New Risk • May 14
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$8.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$8.3m free cash flow). Share price has been highly volatile over the past 3 months (20% average weekly change). Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 5x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.95m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$9.7m net loss next year). Aankondiging • Apr 09
Dermata Therapeutics, Inc., Annual General Meeting, May 27, 2026 Dermata Therapeutics, Inc., Annual General Meeting, May 27, 2026. New Risk • Jan 22
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 10% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (476% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.45m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$9.0m net loss next year). New Risk • Jan 08
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.3m free cash flow). Earnings are forecast to decline by an average of 10% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (476% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.66m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$9.0m net loss next year). Share price has been volatile over the past 3 months (15% average weekly change). New Risk • Sep 04
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (418% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.02m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$9.8m net loss next year). Share price has been volatile over the past 3 months (11% average weekly change). Aankondiging • Jul 08
Dermata Therapeutics, Inc. Announces Panel Grants Company’s Request for an Exception Until August 14, 2025 As previously reported, on May 14, 2025, Dermata Therapeutics, Inc. received a letter from the Listing Qualifications Department of The Nasdaq Stock Market LLC indicating that, based upon the closing bid price of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), for the prior 30 consecutive business days, the Company was not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). The Staff further indicated that, based upon the Company’s implementation of a reverse stock split within the prior one-year period, the Company’s securities were subject to delisting from the Nasdaq Capital Market and would be suspended at the opening of business on May 23, 2025. The Company timely requested a hearing before the Panel, which request stayed any further suspension or delisting action by Nasdaq, pending the ultimate conclusion of the hearing process. On July 2, 2025, the Panel notified the Company that it has granted Company’s request for an exception until August 14, 2025, to demonstrate compliance with the Minimum Bid Price Requirement. Pursuant to the Exception, the Company is required to provide the Panel with prompt notification of any significant events that occur, including any event that may call into question the Company’s ability to satisfy the terms of the Exception. The Company is actively pursuing measures to regain compliance with the Minimum Bid Price Requirement, including seeking shareholder approval for a reverse stock split at its annual stockholders meeting on July 15, 2025, and if approved, implementing a reverse stock split. There can be no assurance that the Company will be able to regain compliance and maintain its listing on the Nasdaq Capital Market. If the Company does not regain compliance, or if the Company fails to satisfy another Nasdaq requirement for continued listing, Nasdaq could provide notice that the Company’s securities will become subject to delisting. Aankondiging • May 26
Dermata Therapeutics, Inc., Annual General Meeting, Jul 15, 2025 Dermata Therapeutics, Inc., Annual General Meeting, Jul 15, 2025. Aankondiging • May 17
Dermata Therapeutics Regains Compliance with the Minimum Stockholders’ Equity Requirement and Receives Written Notice from Nasdaq Due to Non-Compliance with the Minimum Bid Price Requirement As previously reported, on March 25, 2025, Dermata Therapeutics, Inc. (the ‘Company’) received a letter from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market (‘Nasdaq’) notifying the Company that it was no longer in compliance with the minimum stockholders’ equity requirement for continued listing on the Nasdaq Capital Market, pursuant to Nasdaq Listing Rule 5550(b)(1) (‘Stockholder’s Equity Requirement’). On May 14, 2025, the Company received a letter from the Staff indicating that as of May 14, 2025, the Company has regained compliance with the Stockholder’s Equity Requirement and the matter is now closed. On May 14, 2025, the Company received a written notice (the ‘Notice’) from the Staff indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the ‘Bid Price Requirement’). The Staff further indicated that, based upon the Company’s implementation of a reverse stock split within the prior one-year period, the Company’s securities are subject to delisting from the Nasdaq Capital Markets and will be suspended at the opening of business on May 23, 2025, unless the Company requests a hearing before the Nasdaq Hearings Panel (the ‘Panel’) by May 21, 2025. The Company plans to request a hearing before the Panel prior to May 21, 2025, which request will stay any further suspension or delisting action by Nasdaq, pending the ultimate conclusion of the hearing process. However, there can be no assurance that the Company’s compliance