ON March 30, 2021 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, 2020 (Press release, Soligenix, MAR 30, 2021, View Source [SID1234577364]).
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"2021 will be another important year for Soligenix on a number of fronts," stated Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix. "With our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial successfully completed, we are now preparing to begin submission of the rolling new drug application (NDA) in 2Q 2021 for this first-in-class therapy. Compared to the currently approved cutaneous T-cell lymphoma (CTCL) therapies for early disease, the SGX301 treatment response was very rapid, being detected in as little as 6 weeks of treatment (Cycle 1, p=0.0416). Responses continued to improve through 12 weeks of treatment (Cycle 2, p<0.0001 vs end Cycle 1) and 18 weeks of treatment (Cycle 3, p<0.0001 vs end Cycle 1), ultimately enabling nearly half of patients who continued treatment to see sustained and significant improvement in their response rates. Moreover, patients with more difficult to treat plaque lesions also showed this same treatment benefit, an advantage over some other therapies which primarily work only for patch lesions. Under our Public Health Solutions business segment, we continue to advance multiple therapeutic and vaccine candidiates, with the support of non-dilutive government funding, including our heat stable COVID-19 vaccine, CiVax, which recently demonstrated rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity using full-length Spike protein antigens in mice. Overall, our thermostabilization platform has now demonstrated compatibility with two different adjuvants, consistently enabling single-vial vaccine presentations with characteristics for ambient shipping and long-term storage. Further, non-human primate data is expected across our vaccine platform later this year."
Dr. Schaber continued, "With over $30 million in cash, not including our non-dilutive funding, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including moving towards NDA and U.S. commercialization of SGX301 in CTCL. As CTCL is a highly specialized orphan market with a discrete prescriber base, it presents a tailor-made market opportunity for us. 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. With a total addressable worldwide market projected to be approximately $250 million annually, we continue to have ongoing confidential discussions regarding ex-U.S. partnership opportunities."
Soligenix Recent Accomplishments
On March 9, 2021, the Company announced that it received preliminary approval for a tax credit from the New Jersey Economic Development Authority’s (NJEDA) New Jersey Technology Business Tax Certificate Transfer program. As a result, the Company anticipates being able to transfer this credit and receive approximately $865,000 in net proceeds. To view this press release, please click here.
On March 4, 2021, the Company announced publication of pre-clinical immunogenicity studies for CiVax (heat stable COVID-19 vaccine program) demonstrating rapid-onset, broad-spectrum, neutralizing antibody and cell-mediated immunity is confirmed using full-length Spike protein antigens. To view this press release, please click here.
On February 24, 2021, 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 February 1, 2021, the Company announced that the Hong Kong Registrar of Patents granted a patent for the application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 16102842.8), published on January 29, 2021 under Publication No. 1214771 B. To view the press release, please click here.
On January 26, 2021, the Company hosted an Investor Webcast Event regarding U.S. commercial planning for SGX301 (synthetic hypericin) in the treatment of CTCL. To listen to the webcast, please click here.
On January 7, 2021, the Company announced that it signed an exclusive Supply, Distribution and Services Agreement with Daavlin, securing long-term supply and distribution of a commercially ready light device that is an integral component of the regulatory and commercial strategy for SGX301 for the treatment of CTCL. To view the press release, please click here.
On December 28, 2020, the Company announced that the National Institute of Allergy and Infectious Diseases (NIAID) awarded Soligenix a Direct to Phase II Small Business Innovation Research (SBIR) grant of approximately $1.5 million to support manufacture, formulation (including thermostabilization) and characterization of COVID-19 and Ebola Virus Disease vaccine candidates in conjunction with the CoVaccine HT adjuvant. To view the press release, please click here.
On December 22, 2020, the Company announced preliminary top-line results for its pivotal Phase 3 DOM-INNATE trial evaluating SGX942 in the treatment of severe oral mucositis in patients with head and neck cancer receiving chemoradiation. To view the press release, please click here.
On December 16, 2020, the Company announced that it entered into a $20 million convertible debt financing agreement with Pontifax Medison Debt Financing, the healthcare-dedicated venture and debt fund of the Pontifax life science funds. To view the press release, please click here.
On December 8, 2020, the Company announced that it demonstrated extended protection with its heat stable ricin toxin vaccine, RiVax. To view the press release, please click here.
Financial Results – Year Ended December 31, 2020
Soligenix’s revenues for the year ended December 31, 2020 were $2.4 million as compared to $4.6 million for the year ended December 31, 2019. Revenues included payments on a contract in support of RiVax, our ricin toxin vaccine candidate, grants received to support the development of SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases, ThermoVax, our thermostabilization technology, and the assessment of SGX942 safety in juvenile animals.
Soligenix’s basic net loss was $17.7 million, or ($0.64) per share, for the year ended December 31, 2020, as compared to $9.4 million, or ($0.48) per share, for the year ended December 31, 2019. The increase in net loss is primarily due to increased expenditures incurred to support both the pivotal Phase 3 trial of SGX301 in the treatment of CTCL and the pivotal Phase 3 trial of SGX942 in the treatment of oral mucositis in head and neck cancer, as well as a $5 million success milestone payment 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.
Research and development expenses were $10.1 million as compared to $8.1 million for the years ended December 31, 2020 and 2019, respectively. The increase in research and development spending for the year ended December 31, 2020 was related to expenditures incurred in the expansion of the Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301.
General and administrative expenses were $4.0 million as compared to $3.5 million for the years ended December 31, 2020 and 2019, respectively.
As of December 31, 2020, the Company’s cash position was approximately $18.7 million.