On November 12, 2019 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended September 30, 2019 (Press release, Soligenix, NOV 12, 2019, View Source [SID1234551033]).
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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are now approaching data read-out in two Phase 3 clinical programs. We anticipate completing patient enrollment before the end of the year with final top-line results in the first quarter of 2020 for our pivotal double-blind, placebo-controlled Phase 3 study for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin). Following the recent positive recommendation received from the independent Data Monitoring Committee (DMC), we continue to enroll patients in our pivotal double-blind, placebo-controlled Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. The study remains on target to complete enrollment and provide topline results in the second quarter of 2020."
Dr. Schaber continued, "Additionally, we continue to advance our heat stable ricin vaccine, RiVax, with the support of a National Institute of Allergy and Infectious Disease contract award of up to $24.7 million."
Soligenix Recent Accomplishments:
On October 24, 2019, the Company announced that the United States Patent Office had allowed the divisional patent application titled "Systems and Methods for Producing Synthetic Hypericin". The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin. Synthetic hypericin is the active pharmaceutical ingredient in SGX301, the Company’s photodynamic therapy for the treatment of CTCL. To view this press release, please click here.
On September 16, 2019, the Company announced that it had appointed Daniel P. Ring as Vice President of Business Development and Strategic Planning. Mr. Ring has over 22 years of business development and commercial experience in the biopharmaceutical industry. In this new role, Mr. Ring will oversee the Company’s global business development function, which will include balanced and disciplined management of any current or new strategic business opportunities, initiatives, mergers, acquisitions, partnerships, alliances, and/or licensing agreements. To view this press release, please click here.
On September 11, 2019, the Company announced that it had appointed Jonathan Guarino, CPA, CGMA, as its Senior Vice President and Chief Financial Officer. Mr. Guarino has over 20 years of diverse experience in the financial and strategic management of emerging growth and commercial companies, including in the life sciences industry. He has a proven track record and expertise in corporate financial operations, partnerships, as well as growth financings. To view this press release, please click here.
On August 28, 2019, the Company announced it had received a positive recommendation from the independent DMC to continue enrolling into the company’s pivotal Phase 3 "DOM–INNATE" study (Dusquetide treatment in Oral Mucositis – by modulating INNATE immunity) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with HNC. To view this press release, please click here.
On August 15, 2019, the Company announced that the National Institute of Dental and Craniofacial Research (NIDCR), part of the National Institutes of Health (NIH), had awarded Soligenix a Phase I Small Business Innovation Research (SBIR) of approximately $150,000 to support the evaluation of SGX942 (dusquetide) in pediatric indications. This award will facilitate the assessment of SGX942 safety in juvenile animals, supporting future studies in pediatric populations, including oral mucositis indications in pediatric patients undergoing stem cell transplants and treatments for HNC. To view this press release, please click here.
Financial Results – Third Quarter Ended September 30, 2019
Soligenix’s revenues for the quarter ended September 30, 2019 were $1.3 million as compared to $1.4 million for the quarter ended September 30, 2018. Revenues included payments on a contract in support of RiVax, in addition to the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in HNC.
Soligenix’s basic net loss was $2.7 million, or ($0.14) per share, for the quarter ended September 30, 2019, as compared to $1.9 million, or ($0.11) per share, for the quarter ended September 30, 2018.
Research and development expenses were $2.3 million as compared to $1.4 million for the quarters ended September 30, 2019 and 2018, respectively. The increase in research and development spending for the three months ended September 30, 2019 was primarily attributable to higher clinical trial expenditures relating to the two pivotal Phase 3 studies for SGX301 and SGX942, compared to the same period in 2018.
General and administrative expenses were $0.8 million as compared to $0.7 million for the quarters ended September 30, 2019 and 2018, respectively.
As of September 30, 2019, the Company’s cash position was approximately $6.6 million.