Call 800 665 0411 to learn about our services for your stock

Search   Follow Investorideas on Twitter   Investorideas is on Facebook   Investorideas is on Youtube   Investorideas is on Pinterest  Investorideas is on stocktwits   Investorideas is on tumblr   Investorideas is on LinkedIn   Investorideas Instagram   Investorideas Telegram   Investorideas Gettr   Investorideas RSS

Share on StockTwits

Phase 3 Trial in Progress of New Ichthyosis Treatment

Source: Dr. Ram Selvaraju


April 13, 2023 ( Newswire) Patient recruitment is 50% complete for this multicenter study evaluating a designated orphan drug as treatment for these congenital disorders, noted an H.C. Wainwright & Co. report.

Enrollment is about half complete for the Phase 3 ASCEND trial evaluating Timber Pharmaceuticals Inc.'s (TMBR:NYSE.American) lead clinical asset TMB-001 as a treatment for congenital ichthyosis, reported H.C. Wainwright & Co. analyst Dr. Ram Selvaraju in an April 10 research note. Topline data are anticipated in early 2024.

Congenital ichthyosis is a group of disorders in which cornification, or cell death, occurs and results in abnormal skin conditions, such as scaling and redness.

Target Price Boosted

In other news, H.C. Wainwright raised its target price on Timber to US$11 per share from US$1 to account for the reverse stock split that went into effect in November 2022, noted Selvaraju. In comparison, the biopharma's current share price is about US$1.49. The price difference implies a robust 638% potential return for investors.

Timber is rated Buy.

Significant Unmet Needs

Headquartered in New Jersey, Timber is developing novel treatments for rare dermatological diseases for which no approved treatments exist. Its asset, TMB-001, is a topical isotretinoin formulated using the biopharma's patented IPEG delivery system.

TMB-001 has both breakthrough therapy and fast-track designations in the U.S. In Europe, it is a designated orphan drug for autosomal recessive congenital ichthyosis (ARCI) and X-linked recessive ichthyosis (XLRI). Selvaraju noted it is the only compound with orphan drug status for both types of congenital ichthyosis, "underscoring the significant unmet needs" of patients with these disorders.

The Study Design

For the Phase 3 ASCEND trial, the goal is to enroll at least 140 patients with moderate to severe congenital ichthyosis, relayed Selvaraju. The study, randomized, double-blind, and vehicle-controlled, is taking place at multiple research centers in the U.S., Canada, Italy, France, and Germany.

The study's primary endpoint is a change in immunoglobulin A level at week 12. Secondary endpoints include a change in score on Visual Index for Ichthyosis Severity assessment and local skin reactions.

FY22 Financial Results

Also, in his report, Selvaraju summarized Timber's financial reports for the full-year 2022. The biopharma reported a net loss for the year of US$9.19 per share.

The company's expenses for 2022 totaled US$19.2 million ($19.2M), below H.C. Wainwright's estimate of US$20.7M. Similarly, research and development (R&D) costs also were beat, at US$9.3M versus US$10.7M. Selvaraju wrote that Timber's spending on R&D is expected to continue increasing through the completion of ASCEND.

At year-end 2022, the biopharma had US$9.1M in cash and cash equivalents, which, Selvaraju purported, should be enough to fund operations well into H2/23.

1) Doresa Banning wrote 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. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with: None. Please click here for more information.

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 decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Disclosures For H.C. Wainwright & Co., Timber Pharma Inc., April 10, 2023

H.C. Wainwright & Co, LLC (the "Firm") is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Raghuram Selvaraju, Ph.D. and Boobalan Pachaiyappan, Ph.D. , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Timber Pharmaceuticals, Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of March 31, 2023 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Timber Pharmaceuticals, Inc.

Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. Mr. Selvaraju, who is [the][an] author of this report, is the Chairman of and receives compensation from Relief Therapeutics Holding SA, a Swiss, commercial-stage biopharmaceutical company identifying, developing and commercializing novel, patent protected products in selected specialty, rare and ultra-rare disease areas on a global basis ("Relief"). You should consider Mr. Selvaraju's position with Relief when reading this research report.

The firm or its affiliates received compensation from Timber Pharmaceuticals, Inc. for non-investment banking services in the previous 12 months. The Firm or its affiliates did receive compensation from Timber Pharmaceuticals, Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Timber Pharmaceuticals, Inc. during the past 12 months. The Firm does not make a market in Timber Pharmaceuticals, Inc. as of the date of this research report. The securities of the company discussed in this report may be unsuitable for investors depending on their specific investment objectives and financial position.

Past performance is no guarantee of future results. This report is offered for informational purposes only, and does not constitute an offer or solicitation to buy or sell any securities discussed herein in any jurisdiction where such would be prohibited. This research report is not intended to provide tax advice or to be used to provide tax advice to any person. Electronic versions of H.C. Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the expressed permission of H.C. Wainwright & Co., LLC.

Additional information available upon request. H.C. Wainwright & Co., LLC does not provide individually tailored investment advice in research reports. This research report is not intended to provide personal investment advice and it does not take into account the specific investment objectives, financial situation and the particular needs of any specific person. Investors should seek financial advice regarding the appropriateness of investing in financial instruments and implementing investment strategies discussed or recommended in this research report. H.C. Wainwright & Co., LLC's and its affiliates' salespeople, traders, and other professionals may provide oral or written market commentary or trading strategies that reflect opinions that are contrary to the opinions expressed in this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data on the company, industry or security discussed in the report.

All opinions and estimates included in this report constitute the analyst's judgment as of the date of this report and are subject to change without notice. Securities and other financial instruments discussed in this research report: may lose value; are not insured by the Federal Deposit Insurance Corporation; and are subject to investment risks, including possible loss of the principal amount invested.

More Info: Newswire

This news is published on the Newswire - a global digital news source for investors and business leaders

Disclaimer/Disclosure: is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions.

More disclaimer info: Learn more about publishing your news release and our other news services on the newswire

Global investors must adhere to regulations of each country. Please read privacy policy:

That's all it takes to get an article published on Investor Ideas - Learn More - A Leading Global Investor Website for Biotech Industry Stocks - investing ideas in biotechnology stocks, medical technology and life sciences

Like Biotech Stocks? View our Biotech Stocks Directory

Get News Alerts on Biotech Stocks

Buy a biotech guest post on