UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark one)
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2021
OR
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ______ to ______
Commission File Number 001-37411
TIMBER PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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59-3843182 |
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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110 Allen Road, Suite 410
Basking Ridge, NJ 07920
(Address of principal executive offices and zip code)
(908) 636-7160
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, par value $0.001 per share |
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TMBR |
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The NYSE American, LLC |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ⌧ NO ◻
Indicate by check mark whether the registrant has submitted electronically, if any, every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ⌧ NO ◻
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large Accelerated Filer ☐ |
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Accelerated Filer ☐ |
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Non-accelerated Filer ☒ |
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Smaller Reporting Company ☒ |
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Emerging growth company ☐ |
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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. ◻
Indicate by check mark whether registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). YES ☐ NO ☒
Indicate the number of shares outstanding of each of the registrant’s classes of common stock, as of the latest practicable date.
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Class of Common Stock |
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Outstanding Shares as of August 6, 2021 |
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Common Stock, $0.001 par value |
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36,659,685 |
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TIMBER PHARMACEUTICALS, INC. & SUBSIDIARIES
Form 10-Q
For the Quarter Ended June 30, 2021
Table of Contents
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Page
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PART I. FINANCIAL INFORMATION |
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3 |
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Condensed Consolidated Balance Sheets as of June 30, 2021 (unaudited) and December 31, 2020 |
3 |
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4 |
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5 |
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8 |
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Notes to Condensed Consolidated Financial Statements (unaudited) |
9 |
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Management’s Discussion and Analysis of the Results of Operations |
22 |
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33 |
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33 |
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33 |
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33 |
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33 |
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33 |
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34 |
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35 |
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2
Item 1. Financial Statements.
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Balance Sheets
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June 30, |
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December 31, |
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2021 |
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2020 |
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ASSETS |
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(unaudited) |
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Current assets |
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Cash |
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$ |
6,129,035 |
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$ |
10,348,693 |
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Other receivable |
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253,892 |
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— |
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Other current assets |
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378,382 |
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377,290 |
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Total current assets |
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6,761,309 |
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10,725,983 |
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Deposits |
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127,534 |
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114,534 |
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Property and equipment, net |
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16,728 |
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— |
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Right of use asset |
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784,674 |
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787,432 |
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Total assets |
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$ |
7,690,245 |
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$ |
11,627,949 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities |
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Accounts payable |
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$ |
1,385,852 |
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$ |
395,049 |
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Accrued expenses |
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568,732 |
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768,661 |
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Lease liability, current portion |
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295,045 |
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217,651 |
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Total current liabilities |
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2,249,629 |
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1,381,361 |
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Notes payable |
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37,772 |
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37,772 |
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Lease liability |
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505,998 |
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579,455 |
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Deferred tax liability |
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37,842 |
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37,842 |
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Other liabilities |
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73,683 |
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73,683 |
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Total liabilities |
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2,904,924 |
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2,110,113 |
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Commitments and contingencies (Note 7) |
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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 |
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1,981,978 |
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1,909,805 |
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Stockholders' equity |
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Common stock, par value $0.001; 450,000,000 shares authorized; 36,659,685 shares issued and outstanding as of June 30, 2021, and 27,132,420 shares issued and outstanding as of December 31, 2020 |
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36,660 |
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27,132 |
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Additional paid-in capital |
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25,852,542 |
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25,826,295 |
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Accumulated deficit |
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(23,085,859) |
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(18,245,396) |
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Total stockholders' equity |
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2,803,343 |
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7,608,031 |
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Total liabilities, redeemable convertible preferred stock, and stockholders' equity |
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$ |
7,690,245 |
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$ |
11,627,949 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Operations
(Unaudited)
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Three months ended June 30, |
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Six months ended June 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Grant revenue |
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$ |
134,927 |
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$ |
— |
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$ |
175,661 |
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$ |
26,907 |
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Milestone revenue |
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253,892 |
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— |
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253,892 |
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— |
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Total revenue |
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388,819 |
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— |
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429,553 |
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26,907 |
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Operating costs and expenses |
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Research and development |
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1,800,100 |
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536,170 |
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2,649,618 |
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1,554,401 |
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Research and development - license acquired |
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— |
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12,371,332 |
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— |
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12,371,332 |
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Transaction costs |
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— |
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311,291 |
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— |
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1,501,133 |
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Selling, general and administrative |
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1,556,012 |
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1,055,084 |
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2,621,401 |
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1,511,878 |
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Total operating expenses |
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3,356,112 |
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14,273,877 |
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5,271,019 |
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16,938,744 |
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Loss from operations |
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(2,967,293) |
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(14,273,877) |
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(4,841,466) |
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(16,911,837) |
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Other income (expense) |
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Interest expense |
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— |
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(3,314,140) |
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— |
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(4,416,746) |
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Interest income |
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— |
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359,880 |
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— |
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816,655 |
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Change in fair value of investment in BioPharmX |
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— |
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476,245 |
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— |
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559,805 |
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Change in fair value of warrant liability |
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— |
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1,504,511 |
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— |
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1,183,460 |
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Gain on foreign currency exchange |
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1,090 |
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1,772 |
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1,003 |
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4,454 |
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Total other income (expense) |
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1,090 |
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(971,732) |
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1,003 |
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(1,852,372) |
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Net loss |
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(2,966,203) |
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(15,245,609) |
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(4,840,463) |
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(18,764,209) |
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Accrued dividend on preferred stock units |
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— |
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(18,188) |
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— |
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(52,669) |
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Cumulative dividends on Series A preferred stock |
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(36,286) |
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(17,146) |
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(72,173) |
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(17,146) |
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Net loss attributable to common stockholders |
|
$ |
(3,002,489) |
