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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 business update and financial results for Q2 2021, marked by significant clinical advancements. Highlights include the issuance of a patent for a novel production method for SBP-101, a $10 million common stock offering, and inclusion in the Russell Microcap Index. The company reported a net loss of $2.2 million, or $0.22 per share, with total cash at $6.4 million. SBP-101 showed a 48% objective response rate in clinical trials, supporting its further development in pancreatic cancer. Upcoming milestones include new trials by year-end.
Panbela Therapeutics (Nasdaq: PBLA) announced the issuance of U.S. patent US 11,098,005 for a novel method to produce its lead product, SBP-101, developed with Syngene International Ltd. This patent reduces the production steps from seventeen to six and extends patent protection to 2039. The CEO highlighted benefits including shorter manufacturing times and cost efficiency, which could enhance commercialization efforts. SBP-101 targets pancreatic cancer and has shown potential in clinical studies without exacerbating common chemotherapy-related side effects.
Panbela Therapeutics (Nasdaq: PBLA) announced a conference call for August 11, 2021, at 4:30 PM ET to discuss its second quarter results ending June 30, 2021. The call will be accessible via telephone and online. The company is developing its proprietary drug, SBP-101, for treating metastatic pancreatic ductal adenocarcinoma, showing promise in clinical studies. Importantly, SBP-101 has demonstrated potential efficacy without exacerbating common chemotherapy side effects, supporting additional evaluation in clinical trials.
Panbela Therapeutics (Nasdaq: PBLA) announced its participation in the Access to Giving Virtual Conference on July 15, 2021, at 10:30 a.m. ET. The presentation will be delivered by Jennifer K. Simpson, the company's President & CEO. The conference enables companies of varying market capitalizations to engage with investors for charity. Panbela's investigational therapy, SBP-101, aims to treat metastatic pancreatic cancer, showing promise in inhibiting tumor growth without severe side effects traditionally associated with chemotherapy. For registration, visit the event's website.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) has successfully closed a public offering of 3,333,334 shares at $3.00 per share, raising approximately $10 million. The funds will be directed towards the ongoing clinical development of SBP-101, aimed at treating metastatic pancreatic cancer, and for general corporate purposes. This offering was managed by H.C. Wainwright & Co. and conducted under an effective shelf registration statement with the SEC.
Panbela Therapeutics (Nasdaq: PBLA) announced an expanded public offering of 3,333,334 shares at $3.00 per share, raising approximately $10 million. The offering is set to close around July 2, 2021, pending customary conditions. H.C. Wainwright & Co. serves as the sole book-running manager. There is a 30-day option for the underwriter to buy an additional 500,000 shares. Proceeds will fund the clinical development of SBP-101, intended for treating pancreatic cancer, and for general corporate purposes. Shares are offered under an effective SEC registration statement.
Panbela Therapeutics (Nasdaq: PBLA) announced an underwriting agreement with H.C. Wainwright & Co. for the purchase of 1,666,667 shares of common stock at $3.00 each. The public offering, estimated to close around July 2, 2021, is expected to generate approximately $5.0 million in gross proceeds. Proceeds will be utilized for the clinical development of SBP-101 and general corporate needs. The underwriter holds a 30-day option to acquire an additional 250,000 shares. This offering is registered under the effective Form S-3 registration statement.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) will join the Russell Microcap® Index effective June 28, 2021. This inclusion, confirmed by FTSE Russell, grants the company access to a broader investor base and establishes it in appropriate growth and value style indexes. CEO Jennifer K. Simpson expressed optimism about communicating the company's strategies to a larger audience. The membership is crucial as Russell indexes are benchmarks for over $10.6 trillion in assets. The company is focused on SBP-101, a promising treatment for pancreatic cancer, showing potential benefits without exacerbating typical chemotherapy side effects.
Minneapolis, June 4, 2021 - Panbela Therapeutics (Nasdaq: PBLA) announced interim data from its Phase 1b study of SBP-101, a polyamine analogue, combined with gemcitabine and nab-paclitaxel for metastatic Pancreatic Ductal Adenocarcinoma (PDA). The data suggest a potential enhancement in treatment efficacy, particularly with an objective response rate of 71% in cohort 2. However, cohort 4 faced treatment interruptions. The company plans to initiate a randomized Phase 2 study soon and will exclude patients with retinal toxicity history in future trials.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced the retirement of founder Michael T. Cullen, MD, MBA, effective May 25, 2021. Although he steps down as an employee, he will remain as Chair of the Board of Directors. Dr. Cullen's tenure spanned over a decade, where he played a pivotal role in advancing SBP-101 for metastatic pancreatic cancer. CEO Jennifer K. Simpson highlighted Cullen's contributions and expressed enthusiasm for his ongoing guidance in the company's next phase. SBP-101 shows potential for tumor growth inhibition and is being investigated further in clinical trials.
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