share_log

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

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

皮瑪塔治療公司提供公司最新情況並報告2022年第三季度財務業績
Accesswire ·  2022/11/10 17:25

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

- 預計2022年12月,DMT310第二階段背部治療將導致中到重度酒渣鼻-

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

- DMT310 3期治療中重度痤瘡預計將於今年上半年啟動 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.

加利福尼亞州聖迭戈/ACCESSWIRE/2022年11月10日/德瑪塔治療公司(納斯達克代碼:DRMA;DRMAW)(以下簡稱“公司”)是一家專注於治療醫療和美容皮膚疾病的臨牀階段生物製藥公司。該公司今天重點介紹了公司最近的進展,並報告了截至2022年9月30日的季度財務業績。

"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."

德瑪塔董事長兼首席執行官格里·普羅爾説:“我對德瑪塔今年迄今所取得的成就感到興奮,並計劃在我們即將宣佈我們的DMT310第二階段背線治療中重度酒渣鼻患者的結果時繼續保持這一勢頭。”我們相信,DMT310作為一種每週一次的局部候選產品,有可能改變痤瘡和酒渣鼻患者的治療模式。我們相信,我們可以通過在我們的DMT310階段3臨牀計劃中複製我們在治療中到重度痤瘡的DMT310階段2b痤瘡研究中看到的出色結果來證明這一變化。此外,我們期待着我們繼續與DMT410合作討論,為患者提供更多創新的治療選擇。

Anticipated Upcoming Milestones

預期即將到來的里程碑

  • 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期背角線導致中到重度酒渣鼻。Demata預計將於2022年12月公佈其在酒渣鼻DMT310第二階段研究中的TOPLINE結果。這是一項為期12周的雙盲、隨機、安慰劑對照研究,共有180名患者參加。共同的主要終點是(I)炎性病變計數的絕對減少和(Ii)調查者總體評估(IGA),按5分制(0-4)進行分級。要被認為是IGA應答者,患者必須在第12周至少降低2級,評分為0或1。如果結果成功,公司將要求結束與FDA的第二階段會議。
  • DMT310 3期方案治療中重度痤瘡。Dermata計劃要求在2023年上半年結束與FDA的第二階段會議。在收到FDA的反饋後,該公司打算啟動DMT310第三階段痤瘡計劃,該計劃將包括兩項第三階段研究,以支持向FDA提交新藥申請。

Third Quarter 2022 Financial Results

2022年第三季度財務業績

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,德瑪塔擁有810萬美元的現金和現金等價物,而截至2021年12月31日的現金和現金等價物為1080萬美元。德馬塔預計,其目前的現金資源足以為2023年第三季度的運營提供資金。

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,研究和開發支出為160萬美元,而截至2021年9月30日的季度為80萬美元。研發費用的增加是由於DMT310計劃的臨牀、非臨牀和化學、製造和控制(CMC)費用的增加。截至2022年9月30日的季度,可歸因於研究和開發的基於股票的薪酬支出總計為0.5萬美元,而截至2021年9月30日的季度為30萬美元。

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,一般和行政費用為90萬美元,而截至2021年9月30日的季度為90萬美元。截至2022年9月30日的季度,可歸因於一般和行政管理的股票薪酬支出總額為20萬美元,而截至2021年9月30日的季度為10萬美元。

About Dermata Therapeutics

關於皮膚治療學

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

皮瑪塔治療公司是一家臨牀階段的生物技術公司,專注於治療醫療和美容皮膚疾病。該公司的主要候選產品DMT310是從其海綿技術平臺。DMT310是一種每週一次的局部候選產品,來自天然來源的淡水海綿,具有多種獨特的作用機制。DMT310目前正在臨牀開發中,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使用其海綿這項技術是一種局部皮內注射肉毒桿菌毒素的新方法,用於治療多汗症和多種美容皮膚狀況。德瑪塔的總部設在加利福尼亞州的聖地亞哥。欲瞭解更多信息,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 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.

本新聞稿中非嚴格意義上的歷史性陳述為前瞻性陳述。這些陳述是基於公司目前的信念和預期,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,這些因素包括但不限於:有關數據事件時間的預期;有關向監管機構提交的會議和/或答覆的時間的預期;有關公司候選產品的任何潛在合作機會的預期;公司對當前現金和現金等價性以及為運營提供資金的時間的預期;其候選產品DMT310和DMT410的成功、成本和時機以及正在進行和計劃中的臨牀試驗;以及DMT310或DMT410的結果是否會引領未來的產品開發。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因素。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,以及過去的臨牀試驗結果可能不能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預測的結果大不相同。有關這些和其他因素的討論,請參考德馬塔提交給美國證券交易委員會的文件。告誡您不要過度依賴這些前瞻性陳述。, 僅以本合同日期為準。這種謹慎是根據1995年《私人證券訴訟改革法》的安全港條款作出的。所有前瞻性陳述均受本警示聲明的約束,德瑪塔沒有義務修改或更新本新聞稿以反映本新聞稿發佈後的事件或情況,除非法律另有要求。

Investors:

投資者:

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

肖恩·普羅爾
董事高級法律和業務發展部
郵箱:Info@dermatarx.com

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

DERMATA治療公司
(前Demata Treateutics,LLC)
資產負債表

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
以千為單位,不包括共享和每股數據
(未經審計)
資產
現金和現金等價物
$ 8,067 $ 10,799
預付費用和其他流動資產
908 825
總資產
8,975 11,624
負債
應付帳款
484 515
應計負債
1,020 1,002
總負債
1,504 1,517
權益
7,471 10,107
負債和權益總額
$ 8,975 $ 11,624

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

DERMATA治療公司
(前Demata Treateutics,LLC)
營運説明書
(未經審計)

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日的三個月, 截至9月30日的9個月,
2022 2021 2022 2021
以千為單位,不包括共享和每股數據
(未經審計) (未經審計) (未經審計) (未經審計)
運營費用
研究與開發(1)
$ 1,553 $ 800 $ 4,762 $ 2,348
一般事務和行政事務(1)
893 912 3,201 2,956
總運營費用
2,446 1,712 7,963 5,304
運營虧損
(2,446 ) (1,712 ) (7,963 ) (5,304 )
利息支出,淨額
(21 ) 1 (21 ) 46
淨虧損
$ (2,425 ) $ (1,713 ) $ (7,942 ) $ (5,350 )
贖回5,221,156股時當作股息
系列1c優先股
$ - $ 269 $ - $ 269
條款修訂後當作派發股息
$ - $ 2,293 $ - $ 2,293
系列1D可轉換優先股
普通股股東應佔淨虧損
$ (2,425 ) $ (4,275 ) $ (7,942 ) $ (7,912 )
每股普通股基本虧損和攤薄後淨虧損
$ (0.20 ) $ (0.86 ) $ (0.75 ) $ (2.69 )
加權平均已發行普通股、基本普通股和稀釋後普通股
12,276,394 4,980,306 10,622,277 2,945,351
(1)包括以下以股票為基礎的薪酬支出
研發
$ 55 $ 30 $ 163 $ 310
一般和行政
$ 180 $ 113 $ 546 $ 1,107

SOURCE: Dermata Therapeutics

資料來源:皮膚治療學


View source version on accesswire.com:
在accesswire.com上查看源代碼版本:

声明:本內容僅用作提供資訊及教育之目的,不構成對任何特定投資或投資策略的推薦或認可。 更多信息
    搶先評論