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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
TIMBER PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
| 001-37411 |
| 59-3843182 |
(State or other jurisdiction of incorporation) |
| (Commission File Number) |
| (IRS Employer Identification No.) |
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:
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
| Trading Symbol(s) |
| Name of each exchange on which registered |
Common Stock, $0.001 Par Value | TMBR | The NYSE American, LLC |
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. ☐
Item 2.02 Results of Operations and Financial Condition
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.
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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. | |||
Exhibit No. | Exhibit | ||
99.1 | |||
104 | Cover Page Interactive Date File (embedded within the Inline XRBL document) | ||
SIGNATURE
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.
| Timber Pharmaceuticals, Inc. | |
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Date: August 12, 2022 | By: | /s/ John Koconis |
| Name: | John Koconis |
| Title: | Chief Executive Officer and Chairman of the Board of Directors |
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
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 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
| ● | 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. |
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| ● | Timber ended the second quarter with approximately $8.3 million in cash and 63.75 common shares outstanding. On August 8, 2022, Timber raised $8 million in new capital through the sale 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
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TIMBER PHARMACEUTICALS, INC. & SUBSIDIARIES
Condensed Consolidated Balance Sheets
| | June 30, | | December 31, | | ||
| | 2022 | | 2021 | | ||
| | (unaudited) | | | | ||
ASSETS |
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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 | |
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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 | |
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Commitments and contingencies | | | | | | ||
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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 | |
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TIMBER PHARMACEUTICALS, INC. & SUBSIDIARIES
Condensed Consolidated Statements 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 |
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Milestone revenue | | | — | | | 253,892 | | | — | | | 253,892 | |
Total revenue | | | — | | | 388,819 | | | 83,177 | | | 429,553 | |
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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 | |
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) | |
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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 | |
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