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Dermata Therapeutics Provides Corporate Update and Reports Third Quarter 2022 Financial Results

Dermata Therapeutics Provides Corporate Update and Reports Third Quarter 2022 Financial Results

皮玛塔治疗公司提供公司最新情况并报告2022年第三季度财务业绩
Accesswire ·  2022/11/10 17:25

- DMT310 Phase 2 topline results in moderate-to-severe rosacea anticipated in December 2022 -

- 预计2022年12月,DMT310第二阶段背部治疗将导致中到重度酒渣鼻-

- Initiation of DMT310 Phase 3 for moderate-to-severe acne expected in 1H 2023 -

- DMT310 3期治疗中重度痤疮预计将于今年上半年启动 2023 -

SAN DIEGO, CA / ACCESSWIRE / November 10, 2022 / Dermata Therapeutics, Inc. (Nasdaq:DRMA;DRMAW) ("Dermata," or the "Company"), a clinical-stage biopharmaceutical company focusing on the treatment of medical and aesthetic skin conditions, today highlighted recent corporate progress, and reported financial results for the quarter ended September 30, 2022.

加利福尼亚州圣迭戈/ACCESSWIRE/2022年11月10日/德玛塔治疗公司(纳斯达克代码:DRMA;DRMAW)(以下简称“公司”)是一家专注于治疗医疗和美容皮肤疾病的临床阶段生物制药公司。该公司今天重点介绍了公司最近的进展,并报告了截至2022年9月30日的季度财务业绩。

"I am thrilled with all that Dermata has accomplished so far this year and plan to continue the momentum as we near the announcement of our DMT310 Phase 2 topline results in patients with moderate-to-severe rosacea," said Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We believe DMT310 as a once-weekly topical product candidate has the potential to change the treatment paradigm for acne and rosacea patients. We believe we can demonstrate this change by replicating the excellent results we saw in our DMT310 Phase 2b acne study in our DMT310 Phase 3 clinical program for the treatment of moderate-to-severe acne. Additionally, we look forward our continued partnering discussions for DMT410 to provide patients with more innovative treatment options."

德玛塔董事长兼首席执行官格里·普罗尔说:“我对德玛塔今年迄今所取得的成就感到兴奋,并计划在我们即将宣布我们的DMT310第二阶段背线治疗中重度酒渣鼻患者的结果时继续保持这一势头。”我们相信,DMT310作为一种每周一次的局部候选产品,有可能改变痤疮和酒渣鼻患者的治疗模式。我们相信,我们可以通过在我们的DMT310阶段3临床计划中复制我们在治疗中到重度痤疮的DMT310阶段2b痤疮研究中看到的出色结果来证明这一变化。此外,我们期待着我们继续与DMT410合作讨论,为患者提供更多创新的治疗选择。

Anticipated Upcoming Milestones

预期即将到来的里程碑

  • DMT310 Phase 2 topline results in moderate-to-severe rosacea. Dermata expects to announce topline results from its DMT310 Phase 2 study in rosacea in December 2022. The trial was a 12-week, double-blinded, randomized, placebo-controlled study with 180 patients. The co-primary endpoints were (i) absolute reduction in inflammatory lesion count and (ii) Investigator Global Assessment ("IGA"), which was graded on a 5-point scale (0-4). To be considered an IGA responder, a patient must have at least a 2-grade reduction and a score of 0 or 1 at week 12. Upon successful results, the Company will look to request an end of Phase 2 meeting with the FDA.
  • DMT310 Phase 3 program in moderate-to-severe acne. Dermata plans to request an end of Phase 2 meeting with the FDA in the first half of 2023. After receiving feedback from the FDA, the Company intends to initiate the DMT310 Phase 3 acne program, which will consist of two Phase 3 studies to support the submission of a new drug application to the FDA.
  • DMT310 2期背角线导致中到重度酒渣鼻。Demata预计将于2022年12月公布其在酒渣鼻DMT310第二阶段研究中的TOPLINE结果。这是一项为期12周的双盲、随机、安慰剂对照研究,共有180名患者参加。共同的主要终点是(I)炎性病变计数的绝对减少和(Ii)调查者总体评估(IGA),按5分制(0-4)进行分级。要被认为是IGA应答者,患者必须在第12周至少降低2级,评分为0或1。如果结果成功,公司将要求结束与FDA的第二阶段会议。
  • DMT310 3期方案治疗中重度痤疮。Dermata计划要求在2023年上半年结束与FDA的第二阶段会议。在收到FDA的反馈后,该公司打算启动DMT310第三阶段痤疮计划,该计划将包括两项第三阶段研究,以支持向FDA提交新药申请。

Third Quarter 2022 Financial Results

2022年第三季度财务业绩

As of September 30, 2022, Dermata had $8.1 million in cash and cash equivalents, compared to $10.8 million as of December 31, 2021. Dermata expects its current cash resources are sufficient to fund operations into the third quarter of 2023.

