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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 (PBLA) reported Q3 2024 financial results and secured a $12.0 million financing commitment from Nant Capital. The company enrolled its first patient in a Phase I study of CPP-1X-S for STK11 mutant NSCLC. The Phase III ASPIRE trial continues with interim analysis expected in Q1 2025. Q3 financial results showed general and administrative expenses of $1.1 million, R&D expenses of $6.0 million, and a net loss of $7.2 million ($1.48 per share). Total cash was $142,000 as of September 30, 2024, with current assets at $5.2 million and current liabilities at $20.1 million.
Panbela Therapeutics (OTCQB: PBLA), a clinical stage company focused on developing treatments for urgent unmet medical needs, has scheduled its Q3 2024 earnings conference call for November 14, 2024, at 4:30 PM Eastern Time. The call will discuss financial results for the quarter ended September 30, 2024. The company has provided both domestic and international dial-in numbers, along with webcast access for interested participants.
Panbela Therapeutics (OTCQB: PBLA) has announced the enrollment of the first patient in a Phase I dose escalation study evaluating CPP-1X-S (eflornithine sachets) in STK11 mutant non-small cell lung cancer (NSCLC). The study aims to determine the maximum tolerated dose of eflornithine combined with Keytruda, an immune checkpoint inhibitor. Data from this trial is expected by mid-2025, with plans to initiate a Phase II efficacy trial in 2024.
The trial, titled 'Targeting ODC as an Immunotherapeutic Target in STK11 (LKB1) Pathway-Deficient NSCLC,' will be conducted at approximately one academic medical center in the United States. Dr. Jhanelle Gray, Principal Investigator and Chair of Moffitt's Department of Thoracic Oncology, emphasized the importance of combining new agents with immunotherapy to overcome reduced anti-tumor T cell levels in STK11 mutant tumors.
Panbela Therapeutics (OTCQB: PBLA) reported Q2 2024 financial results and provided a business update. Key highlights include:
1. Favorable third independent safety review for Phase 3 ASPIRE clinical trial.
2. Oral presentation at Digestive Disease Week on eflornithine safety and efficacy.
3. Revised timing for ASPIRE trial interim data analysis, now expected in Q1 2025.
4. Gained OTCQB eligibility and new patent issuance in US and Canada.
Financial results: Q2 net loss of $7.1 million ($1.47 per share), compared to $5.8 million ($159.15 per share) in Q2 2023. Research and development expenses increased to $7.0 million from $4.2 million. Total cash as of June 30, 2024, was $59,000.
Panbela Therapeutics (OTCQB: PBLA), a clinical stage company developing therapeutics for urgent unmet medical needs, has announced its upcoming second quarter 2024 earnings conference call. The call is scheduled for August 13, 2024, at 4:30 PM Eastern Time. Investors and interested parties can join via phone or webcast to discuss the company's financial results for the quarter ending June 30, 2024.
The conference call details include:
- Toll-Free: 888-506-0062
- International: 973-528-0011
- Participant Access Code: 405072
A webcast link and replay information have also been provided for those unable to attend the live call.
Panbela Therapeutics announced the third positive safety review from the independent Data Safety Monitoring Board (DSMB) for its Phase 3 ASPIRE clinical trial. This trial evaluates ivospemin in combination with gemcitabine and nab-paclitaxel for treating metastatic pancreatic ductal adenocarcinoma (mPDAC).
The DSMB recommended the continuation of the trial without modifications, covering 395 patients thus far. The lower-than-expected event rate suggests a potential for prolonged survival, with interim survival analysis expected in early 2025. Panbela aims to complete patient enrollment by Q1 2025, ahead of schedule.
Panbela Therapeutics presented findings at the Digestive Disease Week (DDW) conference about the safety and efficacy of eflornithine (DFMO) in patients with gastric premalignant conditions in Latin America. The study, conducted between September 2016 and December 2022, involved 80% H. pylori positive subjects treated with eflornithine or placebo for 18 months. Results showed eflornithine to be safe, well-tolerated, and effective in reducing long-term DNA damage. Adverse events were lower in the eflornithine group compared to placebo. The study was a collaboration with Vanderbilt University Medical Center.
Panbela Therapeutics (PBLA) provided a business update and Q1 2024 financial results. Key clinical updates include the ASPIRE trial's interim data analysis now expected in Q1 2025, with over 50% enrollment completed. The company highlighted ivospemin's (SBP-101) efficacy in treating platinum-resistant ovarian cancer and published phase 1 study results for relapsed neuroblastoma.
Financially, Panbela reported a Q1 2024 net loss of $7.1 million, an increase from $5.1 million last year, primarily due to higher R&D expenses. The company closed a $9 million public offering and transferred its stock to the OTCQB market. Total cash stood at $262,000, with current assets of $1.8 million and liabilities of $10.5 million as of March 31, 2024.
Panbela Therapeutics, Inc. announced the issuance of a new patent in the US and Canada for a fixed dose combination of eflornithine and sulindac, called Flynpovi. Developed in collaboration with Sanofi, this product is aimed at treating patients with Familial Adenomatous Polyposis (FAP). The patents are valid until 2036 and cover territories including Australia, Mexico, Taiwan, and Chile. This patent expands Panbela's global clinical programs, offering a potential breakthrough in FAP treatment.
Panbela Therapeutics, Inc. (OTCQB: PBLA) will host a conference call on May 15, 2024, to discuss the results of its first quarter ended March 31, 2024. The call will focus on the company's disruptive therapeutics for urgent unmet medical needs.
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