Miami Beach, Florida Aug 13, 2019 (Issuewire.com) - Soligenix, Inc. (Nasdaq: SNGX) on Tuesday announced its quarterly results for the period ending June 30 and also provided an update on its late-stage development and commercialization objectives for the coming quarters. Soligenix is a late-stage biopharmaceutical company that is actively developing and commercializing products to treat rare diseases where there is an unmet medical need.
Notably, Soligenix is advancing at least two late-stage clinical programs and is approaching data readouts for both of its Phase III clinical programs. The first report is scheduled to come in September, with the company expected to provide interim efficacy analysis from its completed SGX942 study that evaluated the approximately 90 subjects necessary to support the interim efficacy analysis of the pivotal double-blind, placebo-controlled study. SGX942 (dusquetide) is targeting the treatment of oral mucositis in patients with head and neck cancer receiving chemoradiation therapy.
Commenting on the study, Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix, stated, "It is an exciting time for Soligenix. We are now approaching data readout in two Phase 3 clinical programs. This interim analysis, to be conducted by the independent Data Monitoring Committee (DMC) for the trial, is anticipated to occur during September 2019. We expect completion of full enrollment in the study in the second half of 2019, with final top-line results anticipated in the first half of 2020, pending the DMC recommendation."
Soligenix is also advancing its SGX301 study for the treatment of cutaneous T-cell lymphoma (CTCL). The trial is moving forward following the positive recommendation received from the independent DMC. The study is a pivotal double-blind, placebo-controlled Phase III trial for the treatment of cutaneous T-cell lymphoma (CTCL) with SGX301 (synthetic hypericin). The company stated that they continue to enroll patients and anticipate completing study enrollment in the second half of 2019, with final top-line results expected to be published in the first quarter of 2020.
Second Quarter Ushers In Soligenix Highlights
The Q2 report also provided some positive business updates for the company. On July 29, Soligenix announced that the European Patent Office had issued two patents, both titled "Topically Active Steroids for use in Radiation and Chemotherapeutics Injury." The new patents (#2,373,160 and #2,902,031) claim use of oral beclomethasone 17,21-dipropionate for treatment of damage to the gastrointestinal tract as a result of acute radiation injury, including total body irradiation in an accidental or biodefense context.
Key management was added on July 8, with Soligenix announcing the appointment of Ms. Diane L. Parks to the company's Board of Directors. Ms. Parks brings to the company an extensive C-level background and has been instrumental in driving profitable growth for large pharmaceutical and biotech companies before joining Soligenix.
During May, SNGX announced that it would be participating in a biodefense contract for the development of medical countermeasures against bacterial threat agents. Soligenix was awarded a subcontract of approximately $600,000 over 3 years.
Finally, back in April of this year, Soligenix announced it had reached a significant milestone in its Phase III clinical study (the "DOM-INNATE" study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer. In that update, SNGX reported that patient enrollment was sufficient to support the interim efficacy analysis by the independent DMC.
Soligenix Q2 By The Numbers
From the financial side of the report, Soligenix's revenues for the quarter ended June 30, 2019, were $1.5 million as compared to $1.7 million for the quarter ended June 30, 2018. Total revenues included payments on a contract in support of RiVax®, and from the grants received to support the development of SGX301 for the treatment of CTCL and SGX942 for the treatment of oral mucositis in head and neck cancer.
Soligenix's basic net loss was $2.1 million, with its net loss per share improving over the same period last year. The company's research and development expenses were $1.9 million as compared to $1.2 million for the quarters ended June 30, 2019, and 2018, respectively. The company noted that the increase in research and development spending for the three months ended June 30, 2019, was primarily attributable to higher clinical trial expenditures relating to the two pivotal Phase 3 studies for SGX301 and SGX942, compared to the same period in 2018.
General and administrative expenses posted in at $0.8 million as compared to $0.7 million for the quarters ended June 30, 2019, and 2018, respectively. Those comparably low cash-burn numbers fit well with the company's cash on hand which was reported to be at roughly $7 million on June 30.
Heading Into Third Quarter With Momentum
As SNGX heads into its third quarter, investors are focused on the company's near-term catalysts. Compared against analysts 12-month price targets of $8.00 per share, Soligenix is trading at a sharp discount to projected revenue and market opportunity models. The company has a relatively low-float, with roughly 18 million shares outstanding. The company is also well-positioned to further its growth by capitalizing on its government grants, its potential cash from warrants, and its current cash position of roughly $7 million at the quarter's end.
In addition, investors are focusing attention beyond the projected $550 million market opportunities from its two late-stage drugs and are taking notice of the company's five additional programs that are targeting combined market potentials above $200 million in peak revenues. Furthermore, from a market cap perspective, SNGX is considerably undervalued compared to its peers, and even after applying risk discounts to its clinical programs, the current market cap may not fairly reflect the intrinsic value of the company.
Heading into the back half of the year, investors should focus on the two potential near-term catalysts, with the first set of data expected within four months. And, if patterns hold true, SNGX shares can likely get a bounce before the release as investors look for value opportunity. Thus, with SNGX getting close to two notable data releases, combined with its other clinical programs, the stock may represent a clear value opportunity at these price levels.
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