Dermata Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
Dermata Therapeutics Provides Corporate Update and Reports Second Quarter 2023 Financial Results
- Raised an aggregate of $6.8 million in gross proceeds from two financings completed in 1H 2023 -
-2023年上半年完成的兩筆融資共籌集了680萬美元的總收益-
- Received positive feedback on its End of Phase 2 meeting package from FDA in June 2023 -
-2023 年 6 月,收到了美國食品和藥物管理局對其第二階段結束會議套餐的積極反饋-
- Phase 3 STAR-1 study is projected to start enrolling patients in the 2H 2023 -
-第三階段 STAR-1 研究預計將於 2023 年下半年開始招收患者-
SAN DIEGO, CA / ACCESSWIRE / August 10, 2023 / Dermata Therapeutics, Inc. (Nasdaq: DRMA; DRMAW) ("Dermata," or the "Company"), a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin diseases and conditions, today highlighted recent corporate progress, and reported financial results for the second quarter ended June 30, 2023.
加利福尼亞州聖地亞哥/ACCESSWIRE /2023 年 8 月 10 日 / 專注於治療醫學和美容皮膚病和病症的臨床階段生物技術公司Dermata Therapeutics, Inc.(納斯達克股票代碼:DRMA;DRMAW)(“Dermata” 或 “公司”)今天重點介紹了最近的公司進展,並公佈了截至2023年6月30日的第二季度財務業績。
"The second quarter was another crucial period for our team where we successfully raised additional capital to extend our runway into the second quarter of 2024 and we received positive feedback from FDA on our End of Phase 2 meeting package. We are excited that FDA agreed that our Phase 3 clinical study design appeared acceptable to support filing a new drug application and we have submitted amendments to the Phase 3 protocols to include some additional safety testing as recommended by FDA," said Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We are currently completing the manufacturing of the drug product and placebo batches for the Phase 3 clinical trials in anticipation of final agreement with FDA to initiate the Phase 3 clinical program," concluded Mr. Proehl.
“第二季度對我們的團隊來說是又一個關鍵時期,我們成功籌集了額外資金,將跑道延長到2024年第二季度,我們收到了美國食品藥品管理局對第二階段結束會議套餐的積極反饋。令我們感到高興的是,美國食品藥品管理局同意我們的3期臨床研究設計似乎可以接受以支持提交新藥申請,而且我們已經提交了對3期協議的修正案,納入了FDA建議的一些額外安全測試。” Dermata董事長、總裁兼首席執行官格里·普羅爾說。Proehl先生總結說:“我們目前正在完成3期臨床試驗的藥品和安慰劑批次的生產,預計將與FDA達成最終協議,啓動3期臨床計劃。”
Corporate Highlights
企業要聞
- Dermata successfully closed a $1.8 million offering in May 2023 priced at-the-market under Nasdaq rules. The Compnay closed a registered direct offering of an an aggregate of 800,877 shares of the Company's common stock (or pre-funded warrants in lieu thereof) and accompanying warrants to purchase up to 800,877 shares of common stock at a combined offering price of $2.285 per share of common stock (or pre-funded warrant in lieu thereof) and accompanying warrant, for aggregate gross proceeds of $1.8 million, before deducting the placement agent's fees and other offering expenses payable by the Company.
- FDA provided responses to the Company's End of Phase 2 Meeting Package in June 2023. The Company received responses from FDA on the Company's End of Phase 2 meeting package including an agreement that (1) the Company's nonclinical program appears reasonable to support Phase 3 clinical trials, (2) the overall Phase 3 clinical development program appears acceptable to support filing a New Drug Application (NDA), (3) the three co-primary endpoints and secondary endpoints proposed in the Phase 3 clinical trial protocols are acceptable, and (4) the completed and planned nonclinical studies would be sufficient to support the submission of an NDA. Additionally, at the recommendation of FDA, the Company has agreed to include additional safety evaluations (laboratory measurements, electrocardiograms, and an extension study) in the Phase 3 clinical program and the Company has submitted final amended protocols to FDA.
- 根據納斯達克的規定,Dermata於2023年5月成功完成了180萬美元的發行。 公司完成了總共800,877股公司普通股(或代替普通股的預先注資的認股權證)的註冊直接發行,以及隨附的認股權證,以每股普通股(或代替普通股的預先注資的認股權證)和隨附的認股權證購買了多達800,877股普通股,總收益爲180萬美元,然後扣除配售代理人的費用和公司應支付的其他發行費用。
- 美國食品和藥物管理局於2023年6月對公司的第二階段結束會議套餐做出了回應。 公司收到了美國食品藥品管理局對公司第二階段結束會議一攬子計劃的回應,其中包括(1)該公司的非臨床計劃似乎可以合理地支持3期臨床試驗;(2)支持提交新藥申請(NDA)的整個第三階段臨床開發計劃似乎可以接受;(3)第三階段臨床試驗方案中提出的三個共同主要終點和次要終點是可以接受的,以及(4)已完成和計劃中的非臨床研究足以支持保密協議的提交.此外,根據美國食品藥品管理局的建議,公司已同意在第三階段臨床計劃中納入額外的安全評估(實驗室測量、心電圖和延伸研究),並且公司已向美國食品和藥物管理局提交了最終修正方案。
Anticipated Upcoming Milestones
即將到來的預期里程碑
- Initiate DMT310 Phase 3 Program in Moderate-to-Severe Acne. After receiving responses from FDA on the amended Phase 3 clinical trial protocols, the Company intends to initiate its DMT310 Phase 3 STAR-1 study in 2H 2023. STAR-1 will be the first of two Phase 3 clinical studies the Company will need to complete prior to filing an NDA. If the Phase 3 program is successful, the Company intends to submit an NDA to FDA seeking regulatory approval of DMT310 for the treatment of moderate-to-severe acne.