plan will be accepted or that if it is, the Company will be able to regain compliance and maintain its listing on the Nasdaq Capital Market. If the Company’s plan to regain compliance is not accepted or if Nasdaq does not grant an extension and the Company does not regain compliance, or if the Company fails to satisfy another Nasdaq requirement for continued listing, Nasdaq could provide notice that the Company’s securities will become subject to delisting. New Risk • May 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$10m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$10m free cash flow). Earnings are forecast to decline by an average of 23% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 11x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.23m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$12m net loss next year). Aankondiging • Apr 16
Dermata Therapeutics, Inc. Announces Yymngari Phase 3 Star-1 Clinical Study Design Dermata Therapeutics is a late-stage biotechnology company focusing on the treatment of medical skin diseases and aesthetic applications. The Company's lead product candidate, XYNGARI, is currently in Phase 3 and is the Company's first product candidate being developed from its Spongilla technology platform. XYNGARI is a once-weekly, topical product candidate derived from a naturally sourced freshwater sponge with multiple unique mechanisms of action. In addition to acne, XYNGARI is being studied for the treatment of psoriasis and rosacea. The Company's second product candidate, DMT410, uses its XYNGARI product candidate as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic applications and medical skin diseases. Dermata is headquartered in San Diego, California. These statements are based on the Company's current beliefs and expectations and new risks may emerge from time to time. Aankondiging • Mar 27
Dermata Therapeutics, Inc. Announces Positive Topline Results from First Pivotal Phase 3 Trial of Yymngari Dermata Therapeutics, Inc. announced positive topline results from the Company's first pivotal Phase 3 trial of XYNGARI™?, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. XYNGARITM also appeared to be safe and well tolerated by patients with minimal treatment related adverse events and no serious adverse events attributed to treatment. The XYNGARI™? Phase 3 STAR-1 clinical study evaluated the efficacy, safety, and tolerability of XYNGARI™? in patients with moderate-to-severe facial acne. The STAR-1 study was a randomized (2:1), double-blind, and placebo-controlled study which enrolled 520 patients with moderate-to- severe acne, ages 9 years and older in the United States and Latin America. The STAR-1 study is the first of two pivotal Phase 3 studies, with the second Phase 3 study to be followed by an extension study. If positive, the results of the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration. If the STAR-2 study produces positive results, the Phase 3 program will help support the filing of a new Drug application with the U.S., Food and Drug Administration. Aankondiging • Mar 26
Dermata Therapeutics Receives Non-Compliance Letter from Nasdaq Regarding Minimum Stockholders' Equity Requirement On March 25, 2025, Dermata Therapeutics, Inc. (the Company") received a letter (the Letter") from The Nasdaq Capital Market (Nasdaq") notifying the Company that it is no longer in compliance with the minimum stockholders' equity requirement for continued listing on the Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires listed companies to maintain stockholders' equity of at least $2.5 million. In the Company's Annual Report on Form 10-K for the year ended December 31, 2024, the Company reported stockholders' equity of approximately $1.6 million, which is below the required minimum. In addition, as of March 25, 2025, the Company does not meet the alternative compliance standards relating to the market value of listed securities or net income from continuing operations. The Letter has no immediate effect on the listing of the Company's securities, which will continue to be listed and traded on the Nasdaq Capital Market. Nasdaq has provided the Company with 45 calendar days, or until May 9, 2025, to either regain compliance with the minimum stockholders' equity standard or submit a plan to regain compliance. If the Company's plan to regain compliance is accepted, Nasdaq may grant an extension until September 21, 2025, for the Company to regain compliance. The Company is presently evaluating various courses of action to regain compliance and intends to timely submit a plan to Nasdaq to regain compliance with the Nasdaq Listing Rule 5550(b)(1). However, there can be no assurance that the Company's compliance plan will be accepted or that if it is, the Company will be able to regain compliance and maintain its listing on the Nasdaq Capital Market. If the Company's plan to regain compliance is not accepted or if Nasdaq does not grant an extension until September 21, 2025 and the Company does not regain compliance by May 9, 2025, or if the Company fails to satisfy another Nasdaq requirement for continued listing, Nasdaq could provide notice that the Company's securities will become subject to delisting. In such event, Nasdaq rules permit the Company to request a hearing before an independent Hearings Panel which has the authority to grant the Company an extension of time of up to 180 calendar days to regain compliance. Aankondiging • Mar 04
