On March 16, 2023 Panbela Therapeutics, Inc. (Nasdaq: PBLA), 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 and full year ended December 31, 2022 (Press release, Panbela Therapeutics, MAR 16, 2023, View Source [SID1234628926]). As previously announced, management is hosting earnings call today at 4:30 p.m. ET.
2022 and early 2023 Highlights:
• Significant progress was made on the conduct of the ASPIRE global clinical trial studying ivospemin (SBP-101) in combination with gemcitabine and nab-paclitaxel in the first-line treatment of metastatic pancreatic ductal adenocarcinoma:
o Initiated ASPIRE trial in January 2022
o Received approval from the Australian Human Research Ethics Committee
(HREC) to expand the ASPIRE global clinical trial to Australia o Enrolled first patient in South Korea o Enrolled first patient in Europe o Enrolled first patient in Australia
o Received approvals to open trial sites in Spain, France and Italy
• An abstract for ivospemin will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper), which will be held April 14-19, 2023. The work reflects the Company’s on-going collaboration with Johns Hopkins University School of Medicine
• Closed a registered public offering yielding gross proceeds of approximately $15 million in Q1 of 2023
• Started Phase II Trial of CPP-1X-T for Recent Onset Type I Diabetes in January 2023, in collaboration with Indiana University and the Juvenile Diabetes Research Foundation
• European Medicines Agency (EMA) Committee for Orphan Medicinal Products issued the Adoption of Commission Implementing Decision relating to the designation of ivospemin as an orphan medicinal product in March 2023
• Closed a registered public offering yielding gross proceeds of approximately $6.0 million in Q4 of 2022
• Hosted an R&D call joined by leading experts for a deep dive on the company’s investigational drug, ivospemin, as a polyamine metabolism modulator in ovarian cancer
• Completed the acquisition of Cancer Prevention Pharmaceuticals, Inc. (CPP)
• Presented a poster highlighting the results for ivospemin as a polyamine metabolism modulator in ovarian cancer at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April 2022
• Presented a poster highlighting the Clinical Data on Phase 1b Clinical Trial of ivospemin in Combination with Gemcitabine and Nab-Paclitaxel in Patients with Metastatic PDA at 2022 ASCO (Free ASCO Whitepaper) GI Meeting
"During Q4 and year to date, we progressed our pipeline, which has been principally funded through collaborations," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer of Panbela. "Milestones achieved included first patients enrolled in Australia, Europe and South Korea in our ASPIRE global trial for metastatic pancreatic cancer, and EMA Orphan drug designation. Additionally, we bolstered our balance sheet with gross proceeds from recent public offerings. As we move forward in 2023, we anticipate a consistent stream of milestones to drive shareholder value."
Fourth Quarter ended December 31, 2022 Financial Results
General and administrative expenses were $1.7 million in the fourth quarter of 2022, compared to $1.3 million in the fourth quarter of 2021. The increase primarily is due to severance expenses associated with the acquisition of CPP.
Research and development expenses were $3.5 million in the fourth quarter of 2022, compared to $2.0 million in the fourth quarter of 2021. The change is due primarily to an increase in spending on our clinical studies as we expanded the ASPIRE clinical trial.
Net loss in the fourth quarter of 2022 was $4.7 million, or $5.68 per diluted share, compared to a net loss of $3.5 million, or $10.54 per diluted share, in the fourth quarter of 2021. All share and per-share amounts have been restated to reflect the 40-for-1 reverse split of our common stock, which was effective on January 13, 2023.
Total cash was $1.3 million as of December 31, 2022. Total current assets were $1.8 million and current liabilities were $7.8 million as of the same date. Notes payable, plus accrued interest, on the balance sheet, the result of the acquisition of CPP, totaled approximately $7.2 million. The current portion of the notes payable plus accrued interest totaled approximately $2.0 million.
Subsequent to the end of the year, the Company completed a registered public offering. Gross proceeds from the raise, which closed on January 30, 2023, were approximately $15 million.
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