On August 11, 2016 Soligenix, Inc. (OTCQB: 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 second quarter ended June 30, 2016 (Filing, Q2, Soligenix, 2016, AUG 11, 2016, View Source [SID:1234514528]).
Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "We continue to be very encouraged with the positive results demonstrated in our Phase 2 oral mucositis trial with SGX942 (dusquetide) and expect to report long-term safety data during the fourth quarter of this year. We have engaged the regulatory authorities in both the US and Europe, and anticipate having a pivotal Phase 2b/3 study design of SGX942 during the first half of next year. We also continue to actively enroll patients in our pivotal Phase 3 study in cutaneous T-cell lymphoma with SGX301 (synthetic hypericin)."
Schaber continued, "We continue to advance the development of RiVax and OrbeShield in our biodefense business segment, and are pleased with the government agencies additional non-dilutive funding of over $8 million through newly awarded funding and the exercise of options in support of these programs. The continued support of these programs demonstrates the productive collaboration between the Company and the government agencies."
Soligenix Recent Accomplishments:
· On July 25, 2016, the Company announced that the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID) have each provided additional funding to advance preclinical development of OrbeShield (oral beclomethasone 17,21-dipropionate or oral BDP) as a medical countermeasure for civilian and military use in the treatment of gastrointestinal acute radiation syndrome (GI ARS). The additional funding totaled $634,000.
· On July 18, 2016, the Company announced positive preliminary proof-of-concept results from its collaboration with Axel Lehrer, PhD of the Department of Tropical Medicine, John A. Burns School of Medicine, University of Hawaiʻi and Hawaii Biotech, Inc. to develop a heat stable subunit Ebola vaccine. The Company evaluated its proprietary vaccine thermostabilization technology, ThermoVax, licensed from the University of Colorado, to stabilize components of the vaccine.
· On June 25, 2016, the Company presented preliminary results from its SGX942 Phase 2 clinical trial in oral mucositis at the Multinational Association for Supportive Care in Cancer (MASCC) conference in Adelaide, Australia. The reduction in duration of severe oral mucositis ranged from 50% in the overall population to 67% in the population with the most severe disease.
· On May 25, 2016, the Company announced that NIAID exercised an option for the evaluation of RiVax to fund animal efficacy and toxicology studies. The exercised option will provide an additional $3.2M in funding.
· On May 5, 2016, the Company announced that NIAID exercised an option for RiVax bulk drug substance and finished drug product process scale-up and technology transfer that will support preclinical studies and manufacturing in accordance with current good manufacturing practices. The exercised option will provide an additional $4.3M in funding.
Financial Results – Second Quarter Ended June 30, 2016
Soligenix’s revenues for the quarter ended June 30, 2016 were $3.2 million as compared to $1.1 million for the same period for the prior year. Revenues included contracts with BARDA and NIAID in support of OrbeShield development in the treatment of GI ARS and advanced development of the Company’s thermostabilization technology, ThermoVax, combined with its ricin toxin vaccine RiVax, as a medical countermeasure to prevent the effects of ricin exposure.
Soligenix’s basic net loss was $0.1 million, or $0.00 per share, as compared to $4.0 million, or $0.15 per share, for the quarters ended June 30, 2016 and 2015, respectively. Included in the net loss for quarters ended June 30, 2016 and 2015 is non-cash income of $0.9 million and a non-cash expense of $1.9 million, respectively. This non-cash item reflects the change in fair value of the liability related to warrants issued in the Company’s June 2013 registered public offering and is included in other income/(expense).
Research and development expenses, were $0.8 million as compared to $1.4 million for the quarters ended June 30, 2016 and 2015, respectively. The decrease was related to completion of patient enrollment and treatment in the Phase 2 trial of SGX942 for the treatment of oral mucositis in head and neck cancer. The long-term follow-up safety data from this trial continues to be collected, with completion expected during the second half of 2016.
General and administrative expenses were $1.0 million as compared to $0.9 million for the quarters ended June 30, 2016 and 2015, respectively.
As of June 30, 2016, the Company’s cash position was $3.2 million.
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