Dermata Therapeutics, Inc. Announces Last Patient Completes Last Visit in Pivotal Xymngari Phase 3 Star-1 Clinical Trial for Acne Dermata Therapeutics, Inc. announced that the last patient has completed their last visit in the Company's first pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) trial of XYNGARI, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. The Company remains on track to announce topline data by the end of March 2025. Their efforts helped keep this pivotal Phase 3 trial on schedule. The company could not have completed this study without their contribution. Throughout the conduct of the study, the company have had great interest from clinical sites, investigators, and study participants as the develop XYNGARI, which could potentially change how acne is treated. The XYNGARI Phase 3 STAR-1 clinical study will evaluate the efficacy, safety, and tolerability of XYNGARI in patients with moderate-to-severe facial acne. The STAR-1 study was a randomized (2:1), double-blind, and placebo-controlled study enrolling 520 patients with moderate-to- severe acne, ages 9 years and older in the United States and Latin America. The STAR-1 study is the first of two pivotal Phase 3 studies, of which the second Phase 3 study will be followed by an extension study. If positive, the results the Phase 3 program would be used to support the filing of a new drug application with the U.S. Food and Drug Administration. The Company's lead product candidate, XYNGARI, is the first product candidate being developed from its Spongilla technology platform. The Company's second product candidate, DMT410, uses its XYNGARI product candidate as a new method for needle-free intradermal delivery of botulinum toxin for the treatment of multiple aesthetic and medical skin conditions and diseases. Aankondiging • Jan 23
Dermata Therapeutics, Inc. announced that it has received $2.550008 million in funding Dermata Therapeutics, Inc. announced that it has entered into definitive agreements to issue 2,007,880 shares of common stock and accompanying warrants to purchase up to 2,007,880 shares of common stock at a purchase price of $1.27 per share of common stock for proceeds of $2,550,007.6 on January 23, 2025. The warrants will have an exercise price of $1.27 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares issuable upon exercise of the warrants and will expire five years from the effective date of stockholder approval. The closing of the offering is expected to occur on or about January 23, 2025, subject to the satisfaction of customary closing conditions. Company insiders, including the Company's Chief Executive Officer, Chief Financial Officer and certain members of the Company's board of directors, are participating in the offering. The purchase price per share of common stock (or per pre-funded warrant in lieu thereof) and accompanying warrant for these Company insiders is the same purchase price as paid by other investors in the offering. Aankondiging • Dec 17
Dermata Therapeutics, Inc. Receives Approval from FDA for the Proprietary Name Xyngarifor for Its Phase 3 Clinical Drug Candidate in Acne Dermata Therapeutics, Inc. announced that it received approval from U.S. Food and Drug Administration (FDA) of the proprietary name, Xyngari (pronounced zin-gar-ee) (formerly DMT310), for its Phase 3 clinical drug candidate in acne. The proprietary name, Xyngari, is approved pending the successful submission and acceptance of a new drug application (NDA). The Xyngari Phase 3 Spongilla Treatment of Acne Research (STAR-1) clinical study will evaluate the efficacy, safety, and tolerability of Xyngari in patients with moderate-to-severe facial acne. The STAR-1 study is a randomized (2:1), double-blind, and placebo-controlled study with 520 patients enrolled with moderate-to-severe acne, ages 9 years and older in the United States and Latin America. The primary endpoints include the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response. IGA is measured on a 5-point scale (0-4), with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients are treated once-a-week for 12 weeks with either Xyngari or placebo and are evaluated monthly. The STAR-1 study is the first of two pivotal Phase 3 studies required by the FDA, of which the second Phase 3 study will be followed by an extension study. If positive, the results from both Phase 3 studies would be used to support the filing of an NDA with FDA. Aankondiging • Dec 12
Dermata Therapeutics, Inc. Receives Notice of Allowance for New U.S. Patent for DMT310 for the Treatment of Acne Dermata Therapeutics, Inc. announced receipt of a notice of allowance from the United States Patent and Trademark Office of a new patent for its DMT310 product candidate for the treatment of acne. The allowed patent application, entitled "Compositions and methods for the treatment of skin conditions" (U.S. Application No. 17/420,635), further strengthens Dermata's intellectual property for DMT310. DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. DMT310 has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. DMT310 also observed almost 45% of patients achieving an IGA score of clear or almost clear compared with less than 18% of placebo patients achieving the same at the end of 12 weeks. Aankondiging • Dec 04
