On May 15, 2020 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 March 31, 2020 (Press release, Soligenix, MAY 15, 2020, View Source [SID1234558190]).
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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "This has been a very rewarding year for us thus far. Our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial continues to demonstrate SGX301’s potential to be an important new treatment for early-stage cutaneous T-cell lymphoma (CTCL). In the double-blind, placebo controlled Cycle 1 portion of the study, a statistically significant treatment response (p=0.04) was achieved in the primary endpoint after 6 weeks of therapy. This positive treatment response continued to significantly improve with extended SGX301 treatment in the open-label treatment cycle, referred to as Cycle 2, with an additional 6 weeks of therapy (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment). We also continue to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer (HNC) receiving chemoradiation therapy. Following the positive recommendation received from the independent Data Monitoring Committee, we have successfully achieved our target of 260 patients randomized into the study; however, due to the uncertainty surrounding the coronavirus pandemic, we decided to enroll up to 25 additional patients into the study. We are taking this cautious approach in order to maintain the statistical integrity of the trial, by accounting for patients that may potentially drop out of the study before completing their protocol required study treatment and evaluations. Therefore, the study target to complete enrollment and provide top-line results has been revised to the fourth quarter 2020; however, this will continue to remain dependent on the medical and logistical challenges caused by the coronavirus showing a reasonable level of improvement in the relative near-term."
Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to advance our work with University of Hawaiʻi at Mānoa (UH Mānoa) on filovirus vaccines (protecting against viruses such as Ebola and Marburg) and the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19. We continue to support our heat stable ricin vaccine, RiVax, with a National Institute of Allergy and Infectious Disease contract award of $21.2 million. With over $8M in cash, not including our non-dilutive government funding, along with the at-the-market sales issuance agreement with B. Riley FBR, Inc. to judiciously supplement our cash runway as needed, we anticipate having sufficient capital to achieve multiple inflection points across our rare disease pipeline, including top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."
Soligenix Recent Accomplishments
On May 11, 2020, the Company announced publication of immunogenicity studies for RiVax identifying novel correlates of immune protection to facilitate potential approval under the United States Food and Drug Administration (FDA) "Animal Rule." The article, titled "A Multivariate Model Combining Endpoint and Epitope-specific Antibody Responses as a Correlate of Protection to Ricin Toxin," has been submitted to the peer-reviewed medical journal Vaccine and a preprint is available here. To view this press release, please click here.
On May 7, 2020, the Company announced that it had received approximately $840,000, net of transaction costs, in non-dilutive financing via the State of New Jersey’s Technology Business Tax Certificate Transfer Program. To view this press release, please click here.
On April 30, 2020, the Company announced that continued treatment with SGX301 (synthetic hypericin) twice weekly for 12 weeks increased the positive response rate to 40% (p<0.0001 compared to placebo and p<0.0001 compared to 6-weeks treatment) in Cycle 2 of its pivotal Phase 3 FLASH study for the treatment of early-stage CTCL. These highly statistically significant results confirm the benefit of continued SGX301 treatment in CTCL patients. To view this press release, please click here.
On April 16, 2020, the Company announced it had executed an agreement for the exclusive worldwide license of CoVaccine HT, a novel vaccine adjuvant, from BTG Specialty Pharmaceuticals, a division of Boston Scientific Corporation (NYSE: BSX), for the fields of pandemic flu and coronaviruses, including SARS-CoV-2, the cause of COVID-19. To view this press release, please click here. This collaboration further builds on the recently announced collaboration between the UH Mānoa and Soligenix to develop a SARS-CoV-2 vaccine (available here).
On April 6, 2020, the Company announced that the European patent office has granted the divisional patent application titled "Formulations and Methods of Treatment of Skin Conditions" (No. 2932973). The granted claims are directed to the therapeutic use of synthetic hypericin in the treatment of CTCL. To view this press release, please click here.
Financial Results – Quarter Ended March 31, 2020
Soligenix’s revenues for the quarter ended March 31, 2020 were $0.9 million as compared to $1.1 million for the quarter ended March 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 $7.6 million, or ($0.32) per share, for the quarter ended March 31, 2020, as compared to $1.6 million, or ($0.09) per share, for the quarter ended March 31, 2019. This increase in net loss was primarily the result of the issuance of $5 million of common stock as a milestone payment triggered by the successful Phase 3 clinical trial of SGX301 for the treatment of CTCL and increased research and development spending. The number of shares of common stock issued as a milestone payment was calculated using an effective price of $2.56 per share, based upon a formula set forth in the applicable agreement.
Research and development expenses were $2.7 million as compared to $1.6 million for the quarters ended March 31, 2020 and 2019, respectively. The increase in research and development spending for the quarter ended March 31, 2020 was primarily attributable to the site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942, compared to the same period in 2019.
General and administrative expenses were $0.9 million for both the three months ended March 31, 2020 and 2019.
As of March 31, 2020, the Company’s cash position was approximately $7.2 million, not including the approximate $840,000 recently received from the State of New Jersey’s Technology Business Tax Certificate Transfer Program.