Dermata Therapeutics Provides Corporate Update and Reports Third Quarter 2024 Financial Results
Download as PDF November 13, 2024 4:15pm EST
- 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 / ACCESSWIRE / 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
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.
Anticipated Upcoming Milestones
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.
Dermata Conference Participation
Life Sciences Investor Forum
H.C. Wainwright 26th Annual Global Investment Conference
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 .
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.
DERMATA THERAPEUTICS, INC.
Balance Sheets
| | September, 2024 | | | December 31, 2023 | |
In thousands USD | | (unaudited) | | | | |
Assets | | | | | | |
Cash and cash equivalents | | $ | 6,144 | | | $ | 7,438 | |
Prepaid expenses and other current assets | | | 543 | | | | 541 | |
Total assets | | | 6,687 | | | | 7,979 | |
Liabilities | | | | | | | | |
Accounts payable | | | 864 | | | | 866 | |
Accrued liabilities | | | 1,082 | | | | 757 | |
Total liabilities | | | 1,946 | | | | 1,623 | |
Equity | | | 4,741 | | | | 6,356 | |
Total liabilities and equity | | $ | 6,687 | | | $ | 7,979 | |
DERMATA THERAPEUTICS, INC.
Statements of Operations
(unaudited)
| | Quarter Ended September 30, | | | Nine Months Ended September 30, | |
| | 2024 | | | 2023 | | | 2024 | | | 2023 | |
In thousands, except share and per share data | | | | | | | | | | | | |
Operating expenses | | | | | | | | | | | | |
Research and development (1) | | $ | 2,401 | | | $ | 903 | | | $ | 6,011 | | | $ | 2,935 | |
General and administrative (1) | | | 824 | | | | 909 | | | | 3,302 | | | | 2,887 | |
Total operating expenses | | | 3,225 | | | | 1,812 | | | | 9,313 | | | | 5,822 | |
Loss from operations | | | (3,225) | | | | (1,812) | | | | (9,313) | | | | (5,822) | |
Interest income, net | | | 52 | | | | 93 | | | | 176 | | | | 161 | |
Net loss | | $ | (3,173) | | | $ | (1,719) | | | $ | (9,137) | | | $ | (5,661) | |
| | | | | | | | | | | | | | | | |
Net loss per common share, basic and diluted | | $ | (2.04) | | | $ | (8.09) | | | $ | (10.22) | | | $ | (36.91) | |
Weighted average common shares outstanding, basic and diluted | | | 1,554,680 | | | | 212,544 | | | | 894,168 | | | | 153,380 | |
| | | | | | | | | | | | | | | | |
(1) Includes the following stock-based compensation expense | | | | | | | | | | | | | | | | |
Research and development | | $ | 5 | | | $ | 48 | | | $ | 247 | | | $ | 145 | |
General and administrative | | $ | 16 | | | $ | 83 | | | $ | 381 | | | $ | 248 | |
Investors:
Cliff Mastricola
Investor Relations
cmastricola@dermatarx.com
SOURCE: Dermata Therapeutics
View the original press release on accesswire.com
Released November 13, 2024
Dermata Therapeutics 提供公司更新並報告 2024 年第三季度財務結果
下載爲PDF 2024年11月13日下午4:15(美國東部標準時間)
- Dermata即將完成其DMT310 3期海綿狀痤瘡治療研究(科創板-1)臨床試驗的招募 -
- Dermata與潛在的肉毒毒素合作伙伴繼續進行DMT410的討論 -
- 在2024年第三季度完成的融資中籌集了510萬美元的總收入 -
聖迭戈,加利福尼亞州 / ACCESSWIRE / 2024年11月13日 / Dermata Therapeutics, Inc.(納斯達克:DRMA;DRMAW)("Dermata"或"公司"),是一家專注於治療醫療和美容皮膚疾病及其病症的後期生物技術公司,今天強調了最近的公司進展,並報告了截至2024年9月30日的第三季度財務結果。
