On March 25, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer, reported a business update and reports financial results for the quarter and full year ended December 31, 2020 (Press release, Panbela Therapeutics, MAR 25, 2021, View Source [SID1234583755]). Management is hosting an earnings call today at 4:30 p.m. ET.
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The fourth quarter and full year 2020 was marked by meaningful corporate, financial and clinical progress.
2020 and Recent Highlights
Appointed Garry A. Weems, PharmD as its VP of Clinical Development and Medical Affairs
Entered into a research agreement with the Johns Hopkins University School of Medicine
Completing SBP-101’s enrollment in its Phase 1b trial
Uplisted to Nasdaq Capital Market
Closed $10.5 Million Public Offering
New CEO appointed on July 15, 2020
Fast Track designation received for SBP-101
"2020 was a year of significant accomplishments for SBP-101 and Panbela as a public company. In 2021 we are focused on continued execution of our pancreatic cancer program and expanding our addressable market opportunity outside of pancreatic cancer," said Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Panbela Therapeutics. "Last year’s achievements included securing fast track designation for SB1-101 in 1L metastatic pancreatic cancer, completing Phase 1b trial enrollment, strengthening our leadership team, firming up our balance sheet and uplisting to Nasdaq."
Dr. Simpson continued, "This year we are focused on leveraging 2020’s successes to execute on upcoming SBP-101 milestones in pancreatic cancer. We are also committed to expanding our total addressable market beyond pancreatic cancer. In support of that goal, we have appointed Garry A. Weems, PharmD as VP of Clinical Development and Medical Affairs, and entered into a research agreement with the Johns Hopkins University School of Medicine. We look forward to ongoing preclinical work yielding data in the second half of the year to inform future development pathways across tumors outside of pancreatic cancer as well as the potential combination with checkpoint inhibitors."
Based on interim data from our Phase I trial, SBP-101 demonstrated a 62% objective response rate in combination with gemcitabine & abraxane (G&A); more than double the historical standard of care for metastatic pancreatic cancer with G&A.
We believe SBP-101 has the potential to expand into other cancers with known elevated levels of polyamine metabolism.
Upcoming Milestones
Public release of data from phase 1 trial (targeting 1H’21)
Conference presentations (targeting 1H’21 or 2H’21)
Initiation of randomized phase 2 study (targeting mid-Year 21)
Public release of preclinical data across tumors outside of pancreatic cancer (targeting 2H’21)
Fourth Quarter ended December 31, 2020 Financial Results
General and administrative expenses were $0.9 million in the fourth quarter of 2020, compared to $0.5 million in the fourth quarter of 2019. The change in the third quarter is due primarily to increased headcount, and increased costs associated with our Nasdaq listing.
Research and development expenses were $0.7 million in the fourth quarter of 2020, down from $0.8 million in the fourth quarter of 2019. The change in the fourth quarter is due the lower manufacturing costs of our active ingredient offset in part by higher clinical trial costs and salaries.
Net loss in the fourth quarter of 2020 was $0.9 million, or $0.90 per diluted share, compared to a net loss of $1.0 million, or $0.15 per diluted share, in the fourth quarter of 2019.
Total cash was $9.0 million as of December 31, 2020. Total current assets were $9.8 million and current liabilities were $1.4 million as of the same date. The company had no debt as of December 31, 2020.
Conference Call Information
To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
The call will also be available over the Internet and accessible at: View Source
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. Recently observed serious visual adverse evets are being evaluated and the FDA has issued a partial clinical hold for the impacted study, pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold. For more information, please visit View Source