Dermata Therapeutics, Inc. Completes Enrollment in First Pivotal DMT310 Phase 3 Star-1 Clinical Trial for Acne Dermata Therapeutics, Inc. announced that it has successfully completed enrollment in its pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) study of DMT310, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. The STAR-1 study is the first of two Phase 3 studies that, if positive, would be used by Dermata to support the filing of a new drug application (NDA) for DMT310 for the treatment of moderate- to-severe acne. The DMT310 Phase 3 STAR-1 clinical study data will evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne. The STAR-1 trial is a randomized (2:1), double-blind, and placebo-controlled study enrolling 520 patients with moderate-to- severe acne, ages 9 years and older in the United States and Latin America. Patients are treated once-a-week for 12 weeks with either DMT310 or placebo and are evaluated monthly. The STAR-1 study are the first of two pivotal Phase 3 studies, of which the second Phase 3 study will be followed by an extension study. If positive, the results from both Phase 3 studies would be used to support the filing of an NDA with FDA. New Risk • Nov 15
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.4m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.4m free cash flow). Share price has been highly volatile over the past 3 months (19% average weekly change). Earnings are forecast to decline by an average of 9.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 6x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.80m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$14m net loss in 2 years). New Risk • Aug 09
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$7.7m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.7m free cash flow). Share price has been highly volatile over the past 3 months (39% average weekly change). Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (226% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.82m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 2 years (US$16m net loss in 2 years). Aankondiging • Jul 18
Dermata Therapeutics, Inc. Announces Achievement of 50% Enrollment in Pivotal Dmt310 Phase 3 Star-1 Clinical Trial for Acne Dermata Therapeutics, Inc. announced that it has successfully enrolled 50% of patients in its pivotal Phase 3 Spongilla Treatment for Acne Research (STAR-1) study of DMT310, a novel, once-weekly, topical product candidate for the treatment of moderate-to-severe acne. The STAR-1 study is the first of two Phase 3 studies that, if positive, would be used by the Company to support the filing of a new drug application (NDA) for DMT310 for the treatment of moderate- to-severe acne. The DMT310 Phase 3 clinical program will include two Phase 3 clinical trials to evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne. Each Phase 3 trial will be randomized (2:1), double-blind, and placebo-controlled, enrolling approximately 550 patients with moderate-to- severe acne, ages 9 years and older in the United States and Latin America. Patients will be treated once a week for 12 weeks with either DMT310 or placebo and will be evaluated monthly. STAR-1 is the first of two pivotal Phase 3 trials, of which the second Phase 3 study will be followed by a long-term extension study. If positive, the results from the Phase 3 program would be used to support the filing of an NDA with FDA. Aankondiging • May 25
Dermata Therapeutics Regains Compliance with Listing Rule 5550(a)(4) On May 20, 2024, Dermata Therapeutics, Inc. (the ‘Company’) received a written letter from the Listing Qualifications Department (the ‘Staff’) of The Nasdaq Stock Market (‘Nasdaq’) informing the Company that it was not in compliance with Listing Rule 5550(a)(4)(the ‘Rule’), which requires the Company to have at least 500,000 publicly held shares to maintain a listing on Nasdaq. Based on additional information provided to the Staff by the Company, the Staff notified the Company that as of May 24, 2024, the Company has regained compliance with the Rule and the listing matter was closed. Aankondiging • May 16
Dermata Therapeutics, Inc. Gets Nasdaq Extension to Regain Compliance As previously reported, on November 15, 2023, Dermata Therapeutics, Inc. (the Company") received a letter from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") indicating that, based upon the closing bid price of the Company's common stock, par value $0.0001 per share (the Common Stock"), for the prior 30 consecutive business days, the Company was not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set in Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Price Requirement"). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a grace period of 180 days, or until May 13, 2024, to regain compliance with the Minimum Bid Price Requirement. On May 14, 2024, the Company received a letter from Nasdaq advising that the Company had been granted a 180-day extension to November 11, 2024, to regain compliance with the Minimum Bid Price Requirement. As previously disclosed on May 14, 2024, in order to regain compliance with the Minimum Bid Price Requirement, the Company has filed a Certificate of Amendment to the Company's Amended and Restated Certificate of Incorporation with the Secretary of State of the State of Delaware which will effect, at 12:01 a.m. Eastern Time, on May 16, 2024, a one-for-fifteen (1:15) reverse stock split of the Company's issued and outstanding shares of Common Stock. There can be no assurance, however, that the Company will be able to regain compliance with the Minimum Bid Price Requirement or that it will otherwise be in compliance with other Nasdaq listing rules within the 180-day compliance period. The Company will continue to monitor the closing bid price of its Common Stock. If the Company does not regain compliance within the allotted compliance period, Nasdaq will provide notice that the Company's Common Stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. New Risk • Mar 27
