On August 21, 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 June 30, 2023 (Press release, Soligenix, AUG 21, 2023, View Source [SID1234634599]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"During the second quarter we advanced multiple clinical trials, while continuing 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. "A HyBryte expanded treatment CTCL trial at the University of Pennsylvania was recently opened for patient enrollment, supported by a $2.6 million Orphan Products Development grant award from the FDA. We are continuing 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. Additionally, we announced positive clinical results from a compatibility study evaluating HyBryte in the treatment of CTCL that confirmed and extended response results from the first Phase 3 study conducted."
Dr. Schaber continued, "During the second quarter of 2023, we completed a public offering with gross proceeds of approximately $8.5 million, which has allowed us to continue to move our rare disease pipeline forward. With approximately $13.2 million in cash at June 30, 2023, we are managing cash burn very carefully in order to achieve our near-term milestones, as we continue to assess all strategic options, including but not limited to, partnership and merger and acquisition opportunities."
Soligenix Recent Accomplishments
On August 10, 2023, the Company announced that patient enrollment had been opened for the HyBryte expanded treatment investigator-initiated CTCL study at the University of Pennsylvania, supported by a $2.6 million Orphan Products Development grant award from the FDA. To view this press release, please click here.
On July 11, 2023, the Company announced the expansion of its Phase 2a trial of SGX302 for the treatment of mild-to-moderate psoriasis after demonstration of biological effect in all five of the initial subjects. To view this press release, please click here.
On May 16, 2023, the Company announced the European Patent Office had granted a patent entitled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis". To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2023
Soligenix’s revenues for the quarters ended June 30, 2023 and 2022 were $0.2 million. Revenues primarily relate to third party licensing and the government contracts and grants awarded in support of HyBryte, our therapeutic candidate for early-stage CTCL; SGX943, our therapeutic candidate 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 net loss was $1.6 million, or ($0.22) per share, for the quarter ended June 30, 2023, as compared to $2.4 million, or ($0.83) per share, for the quarter ended June 30, 2022. The decrease in net loss was primarily due to a decrease in operating expenses.
Research and development expenses were $0.8 million as compared to $2.0 million for the quarters ended June 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 $0.9 million and $1.4 million for the quarters ended June 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 June 30, 2023, the Company’s cash position was approximately $13.2 million.