On November 13, 2023 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, 2023 (Press release, Soligenix, NOV 13, 2023, View Source [SID1234637563]).
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"We continue our collaborative discussions with the U.S. Food and Drug Administration (FDA) regarding the design of a second, confirmatory Phase 3 pivotal study evaluating HyBryte (synthetic hypericin sodium) in the treatment of cutaneous T-cell lymphoma (CTCL), where we successfully demonstrated statistically significant results in the first Phase 3 clinical trial," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We continue to actively enroll patients in the Phase 2a trial of SGX302 (synthetic hypericin sodium) for the treatment of mild-to-moderate psoriasis after demonstration of a clear biological signal in all five of the initial patients, with the majority recording an improvement in their PASI (psoriasis area and severity index) score. Under our Public Health Solutions business segment, we continue to advance our heat stable vaccine platform technology, ThermoVax. Most recently, we successfully demonstrated two year stability of thermostabilized bivalent and trivalent filovirus vaccine candidates at temperatures of 40 degrees Celsius (104 degrees Fahrenheit) when formulated in a single vial, needing reconstitution only with sterile water immediately prior to use. This follows the previous successful demonstration of 100% protection of non-human primates against lethal Sudan ebolavirus and Marburg marburgvirus challenge with the bivalent vaccine."
Dr. Schaber continued, "With approximately $10.3 million in cash at September 30, 2023, not including our non-dilutive government funding, we are managing cash burn very carefully in order to achieve our near-term milestones. We continue to evaluate a number of strategic options, including but not limited to, partnership and merger and acquisition opportunities."
Financial Results – Quarter Ended September 30, 2023
Soligenix’s revenues for the quarters ended September 30, 2023 were $0.1 million as compared to $0.2 million for the quarter ended September 30, 2022. Revenues primarily relate to government contracts and grants awarded in support of SGX943, our therapeutic candidate for treatment of emerging and/or antibiotic-resistant infectious diseases; and CiVax, our vaccine candidate for the prevention of COVID-19.
Soligenix’s net loss was $1.7 million, or ($0.16) per share, for the quarter ended September 30, 2023, as compared to $3.3 million, or ($1.15) per share, for the quarter ended September 30, 2022. The decrease in net loss was primarily due to decreases in operating expenses and interest expense and an increase in other income.
Research and development expenses were $0.8 million as compared to $1.8 million for the quarters ended September 30, 2023 and 2022, respectively. The decrease was primarily due to the decrease in manufacturing and regulatory costs associated with the HyBryte new drug application filing.
General and administrative expenses were $1.0 million and $1.3 million for the quarters ended September 30, 2023 and 2022, respectively. This decrease in general and administrative expenses is primarily attributable to a reduction in legal and consulting expenses associated with the arbitration against Emergent BioSolutions, Inc. and certain of its subsidiaries.
As of September 30, 2023, the Company’s cash position was approximately $10.3 million.