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 19% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 19% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (179% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.69m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$15m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Aankondiging • Mar 27
Dermata Therapeutics, Inc., Annual General Meeting, May 07, 2024 Dermata Therapeutics, Inc., Annual General Meeting, May 07, 2024, at 09:00 Pacific Standard Time. Agenda: To elect three director nominees to serve as directors until the 2027 annual meeting of stockholders; to approve an amendment to the Dermatan therapeutics, inc. 2021 omnibus equity incentive plan in substantially the form attached to the accompanying proxy statement as annex a, to increase the maximum aggregate number of shares of common stock, par value $0.0001, per share which shall be reserved for issuance under the 2021 plan to 1,198,951 shares and the annual evergreen portion of the overall share limit such that the number; to ratify the appointment of moss Adams LLP as the company’s independent registered public accounting firm for the year ending December 31, 2024 (the “auditor proposal”); and to discuss other matters. New Risk • Mar 23
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.1m free cash flow). Earnings are forecast to decline by an average of 1.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (179% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.77m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$4.7m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). New Risk • Jan 17
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.1m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (360% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.60m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$7.4m net loss in 3 years). Aankondiging • Dec 21
Dermata Therapeutics, Inc. Enrolls First Patient in Pivotal DMT310 Phase 3 STAR-1 Clinical Trial for Acne Dermata Therapeutics, Inc. announced that it successfully enrolled the first patient in its pivotal DMT310 Phase 3 Spongilla Treatment for Acne Research (STAR-1) study. The STAR-1 study is the first of two Phase 3 studies that, if positive, will be used by the Company to support the filing of a new drug application (NDA) for DMT310 for the treatment of moderate-to-severe acne. The DMT310 Phase 3 clinical program will include two Phase 3 clinical trials to evaluate the efficacy, safety, and tolerability of DMT310 in patients with moderate-to-severe facial acne. Each Phase 3 trial will be randomized (2:1), double-blind, and placebo-controlled, enrolling approximately 550 patients with moderate-to-severe acne, ages 9 years and older in the United States and Latin America. The primary endpoints are the mean change from baseline in inflammatory and noninflammatory lesion counts and the Investigator Global Assessment (IGA) treatment response rate. IGA is measured on a 5-point scale (0-4), with a treatment response defined as at least a 2-point improvement from baseline and an IGA score of 0 (clear) or 1 (almost clear). Patients will be treated once a week for 12 weeks with either DMT310 or placebo and will be evaluated monthly. STAR-1 is the first of two pivotal Phase 3 trials, which will be followed by a long-term extension study. If positive, the results from both Phase 3 clinical trials will be used to support the filing of an NDA with FDA. DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. DMT310 has multiple mechanisms of action that include mechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria), and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. DMT310 also observed almost 45% of patients achieve an IGA score of clear or almost clear compared with less than 18% of placebo patients achieving the same at the end of 12 weeks. New Risk • Nov 08
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.9m free cash flow). Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 8.3% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (405% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.65m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). New Risk • Aug 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$7.9m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.9m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings are forecast to decline by an average of 4.6% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (453% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.60m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Aankondiging • Jun 28