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$ |
(15,280,943) |
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$ |
(4,912,636) |
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$ |
(18,834,024) |
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Basic and diluted net loss per share attributable to common stockholders |
|
$ |
(0.08) |
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$ |
(1.36) |
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$ |
(0.14) |
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$ |
(2.15) |
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Basic and diluted weighted average number of shares outstanding |
|
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36,659,685 |
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11,222,258 |
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|
35,873,780 |
|
|
8,758,991 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Members’ and Stockholders’ Equity (Deficit)
(Unaudited)
For the Three Months Ended June 30, 2021
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Total |
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Series A Preferred Stock |
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Common Stock |
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Additional |
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Accumulated |
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Stockholders' |
|||||||||
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Shares |
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Amount |
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Shares |
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Amount |
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Paid-in Capital |
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Deficit |
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Equity |
|||||
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Balance at April 1, 2021 |
|
1,819 |
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$ |
1,945,692 |
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36,659,685 |
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$ |
36,660 |
|
$ |
25,839,395 |
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$ |
(20,119,656) |
|
$ |
5,756,399 |
|
Accrued dividend Series A preferred stock |
|
— |
|
|
36,286 |
|
— |
|
|
— |
|
|
(36,286) |
|
|
— |
|
|
(36,286) |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
49,433 |
|
|
— |
|
|
49,433 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(2,966,203) |
|
|
(2,966,203) |
|
Balance at June 30, 2021 |
|
1,819 |
|
$ |
1,981,978 |
|
36,659,685 |
|
$ |
36,660 |
|
$ |
25,852,542 |
|
$ |
(23,085,859) |
|
$ |
2,803,343 |
For the Three Months Ended June 30, 2020
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Total Members' |
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Series A Preferred Stock |
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Preferred Units |
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Common Units |
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Common Stock |
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Additional |
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Accumulated |
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and Stockholders' |
|||||||||||||||
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Shares |
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Amount |
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Units |
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Amount |
|
Units |
|
Amount |
|
Shares |
|
Amount |
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Paid-in Capital |
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Deficit |
|
Deficit |
|||||||
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Balance at April 1, 2020 |
|
— |
|
$ |
— |
|
1,801,101 |
|
$ |
1,801,101 |
|
10,000 |
|
$ |
92,884 |
|
— |
|
$ |
— |
|
$ |
— |
|
$ |
(6,628,194) |
|
$ |
(4,734,209) |
|
Issuance of common stock for acquisition of BioPharmX |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
1,367,326 |
|
|
1,367 |
|
|
8,366,665 |
|
|
— |
|
|
8,368,032 |
|
Issuance of common stock and warrants, net of costs |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
4,180,208 |
|
|
4,180 |
|
|
17,495,820 |
|
|
— |
|
|
17,500,000 |
|
Series A liability classified warrants |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
(16,511,634) |
|
|
— |
|
|
(16,511,634) |
|
Bridge loan converted to equity |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
5,000,000 |
|
|
— |
|
|
5,000,000 |
|
Reclassification of bridge warrant |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
3,423,204 |
|
|
— |
|
|
3,423,204 |
|
Accrued preferred unit dividend |
|
— |
|
|
— |
|
18,188 |
|
|
18,188 |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(18,188) |
|
|
— |
|
Conversion of common units to common stock pursuant to BioPharmX acquisition |
|
— |
|
|
— |
|
— |
|
|
— |
|
(10,000) |
|
|
(92,884) |
|
6,295,724 |
|
|
6,296 |
|
|
86,588 |
|
|
— |
|
|
— |
|
Conversion of preferred units to Series A preferred stock pursuant to BioPharmX acquisition |
|
1,819 |
|
|
1,819,289 |
|
(1,819,289) |
|
|
(1,819,289) |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,819,289) |
|
Accrued dividend Series A preferred stock |
|
— |
|
|
17,146 |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(17,146) |
|
|
(17,146) |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
43,445 |
|
|
— |
|
|
43,445 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(15,245,609) |
|
|
(15,245,609) |
|
Balance at June 30, 2020 |
|
1,819 |
|
$ |
1,836,435 |
|
— |
|
$ |
— |
|
— |
|
$ |
— |
|
11,843,258 |
|
$ |
11,843 |
|
$ |
17,904,088 |
|
$ |
(21,909,137) |
|
$ |
(3,993,206) |
5
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Members’ and Stockholders’ Equity
(Unaudited)
For the Six Months Ended June 30, 2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
Series A Preferred Stock |
|
Common Stock |
|
Additional |
|
Accumulated |
|
Stockholders' |
|||||||||
|
|
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
Paid-in Capital |
|
Deficit |
|
Equity |
|||||
|
Balance at January 1, 2021 |
|
1,819 |
|
$ |
1,909,805 |
|
27,132,420 |
|
$ |
27,132 |
|
$ |
25,826,295 |
|
$ |
(18,245,396) |
|
$ |
7,608,031 |
|
Accrued dividend Series A preferred stock |
|
— |
|
|
72,173 |
|
— |
|
|
— |
|
|
(72,173) |
|
|
— |
|
|
(72,173) |
|
Exercise of Series A warrants |
|
— |
|
|
— |
|
2,059,613 |
|
|
2,060 |
|
|
(2,060) |
|
|
— |
|
|
— |
|
Exercise of Series B warrants |
|
— |
|
|
— |
|
7,467,652 |
|
|
7,468 |
|
|
(7,468) |
|
|
— |
|
|
— |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
107,948 |
|
|
— |
|
|
107,948 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(4,840,463) |
|
|
(4,840,463) |
|
Balance at June 30, 2021 |
|
1,819 |
|
$ |
1,981,978 |
|
36,659,685 |
|
$ |
36,660 |
|
$ |
25,852,542 |
|
$ |
(23,085,859) |
|
$ |
2,803,343 |
6
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Members’ and Stockholders’ Deficit
(Unaudited)
For the Six Months Ended June 30, 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Members' |
|
|
|
|
Series A Preferred Stock |
|
Preferred Units |
|
Common Units |
|
Common Stock |
|
Additional |
|
Accumulated |
|
and Stockholder's |
|||||||||||||||
|
|
|
Shares |
|
Amount |
|
Units |
|
Amount |
|
Units |
|
Amount |
|
Shares |
|
Amount |
|
Paid-in Capital |
|
Deficit |
|
Deficit |
|||||||
|
Balance at January 1, 2020 |
|
— |
|
$ |
— |
|
1,624,228 |
|
$ |
1,624,228 |
|
10,000 |
|
$ |
74,667 |
|
— |
|
$ |
— |
|
$ |
— |
|
$ |
(3,075,113) |
|
$ |
(1,376,218) |
|
Issuance of common stock for acquisition of BioPharmX |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
1,367,326 |
|
|
1,367 |
|
|
8,366,665 |
|
|
— |
|
|
8,368,032 |
|
Issuance of common stock and warrants, net of costs |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
4,180,208 |
|
|
4,180 |
|
|
17,495,820 |
|
|
— |
|
|
17,500,000 |
|
Series A liability classified warrants |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
(16,511,634) |
|
|
— |
|
|
(16,511,634) |
|
Bridge loan converted to equity |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
5,000,000 |
|
|
— |
|
|
5,000,000 |
|
Reclassification of bridge warrant |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
3,423,204 |
|
|
— |
|
|
3,423,204 |
|
Non-cash contribution from TardiMed |
|
— |
|
|
— |
|
142,392 |
|
|
142,392 |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
142,392 |
|
Accrued preferred unit dividend |
|
— |
|
|
— |
|
52,669 |
|
|
52,669 |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(52,669) |
|
|
— |
|
Conversion of common units to common stock pursuant to BioPharmX acquisition |
|
— |
|
|
— |
|
— |
|
|
— |
|
(10,000) |
|
|
(74,667) |
|
6,295,724 |
|
|
6,296 |
|
|
68,371 |
|
|
— |
|
|
— |
|
Conversion of preferred units to Series A preferred stock pursuant to BioPharmX acquisition |
|
1,819 |
|
|
1,819,289 |
|
(1,819,289) |
|
|
(1,819,289) |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,819,289) |
|
Accrued dividend Series A preferred stock |
|
— |
|
|
17,146 |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(17,146) |
|
|
(17,146) |
|
Stock-based compensation |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
61,662 |
|
|
— |
|
|
61,662 |
|
Net loss |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
— |
|
|
— |
|
|
— |
|
|
(18,764,209) |
|
|
(18,764,209) |
|
Balance at June 30, 2020 |
|
1,819 |
|
$ |
1,836,435 |
|
— |
|
$ |
— |
|
— |
|
$ |
— |
|
11,843,258 |
|
$ |
11,843 |
|
$ |
17,904,088 |
|
$ |
(21,909,137) |
|
$ |
(3,993,206) |
|
(a) |
On May 18, 2020, an exchange ratio of approximately 629.57 shares of the Timber Pharmaceuticals, Inc. common stock, par value $0.001 per share, was used for each Timber Pharmaceuticals LLC (“Timber Sub”) unit. The exchange ratio of 0.001 was used for conversion of the preferred units of Timber Sub to the newly created convertible Series A preferred stock. All share information has been retroactively adjusted to reflect the stock split within the condensed consolidated statements of member’s and stockholders’ equity (deficit) and proceeding disclosures. |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
Timber Pharmaceuticals, Inc. & Subsidiaries
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
||||
|
|
|
2021 |
|
2020 |
||
|
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,840,463) |
|
$ |
(18,764,209) |
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Research and development-licenses acquired |
|
|
— |
|
|
12,371,332 |
|
Non-cash contribution from TardiMed |
|
|
— |
|
|
142,392 |
|
Stock-based compensation |
|
|
107,948 |
|
|
61,662 |
|
Change in fair value of warrant liability |
|
|
— |
|
|
(1,183,460) |
|
Change in fair value of investment in BioPharmX |
|
|
— |
|
|
(559,805) |
|
Amortization of loan discount |
|
|
— |
|
|
(775,000) |
|
Amortization of debt discount |
|
|
— |
|
|
4,232,718 |
|
Amortization of right of use assets |
|
|
125,567 |
|
|
16,140 |
|
Depreciation |
|
|
175 |
|
|
— |
|
Accrued interest on BioPharmX loan |
|
|
— |
|
|
(41,655) |
|
Accrued interest on bridge notes |
|
|
— |
|
|
183,333 |
|
Changes in assets and liabilities: |
|
|
|
|
|
|
|
Other receivable |
|
|
(253,892) |
|
|
|
|
Other current assets |
|
|
(1,092) |
|
|
(211,799) |
|
Deposits |
|
|
(13,000) |
|
|
— |
|
Accounts payable |
|
|
990,803 |
|
|
(498,761) |
|
Accrued expenses |
|
|
(199,929) |
|
|
(39,210) |
|
Lease liability |
|
|
(118,872) |
|
|
(16,140) |
|
Net cash used in operating activities |
|
|
(4,202,755) |
|
|
(5,082,462) |
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
Cash acquired with acquisition of BioPharmX |
|
|
— |
|
|
340,786 |
|
Loan to BioPharmX |
|
|
— |
|
|
(2,250,000) |
|
Purchase of property and equipment |
|
|
(16,903) |
|
|
— |
|
Purchase of research and development licenses - AFT Pharmaceuticals Limited |
|
|
— |
|
|
(750,000) |
|
Net cash used in investing activities |
|
|
(16,903) |
|
|
(2,659,214) |
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
Proceeds from PPP loan |
|
|
— |
|
|
37,772 |
|
Proceeds from the issuance of common stock and warrants, net of issuance costs |
|
|
— |
|
|
17,500,000 |
|
Proceeds from bridge notes payable |
|
|
— |
|
|
3,700,000 |
|
Net cash provided by financing activities |
|
|
— |
|
|
21,237,772 |
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents |
|
|
(4,219,658) |
|
|
13,496,096 |
|
Cash and cash equivalents, beginning of period |
|
|
10,348,693 |
|
|
57,073 |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
6,129,035 |
|
$ |
13,553,169 |
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
— |
|
$ |
183,333 |
|
|
|
|
|
|
|
|
|
Non cash investing and financing activities: |
|
|
|
|
|
|
|
Issuance of common stock for acquisition of BioPharmX |
|
$ |
— |
|
$ |
8,368,032 |
|
Conversion of preferred units to Series A preferred stock pursuant to BioPharmX acquisition |
|
$ |
— |
|
$ |
1,819,289 |
|
Conversion of common units to common stock pursuant to BioPharmX acquisition |
|
$ |
— |
|
$ |
6,296 |
|
Bridge loan converted to equity |
|
$ |
— |
|
$ |
5,000,000 |
|
Reclassification of bridge warrant |
|
$ |
— |
|
$ |
3,423,204 |
|
Series A liability classified warrants |
|
$ |
— |
|
$ |
16,511,634 |
|
Accrued Series A preferred stock dividend |
|
$ |
72,173 |
|
$ |
— |
|
Cashless exercise of Series A warrants |
|
$ |
2,060 |
|
$ |
— |
|
Cashless exercise of Series B warrants |
|
$ |
7,468 |
|
$ |
— |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
8
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 1. Organization and description of business operations
Timber Pharmaceuticals, Inc., formerly known as BioPharmX Corporation (together with its subsidiaries Timber Pharmaceuticals Australia Pty Ltd., BioPharmX Inc. and Timber Pharmaceuticals LLC, the “Company” or “Timber”) is incorporated under the laws of the state of Delaware. Timber was founded in 2019 to develop treatments for unmet needs in medical dermatology. Timber has a particular focus on rare diseases or conditions of the skin for which there are no current treatments. Timber is initially targeting multiple indications in rare/orphan dermatology with no approved treatments.
These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes in Item 8 of Part II, “Financial Statements and Supplementary Data,” of our Annual Report on Form 10-K for the year ended December 31, 2020.
Merger Agreement
On May 18, 2020, BioPharmX Corporation (“BioPharmX”) completed its business combination with Timber Pharmaceuticals LLC, a Delaware limited liability company (“Timber Sub”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of January 28, 2020 (the “Merger Agreement”), by and among BioPharmX, Timber Sub and BITI Merger, Inc., a Delaware corporation and wholly-owned subsidiary of the Company (“Merger Sub”), as amended by Amendment No. 1 thereto made and entered into as of March 24, 2020 (the “First Amendment”) and Amendment No. 2 thereto made and entered into as of April 27, 2020 (the “Second Amendment”) (the Merger Agreement, as amended by the First Amendment and the Second Amendment, the “Amended Merger Agreement”), pursuant to which Merger Sub merged with and into Timber Sub, with Timber Sub surviving as a wholly-owned subsidiary of the Company (the “Merger”). In connection with, and immediately prior to the completion of, the Merger, BioPharmX effected a reverse stock split of the Company’s common stock, par value $0.001 per share (the “Common Stock”), at a ratio of 1-for-12 (the “Reverse Stock Split”). Immediately after completion of the Merger, BioPharmX changed its name to “Timber Pharmaceuticals, Inc.” and the officers and directors of Timber Sub became the officers and directors of the Company.