- DMT410 Partnership Discussions. The Company continues to pursue partnership discussions for its DMT410 program for the topical delivery of botulinum toxin.
- 在中度至重度痤瘡中啓動 DMT310 第 3 階段計劃。 在收到美國食品藥品管理局對修訂後的第三期臨床試驗方案的回應後,該公司打算在2023年下半年啓動其 DMT310 3 期 STAR-1 研究。STAR-1 將是公司在提交保密協議之前需要完成的兩項第 3 期臨床研究中的第一項。如果第 3 階段計劃取得成功,公司打算向 FDA 提交保密協議,尋求監管部門批准 DMT310 用於治療中度至重度痤瘡。
- DMT410 合作伙伴關係討論。 該公司繼續就其局部輸送肉毒毒素的 DMT410 計劃進行合作伙伴關係討論。
Second Quarter 2023 Financial Results
2023 年第二季度財務業績
As of June 30, 2023, Dermata had $8.4 million in cash and cash equivalents, compared to $6.2 million as of December 31, 2022. The increase in cash and cash equivalents resulted from $5.7 million net proceeds from the financing that closed in March 2023 and May 2023, offset by $3.5 million of cash used in operations for the six months ended June 30, 2023. Dermata expects its current cash resources are sufficient to fund operations into the second quarter of 2024.
截至2023年6月30日,Dermata擁有840萬美元的現金及現金等價物,而截至2022年12月31日爲620萬美元。現金及現金等價物的增加源於2023年3月和2023年5月完成的融資淨收益爲570萬美元,但被截至2023年6月30日的六個月中用於運營的350萬美元現金所抵消。Dermata預計,其目前的現金資源足以爲2024年第二季度的運營提供資金。
Research and development expenses were $0.8 million for the quarter ended June 30, 2023, compared to $1.6 million for the quarter ended June 30, 2022. The decrease in research and development expenses was due to decreased clinical expenses, offset by increased non-clinical and chemicals, manufacturing, and controls expenses for the DMT310 program.
截至2023年6月30日的季度,研發支出爲80萬美元,而截至2022年6月30日的季度爲160萬美元。研發費用的減少是由於臨床費用減少,但被 DMT310 計劃的非臨床和化學品、製造和控制費用增加所抵消。
General and administrative expenses were $0.9 million for the quarter ended June 30, 2023, compared to $1.1 million for the quarter ended June 30, 2022, resulting from decreases in payments for insurance policy premiums.
截至2023年6月30日的季度一般和管理費用爲90萬美元,而截至2022年6月30日的季度爲110萬美元,這是由於保單保費支付額的減少。
About Dermata Therapeutics
關於 Dermata Therapeut
Dermata Therapeutics, Inc. is a clinical-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. 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 product candidate, DMT410, uses its Spongilla technology 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
Dermata Therapeutics, Inc. 是一家臨床階段的生物技術公司,專注於治療醫學和美容皮膚疾病和病症。該公司的主要候選產品 DMT310 是該公司在其基礎上開發的第一款候選產品 Spongilla 技術平台。DMT310 是一種每週一次的外用候選產品,源自天然來源的淡水海綿,具有多種獨特的作用機制。DMT310 已被研究用於治療痤瘡、酒渣鼻和牛皮癬。該公司的第二個候選產品 DMT410 使用了其 Spongilla 技術是局部皮內輸送肉毒桿菌毒素的新方法,用於治療多汗症和多種皮膚美容疾病。Dermata 總部位於加利福尼亞州聖地亞哥。欲了解更多信息,請訪問
Forward-Looking Statements
前瞻性陳述
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; 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.
本新聞稿中嚴格來說不是歷史性質的陳述是前瞻性陳述。這些陳述基於公司當前的信念和期望,可能會不時出現新的風險。前瞻性陳述受已知和未知風險、不確定性、假設和其他因素的影響,包括但不限於與以下內容相關的陳述:對與監管機構舉行會議的時間和/或回應的預期;對提交保密協議時間的預期;臨床試驗固有的不確定性;對公司任何候選產品任何潛在合作機會的預期;公司對當前現金和現金的預期等效物及其爲運營提供資金的時間;其候選產品 DMT310 和 DMT410 開發活動以及正在進行和計劃中的臨床試驗的成功、成本和時機;以及 DMT310 或 DMT410 的任何正在進行或計劃中的臨床試驗的結果是否會導致未來的產品開發。這些陳述只是基於當前信息和預期的預測,涉及許多風險和不確定性。由於各種因素,包括藥物開發、批准和商業化所固有的風險和不確定性,以及過去的臨床試驗結果可能無法預示未來的試驗結果,實際事件或結果可能與任何此類陳述中的預測存在重大差異。有關這些因素和其他因素的討論,請參閱Dermata向美國證券交易委員會提交的文件。提醒您不要過分依賴這些前瞻性陳述,這些陳述僅代表截至本文發佈之日。這種謹慎態度是根據1995年《私人證券訴訟改革法》的安全港條款提出的。所有前瞻性陳述均受本警告聲明的全部限制,除非法律要求,否則Dermata沒有義務修改或更新本新聞稿以反映本新聞稿發佈之日之後的事件或情況。
DERMATA THERAPEUTICS, INC.
