Statistically Significant Data from Late Stage Clinical Assets & Continued Funding from the Government Positions Soligenix Attractively for a Potential Suitor

BEND, OR / ACCESSWIRE / April 4, 2017 / 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 its recent accomplishments and financial results for the year ended December 31, 2016 on Monday, March 27th.

In December, the Company reported positive results from the Phase 2 study of SGX942 (dusquetide) for the treatment of oral mucositis in patients with head and neck cancer. The Company is encouraged by the response received from the EMA that the proposed Phase 3 clinical study, if positive, is sufficient to establish the efficacy and safety of SGX942 in support of potential marketing authorization in Europe. Soligenix believes that this positive Scientific Advice outcome represents a significant step forward in their oral mucositis development program and has the potential to accelerate the registration timetable in Europe. Given the current timeline, Soligenix anticipates initiating this pivotal Phase 3 clinical trial in the first half of 2017. As a reminder, numerous analysts covering or writing about Soligenix have valued SGX942 (NPV calcualtion) at value of $100M or more, a value that is nearly 5 times that of the current market cap.

Soligenix continues to actively enroll patients in their pivotal Phase 3 study in cutaneous T-cell lymphoma with SGX301 (synthetic hypericin), in which the Company expects data by the end of 2017. The Company’s Vaccines/BioDefense business segment achieved revenues of $10.4 million through government contracts as Soligenix continued to advance the development of their heat stable ricin vaccine, RiVax™ and their therapeutic for gastrointestinal acute radiation syndrome, OrbeShield®.I recently spoke with Dr. Alan Rook who has treated patients using SGX301 and he was highly optimistic as it related to the possibility of SGX301 receiving FDA approval. In addition, Dr. Rook also mentioned
the possibility of SGX301 having utility or serving as a treatment option, potentially serving as the best treatment option, for patients afflicted with psoriasis which is a mulit-billion dollar market in the U.S. alone.

Soligenix Recent Accomplishments:

On February 22, 2017, the Company announced that its proprietary formulation of synthetic hypericin had been granted a European patent for the treatment of psoriasis. The issued patent, EP 2571507, Formulations and methods of treatment of skin conditions, complements the method of treatment claims covered by the previously issued US patent 6001882, Photoactivated hypericin and the use thereof.

On February 2, 2017, the Company announced that SGX301 had been granted Promising Innovative Medicine (PIM) designation in the United Kingdom (UK) by the Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of cutaneous T-cell lymphoma (CTCL). The PIM designation is the first step towards inclusion in the Early Access to Medicines Scheme which offers severely ill patients with life-threatening and seriously debilitating conditions the lifeline of trying ground-breaking new medicines much earlier than they would normally be accessible.

On January 5, 2017, the Company announced it had received positive Scientific Advice from the European Medicines Agency (EMA) for the development of SGX942 as a treatment for oral mucositis in patients with head and neck cancer receiving chemoradiation therapy (CRT). The Scientific Advice from the EMA indicates that a single, double-blind, placebo-controlled, multinational, Phase 3 pivotal study (IDR-OM-02), if successful, in conjunction with the Phase 2 dose-ranging study IDR-OM-01, is generally considered sufficient to support a marketing authorization application (MAA) to the EMA for potential licensure in Europe.

On December 16, 2016, the Company announced the completion of an underwritten public offering of its common stock and warrants and the simultaneous uplisting to the Nasdaq Capital Market. Gross proceeds from this offering were approximately $5.3 million before deducting underwriting discounts and commissions and other estimated offering expenses.

On December 12, 2016, the Company announced that SGX942 had been granted PIM designation in the UK by the MHRA for the treatment of severe oral mucositis in head and neck cancer patients receiving chemoradiation therapy.

On December 8, 2016, the Company announced the long-term follow-up data from its Phase 2 clinical trial with SGX942, a first-in-class Innate Defense Regulator (IDR), in the treatment of oral mucositis in head and neck cancer patients undergoing CRT. The additional 12-month safety data remains consistent with the preliminary positive safety and efficacy findings from the Phase 2 study. The study met all of its objectives including defining a clinically effective dose of SGX942 – specifically the 1.5 mg/kg as seen in both the acute and long-term follow-up phases of the trial. It also identified the most appropriate clinical endpoint and patient population to use in the future Phase 3 pivotal study. The impact of the drug on the reported infection rates as well as the trends in improved survival rates and complete tumor responses at both one and 12 months following CRT confirmed the long-term safety and tolerability of SGX942 in a sick patient population.

As of December 31, 2016, the Company’s cash position was $8.8 million, which the Company believes is sufficient to fund all initiatives in the product pipeline through 2017 and into 2018. An illustration of the Company’s Clinical Pipeline is below:

Source: Soligenix Investor Presentation March 2017

In summary, Soligenix has demonstrated highly compelling clinical results and been able to garner significant funding from government agencies for its vaccine programs. We believe Soligenix offers investors a considerable upside from its current levels and may offer one of the best risk/reward profiles of any biotech company in existence, public or private. It would not surprise us if the Company were to monetize one of their vaccine assets or partner one of their therapeutic assets, both in development, in the not too distant future for a value considerably greater than that of the current market capitalization. Additional information on Soligenix can be found on their website, www.soligenix.com. As always, consult with your financial advisor regarding the suitability of an investment in a company like Soligenix or any company mentioned on our website, www.sylvacap.com.

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SOURCE: Sylva International, LLC

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