Dermata Therapeutics, Inc. Announces Positive Feedback from FDA on the DMT310 Phase 3 Clinical Development Program in Moderate-To-Severe Acne Dermata Therapeutics, Inc. announced that following the Company's receipt of FDA responses to its End of Phase 2 meeting package, the Company's DMT310 Phase 3 clinical development program for the once-weekly topical treatment of patients with moderate-to-severe acne is on track to begin in the second half of 2023. The Company submitted data from its Phase 1 and 2 clinical trials, as well as a nonclinical data package supporting the efficacy, safety, and tolerability of DMT310 for the treatment of moderate-to-severe acne for its Phase 3 clinical development program. FDA provided written responses to the Company's End of Phase 2 meeting package including an agreement that the Company's nonclinical program appears reasonable to support Phase 3 clinical trials, the overall Phase 3 clinical development program appears acceptable for filing a New Drug Application (NDA), the three co-primary endpoints and secondary endpoints proposed in the Phase 3 clinical trial protocols are acceptable, and 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 plans to submit final updated protocols to FDA shortly. Based on FDA's feedback, the Company anticipates that the Phase 3 clinical program will consist of two independent pivotal trials and an extension study. Each pivotal trial will evaluate the efficacy, safety, andolerability of DMT310 in patients with moderate-to- severe facial acne. Patients will be treated weekly with DMT310 and will be followed for 12 months to evaluate long-term safety. DMT310 is a novel, once-weekly, topical product candidate derived from a freshwater sponge being developed for the treatment of multiple skin diseases. It has multiple mechanisms of action that includemechanical components and chemical compounds to help treat inflammatory skin diseases, like acne. After processing, the sponge powder contains precisely sized and shaped silica spicules that upon application may help exfoliate the skin, promote collagen production, open closed comedones (creating an aerobic environment to help kill C. acne bacteria) and create microchannels to facilitate penetration of the sponge's naturally occurring chemical compounds. These chemical compounds have been shown, in-vitro, to have both antimicrobial and anti-inflammatory properties, which may play a significant role in the treatment of inflammatory skin diseases. DMT310 has previously shown its treatment effect in moderate-to-severe acne in a Phase 2b study where DMT310 applied once weekly, achieved statistically significant results at all timepoints for all primary and secondary endpoints. Aankondiging • Jun 24
Dermata Therapeutics, Inc., Annual General Meeting, Aug 03, 2023 Dermata Therapeutics, Inc., Annual General Meeting, Aug 03, 2023, at 09:00 Pacific Standard Time. Agenda: To elect three director nominees to serve as directors until the 2026 annual meeting of stockholders; to ratify the appointment of Mayer Hoffman Mccann p.c. as company independent registered public accounting firm for the year ending December 31, 2023; to approve an amendment to the Dermata therapeutics, inc. 2021 omnibus equity incentive plan (the “2021 plan”) to increase the number of the shares of common stock authorized for issuance thereunder by 513,150 shares to 629,069 shares; and to consider any other matters that may properly come before the annual meeting. Aankondiging • Jun 09
Dermata Therapeutics, Inc. Announces Positive Results from its DMT310 Phase 2b Study of Its Once-Weekly Topical Treatment in Patients with Moderate-To-Severe Acne Vivis Dermata Therapeutics, Inc. announced that positive results from its DMT310 Phase 2b study of its once-weekly topical treatment in patients with moderate-to-severe acne vulgaris was published in the prestigious, peer-reviewed Journal of the American Academy of Dermatology (JAAD) and can by found at this link. The study found that once-weekly topical treatment with DMT310 resulted in significant improvements across multiple efficacy endpoints at 12 weeks in patients with moderate-to -severe acne when compared with placebo. DMT310 Phase 2b Trial Design: The DMT310 Phase 2b randomized, double-blind, placebo-controlled trial was designed to evaluate the efficacy, safety, and tolerability of DMT310 applied once-weekly in 181 participants 12 years of age and older with moderate-to-severe facial acne. Participants were randomized in a 1:1 ratio to receive either DMT310 mixed with 6 ml of 3% hydrogen peroxide or placebo mixed with 6 ml of 3% hydrogen peroxide. The assigned study drug was applied to the entire face once-weekly for 12 weeks. DMT310 Phase 2b Key Findings: All primary and secondary efficacy endpoints were met. DMT310 demonstrated statistically significant reductions in inflammatory (-15.6 vs. -10.8, p < 0.01) and noninflammatory (-18.3 vs. -12.4, p < 0.01) lesion counts at week 12 when compared to placebo. Notably, DMT310 patients experienced an early statistically significant effect in the percent reductions from baseline in inflammatory (-45.2% vs. -23.8%, p < 0.001) and noninflammatory (-36.4% vs. -14.3%, p < 0.001) lesion counts at week 4 when compared to placebo. DMT310 also demonstrated statistically significant improvements in IGA at all time points with a responder defined as having a 2-grade change and an IGA score of 0 (clear) or 1 (almost clear). DMT310 appeared to be safe and well tolerated with no drug-related serious adverse events reported during the 12-week study. Price Target Changed • Apr 06