Balance Sheets
DERMATA THERAPEUTICS, INC
資產負債表
June 30, 2023 | December 31, 2022 | ||||
In 000's |
(unaudited) | ||||
Assets |
|||||
Cash and cash equivalents |
$ | 8,439 | $ | 6,241 | |
Prepaid expenses and other current assets |
274 | 703 | |||
Total assets |
8,713 | 6,944 | |||
Liabilities |
|||||
Accounts payable |
438 | 496 | |||
Accrued liabilities |
245 | 426 | |||
Total liabilities |
683 | 922 | |||
Equity |
8,030 | 6,022 | |||
Total liabilities and equity |
$ | 8,713 | $ | 6,944 |
2023年6月30日 | 2022年12月31日 | ||||
在千年代 |
(未經審計) | ||||
資產 |
|||||
現金和現金等價物 |
$ | 8,439 | $ | 6,241 | |
預付費用和其他流動資產 |
274 | 703 | |||
總資產 |
8,713 | 6,944 | |||
負債 |
|||||
應付賬款 |
438 | 496 | |||
應計負債 |
245 | 426 | |||
負債總額 |
683 | 922 | |||
公平 |
8,030 | 6,022 | |||
負債和權益總額 |
$ | 8,713 | $ | 6,944 |
DERMATA THERAPEUTICS, INC.
Statements of Operations
DERMATA THERAPEUTICS, INC
運營聲明
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
In 000's, except share and per share data |
(unaudited) | (unaudited) | (unaudited) | (unaudited) | |||||||
Operating expenses |
|||||||||||
Research and development (1)
|
$ | 839 | $ | 1,613 | $ | 2,032 | $ | 3,208 | |||
General and administrative (1)
|
893 | 1,118 | 1,979 | 2,308 | |||||||
Total operating expenses |
1,732 | 2,731 | 4,010 | 5,516 | |||||||
Loss from operations |
(1,732) | (2,731) | (4,010) | (5,516) | |||||||
Interest income, net |
(31) | - | (69) | - | |||||||
Net loss |
$ | (1,701) | $ | (2,731) | $ | (3,942) | $ | (5,516) | |||
Net loss per common share, basic and diluted |
$ | (0.63) | $ | (3.90) | $ | (2.13) | $ | (9.02) | |||
Weighted average common shares outstanding, basic and diluted |
2,704,987 | 699,679 | 1,850,167 | 611,344 | |||||||
(1) Includes the following stock-based compensation expense: |
|||||||||||
Research and development |
$ | 48 | $ | 53 | $ | 97 | $ | 109 | |||
General and administrative |
$ | 83 | $ | 208 | $ | 166 | $ | 366 |
截至6月30日的三個月 | 截至6月30日的六個月 | ||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||
以 000 年代爲單位,股票和每股數據除外 |
(未經審計) | (未經審計) | (未經審計) | (未經審計) | |||||||
運營費用 |
|||||||||||
研究和開發 (1)
|
$ | 839 | $ | 1,613 | $ | 2,032 | $ | 3,208 | |||
一般和行政 (1)
|
893 | 1,118 | 1,979 | 2,308 | |||||||
運營費用總額 |
1,732 | 2,731 | 4,010 | 5,516 | |||||||
運營損失 |
(1,732) | (2,731) | (4,010) | (5,516) | |||||||
淨利息收入 |
(31) | - | (69) | - | |||||||
淨虧損 |
$ | (1,701) | $ | (2,731) | $ | (3,942) | $ | (5,516) | |||
每股普通股淨虧損,基本虧損和攤薄後 |
$ | (0.63) | $ | (3.90) | $ | (2.13) | $ | (9.02) | |||
已發行普通股、基本股和攤薄後加權平均值 |
2,704,987 | 699,679 | 1,850,167 | 611,344 | |||||||
(1) 包括以下股票薪酬支出: |
|||||||||||
研究和開發 |
$ | 48 | $ | 53 | $ | 97 | $ | 109 | |||
一般和行政 |
$ | 83 | $ | 208 | $ | 166 | $ | 366 |
Investors:
Sean Proehl
Senior Director, Legal and Business Development
info@dermatarx.com
投資者:
肖恩·普羅爾
法律和業務發展高級總監
info@dermatarx.com
SOURCE: Dermata Therapeutics
來源: Dermata Therapeu