Under the terms of the Amended Merger Agreement, BioPharmX issued shares of Common Stock to the holders of common units of Timber Sub. Immediately after the Merger, there were approximately 11,849,031 shares of Common Stock outstanding (after the Reverse Stock Split). Pursuant to the terms of the Amended Merger Agreement, the former holders of common units of Timber Sub (including the Investors, as defined below, but excluding Value Appreciation Rights of Timber Sub (“VARs”), as defined below) owned in the aggregate approximately 88.5% of the outstanding Common Stock, with the Company’s stockholders immediately prior to the Merger owning approximately 11.5% of the outstanding Common Stock. The number of shares of Common Stock issued to the holders of common units of Timber Sub for each common unit of Timber Sub outstanding immediately prior to the Merger was calculated using an exchange ratio of approximately 629.57 shares of Common Stock for each Timber Sub unit. In addition, the 584 VARs that were outstanding immediately prior to Merger became denoted and payable in 367,670 shares of Common Stock at the Effective Time of the Merger (the “Effective Time”). Further, the holder of the 1,819,289 preferred units of Timber Sub outstanding immediately prior to the Merger received 1,819 shares of the newly created convertible Series A preferred stock at the Effective Time.
Securities Purchase Agreement
On May 18, 2020, Timber and Timber Sub completed a private placement transaction (the “Pre-Merger Financing”) with the Investors pursuant to the Securities Purchase Agreement for an aggregate purchase price of approximately $25.0 million (comprised of (i) approximately $5 million credit with respect to the senior secured notes issued in connection with the bridge loan that certain of the Investors made to Timber Sub at the time of the execution of the Merger Agreement and (ii) approximately $20 million in cash from the Investors).
9
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Liquidity and Capital Resources
The Company has no product revenues, incurred operating losses since inception, and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. The Company had an accumulated deficit of approximately $23.1 million at June 30, 2021, a net loss of approximately $4.8 million, and approximately $4.2 million of net cash used in operating activities for the six months ended June 30, 2021. As of June 30, 2021 the Company had $6.1 million of cash.
Going Concern
The Company has evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about its ability to continue as a going concern within one year beyond the filing of this Quarterly Report on Form 10-Q. Based on such evaluation and the Company's current plans, which are subject to change, management believes that the Company's existing cash and cash equivalents as of June 30, 2021 are not sufficient to satisfy our operating cash needs for the year after the filing of this Quarterly Report on Form 10-Q.
The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and settlement of liabilities in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classifications of liabilities that may result from uncertainty related to its ability to continue as a going concern.
The Company’s future liquidity and capital funding requirements will depend on numerous factors, including:
| ● | its ability to raise additional funds to finance its operations, including its ability to access financing that may be unavailable due to contractual limitations under the Securities Purchase Agreement; |
| ● | the dilutive effect of the Company's outstanding securities; |
| ● | the impact of the COVID-19 pandemic on the Company's operations, including on the Company's clinical development plans and timelines; |
| ● | the outcome, costs and timing of clinical trial results for the Company’s current or future product candidates, including the timing, progress, costs and results of its Phase 2b clinical trial of TMB-001 for the treatment of congenital ichthyosis as well as its ongoing Phase 2b clinical trial of TMB-002 for the treatment of facial angiofibromas in tuberous sclerosis complex; |
| ● | the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities; |
| ● | the emergence and effect of competing or complementary products; |
| ● | its ability to maintain, expand and defend the scope of its intellectual property portfolio, including the amount and timing of any payments the Company may be required to make, or that it may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
| ● | the cost and timing of completion of commercial-scale manufacturing activities; |
10
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
| ● | the cost of establishing sales, marketing and distribution capabilities for its products in regions where it chooses to commercialize its products on its own; |
| ● | the initiation, progress, timing and results of the commercialization of its product candidates, if approved for commercial sale; |
| ● | the volatility of the price of the Company's common stock; |
| ● | acceptance of the Company's products in the Company's industry; |
| ● | the accuracy of the Company's estimates regarding expenses and capital requirements; |
| ● | its ability to retain its current employees and the need and ability to hire additional management and scientific and medical personnel; and |
| ● | the terms and timing of any collaborative, licensing or other arrangements that it has or may establish. |
The Company will need to raise substantial additional funds through one or more of the following: issuance of additional debt or equity and/or the completion of a licensing or other commercial transaction for one or more of the Company's product candidates. If the Company is unable to maintain sufficient financial resources, its business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. There can be no assurance that the Company will be able to obtain the needed financing on acceptable terms or at all. Additionally, equity or convertible debt financings will likely have a dilutive effect on the holdings of the Company's existing stockholders.
The impact of the worldwide spread of a novel strain of coronavirus (“COVID-19”) has been unprecedented and unpredictable. Site activation and patient enrollment have been impacted by the COVID-19 pandemic in the TMB-002 study, especially at our contracted test sites in Eastern Europe. As of June 30, 2021, all 17 sites are open and 50% of patients in the Phase 2b study have been enrolled for the TMB-002 program. The Company is also continuing to assess the effect of COVID-19 on the TMB-002 study as well as the Company’s overall operations by monitoring the spread of COVID-19 and the actions implemented to combat the virus throughout the world. The Company’s assessment of the impact of COVID-19 may change in the future.
Note 2. Significant accounting policies
Basis of presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10- Q and Article 8 of Regulation S-X of the SEC. In the opinion of management, the accompanying unaudited condensed financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results.
The results for the unaudited condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2021 or for any future interim period. The unaudited condensed consolidated financial statements do not include all of the information and notes required by U.S. GAAP for complete financial statements.
11
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Use of estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s unaudited condensed consolidated financial statements relate to the valuations of warrants, and equity-based awards and member units. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.
Loss Per Share
Basic net loss per share (“EPS”) of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity.
To calculate the basic EPS numerator, income available to common stockholders must be computed by deducting both the dividends declared in the period on preferred stock (whether or not paid) and the dividends accumulated for the period on cumulative preferred stock (whether or not declared) from income from continuing operations and also from net income. If there is a loss from continuing operations or a net loss, the amount of the loss shall be increased by those preferred dividends. The outstanding Series A Preferred Stock has cumulative dividends, whether or not declared.
The basic and diluted net loss amounts are the same for the three and six months ended June 30, 2021 and 2020, as a result of the net loss and anti-dilutive impact of the potentially dilutive securities. Potentially dilutive shares are determined by applying the treasury stock method to the assumed exercise of outstanding stock options, value appreciation rights, and warrants. Potentially dilutive shares issuable upon conversion of the Series A Preferred Stock are calculated using the if-converted method.
The following is a reconciliation of the numerator and denominator of the diluted net loss per share computations for the periods presented below:
12
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Securities that could potentially dilute loss per share in the future were not included in the computation of diluted loss per share for the six months ended June 30, 2021 and 2020, because their inclusion would be anti-dilutive are as follows (unaudited):
Recent accounting pronouncements
In August 2020, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2020-06, Debt-Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging-Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which simplifies accounting for convertible instruments by removing major separation models required under current GAAP. The ASU removes certain settlement conditions that are required for equity contracts to qualify for the derivative scope exception and it also simplifies the diluted earnings per share calculation in certain areas. This ASU is effective for annual reporting periods beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020. This update permits the use of either the modified retrospective or fully retrospective method of transition. The Company is currently evaluating the impact this ASU will have on its condensed consolidated financial statements and related disclosures.
Note 3. Acquisition of BioPharmX
As described in Note 1, on May 18, 2020, the Company completed its acquisition of BioPharmX in accordance with the terms of the Merger Agreement. The acquisition was accounted for as an asset acquisition/reverse merger.
Pursuant to the Merger Agreement, following the Merger, the Timber Sub members, including the investors funding the $20 million investment and the bridge investors, owned approximately 88.5% of the outstanding common stock of BioPharmX, and the BioPharmX stockholders own approximately 11.5% of the outstanding common stock as of the date of the merger. The cost of the BioPharmX acquisition, which represents the consideration transferred to BioPharmX stockholders in the BioPharmX acquisition, of $12.4 million consists of the following:
13
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
The total cost of the BioPharmX acquisition was allocated to the net liabilities acquired as follows:
Note 4. Purchases of Assets
Acquisition of Intellectual Property Rights from Patagonia Pharmaceuticals LLC (“Patagonia”)
On February 28, 2019, the Company acquired the intellectual property rights to a topical formulation of isotretinoin for the treatment of congenital ichthyosis and identified as TMB-001, formerly PAT-001, from Patagonia (the “TMB-001 Acquisition”).
Upon closing of the TMB-001 Acquisition, the Company paid a one-time upfront payment of $50,000 to Patagonia. Patagonia is entitled to up to $27.0 million of cash milestone payments relating to certain regulatory and commercial achievements of TMB-001, with the first being $4.0 million for the initiation of a Phase 3 pivotal trial, as agreed with the FDA. In addition, Patagonia is entitled to net sales earn-out payments ranging from low single digits to mid-double digits. The Company is responsible for all development activities. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at June 30, 2021 and December 31, 2020.
On June 26, 2019 the Company acquired the intellectual property rights to a locally administered formulation of Sitaxsentan for the treatment of cutaneous fibrosis and/or pigmentation disorders, and identified as TMB-003, formerly PAT-S03, from Patagonia (the “TMB-003 Acquisition”).
Upon closing of the TMB-003 Acquisition, the Company paid a one-time upfront payment of $20,000 to Patagonia. Patagonia is entitled to up to $10.25 million of cash milestone payments relating to certain regulatory and commercial achievements of TMB-003, with the first being a one-time payment of $250,000 upon the opening of an IND with the FDA. In addition, Patagonia is entitled to net sales earn-out payments ranging from low to mid-single digits. The Company is responsible for all development activities. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at June 30, 2021 and December 31, 2020.
On January 12, 2021, the Company announced that the U.S. Food and Drug Administration has granted orphan drug designation to TMB-003.
Acquisition of License from AFT Pharmaceuticals Limited (“AFT”)
On July 5, 2019, the Company and AFT entered into a license agreement which provides the Company with (i) an exclusive license to certain licensed patents, licensed know-how and AFT trademarks to commercialize the Pascomer product in the United States, Canada and Mexico and (2) a co-exclusive license to develop the Pascomer product in this territory.
14
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Concurrently, the Company granted to AFT an exclusive license to commercialize the Pascomer product outside of the Company’s territory and co-exclusive sublicense to develop and manufacture the licensed product for commercialization outside of the Company’s territory (the “AFT License Agreement”).
