On November 10, 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 September 30, 2022 (Press release, Soligenix, NOV 10, 2022, View Source [SID1234623750]).
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"We have continued to achieve significant milestones across our development pipeline in 2022. The most important is still to come this quarter with the filing of our new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for HyBryte (synthetic hypericin) in the treatment of cutaneous T-cell lymphoma (CTCL)," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We were also pleased with the FDA Orphan Products Development grant award of a $2.6 million over 4 years to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL, including in the home setting. Additionally, we are advancing synthetic hypericin development into other disease indications, such as psoriasis, where we plan to work in conjunction with our recently established Medical Advisory Board (MAB) to initiate a Phase 2a clinical study for the treatment of mild-to-moderate psoriasis in December.
Supported by funding from the National Institute of Allergy and Infectious Diseases, we were able to demonstrate 100% protection of non-human primates against both lethal Sudan ebolavirus and Marburg marburgvirus challenge with our SuVax and MarVax vaccines, respectively. With the achievement of these important milestones, we were fortunate to receive an invitation by the Biomedical Advanced Research and Development Authority (BARDA) Division of Chemical, Biological, Radiological and Nuclear (CBRN) Medical Countermeasures to submit a full contract proposal for the further development of these novel vaccine candidates as medical countermeasures for use in the event of a Sudan ebolavirus or Marburg marburgvirus outbreak. While an invitation to submit a contract proposal is not a guarantee of funding, we believe that we are well-positioned to receive BARDA development support for this indication allowing us to further demonstrate the growing body of compelling scientific evidence supporting our heat stable filovirus vaccine platform, including vaccine candidates directed towards Sudan ebolavirus and Marburg marburgvirus."
Dr. Schaber continued, "With approximately $16.9 million in cash, not including our non-dilutive government funding, we anticipate having the necessary capital to achieve our near-term milestones, as we continue to assess various strategic options, including but not limited to, partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
On October 27, 2022, the Company announced it had been invited by BARDA Division of CBRN Medical Countermeasures to submit a full contract proposal for the development of single-vial, adjuvanted, heat stable subunit vaccines to prevent filovirus infection. To view this press release, please click here.
On October 25, 2022, the Company announced the formation of a MAB to provide medical/clinical strategic guidance to the Company as it advances the Phase 2a clinical development of SGX302 (synthetic hypericin) for the treatment of mild-to-moderate psoriasis. To view this press release, please click here.
On September 6, 2022, the Company announced the FDA had awarded an Orphan Products Development grant to support the evaluation of HyBryte for expanded treatment in patients with early-stage CTCL. To view this press release, please click here.
Financial Results – Quarter Ended September 30, 2022
Soligenix’s revenues were $0.2 million for the quarter ended September 30, 2022 and 2021, respectively. Revenues primarily relate to third party licensing and the government contracts and grants awarded in support of RiVax, its ricin toxin vaccine candidate; SGX943, for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, its thermostabilization platform technology; and CiVax, its vaccine candidate for the prevention of COVID-19.
Soligenix’s net loss was $3.3 million, or ($0.08) per share, for the quarter ended September 30, 2022, as compared to $3.6 million, or ($0.09) per share, for the three months ended September 30, 2021. The decrease in net loss was primarily attributed to decrease in research and development expenses partially offset by an increase in legal and consulting expenses associated with the arbitration against Emergent BioSolutions, Inc. (EBS) and certain of its subsidiaries.
Research and development expenses were $1.9 million as compared to $2.2 million for the quarter ended September 30, 2022 and 2021, respectively. The decrease in research and development spending for the quarter ended September 30, 2022 was primarily attributable to the completion of the oral mucositis Phase 3 clinical trial.
General and administrative expenses were $1.2 million and $1.1 million for the quarter ended September 30, 2022 and 2021, respectively. This increase in general and administrative expenses is primarily attributable to an increase in expenses associated with the 2022 Annual Shareholder Meeting as well as increased expenses associated with the commercialization of HyBryte.
As of September 30, 2022, the Company’s cash position was approximately $16.9 million.