SNGX Q1 EPS $.06 Up From $.32 YoY. Cash $30.5mm.
"7:30 am ET May 17, 2021 (PR Newswire) Print
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 March 31, 2021.
"This year continues to be an exciting year of progress for Soligenix," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "We recently announced presentation of clinical data from our successful pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) clinical trial for HyBryte(TM) (SGX301) in the treatment of cutaneous T-cell lymphoma (CTCL) at both the American Academy of Dermatology, where HyBryte(TM) was designated "Top 12 late-breaking research," and the Society for Investigative Dermatology. We also received U.S. Food and Drug Administration (FDA) conditional acceptance of HyBryte(TM) as the proposed brand name for SGX301 (synthetic hypericin), as we continue to prepare for a new drug application (NDA) submission and U.S. commercialization for this novel first-in-class photodynamic therapy for treatment of early stage CTCL. Under our Public Health Solutions business segment, supported by non-dilutive government funding, we continue to advance multiple therapeutic and vaccine candidates. CiVax(TM), our heat stable COVID-19 vaccine, recently demonstrated that the proprietary subunit protein antigen, locked into its receptor-binding configuration, was immunogenic in both mice and non-human primates, which is an important step in advancing CiVax(TM) towards human clinical trials."
Dr. Schaber continued, "With approximately $30 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing and U.S. commercialization of HyBryte(TM) in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million."
Soligenix Recent Accomplishments
-- On May 10, 2021, the Company announced that HyBryte(TM) (hypericin) was awarded an "Innovation Passport" for the treatment of early stage CTCL in adults under the United Kingdom's (UK's) Innovative Licensing and Access Pathway (ILAP). To view this press release, please click here.
-- On April 28, 2021, the Company announced that its Senior Vice President and Chief Scientific Officer, Oreola Donini, PhD, delivered a presentation demonstrating the potency of the CiVax(TM) (COVID-19 vaccine) development program in mice and non-human primates (NHPs), at the Annual Conference on Vaccinology Research, held April 26-27, 2021. To view this press release, please click here.
-- On April 26, 2021, the Company announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study, delivered a presentation at the American Academy of Dermatology Association Virtual Meeting Experience, held April 23-25, 2021, expanding on data related to the efficacy and safety of HyBryte(TM) in the treatment of CTCL. To view this press release, please click here.
-- On April 7, 2021, the Company announced that the FDA had conditionally accepted HyBryte(TM) as the proposed brand name for SGX301 (synthetic hypericin), the Company's novel first-in-class photodynamic therapy for first-line treatment of early stage CTCL. To view this press release, please click here.
-- On March 30, 2021, the Company announced its recent accomplishments and financial results for the year ended December 31, 2020. To view this press release, please click here.
Financial Results - Quarter Ended March 31, 2021
Soligenix's revenues for the quarter ended March 31, 2021 were $0.1 million as compared to $0.9 million for the quarter ended March 31, 2020. Revenues included payments on a contract in support of RiVax(R), our ricin toxin vaccine candidate, and grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax(R), our thermostabilization technology; and CiVax(TM), our vaccine candidate for the prevention of COVID-19.
Soligenix's basic net loss was $2.4 million, or ($0.06) per share, for the quarter ended March 31, 2021, as compared to $7.6 million, or ($0.32) per share, for the quarter ended March 31, 2020. This decrease in net loss was primarily due to a $5.0 million success milestone due to Hy Biopharma that was paid in common stock (based upon an effective per share price of $2.56) as a result of SGX301 demonstrating statistically significant treatment response in the pivotal Phase 3 clinical trial Inc. during the three months ended March 31, 2020.
Research and development expenses were $1.4 million as compared to $2.7 million for the quarters ended March 31, 2021 and 2020, respectively. The decrease in research and development spending for the quarter ended March 31, 2021 was primarily attributable to the reduction in expense due to the completion of the HyBryte(TM) and SGX942 clinical trials.
General and administrative expenses were $0.9 million for both the three months ended March 31, 2021 and 2020.
As of March 31, 2021, the Company's cash position was approximately $30.5 million."
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