On March 29, 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 year ended December 31, 2021 (Press release, Soligenix, MAR 29, 2022, View Source [SID1234611093]).

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"This year will be a pivotal year for the Company as we anticipate achieving a number of transformational milestones," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "Most importantly, these milestones include submission of the new drug application (NDA) to the United States (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), a rare form of skin cancer. Additionally, we anticipate initiating a Phase 2a clinical trial in mild-to-moderate psoriasis with SGX302 (synthetic hypericin), where we have already demonstrated positive proof of concept in a small Phase 1/2 pilot study. Under our Public Health Solutions business segment, we continue to advance our heat stable vaccine platform technology, ThermoVax, including through development of filovirus vaccine candidates (targeting Ebola, Sudan, and Marburg viruses), a novel heat stable COVID-19 vaccine candidate, CiVax, and a ricin toxin vaccine, RiVax, where non-human primate (NHP) data for all three vaccine programs has demonstrated significant efficacy."

Dr. Schaber continued, "With approximately $23.3 million in cash, not including our non-dilutive government funding, we expect to have the capital required to accomplish our near-term milestones, including NDA filing and expansion into psoriasis with the conduct of the Phase 2a clinical trial. We continue to evaluate various strategic options, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

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.
On January 10, 2022, the Company issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber. To view this press release, please click here.
On January 4, 2022, the Company announced that dusquetide is effective at reducing tumor size in nonclinical xenograft models. To view this press release, please click here.
On December 2, 2021, the Company announced 100% protection of NHPs against lethal Sudan ebolavirus challenge using a bivalent, thermostabilized vaccine formulated in a single vial, reconstituted only with water immediately prior to use. To view this press release, please click here.
Financial Results – Year Ended December 31, 2021

Soligenix’s revenues for the year ended December 31, 2021 were $0.8 million as compared to $2.4 million for the year ended December 31, 2020. Revenues primarily included payments on grants received to support the development of: 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 $12.6 million, or ($0.31) per share, for the year ended December 31, 2021, as compared to $17.7 million, or ($0.64) per share, for the year ended December 31, 2020. The decrease in net loss is primarily due to the additional costs in 2020 relating to the issuance of $5.0M worth of fully vested shares of common stock to Hy Biopharma, Inc. ("Hy Biopharma") in connection with the achievement of a development milestone.

Research and development expenses were $8.4 million as compared to $9.8 million for the years ended December 31, 2021 and 2020, respectively. The decrease in research and development spending for the year ended December 31, 2021 was related to the conclusion of the CTCL and oral mucositis Phase 3 studies.

General and administrative expenses were $4.8 million and $4.3 million for the years ended December 31, 2021 and 2020, respectively. This increase in general and administrative expenses is primarily due to an increase in legal fees associated with the Emergent arbitration partially offset by a decrease in company headcount.

As of December 31, 2021, the Company’s cash position was approximately $26.0 million.