On August 11, 2020 Sun BioPharma, Inc. (OTCQB: SNBP), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with pancreatic cancer, reported financial results for the quarter ended June 30, 2020 (Press release, Sun BioPharma, AUG 11, 2020, View Source;utm_medium=rss&utm_campaign=sbp-provides-business-update-and-reports-q2-2020-financial-results [SID1234563422]). The second quarter of 2020 was marked by meaningful corporate, financial and clinical progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Highlights

New CEO appointed on July 15, 2020
Enrollment in clinical trial of SBP-101 has resumed, after temporary, Covid-19 related pause
Fast Track designation received for SBP-101
Additional funds raised through sale of equity securities
CEO Appointment
In July, the company appointed of Jennifer K. Simpson, PhD, MSN, CRNP as President and Chief Executive Officer and as a member of the Board of Directors. Dr. Simpson brings more than two decades of public company executive and fundraising experience in oncology drug development and commercialization to the company. Sun BioPharma co-founder Michael T. Cullen, MD, MBA, has continued to serve as Executive Chairman of our Board of Directors.

"I’m excited that we were able to resume enrollment in our clinical trial of SBP-101 in order to keep advancing this program for the patients who need it most," said Jennifer K. Simpson, PhD, MSN, CRNP President & Chief Executive Officer of Sun BioPharma. "The company is well positioned to maximize the opportunity for value of this product candidate for patients, caregivers and investors, and we look forward to completing the design of our Phase 2 development program shortly."

Enrollment Resumed in Ongoing Clinical Trial of SBP-101
In June, Sun BioPharma authorized clinical trial sites to resume enrollment in the expansion cohort of its Phase 1a/b clinical trial of SNBP-101. Enrollment in many clinical trials across the industry had been temporarily paused earlier this year to enable hospitals to prioritize the treatment of patients with COVID-19. This trial, a Phase 1a/1b study of the combination of SBP-101 with gemcitabine and nab-paclitaxel in patients previously untreated for metastatic pancreatic ductal adenocarcinoma (PDA), is being conducted at 6 sites in the United States and Australia.

FDA Fast Track Designation Received for SBP-101
During the second quarter, the company received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for SBP-101 for first-line treatment of patients with metastatic PDA when administered in combination with gemcitabine and nab-paclitaxel. One of FDA’s Expedited Programs for Serious Conditions, Fast Track is a process designed to facilitate the development and potentially expedite the review of drugs intended to treat serious conditions and address unmet medical needs. This designation is expected to enhance Sun BioPharma’s ability to develop SBP-101 as efficiently as possible.

Recent Sales of Common Stock and Warrants Raised $1.7 Million
In May and June, the company sold common stock and warrants in private placements resulting in net proceeds totaling approximately $1.7 million, which the company intends to use primarily to support its ongoing clinical trial. A total of 437,000 shares of common stock were issued in addition to warrants to purchase an equal number of shares of common stock.

Second Quarter ended June 30, 2020 Financial Results

General and administrative expenses increased to $0.7 million in the second quarter of 2020, up from $0.6 million in the second quarter of 2019. The increase in the second quarter is due to higher consulting and legal expense offset in part by lower stock compensation expense.

Research and development expenses decreased to $0.4 million in the second quarter of 2020, down from $0.5 million in the second quarter of 2019. The decrease in the second quarter is due to lower spending on preclinical studies and lower stock compensation expense.

Operating expenses in the second quarter were partially offset by a foreign currency exchange gain on the intercompany receivable balance. In the second quarter of 2019, other expense was primarily interest expense which resulted from the amortization of debt discount on convertible notes sold in 2018 and 2019.

Net loss in the second quarter of 2020 was $0.4 million, or $0.06 per diluted share, compared to a net loss of $2.3 million, or $0.45 per diluted share, in the second quarter of 2019.

Total cash was $2.3 million as of June 30, 2020. Total current assets were $3.3 million and current liabilities were $1.7 million as of the same date.

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