastatic PDA at sites in the United States and Australia. SBP -101 has received Fast Track and orphan drug designation from FDA.
Is New 90 Day High Low • Dec 10New 90-day high: US$4.37The company is up 52% from its price of US$2.87 on 10 September 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 21% over the same period.
お知らせ • Aug 29Sun BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $10.5 million.Sun BioPharma, Inc. has completed a Follow-on Equity Offering in the amount of $10.5 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 2,545,454 Price\Range: $4.125 Security Name: Warrants Security Type: Equity Warrant Securities Offered: 2,545,454
お知らせ • Jul 18Sun Biopharma, Inc. Announces Appointment of Jennifer K. Simpson, Ph.D., as Chief Executive OfficerSun BioPharma, Inc. announced the appointment of Jennifer K. Simpson, Ph.D., as Chief Executive Officer. Dr. Simpson brings more than two decades of public company executive and fundraising experience in oncology drug development and commercialization to Sun BioPharma, most recently having served as CEO of Delcath Systems, Inc.
