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

·8 min read
Timber Pharmaceuticals
Timber Pharmaceuticals

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

BASKING RIDGE, NJ, Aug. 11, 2022 (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 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 IPEGTM 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

  • On June 23, 2022, Timber announced that it had enrolled the first patients in its Phase 3 ASCEND clinical trial evaluating its lead asset, TMB-001, a topical isotretinoin formulated using Timber's patented IPEGTM delivery system, for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI). The pivotal trial expected to enroll more than 140 patients with moderate to severe Congenital Ichthyosis at leading research centers in the U.S., Canada, Italy, France, and Germany.

  • In May 2022, Timber received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for TMB-001. Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat serious or life-threatening conditions and that have demonstrated substantial improvement over available therapy on a clinically significant endpoint in preliminary clinical evidence.

  • In April 2022, Timber announced that FDA granted Fast Track designation to TMB-001. Fast Track status facilitates the development and expedites the review of drugs that treat serious conditions and fill an unmet medical need.

  • Results from the previously completed Phase 2b CONTROL study that demonstrated clinically meaningful efficacy with a favorable safety profile for TMB-001 were recently published on-line pre-proof in the world renowned, peer-reviewed Journal of the American Academy of Dermatology.

  • Timber expects to present additional analysis of its study data on TMB-001 at several U.S. and international medical conferences in the coming months.

  • Timber recognized no revenue in the second quarter of 2022 compared to revenue of $388,819 for the second quarter of 2021. First the first six months of 2022, Timber recognized revenue of $83,177 in the 2022 period and $429,553 in the 2021 period. Revenue for all 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.

  • Timber ended the second quarter with approximately $8.3 million in cash and 63.75 common shares outstanding. On August 8, 2022, Timber completed an $8 million public offering consisting of common shares and warrants.

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.

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.

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
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, Inc. & Subsidiaries

 

 

 

Condensed Consolidated Balance Sheets

 

 

 

 

 

 

 

 

    

June 30,

    

December 31, 

 

 

 

2022

 

 

2021

 

 

 

 

 

(unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

  

 

Current assets

 

 

  

 

 

  

 

Cash

 

$

8,273,728

 

 

$

16,808,539

 

 

Prepaid research and development

 

 

767,650

 

 

 

66,217

 

 

Other current assets

 

 

237,158

 

 

 

244,021

 

 

Total current assets

 

 

9,278,536

 

 

 

17,118,777

 

 

Deposits

 

 

127,534

 

 

 

127,534

 

 

Property and equipment, net

 

 

20,531

 

 

 

16,377

 

 

Right of use asset

 

 

482,986

 

 

 

638,786

 

 

Total assets

 

$

9,909,587

 

 

$

17,901,474

 

 

 

 

 

  

 

 

  

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

  

 

 

  

 

Current liabilities

 

 

  

 

 

  

 

Accounts payable

 

$

420,353

 

 

$

953,349

 

 

Accrued expenses

 

 

1,408,968

 

 

 

850,557

 

 

Lease liability, current portion

 

 

341,308

 

 

 

332,817

 

 

Short-term milestone payable due to Patagonia Pharmaceuticals LLC

 

 

2,250,000

 

 

 

 

 

Redeemable Series A preferred stock under redemption

 

 

2,151,675

 

 

 

2,055,348

 

 

Total current liabilities

 

 

6,572,304

 

 

 

4,192,071

 

 

Note payable

 

 

 

 

 

37,772

 

 

Lease liability

 

 

163,985

 

 

 

331,152

 

 

Long-term milestone payable due to Patagonia Pharmaceuticals LLC

 

 

1,750,000

 

 

 

 

 

Other liabilities

 

 

73,683

 

 

 

73,683

 

 

Total liabilities

 

 

8,559,972

 

 

 

4,634,678

 

 

 

 

 

  

 

 

  

 

Commitments and contingencies

 

 

  

 

 

  

 