"第三季度是我們團隊忙碌的時刻,我們接近完成DMT310 3期科創板-1研究的招募,並能夠籌集資金,我們相信這些資金將使我們能夠在2025年第一季度達到科創板-1研究的頂線數據公佈,"Dermata董事長、總裁兼首席執行官Gerry Proehl評論道。"我們相信患者應該得到一種安全、耐受良好的痤瘡治療方案,每週僅應用一次,在僅四次應用後,炎症病竈減少了45%,這在我們的DMT310 20億痤瘡研究中得到了驗證。我們相信DMT310具有許多獨特特徵和益處,如果獲得批准,可以在中度至重度痤瘡的治療中造成範式轉變,"Proehl先生總結道。
企業要聞
預計即將到來的里程碑
Dermata會議參與
2024年第三季度財務結果
截至2024年9月30日,公司擁有現金及現金等價物610萬,相比於截至2023年12月31日的740萬。2024年9月30日止九個月中現金及現金等價物減少130萬,主要是因爲運營中使用了820萬的現金,抵消了700萬的淨融資收入。公司預計其當前的現金資源足以支持到2025年第二季度的運營。
2024年9月30日止季度的研發費用爲240萬,相比於2023年9月30日止季度的90萬。研發費用的增加是由於公司STAR-1臨床研究的臨床試驗費用增加,抵消了2024年第三季度非臨床和化學、製造與控制費用的減少。
2024年9月30日止季度的管理費用爲80萬,相比於2023年9月30日止季度的90萬。管理費用的減少是由於保險成本的降低。
關於Dermata Therapeutics
Dermata Therapeutics, Inc.是一家處於晚期的生物技術公司,專注於治療醫療和美容皮膚疾病及狀況。該公司的主要產品候選DMT310是從其Spongilla科技平台開發的首個產品候選,目前正在進行第三期項目評估。DMT310是每週使用一次的局部產品候選,來源於天然淡水海綿,具有多種獨特的作用機制。DMT310已用於治療痤瘡、玫瑰痤瘡和銀屑病。該公司的第二個項目DMT410,使用DMT310產品作爲局部皮內注射肉毒毒素治療多汗症和多種美容皮膚狀況的新方法。Dermata總部位於加利福尼亞州聖地亞哥。如需更多信息,請訪問。
前瞻性聲明
本新聞稿中的聲明並非全部是歷史性的,而是前瞻性聲明。這些聲明基於公司的當前信念和期望,並且新風險可能不時出現。前瞻性聲明受到已知和未知風險、不確定性、假設及其他因素的影響,包括但不限於與以下內容相關的聲明:關於與監管機構的會議和/或提交響應時間的預期;關於NDA提交時間的預期;臨床試驗中固有的不確定性,包括按時招募足夠數量的患者或是否能按計劃完成;生成臨床數據的時間和能力;關於與公司任何產品候選相關的潛在合作機會的預期;公司對當前現金及現金等價物的預期及其資助運營的時間;其產品候選DMT310和DMT410的開發活動及正在進行和計劃中的臨床試驗的成功、成本和時間;以及DMT310或DMT410的任何正在進行或計劃中的臨床試驗結果是否會導致未來的產品開發。這些聲明僅是基於當前信息和期望的預測,並涉及衆多風險和不確定性。實際事件或結果可能因各種因素與這些聲明中預測的情況存在重大差異,其中包括藥物開發、批准和商業化固有的風險與不確定性,以及臨床試驗的過去結果可能並不代表未來試驗結果的事實。有關這些和其他因素的討論,請參閱Dermata在證券交易委員會的備案文件。您被警告不要過分依賴這些前瞻性聲明,這些聲明僅代表本日期的意見。該警告是根據1995年《私人證券訴訟改革法》中的安全港條款做出的。所有前瞻性聲明均受到此警告聲明的完全限制,Dermata沒有義務修訂或更新本新聞稿,以反映本日期後的事件或情況,除非法律要求。
德瑪達治療股份有限公司
資產負債表
| | 2024年9月 | | | 2023年12月31日 | |
以千美元計 | | (未經審計) | | | | |
資產 | | | | | | |
現金及現金等價物 | | $ | 6,144 | | | $ | 7,438 | |
預付費用及其他流動資產 | | | 543 | | | | 541 | |
總資產 | | | 6,687 | | | | 7,979 | |
負債 | | | | | | | | |
應付賬款 | | | 864 | | | | 866 | |
應計負債 | | | 1,082 | | | | 757 | |
總負債 | | | 1,946 | | | | 1,623 | |
股權 | | | 4,741 | | | | 6,356 | |
總負債和權益 | | $ | 6,687 | | | $ | 7,979 | |
德瑪達治療股份有限公司
損益表
(未經審計)
| | 截至9月30日季度 | | | 截至9月30日的九個月 | |
| | 2024 | | | 2023 | | | 2024 | | | 2023 | |
以千爲單位,除股數和每股數據外 | | | | | | | | | | | | |
運營費用 | | | | | | | | | | | | |
研究和開發(1) | | $ | 2,401 | | | $ | 903 | | | $ | 6,011 | | | $ | 2,935 | |
總行政費用 (1) | | | 824 | | | | 909 | | | | 3,302 | | | | 2,887 | |
總營業費用 | | | 3,225 | | | | 1,812 | | | | 9,313 | | | | 5,822 | |
營業損失 | | | (3,225) | | | | (1,812) | | | | (9,313) | | | | (5,822) | |
利息收入,淨額 | | | 52 | | | | 93 | | | | 176 | | | | 161 | |
淨虧損 | | $ | (3,173) | | | $ | (1,719) | | | $ | (9,137) | | | $ | (5,661) | |
| | | | | | | | | | | | | | | | |
普通股每股淨虧損,基本和稀釋 | | $ | (2.04) | | | $ | (8.09) | | | $ | (10.22) | | | $ | (36.91) | |
已發行普通股的加權平均數(基本和攤薄) | | | 1,554,680 | | | | 212,544 | | | | 894,168 | | | | 153,380 | |
| | | | | | | | | | | | | | | | |
(1) 包括以下股票基礎的補償費用 | | | | | | | | | | | | | | | | |
研發 | | $ | 5 | | | $ | 48 | | | $ | 247 | | | $ | 145 | |
一般和行政 | | $ | 16 | | | $ | 83 | | | $ | 381 | | | $ | 248 | |
投資者:
克利夫·馬斯特里科拉
投資者關係
cmastricola@dermatarx.com
資料來源:Dermata Therapeutics
在accesswire.com上查看原始新聞稿
發佈時間爲2024年11月13日