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

Streetwise Reports, Streetwise Reports
0 Comments| August 22, 2019

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

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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.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures for Dawson James Securities, Soligenix Inc., August 14, 2019,

The Firm does not make a market in the securities of the subject company(s). The Firm has NOT engaged in investment banking relationships with Dare in the prior twelve months, as a manager or co-manager of a public offering and has NOT received compensation resulting from those relationships. The Firm may seek compensation for investment banking services in the future from the subject company(s). The Firm has not received any other compensation from the subject company(s) in the last 12 months for services unrelated to managing or co-managing of a public offering.

Neither the research analyst(s) whose name appears on this report nor any member of his (their) household is an officer, director or advisory board member of these companies. The Firm and/or its directors and employees may own securities of the company(s) in this report and may increase or decrease holdings in the future. As of July 31, 2019, the Firm as a whole did not beneficially own 1% or more of any class of common equity securities of the subject company(s) of this report. The Firm, its officers, directors, analysts or employees may affect transactions in and have long or short positions in the securities (or options or warrants related to those securities) of the company(s) subject to this report. The Firm may affect transactions as principal or agent in those securities.

Analysts receive no direct compensation in connection with the Firm's investment banking business. All Firm employees, including the analyst(s) responsible for preparing this report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of the Firm and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analyst’s compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.



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