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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) 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.
On November 28, 2022, Panbela Therapeutics (Nasdaq: PBLA) announced the enrollment of its first patients in Europe for the ASPIRE global clinical trial, aimed at treating metastatic pancreatic cancer with ivospemin, gemcitabine, and nab-Paclitaxel. Following recent regulatory approvals, the trial is expected to grow to approximately 95 sites worldwide by early to mid-2023. The company anticipates an interim analysis in early 2024, with promising clinical results showing median overall survival of 14.6 months in previous studies of ivospemin.
On November 10, 2022, Panbela Therapeutics, Inc. (Nasdaq: PBLA) reported its Q3 financial results, highlighting key milestones in its drug development pipeline. The Aspire Trial for metastatic pancreatic cancer saw its first patient enrolled, with regulatory approvals for sites in Spain, France, Italy, and Australia. The company completed a public offering, raising $6 million. However, Q3 net loss was $4.4 million, increasing from $2.1 million a year prior, with total cash at $0.9 million and current liabilities at $8 million. Panbela anticipates ongoing milestones to enhance shareholder value in 2023.
Panbela Therapeutics (Nasdaq: PBLA) will host a conference call on November 10, 2022, at 4:30 PM ET to discuss its third-quarter results for the period ending September 30, 2022. The company is focused on developing innovative therapeutics aimed at urgent medical needs, especially for conditions like familial adenomatous polyposis (FAP) and pancreatic cancer. Their lead candidates include SBP-101, which demonstrates promising survival rates in clinical trials, and Flynpovi, which has shown significant efficacy in preventing pre-cancerous growths.
Panbela Therapeutics (Nasdaq: PBLA) announced participation in the inaugural Roth Healthcare Opportunities Conference on October 6, 2022, in New York. The event aims to connect public healthcare companies with investors through presentations and one-on-one meetings. Panbela's pipeline targets critical conditions including familial adenomatous polyposis and pancreatic cancer. Lead assets include Ivospemin, demonstrating a median overall survival of 14.6 months in trials, and Flynpovi, showing over 90% prevention of pre-cancerous adenomas. For more details, visit www.panbela.com.
Panbela Therapeutics (PBLA) announced a public offering of 20,100,000 shares at $0.30 each, along with warrants for 30,150,000 shares. The offering, expected to close around October 4, 2022, will generate approximately $6 million in gross proceeds. Funds will support the clinical development of ivospemin (SBP-101) and eflornithine (CPP-1X), along with general corporate purposes. Roth Capital Partners leads the placement, with regulatory filings completed on September 29, 2022. The company's pipeline targets urgent medical needs, including various cancers.
Panbela Therapeutics (Nasdaq: PBLA) announced regulatory approval for trial sites in Spain, France, and Italy for their ASPIRE clinical trial. This global trial evaluates ivospemin combined with gemcitabine and nab-paclitaxel for treating metastatic pancreatic cancer. With 95 sites planned worldwide, site initiation will accelerate, with expectations for a significant number of global sites open by year-end. Interim analysis is anticipated in early 2024. Ivospemin has shown promising clinical results, including a median overall survival of 14.6 months in previous studies.
Panbela Therapeutics (Nasdaq: PBLA) announced a business update and financial results for Q2 2022. Key highlights include the enrollment of the first patient in the Aspire Trial, approval to expand global trials to Australia, and the acquisition of Cancer Prevention Pharmaceuticals (CPP). The combined entity targets a $5 billion market opportunity. Q2 financials show a net loss of $21.1 million, or $1.51 per share, with cash totaling $2.5 million. The company expects significant developments in its pipeline, including a fully funded Phase III trial beginning in early 2023.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) has initiated the ASPIRE trial, a global clinical study evaluating SBP-101 combined with Gemcitabine and Nab-Paclitaxel for metastatic pancreatic ductal adenocarcinoma. The first patient has been enrolled in Australia, with over 90 additional sites expected to open by early 2023. An interim analysis is slated for early 2024, with a total sample size of 600 subjects. SBP-101 has shown promising results in prior studies, with a median overall survival of 14.6 months and an objective response rate of 48%, highlighting its potential against standard treatments.
Panbela Therapeutics (Nasdaq: PBLA) announced the approval from the Australian Human Research Ethics Committee to extend its ASPIRE trial to Australia, testing SBP-101 with Gemcitabine and Nab-Paclitaxel for metastatic pancreatic cancer. The trial aims at overall survival as its primary endpoint and will involve around 90 sites across 10 countries by early 2023. Patient screening has started, with interim analysis enrollment expected to finish in early 2024. The pipeline includes candidates for various cancers, with SBP-101 displaying promising efficacy in clinical studies.
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