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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) will hold a conference call on May 12, 2021, at 4:30 PM ET to discuss first-quarter results for the period ending March 31, 2021. The call can be accessed via toll-free and international numbers provided in the release. The company’s key product, SBP-101, is a therapeutic for metastatic pancreatic cancer, currently showing promising clinical trial results without significant exacerbation of common chemotherapy-related adverse events. For more details, visit Panbela's website.
Panbela Therapeutics (Nasdaq: PBLA) announced that the FDA has lifted the partial clinical hold on its Phase 1 study for SBP-101. This therapeutic candidate aims to treat metastatic pancreatic ductal adenocarcinoma in combination with gemcitabine and nab-paclitaxel. The study will now exclude patients with a history of retinopathy and include ophthalmologic monitoring. SBP-101 has shown promise in inhibiting tumor growth without exacerbating common chemotherapy-related adverse effects. The FDA's decision allows for continued evaluation of SBP-101 in clinical trials.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) announced that an abstract for its product candidate SBP-101 has been accepted for a poster presentation at the ASCO Annual Meeting from June 4-8, 2021. The presentation will focus on SBP-101's potential efficacy as a first-line treatment for metastatic pancreatic ductal adenocarcinoma in combination with standard therapies. While the initial studies indicate promising signals of efficacy, safety concerns remain, as the FDA has issued a partial clinical hold due to serious adverse events requiring further evaluation.
Panbela Therapeutics (PBLA) re-issued its press release to correct a decimal error in Q4 2020 net loss per share. For Q4 2020, net loss was $0.9 million, or $0.09 per diluted share, an improvement from a net loss of $1.0 million and $0.15 per diluted share in Q4 2019. Total cash as of December 31, 2020, stood at $9.0 million. Notable achievements in 2020 included appointing Garry A. Weems as VP of Clinical Development, entering a research agreement with Johns Hopkins, and receiving Fast Track designation for SBP-101 in metastatic pancreatic cancer.
Panbela Therapeutics, Inc. (Nasdaq: PBLA) provided a business update and reported financial results for the year ended December 31, 2020. Highlights include a successful enrollment completion for its SBP-101 Phase 1b trial and a strategic partnership with Johns Hopkins University. The company recorded a net loss of $0.9 million for Q4 2020, improving from a $1.0 million loss in Q4 2019. Total cash stood at $9.0 million, with no debt reported. Looking ahead, Panbela aims to leverage 2020’s accomplishments to advance SBP-101 and explore opportunities beyond pancreatic cancer.
Panbela Therapeutics (Nasdaq: PBLA) announced a conference call on March 25, 2021, to discuss its fourth-quarter results for 2020. The call will feature insights into the performance of SBP-101, a therapeutic candidate for pancreatic cancer, which has shown promise in clinical studies without exacerbating chemotherapy-related adverse events. However, a partial clinical hold has been placed by the FDA due to serious visual adverse events, pending further evaluation. Investors are advised to stay tuned for updates post-call.
Panbela Therapeutics, Inc. (PBLA) has appointed Garry A. Weems, PharmD, as Vice President of Clinical Development. Weems brings over 25 years of oncology experience, previously serving at Cerecor, Inc. Significant milestones expected for SBP-101, a therapeutic for pancreatic cancer, will shape future development plans. The compound has shown potential in clinical studies, with the FDA placing a partial hold on one study due to serious visual adverse events. Continued evaluation and subsequent randomized trials depend on regulatory feedback.
Panbela Therapeutics (Nasdaq: PBLA) announced participation in three virtual investor conferences in March 2021: H.C. Wainwright Global Life Sciences Conference (March 9-10), 33rd Annual ROTH Conference (March 15-17), and Maxim Emerging Growth Conference (March 17-18). The company is developing SBP-101, a therapeutic for metastatic pancreatic ductal adenocarcinoma. Clinical data show potential for tumor growth inhibition without exacerbating chemotherapy-related side effects, though a partial clinical hold from the FDA is currently in place.
Panbela Therapeutics (Nasdaq: PBLA) announced a research agreement with Johns Hopkins University School of Medicine to advance SBP-101, a polyamine analogue aimed at treating pancreatic cancer. This collaboration will explore SBP-101's effectiveness across various cancer cell lines, its biomarker potential, and its compatibility with checkpoint inhibitors. Led by Prof. Robert Casero, SBP-101 has demonstrated tumor growth inhibition in clinical studies without aggravating typical chemotherapy side effects. Future evaluations will depend on regulatory approvals and ongoing clinical trials.
Panbela Therapeutics (Nasdaq: PBLA) is conducting a Phase 1 clinical trial of SBP-101, an investigational agent for patients with metastatic pancreatic ductal adenocarcinoma (PDA), in combination with standard care agents gemcitabine and nab-paclitaxel. The independent data safety monitoring board (DSMB) has recommended pausing SBP-101 dosing due to reports of visual disturbances in some patients, while other trial activities will continue. Panbela is finalizing a visual screening program and remains confident in SBP-101's potential benefits. All trial enrollments were completed by December 2020.
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