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Timber Pharmaceuticals, Inc. (TMBR)

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  • Timber Pharmaceuticals Announces Adjournment of Annual Meeting
    GlobeNewswire

    Timber Pharmaceuticals Announces Adjournment of Annual Meeting

    Basking Ridge, NJ, June 03, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- 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 announced that on June 3, 2021 its 2021 Annual Meeting of Stockholders (the “Annual Meeting”) was convened without a quorum. As a result, in order to provide stockholders additional time within which to vote

  • Timber Pharmaceuticals Announces Completion of Patient Enrollment in Phase 2b CONTROL Study Evaluating TMB-001 in Congenital Ichthyosis
    GlobeNewswire

    Timber Pharmaceuticals Announces Completion of Patient Enrollment in Phase 2b CONTROL Study Evaluating TMB-001 in Congenital Ichthyosis

    - Company plans to ask for end-of-Phase 2 meeting with FDA by end of 2021 - Basking Ridge, N.J., May 26, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- 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 announced that it is completing patient enrollment in the Phase 2b CONTROL study evaluating TMB-001, a topical pharmaceutical composition of isotretinoin, in patients with moderate to severe subtypes of congenital ichthyosis (CI) on May 31, 2021 in order to move forward with Phase 3 trial planning. “Based on the positive safety and efficacy data from our unblinded Phase 2a program and feedback from investigators in our Phase 2b CONTROL study on the results achieved in many of the 35 enrolled subjects, we feel we are in a strong position to end enrollment early (trial originally planned for 45 subjects) so that we can prepare for our pivotal Phase 3 study, starting by requesting end of Phase 2 meetings with the U.S. Food and Drug Administration (FDA) and global health authorities in the near future,” said Alan Mendelsohn, M.D., Chief Medical Officer of Timber. “People living with CI have significant unmet treatment needs and we are taking this step in a continued effort to advance the development of TMB-001 as quickly as possible for this rare orphan disease community.” CI is a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. People living with CI may have limited range of motion, chronic itching, an inability to sweat normally, high risk of secondary infections, and impaired eyesight or hearing. The management of CI is a life-long endeavor, which remains largely symptomatic and commonly focused on reducing scaling and/or skin lubrication with both systemic and topical treatments. In 2018, the FDA awarded TMB-001 a $1.5 million grant to support Phase 2a and Phase 2b clinical trials through its Orphan Products Clinical Trials Grant program. Timber expects to announce top line results from the Phase 2b CONTROL study in the fourth quarter of 2021 and is planning for an end-of-Phase 2 meeting with the FDA by the end of the year. 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 scleroderma. For more information, visit www.timberpharma.com Forward-Looking StatementsThis 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, 2020 as well as other documents that may be filed by the Company from time to time 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 jkoconis@timberpharma.com Investor Relations: Stephanie Prince PCG Advisory (646) 863-6341 sprince@pcgadvisory.com Media Relations: Adam Daley Berry & Company Public Relations (212) 253-8881 adaley@berrypr.com

  • Timber Pharmaceuticals Provides Business Update and Announces First Quarter 2021 Financial Results
    GlobeNewswire

    Timber Pharmaceuticals Provides Business Update and Announces First Quarter 2021 Financial Results

