Dermata Therapeutics Provides Corporate Update and Reports Full Year 2022 Financial Results
Dermata Therapeutics Provides Corporate Update and Reports Full Year 2022 Financial Results
- End of Phase 2 meeting with FDA for DMT310 for moderate-to-severe acne expected in 2Q 2023 -
-与FDA就DMT310治疗中重度痤疮的第二阶段会议结束，预计2023年第二季度-
- Initiation of DMT310 Phase 3 clinical trial program in moderate-to-severe acne patients expected in 2H 2023 -
-预计2023年下半年在中至重度痤疮患者中启动DMT310阶段3临床试验计划-
- DMT410 partnering discussions ongoing -
-DMT410合作讨论正在进行-
SAN DIEGO, CA / ACCESSWIRE / February 21, 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 conditions, today highlighted recent corporate progress, and reported financial results for the year ended December 31, 2022.
加利福尼亚州圣迭戈/ACCESSWIRE/2023年2月21日/皮玛塔治疗公司(纳斯达克：DRMA；DRMAW)(以下简称“皮玛”或“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技术公司，今天重点介绍了公司最近的进展，并报告了截至2022年12月31日的一年的财务业绩。
"We are very excited for what Dermata has planned for 2023 for both our DMT310 and DMT410 programs," said Gerry Proehl, Dermata's Chairman, President, and Chief Executive Officer. "We believe advancing the DMT310 acne program into Phase 3 will be a significant step for our company. I am confident that our team can continue forward progress and build upon the results we saw in our positive DMT310 Phase 2b acne study,in which almost 45% of patients achieved an investigator global assessment, or IGA, score of 'clear' or 'almost clear' at the end of the 12-week clinical study. We are also encouraged by the progress made to further develop DMT410 as a potential method to topically deliver botulinum toxin for hyperhidrosis and aesthetic skin conditions."
德马塔董事长兼首席执行官格里·普罗尔表示：“我们对德马塔在2023年为我们的DMT310和DMT410项目制定的计划感到非常兴奋。”我们相信，将DMT310痤疮计划推进到第三阶段将是我们公司的重要一步。我相信，我们的团队能够继续前进，并在我们的阳性DMT310阶段2b痤疮研究中看到的结果的基础上再接再厉，在为期12周的临床研究结束时，近45%的患者获得了调查员全球评估或IGA评分‘无障碍’或‘几乎无障碍’。我们还对进一步开发DMT410作为局部注射肉毒杆菌毒素治疗多汗症和美容皮肤疾病的潜在方法的进展感到鼓舞。“
Anticipated Upcoming Milestones
预期即将到来的里程碑
- Type C Meeting Request with FDA on DMT310 Chemistry, Manufacturing, and Controls (CMC) questions. Dermata has submitted a Type C meeting request to FDA with questions in order to receive feedback related to the CMC of DMT310 for Phase 3 and, if successful, a new drug application, or NDA, to FDA. The company expects to receive feedback from FDA in 1H 2023.
- DMT310 End of Phase 2 Meeting with FDA. Dermata plans to request an end of Phase 2 meeting with FDA in 2Q 2023. Feedback from FDA will help guide Dermata's design of its DMT310 Phase 3 clinical trial program in moderate-to-severe acne patients.
- DMT310 Phase 3 Program in Moderate-to-Severe Acne. After receiving feedback from the end of Phase 2 meeting with FDA, the Company intends to initiate its DMT310 Phase 3 clinical trial acne program in 2H 2023. If the Phase 3 program is successful, the Company intends to submit an NDA to FDA seeking regulatory approval of DMT310 for moderate-to-severe acne.
- DMT410 Partnership Discussions. Dermata continues to move forward with partnership discussions surrounding its DMT410 program for the topical delivery of botulinum toxin.
- 与FDA就DMT310化学、制造和控制(CMC)问题进行C类会议请求。Dermata已经向FDA提交了C型会议请求，并提出了问题，以便收到与DMT310在第三阶段的CMC相关的反馈，如果成功，还将向FDA提交新药申请或NDA。该公司预计将在2023年上半年收到FDA的反馈。
- DMT310结束与FDA的第二阶段会议。Dermata计划要求在2023年第二季度结束与FDA的第二阶段会议。来自FDA的反馈将有助于指导Dermata在中到重度痤疮患者中设计其DMT310阶段3临床试验计划。
- DMT310治疗中重度痤疮的3期方案。在收到FDA第二阶段会议结束后的反馈后，该公司打算在2023年下半年启动其DMT310第三阶段临床试验痤疮计划。如果第三阶段计划成功，该公司打算向FDA提交一份保密协议，寻求监管部门批准DMT310用于中到重度痤疮。
- DMT410合作伙伴关系讨论。德玛塔继续围绕其用于肉毒杆菌毒素局部递送的DMT410计划进行合作谈判。
Full Year 2022 Financial Results
2022年全年财务业绩
As of December 31, 2022, Dermata had $6.2 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 3Q 2023.
截至2022年12月31日，德玛塔拥有620万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。德玛塔预计，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 $5.7 million for the year ended December 31, 2022, compared to $3.5 million for the year ended December 31, 2021. The increase in research and development expenses was due to increased clinical, non-clinical, and CMC expenses for the DMT310 program. Stock-based compensation expense attributable to research and development totaled $0.2 million for the year ended December 31, 2022, compared to $0.4 million for the year ended December 31, 2021.
