On November 12, 2020-Sun BioPharma, Inc. (Nasdaq: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported financial results for the quarter ended September 30, 2020 (Press release, Sun BioPharma, NOV 12, 2020, View Source;utm_medium=rss&utm_campaign=sbp-provides-business-update-and-reports-q3-2020-financial-results [SID1234570802]). Management is hosting an earnings call today at 4:30 p.m. ET.
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The third quarter of 2020 was marked by meaningful corporate, financial and clinical progress.
Highlights
• New CEO appointed on July 15, 2020
• Fast Track designation received for SBP-101
• Uplisted to Nasdaq Capital Market
• Closed $10.5 Million Public Offering
"During the third quarter we strengthened our leadership team, bolstered the balance sheet and broadened our potential investor audience by uplisting to Nasdaq," said Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Sun BioPharma. "These Q3 accomplishments lay the foundation to execute on near-term milestones. Those upcoming milestones include completing SBP-101’s enrollment in the current Phase 1b trial in Q4 2020, reporting data from our Phase 1 trial in 1H 2021, initiating a randomized Phase 2 study in 1H 2021 while evaluating additional opportunities for SBP-101. Looking ahead, we’re focused on rapidly advancing SBP-101’s clinical development to create significant shareholder value."
Based on interim data from our Phase I trial, SBP-101 demonstrated a 54% objective response rate in combination with gemcitabine & abraxane (G&A); more than double 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
• Completion of enrollment in the expansion cohort targeting (Q4’20)
• Data from phase 1 trial (1H’21)
• Conference presentations (1H’21 or 2H’21)
• Initiation of randomized phase 2 study (1H’21)
Third Quarter ended September 30, 2020 Financial Results
General and administrative expenses increased to $1.2 million in the third quarter of 2020, up from $0.6 million in the third quarter of 2019. The change in the third quarter is due primarily to increased employee compensation expense.
Research and development expenses increased to $0.8 million in the third quarter of 2020, up from $0.7 million in the third quarter of 2019. The change in the third quarter is due to increased spending on the company’s clinical study.
Operating expenses in the third quarter of 2020 were partially offset by a foreign currency exchange gain on the intercompany receivable balance; for the same quarter in 2019 other expense, net was primarily a foreign currency exchange loss.
Net loss in the third quarter of 2020 was $1.7 million, or $0.21 per diluted share, compared to a net loss of $1.4 million, or $0.23 per diluted share, in the third quarter of 2019.
Total cash was $10.9 million as of September 30, 2020. Total current assets were $11.4 million and current liabilities were $1.9 million as of the same date.
Conference Call Information To participate in this event, dial approximately 5 to 10 minutes before the beginning of the call.
A replay of the call will be available from November 13, 2020 through November 26, 2020
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 the exocrine pancreas and pancreatic ductal adenocarcinoma. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting complementary activity with an existing FDA-approved chemotherapy regimen. In clinical studies to date, SBP-101 has not shown exacerbation of the typical chemotherapy-related adverse events of bone marrow suppression and peripheral neuropathy. The safety data and PMI profile observed in Sun BioPharma’s current clinical trial provides support for continued evaluation of the compound in a randomized clinical trial. For more information, please visit View Source