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Dermata Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results

Dermata Therapeutics Provides Corporate Update and Reports Second Quarter 2024 Financial Results

Dermata治療提供企業更新和報告2024年第二季度財務結果
Accesswire ·  08/08 04:05

- DMT310 Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical trial has enrolled over 50% of patients

- DMT310第三階段海綿治療痤瘡研究(STAR-1)臨床試驗已招募超過50%的患者

- Dermata continues discussions with potential botulinum toxin partners for DMT410

- Dermata繼續與潛在肉毒毒素合作伙伴就DMT410進行討論

- Raised $2.3 million in net proceeds from financing completed in 2Q 2024

- 從2024年第二季度完成的融資中籌集了淨收益230萬美元

SAN DIEGO, CA / ACCESSWIRE / August 7, 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 second quarter ended June 30, 2024.

加利福尼亞州聖迭戈市/ ACCESSWIRE / 2024年8月7日 / Dermata Therapeutics,Inc.(納斯達克股票代碼:DRMA,DRMAW)("Dermata"或"公司")是一家致力於治療醫學和美容皮膚疾病的後期生物技術公司,今天強調了最近的公司進展並公佈了截至2024年6月30日的第二季度財務業績。

"We are excited to have enrolled over 50% of patients in our DMT310 Phase 3 STAR-1 trial, and we look forward to the second half of 2024 as our team continues to work diligently to complete enrollment of the DMT310 STAR-1 trial," commented Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We still believe that patient compliance is a considerable issue with current acne treatments and, if approved, DMT310 as a once-weekly, natural, topical product candidate with an acceptable tolerability profile could provide these patients with a unique product to potentially meet their treatment needs," concluded Mr. Proehl.

"我們很高興在DMT310第三階段STAR-1臨床試驗中招募了超過50%的患者,我們期待2024年下半年我們的團隊將繼續努力完成DMT310 STAR-1試驗的招募,"Gerry Proehl評論道,他是Dermata的董事長,總裁兼首席執行官。"我們仍然認爲,患者的服從度是目前痤瘡治療中相當大的問題,如果獲批,DMT310作爲一種每週一次的天然局部治療產品候選人,具有可接受的耐受性,可能爲這些患者提供獨特的產品,以滿足他們的治療需求,"Proehl先生總結道。

Anticipated Upcoming Milestones

預計即將到來的里程碑

  • Complete DMT310 Phase 3 STAR-1 clinical trial in moderate-to-severe acne. After achieving the 50% enrollment milestone in July 2024, Dermata still expects to receive topline results from STAR-1 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.
  • 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 Spongilla technology 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 acne, hyperhidrosis, and facial aesthetics.
  • 在招募2024年7月份達到50%的里程碑後,完成中度至重度痤瘡的DMT310第3期STAR-1臨床試驗。 STAR-1是公司需要完成的兩個第3期臨床試驗之一,包括一個長期延伸研究,然後再提交新藥申請。Dermata仍期望在2025年第一季度獲得STAR-1的最終報告結果。
  • DMT410夥伴關係討論。該公司繼續在其DMT410計劃的合作伙伴關係討論中取得進展,以實現通過頂部輸送肉毒毒素的目標。 DMT410是公司的組合治療方案,利用公司海綿技術的獨特機械特性,通過局部應用而不是通過針頭進行多次注射來促進肉毒毒素的皮內輸送。 該公司認爲DMT410有可能成爲面部美容、多汗症和痤瘡的首例治療方法。

Upcoming Conference Participation

即將舉行的會議

  • H.C. Wainwright 26th Annual Global Investment Conference September 9-11, 2024.Mr. Gerald Proehl, President and Chief Executive Officer of Dermata, will present anupdate on the Company's ongoing DMT310 Phase 3 program and corporate updates.
  • H.C. Wainwright第26屆全球投資會議,於2024年9月9日至11日舉行。Dermata的總裁兼首席執行官Gerald Proehl先生,將就公司正在進行的DMT310第三階段計劃和公司更新進行展示。

Second Quarter 2024 Financial Results

2024年第二季度財務結果

As of June 30, 2024, the Company had $4.9 million in cash and cash equivalents, compared to $7.4 million as of December 31, 2023. The $2.5 million decrease in cash and cash equivalents for the six months ended June 30, 2024, resulted from $4.8 million of cash used in operations offset by $2.3 million in net proceeds from the May 2024 warrant inducement financing. The Company expects its current cash resources to be sufficient to fund operations into the fourth quarter of 2024.

2024年6月30日結束的季度,研發費用爲200萬美元,而截至2023年6月30日的季度爲80萬美元。研發費用的增加是由於該公司的STAR-1臨床研究的臨床試驗費用增加,而2024年第二季度非臨床費用和化學、製造和控制費用減少,抵消了部分費用的增加。

Research and development expenses were $2.0 million for the quarter ended June 30, 2024, compared to $0.8 million for the quarter ended June 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 second quarter of 2024.

截至2024年6月30日的季度研究與開發費用爲200萬美元,而截至2023年6月30日的同期數爲80萬美元。研究和開發費用的增加是公司STAR-1臨床研究的臨床試驗費用的增加,而非臨床和化學,製造和控制費用在2024年第二季度有所下降。

General and administrative expenses were $0.9 million for the quarters ended June 30, 2024, and June 30, 2023.

