On February 17, 2022, Zosano Pharma Corporation (“Zosano” or the “Company”) received a response letter from the U.S. Food and Drug Administration (“FDA”) with regard to the Company’s January 18, 2022 resubmission of the 505(b)(2) New Drug Application for M207 (zolmitriptan microneedle system) (“M207 NDA”). The response letter stated that the FDA did not consider the resubmitted M207 NDA to be a complete response to the deficiencies identified in the FDA’s October 19, 2020 Complete Response Letter, and that the FDA will not begin substantive review of the application until a complete response is received.
Among other things, the FDA’s response letter stated that the Company’s strategy for establishing a pharmacokinetic (“PK”) bridge to Zomig Nasal Spray 5 mg (“Zomig NS”) by relying primarily on data from the Company’s recently completed Phase 1 PK study (“Study CP-2021-001”) was not acceptable, due in part to differences between the design of Study CP-2021-001, which compared the PK of M207 to two sequential doses of 5 mg Zomig NS, and the criteria for re-dosing set forth in the labeling instructions for 5 mg Zomig NS.
The FDA’s response letter described alternative methods through which the Company may establish a PK bridge to 5mg Zomig NS, including: (i) by demonstrating bioequivalence to Zomig NS using standard criteria for all PK exposure metrics, including through a combination of relevant PK data and modeling or simulation procedures; or (ii) by conducting a relative bioavailability study in healthy volunteer subjects.
The Company is evaluating next steps in relation to the FDA’s response letter as part of its financial and strategic planning; however, there can be no assurances that the Company’s resources will enable the Company to continue to pursue FDA approval of M207. As previously disclosed, the Company has retained SierraConstellation Partners, LLC as an independent financial advisor to assist in exploring financial and strategic alternatives to maximize value, which may include, but not be limited to, asset or equity sales, joint venture and partnership opportunities, and restructuring, amendment or refinancing of existing liabilities, and is evaluating various alternatives to improve its liquidity. However, there can be no assurances that the Company will achieve any of these objectives.
Forward Looking Statements
This current report on Form 8-K contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding evaluation of next steps in relation to the FDA’s response letter, capital requirements, exploration of financial and strategic alternatives to maximize value and other future events and expectations described in this report. Readers are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “scheduled,” “goal,” “approximately” or the negative