The development of the Pascomer product is being conducted pursuant to a written development plan, written by AFT and approved by the joint steering committee, which is reviewed on at least an annual basis. AFT shall perform clinical trials of the Pascomer product in the specified territory and shall perform all CMC (chemistry, manufacturing and controls) and related activities to support regulatory approval. The Company is responsible for all expenses incurred by AFT during the term of the AFT License Agreement and shall equally share all costs and expenses with AFT, incurred by AFT for development and marketing work performed in furtherance of regulatory approval and commercialization worldwide, outside of the specified territory. The Company is entitled to receive a significant percentage of the economics (royalties and milestones) in any licensing transaction that AFT executes outside of North America, Australia, New Zealand, and Southeast Asia. In March 2021 the Company announced that its development partner, AFT Pharmaceuticals Limited has signed an exclusive license and supply agreement with Desitin Arzneimittel GmbH (“Desitin”) for Pascomer® (TMB-002 topical rapamycin) for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in Europe. The Company is entitled to €213,750 related to an upfront milestone payment paid to AFT by Desitin during the quarter ending June 30, 2021 and has recorded approximately $0.3 million in these financial statements.
Pursuant to the AFT License Agreement, the Company was obligated to reimburse AFT for previously spent development costs, subject to certain limitations, and to pay a one-time, irrevocable and non-creditable upfront payment to AFT, payable in scheduled installments. The Company paid $0.25 million in October 2019 and the remaining $0.75 million was paid during the year ended December 31, 2020.
AFT is entitled to up to $25.5 million of cash milestone payments relating to certain regulatory and commercial achievements of the AFT License. In addition, AFT is entitled to net sales royalties ranging from high single digits to low double digits for the program licensed. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at June 30, 2021 and December 31, 2020.
Note 5. Accrued Expenses
As of June 30, 2021 and December 31, 2020, the Company’s accrued expenses consisted of the following:
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|
June 30, |
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December 31, |
||
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|
|
2021 |
|
2020 |
||
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Research and development |
|
$ |
45,443 |
|
$ |
158,911 |
|
Professional fees |
|
|
181,234 |
|
|
142,599 |
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Personnel expenses |
|
|
342,055 |
|
|
438,722 |
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Other |
|
|
— |
|
|
28,429 |
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Total |
|
$ |
568,732 |
|
$ |
768,661 |
15
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 6. Temporary Equity, and Members’ and Stockholder’s Equity (Deficit)
The Company entered into a Merger Agreement with BioPharmX and effective May 18, 2020, the Company converted its common and preferred units into shares of common and preferred stock.
Common Stock
On May 18, 2020, pursuant to the Merger Agreement (see Note 1), 1,367,326 shares of common stock were issued for the acquisition of BioPharmX, with a fair value of approximately $8.4 million or $6.12 per share.
On May 18, 2020, pursuant to the Merger Agreement, 4,185,981 shares of common stock were issued to the investors in the $20 million private placement financing (see Note 1), with aggregate net proceeds received totaling $17.5 million) and to settle the $5 million Bridge Notes.
Series B Warrants
During the six months ended June 30, 2021, the remaining Series B Warrants outstanding totaling 7,474,033 were exercised on a cashless basis, and the Company issued 7,467,652 shares of its common stock.
Series A Warrants
During the six months ended June 30, 2021, 3,476,390 Series A Warrants were exercised on a cashless basis, and the Company issued 2,059,613 shares of its common stock. The following is a summary of Series A Warrants outstanding as of June 30, 2021:
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Weighted |
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Average |
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Shares |
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Weighted |
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Remaining |
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Aggregate |
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Underlying |
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Average |
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Contractual |
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Intrinsic |
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Options |
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Exercise Price |
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Term (Years) |
|
Value |
||
|
Outstanding as of December 31, 2020 |
|
20,178,214 |
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$ |
1.16 |
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4.4 |
|
$ |
— |
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Exercised |
|
(3,476,390) |
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$ |
1.16 |
|
— |
|
|
— |
|
Outstanding and exercisable as of June 30, 2021 |
|
16,701,824 |
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$ |
1.16 |
|
3.9 |
|
$ |
1,002,109 |
16
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Bridge Warrants
The following table summarizes the Company's Bridge Warrants for the six months ended June 30, 2021:
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Weighted |
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Average |
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Shares |
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Weighted |
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Remaining |
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Aggregate |
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Underlying |
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Average |
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Contractual |
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Intrinsic |
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Options |
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Exercise Price |
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Term (Years) |
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Value |
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|
Outstanding as of December 31, 2020 |
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413,751 |
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$ |
2.24 |
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4.4 |
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$ |
— |
|
Outstanding and exercisable as of June 30, 2021 |
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413,751 |
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$ |
2.24 |
|
3.9 |
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$ |
— |
Redeemable Series A Convertible Preferred Stock
In connection with the Merger, on May 18, 2020, the Company filed a Certificate of Designation of Preferences, Rights and Limitations (the “Certificate of Designations”) with the Secretary of State of the State of Delaware designating 2,500 shares of the Company’s previously undesignated preferred stock as Series A Preferred (the “Series A Preferred Stock”), and issued to the holder of 1,819,289 preferred units of Timber Sub outstanding immediately prior to the Merger, 1,819 shares of the newly created Series A Preferred Stock. The shares of Series A Preferred Stock have no voting rights. The holders of the Series A Preferred Stock are entitled to cumulative dividends from and after the date of issuance at a per annum of eight percent (8.00%) of the stated value. Dividends will be payable as and if declared by the Board of Directors of the Company (the “Board”) out of amounts legally available therefore or upon a liquidation or redemption. Each share of Series A Preferred Stock is convertible at any time at the holder’s option into a number of shares of common stock (subject to adjustment for reverse and forward stock splits, stock dividends, stock combinations and other similar transactions as specified in the Certificate of Designations) at a conversion price equal to the stated value of the Series A Preferred Stock of $1,000 (plus any accrued dividends) divided by the conversion price of $18.054. Holders of the Series A Preferred Stock are entitled to a liquidation preference in the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company. In addition, upon a Change of Control, the Series A Preferred Stock is redeemable for cash at the option of the holders, in whole or in part.
As a Change of Control has occurred, the Company’s Series A Preferred Stock is currently redeemable at June 30, 2021 at the option of the holder and has been recorded at the redemption value of $2.0 million. Redemption is subject to certain limitations under Delaware law, so that the Company’s ability to pay the redemption price to such holder is limited. The following table summarizes the Company’s Series A preferred stock for the six months ended June 30, 2021:
17
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 7. Equity-based compensation
On May 18, 2020, the Company’s 2020 Omnibus Equity Incentive Plan (the “2020 Plan”) became effective, and the 2020 Plan reserved a total of 970,833 shares of common stock for issuance. The 2020 Plan provides for options to purchase shares of common stock, stock appreciation rights, restricted stock units, restricted or unrestricted shares of common stock, performance shares, performance units, incentive bonus awards, other stock-based awards and other cash-based awards. Options granted generally vest over a period of three years and have a maximum term of ten years from the date of grant. As of June 30, 2021, 2,056,130 shares of common stock were reserved for issuance under the 2020 Plan. On April 20, 2021, the Board of Directors of the Company approved an amendment increasing the number of shares available for issuance under the 2020 Plan from 2,056,130 to 4,668,319, which was approved by the Company's stockholders on July 1, 2021.
Furthermore, as a result of the Merger, the Company assumed the TardiMed 2019 Equity Incentive Plan (the “2019 Plan”) from Timber Sub. The 2019 Plan permits the granting of incentive units (the “Incentive Units”). The maximum aggregate Incentive Units that may be subject to awards and issued under the Plan is 699,454. At June 30, 2021 and December 31, 2020, Incentive Units outstanding under the 2019 Plan were 367,670 units for each period comprised of VARs.
During the three and six months ended June 30, 2021 and 2020 equity-based compensation expenses were as follows (unaudited):
Value Appreciation Rights
In 2019 the Company granted equity-based awards similar to stock options under the 2019 Plan as VARs. The VARs have an exercise price, a vesting period and an expiration date, in addition to other terms similar to typical equity option grant terms.
During the period ended June 30, 2021 there were no grants or forfeitures of VARs. The following is a summary of VARs outstanding as of June 30, 2021:
As of June 30, 2021, the unrecognized compensation costs were approximately $0.1 million, which will be recognized over an estimated weighted-average amortization period of 0.8 years.
18
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Stock Options
During the period ended June 30, 2021 there were no grants or forfeitures of stock options. The following is a summary of the options outstanding as of June 30, 2021:
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Weighted |
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Average |
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Shares |
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Weighted |
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Remaining |
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Aggregate |
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Underlying |
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Average |
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Contractual |
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Intrinsic |
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Options |
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Exercise Price |
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Term (Years) |
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Value |
||
|
Outstanding as of December 31, 2020 |
|
184,456 |
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$ |
2.87 |
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9.4 |
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$ |
— |
|
Outstanding as of June 30, 2021 |
|
184,456 |
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$ |
2.87 |
|
8.9 |
|
$ |
— |
|
Exercisable at June 30, 2021 |
|
57,240 |
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$ |
2.87 |
|
8.9 |
|
$ |
— |
In accordance with the "evergreen" provision in the 2020 Plan, an additional 1,085,297 shares of common stock were automatically made available for issuance on the first day of 2021, which represents 4% of the number of shares of common stock outstanding on December 31, 2020.
As part of the Merger, the Company assumed the following legacy stock options and warrants:
The fair value of stock option grants is estimated on the date of grant using the Black-Scholes option-pricing model. The Company was historically a private company and lacked company-specific historical and implied volatility information. Therefore, it estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies. Additionally, due to an insufficient history with respect to stock option activity and post-vesting cancellations, the expected term assumption for employee grants is based on a permitted simplified method, which is based on the vesting period and contractual term for each tranche of awards. The mid-point between the weighted-average vesting term and the expiration date is used as the expected term under this method. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect for time periods approximately equal to the expected term of the award. Expected dividend yield is zero based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future.
As of June 30, 2021, the unrecognized compensation costs related to stock options were approximately $0.1 million, which will be recognized over an estimated weighted-average amortization period of 0.7 years.