截至2024年6月30日和2023年6月30日的季度普通和管理費用分別爲90萬美元。

About Dermata Therapeutics

關於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 Spongillatechnology 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 product candidate, DMT410, uses its Spongillatechnology 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.是一家後期生物技術公司,專注於治療醫學和美容皮膚疾病。該公司的首席產品候選藥物DMT310是該公司從其Spongillaplatform技術開發的第一種產品候選藥物,目前正在評估第三階段計劃中。 DMT310是從天然淡水海綿衍生出來的每週一次的局部產品候選藥物,具有多種獨特的作用機制。DMT310已被研究用於治療痤瘡,酒渣鼻和銀屑病。該公司的第二個產品候選藥物DMT410使用其Spongillatechnology作爲頂部皮內輸送肉毒毒素的新方法,用於治療多汗症和多種美容皮膚條件。 Dermata總部位於加利福尼亞州聖地亞哥。如需更多信息,請訪問。

Forward-Looking Statements

前瞻性聲明

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.

本新聞公告中與過去嚴格歷史無關的聲明均爲前瞻性聲明。這些聲明基於公司當前的信念和預期,新的風險可能會不時出現。前瞻性聲明面臨着已知和未知的風險、不確定性、假設和其他因素,包括但不限於:與會議的時間和/或監管部門提交的回覆相關的預期;在臨床試驗中的風險和不確定性,包括及時招募足夠的患者或是否能按計劃完成試驗;時間和產生臨床數據的能力;關於任何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以及其資金運營的時間;其候選者DMT310和DMT410的開發活動和進行的持續和計劃臨床試驗的成功、成本和時間,以及是否會有進一步的產品開發;任何進行中或計劃中的DMT310或DMT410臨床試驗的結果是否會導致未來的產品開發。這些聲明僅基於當前的信息和預期,涉及到許多風險和不確定性。實際事件或結果可能會因各種因素而與此類聲明中所預示的情況不同,包括與藥物開發、批准和商業化有關的風險和不確定性, 以及臨床試驗的過去結果可能並不預示未來的結果。有關這些和其他因素的討論,請參閱Dermata提交的證券交易委員會文件。請注意,不能過度依賴這些前瞻性聲明,它們僅在此處作爲1995 年私人證券訴訟改革法案的安全港規定下的聲明。本警示僅對完整的前瞻性聲明有限制性的效力,Dermata不會在此之後就任何事件或情況進行修訂或更新,除非法律規定。

DERMATA THERAPEUTICS, INC.
Balance Sheets

德瑪達治療股份有限公司
資產負債表

June 30,
2024

December 31, 2023

In thousands USD

(unaudited)

Assets
Cash and cash equivalents

$

4,947

$

7,438

Prepaid expenses and other current assets

289

541

Total assets

5,236

7,979

Liabilities
Accounts payable

1,327

866

Accrued liabilities

591

757

Total liabilities

1,918

1,623

Equity

3,318

6,356

Total liabilities and equity

$

5,236

$

7,979

2020年6月30日
2024

2023年12月31日

以千美元爲單位

(未經審計)

資產
現金及現金等價物

$

4,947

$

7,438

資產預付款和其他流動資產的變動

289

541

總資產

5,236

7,979

負債
應付賬款

1,327

866

應計負債

591

757

負債合計

1918

1,623

股權

3,318

6,356

負債和股東權益總額

$

5,236

$

7,979

DERMATA THERAPEUTICS, INC.
Statements of Operations
(unaudited)

德瑪達治療股份有限公司
損益表
(未經審計)

Quarter Ended June 30,

Six Months Ended June 30,

2024

2023

2024

2023

In thousands, except share and per share data
Operating expenses
Research and development (1)

$

2,009

$

839

$

3,610

$

2,032

General and administrative (1)

875

893

2,477

1,979

Total operating expenses

2,884

1,732

6,087

4,011

Loss from operations
(2,884) (1,732) (6,087) (4,011)
Interest income, net

55

31

124

69

Net loss

$

(2,829)

$

(1,701)

$

(5,963)

$

(3,942)
Net loss per common share, basic and diluted

$

(4.18)

$

(9.43)

$

(10.64)

$

(31.96)
Weighted average common shares outstanding, basic and diluted

676,567

180,332

560,282

123,344

(1) Includes the following stock-based compensation expense
Research and development

$

5

$

48

$

242

$

97

General and administrative

$

15

$

83

$

365

$

166

截至6月30日的季度

截至6月30日的六個月

2024

2023

2024

2023

以千爲單位,除股份和每股數據外
營業費用
研究和開發(1)

$

2,009

$

839

$

3,610

$

2,032

總行政費用 (1)

875

893

2,477

1,979

營業費用總計

2,884

1,732

6,087

4,011

經營虧損
(2,884) (1732美元) (6,087) (4,011)
利息收入,淨額

55

31

124

69

淨虧損

$

(2,829)

$

(1,701)

$

(5,963)

$

(3,942)
普通股每股淨虧損,基本和稀釋

$

(4.18)

$

(9.43)

$

(10.64)

$

(31.96)
普通股基本和稀釋平均股數

676,567

180,332

560,282

123,344

(1)包括以下股份補償費用
研發

$

5

$

48

$

242

$

97

普通和管理

$

15

$

83

$

365

$

166

Investors:
Sean Proehl
Associate General Counsel
info@dermatarx.com

投資者:
Sean Proehl
副總顧問
info@dermatarx.com

SOURCE: Dermata Therapeutics

資料來源:Dermata Therapeutics


譯文內容由第三人軟體翻譯。


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