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

Rhea-AI Summary

Timber Pharmaceuticals (TMBR) provided a business update and Q2 financial results for the quarter ending June 30, 2021. The Phase 2b CONTROL study for lead asset TMB-001 in Congenital Ichthyosis completed recruitment with 34 patients, expecting results in Q4 2021. TMB-002's trial for facial angiofibromas has surpassed 50% recruitment, aiming for completion by Q3 2021. The company recognized $388,819 in revenue from FDA reimbursements and a licensing milestone. Cash reserves stood at $6.1 million at quarter's end.

Positive

• Successful recruitment completion in Phase 2b CONTROL study for TMB-001 with 34 patients.
• TMB-002 trial has passed 50% recruitment mark.
• Revenue of $388,819 recognized from FDA milestones and licensing agreements.
• Cash reserves of $6.1 million at the end of Q2.

Negative

• None.

BASKING RIDGE, NJ, Aug. 10, 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 second quarter ended June 30, 2021.

John Koconis, Chairman and Chief Executive Officer of Timber, commented, “In the second quarter Timber’s core programs for rare and orphan dermatologic diseases all continued to progress.

• During the quarter Timber announced that as of May 31st, the Phase 2b CONTROL Study of Congenital Ichthyosis for lead asset, TMB-001, had completed recruitment at all of its sites with 34 patients randomized. 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.

• In June Timber confirmed that all 17 sites were open for the Phase 2b clinical trial evaluating TMB-002 (topical rapamycin) for the treatment of facial angiofibromas (FAs) in tuberous sclerosis complex (TSC) and that the 50% recruitment point had been passed. Recruitment is expected to be completed by the end of the third quarter of 2021 and, as per protocol, data is expected six months from the date that the last patient was enrolled.

• In April Timber announced that the Japanese Patent Office had decided to grant a patent (No. 2018542677) for TMB-001. In May, the Company received notice that the Australian Patent Office had decided to grant a patent (No. 2016346203) for TMB-001 as well. TMB-001 has also been issued patents in the U.S. and has additional patent applications pending in other markets around the world.

• Timber recognized revenue of $388,819 in the second quarter, consisting of reimbursements received from the FDA as a result of achieving certain clinical milestones in the development of TMB-001, partof a $1.5 million grant from the Orphan Products Clinical Trials Grants Program of the FDA’s Office of Orphan Products Development, and from a TMB-002 milestone for a licensing agreement with AFT.

• Timber ended the second quarter with $6.1 million in cash and common shares outstanding of 36.7 million at June 30, 2021.

“The Timber team has persevered through the headwinds of the global pandemic to reach the clinical milestones we’ve achieved thus far as well as those we expect to achieve over the next nine months.  We anticipate the end of recruitment in the TMB-002 Phase 2b trial at the end of the third quarter and reporting data for the TMB-001 Phase 2b CONTROL trial early in the fourth quarter,” concluded Mr. Koconis.

For Timber’s complete financial results for the period ended June 30, 2021, see the Company’s quarterly Form 10-Q filed with the Securities and Exchange Commission on August 9, 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 Daley
Berry & Company Public Relations
(212) 253-8881
adaley@berrypr.com

- Tables Follow -

Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Balance Sheets

ASSETS			(unaudited)
Current assets
Cash		$	6,129,035		$	10,348,693
Other receivable			253,892			—
Other current assets			378,382			377,290
Total current assets			6,761,309			10,725,983
Deposits			127,534			114,534
Property and equipment, net			16,728			—
Right of use asset			784,674			787,432
Total assets		$	7,690,245		$	11,627,949
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities
Accounts payable		$	1,385,852		$	395,049
Accrued expenses			568,732			768,661
Lease liability, current portion			295,045			217,651
Total current liabilities			2,249,629			1,381,361
Notes payable			37,772			37,772
Lease liability			505,998			579,455
Deferred tax liability			37,842			37,842
Other liabilities			73,683			73,683
Total liabilities			2,904,924			2,110,113
Commitments and contingencies (Note 7)
Redeemable Series A convertible preferred stock, par value $0.001; 2,500 shares authorized; 1,819 shares issued and outstanding as of June 30, 2021 and December 31, 2020			1,981,978			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 June 30, 2021, and 27,132,420 shares issued and outstanding as of December 31, 2020			36,660			27,132
Additional paid-in capital			25,852,542			25,826,295
Accumulated deficit			(23,085,859)			(18,245,396)
Total stockholders' equity			2,803,343			7,608,031
Total liabilities, redeemable convertible preferred stock, and stockholders' equity		$	7,690,245		$	11,627,949

Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)

		Three months ended June 30,						Six months ended June 30,
		2021			2020			2021			2020
Grant revenue		$	134,927		$	—		$	175,661		$	26,907
Milestone revenue			253,892			—			253,892			—
Total revenue			388,819			—			429,553			26,907
Operating costs and expenses
Research and development			1,800,100			536,170			2,649,618			1,554,401
Research and development - license acquired			—			12,371,332			—			12,371,332
Transaction costs			—			311,291			—			1,501,133
Selling, general and administrative			1,556,012			1,055,084			2,621,401			1,511,878
Total operating expenses			3,356,112			14,273,877			5,271,019			16,938,744
Loss from operations			(2,967,293)			(14,273,877)			(4,841,466)			(16,911,837)
Other income (expense)
Interest expense			—			(3,314,140)			—			(4,416,746)
Interest income			—			359,880			—			816,655
Change in fair value of investment in BioPharmX			—			476,245			—			559,805
Change in fair value of warrant liability			—			1,504,511			—			1,183,460
Gain on foreign currency exchange			1,090			1,772			1,003			4,454
Total other income (expense)			1,090			(971,732)			1,003			(1,852,372)
Net loss			(2,966,203)			(15,245,609)			(4,840,463)			(18,764,209)
Accrued dividend on preferred stock units			—			(18,188)			—			(52,669)
Cumulative dividends on Series A preferred stock			(36,286)			(17,146)			(72,173)			(17,146)
Net loss attributable to common stockholders		$	(3,002,489)		$	(15,280,943)		$	(4,912,636)		$	(18,834,024)
Basic and diluted net loss per share attributable to common stockholders		$	(0.08)		$	(1.36)		$	(0.14)		$	(2.15)
Basic and diluted weighted average number of shares outstanding			36,659,685			11,222,258			35,873,780			8,758,991

FAQ

What were Timber Pharmaceuticals' financial results for Q2 2021?

Timber Pharmaceuticals recognized revenue of $388,819 for Q2 2021.

What is the status of the Phase 2b CONTROL study for TMB-001?

The Phase 2b CONTROL study for TMB-001 completed recruitment with 34 patients.

When can we expect data from the TMB-001 Phase 2b trial?

Top line results from the TMB-001 Phase 2b trial are expected in Q4 2021.

What is the recruitment status of the TMB-002 trial?

The TMB-002 trial has surpassed the 50% recruitment milestone and is expected to complete recruitment by the end of Q3 2021.

How much cash does Timber Pharmaceuticals have as of June 30, 2021?

Timber Pharmaceuticals had $6.1 million in cash at the end of Q2 2021.