Price target decreased by 96% to US$4.00 Down from US$96.00, the current price target is provided by 1 analyst. New target price is 251% above last closing price of US$1.14. Stock is down 94% over the past year. The company is forecast to post a net loss per share of US$5.01 next year compared to a net loss per share of US$13.92 last year. Aankondiging • Dec 17
Nasdaq Grants Dermata Therapeutics A 180-Day Extension to Regain Compliance with the Minimum Bid Price Requirement As previously reported, on June 17, 2022, Dermata Therapeutics, Inc. (the “Company”) received a letter from the Listing Qualifications Department (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, based upon the closing bid price of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), for the prior 30 consecutive business days, the Company was not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq, as set forth in Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company was provided a grace period of 180 days, or until December 14, 2022, to regain compliance with the Minimum Bid Price Requirement. On December 15, 2022 the Company received a letter from Nasdaq advising that the Company had been granted a 180-day extension to June 12, 2023, to regain compliance with the Minimum Bid Price Requirement. The Company will continue to monitor the closing bid price of its Common Stock and may, if appropriate, consider implementing available options, including but not limited to, implementing a reverse stock split of its outstanding securities, to regain compliance with the Minimum Bid Price Requirement. If the Company does not regain compliance within the allotted compliance period, Nasdaq will provide notice that the Company’s Common Stock will be subject to delisting. The Company would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that the Company will regain compliance with the Minimum Bid Price Requirement during this 180-day extension. Aankondiging • Dec 06
Dermata Therapeutics, Inc. Announces Topline Results from Its Phase 2 Trial of Once-Weekly Topical Application of DMT310 for the Treatment of Moderate-To-Severe Rosacea Dermata Therapeutics, Inc. announced topline results from its Phase 2 trial of once-weekly topical application of DMT310 for the treatment of moderate-to-severe rosacea. DMT310 is Dermata's lead product candidate, with both mechanical and chemical mechanisms of action, with positive Phase 2 data in moderate-to-severe acne and Phase 1b data in mild-to-moderate psoriasis. DMT310 is Dermata's lead product candidate and incorporates the Company's proprietary Spongilla technology to topically treat a variety of dermatological skin diseases and conditions. DMT310 is a multifactorial natural product candidate derived from Spongilla lacustris, a unique freshwater sponge that is harvested under specific environmental conditions and then processed into a powder. The powder is mixed with a fluidizing agent immediately prior to its once-weekly application. In addition to its mechanical components which create microchannels into the dermis and promote skin turnover, DMT310's organic components contain chemical compounds that when tested in vitro have shown a dose dependent inhibition of inflammatory mediators, which they believe play a role in a variety of skin diseases. Board Change • Nov 16
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Brittany Bradrick was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Jun 23
Dermata Therapeutics, Inc. Receives Written Notice from the Listing Qualifications Department of Nasdaq for Compliance with the $1.00 Minimum Bid Price Requirement On June 17, 2022, Dermata Therapeutics, Inc. received a written notice (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Bid Price Requirement”). The Notice does not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company’s common stock for the last 30 consecutive business days, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days in which to regain compliance, or until December 14, 2022. If at any time during this period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the “Staff”) will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a hearings panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company’s receipt of the Notice does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. Aankondiging • Jun 02
Dermata Therapeutics, Inc., Annual General Meeting, Jul 11, 2022 Dermata Therapeutics, Inc., Annual General Meeting, Jul 11, 2022, at 09:00 Pacific Standard Time. Agenda: To elect two director nominees to serve as directors until the 2025 annual meeting of stockholders; to ratify the appointment of Mayer Hoffman Mccann p.c. as independent registered public accounting firm for the year ending December 31, 2022; to approve an amendment to company's amended and restated certificate of incorporation, to increase the company’s authorized shares of common stock from 90,000,000 to 250,000,000; and to consider any other matters that may properly come before the annual meeting. Board Change • Apr 27
High number of new directors There are 6 new directors who have joined the board in the last 3 years. Independent Director Brittany Bradrick was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Mar 04
