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Panbela Therapeutics, Inc. (NASDAQ: PBLA) is a clinical-stage biopharmaceutical company focused on developing innovative therapeutics to address unmet medical needs in cancer treatment and prevention. Headquartered in Minneapolis, Panbela's primary assets include Ivospemin (SBP-101) and Flynpovi.
Panbela's core business revolves around advancing its drug pipeline through clinical trials. The company has made significant strides in 2023 and early 2024, particularly with its Phase III ASPIRE trial, which targets untreated metastatic pancreatic ductal adenocarcinoma. This trial has surpassed 50% enrollment, bringing it closer to its goal of enrolling approximately 600 patients by Q1 2025. The recent approval of Onivyde in the same therapeutic area for the first time in over a decade augments Panbela's optimism regarding its interim analysis and potential for providing additional treatment options.
Financially, Panbela reported a net loss of $6.5 million in 2023's fourth quarter, with general and administrative expenses decreasing to $0.9 million. Research and development expenses rose to $6.1 million, reflecting the company's robust commitment to its clinical programs. As of December 31, 2023, Panbela had $2.6 million in cash and current assets totaling $3.1 million against current liabilities of $12.3 million. The completion of a public offering in January 2024 raised approximately $9 million in gross proceeds, bolstering the company's financial standing.
Panbela collaborates with renowned institutions like Johns Hopkins University School of Medicine, enhancing its research capabilities. The company's development programs encompass various cancers, including familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, ovarian cancer, and diabetes.
- Ivospemin (SBP-101): This proprietary polyamine analogue aims to inhibit polyamine metabolism in pancreatic ductal adenocarcinoma and other tumors. Clinical studies have shown promising results, including a median overall survival of 14.6 months and an objective response rate of 48%, outperforming standard chemotherapy regimens. Ivospemin has not exacerbated chemotherapy-related adverse events, supporting its continued evaluation in the ASPIRE trial.
- Flynpovi™: A combination of CPP-1X (eflornithine) and sulindac, Flynpovi inhibits polyamine synthesis and enhances polyamine catabolism. Phase III trials have demonstrated its efficacy in preventing precancerous sporadic adenomas and delaying surgical events in FAP patients. The safety profile of Flynpovi supports its ongoing evaluation.
- CPP-1X (Eflornithine): Developed as a single agent for indications like gastric cancer prevention and recent onset Type 1 diabetes, CPP-1X has shown potential activity and tolerability in preclinical and early-phase trials.
Panbela's common stock is listed on the OTCQB market under the symbol “PBLA”. The company remains dedicated to advancing its clinical programs and maximizing stockholder value through strategic initiatives and potential regulatory approvals.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced a conference call scheduled for March 24, 2022, at 4:30 PM ET to discuss its fourth-quarter results for the period ending December 31, 2021. The call will focus on the performance and outlook for SBP-101, its lead product for treating metastatic pancreatic cancer, which has shown a median overall survival of 12 months and an objective response rate of 48% in clinical studies. Investors can participate via toll-free or international numbers, or through an online webcast.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announces that an abstract for SBP-101, a proprietary polyamine analogue, will be presented at the American Association for Cancer Research (AACR) meeting from April 8-13, 2022. This research highlights a collaboration with Johns Hopkins University. SBP-101 aims to inhibit polyamine metabolism, showing promising results in clinical studies for metastatic pancreatic cancer, including a median overall survival of 12 months and an objective response rate of 48%. The safety profile indicates no exacerbation of common chemotherapy-related side effects.
Panbela Therapeutics (Nasdaq: PBLA) announced an agreement to acquire Cancer Prevention Pharmaceuticals to diversify its pipeline, targeting a $5 billion market for cancer therapies. The combined pipeline spans pre-clinical to registration studies, expected to generate significant catalysts. A fully funded registration trial for the lead asset will initiate by year-end. Post-merger, Panbela stockholders will hold approximately 59% of the company, while CPP stakeholders will own 41%. The deal aims to maximize shareholder value through operational synergies and enhanced patient treatment capabilities.
Panbela Therapeutics (Nasdaq: PBLA) has announced the launch of its global Phase 2 clinical trial, named the ASPIRE trial, for SBP-101 in combination with Gemcitabine and Nab-Paclitaxel to treat metastatic pancreatic ductal adenocarcinoma. The trial has begun at Summit Cancer Centers with plans to activate around 60 additional sites in 2022. The study is a randomized, double-blind, placebo-controlled trial focused on overall survival, with a completion target of patient enrollment within 12 months. SBP-101 has shown potential in previous studies without exacerbating common chemotherapy-related adverse effects.
Panbela Therapeutics (Nasdaq: PBLA) reported interim results from its Phase 1b study of SBP-101 in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic ductal adenocarcinoma. The interim data revealed a median overall survival of 12.0 months and an objective response rate of 48%, both exceeding historical rates. Despite dose interruptions affecting results, cohort 2 showed an impressive 71% response rate. The safety profile indicated manageable Grade ≥3 adverse events. Panbela plans to advance to a Phase 2 randomized trial and explore additional indications.
Panbela Therapeutics (Nasdaq: PBLA) announced promising preclinical results for SBP-101 in ovarian cancer cell lines, highlighting its potential in a field of significant unmet medical need. The company aims to initiate a development program for SBP-101 in ovarian cancer in H1 2022 and will conduct a virtual R&D day to provide further insights. With ovarian cancer being a major cause of cancer deaths among women, the focus on SBP-101 underscores the importance of addressing this critical health issue.
Panbela Therapeutics (Nasdaq: PBLA) announced the acceptance of an abstract for a poster presentation of SBP-101 at the ASCO Gastrointestinal Cancers Symposium from January 20-22, 2022. The presentation will focus on the efficacy of SBP-101, a polyamine metabolic inhibitor, in combination with gemcitabine and nab-paclitaxel for first-line treatment of metastatic pancreatic ductal adenocarcinoma. The safety profile shows no exacerbation of common chemotherapy-related adverse events. Further evaluation in a randomized clinical trial is planned.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) reported positive clinical progress and financial results for Q3 2021. The company highlighted that 16 patients are in survival follow-up, with two exceeding 28 months. A patent notification was issued for a new production method for SBP-101, reducing synthesis steps significantly. Financially, the company recorded a net loss of $2.1 million, or $0.16 per share, and reported cash and equivalents of $14.1 million. Management aims to initiate randomized trials and expand indications by year-end.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) will host a conference call on November 10, 2021, at 4:30 PM ET to discuss its third-quarter results for the period ending September 30, 2021. Participants can join via a toll-free number or online. The company is developing SBP-101, a treatment targeting metastatic pancreatic cancer, with promising clinical signals of efficacy. Safety data from trials indicate that SBP-101 does not exacerbate chemotherapy-related adverse effects, which supports further clinical evaluation.
Panbela Therapeutics (Nasdaq: PBLA) announced participation in two upcoming investor conferences:
- H.C. Wainwright 23rd Annual Global Investment Conference: September 13-15, 2021. Presentation available on-demand from September 13.
- Oppenheimer Fall Healthcare Life Sciences & MedTech Summit: September 20-23, 2021, with a presentation on September 21 at 9:55am ET.
Management will host 1x1 investor meetings at both events. Panbela is focused on developing SBP-101, a treatment for pancreatic cancer.
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