On November 9, 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 ended September 30, 2023 (Press release, Panbela Therapeutics, NOV 9, 2023, View Source [SID1234637411]). As previously announced, management is hosting an earnings call today at 4:30 p.m. ET.

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Q3 2023 and Recent Highlights Collaborations

• Divestiture of assets within eflornithine (DFMO) pediatric neuroblastoma program to US WorldMeds for an upfront payment of $400,000 and contingent payments totaling up to an additional $9.1 million.

Clinical

• The independent Data Safety Monitoring Board (DSMB) of the ASPIRE trial completed its pre-specified review of safety data for treated patients in the trial. The DSMB recommended that the study continue without modification.
• Opened enrollment in the UK and Germany and have all planned countries in the ASPIRE trial for pancreatic cancer now open and actively enrolling.
• Entered into a clinical trial agreement for a Phase 2 trial in castration resistant metastatic prostate cancer (mCRPC) which is actively enrolling.

Financial/Business

• Last week, certain holders of our existing warrants exercised for an aggregate 2,130,000 shares of common stock at a reduced exercise price of $0.78 per share, in exchange for receiving new warrants, the exercisability of which remains subject to stockholder approval. The aggregate gross proceeds from the exercise of the existing warrants totaled approximately $1.9 million, before deducting financial advisory fees.
• Issued a new patent in China for claims of a novel process for the production of ivospemin (SBP-101). Patent developed in collaboration with Syngene International Ltd.
• Issued a new patent in Chile for claims of a novel process for the production of Flynpovi, Patent developed in collaboration with Sanofi.
• Issued a new patent in Australia for claims of a novel process for the production of ivospemin (SBP-101).

"In the third quarter, we achieved important milestones and advanced our robust product pipeline, primarily funded through strategic collaboration. Notably, our Phase III ASPIRE trial for untreated metastatic pancreatic ductal adenocarcinoma received a favorable safety review from the independent DSMB, recommending no changes to the trial protocol. We have opened enrollment in the UK and Germany, and now have all planned countries in the ASPIRE trial open and actively enrolling," said Jennifer K. Simpson, PhD, MSN, CRNP, President & CEO of Panbela.

"Additionally, we fortified our intellectual property portfolio, obtaining patents in China, Chile, and Australia. Moreover, we finalized an agreement for up to $9.5M in non-dilutive funding through the divestiture of our neuroblastoma program to our strategic partner, US WorldMeds, who recently received a positive vote from the Oncologic Drugs Advisory Committee (ODAC) meeting on October 4, 2023." Dr. Simpson added, "Looking ahead, Panbela remains committed to delivering value for both patients and shareholders. We are moving towards a number of upcoming catalysts, including the release of ASPIRE interim data around mid-year 2024."

Third Quarter ended September 30, 2023

Financial Results General and administrative expenses were $1.1 million in the third quarter of 2023, compared to $1.3 million in the third quarter of 2022. The change is primarily due to decreased legal and financial services costs.

Research and development expenses were $6.7 million in the third quarter of 2023, compared to $2.3 million in the third quarter of 2022. The increase is primarily due to the cost of approximately $3.2 million or approximately 6 months’ supply of Abraxane, a standard of care drug, used in the ASPIRE clinical trial and first made available to the clinical sites during the three months ended September 30, 2023. The remaining increase is associated with other ASPIRE clinical trial costs.

Net loss in the third quarter of 2023 was $7.8 million, or $2.69 per diluted share, compared to a net loss of $4.4 million, or $257.36 per diluted share, in the third quarter of 2022. All share and per share amounts have been restated for two reverse stock splits which occurred in the nine months ended September 30, 2023. Total cash was $0.9 million as of September 30, 2023.

Total current assets were $1.9 million and current liabilities were $8.9 million as of the same date. Notes payable, plus accrued interest, on the balance sheet, which was the result of the acquisition of CPP, included 1.2 million in current liabilities and 4.2 in debt, net of current portion.

Conference Call Information

To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
Date: November 9, 2023
Time: 4:30 PM Eastern Time
Participant Numbers: Toll Free: 888-506-0062; Code: 100225 International: 973-528-0011; Code: 100225 Webcast: View Source