19
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Note 8. Commitments and contingencies
Leases
On March 10, 2021, the Company entered into a lease agreement with SIG 110 LLC with respect to a 3,127 square foot office space at 110 Allen Road, Suite 401, Basking Ridge, New Jersey. Pursuant to the terms of the lease agreement, the initial term is for twenty-four (24) months expiring on March 10, 2023. The initial base rent is $4,690.50 per month for the first twelve (12) months and $6,514.58 for the remaining twelve (12) months. During the six months ended June 30, 2021, in connection with the lease, the Company paid a security deposit of $13,000, which is included in deposits on the accompanying condensed consolidated balance sheet as of June 30, 2021.
In connection with the Merger of BioPharmX, the Company acquired a lease and corresponding sublease for the BioPharmX facility in San Jose, California. The sublease is to be used for general office and research laboratory purposes, has an effective date of February 1, 2020, and has a lease term of 4 years which expires on December 30, 2023. The lease expense is significantly reduced by the payments received in connection with the sublease.
The components of lease expense were as follows:
Other information:
As of June 30, 2021, future minimum payments for the lease are as follows:
20
Timber Pharmaceuticals, Inc. & Subsidiaries
Notes to Condensed Consolidated Financial Statements
(Unaudited)
Litigation
From time to time, the Company is involved in routine litigation that arises in the ordinary course of business. There are no pending significant legal proceedings to which the Company is a party, for which management believes the ultimate outcome would have a material adverse effect on the Company’s financial position.
Note 9. Related party transactions
Patagonia
Patagonia is a private, family-owned company founded in 2013 to address the medical needs of people with rare and serious dermatological conditions. On February 28, 2019 and June 26, 2019, the Company acquired the TMB-001 and TMB-003 licenses from Patagonia (see Note 3 for the payment terms and more details), respectively. The Chief Operating Officer, Executive Vice-President and Secretary of the Company is also the President of Patagonia. On February 27, 2019, the Company issued 1,000 founder common units to Patagonia for $10. As of December 31, 2019, Patagonia held 1,000 common units which represented 10% of the total voting units outstanding. During the year ended December 31, 2020, the 1,000 common units were converted to 629,572 shares of the Company's common stock in connection with its merger with BioPharmX (See Note 1). As of June 30, 2021 and December 31, 2020, Patagonia owns 45 shares of the Company's common stock.
TardiMed
The former Chairman of the Board of the Company is a Managing Member of TardiMed. The Chief Operating Officer, Executive Vice President and Secretary and the Chief Financial Officer, Treasurer and Executive Vice President of the Company are partners of TardiMed. As of June 30, 2021, TardiMed holds 4,609,067 shares of common stock, which represents 12.5% of the total voting shares outstanding. During the year ended December 31, 2020, TardiMed contributed an additional $0.1 million in exchange for 142,392 preferred units. In connection with the Merger Agreement, these preferred units and dividends have converted into 1,819 shares of Series A preferred stock. The Company reimbursed TardiMed $63,936 and $319,790 for management fees and reimbursed expenses for the six month period ended June 30, 2021 and 2020, respectively.
Note 10. Subsequent Events
On July 1, 2021, the Company issued 587,023 grants of options at an exercise price of $1.18 to an employee and non-employee directors. For the non-employee directors, each stock option award vests and becomes exercisable in equal monthly installments over one year from the vesting commencement date, subject to such non-employee director’s continued service on the Board. Each of the non-employee director awards have 10 year terms from the date of grant, subject to termination three years following the date such director ceases to be one of our directors or consultants. For Dr. Mendelsohn, 25% of his stock option award will vest one year from the date of grant and the remainder become exercisable in equal monthly installments over 36 months following the anniversary of the date of grant. Dr. Mendelsohn’s award has a 10 year term from the date of grant.
21
Item 2. Financial Information.
Management’s Discussion and Analysis of the Results of Operations
The following discussion and analysis of our financial condition and results of operations should be read together with our financial statements and the related notes and the other financial information included elsewhere in this Quarterly Report. This discussion contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those discussed below and elsewhere in this Quarterly Report, particularly those under “Risk Factors.” Additionally, many of these risks and uncertainties are currently elevated by and may or will continue to be elevated by the COVID-19 pandemic. We undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.
There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:
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· |
our lack of operating history and history of operating losses; |
|
· |
our current and future capital requirements and our ability to satisfy our capital needs, including our ability to access financing that may be unavailable due to contractual limitations under the Securities Purchase Agreement (as defined below); |
|
· |
the dilutive effect of our outstanding convertible securities; |
|
· |
our ability to successfully complete required clinical trials of our products and obtain approval from the U.S. Food and Drug Administration (“FDA”) or other regulatory agents in different jurisdictions; |
|
· |
the impact of the recent COVID-19 pandemic on our operations, including on our clinical development plans and timelines; |
|
· |
the outcome, costs and timing of clinical trial results for the Company’s current or future product candidates; |
|
· |
our ability to maintain or protect the validity of our patents and other intellectual property; |
|
· |
the volatility of the price of our common stock; |
|
· |
our ability to retain key executives; |
|
· |
our ability to internally develop new inventions and intellectual property; |
22
|
· |
interpretations of current laws and future laws; |
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· |
acceptance of our products in our industry; |
|
· |
the accuracy of our estimates regarding expenses and capital requirements; and |
|
· |
our ability to adequately support growth. |
Overview
Timber Pharmaceuticals, Inc. (“Timber”, the “Company”, “we”, “us”) is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases. Our investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. We are 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. Our lead programs are TMB-001, TMB-002 and TMB-003.
TMB-001
TMB-001, a patented topical formulation of isotretinoin, is currently being evaluated in a Phase 2b clinical trial for the treatment of moderate to severe subtypes of congenital ichthyosis (“CI”), a group of rare genetic keratinization disorders that lead to dry, thickened, and scaling skin. A prior Phase 1/2 study involving 19 patients with CI demonstrated safety and a signal of preliminary efficacy of TMB-001, as well as minimal systemic absorption. In 2018, the FDA awarded us the first tranche of a $1.5 million grant in the amount of $500,000 to support clinical trials evaluating TMB-001 through its Orphan Products Grant program. In March 2020 and March 2021, the FDA awarded us the second and third tranches of the grant, respectively, each in the amount of $500,000.
On July 1, 2020, we announced that all 11 sites across the United States and Australia in the Phase 2b CONTROL study evaluating TMB-001 in patients with moderate to severe CI were enrolling patients. As of December 31, 2020, all sites participating in a Phase 2b clinical trial evaluating TMB-001 were opened and enrolling patients. On May 31, 2021, we completed patient enrollment in the Phase 2b clinical trial with 34 patients randomized. We continue to anticipate topline data readout at the end of the third quarter for the Phase IIb TMB-001 trial.
On December 15, 2020, we announced that we had received a notice of allowance from the USPTO for a Company patent application covering TMB-001 (U.S. Patent Application No.: 15/772,456) and the application subsequently issued on February 10, 2021 as US 10,933,018.
On April 28, 2021, we announced that the Japanese Patent Office had decided to grant a patent (No. 2018542677) for TMB-001.
On May 18, 2021, we received notice that the Australian Patent Office had decided to grant a patent (No. 2016346203) for TMB-001.
TMB-002
TMB-002, a proprietary topical formulation of rapamycin, is currently being evaluated in a Phase 2b clinical trial for the treatment of FAs in TSC, a multisystem genetic disorder resulting in the growth of hamartomas in multiple organs. TSC results from dysregulation in the mTOR pathway, and as a topical mTOR inhibitor, TMB-002 may address FAs in TSC without the systemic absorption of an oral agent.
As of April 30, 2021, all sites participating in a Phase 2b clinical trial evaluating TMB-002 were opened and are currently enrolling patients. Site activation and patient enrollment and data collection have been impacted by the COVID-19 pandemic in the larger and longer TMB-002 study, especially at our contracted test sites in Eastern Europe. As of June 30, 2021, all 17 sites are open and 50% of patients in the Phase 2b study have been enrolled for the TMB-002 program. We
23
expect recruitment to be completed by the end of Q3 2021 and anticipate topline data readout in mid-2022. The Company is also continuing to assess the effect of COVID-19 on the TMB-002 study as well as the Company’s overall operations by monitoring the spread of COVID-19 and the actions implemented to combat the virus throughout the world. The Company’s assessment of the impact of COVID-19 may change in the future.
On March 17, 2021, we announced that AFT Pharmaceuticals Limited (“AFT”), one of our development partners, entered into a license and supply agreement with Desitin Arzneimittel GmbH (“Desitin”) for Pascomer® (TMB-002 topical rapamycin) for the treatment of FAs associated with TSC in Europe. Pursuant to the AFT Licensing and Development Agreement, we are entitled to receive a significant percentage of the economics (royalties and milestones) in any licensing transaction that AFT executes outside of North America, Australia, New Zealand, and Southeast Asia. The current transaction with Desitin is included in the scope of this provision and as such in Q2 the Company has recorded a €213,750 receivable related to an upfront milestone payment paid to AFT by Desitin during the quarter ending June 30, 2021 and has recorded approximately $0.3 million in these financial statements..
TMB-003
The product in its earliest stage in our pipeline is TMB-003, a proprietary formulation of Sitaxsentan, a new chemical entity in the U.S., which is a selective endothelin-A receptor antagonist. It is currently in preclinical development as a locally applied formulation for the treatment of fibrotic and sclerotic skin disorders, such as scleroderma, a rare connective tissue disorder characterized by abnormal thickening of the skin.
On January 12, 2021, we announced that the FDA has granted orphan drug designation for TMB-003, our locally delivered formulation of Sitaxsentan, for the treatment of systemic sclerosis. We are planning to pursue additional orphan drug designations in other indications.
BPX-01 and BPX-04
Pursuant to the Merger Agreement, BPX-01 (Topical Minocycline, 2%) and BPX-04 (Topical Minocycline, 1%) were added to our portfolio. BPX-01 and BPX-04 are assets currently in development for acne vulgaris and papulopustular rosacea, respectively. On July 22, 2020, we announced that we had received notice from the European Patent Office that it intends to grant a patent for the Company’s topical composition of pharmaceutical tetracycline (including minocycline) for dermatological use (European Patent Application No. 16714168.8) and the application subsequently issued on December 16, 2020 as EP 3273940. Patents covering the BPX-01 and BPX-04 assets have previously been granted in the United States, Japan, South Africa, and Australia. We are currently evaluating our strategic options regarding these assets.
