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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 13, 2024
Dermata Therapeutics, Inc. |
(Exact name of registrant as specified in its charter) |
Delaware |
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001-40739 |
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86-3218736 |
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(State or Other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(I.R.S. Employer Identification No.) |
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3525 Del Mar Heights Rd., #322 San Diego, CA |
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92130 |
(Address of principal executive offices) |
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(Zip Code) |
(858) 800-2543
(Registrant’s telephone number, including area code)
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class: |
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Trading Symbol |
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Name of Each Exchange on which Registered |
Common Stock, par value $0.0001 per share |
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DRMA |
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The Nasdaq Capital Market |
Warrants, exercisable for one share of Common Stock |
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DRMAW |
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The Nasdaq Capital Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR§230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
Item 2.02. Results of Operations and Financial Condition.
On November 13, 2024, Dermata Therapeutics, Inc. (the “Company”) issued a press release disclosing certain information regarding its results of operations for the quarter ended September 30, 2024. A copy of the press release is furnished under Item 2.02 as Exhibit 99.1.
The information included in this Item 2.02, and Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed “filed” for the purposes of or otherwise subject to the liabilities under Section 18 of the Securities Exchange Act of 1934 as amended (the “Exchange Act”). Unless expressly incorporated into a filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act made after the date hereof, the information contained in this Item 2.02 and Exhibit 99.1 hereto shall not be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 7.01. Regulation FD Disclosure.
See “Item 2.02 Results of Operations and Financial Condition” above.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
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Description |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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DERMATA THERAPEUTICS, INC. |
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Dated: November 13, 2024 |
By: |
/s/ Gerald T. Proehl |
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Gerald T. Proehl |
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Chief Executive Officer |
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EXHIBIT 99.1
Dermata Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results
- Dermata nears completion of enrollment in its DMT310 Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial -
- Dermata continues discussions with potential botulinum toxin partners for DMT410 -
- Raised $5.1 million in gross proceeds from financings completed in 3Q 2024 –
SAN DIEGO, CA, November 13, 2024 – Dermata Therapeutics, Inc. (Nasdaq: DRMA; DRMAW) (“Dermata,” or the “Company”), a late-stage biotechnology company focused on the treatment of medical and aesthetic skin diseases and conditions, today highlighted recent corporate progress and reported financial results for the third quarter ended September 30, 2024.
“The third quarter was a busy time for our team as we approach completing enrollment in our DMT310 Phase 3 STAR-1 study and were able to raise funds, which we believe will allow us to reach the topline data readout in the STAR-1 study in the first quarter of 2025,” commented Gerry Proehl, Dermata’s Chairman, President, and Chief Executive Officer. “We believe patients deserve an acne treatment that is safe, well-tolerated, applied only once-a-week, with a significant 45% reduction in inflammatory lesions after just four applications, as seen in our DMT310 Phase 2b acne study. With many unique features and benefits, we believe DMT310 can cause a paradigm shift in the treatment of moderate-to-severe acne, if approved,” concluded Mr. Proehl.
Corporate Highlights
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| · | Achieved 50% enrollment in its DMT310 Phase 3 STAR-1 clinical trial in moderate-to-severe acne. After achieving the 50% enrollment milestone in July 2024, Dermata expects to receive topline results from the STAR-1 study in the first quarter of 2025. STAR-1 is the first of two Phase 3 clinical trials, including a long-term extension study, which the Company will need to complete prior to filing a new drug application with the U.S. Food and Drug Administration. |
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| · | Raised $7.8 million in gross proceeds during 2024. The funds raised during 2024, along with the Company’s existing cash, is expected to fund its operations into the second quarter of 2025. |
Anticipated Upcoming Milestones
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| · | Complete enrollment in its DMT310 Phase 3 STAR-1 clinical trial in moderate-to-severe acne. Dermata expects to complete enrollment in the STAR-1 study by the end of 2024 and plans to announce topline results from the DMT310 Phase 3 STAR-1 study in the first quarter of 2025. |
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| · | DMT410 Partnership Discussions. The Company continues to make progress on partnership discussions for its DMT410 program for the topical delivery of botulinum toxin. DMT410 is the Company’s combination treatment regimen that uses the unique mechanical features of the Company’s DMT310 product to facilitate the intradermal delivery of botulinum toxin by topical application rather than through multiple injections with a needle. The Company believes DMT410 has the potential be to a first-in-class treatment for hyperhidrosis, acne, and facial aesthetics. |
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Dermata Conference Participation
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| · | Life Sciences Investor Forum |
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| o | Date: Thursday, November 14, 2024 |
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| o | Time: 12:00pm ET |
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| o | Link: https://bit.ly/3NuUDa4 |
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| · | H.C. Wainwright 26th Annual Global Investment Conference |
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| · | 2024 Maxim Healthcare Virtual Summit |
Third Quarter 2024 Financial Results
As of September 30, 2024, the Company had $6.1 million in cash and cash equivalents, compared to $7.4 million as of December 31, 2023. The $1.3 million decrease in cash and cash equivalents for the nine months ended September 30, 2024, resulted from $8.2 million of cash used in operations offset by $7.0 million in net financing proceeds. The Company expects its current cash resources to be sufficient to fund operations into the second quarter of 2025.