截至2022年9月30日,德玛塔拥有810万美元的现金和现金等价物,而截至2021年12月31日的现金和现金等价物为1080万美元。德马塔预计,其目前的现金资源足以为2023年第三季度的运营提供资金。

Research and development expenses were $1.6 million for the quarter ended September 30, 2022, compared to $0.8 million for the quarter ended September 30, 2021. The increase in research and development expenses was due to increased clinical, non-clinical, and chemistry, manufacturing, and controls, or CMC, expenses for the DMT310 program. Stock-based compensation expense attributable to research and development totaled $0.05 million for the quarter ended September 30, 2022 compared to $0.03 million for the quarter ended September 30, 2021.

截至2022年9月30日的季度,研究和开发支出为160万美元,而截至2021年9月30日的季度为80万美元。研发费用的增加是由于DMT310计划的临床、非临床和化学、制造和控制(CMC)费用的增加。截至2022年9月30日的季度,可归因于研究和开发的基于股票的薪酬支出总计为0.5万美元,而截至2021年9月30日的季度为30万美元。

General and administrative expenses were $0.9 million for the quarter ended September 30, 2022, compared to $0.9 million for the quarter ended September 30, 2021. Stock-based compensation expense attributable to general and administrative totaled $0.2 million for the quarter ended September 30, 2022 compared to $0.1 million for the quarter ended September 30, 2021.

截至2022年9月30日的季度,一般和行政费用为90万美元,而截至2021年9月30日的季度为90万美元。截至2022年9月30日的季度,可归因于一般和行政管理的股票薪酬支出总额为20万美元,而截至2021年9月30日的季度为10万美元。

About Dermata Therapeutics

关于皮肤治疗学

Dermata Therapeutics, Inc. is a clinical-stage biotechnology company focusing on the treatment of medical and aesthetic skin conditions. The Company's lead product candidate, DMT310, is the 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 is currently under clinical development 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

皮玛塔治疗公司是一家临床阶段的生物技术公司,专注于治疗医疗和美容皮肤疾病。该公司的主要候选产品DMT310是从其海绵技术平台。DMT310是一种每周一次的局部候选产品,来自天然来源的淡水海绵,具有多种独特的作用机制。DMT310目前正在临床开发中,用于治疗痤疮、酒渣鼻和牛皮癣。该公司的第二个候选产品DMT410使用其海绵这项技术是一种局部皮内注射肉毒杆菌毒素的新方法,用于治疗多汗症和多种美容皮肤状况。德玛塔的总部设在加利福尼亚州的圣地亚哥。欲了解更多信息,请访问

Forward-Looking Statements

前瞻性陈述

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 data events; expectations with regard to the timing of meetings and/or responses from submissions with regulatory bodies; expectations with regard to any potential partnership opportunities for the Company's product candidates; the Company's expectations with regard to current cash and cash equivalence 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 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.

本新闻稿中非严格意义上的历史性陈述为前瞻性陈述。这些陈述是基于公司目前的信念和预期,可能会不时出现新的风险。前瞻性陈述受已知和未知风险、不确定性、假设和其他因素的影响,这些因素包括但不限于:有关数据事件时间的预期;有关向监管机构提交的会议和/或答复的时间的预期;有关公司候选产品的任何潜在合作机会的预期;公司对当前现金和现金等价性以及为运营提供资金的时间的预期;其候选产品DMT310和DMT410的成功、成本和时机以及正在进行和计划中的临床试验;以及DMT310或DMT410的结果是否会引领未来的产品开发。这些陈述只是基于当前信息和预期的预测,涉及许多风险和不确定因素。由于各种因素,包括药物开发、批准和商业化所固有的风险和不确定性,以及过去的临床试验结果可能不能预示未来的试验结果,实际事件或结果可能与任何此类陈述中预测的结果大不相同。有关这些和其他因素的讨论,请参考德马塔提交给美国证券交易委员会的文件。告诫您不要过度依赖这些前瞻性陈述。, 仅以本合同日期为准。这种谨慎是根据1995年《私人证券诉讼改革法》的安全港条款作出的。所有前瞻性陈述均受本警示声明的约束,德玛塔没有义务修改或更新本新闻稿以反映本新闻稿发布后的事件或情况,除非法律另有要求。

