On August 13, 2021 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 June 30, 2021 (Press release, Soligenix, AUG 13, 2021, View Source [SID1234586553]).
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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "2021 remains a crucial year for Soligenix. Under our Specialized BioTherapeutics business segment, our HyBryte (SGX301) positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL) was recently selected for presentation at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting. Additionally, HyBryte received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA), which is a key component of the regulatory process for marketing authorization in Europe. We continue to move our pipeline forward with multiple data readouts expected this year under our Public Health Solutions business segment. This data is critial in our efforts to advance our therapeutic and vaccine candidates such as CiVax, our heat stable COVID-19 vaccine."
Dr. Schaber continued, "With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing in the first half of 2022 and U.S. commercialization of HyBryte in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million. We are also aggressively exploring and evaluating multiple strategic options moving forward, including but not limited to, partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
On June 22, 2021, the Company announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study in CTCL, would present key details of HyBryte (hypericin ointment 0.25%) efficacy and safety profile demonstrated in the FLASH study at the USCLC Annual Meeting, to be held on June 26, 2021. To view this press release, please click here.
On June 10, 2021, the Company announced that it had received a PIP waiver from the EMA for HyBryte, which has recently and successfully concluded a Phase 3, pivotal clinical study for the treatment of early stage CTCL. To view this press release, please click here.
On June 9, 2021, the Company announced that it had received approximately $865,000, net of transaction costs, in non-dilutive financing via the state of New Jersey’s Technology Business Tax Certificate Transfer Program. To view this press release, please click here.
On May 20, 2021, the Company announced that the Japan Patent Office had allowed the 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, and are similar to those previously allowed in the United States. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2021
Soligenix’s revenues for the quarter ended June 30, 2021 were $0.2 million as compared to $0.5 million for the quarter ended June 30, 2020. Revenues included payments on grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization technology; and CiVax, our vaccine candidate for the prevention of COVID-19.
Soligenix’s basic net loss was $1.9 million, or ($0.05) per share, for the quarter ended June 30, 2021, as compared to $2.8 million, or ($0.10) per share, for the quarter ended June 30, 2020. This decrease in net loss was primarily due to the gain on the forgiveness of the Payroll Protection Program loan and the sale of New Jersey NOL carryforwards offset by reduced contract revenues and the interest expense on convertible debt.
Research and development expenses were $2.1 million as compared to $2.2 million for the quarters ended June 30, 2021 and 2020, respectively. The decrease in research and development spending for the quarter ended June 30, 2021 was primarily attributable to the reduction in expense due to the completion of the HyBryte and SGX942 clinical trials.
General and administrative expenses were $0.9 million and $0.8 million for the three months ended June 30, 2021 and 2020, respectively.
As of June 30, 2021, the Company’s cash position was approximately $29.0 million.