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SNGX: Enrollment Target Reached for Interim Analysis of SGX942 Phase 3 Trial…

Update time : 2019-05-15 17:55:00

By David Bautz, PhD

NASDAQ:SNGX

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Business Update

Enrollment purpose Reached because Interim Analysis of SGX942 aspect 3 Trial

On April 18, 2019, Soligenix, Inc. (SNGX) announced that it has reached the enrollment purpose because the aspect 3 clinical trial of SGX942 (dusquetide) ought back the planned interim efficacy analysis by the independent data Monitoring committee (DMC). The aspect 3 DOM-INNATE (Dusquetide treatment at oral Mucositis – by modulating INNATE immunity) clinical trial is evaluating SGX942 because the treatment of sever oral mucositis (OM) at patients with squamous prison carcinoma of the oral cavity and oropharynx undergoing chemoradiation therapy. The trial is being supported at divide by a $1.5 million SBIR concord awarded by the National club of Dental and Craniofacial inquiry (NIDCR), a divide of the NIH.

The feasible DMC recommendations stemming from the interim analysis include: a) stopping the learn because overwhelming efficacy; b) stopping the learn because earnest safety concern; c) stopping the learn because futility; d) continuing enrollment at the learn at the pre-specified instance size of about 190 subjects; or e) re-estimating instance size up or down ought affirm the study’s statistical power. We hope results from the interim analysis at September 2019.

In the meantime, the corporation will persist enrolling patients into the trial, and pending the consequence of the interim analysis, we currently worth patient enrollment will deduce at the fourth district of 2019 and topline results being announced at the first half of 2020.

peptides because Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity”. The patent provides prose of affair refuge because a amount of innate defense regulator (IDR) analogs and includes therapeutic avail claims at oral mucositis, colitis, and infectious disease, with and without the avail of antibiotics. Conclusion We evaluate Soligenix using a probability adjusted discounted cash river analysis based above latent future revenues of SGX301 at CTCL and SGX942 at OM. because SGX301, we xerox because approval at 2021 and range revenues of about $200 million worldwide. Using a 70% probability of approval and a 13% discount worth leads ought a net grant evaluate of $73 million. because SGX942, we xerox because approval at 2021 and range revenues of about $350 million worldwide. Using a 60% probability of approval and a 13% discount worth leads ought a net grant evaluate of $104 million. Combining the net grant evaluate because those two products with the company’s modern cash position, the latent cash from exercising warrants, and using a fully diluted portion calculate of 25.0 million shares leads ought a valuation of about $8.50 per share. Soligenix is currently trading at a significant discount ought our valuation, and with two aspect 3 readouts due by the first half of 2020 we count investors used to exist vigorous served ought receive a closer appearance at the corporation at the leadup ought those readouts. <a href="http://scr.zacks.com/Subscribe/defaultaspx/default.aspx" style="color: rgb(242, 132, 16); font-family: HelveticaNeue; text-size-adjust: auto;" rel="nofollow noopener" target="_blank">SUBSCRIBE ought ZACKS small cap RESEARCH</a> to receive our articles and reports emailed direct ought you each morning. entertain watch our <a href="http://scr.zacks.com/Home/default.aspx" style="color: rgb(242, 132, 16); font-family: HelveticaNeue; text-size-adjust: auto;" rel="nofollow noopener" target="_blank">website</a> for additional data above Zacks SCR.  DISCLOSURE: Zacks SCR has received compensation from the issuer direct or from an investor relations consulting firm, engaged by the issuer, because providing inquiry coverage because a epoch of no less than one year. inquiry articles, because seen here, are divide of the service Zacks provides and Zacks receives quarterly payments totaling a maximum charge of $30,000 annually because these services. total Disclaimer <a href="http://scr.zacks.com/Disclaimer/default.aspx" style="color: rgb(242, 132, 16);" rel="nofollow noopener" target="_blank">HERE</a>.' data-reactid="12">

Pediatric inquiry project because SGX942 Accepted by EMA

On April 9, 2019, Soligenix announced that the European Medicines Agency (EMA) has agreed ought the company’s Pediatric inquiry project (PIP) because SGX942. at addition, the EMA agreed that the corporation can delay conducting the PIP until successful completion of the ongoing aspect 3 DOM-INNATE clinical trial. total pharmaceuticals approved at Europe make ought read an approved PIP. at Soligenix’s case, the corporation will exist allowed ought row a Marketing Authorization application (MAA) because the adult symptom previous ought completion of the PIP owing ought the Pediatric committee of the EMA permitting its deferral until the risk/benefit of SGX942 has been established at an adult population.

Non-Dilutive Funding from NJ tax Program

On April 15, 2019, Soligenix announced the receipt of about $611,000 via the say of New Jersey’s technique care tax Certificate inspire Program. The program allows because different technique companies ought sell their Net Operating Loss (NOL) Carryovers and unused R&D tax Credits ought unaffiliated, corporate taxpayers at New Jersey. This is the ninth year that the corporation has received NOL funding and total told has received about $5 million above that span.

Expansion of IP refuge because IDR’s

On April 4, 2019, Soligenix announced the US Patent and brand Office will circulate U.S. Patent No. 10,253,068 titled “Novel peptides because Treating and Preventing Immune-Related Disorders, Including Treating and Preventing Infection by Modulating Innate Immunity”. The patent provides prose of affair refuge because a amount of innate defense regulator (IDR) analogs and includes therapeutic avail claims at oral mucositis, colitis, and infectious disease, with and without the avail of antibiotics.

Conclusion

We evaluate Soligenix using a probability adjusted discounted cash river analysis based above latent future revenues of SGX301 at CTCL and SGX942 at OM. because SGX301, we xerox because approval at 2021 and range revenues of about $200 million worldwide. Using a 70% probability of approval and a 13% discount worth leads ought a net grant evaluate of $73 million. because SGX942, we xerox because approval at 2021 and range revenues of about $350 million worldwide. Using a 60% probability of approval and a 13% discount worth leads ought a net grant evaluate of $104 million. Combining the net grant evaluate because those two products with the company’s modern cash position, the latent cash from exercising warrants, and using a fully diluted portion calculate of 25.0 million shares leads ought a valuation of about $8.50 per share. Soligenix is currently trading at a significant discount ought our valuation, and with two aspect 3 readouts due by the first half of 2020 we count investors used to exist vigorous served ought receive a closer appearance at the corporation at the leadup ought those readouts.

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