Investors:

投资者:

Sean Proehl
Senior Director, Legal and Business Development
info@dermatarx.com

肖恩·普罗尔
董事高级法律和业务发展部
邮箱:Info@dermatarx.com

DERMATA THERAPEUTICS, INC.
(Formerly Dermata Therapeutics, LLC)
Balance Sheets

DERMATA治疗公司
(前Demata Treateutics,LLC)
资产负债表

September 30, 2022 December 31, 2021
In thousands, except share and per share data
(unaudited)
Assets
Cash and cash equivalents
$ 8,067 $ 10,799
Prepaid expenses and other current assets
908 825
Total assets
8,975 11,624
Liabilities
Accounts payable
484 515
Accrued liabilities
1,020 1,002
Total liabilities
1,504 1,517
Equity
7,471 10,107
Total liabilities and equity
$ 8,975 $ 11,624
2022年9月30日 2021年12月31日
以千为单位,不包括共享和每股数据
(未经审计)
资产
现金和现金等价物
$ 8,067 $ 10,799
预付费用和其他流动资产
908 825
总资产
8,975 11,624
负债
应付帐款
484 515
应计负债
1,020 1,002
总负债
1,504 1,517
权益
7,471 10,107
负债和权益总额
$ 8,975 $ 11,624

DERMATA THERAPEUTICS, INC.
(Formerly Dermata Therapeutics, LLC)
Statements of Operations
(unaudited)

DERMATA治疗公司
(前Demata Treateutics,LLC)
营运说明书
(未经审计)

Three Months Ended September 30, Nine Months Ended September 30,
2022 2021 2022 2021
In thousands, except share and per share data
(unaudited) (unaudited) (unaudited) (unaudited)
Operating expenses
Research and development (1)
$ 1,553 $ 800 $ 4,762 $ 2,348
General and administrative (1)
893 912 3,201 2,956
Total operating expenses
2,446 1,712 7,963 5,304
Loss from operations
(2,446 ) (1,712 ) (7,963 ) (5,304 )
Interest expense, net
(21 ) 1 (21 ) 46
Net loss
$ (2,425 ) $ (1,713 ) $ (7,942 ) $ (5,350 )
Deemed dividend upon redemption of 5,221,156 shares
of Series 1c preferred stock
$ - $ 269 $ - $ 269
Deemed dividend upon the amendment of terms of
$ - $ 2,293 $ - $ 2,293
the Series 1d convertible preferred stock
Net loss attributable to common stockholders
$ (2,425 ) $ (4,275 ) $ (7,942 ) $ (7,912 )
Net loss per common share, basic and diluted
$ (0.20 ) $ (0.86 ) $ (0.75 ) $ (2.69 )
Weighted average common shares outstanding, basic and diluted
12,276,394 4,980,306 10,622,277 2,945,351
(1) Includes the following stock-based compensation expense
Research and development
$ 55 $ 30 $ 163 $ 310
General and administrative
$ 180 $ 113 $ 546 $ 1,107
截至9月30日的三个月, 截至9月30日的9个月,
2022 2021 2022 2021
以千为单位,不包括共享和每股数据
(未经审计) (未经审计) (未经审计) (未经审计)
运营费用
研究与开发(1)
$ 1,553 $ 800 $ 4,762 $ 2,348
一般事务和行政事务(1)
893 912 3,201 2,956
总运营费用
2,446 1,712 7,963 5,304
运营亏损
(2,446 ) (1,712 ) (7,963 ) (5,304 )
利息支出,净额
(21 ) 1 (21 ) 46
净亏损
$ (2,425 ) $ (1,713 ) $ (7,942 ) $ (5,350 )
赎回5,221,156股时当作股息
系列1c优先股
$ - $ 269 $ - $ 269
条款修订后当作派发股息
$ - $ 2,293 $ - $ 2,293
系列1D可转换优先股
普通股股东应占净亏损
$ (2,425 ) $ (4,275 ) $ (7,942 ) $ (7,912 )
每股普通股基本亏损和摊薄后净亏损
$ (0.20 ) $ (0.86 ) $ (0.75 ) $ (2.69 )
加权平均已发行普通股、基本普通股和稀释后普通股
12,276,394 4,980,306 10,622,277 2,945,351
(1)包括以下以股票为基础的薪酬支出
研发
$ 55 $ 30 $ 163 $ 310
一般和行政
$ 180 $ 113 $ 546 $ 1,107

SOURCE: Dermata Therapeutics

资料来源:皮肤治疗学


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