    BASKING RIDGE, NJ, May 11, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire -- 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 ended March 31, 2021. John Koconis, Chairman and Chief Executive Officer of Timber, commented, “In the first quarter Timber continued to advance on all of its programs. In January, we announced that the Phase 2b CONTROL Study of Congenital Ichthyosis for our lead asset, TMB-001, had reached 50% enrollment. The Company anticipates topline data readout in the third quarter of 2021 for the TMB-001 study. The Phase 2b clinical trial evaluating TMB-002 (topical rapamycin) for the treatment of facial angiofibromas (FAs) in tuberous sclerosis complex (TSC) has made significant progress towards its clinical milestones as well. In March, our development partner on TMB-002, AFT Pharmaceuticals, entered into a licensing agreement for TMB-002 (trade name Pascomer®) in Europe with a third party. Under Timber’s agreement with AFT, Timber is entitled to a significant share of the royalties and milestones from the third party agreement and we believe that this provides further validation of our program. Also in January, we received confirmation that the U.S. Food and Drug Administration (“FDA”) had granted orphan drug designation for TMB-003, Timber’s locally delivered formulation of sitaxsentan, for the treatment of systemic sclerosis. All three of our programs now have orphan status and we expect continued progress on the clinical front, which is now being led by the Company’s new Chief Medical Officer, Alan Mendelsohn, M.D. who joined our team in January 2021. Timber ended the first quarter with $8.5 million cash and common shares outstanding of 36.7 million at March 31, 2021. We look forward to holding our first shareholder meeting as a public company on June 3rd, 2021 for shareholders of record as of April 12, 2021,” concluded Mr. Koconis. For Timber’s complete financial results for the period ended March 31, 2021, see the Company’s quarterly Form 10-Q filed with the Securities and Exchange Commission on May 11, 2021. 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 scleroderma. 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, 2020 as well as other documents that may be filed by the Company from time to time 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 jkoconis@timberpharma.com Investor Relations: Stephanie Prince PCG Advisory (646) 863-6341 sprince@pcgadvisory.com Media Relations: Adam DaleyBerry & Company Public Relations(212) 253-8881adaley@berrypr.com Jenna UrbanBerry & Company Public Relations(212) 253-8881jurban@berrypr.com - Tables Follow - Timber Pharmaceuticals, Inc. & SubsidiariesCondensed Consolidated Balance Sheets March 31, December 31, 2021 2020ASSETS(unaudited) Current assets Cash $ 8,500,053 $ 10,348,693Other current assets 291,929 377,290Total current assets 8,791,982 10,725,983Deposits 127,534 114,534Right of use asset 854,184 787,432Total assets $ 9,773,700 $ 11,627,949 LIABILITIES AND MEMBERS' AND STOCKHOLDERS' EQUITY Current liabilities Accounts payable $ 523,793 $ 395,049Accrued expenses 532,373 768,661Lease liability, current portion 278,059 217,651Total current liabilities 1,334,225 1,381,361Notes payable 37,772 37,772Lease liability 588,087 579,455Deferred tax liability 37,842 37,842Other liabilities 73,683 73,683Total liabilities 2,071,609 2,110,113 Commitments and contingencies (Note 8) Redeemable Series A convertible preferred stock, par value $0.001; 2,500 shares authorized; 1,819 shares issued and outstanding as of March 31, 2021 and December 31, 2020 1,945,692 1,909,805 Stockholders' equity Common stock, par value $0.001; 450,000,000 shares authorized; 36,659,685 shares issued and outstanding as of March 31, 2021, and 27,132,420 shares issued and outstanding as of December 31, 2020 36,660 27,132Additional paid-in capital 25,839,395 25,826,295Accumulated deficit (20,119,656) (18,245,396)Total stockholders' equity 5,756,399 7,608,031Total liabilities, redeemable convertible preferred stock, and stockholders' equity $ 9,773,700 $ 11,627,949 Timber Pharmaceuticals, Inc. & SubsidiariesCondensed Consolidated Statements of Operations(Unaudited) Three months ended March 31, 20212020 Grant revenues $ 40,734 $ 26,907 Operating costs and expenses Research and development 849,518 1,018,231Transaction costs - 1,189,842Selling, general and administrative 1,065,389 456,794Total operating expenses 1,914,907 2,664,867Loss from operations (1,874,173) (2,637,960) Other income (expense) Interest expense - (1,102,606)Interest income - 456,775Change in fair value of investment in BioPharmX - 83,560Change in fair value of warrant liability - (321,051)(Loss) gain on foreign currency exchange (87) 2,682Total other expense (87) (880,640)Net loss (1,874,260) (3,518,600)Accrued dividend on preferred stock units - (34,481)Cumulative dividends on Series A preferred stock (35,887) - Net loss attributable to common stockholders $ (1,910,147) $ (3,553,081)Basic and diluted net loss per share attributable to common stockholders $ (0.05) $ (0.56)Basic and diluted weighted average number of shares outstanding 35,079,143 6,295,724