Soligenix Announces Recent Accomplishments And Second Quarter 2020 Financial Results

Source: Soligenix, Inc. 8/14/2020

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, announced today its recent accomplishments and financial results for the quarter ended June 30, 2020.

Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We continue to execute on our strategy with a number of positive accomplishments. 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).  The optional, compassionate-use, treatment cycle (Cycle 3) and the subsequent 6-month follow-up is expected in the fourth quarter of 2020, with the majority of patients enrolled having elected to continue with this optional cycle of the study – a clear indication of their satisfaction.  We also continue to advance our pivotal Phase 3 clinical trial of SGX942 (dusquetide), referred to as the DOM-INNATE (Dusquetide treatment in Oral Mucositis – by modulating INNATE Immunity) study, 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 (DMC) and after taking a conservative approach to assessing the potential impact of COVID-19 on the study, we have successfully enrolled 268 subjects.   With enrollment completed, top-line results continue to be expected in the fourth quarter 2020."

Dr. Schaber continued, "Under our Public Health Solutions business segment, we continue to advance our work with the University of Hawaiʻi at Mānoa (UHM) and Hawaii Biotech Inc. 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 recently announced publication of positive pre-clinical data from immunogenicity studies with CiVax™ (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine HT™ adjuvant.  Our heat stable ricin vaccine, RiVax^®, continues to be supported with a National Institute of Allergy and Infectious Disease contract award of $21.2 million.  With over $11M 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 final top-line results in our SGX942 Phase 3 clinical trial in oral mucositis."

Soligenix Recent Accomplishments

• On July 28, 2020, the Company announced publication of pre-clinical immunogenicity studies for its CiVax™ program (heat stable COVID-19 vaccine candidate), demonstrating immunity of both broad-spectrum antibody and cell-mediated, rapid onset immunity is possible using the CoVaccine adjuvant. The article, authored by collaborators at the UHM, is titled, "CoVaccine HT™ adjuvant potentiates robust immune responses to recombinant SARS-CoV-2 spike-S1 immunization," and has been submitted for peer-review to the journal npj Vaccines. An accelerated preprint of the manuscript has been made available here. To view this press release, please click here.
• On July 20, 2020, the Company announced that it had issued an update letter from its President and Chief Executive Officer, Dr. Christopher J. Schaber, highlighting important catalysts for the second half of 2020. To view this press release and letter, please click here.
• On June 24, 2020, the Company announced that it had completed patient enrollment in its Phase 3 DOM-INNATE study for SGX942 (dusquetide) in the treatment of oral mucositis in HNC patients. The study successfully enrolled 268 subjects, following positive interim analysis, which included a prospectively defined, unblinded assessment of the study's primary efficacy endpoint by an independent DMC. To view this press release, please click here.
• On June 22, 2020, the Company announced that it would join the Russell Microcap^® Index at the conclusion of the 2020 Russell indexes annual reconstitution, effective after the US market opens on June 29th, according to a final list of additions posted June 15th. To view this press release, please click here.

Financial Results – Quarter Ended June 30, 2020

Soligenix's revenues for the quarter ended June 30, 2020 were $0.5 million as compared to $1.4 million for the quarter ended June 30, 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 $2.8 million, or ($0.10) per share, for the quarter ended June 30, 2020, as compared to $2.1 million, or ($0.12) per share, for the quarter ended June 30, 2019.  This increase in net loss was primarily the result of increased research and development spending primarily attributable to higher clinical trial site and patient fees for the pivotal Phase 3 clinical trials of SGX301 and SGX942.

Research and development expenses were $2.2 million as compared to $1.9 million for the quarters ended June 30, 2020 and 2019, respectively.  The increase in research and development spending for the quarter ended June 30, 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 $0.8 million for both the three months ended June 30, 2020 and 2019.

As of June 30, 2020, the Company's cash position was approximately $11.2 million.

About Soligenix, Inc.

Soligenix is a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need. Our Specialized BioTherapeutics business segment is developing SGX301 as a novel photodynamic therapy utilizing safe visible light for the treatment of cutaneous T-cell lymphoma, our first-in-class innate defense regulator (IDR) technology, dusquetide (SGX942) for the treatment of oral mucositis in head and neck cancer, and proprietary formulations of oral beclomethasone 17,21-dipropionate (BDP) for the prevention/treatment of gastrointestinal (GI) disorders characterized by severe inflammation including pediatric Crohn's disease (SGX203) and acute radiation enteritis (SGX201).

Our Public Health Solutions business segment includes active development programs for RiVax^®, our ricin toxin vaccine candidate, SGX943, our therapeutic candidate for antibiotic resistant and emerging infectious disease, and vaccine programs targeting both filoviruses (such as Marburg and Ebola) and coronaviruses. The development of our vaccine programs incorporates the use of our proprietary heat stabilization platform technology, known as ThermoVax^®.  To date, this business segment has been supported with government grant and contract funding from the National Institute of Allergy and Infectious Diseases (NIAID), the Biomedical Advanced Research and Development Authority (BARDA), and the Defense Threat Reduction Agency (DTRA).

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.