On September 15, 2020, we announced that we had received a notice of allowance from the U.S. Patent and Trademark Office (USPTO) for a Company patent application covering BPX-01 and BPX-04, our pharmaceutical tetracycline (including minocycline) compositions for dermatological use (U.S. Patent Application No.: 16/514,459) and the application subsequently issued on January 5, 2021 as US 10,881,672.
The Merger, Reverse Stock Split and Name Change
On May 18, 2020, we completed our business combination with Timber Pharmaceuticals, LLC (
“Timber Sub”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of January 28, 2020, as amended, by and among Timber, Timber Sub and BITI Merger Sub Inc., a wholly-owned subsidiary of Timber (“Merger Sub”) (as amended, the “Merger Agreement”), pursuant to which Merger Sub merged with and into Timber Sub, with Timber Sub surviving as a wholly owned subsidiary of Timber (the “Merger”).
In connection with, and immediately prior to the completion of, the Merger, we effected a reverse stock split of our common stock, at a ratio of 1-for-12 (the “Reverse Stock Split”). Under the terms of the Merger Agreement, after taking into account the Reverse Stock Split, we issued shares of common stock to Timber Sub’s unitholders at an exchange rate of 629.57 shares of common stock for each Timber Sub common unit outstanding immediately prior to the Merger. In
24
connection with the Merger, we changed our name from “BioPharmX Corporation” to “Timber Pharmaceuticals, Inc.,” and the business conducted by the Company became the business conducted by Timber Sub.
Private Placement of Common Stock and Warrants
On May 18, 2020, Timber and Timber Sub completed a private placement transaction (the “Pre-Merger Financing”) with the Investors pursuant to the Securities Purchase Agreement, dated March 27, 2020 (as amended, the “Securities Purchase Agreement”) for an aggregate purchase price of approximately $25.0 million (comprised of (i) approximately $5 million credit with respect to the senior secured notes issued in connection with the bridge loan that certain of the Investors made to Timber Sub at the time of the execution of the Merger Agreement and (ii) approximately $20 million in cash from the Investors).
Pursuant to the Pre-Merger Financing, (i) Timber Sub issued and sold to the Investors common units of Timber Sub which converted pursuant to the exchange ratio in the Merger into an aggregate of approximately 4,137,509 shares (the “Converted Shares”) of common stock; and (ii) the Company agreed to issue to each Investor, on the tenth trading day following the consummation of the Merger, (A) Series A Warrants representing the right to acquire shares of common stock equal to 75% of the sum of (a) the number of Converted Shares issued to the Investor, without giving effect to any limitation on delivery contained in the Securities Purchase Agreement, and (b) the number of shares of common stock underlying the Series B Warrants issued to the Investor (the “Series B Warrants”) and (B) the Series B Warrants. On June 2, 2020, pursuant to the terms of the Securities Purchase Agreement, the Company issued the Series A Warrants and the Series B Warrants.
In addition, pursuant to the terms of the Securities Purchase Agreement, dated as of January 28, 2020 between Timber Sub and several of the Investors, the Company issued to such purchasers, on May 22, 2020, warrants to purchase 413,751 shares of our common stock (the “Bridge Warrants”) which have an exercise price of $2.2362 per share, subject to full ratchet anti-dilution and adjustment if shares are sold for a price less than the exercise price of the warrants.
Pursuant to the Waiver Agreements we entered into with the Selling Stockholders on November 19, 2020, (A) the exercise price of the Series A Warrants was definitively set at $1.16 per share, (B) the number of shares underlying all of the Series A Warrants was definitively set at 20,178,214 and (C) the number of shares underlying all of the Series B Warrants was definitively set at 22,766,776. As of March 4, 2021, all Series B Warrants had been exercised in full.
Corporate History
We have a limited operating history as the Company was formed on February 26, 2019. Since inception, Timber’s operations have focused on establishing its intellectual property portfolio, including acquiring rights to the proprietary formulations of isotretinoin, rapamycin and Sitaxsentan, as described above, organizing and staffing the Company, business planning, raising capital, and conducting clinical trials. Since inception, we have financed our operations with net proceeds totaling a net of $18.9 million through capital contributions.
Since inception, we have incurred significant operating losses. For the six months ended June 30, 2021, our net loss was $4.8 million. As of June 30, 2021, we had an accumulated deficit of $23.1 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we continue to develop the pipeline of programs.
Asset Purchase Agreements with Patagonia Pharmaceuticals LLC (“Patagonia”)
On February 28, 2019, we acquired the intellectual property rights for a topical formulation of isotretinoin for the treatment of CI and identified as TMB-001, formerly PAT-001 including the IPEGTM brand, from Patagonia (the “TMB-001 Acquisition”).
Under the terms of the TMB-001 Acquisition, we paid a one-time upfront payment of $50,000 to Patagonia. Patagonia is entitled to up to $27.0 million of cash milestone payments relating to certain regulatory and commercial achievements of the TMB-001 Acquisition, with the first being $4.0 million from the initiation of a Phase 3 pivotal trial, as agreed with the
25
FDA. In addition, Patagonia is entitled to net sales earn-out payments ranging from low single digits to mid-double digits for the program licensed. We are responsible for all development activities under the license. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at June 30, 2021 and December 31, 2020.
On June 26, 2019, we acquired the intellectual property rights for a locally administered formulation of Sitaxsentan for the treatment of cutaneous fibrosis and/or pigmentation disorders, and identified as TMB-003, formerly PAT-S03, from Patagonia (the “TMB-003 Acquisition”).
Upon closing of the TMB-003 Acquisition, we paid a one-time upfront payment of $20,000 to Patagonia. Patagonia is entitled to up to $10.25 million of cash milestone payments subject to adjustments relating to certain regulatory and commercial achievements of the TMB-003 License, with the first being a one-time payment of $250,000 upon the opening of an IND with the FDA. In addition, Patagonia is entitled to net sales earn-out payments ranging from low to mid-single digits for the program licensed. We are responsible for all development activities under the license. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at June 30, 2021 and December 31, 2020.
Acquisition of License from AFT Pharmaceuticals Limited
On July 5, 2019, we entered into a license agreement with AFT which provides us with (i) an exclusive license to certain licensed patents, licensed know-how and AFT trademarks to commercialize the Pascomer® product in the United States, Canada and Mexico and (2) a co-exclusive license to develop the Pascomer product in this territory. Concurrently, we granted to AFT an exclusive license to commercialize the Pascomer product outside of its territory and co-exclusive sublicense to develop and manufacture the licensed product for commercialization outside of its territory (the “AFT License Agreement”).
The AFT License Agreement also provides for the formation of a joint steering committee to oversee, coordinate and review recommendations and approve decisions in respect of the matters related to the development and commercialization of the Pascomer product, in which both the Company and AFT have the right to appoint two members. The committee is currently comprised of three members. We have final decision-making authority on all matters relating to the commercialization of the Pascomer product in the specified territory and on all matters related to the development (and regulatory approval) of the Pascomer product, with certain exceptions.
The development of the Pascomer product is being conducted pursuant to a written development plan, written by AFT and approved by the joint steering committee, which is reviewed on at least an annual basis. AFT shall perform clinical trials of the Pascomer product in the specified territory and shall perform all CMC (chemistry, manufacturing and controls) and related activities to support regulatory approval. We are responsible for all expenses incurred by AFT during the term of the AFT License Agreement and shall equally share all costs and expenses with AFT, incurred by AFT for development and marketing work performed in furtherance of regulatory approval and commercialization worldwide, outside of the specified territory. We are also entitled to receive a significant percentage of the economics (royalties and milestones) in any licensing transaction that AFT executes outside of North America, Australia, New Zealand, and Southeast Asia. In March 2021 the Company announced that its development partner, AFT Pharmaceuticals Limited has signed an exclusive license and supply agreement with Desitin Arzneimittel GmbH (“Desitin”) for Pascomer® (TMB-002 topical rapamycin) for the treatment of facial angiofibromas (FA) associated with Tuberous Sclerosis Complex (TSC) in Europe. The Company is entitled to €213,750 related to an upfront milestone payment paid to AFT by Desitin during the quarter ending June 30, 2021 and has recorded approximately $0.3 million in these financial statements.
Upon closing of the AFT License Agreement, we were obligated to reimburse AFT for previously spent development costs, subject to certain limitations and were obligated to pay a one-time, irrevocable and non-creditable upfront payment to AFT, payable in scheduled installments. AFT is entitled to up to $25.5 million of cash milestone payments relating to certain regulatory and commercial achievements of the AFT License. In addition, AFT is entitled to net sales royalties ranging from high single digits to low double digits for the program licensed. The potential regulatory and commercial milestones are not yet considered probable, and no milestone payments have been accrued at June 30, 2021 and December 31, 2020.
26
Results of Operations
Comparison of the Three Months Ended June 30, 2021 and 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
|
|
||||
|
|
|
2021 |
|
2020 |
|
Change $ |
|
Change % |
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
134,927 |
|
$ |
— |
|
$ |
134,927 |
|
N/A |
% |
|
Milestone revenue |
|
|
253,892 |
|
|
— |
|
|
253,892 |
|
N/A |
|
|
Total revenue |
|
|
388,819 |
|
|
— |
|
|
388,819 |
|
N/A |
|
|
Research and development |
|
|
1,800,100 |
|
|
536,170 |
|
|
1,263,930 |
|
236 |
% |
|
Research and development - license acquired |
|
|
— |
|
|
12,371,332 |
|
|
(12,371,332) |
|
(100) |
% |
|
Transaction costs |
|
|
— |
|
|
311,291 |
|
|
(311,291) |
|
(100) |
% |
|
Selling, general and administrative |
|
|
1,556,012 |
|
|
1,055,084 |
|
|
500,928 |
|
47 |
% |
|
Loss from operations |
|
|
(2,967,293) |
|
|
(14,273,877) |
|
|
11,306,584 |
|
(79) |
% |
|
Interest expense |
|
|
— |
|
|
(3,314,140) |
|
|
3,314,140 |
|
(100) |
% |
|
Interest income |
|
|
— |
|
|
359,880 |
|
|
(359,880) |
|
(100) |
% |
|
Change in fair value of investment in BioPharmX |
|
|
— |
|
|
476,245 |
|
|
(476,245) |
|
(100) |
% |
|
Change in fair value of warrant liability |
|
|
— |
|
|
1,504,511 |
|
|
(1,504,511) |
|
(100) |
% |
|
Gain (loss) on foreign currency exchange |
|
|
1,090 |
|
|
1,772 |
|
|
(682) |
|
(38) |
% |
|
Net loss |
|
|
(2,966,203) |
|
|
(15,245,609) |
|
|
12,279,406 |
|
(81) |
% |
|
Accrued dividend on preferred stock units |
|
|
— |
|
|
(18,188) |
|
|
18,188 |
|
(100) |
% |
|
Cumulative dividends on Series A preferred stock |
|
|
(36,286) |
|
|
(17,146) |
|
|
(19,140) |
|
112 |
% |
|
Net loss attributable to common stockholders |
|
$ |
(3,002,489) |
|
$ |
(15,280,943) |
|
$ |
12,278,454 |
|
(80) |
% |
Grant and milestone revenue
During the three months ended June 30, 2021 and 2020, we recognized revenue of $388,819 and zero, respectively. The revenue consisted of reimbursements received from the FDA as a result of achieving certain clinical milestones in the development of TMB-001 and from milestone for a licensing agreement with AFT.
