Company Plans to Initiate Phase 3 Study for TMB-001 in Q2 2022
BASKING RIDGE, NJ, March 31, 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 fourth quarter and year ended December 31, 2021.
John Koconis, Chairman and Chief Executive Officer of Timber, commented, “Timber achieved multiple milestones over the past few months. In October, we reported positive topline data for our lead asset TMB-001 and just a few weeks ago, we had a productive follow-up meeting with the FDA, positioning us to launch a Phase 3 study in the second quarter of 2022. We also anticipate reporting top line data for the recently completed Phase 2b study for TMB-002 in the third quarter of this year. It’s an exciting time at Timber as we move into late-stage clinical development for our two lead assets.”
Recent Highlights
- During the fourth quarter, Timber announced positive top line results of its Phase 2b CONTROL Study of congenital ichthyosis (CI) for its lead asset, TMB-001, a topical isotretinoin formulated using the company’s patented IPEG™ delivery system. Clinically meaningful efficacy with a favorable safety profile demonstrated the potential of TMB-001 to be an important option for the treatment of CI where no FDA-approved treatments are currently available and the options for standard of care is limited.
- Timber presented the TMB-001 Phase 2b study results at the European Academy of Dermatology and Venereology’s (EADV) 30th anniversary congress that was held virtually from September 29 - October 2, 2021. Full data was also presented at the 2022 Winter Clinical Dermatology Conference held January 14 – 19, 2022 in Koloa, Hawaii. In addition, a late-breaking presentation of a sub-analysis of the TMB-001 Phase 2b study was presented by a third party at the American Academy of Dermatology 2022 Annual Meeting held March 25-29, 2022 in Boston, Massachusetts.
- 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 in the second quarter of 2022.
- Timber ended the fourth quarter with $16.8 million in cash and common shares outstanding of 63.6 million on December 31, 2021. This includes $17.25 million in total gross proceeds from a successful public offering that closed in November 2021.
- Timber recognized revenue of $190,005 in the fourth quarter of 2021 compared to $102,382 for the fourth quarter of 2020. 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 the twelve months ended December 31, 2021, Timber recognized revenue of $886,532 compared to $453,810 for the prior year. Reimbursements from achieving certain clinical milestones in the development of TMB-001, totaled $590,794 compared to $453,810 for 2020, part of a $1.5 million grant from the FDA’s Orphan Products Clinical Trials Grants Program. In 2021, Timber also recognized $295,738 from a TMB-002 milestone payment from its licensing agreement with AFT.
The Company advises that its audited consolidated financial statements for the fiscal year ended December 31, 2021, included in the Company’s Annual Form on Form 10-K, contained an audit report from its independent registered public accounting firm with a going concern emphasis of matter. Release of this information is required by Section 610(b) of the NYSE American Company Guide. It does not represent any change or amendment to any of the Company’s filings for the fiscal year ended December 31, 2021.
For Timber’s complete financial results for the twelve-month period ended December 31, 2021, see the Company’s Annual Form 10-K filed with the Securities and Exchange Commission on March 31, 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
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 | ||||||
| Consolidated Balance Sheets | ||||||
| December 31, | December 31, | |||||
| 2021 | 2020 | |||||
| ASSETS | ||||||
| Current assets | ||||||
| Cash | $ | 16,808,539 | $ | 10,348,693 | ||
| Other current assets | 310,238 | 377,290 | ||||
| Total current assets | 17,118,777 | 10,725,983 | ||||
| Deposits | 127,534 | 114,534 | ||||
| Property and equipment, net | 16,377 | — | ||||
| Right of use asset | 638,786 | 787,432 | ||||
| Total assets | $ | 17,901,474 | $ | 11,627,949 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||
| Current liabilities | ||||||
| Accounts payable | $ | 953,349 | $ | 395,049 | ||
| Accrued expenses | 850,557 | 768,661 | ||||
| License payable | — | — | ||||
| Lease liability, current portion | 332,817 | 217,651 | ||||
| Redeemable Series A convertible preferred stock under redemption | 2,055,348 | — | ||||
| Total current liabilities | 4,192,071 | 1,381,361 | ||||
| Notes payable | 37,772 | 37,772 | ||||
| Lease liability | 331,152 | 579,455 | ||||
| Deferred tax liability | — | 37,842 | ||||
| Other liabilities | 73,683 | 73,683 | ||||
| Total liabilities | 4,634,678 | 2,110,113 | ||||
| Commitments and contingencies | ||||||
| Redeemable Series A convertible preferred stock, par value $0.001; 2,500 shares authorized; 1,819 shares issued and outstanding as of December 31, 2020 | — | 1,909,805 | ||||
| Stockholders' equity | ||||||
| Preferred stock - member units | — | — | ||||
| Common stock - member units | — | — | ||||
| Common stock, par value $0.001; 450,000,000 shares authorized; 63,619,140 shares issued and outstanding as of December 31, 2021, and 27,132,420 shares issued and outstanding as of December 31, 2020 | 63,619 | 27,132 | ||||
| Additional paid-in capital | 42,087,719 | 25,826,295 | ||||
| Accumulated deficit | (28,884,542) | (18,245,396) | ||||
| Total stockholders' equity | 13,266,796 | 7,608,031 | ||||
| Total liabilities, redeemable convertible preferred stock, and stockholders' equity | $ | 17,901,474 | $ | 11,627,949 | ||
| TIMBER PHARMACEUTICALS, INC. & SUBSIDIARIES | ||||||
| Consolidated Statements of Operations | Year ended December 31, | |||||
| 2021 | 2020 | |||||
| Grant revenue | $ | 590,794 | $ | 453,810 | ||
| Milestone revenue | 295,738 | — | ||||
| Total revenue | 886,532 | 453,810 | ||||
| Operating costs and expenses | ||||||
| Research and development | 6,149,586 | 2,733,026 | ||||
| Research and development - license acquired | — | 12,371,332 | ||||
| Transaction costs | — | 1,501,133 | ||||
| Selling, general and administrative | 5,387,164 | 4,060,186 | ||||
| Total operating expenses | 11,536,750 | 20,665,677 | ||||
| Loss from operations | (10,650,218) | (20,211,867) | ||||
| Other (expense) income | ||||||
| Interest expense | (15,551) | (4,416,746) | ||||
| Interest income | — | 816,657 | ||||
| Change in fair value of investment in BioPharmX | — | 559,805 | ||||
| Change in fair value of warrant liability | — | 8,156,770 | ||||
| (Loss) gain on foreign currency exchange | (3,619) | 15,609 | ||||
| Total other (expense) income | (19,170) | 5,132,095 | ||||
| Loss before provision for income taxes | (10,669,388) | (15,079,772) | ||||
| Provision for income taxes | — | — | ||||
| Loss before provision for income taxes | (10,669,388) | (15,079,772) | ||||
| (Benefit) Provision for income taxes | (30,242) | 37,842 | ||||
| Net loss | (10,639,146) | (15,117,614) | ||||
| Accrued dividend on preferred stock units | — | (52,669) | ||||
| Cumulative dividends on Series A preferred stock | (129,992) | (90,516) | ||||
| Net loss attributable to common stockholders | $ | (10,769,138) | $ | (15,260,799) | ||
| Basic and diluted net loss per share attributable to common stockholders | $ | (0.27) | $ | (0.97) | ||
| Basic and diluted weighted average number of shares outstanding | 40,440,570 | 15,699,869 | ||||
