On November 10, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported financial results for the quarter ended September 30, 2021 (Press release, Panbela Therapeutics, NOV 10, 2021, View Source [SID1234595186]). Management is hosting an earnings call today at 4:30 p.m. ET.
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The third quarter 2021 was marked by further meaningful clinical progress.
Recent Highlights
16 patients are in survival follow up since enrollment completed in December 2020, with 2 patients from cohort 2 now exceeding 26.9 and 28.7 months. Median overall survival for cohort 4 plus phase 1b (N=29) has not yet been reached.
Issue Notification for patent US 11,098,005 titled "METHODS FOR PRODUCING (6S,15S)-3,8,13,18- TETRAAZAICOSANE-6,15-DIOL". A novel process for the production of our lead investigational product SBP-101, reduces the number of synthetic steps for its production from seventeen to six, and provides patent coverage to 2039.
$10.0 million bought offering of common stock closed July 2021.
"We have had a great third quarter and year to date," said Jennifer K. Simpson, PhD, MSN, CRNP, President & Chief Executive Officer. "Highlights included reporting on 16 patients in survival follow up, since enrollment completed last December, with two patients north of 2-years. Additionally, we announced the issue notification to produce SBP-101. We also bolstered our balance sheet with the previously announced underwritten common stock offering, which will allow us to finish the current clinical trial, start a randomized trial in 2021 and expand into other cancer indications."
Upcoming Milestones
Initiation of randomized trial by year-end.
Initiation of a neoadjuvant study in pancreatic cancer by year-end.
Pre-clinical data which may support new development programs outside of pancreatic cancer by year-end and the initiation of a clinical trial in 1H ’22.
Third Quarter ended September 30, 2021 Financial Results
General and administrative expenses were $0.9 million in the third quarter of 2021, compared to $1.2 million in the third quarter of 2020. The decrease in the quarter is primarily associated with lower non-cash employee compensation.
Research and development expenses were $1.3 million in the third quarter of 2021, compared to $0.8 million in the third quarter of 2020. The increase in the quarter is due primarily to higher manufacturing costs in preparation for future clinical trials.
Net loss was $2.1 million, or $0.16 per diluted share, compared to a net loss of $1.7 million, or $0.21 per diluted share, in the third quarter of 2020.
Total cash and cash equivalents was $14.1 million as of September 30, 2021. Total current assets were $14.7 million and current liabilities were $1.3 million as of the same date.
The company had no debt as of September 30, 2021.
Conference Call Information
About SBP-101
SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Serious visual adverse events have been evaluated and patients with a history of retinopathy or at risk of retinal detachment will be excluded from future SBP-101 studies. The safety data and PMI profile observed in the current Panbela sponsored clinical trial provides support for continued evaluation of SBP-101 in a randomized clinical trial. For more information, please visit View Source .