Form 8-K Timber Pharmaceuticals, For: Aug 11

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 11, 2022

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TIMBER PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

110 Allen Road, Suite 401

Basking Ridge, NJ 07920

(Address of principal executive offices)

Registrant’s telephone number, including area code: (908) 636-7160

N/A

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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 Item 2.02 Results of Operations and Financial Condition

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On August 11, 2022, Timber Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results and other information for the quarter ended June 30, 2022.   A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

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The information in this Item 2.02 and Exhibit 99.1 attached hereto is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

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Item 9.01. Financial Statements and Exhibits.

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SIGNATURE

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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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Exhibit 99.1

Timber Pharmaceuticals Provides Business Update and Announces Second Quarter 2022 Financial Results

Timber Enrolls First Patients in Phase 3 ASCEND Clinical Trial after Receiving Breakthrough Designation from FDA for Lead Asset TMB-001

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BASKING RIDGE, NJ, August 11, 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 second quarter of 2022, ended June 30, 2022.

John Koconis, Chairman and Chief Executive Officer of Timber, commented, “During the second quarter, Timber achieved several significant milestones for our lead asset, TMB-001. These include the launch and enrollment of the first patients for the pivotal Phase 3 ASCEND study, and the receipt of Breakthrough Therapy designation from the FDA in May and Fast Track designation in April. Breakthrough Therapy designation especially isn’t granted often, and we believe that this underscores the FDA’s recognition of the potential benefit of our treatment to address the significant unmet need for patients with moderate to severe Congenital Ichthyosis, who have very limited therapeutic options.”

“In our studies to date, Timber’s patented IPEG^TM delivery system has demonstrated that it may result in substantially less systemic exposure to isotretinoin compared to oral retinoids. This will enable our topical formulation to deliver isotretinoin directly to the target skin, potentially providing efficacy and relief to patients while mitigating systemic toxicity. We were very excited to kick off the pivotal Phase 3 ASCEND clinical trial in June, which has been designed for a larger patient group to be studied over a longer time frame. Our clinical team is also expected to present further analysis of the compelling Phase 2b data at additional medical conferences both here and abroad in the coming months. Timber ended the quarter with approximately $8.3 million in cash and subsequently completed an $8 million financing in August,” concluded Mr. Koconis.

Recent Highlights

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For Timber’s complete financial results for the three-month period ended June 30, 2022, see the Company’s Quarterly Form 10-Q filed with the Securities and Exchange Commission on August 11, 2022.

About Timber Pharmaceuticals, Inc.

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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), and other sclerotic skin diseases. For more information, visit www.timberpharma.com.

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Forward-Looking Statements

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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.

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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.

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For more information, contact:

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Timber Pharmaceuticals, Inc.

John Koconis

Chairman and Chief Executive Officer

[email protected]

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Investor Relations:

Stephanie Prince

PCG Advisory

(646) 863-6341

[email protected]

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Media Relations:

Adam Daley

Berry & Company Public Relations

(212) 253-8881

[email protected]

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- Tables Follow -

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TIMBER PHARMACEUTICALS, INC. & SUBSIDIARIES

Condensed Consolidated Balance Sheets

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TIMBER PHARMACEUTICALS, INC. & SUBSIDIARIES

Condensed Consolidated Statements of Operations

(Unaudited)

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