On May 15, 2024 Panbela Therapeutics, Inc., a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported a business update and reports financial results for the quarter ended March 31, 2024 (Press release, Panbela Therapeutics, MAY 15, 2024, View Source [SID1234643336]). As previously announced, management is hosting earnings call today at 4:30 p.m. ET.
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Q1 2024 and recent Highlights:
Clinical
Announced revised timing for the interim data analysis for its ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma (mPDAC). The analysis is now expected in Q1 2025 due to a lower-than-anticipated event rate, which suggests high potential for improved survival outcomes for patients in the trial.
Poster presentation of Ivospemin (SBP-101) at AACR (Free AACR Whitepaper) highlighting the efficacy of SBP-101 in combination with doxorubicin to treat platinum-resistant ovarian cancer
ASPIRE trial has exceeded 50% enrollment; complete enrollment of approximately 600 patients anticipated by Q1 2025
Publication of Clinical Data: Phase 1 study of high-dose DFMO, celecoxib, cyclophosphamide and topotecan for patients with relapsed neuroblastoma: a New Approaches to Neuroblastoma Therapy trial. Br J Cancer 130, 788–797 (2024)
Financial / Business
• Gained eligibility for quotation of common stock on the OTCQB
• Closed $9.0 million public offering of common stock and warrants
• Issuance of a New Patent in the US and Canada for Claims of a Fixed Dose Combination of Eflornithine and Sulindac
"We were thrilled to announce that our ongoing ASPIRE trial, evaluating ivospemin (SBP-101) in combination with standard-of-care for metastatic pancreatic ductal adenocarcinoma, or mPDAC, is now expected to reach its interim data analysis in the first quarter of 2025, due to a lower-than-anticipated event rate, suggesting improved survival outcomes for patients in the trial. This gives us hope for meaningful advancements in mPDAC treatment beyond the incremental benefits seen with recently approved therapies," said Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela.
"In addition to the progress in our ASPIRE trial, which has now exceeded 50% enrollment with complete enrollment of approximately 600 patients anticipated by Q1 2025, we were pleased to present a poster highlighting the efficacy of SBP-101 in combination with doxorubicin for treating platinum-resistant ovarian cancer at AACR (Free AACR Whitepaper). We also welcomed the publication of clinical data from our Phase I study of high-dose DFMO, celecoxib, cyclophosphamide, and topotecan for patients with relapsed neuroblastoma in the British Journal of Cancer. On the financial and business front, we announced the transfer of our common stock to the OTCQB market and successfully closed a $9.0 million public offering. As we look ahead, Panbela remains steadfast in its commitment to improving patient outcomes and driving value for our stockholders, with several key catalysts on the horizon, including the highly anticipated overall survival interim analysis in our Phase III ASPIRE Trial."
First Quarter ended March 31, 2024 Financial Results
General and administrative expenses were approximately $1.2 million in the quarter, compared to $1.4 million in the same period last year. The decrease is due primarily to reduced legal and other professional services.
Research and development expenses were approximately $5.5 million, compared to $3.5 million in the same period last year. This increase is primarily due to significant growth in the number of active sites and enrollment in project ASPIRE.
Net loss in the quarter was approximately $7.1 million, or $2.28 per diluted share, compared to a net loss of $5.1 million, or $392.76 per diluted share, in the same period last year. This increased loss is due to the incremental research and development expenses.
Total cash was $262,000 as of March 31, 2024. Total current assets were $1.8 million and current liabilities were $10.5 million as of the same date. In April the Company’s partner in Pediatric Neuroblastoma, US WorldMeds, provided a nondilutive payment of approximately $0.8 million in exchange for a reduction in the potential future milestone payments.
Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $4.2 million. The current portion of the notes payable plus accrued interest totaled approximately $1.3 million and was paid to the noteholder in the first quarter of 2024.
During the first quarter, the Company completed a registered public offering. Net proceeds from the raise, which closed on January 31, 2024, were approximately $8.1 million.