Research and development expenses were $2.4 million for the quarter ended September 30, 2024, compared to $0.9 million for the quarter ended September 30, 2023. The increase in research and development expense was the result of increased clinical trial expenses from the Company’s STAR-1 clinical study, offset by decreased non-clinical and chemistry, manufacturing, and control expenses during the third quarter of 2024.
General and administrative expenses were $0.8 million for the quarter ended September 30, 2024, compared to $0.9 million for the quarter ended September 30, 2023. The decrease in general and administrative expenses was the result of decreased insurance costs.
About Dermata Therapeutics
Dermata Therapeutics, Inc. is a late-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions. The Company's lead product candidate, DMT310, is the Company’s first product candidate being developed from its Spongilla technology platform and is currently being evaluated in a Phase 3 program. DMT310 is a once-weekly topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. DMT310 has been studied for the treatment of acne, rosacea, and psoriasis. The Company's second program, DMT410, uses its DMT310 product as a new method for topical intradermal delivery of botulinum toxin for the treatment of hyperhidrosis and multiple aesthetic skin conditions. Dermata is headquartered in San Diego, California. For more information, please visit http://www.dermatarx.com/.
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Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors including, but are not limited to, statements related to: expectations with regard to the timing of meetings and/or responses from submissions with regulatory bodies; expectations with regard to the timing of submission of an NDA; the uncertainties inherent in clinical trials including enrolling an adequate number of patients on time or be completed on schedule, if at all; timing and ability to generate clinical data; expectations with regard to any potential partnership opportunities for any of the Company's product candidates; the Company's expectations with regard to current cash and cash equivalents and the amount of time it will fund operations; the success, cost, and timing of its product candidates DMT310 and DMT410 development activities and ongoing and planned clinical trials; and whether the results of any ongoing or planned clinical trials of DMT310 or DMT410 will lead to future product development. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks and uncertainties inherent in drug development, approval, and commercialization, and the fact that past results of clinical trials may not be indicative of future trial results. For a discussion of these and other factors, please refer to Dermata's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and Dermata undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof, except as required by law.
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DERMATA THERAPEUTICS, INC.
Balance Sheets
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| September, 2024 |
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| December 31, 2023 |
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| In thousands USD |
| (unaudited) |
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| Assets |
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| Cash and cash equivalents |
| $ | 6,144 |
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| $ | 7,438 |
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| Prepaid expenses and other current assets |
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| 543 |
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| 541 |
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| Total assets |
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| 6,687 |
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| 7,979 |
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| Liabilities |
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| Accounts payable |
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| 864 |
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| 866 |
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| Accrued liabilities |
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| 1,082 |
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| 757 |
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| Total liabilities |
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| 1,946 |
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| 1,623 |
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| Equity |
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| 4,741 |
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| 6,356 |
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| Total liabilities and equity |
| $ | 6,687 |
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| $ | 7,979 |
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DERMATA THERAPEUTICS, INC.
Statements of Operations
(unaudited)
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| Quarter Ended September 30, |
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| Nine Months Ended September 30, |
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| 2024 |
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| 2023 |
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| 2024 |
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| 2023 |
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| In thousands, except share and per share data |
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| Operating expenses |
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| Research and development (1) |
| $ | 2,401 |
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| $ | 903 |
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| $ | 6,011 |
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| $ | 2,935 |
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| General and administrative (1) |
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| 824 |
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| 909 |
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| 3,302 |
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| 2,887 |
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| Total operating expenses |
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| 3,225 |
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| 1,812 |
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| 9,313 |
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| 5,822 |
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| Loss from operations |
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| (3,225 | ) |
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| (1,812 | ) |
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| (9,313 | ) |
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| (5,822 | ) |
| Interest income, net |
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| 52 |
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| 93 |
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| 176 |
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| 161 |
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| Net loss |
| $ | (3,173 | ) |
| $ | (1,719 | ) |
| $ | (9,137 | ) |
| $ | (5,661 | ) |
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| Net loss per common share, basic and diluted |
| $ | (2.04 | ) |
| $ | (8.09 | ) |
| $ | (10.22 | ) |
| $ | (36.91 | ) |
| Weighted average common shares outstanding, basic and diluted |
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| 1,554,680 |
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| 212,544 |
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| 894,168 |
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| 153,380 |
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| (1) Includes the following stock-based compensation expense |
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| Research and development |
| $ | 5 |
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| $ | 48 |
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| $ | 247 |
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| $ | 145 |
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| General and administrative |
| $ | 16 |
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| $ | 83 |
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| $ | 381 |
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| $ | 248 |
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Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com
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