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.
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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.
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