In September 2018, Patagonia was awarded a $1.5 million grant (the “Grant”) from the FDA as part of the Orphan Products Clinical Trials Grants Program of the Office of Orphan Products Development. The Grant funds are available in three annual installments of $500,000 per year, which commenced in September 2018. The Grant was transferred to Timber pursuant to its TMB-001 Acquisition Agreement with Patagonia in February 2019. A six-month no cost extension was granted to Timber in September 2019 and ended in February 2020. During the course of each year for which the Grant was active, the Company submitted its allowable expenses and is reimbursed up to the maximum amount of each installment.
Pursuant to the AFT Licensing and Development Agreement, we are entitled to receive a significant percentage of the economics (royalties and milestones) in any licensing transaction that AFT executes outside of North America, Australia, New Zealand, and Southeast Asia. The current transaction with Desitin is included in the scope of this provision and as such in Q2 the Company is entitled to €213,750 related to an upfront milestone payment paid to AFT by Desitin during the quarter ending June 30, 2021 and has recorded approximately $0.3 million in these financial statements.
Operating costs and expenses
Research and development expense
During the three months ended June 30, 2021 and 2020, research and development expenses were $1.8 and $0.5 million respectively. Research and development expenses are primarily related to costs incurred related to our Phase 2a clinical trials of TMB-001 and TMB-002, such as CRO direct and pass-through expenses.
27
Research and development costs are expensed as incurred. Costs for certain activities, such as preclinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to it by Timber’s vendors and collaborators.
Transaction Costs
There were no transaction costs for the three months ended June 30, 2021. For the three months ended June 30, 2020, transaction costs were $0.3 million, consisting of legal and professional fees related to our acquisition of BioPharmX.
General and administrative expense
During the three months ended June 30, 2021, general and administrative expense was $1.6 million compared to $1.1 million for the three months ended June 30, 2020. The increase in general and administrative expenses of approximately $0.5 million was due to increased personnel and related costs of $0.2 million due to increased professional expense, and other overhead expenses of $0.3 million.
Other income (expense)
During the three months ended June 30, 2021 and 2020, respectively, other expense was zero and $1.0 million. For the three months ended June 30, 2020, other expense primarily consisted of interest expense of $3.3 million related to amortization of the debt discount for our bridge loan offset by $1.5 million for the change in fair value of our warrant liability, $0.5 million related to change in investment in BioPharmX and by $0.3 million of interest income related to our BioPharmX loan.
Income Taxes
The Company did not record tax expense for the three-months ended June 30, 2021 due to the Company’s loss position and full valuation allowance. The Company did not record tax expense for the three-months ended June 30, 2020 as the Company was a non-taxable flow-through entity for US federal income tax purposes through May 18, 2020 and the Company’s loss position and full valuation allowance through June 30, 2020.
Comparison of the Six Months Ended June 30, 2021 and 2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
|
|
|
|
||||
|
|
|
2021 |
|
2020 |
|
Change $ |
|
Change % |
|
|
|||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grant revenue |
|
$ |
175,661 |
|
$ |
26,907 |
|
$ |
148,754 |
|
553 |
% |
|
|
Milestone revenue |
|
|
253,892 |
|
|
— |
|
|
253,892 |
|
N/A |
|
|
|
Total revenue |
|
|
429,553 |
|
|
26,907 |
|
|
402,646 |
|
1,496 |
|
|
|
Research and development |
|
|
2,649,618 |
|
|
1,554,401 |
|
|
1,095,217 |
|
70 |
% |
|
|
Research and development - license acquired |
|
|
— |
|
|
12,371,332 |
|
|
(12,371,332) |
|
(100) |
% |
|
|
Transaction costs |
|
|
— |
|
|
1,501,133 |
|
|
(1,501,133) |
|
(100) |
% |
|
|
Selling, general and administrative |
|
|
2,621,401 |
|
|
1,511,878 |
|
|
1,109,523 |
|
73 |
% |
|
|
Loss from operations |
|
|
(4,841,466) |
|
|
(16,911,837) |
|
|
12,070,371 |
|
(71) |
% |
|
|
Interest expense |
|
|
— |
|
|
(4,416,746) |
|
|
4,416,746 |
|
(100) |
% |
|
|
Interest income |
|
|
— |
|
|
816,655 |
|
|
(816,655) |
|
(100) |
% |
|
|
Change in fair value of investment in BioPharmX |
|
|
— |
|
|
559,805 |
|
|
(559,805) |
|
(100) |
% |
|
|
Change in fair value of warrant liability |
|
|
— |
|
|
1,183,460 |
|
|
(1,183,460) |
|
(100) |
% |
|
|
Gain (loss) on foreign currency exchange |
|
|
1,003 |
|
|
4,454 |
|
|
(3,451) |
|
(77) |
% |
|
|
Net loss |
|
|
(4,840,463) |
|
|
(18,764,209) |
|
|
13,923,746 |
|
(74) |
% |
|
|
Accrued dividend on preferred stock units |
|
|
— |
|
|
(52,669) |
|
|
52,669 |
|
(100) |
% |
|
|
Cumulative dividends on Series A preferred stock |
|
|
(72,173) |
|
|
(17,146) |
|
|
(55,027) |
|
321 |
% |
|
|
Net loss attributable to common stockholders |
|
$ |
(4,912,636) |
|
$ |
(18,834,024) |
|
$ |
13,921,388 |
|
(74) |
% |
|
28
Grant and milestone revenue
For the six months ended June 30, 2021, revenue was approximately $429,554 compared to $26,907 revenue for the six months ended June 30, 2020. Revenue for the six months ended June 30, 2021 consisted of reimbursements received from the FDA as a result of achieving certain clinical milestones in the development of TMB-001 and from milestone for a licensing agreement with AFT. In September 2018, Patagonia was awarded a $1.5 million grant (the “Grant”) from the FDA as part of the Orphan Products Clinical Trials Grants Program of the Office of Orphan Products Development. The Grant funds are available in three annual installments of $500,000 per year, which commenced in September 2018. The Grant was transferred to Timber pursuant to its TMB-001 Acquisition Agreement with Patagonia in February 2019. A six-month no cost extension was granted to Timber in September 2019 and ended in February 2020. During the course of each year for which the Grant is active, the Company submits its allowable expenses and is reimbursed up to the maximum amount of each installment. The Company is entitled to €213,750 related to an upfront milestone payment paid to AFT by Desitin during the six months ending June 30, 2021 and has recorded approximately $0.3 million in these financial statements.
Operating costs and expenses
Research and development expense
For the six months ended June 30, 2021, research and development expenses were $2.6 million compared to $1.6 million for the six months ended June 30, 2020. The increase of $1.0 million is primarily related to increased costs incurred related to our Phase 2a clinical trials of TMB-001 and TMB-002, such as CRO direct and pass through expenses.
Research and development costs are expensed as incurred. Costs for certain activities, such as preclinical studies and clinical trials, are generally recognized based on an evaluation of the progress to completion of specific tasks using information and data provided to it by Timber’s vendors and collaborators.
Research and development expense- license acquired
For the six months ended June 30, 2021, the research and development expense – license acquired was zero compared to $12.4 million as of June 30, 2020, primarily related to our acquisition of BioPharmX.
Transaction Costs
For the six months ended June 30, 2021, transaction costs were zero compared to $1.5 million as of June 30, 2020, consisting of legal and professional fees related to our acquisition of BioPharmX.
General and administrative expense
For the six months ended June 30, 2021, general and administrative expense were $2.6 million compared to $1.5 million for the six months ended June 30, 2020. The increase in general and administrative expenses of approximately $1.1 million was due to increased legal and professional fees of $0.2 million, increased personnel and related costs of $0.5 million due to increased headcount, and other overhead expenses of $0.4 million.
Liquidity and Capital Resources
Since inception, Timber has not generated revenue from product sales and has incurred net losses and negative cash flows from its operations. At June 30, 2021, we had working capital of approximately $4.5 million, which included cash and cash equivalents of $6.1 million. We reported a net loss of $4.8 million during the six months ended June 30, 2021.
29
Cash Flows for the Six Months Ended June 30, 2021 and 2020
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
||||
|
|
|
2021 |
|
2020 |
||
|
|
|
|
|
|
|
|
|
Cash provided by (used in) continuing operations: |
|
|
|
|
|
|
|
Operating activities |
|
$ |
(4,202,755) |
|
$ |
(5,082,462) |
|
Investing activities |
|
|
(16,903) |
|
|
(2,659,214) |
|
Financing activities |
|
|
— |
|
|
21,237,772 |
|
Net increase in cash and cash equivalents |
|
$ |
(4,219,658) |
|
$ |
13,496,096 |
Operating Activities
For the six months ended June 30 2021, net cash used in operating activities was $4.2 million, which primarily consisted of our net loss of $4.8 million, adjusted for non-cash expenses of $0.1 million of stock-based compensation expense offset by the change in assets and liabilities of $0.5 million, which is primarily due to increase in other receivable of $0.3 million and offset by an increase in accounts payable of $1.0 million and a decrease in accrued expenses of $0.2 million.
