MLYS — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

• We are a biopharmaceutical company focused on developing medicines to target diseases driven by dysregulated aldosterone. Our initial product candidate, lorundrostat, is an investigational, proprietary, orally administered, highly selective aldosterone synthase inhibitor that we are developing for t…

• develop and market product candidates that we would otherwise prefer to develop and market ourselves. For more information, see “Liquidity and Capital Resources.”

• In July 2020, we entered into an exclusive license agreement (as amended, the Tanabe License) with Tanabe Pharma Corporation (Tanabe) (formerly Mitsubishi Tanabe Pharma Corporation), pursuant to which Tanabe granted us an exclusive, worldwide, royalty-bearing, sublicensable license under Tanabe’s pa…

• On June 2, 2026, we entered into a fourth amendment to the Tanabe License (the Fourth Amendment), pursuant to which our obligation to pay Tanabe royalties on net sales of Lorundrostat Products was terminated, the license was amended and restated to grant us an exclusive, worldwide, royalty-free, sub…

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We are a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA), and other diseases driven by dysregulated aldosterone. Our initial product candidate, lorundrostat, is a proprietar…

• In July 2020, we entered into an exclusive license agreement (the Tanabe License) with Tanabe Pharma Corporation (Tanabe) (formerly Mitsubishi Tanabe Pharma Corporation), pursuant to which Tanabe granted us an exclusive, worldwide, royalty-bearing, sublicensable license under Tanabe’s patent and oth…

• We are obligated to use commercially reasonable efforts to conduct and complete the development activities and to file for regulatory approval for at least one Lorundrostat Product in a major market country and consider in good faith developing at least one Lorundrostat Product in a non-major market…

• On March 11, 2025, we entered into an underwriting agreement relating to the issuance and sale of 14,907,406 shares of our common stock at a price of $13.50 per share for net proceeds of approximately $188.7 million after deducting an underwriting discount of 6% and offering expenses. The offering w…

• On November 10, 2025, we entered into an ATM Equity Offering Sales Agreement (the ATM Agreement) with BofA Securities, Inc., Evercore Group L.L.C., and Goldman Sachs & Co. LLC, pursuant to which we may sell shares of our common stock having an aggregate offering price of up to $300.0 million from ti…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• We are exposed to market risk related to changes in interest rates of our investment portfolio of cash equivalents and investments and our variable-rate indebtedness under the Loan Agreement.

• As of June 30, 2026, our cash equivalents and investments consisted of money market funds and U.S. Treasury securities. Our primary exposure to market risk from these assets is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. The fair value of ou…

• On June 2, 2026, we entered into the Loan Agreement and borrowed $100.0 million under the Tranche A Loan. Borrowings under the Loan Agreement bear interest at a variable rate equal to three-month SOFR (subject to a 3.25% floor) plus 5.50%. The effective interest rate on the Tranche A Loan was 9.91% …

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• We are exposed to market risk related to changes in interest rates of our investment portfolio of cash equivalents and investments. As of March 31, 2026, our cash equivalents and investments consisted of money market funds and U.S. treasury securities. Our primary exposure to market risk is interest…

Text added vs the prior filing · source: 10-Q · 2026-08-11

• The following risk factors are new as a result of entering into the Loan Agreement in June 2026:

• Servicing the Loan Agreement will require a significant amount of cash, and we may not have sufficient cash flow to pay our indebtedness.

• Our ability to make scheduled payments of the principal of, to pay interest on, or to refinance our indebtedness associated with the Loan Agreement depends on our future performance, which is subject to many factors, including economic, financial, competitive, and others, that are beyond our control…

• Our indebtedness and liabilities could have significant negative consequences for our security holders and our business, results of operations, and financial condition by, among other things:

• •increasing our vulnerability to adverse economic and industry conditions;

Text added vs the prior filing · source: 10-Q · 2026-08-11

• During the three months ended June 30, 2026, one of our officers (as defined in Rule 16a-1(f) of the Exchange Act) and none of our directors adopted or terminated a contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense …

Text removed vs the prior filing · source: 10-Q · 2026-05-06

• During the three months ended March 31, 2026, an affiliate of the Company, Catalys Pacific Fund, LP, entered into a Rule 10b5-1 trading plan. Catalys Pacific Fund GP, LP is the general partner of Catalys Pacific Fund, LP. Brian Taylor Slingsby, M.D., Ph.D., M.P.H., one of our directors, is the manag…

• Except as set forth above, during the three months ended March 31, 2026, none of our directors or officers (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated any contract, instruction, or written plan for the purchase or sale of our securities that was intended to satisfy the af…