UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____ to ______ Commission File Number: 001-40739 DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in the charter) (State or other jurisdiction of (I.R.S. E ...

S-1 1 drma_s1.htm FORM S-1 As filed with the Securities and Exchange Commission on July 7, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3218736 (I.R.S. Employer Identificatio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended March 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Transition Period from _____ to ______ Commission File Number: 001-40739 DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in the charter) (State or other jurisdiction of (I.R.S. ...

S-1/A 1 drma_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission March 16, 2023 Registration No. 333-270195 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 3 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3218736 (Primary Standard Industrial Classification Code Number) ( ...

S-1/A 1 drma_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission March 15, 2023 Registration No. 333-270195 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Please send copies of all communications to: (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3218736 (Primary Stan ...

S-1/A 1 drma_s1a.htm FORM S-1/A As filed with the Securities and Exchange Commission March 13, 2023 Registration No. 333-270195 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3218736 (Primary Standard Industrial Classification Code Number) ( ...

As filed with the Securities and Exchange Commission March 1, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 S-1 1 drma_s1.htm FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3218736 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification No.) 3525 ...

Financial Performance - The company incurred net losses of approximately $9.6 million and $7.9 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of approximately $45.6 million as of December 31, 2022[172]. - As of December 31, 2022, the company had capital resources consisting of cash and cash equivalents of $6.2 million, which is expected to fund operations into the third quarter of 2023[176]. - The company has never generated revenue from operations and is unlikely to do so for several years, anticipating significant increases in operating costs related to clinical development[172]. - The company will require additional capital to fund operations, with anticipated expenditures for product candidates exceeding existing cash resources[178]. - The independent auditors expressed substantial doubt about the company's ability to continue as a going concern in their reports for the fiscal years ended December 31, 2022, and 2021[185]. Regulatory and Compliance Risks - The company may face significant costs and uncertainties associated with compliance with extensive governmental regulations affecting its operations[173]. - The company is subject to ongoing regulatory review and compliance obligations, including potential costly post-approval studies and surveillance[232]. - The company must comply with stringent marketing regulations, and any off-label promotion could lead to significant penalties and harm its reputation[244]. - The company faces risks related to adverse government regulation that could delay or prevent regulatory approval of its product candidates[233]. - The FDA and foreign regulatory bodies have substantial discretion in the approval process, which could delay or deny approval of product candidates, adversely impacting commercialization and revenue generation[211][219]. Product Development and Clinical Trials - The company is a pre-revenue clinical-stage biopharmaceutical entity facing substantial risks and uncertainties in developing and commercializing its product candidates, DMT310 and DMT410[169]. - Clinical trials are inherently uncertain, and many product candidates that enter trials do not receive regulatory approval, posing a risk to the company's business model[200]. - The company has not yet completed all clinical trials for its product candidates and may face additional requirements from the FDA that could alter clinical plans or necessitate reformulation[201]. - The company currently has no products approved for sale and may never obtain regulatory approval for its product candidates[212]. - The company announced topline results from its Phase 2 trial of DMT310 for moderate-to-severe rosacea, which did not meet its primary endpoints, leading to the decision to discontinue further development for this indication[250]. Market and Competitive Risks - The company is subject to risks related to competition from both brand and generic companies, which could limit growth and adversely affect financial results[173]. - The company anticipates facing significant competition from other approved therapies and unregulated treatments, which could pressure pricing and market share for its product candidates[228]. - The company may face generic competition upon patent expiration, which could significantly reduce sales and adversely affect financial performance[229]. - The company may need to raise additional capital through equity offerings or debt financings, which could dilute existing shareholders' interests[182]. - The market for the company's product candidates will depend significantly on access to third-party payors' drug formularies, which may lead to pricing pressures[253]. Supply Chain and Manufacturing Risks - The company relies on a limited number of product candidates, and failure to obtain regulatory approval for these could materially adversely affect its business[173]. - The company relies on a single supplier for the raw material used in DMT310 and DMT410, and any disruption in this supply could adversely affect product development and business operations[278]. - The company does not have the infrastructure to supply, manufacture, or distribute drug substances or products, relying entirely on third-party suppliers[289]. - Any interruption in the supply of raw materials or manufacturing could materially adversely affect the company's business and financial condition[291]. - The company relies on third-party contract research organizations (CROs) for clinical trials, which poses risks if these parties do not meet requirements or timelines[286]. Intellectual Property Risks - The ability to obtain and enforce patent rights is uncertain, which may allow third parties to compete against the company[332]. - The patent application process is expensive and time-consuming, potentially hindering the ability to secure necessary patent protections[335]. - The company is at risk of patent infringement claims from third parties, which could be costly and time-consuming, potentially impacting operating results[356]. - The company may need to seek licenses from third parties to avoid infringement claims, which may not be available on commercially acceptable terms[357]. - The company has agreed to indemnify certain third-party licensors against claims of infringement, which could lead to additional financial liabilities[360]. Operational and Management Risks - The company is highly dependent on key personnel, and the loss of any significant individuals could impede the development of its product pipeline[307]. - The company faces risks related to managing growth, including the need to attract and retain qualified employees amid intense competition in the biotechnology sector[308]. - The company may incur substantial costs related to acquisitions and integrations, which could adversely affect its financial condition[315]. - The company must establish effective sales, marketing, and distribution capabilities to successfully commercialize its product candidates[311]. - The company's operating results and liquidity could be negatively affected by economic conditions, particularly in the discretionary medical products market[65].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OFTHE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2022 Commission File Number: 001-40739 | --- | |-------| | | | | | | | | | | | | | | | | | | DERMATA THERAPEUTICS, INC. (Exact name of registrant as specified in the charter) Delaware (State or other jurisdiction of incorporation or organization) 3525 Del Mar Heights Rd., #322, San Diego, CA 921 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OFTHE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number: 001-40739 | --- | --- | --- | |--------------------------------------------------------------------------------|------------ ...