Lead Asset TMB-001 Receives Fast Track Designation in Advance of Phase 3 Study Initiation by June 30th, 2022
BASKING RIDGE, NJ - 
(NewMediaWire) - May 12, 2022 - Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the first quarter of 2022, ended March 31, 2022.
John Koconis, Chairman and Chief Executive Officer of Timber, commented, “Timber’s lead asset, TMB-001, continues to progress following the receipt of Fast Track designation late last month, which is an important milestone on the path to approval. We believe that TMB-001 has the potential to be the first FDA approved therapy for Congenital Ichthyosis (CI), which has no FDA-approved treatments and limited therapeutic options, and as such, we’ve prioritized its development. This decision follows a series of milestones that includes reporting positive top-line results from our Phase 2b CONTROL study and the successful completion of an end-of-Phase 2 meeting with the FDA. We also expect to present the Phase 2b data at a number of medical conferences in the U.S. and internationally over the next several months. Near term, we remain focused on launching the Phase 3 ASCEND clinical trial by June 30th, 2022 and advancing the development of this therapy to the patient as quickly as possible.”
Recent Highlights
· Most recently, and subsequent to quarter end, Timber announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its lead asset, TMB-001, a topical isotretinoin formulated using Timber's patented IPEG™ delivery system, for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI). Fast Track status facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need.
· In February 2022, Timber announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) that resulted in a clear path to the launch of a pivotal Phase 3 study for TMB-001. Timber plans to initiate the Phase 3 study by June 30th, 2022.
· In March 2022, Christopher Bunick, MD, PhD, Yale University School of Medicine, made a late-breaking presentation of a sub-analysis of Timber’s Phase 2b CONTROL study data that evaluated TMB-001 at the American Academy of Dermatology (AAD) 2022 Annual Meeting in Boston, MA. The sub-analysis assessed whether primary efficacy results for TMB-001 differed by CI subtype, and the results demonstrated that patients could achieve treatment success with TMB-001 regardless of the subtype of congenital ichthyosis (CI).
· Timber ended the first quarter with $13.9 million in cash and common shares outstanding of 63.7 million on March 31, 2022.
· Timber recognized revenue of $83,177 in the first quarter of 2022 compared to $40,734 for the first quarter of 2021. Revenue for both periods consisted of reimbursements from achieving certain clinical milestones in the development of TMB-001, part of a $1.5 million grant from the FDA’s Orphan Products Clinical Trials Grants Program.
For Timber’s complete financial results for the three-month period ended March 31, 2022, see the Company’s Quarterly Form 10-Q filed with the Securities and Exchange Commission on May 12, 2022.
About Timber Pharmaceuticals, Inc.
Timber Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI), facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), and other sclerotic skin diseases. For more information, visit www.timberpharma.com.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, intellectual property rights, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2021 as well as other documents filed by the Company from time to time thereafter with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
For more information, contact:
Timber Pharmaceuticals, Inc.
John Koconis
Chairman and Chief Executive Officer
Investor Relations:
Stephanie Prince
PCG Advisory
(646) 863-6341
Media Relations:
Adam Daley
Berry & Company Public Relations
(212) 253-8881
- Tables Follow -
| Timber Pharmaceuticals, Inc. & Subsidiaries | ||||||
| Condensed Consolidated Statement of Operations | ||||||
| (Unaudited) | ||||||
| Three months ended March 31, | ||||||
| 2022 | 2021 | |||||
| Grant revenue | $ | 83,177 | $ | 40,734 | ||
| Milestone revenue | — | — | ||||
| Total revenue | 83,177 | 40,734 | ||||
| Operating costs and expenses | ||||||
| Research and development | 1,518,959 | 849,518 | ||||
| Research and development - license acquired | — | — | ||||
| Transaction costs | — | — | ||||
| Selling, general and administrative | 1,702,395 | 1,065,389 | ||||
| Total operating expenses | 3,221,354 | 1,914,907 | ||||
| Loss from operations | (3,138,177) | (1,874,173) | ||||
| Other income (expense) | ||||||
| Interest expense | (54,252) | — | ||||
| Other income | 75,000 | — | ||||
| Forgiveness of PPP loan | 37,772 | — | ||||
| Gain (loss) on foreign currency exchange | 6,262 | (87) | ||||
| Total other income (expense) | 64,783 | (87) | ||||
| Loss before provision for income taxes | (3,073,394) | (1,874,260) | ||||
| Provision for income taxes | — | — | ||||
| Loss before provision for income taxes | (3,073,394) | (1,874,260) | ||||
| Provision for income taxes | — | — | ||||
| Net loss | (3,073,394) | (1,874,260) | ||||
| Accrued dividend on preferred stock units | — | — | ||||
| Cumulative dividends on Series A preferred stock | — | (35,887) | ||||
| Net loss attributable to common stockholders | $ | (3,073,394) | $ | (1,910,147) | ||
| Basic and diluted net loss per share attributable to common stockholders | $ | (0.05) | $ | (0.05) | ||
| Basic and diluted weighted average number of shares outstanding | 63,637,712 | 35,079,143 | ||||
| | ||||||