Dermata Therapeutics, Inc. Receives Correspondence from the U.S. Food and Drug Administration for Waiver Request for the Requirements to Complete a 90-Day Dermal Toxicity Dermata Therapeutics, Inc. received correspondence from the U.S. Food and Drug Administration (the “FDA”) regarding the Company’s submitted waiver request for the requirements to complete a 90-day dermal toxicity minipig study and a standard pharmacokinetic (“PK”) study prior to holding an End of Phase 2 meeting with the FDA for the Company’s DMT310 acne program. The FDA has confirmed the Company should complete a 90-day dermal minipig study and PK study prior to initiating the Phase 3 acne program. The FDA agreed with the dosing and treatment timeline proposed by the Company for the 90-day dermal minipig study. The Company plans to initiate the 90-day dermal minipig study in the first half of 2022. Accordingly, the Company plans to request an End of Phase 2 meeting with the FDA in the first half of 2023 and begin the Phase 3 acne program in the first half of 2023. The FDA also informed the Company that the requirement to conduct certain pharmacology studies and systemic toxicity studies may be waived if the Company can demonstrate limited systemic exposure of DMT310 in the minipig and PK studies. Aankondiging • Feb 06
Dermata Therapeutics, Inc. Submits Requests to the U.S. Food and Drug Administration for the Waiver of the Requirements to Complete A 90-Day Dermal Minipig Study and a Standard Dermal Pharmacokinetic Study Dermata Therapeutics, Inc. (the “Company”) has submitted requests to the U.S. Food and Drug Administration (the “FDA”) for the waiver of the requirements to complete a 90-day dermal minipig study and a standard dermal pharmacokinetic study prior to holding an End of Phase 2 meeting with the FDA for the Company’s DMT310 acne program. While the Company has already planned and budgeted to conduct both studies, the Company submitted the requests for waiver because DMT310 has been used in clinical trials by over 170 human patients exhibiting an acceptable safety and tolerability profile. Further, the Company was given approval by the FDA to use DMT310 in the Company’s ongoing 180 human patient Phase 2 study for the treatment of rosacea. Typically, the FDA requires the 90-day dermal minipig study to be conducted prior to filing an Investigational New Drug application and proceeding to trials in humans for a topical dermatology development product candidate. However, due in part to DMT310’s historical safety profile and the Company’s ability to reference the FDA’s Botanical Drug Development Guidance for Industry for certain aspects of the development of DMT310, the FDA allowed DMT310 to proceed directly into human trials without first completing this 90-day dermal minipig study. Considering the human safety data collected from DMT310 clinical trials and the historical safety data collected to date, the Company believes the FDA may grant the waiver request with respect to the 90-day dermal minipig study. If the FDA grants the waiver request with respect to conducting a 90-day dermal minipig study, the Company believes it would provide a cost savings of approximately $600,000 in development costs. Alternatively, the FDA may waive the Company’s requirement to complete the 90-day dermal minipig study prior to initiating the Phase 3 acne program, but still require the study be completed prior to a New Drug Application submission. The Company has also submitted a request to the FDA for the waiver of the requirement to conduct the standard dermal pharmacokinetic study. The Company submitted this request for waiver based on the human tolerability and safety profile of DMT310 observed to date. If the FDA grants both waiver requests, the Company plans to immediately request an End of Phase 2 meeting with the FDA and begin the process to initiate the Company’s Phase 3 acne program in the second half of 2022. If the FDA grants the Company’s waiver request only with respect to the 90-day dermal minipig study, the Company believes it can still complete the standard dermal pharmacokinetic study and initiate the Phase 3 program in 2022, as planned. If the FDA grants the waiver request only with respect to the standard dermal pharmacokinetic study, or denies both of waiver requests, the Company may be forced to delay the start of its Phase 3 program into 2023 due to supply chain constraints relating to the acquisition of the required minipigs used in the 90-day dermal minipig study. Board Change • Jan 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Steven Mento was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Executive Departure • Sep 03
Chief Financial Officer Thomas Insley has left the company On the 1st of September, Thomas Insley's tenure as Chief Financial Officer ended after 6.3 years in the role. We don't have any record of a personal shareholding under Thomas' name. Thomas is the only executive to leave the company over the last 12 months. Aankondiging • Aug 14
Dermata Therapeutics, Inc. has completed an IPO in the amount of $17.999996 million. Dermata Therapeutics, Inc. has completed an IPO in the amount of $17.999996 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 2,571,428
Price\Range: $7
Transaction Features: Sponsor Backed Offering Board Change • Aug 13
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 3 non-independent directors. Independent Director Kathy Scott was the last independent director to join the board, commencing their role in 2021. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model.