On May 13, 2022 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 March 31, 2022 (Press release, Soligenix, MAY 13, 2022, View Source [SID1234614521]).
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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We remain focused on our significant upcoming milestones for 2022. We anticipate submitting a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing authorization of HyBryte (SGX301 or synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL) in the second half of this year. We expect to initiate a Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin) in the second half of this year as well. With approximately $22.9 million in cash, not including our non-dilutive government funding, we anticipate having the capital required to achieve our near-term milestones, including NDA filing and expansion into psoriasis with the initiation of the Phase 2a clinical study."
Dr. Schaber continued, "Supported by funding from the National Institute of Allergy and Infectious Diseases, our Public Health Solutions business segment continues to achieve key objectives with our heat stable vaccine platform technology, ThermoVax. Recently, we announced results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in non-human primates (NHPs) demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. As always, we continue to evaluate various strategic options, including but not limited to, partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
On April 19, 2022, the Company announced it had received approximately $1.4 million, net of transaction costs, in non-dilutive funding via multiple government tax programs. To view this press release, please click here.
On March 17, 2022, the Company announced the results of a booster vaccination study using CiVax (heat stable COVID-19 subunit vaccine program) in NHPs demonstrating rapid enhancement of neutralizing antibody responses to SARS-CoV-2, including against Delta and Omicron variants. To view this press release, please click here.
Financial Results – Year Ended March 31, 2022
Soligenix’s revenues for the quarter ended March 31, 2022 were $0.2 million as compared to $0.1 million for the quarter ended March 31, 2021. Revenues primarily included payments on government contracts and grants received to support the development of: RiVax, our ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization platform technology; and CiVax, our vaccine candidate for the prevention of COVID-19.
Soligenix’s basic net loss was $4.3 million, or ($0.10) per share, for the quarter ended March 31, 2022, as compared to $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021. The increase in net loss was primarily attributed to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries as well as an increase in research and development expenses associated with preparation of the upcoming HyBryte NDA filing.
Research and development expenses were $1.7 million as compared to $1.3 million for the quarter ended March 31, 2022 and 2021, respectively. The increase in research and development spending for the quarter ended March 31, 2022 was primarily attributable to the increased expenses associated with preparation of the upcoming HyBryte NDA filing.
General and administrative expenses were $2.6 million and $1.0 million for the quarter ended March 31, 2022 and 2021, respectively. This increase in general and administrative expenses is primarily attributable to an increase in legal and consulting services associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries.
As of March 31, 2022, the Company’s cash position was approximately $22.9 million.