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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 (Nasdaq: PBLA) reported significant advances in its clinical programs and financial metrics for the year ending December 31, 2022. The company initiated the ASPIRE clinical trial in January 2022, expanding to multiple countries including Australia and Europe. Notably, it received EMA orphan drug designation for ivospemin. Financially, the fourth quarter showed a net loss of $4.7 million, improved from the previous year's loss of $3.5 million, with total cash at $1.3 million. The company raised approximately $15 million through public offerings in early 2023, bolstering its financial position as it progresses with its pipeline.
Panbela Therapeutics (Nasdaq: PBLA) has announced a conference call on March 16, 2023, at 4:30 PM ET to discuss fourth quarter and year-end results for December 31, 2022. The company is focused on developing disruptive therapeutics for urgent medical needs, with a pipeline that includes Ivospemin (SBP-101) and Flynpovi. Ivospemin has shown promising clinical results, achieving a median overall survival of 14.6 months in pancreatic cancer patients. Flynpovi demonstrated over 90% effectiveness in preventing pre-cancerous adenomas in trials. Investors can access the call via specified toll-free numbers or a webcast link.
Panbela Therapeutics (Nasdaq: PBLA) announced the enrollment of its first patient in South Korea for the ASPIRE trial, aimed at treating metastatic pancreatic cancer. This global, randomized, double-blind, placebo-controlled study will evaluate ivospemin with standard chemotherapy agents gemcitabine and nab-Paclitaxel. The study plans to involve approximately 95 sites across the U.S., Europe, Australia, and South Korea, targeting an interim analysis in early 2024. The ivospemin drug has previously shown improved survival rates compared to current treatments, making this trial crucial for advancing treatment options.
Panbela Therapeutics (Nasdaq: PBLA) announced that an abstract for SBP-101, a proprietary polyamine analogue, has been accepted for poster presentation at the AACR Annual Meeting from April 14-19, 2023. This presentation highlights the ongoing collaboration with Johns Hopkins University to evaluate SBP-101's efficacy in combination with chemotherapy for ovarian cancer. The abstract, detailing positive data from clinical studies, reports a median overall survival of 14.6 months and an objective response rate of 48%. The company is further advancing its pipeline, including products targeting various cancers, reflecting a steady cadence of clinical catalysts.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced that it regained compliance with Nasdaq listing standards following a $15 million public offering of common stock and warrants on January 30, 2023. Nasdaq confirmed compliance regarding minimum bid price and stockholders’ equity deficiencies, hence canceling the scheduled delisting hearing. The offering included 6,675,000 shares priced at $2.25 per share with warrants allowing purchase at $2.75. The funds will support clinical development of its candidates, including ivospemin (SBP-101) and eflornithine (CPP-1X), as well as general corporate purposes.
Panbela Therapeutics (Nasdaq: PBLA) announced a public offering of 6,675,000 shares of common stock at $2.25 per share, along with warrants for 13,350,000 shares. The expected gross proceeds are approximately $15.0 million, aimed at supporting clinical development of ivospemin (SBP-101) and eflornithine (CPP-1X), alongside working capital needs. The offering is set to close around January 30, 2023. Roth Capital Partners and Maxim Group LLC are the placement agents for this offering. The securities are offered under an effective registration statement with the SEC.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced that the European Medicines Agency has designated ivospemin (SBP-101) as an orphan medicinal product for treating metastatic pancreatic ductal adenocarcinoma, combined with gemcitabine and nab-Paclitaxel. This decision, adopted on January 13, 2023, follows a similar designation from the FDA. The orphan drug status grants financial and regulatory incentives, including a 10-year marketing exclusivity in the EU post-approval. Panbela aims to advance its ASPIRE trial, with full site enrollment expected by mid-2023. This milestone underscores the potential of ivospemin in addressing a critical health need.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced a 1-for-40 reverse stock split effective January 13, 2023. This decision aims to increase the market price per share to comply with Nasdaq's listing requirements. The reverse split will reduce the total shares outstanding to approximately 1,177,000. Each stockholder will receive one share for every forty they own, with adjustments made to options and warrants. The reverse split does not affect shareholders' relative equity interests but may result in cash payments for fractional shares.
Panbela Therapeutics (Nasdaq: PBLA) announced the initiation of a Phase II clinical trial for CPP-1X-T (Eflornithine tablets) targeting recent onset type 1 diabetes. This study, funded by JDRF and conducted in collaboration with Indiana University, aims to enroll 70 patients across six U.S. centers. Participants will receive either the treatment or placebo over six months, assessing its effectiveness through various metrics, including C-peptide levels. The company's pipeline includes other significant projects targeting various cancers, with promising results from previous studies.
Panbela Therapeutics (Nasdaq: PBLA) announced a positive opinion from the European Medicines Agency (EMA) for the orphan designation of ivospemin (SBP-101) in combination with gemcitabine and nab-Paclitaxel for treating metastatic pancreatic ductal adenocarcinoma. Previously, the FDA granted orphan drug designation to SBP-101. The orphan designation offers financial and regulatory incentives, including a 10-year marketing exclusivity. The company is focused on expanding clinical trials, aiming for interim analysis in early 2024.
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