For the six months ended June 30, 2020, net cash used in operating activities was $5.1 million, which primarily consisted of our net loss of $18.8 million, adjusted for non-cash expenses of $14.4 million primarily consisting of, $12.4 million of research and development – licenses acquired, $4.2 million of amortization expense related to the Bridge Notes, $0.2 million of accrued interest on the Bridge Notes, offset by $1.2 million for the change in fair value of our warrant liability, $0.8 million for the amortization of our loan discount, and $0.6 million for the change in fair value of our investment in BioPharmX. The change in assets and liabilities of $0.8 million is primarily due to increases in prepaid insurance of $0.2 million and a decrease in accounts payable, accrued expenses and other liabilities of $0.6 million.
Investing Activities
For the six months ended June 30, 2021, net cash used in investing activities was de minimis spending related to property and equipment.
For the six months ended June 30, 2020, net cash used in investing activities was approximately $2.7 million which primarily consisted of our loan to BioPharmX of $2.3 million and our payment of $0.7 million for research and development licenses, offset by the cash acquired with our acquisition of BioPharmX of $0.3 million.
Financing Activities
For the six months Ended June 30, 2021, net cash provided by financing activities was zero.
For the six months ended June 30, 2020, net cash provided by financing activities was approximately $21.2 million, which consisted of the net proceeds received from the issuance of common stock related to our financing of $17.5 million and the proceeds received from our Bridge Notes of $3.7 million.
Funding requirements
We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of our pipeline of programs. Furthermore, following the completion of the Merger, we have been incurring additional costs as a public company. Accordingly, we will need to obtain additional funding. If we are unable to raise capital or otherwise obtain funding when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.
As discussed above, Timber Sub and BioPharmX entered into the Securities Purchase Agreement pursuant to which, among other things, we issued the Investor Warrants to the Investors in a private placement transaction for an aggregate
30
purchase price of approximately $25 million (which amount is comprised of (x) a $5 million credit with respect to the Bridge Notes and (y) $20 million in cash from the Investors).
In addition, on July 17, 2020, we entered into an Amended and Restated Registration Rights Agreement (as amended, the “Registration Rights Agreement”) with the Investors. Pursuant to the Registration Rights Agreement, we agreed to provide certain demand registration rights to the Investors relating to the registration of the shares underlying the Investor Warrants and the Bridge Warrants. In connection with the entry into the Registration Rights Agreement and pursuant to the Securities Purchase Agreement, we were restricted from various financing activities until August 16, 2022. On November 19, 2020 we entered into Waiver Agreements with the investors revising the restriction date to April 30, 2021.
Further, the Company has a class of Series A Preferred Stock which is currently subject to redemption at any time in whole or in part at the request of the holder, TardiMed. The redemption price is equal to approximately $1.9 million in the aggregate, including accumulated and unpaid dividends which accrue at the rate of 8% per annum. Redemption is subject to certain limitations under Delaware law, so that our ability to pay the redemption price to TardiMed is and may be limited.
We have evaluated whether there are any conditions and events, considered in the aggregate, that raise substantial doubt about our ability to continue as a going concern within one year beyond the filing of this Annual Report on Form 10-K. Based on such evaluation and the Company’s current plans, which are subject to change, management believes that the Company’s existing cash and cash equivalents as of June 30, 2021 are not sufficient to satisfy our operating cash needs for the year after the filing of the Quarterly Report on Form 10-Q and are sufficient only to satisfy our operating cash needs through the third quarter of 2021.
The Company’s future liquidity and capital funding requirements will depend on numerous factors, including:
| ● | our ability to raise additional funds to finance our operations, including our ability to access financing that may be unavailable due to contractual limitations under the Securities Purchase Agreement; |
| ● | the dilutive effect of our outstanding securities; |
| ● | the impact of the recent COVID-19 pandemic on our operations, including on our clinical development plans and timelines; |
| ● | the outcome, costs and timing of clinical trial results for our current or future product candidates, including the timing, progress, costs and results of our Phase 2b clinical trial of TMB-001 for the treatment of congenital ichthyosis as well as our ongoing Phase 2b clinical trial of TMB-002 for the treatment of facial angiofibromas in tuberous sclerosis complex; |
| ● | the outcome, timing and cost of meeting regulatory requirements established by the FDA and other comparable foreign regulatory authorities; |
| ● | the emergence and effect of competing or complementary products; |
| ● | our ability to maintain, expand and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights; |
| ● | the cost and timing of completion of commercial-scale manufacturing activities; |
| ● | the cost of establishing sales, marketing and distribution capabilities for our products in regions where we choose to commercialize our products on our own; |
| ● | the initiation, progress, timing and results of the commercialization of our product candidates, if approved for commercial sale; |
31
| ● | the volatility of the price of our common stock; |
| ● | acceptance of our products in our industry; |
| ● | the accuracy of our estimates regarding expenses and capital requirements; |
| ● | our ability to retain our current employees and the need and ability to hire additional management and scientific and medical personnel; and |
| ● | the terms and timing of any collaborative, licensing or other arrangements that we have or may establish. |
We will need to raise substantial additional funds through one or more of the following: issuance of additional debt or equity and/or the completion of a licensing or other commercial transaction for one or more of our product candidates. If we are unable to maintain sufficient financial resources, our business, financial condition and results of operations will be materially and adversely affected. This could affect future development and business activities and potential future clinical studies and/or other future ventures. There can be no assurance that we will be able to obtain the needed financing on acceptable terms or at all. Additionally, equity or convertible debt financings will likely have a dilutive effect on the holdings of our existing stockholders.
As discussed above, the impact of the worldwide spread of COVID-19 has been unprecedented and unpredictable. Site activation and patient enrollment have recently been impacted by the COVID-19 pandemic in the larger and longer TMB-002 study, especially at our contracted test sites in Eastern Europe. As of June 30, 2021, all 17 sites are open and 50% of patients in the Phase 2b study have been enrolled for the TMB-002 program. We expect recruitment to be completed by the end of Q3 2021 and anticipate topline data readout in mid-2022. We are also continuing to assess the effect of COVID-19 on the TMB-002 study as well as the Company’s overall operations by monitoring the spread of COVID-19 and the actions implemented to combat the virus throughout the world. Our assessment of the impact of COVID-19 may change in the future.
Off-balance sheet arrangements
Timber does not have any relationships with unconsolidated entities or financial partnerships, including entities sometimes referred to as structured finance or special purpose entities that were established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. Timber does not engage in off-balance sheet financing arrangements. In addition, Timber does not engage in trading activities involving non-exchange traded contracts. Timber therefore believe that Timber is not materially exposed to any financing, liquidity, market or credit risk that could arise if it had engaged in these relationships.
Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP. The preparation of these financials statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the revenue and expenses incurred during the reporting periods. On an ongoing basis, we evaluate our estimates and adjustments, including those related to accrued expenses and share-based compensation. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ from these estimates under different assumptions or conditions.
There have been no material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates described in our latest Annual report Form 10-K.
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Item 3. Quantitative and Qualitative Disclosures about Market Risk
N/A.
Item 4. Controls and Procedures
Evaluation of disclosure controls and procedures.
The Company maintains disclosure controls and procedures (as defined in Rule 13a-15 (e) or 15d-15(e) of the Exchange Act) that are designed to ensure that information required to be disclosed in periodic reports filed with the SEC under the Securities Exchange Act of 1934 is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including its Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. Under the supervision and with the participation of our management, including the Chief Executive Officer and Chief Financial Officer, we have evaluated the effectiveness of our disclosure controls and procedures as defined in Rule 13(a)-15(e) under the Exchange Act as of the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of June 30, 2021.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the fiscal period ended June 30, 2021, which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Part II. Other Information
Item 1. Legal Proceedings.
We are not involved in any litigation that we believe could have a material adverse effect on our financial position or results of operations. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of our executive officers, threatened against or affecting our Company or our officers or directors in their capacities as such.
Item 1A. Risk Factors
As a smaller reporting company, we are not required to provide the information required by this item.
There have been no material changes in or additions to the risk factors included in our Annual Report on Form 10-K for the year ended December 31, 2020 and in our Quarterly Report on Form 10-Q for the period ended March 31, 2021.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
During the period covered by this report, we have not issued any unregistered securities. We have not furnished information under this item as such information previously has been included in our Annual Report on Form 10-K.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosure.
Not applicable.
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Item 5. Other Information.
None.
Item 6. Exhibits
*Filed herewith.
**The certifications furnished in Exhibits 32.1 and 32.2 hereto are deemed to accompany this Quarterly Report on Form 10-Q and will not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, except to the extent that the registrant specifically incorporates it by reference
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SIGNATURES
Pursuant to the requirements of the Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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Timber Pharmaceuticals, Inc. |
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Date: August 10, 2021 |
By: |
/s/ John Koconis |
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John Koconis |
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Chief Executive Officer and Chairman of the Board of Directors |
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(Principal Executive Officer) |
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Exhibit 31.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO RULES 13A-14(A) AND 15D-14(A) UNDER
THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302 OF THE SARBANES
OXLEY ACT OF 2002
I, John Koconis, certify that:
1.I have reviewed this report on Form 10-Q of Timber Pharmaceuticals, Inc.;
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions): |
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
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/s/ John Koconis |
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John Koconis |
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Chief Executive Officer and Chairman of the Board of Directors |
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(Principal Executive Officer) |
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August 10, 2021 |
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Exhibit 31.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO RULES 13A-14(A)
AND 15D-14(A) UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS ADOPTED PURSUANT TO SECTION 302
OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph Lucchese, certify that:
1.I have reviewed this report on Form 10-Q of Timber Pharmaceuticals, Inc.;
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
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The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent functions): |
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All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
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/s/ Joseph Lucchese |
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Joseph Lucchese |
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Chief Financial Officer |
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(Principal Financial Officer) |
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August 10, 2021 |
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Exhibit 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, John Koconis, Chief Executive Officer of Timber Pharmaceuticals, Inc. (the “Company”), in compliance with 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby certify that, to the best of my knowledge, the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2021 (the “Report”) filed with the Securities and Exchange Commission:
·Fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
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/s/ John Koconis |
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John Koconis |
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Chief Executive Officer and Chairman of the Board of Directors |
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(Principal Executive Officer) |
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August 10, 2021 |
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Exhibit 32.2
CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
I, Joseph Lucchese, Chief Financial Officer of Timber Pharmaceuticals, Inc. (the “Company”), in compliance with 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, hereby certify that, to the best of my knowledge, the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2021 (the “Report”) filed with the Securities and Exchange Commission:
·Fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
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/s/ Joseph Lucchese |
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Joseph Lucchese |
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Chief Financial Officer |
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(Principal Financial Officer) |
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August 10, 2021 |
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