Panbela Therapeutics, Inc., a clinical-stage company based in Minneapolis, reported its business updates and financial results for the second quarter ending on June 30, 2024. The company is advancing disruptive therapeutics aimed at addressing urgent unmet medical needs.
Clinical Progress
A significant highlight in Panbela's clinical progress is the Phase 3 ASPIRE clinical trial, which received a positive third independent safety review. The Data and Safety Monitoring Board (DSMB) recommended continuing the trial without any modifications. This trial focuses on evaluating ivospemin (SBP-101) combined with standard treatments for metastatic pancreatic ductal adenocarcinoma (mPDAC).
Additionally, Panbela presented an oral evaluation of the safety and efficacy of eflornithine (DFMO) in patients with gastric premalignant conditions at Digestive Disease Week (DDW). This presentation underscores the company's commitment to advancing treatments for serious gastrointestinal conditions in high-incidence areas of Latin America.
The timing for interim data analysis in the ASPIRE trial has been revised due to a lower-than-expected event rate, suggesting potential for improved patient survival outcomes. This analysis is now anticipated in the first quarter of 2025, indicating promising prospects for ivospemin’s efficacy.
Financial and Business Updates
In the financial realm, Panbela achieved eligibility for common stock quotation on the OTCQB. The company also successfully obtained a new patent in the U.S. and Canada for a fixed-dose combination of eflornithine and sulindac.
Financially, the company reported $1.1 million in general and administrative expenses for Q2 2024, a decrease from $1.6 million in the same period last year. This reduction was attributed mainly to lowered legal and compensation expenses. However, research and development expenses rose to $7 million from $4.2 million, driven by increased activity and enrollment in the ASPIRE project.
The net loss for the quarter was approximately $7.1 million, translating to $1.47 per diluted share, compared to a net loss of $5.8 million, or $159.15 per diluted share, in the same quarter of the previous year. This increase is primarily due to higher research and development costs.
Cash and Assets
As of June 30, 2024, Panbela reported total cash of $59,000, with current assets totaling $0.8 million and current liabilities at $16.8 million. The company secured a nondilutive payment of around $0.8 million from its partner, US WorldMeds®, in exchange for a reduction in potential future milestone payments. Additionally, in July, Panbela obtained a $1.5 million loan from the same partner.
Notes payable, along with accrued interest, from the acquisition of Cancer Prevention Pharmaceuticals, Inc., amounted to approximately $4.3 million, with the current portion totaling around $1.1 million.
Leadership Comments
Jennifer K. Simpson, PhD, MSN, CRNP, President and CEO of Panbela, highlighted the company's substantial progress in clinical programs and corporate initiatives. Dr. Simpson emphasized the importance of the favorable safety review for the ASPIRE trial and the significance of their DDW presentation on eflornithine.
She also remarked on the revised timeline for the interim data analysis of the ASPIRE trial, suggesting that the lower event rate might indicate better survival outcomes for patients. Dr. Simpson reiterated Panbela's commitment to advancing clinical programs, exploring new indications, and creating value for stockholders. Looking ahead, the company is focused on key milestones, including the anticipated interim analysis of overall survival in the ASPIRE Trial.
Financial Summary
For the quarter ended June 30, 2024, Panbela reported general and administrative expenses of $1.1 million, down from $1.6 million in the previous year’s quarter. Research and development expenses increased to $7 million from $4.2 million, reflecting growth in active sites and enrollment for the ASPIRE project. The net loss for the quarter was $7.1 million, compared to $5.8 million in the same period of the previous year, primarily due to the rise in research and development expenses.
Overall, Panbela Therapeutics continues to progress in its clinical trials and corporate strategies, aiming to make significant advancements in treating urgent unmet medical needs.
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