 

 

 

  

 

 

  

 

Stockholders' equity

 

 

  

 

 

  

 

Common stock, par value $0.001; 450,000,000 shares authorized; 63,753,834 shares issued and outstanding as of June 30, 2022, and 63,619,140 shares issued and outstanding as of December 31, 2021

 

 

63,754

 

 

 

63,619

 

 

Additional paid-in capital

 

 

42,739,793

 

 

 

42,087,719

 

 

Accumulated deficit

 

 

(41,453,932

)

 

 

(28,884,542

)

 

Total stockholders' equity

 

 

1,349,615

 

 

 

13,266,796

 

 

Total liabilities and stockholders' equity

 

$

9,909,587

 

 

$

17,901,474

 

 

 

 

 

 

 

 

 

 



Timber Pharmaceuticals, Inc. & Subsidiaries

 

 

 

 

 

Condensed Consolidated Statement of Operations

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(Unaudited)

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

    

Three months ended June 30, 

    

Six months ended June 30, 

    

 

 

 

    

2022

 

    

2021

 

    

2022

 

    

2021

 

    

 

 

 

 

 

(Unaudited)

 

 

(Unaudited)

 

 

(Unaudited)

 

 

(Unaudited)

 

 

 

Grant revenue

 

$

 

 

$

134,927

 

 

$

83,177

 

 

$

175,661

 

 

 

 

Milestone revenue

 

 

 

 

 

253,892

 

 

 

 

 

 

253,892

 

 

 

 

Total revenue

 

 

 

 

 

388,819

 

 

 

83,177

 

 

 

429,553

 

 

 

 

 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Operating costs and expenses

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Research and development

 

 

3,891,500

 

 

 

1,800,100

 

 

 

5,410,459

 

 

 

2,649,618

 

 

 

 

Research and Development - Milestone expense for Patagonia Pharmaceuticals LLC

 

 

4,000,000

 

 

 

 

 

 

4,000,000

 

 

 

 

 

 

 

Selling, general and administrative

 

 

1,512,343

 

 

 

1,556,012

 

 

 

3,214,738

 

 

 

2,621,401

 

 

 

 

Total operating expenses

 

 

9,403,843

 

 

 

3,356,112

 

 

 

12,625,197

 

 

 

5,271,019

 

 

 

 

Loss from operations

 

 

(9,403,843

)

 

 

(2,967,293

)

 

 

(12,542,020

)

 

 

(4,841,466

)

 

 

 

Other income (expense)

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Interest expense

 

 

(42,077

)

 

 

 

 

 

(96,328

)

 

 

 

 

 

 

Other income

 

 

 

 

 

 

 

 

75,000

 

 

 

 

 

 

 

Forgiveness of PPP loan

 

 

 

 

 

 

 

 

37,772

 

 

 

 

 

 

 

(Loss) gain on foreign currency exchange

 

 

(50,076

)

 

 

1,090

 

 

 

(43,814

)

 

 

1,003

 

 

 

 

Total other income (expense)

 

 

(92,153

)

 

 

1,090

 

 

 

(27,370

)

 

 

1,003

 

 

 

 

Provision for income taxes

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

(9,495,996

)

 

 

(2,966,203

)

 

 

(12,569,390

)

 

 

(4,840,463

)

 

 

 

Dividends on Series A preferred stock

 

 

 

 

 

(36,286

)

 

 

 

 

 

(72,173

)

 

 

 

Net loss attributable to common stockholders

 

$

(9,495,996

)

 

$

(3,002,489

)

 

$

(12,569,390

)

 

$

(4,912,636

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share attributable to common stockholders

 

$

(0.15

)

 

$

(0.08

)

 

$

(0.20

)

 

$

(0.14

)

 

 

 

Basic and diluted weighted average number of shares outstanding

 

 

63,731,582

 

 

 

36,659,685

 

 

 

63,684,906

 

 

 

35,872,780