Panbela Releases Q1 2024 Financial Results and Business Update

May 15, 2024 – Panbela Therapeutics Inc. (OTCQB: PBLA), a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for critical unmet medical needs, has released a business update and financial results for the quarter ending March 31, 2024. An earnings call was scheduled for today at 4:30 p.m. ET.

Q1 2024 and Recent Highlights

Clinical Updates:

Panbela Therapeutics announced a revised schedule for the interim data analysis of the ongoing ASPIRE trial, which evaluates ivospemin (SBP-101) in conjunction with standard-of-care for treating metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis, initially planned for an earlier date, has been postponed to Q1 2025 due to a lower-than-expected event rate, raising hopes for better survival outcomes for trial participants.

At the AACR conference, Panbela presented a poster detailing the efficacy of ivospemin (SBP-101) when combined with doxorubicin for treating platinum-resistant ovarian cancer. The ASPIRE trial has now surpassed 50% enrollment, with complete enrollment of around 600 patients anticipated by Q1 2025.

Additionally, clinical data from a Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide, and topotecan for patients with relapsed neuroblastoma were published in the British Journal of Cancer (Br J Cancer 130, 788–797, 2024).

Financial and Business Updates:

The company’s common stock has been approved for quotation on the OTCQB market. Panbela successfully closed a $9.0 million public offering of common stock and warrants. Furthermore, a new patent in the US and Canada was issued for a fixed dose combination of Eflornithine and Sulindac.

Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela, expressed enthusiasm about the progress, highlighting the potential for significant advancements in mPDAC treatment. Simpson also noted the importance of the ASPIRE trial's progress, the encouraging data presented at AACR, and the recently published clinical data on neuroblastoma.

Financial Results for Q1 2024:

General and administrative expenses for the quarter were approximately $1.2 million, a decrease from $1.4 million in the same period last year, primarily due to reduced legal and professional service costs. Research and development expenses rose significantly to about $5.5 million, compared to $3.5 million last year, driven by the expansion of active sites and enrollment in the ASPIRE project.

The net loss for Q1 2024 was approximately $7.1 million, equating to $2.28 per diluted share, compared to a net loss of $5.1 million and $392.76 per diluted share in Q1 2023. This increase in net loss is primarily attributed to increased research and development expenses. As of March 31, 2024, Panbela’s total cash stood at $262,000, with total current assets amounting to $1.8 million and current liabilities at $10.5 million.

A notable financial move in April included a non-dilutive payment of approximately $0.8 million from US WorldMeds®, Panbela’s partner in Pediatric Neuroblastoma, in exchange for a reduction in potential future milestone payments.

Pipeline Overview:

Panbela’s clinical pipeline targets several critical areas, including familial adenomatous polyposis (FAP), first-line metastatic pancreatic cancer, neoadjuvant pancreatic cancer, colorectal cancer prevention, ovarian cancer, and diabetes. Key assets under development include:

Ivospemin (SBP-101): This proprietary polyamine analogue is designed to inhibit polyamine metabolism, demonstrating promising results in metastatic pancreatic cancer by showing a median overall survival of 14.6 months and an objective response rate of 48%.

Flynpovi™: A combination of eflornithine and sulindac, Flynpovi has shown significant benefits in delaying surgical events for FAP patients with specific lower gastrointestinal tract anatomy.

CPP-1X Eflornithine: Being developed as a single agent for various indications, including gastric cancer prevention and recent onset Type 1 diabetes, CPP-1X has shown potential in preclinical studies and early-phase clinical trials.

About Panbela Therapeutics:

Panbela Therapeutics, Inc. is committed to developing transformative therapies for critical unmet medical needs. With a focus on innovative treatments like Ivospemin (SBP-101) and Flynpovi, Panbela aims to enhance patient outcomes and deliver value to stakeholders. Panbela’s common stock is listed on the OTCQB under the symbol “PBLA.”

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