截至2022年12月31日的一年，研发费用为570万美元，而截至2021年12月31日的一年，研发费用为350万美元。研究和开发费用的增加是由于DMT310计划的临床、非临床和CMC费用增加。在截至2022年12月31日的一年中，可归因于研发的基于股票的薪酬支出总计20万美元，而截至2021年12月31日的一年为40万美元。
General and administrative expenses were $4.0 million for the year ended December 31, 2022, compared to $4.4 million for the year ended December 31, 2021. Stock-based compensation expense attributable to general and administrative totaled $0.7 million for the year ended December 31, 2022, compared to $1.6 million for the year ended December 31, 2021.
截至2022年12月31日的一年，一般和行政费用为400万美元，而截至2021年12月31日的一年为440万美元。在截至2022年12月31日的一年中，可归因于一般和行政的基于股票的薪酬支出总计为70万美元，而截至2021年12月31日的一年为160万美元。
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 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
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是该公司从其海绵技术平台。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已被研究用于治疗痤疮、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 meetings and/or responses from submissions with regulatory bodies; 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：与向监管机构提交的会议和/或回应的时间有关的预期；临床试验中固有的不确定性；对公司任何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物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；以及任何正在进行或计划中的DMT310或DMT410临床试验的结果是否会导致未来的产品开发。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。
DERMATA THERAPEUTICS, INC.
(Formerly Dermata Therapeutics, LLC)
Balance Sheets
DERMATA治疗公司
(前Demata Treateutics，LLC)
资产负债表
| December 31, 2022 | December 31, 2021 | |||||
In thousands, except share and per share data |
||||||
Assets |
||||||
Cash and cash equivalents |
$ | 6,241 | $ | 10,799 | ||
Prepaid expenses and other current assets |
703 | 825 | ||||
Total assets |
6,944 | 11,624 | ||||
Liabilities |
||||||
Accounts payable |
496 | 515 | ||||
Accrued liabilities |
426 | 1,002 | ||||
Total liabilities |
922 | 1,517 | ||||
Equity |
6,022 | 10,107 | ||||
Total liabilities and equity |
$ | 6,944 | $ | 11,624 | ||
| 2022年12月31日 | 2021年12月31日 | |||||
以千为单位，不包括共享和每股数据 |
||||||
资产 |
||||||
现金和现金等价物 |
$ | 6,241 | $ | 10,799 | ||
预付费用和其他流动资产 |
703 | 825 | ||||
总资产 |
6,944 | 11,624 | ||||
负债 |
||||||
应付帐款 |
496 | 515 | ||||
应计负债 |
426 | 1,002 | ||||
总负债 |
922 | 1,517 | ||||
权益 |
6,022 | 10,107 | ||||
负债和权益总额 |
$ | 6,944 | $ | 11,624 | ||
DERMATA THERAPEUTICS, INC.
(Formerly Dermata Therapeutics, LLC)
Statements of Operations
DERMATA治疗公司
(前Demata Treateutics，LLC)
营运说明书
| Years Ended December 31, | ||||||||
In thousands, except share and per share data |
2022 | 2021 | ||||||
Operating expenses |
||||||||
Research and development (1) |
$ | 5,651,041 | $ | 3,459,340 | ||||
General and administrative (1) |
4,023,445 | 4,397,524 | ||||||
Total operating expenses |
9,674,486 | 7,856,864 | ||||||
Loss from operations |
(9,674,486 | ) | (7,856,864 | ) | ||||
Interest (income) expense, net |
(63,573 | ) | 45,613 | |||||
Net loss |
$ | (9,610,913 | ) | $ | (7,902,477 | ) | ||
Deemed dividend upon redemption of 5,221,156 shares |
||||||||
of Series 1c preferred stock |
$ | - | $ | 269,038 | ||||
Deemed dividend upon the amendment of terms of |
$ | - | $ | 2,293,199 | ||||
the Series 1d convertible preferred stock |
||||||||
Net loss attributable to common stockholders |
$ | (9,610,913 | ) | $ | (10,464,714 | ) | ||
Net loss per common share, basic and diluted |
$ | (0.87 | ) | $ | (2.43 | ) | ||
Weighted average common shares outstanding, basic and diluted |
11,050,662 | 4,302,232 | ||||||
(1) Includes the following stock-based compensation expense |
||||||||
Research and development |
$ | 218,324 | $ | 354,201 | ||||
General and administrative |
$ | 712,001 | $ | 1,551,207 | ||||
| 截至十二月三十一日止的年度， | ||||||||
以千为单位，不包括共享和每股数据 |
2022 | 2021 | ||||||
运营费用 |
||||||||
研究与开发(1) |
$ | 5,651,041 | $ | 3,459,340 | ||||
一般事务和行政事务(1) |
4,023,445 | 4,397,524 | ||||||
总运营费用 |
9,674,486 | 7,856,864 | ||||||
运营亏损 |
(9,674,486 | ) | (7,856,864 | ) | ||||
利息(收入)费用净额 |
(63,573 | ) | 45,613 | |||||
净亏损 |
$ | (9,610,913 | ) | $ | (7,902,477 | ) | ||
赎回5,221,156股时当作股息 |
||||||||
系列1c优先股 |
$ | - | $ | 269,038 | ||||
条款修订后当作派发股息 |
$ | - | $ | 2,293,199 | ||||
系列1D可转换优先股 |
||||||||
普通股股东应占净亏损 |
$ | (9,610,913 | ) | $ | (10,464,714 | ) | ||
每股普通股基本亏损和摊薄后净亏损 |
$ | (0.87 | ) | $ | (2.43 | ) | ||
加权平均已发行普通股、基本普通股和稀释后普通股 |
11,050,662 | 4,302,232 | ||||||
(1)包括以下以股票为基础的薪酬支出 |
||||||||
研发 |
$ | 218,324 | $ | 354,201 | ||||
一般和行政 |
$ | 712,001 | $ | 1,551,207 | ||||
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
SOURCE: Dermata Therapeutics
资料来源：皮肤治疗学