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'Data Readouts Approaching in Two Pivotal Trials' for Biopharma Targeting Unmet Needs
Research Report

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The next steps for each of the programs are outlined in a Dawson James Securities report.

In an Aug. 14 research note, Dawson James Securities analyst Jason Kolbert reported that Soligenix Inc. (SNGX:NASDAQ) "is now focused on the two pivotal programs, in cutaneous T-cell lymphoma (SGX301) and mucositis (dusquetide), while moving the public health solutions platform forward."

Kolbert provided updates on all three efforts, highlighting that the two involving Phase 3 biotherapeutics are nearing topline data readout.

As for Soligenix's SGX301, or synthetic hypericin, program for cutaneous T-cell lymphoma (CTCL), the independent data monitoring committee gave the pivotal trial a positive recommendation. Enrollment is taking place of about 40 more people "to maintain the assumption of 90% statistical power for the primary efficacy endpoint," noted Kolbert. Soligenix expects to finish enrollment in H2/19 and subsequently release topline results in Q1/20.

Regarding Soligenix's SGX942 (dusquetide) program for mucositis associated with head and neck cancer, enrollment of 90 patients is slated to start in September for the interim efficacy analysis. With enrollment expected to be done in H2/19, final topline results are anticipated in H1/20.

With respect to Soligenix's public health platform, the company continues to advance RiVax, a ricin toxin vaccine. In H2/19, it will commence a Phase 1/2, immunogenicity and safety trial involving healthy volunteers. Also, the company plans to conduct efficacy studies in nonhuman primates to build a "larger database of biomarkers for correlation with human clinical results," Kolbert explained.

The analyst also included in his report a brief recap of Soligenix's Q2/19 financials. The biopharma spent $2.1 million during the quarter and ended it with $7 million in cash.

Dawson James has a $3 per share price target and a Buy rating on Soligenix, whose stock is currently trading at around $1.09 per share.

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