Business
Soligenix Announces Recent Accomplishments And Third Quarter 2021 Financial Results
PRINCETON, N.J., Nov. 12, 2021 /PRNewswire/ -- Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on
About this update from Soligenix, Inc.
[{"type":"text","content":"PRINCETON, N.J., Nov. 12, 2021 /PRNewswire/ -- 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, announced today its recent accomplishments and financial results for the quarter ended September 30, 2021.\nChristopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, \"There continues to be a great deal of activity across our Specialized BioTherapeutics and Public Health Solutions business segments. We continue to work diligently to prepare the new drug application (NDA) for HyBryte™ (SGX301 or synthetic hypericin) following the positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL). The Office of Orphan Products Development of the United States (U.S.) Food and Drug Administration (FDA) granted orphan drug designation to the active ingredient hypericin for the treatment of T-cell lymphoma, expanding the treatment population beyond CTCL. Additionally, we announced expansion of synthetic hypericin development into psoriasis, under the research name SGX302, where we plan to initiate a Phase 2a clinical study in the second half of 2022. This decision follows validation of synthetic hypericin's biologic activity in the FLASH study, as well as positive proof-of-concept (PoC) demonstrated in a small Phase 1/2 pilot study in mild-to-moderate psoriasis patients, a large and underserved market with a significant unmet medical need. Under our Public Health Solutions business segment, we remain focused on developing heat-stable vaccines for global use. Most notably, we announced publication of compelling pre-clinical immunogenicity studies for CiVax™ (heat stable COVID-19 vaccine program) demonstrating durable broad-spectrum neutralizing antibody responses in non-human primates (NHPs), including against the Beta, Gamma and Delta variants.\"\nDr. Schaber continued, \"With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having the necessary capital to achieve our upcoming milestones, including NDA filing and expansion into psoriasis with the conduct of the Phase 2a clinical trial. We are also continuing to actively assess various strategic opt...