On March 30, 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 year ended December 31, 2019 (Press release, Soligenix, MAR 30, 2020, View Source [SID1234556004]).
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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We are extremely pleased to have achieved positive top-line results in our pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) trial that demonstrates SGX301’s potential to be an important new treatment for early stage cutaneous T-cell Lymphoma (CTCL). Having demonstrated statistical significance in the study’s primary endpoint, we will now look to report results from the extended treatment portion of the trial, which we anticipate announcing in June 2020. Following the positive recommendation received from the independent Data Monitoring Committee, we have successfully achieved our target of 260 patients randomized into the 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; however, due to the uncertainty surrounding the coronavirus pandemic, we have decided to enroll approximately 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 evaluation. Therefore, the study target to complete enrollment and provide top-line results is being revised from the second quarter of 2020 to the fourth quarter 2020; however, this will 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 progress our heat stable ricin vaccine, RiVax, with the support of a National Institute of Allergy and Infectious Disease contract award of up to $24.7 million. We are also excited to advance our work with University of Hawaiʻi at Mānoa (UH Mānoa) beyond filovirus vaccines (protecting against viruses such as Ebola and Marburg) to the development of vaccines to potentially combat coronaviruses, including SARS-CoV-2, the cause of COVID-19. With over $7.5M in cash, not including our State and Federal funding, we anticipate having the cash resources sufficient 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 March 23, 2020, the Company announced that it expanded its research collaboration with UH Mānoa to investigate potential coronavirus vaccines. The Company and UH Mānoa are expanding the technology platform, developed as part of their filovirus program, to assess compatibility with coronaviruses including SARS-CoV-2, the cause of COVID-19. The resulting vaccines have the potential to be broadly applicable, including to individuals often excluded from common viral vector vaccine approaches such as children, the elderly and the immunocompromised. To view this press release, please click here.
On March 19, 2020, the Company announced positive preliminary top-line results for its pivotal Phase 3 FLASH trial evaluating SGX301 (synthetic hypericin) in the treatment of CTCL. The study enrolled 169 patients randomized 2:1 to receive either SGX301 or placebo, demonstrating statistically significant treatment response (p=0.04) in the Composite Assessment of Index Lesion Score (CAILS) primary endpoint assessment at 8 weeks for Cycle 1. To view this press release, please click here.
On February 13, 2020, the Company announced that its RiVax (heat stable ricin toxin vaccine) development program for prevention of ricin intoxication had received "Fast Track" designation from the FDA. To view this press release, please click here.
On February 3, 2020, the Company announced that its ongoing collaboration with the UH Mānoa and Hawaii Biotech Inc. had resulted in what the Company believes is a significant milestone in the development of heat stable filovirus vaccines, in which the platform has demonstrated feasible thermostable formulations and protection in non-human primate models with both monovalent and bivalent vaccine candidates in the three most deadly human pathogenic filoviruses (Ebola virus, Sudan virus and Marburg virus). To view this press release, please click here.
On February 3, 2020, the Company announced that the Japanese Patent Office had granted the patent titled "Novel Peptides and Analogs for Use in the Treatment of Oral Mucositis." This allowance builds on similar intellectual property in the US, New Zealand, Australia and Singapore and patent applications pending in other jurisdictions worldwide. The new claims cover therapeutic use of dusquetide (active ingredient in SGX942) and related innate defense regulator (IDR) analogs, and add to composition of matter claims for dusquetide and related analogs that have been granted in the US and worldwide. To view this press release, please click here.
On January 14, 2020, 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 December 18, 2019, the Company announced that it had 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 $850,000 in net proceeds. To view this press release, please click here.
On December 3, 2019, the Company announced it had completed patient enrollment in its Phase 3 FLASH study for SGX301 in the treatment of CTCL. The study successfully enrolled 169 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study’s primary efficacy endpoint by an independent Data Monitoring Committee. To view this press release, please click here.
Financial Results – Year Ended December 31, 2019
Soligenix’s revenues for the year ended December 31, 2019 were $4.6 million as compared to $5.2 million for the year ended December 31, 2018. Revenues included payments on a contract in support of RiVax, in addition to the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in HNC.
Soligenix’s basic net loss was $9.4 million, or ($0.48) per share, for the year ended December 31, 2019, as compared to $8.9 million, or ($0.68) per share, for the year ended December 31, 2018.
Research and development expenses were $8.1 million as compared to $6.8 million for the years ended December 31, 2019 and 2018, respectively. The increase in research and development spending for the year ended December 31, 2019 was primarily attributable to the expansion of the Phase 3 clinical trial of SGX942 as well as the ongoing Phase 3 clinical trial of SGX301, compared to the same period in 2018.
General and administrative expenses were $3.4 million as compared to $3.0 million for the years ended December 31, 2019 and 2018, respectively.
As of December 31, 2019, the Company’s cash position was approximately $5.4 million.