Announcement • Oct 30
Nant Capital Engages in Discussions with Panbela Therapeutics On 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. Announcement • Jun 24
Panbela Therapeutics Announces Third Independent Safety Review of Phase 3 ASPIRE Clinical Trial DSMB Recommended Continuation with No Trial Modification Panbela 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. Announcement • Apr 27
Panbela Therapeutics, Inc. Announces Nasdaq Files A Form 25 Notification of Removal from Listing On 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". Announcement • Apr 24
Panbela Therapeutics, Inc. Announces Interim Data Analysis for its Ongoing ASPIRE Trial Pushed to First Quarter of 2025 Panbela 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. Announcement • Apr 20
Panbela Announces Poster Presentation At American Association for Cancer Research Panbela 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. Announcement • Feb 02
Panbela 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 Announcement • Jan 26
Panbela Therapeutics, Inc. Exceeds 50% Enrollment for Aspire Trial in Pancreatic Cancer, Exceeding Anticipated Timelines with Accelerated Momentum Panbela 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. Announcement • Jan 25
Panbela 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. Announcement • Jan 18
Panbela Therapeutics, Inc. Announces Publication of Clinical Data Titled: Phase 1 Study of High-Dose DFMO, Celecoxib, Cyclophosphamide and Topotecan for Patients with Relapsed Neuroblastoma Panbela 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. Announcement • Nov 29
Panbela Therapeutics, Inc. Announces second Independent Safety Review of the ASPIRE Registration Clinical Trial Panbela 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 11
New major risk - Negative shareholders equity The 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). Announcement • Nov 04
Panbela Announces Publication of Preclinical and Clinical Data Titled: Inhibition of Polyamine Biosynthesis Preserves B Cell Function in Type 1 Diabetes Panbela 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 03
New minor risk - Share price stability The 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). Announcement • Oct 26
Panbela Therapeutics, Inc. Announces Acceptance of Polyamine Inhibitor Car-T Combination Abstract for Online Publication Panbela 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 13
New major risk - Revenue and earnings growth Earnings 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). Announcement • Jul 25
Panbela Therapeutics, Inc. Opens Enrollment in UK and Germany for Aspire Trial in Pancreatic Cancer Panbela 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. Announcement • Jul 11
Panbela Announces Preliminary Safety Analysis for ASPIRE Trial Panbela 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. Announcement • Jun 29
Panbela Therapeutics, Inc. Announces PACES S0820 Phase III Trial Passes Pre-Planned Futility Analysis Panbela 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. Announcement • Jun 22
Panbela 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 Announcement • Jun 18
Panbela 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 Announcement • Jun 02
Panbela Announces 1-For-30 Reverse Stock Split Effective June 1, 2023 to Regain Compliance with the Continued Listing Requirements of the Nasdaq Capital Market Panbela 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 18
Forecast to breakeven in 2025 The 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. Announcement • Feb 14
Panbela Therapeutics Regains Compliance with Nasdaq Listing Standards Panbela 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 01
Forecast to breakeven in 2025 The 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. Announcement • Jan 27
Panbela 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 Announcement • Jan 12
Panbela 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 JDRF Panbela 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 16
Price target decreased to US$6.00 Down 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. Board Change • Jun 22
Less than half of directors are independent Following 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. Announcement • May 02
Panbela Therapeutics, Inc., Annual General Meeting, Jun 08, 2022 Panbela 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 27
Price target increased to US$8.00 Up 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. Announcement • Feb 24
Panbela 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. Announcement • Jan 25
Panbela 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 Meeting Panbela 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. Announcement • Dec 15
Panbela Therapeutics, Inc. Announces Positive Preclinical Data Strongly Supporting the Activity of SBP-101 in Ovarian Cancer Cell Lines Panbela 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. Director Overboarding • Aug 05
Director Jennifer Simpson has joined 3rd company board CEO, 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. Announcement • Jun 05
Panbela 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 Meeting Panbela 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 18
Forecast to breakeven in 2025 The 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. Is New 90 Day High Low • Jan 28
New 90-day high: US$4.93 The 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. Announcement • Dec 10
Panbela Therapeutics, Inc. Completes Enrollment in Its Phase 1B Trial Investigating SBP-101 Combination Therapy for First Line Metastatic Pancreatic Cancer Panbela 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 10
New 90-day high: US$4.37 The 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. Announcement • Aug 29
Sun 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 Announcement • Jul 18
Sun Biopharma, Inc. Announces Appointment of Jennifer K. Simpson, Ph.D., as Chief Executive Officer Sun 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.