ADDED
The terms of our February 28, 2025 Loan Agreement with Avenue Venture Opportunities Fund place restrictions on our operating and financial flexibility.
If we raise additional capital through debt financing, the terms of any new debt could further restrict our operating and financial flexibility.
Our need for additional capital raises substantial doubt about our ability to continue as a going concern.
International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
Our product candidates target calcium release-activated calcium ( CRAC ) channels and, if approved, would represent a new class of therapeutics.
Clinical and preclinical data suggest that inhibition of CRAC channels may have therapeutic potential through a dual mechanism involving modulation of inflammatory signaling and protection of tissue cells from calcium-mediated injury.
Dysregulated CRAC channel signaling has been implicated in a range of acute and chronic diseases characterized by immune activation, inflammation, and cellular injury.
We seek to leverage our CRAC channel inhibitor platform to develop therapies for indications in which these pathways are clinically relevant.
Our lead product candidate is Auxora, a potent and selective, intravenously formulated small-molecule CRAC channel inhibitor containing the active compound zegocractin (formerly CM4620).
Auxora has been evaluated in multiple Phase 2 clinical trials across acute critical care settings, including acute pancreatitis ( AP ), severe COVID-19 pneumonia, and pediatric asparaginase-induced pancreatic toxicity ( AIPT ), and acute kidney injury ( AKI ) with associated acute hypoxemic respiratory failure ( AHRF ).
REMOVED
The addressable market of our product candidates have not been established with precision and may be smaller than we estimate.
The 2025 Loan and Security Agreement with Avenue Venture Opportunities Fund includes customary affirmative and negative covenants, as well as standard events of default, that could restrict our operating and financial flexibility.
iii EXPLANATORY NOTE On March 20, 2023, the Delaware corporation formerly known as Graybug Vision, Inc.
completed its merger transaction in accordance with the terms and conditions of the Agreement and Plan of Merger and Reorganization, dated as of November 21, 2022, as amended on February 10, 2023 (the Merger Agreement ), by and among Graybug Vision, Inc.
( Graybug ), Camaro Merger Sub, Inc., a wholly owned subsidiary of Graybug ( Merger Sub ), and CalciMedica, Inc.
( Private CalciMedica ), pursuant to which Merger Sub merged with and into Private CalciMedica, with Private CalciMedica surviving the merger as a wholly owned subsidiary of Graybug (the Merger ).
Additionally, on March 20, 2023, the Company changed its name from Graybug Vision, Inc.
On March 17, 2023, in connection with the transactions contemplated by the Merger Agreement, Graybug filed an Amended and Restated Certificate of Incorporation effecting a reverse stock split of Graybug s common stock at a ratio of 14:1 (the Reverse Stock Split ).
As a result of the Reverse Stock Split, the number of issued and outstanding shares of Graybug s common stock immediately prior to the Reverse Stock Split was reduced into a smaller number of shares, such that every 14 shares of Graybug s common stock held by a stockholder immediately prior to the Reverse Stock Split were combined and reclassified into one share of common stock after the Reverse Stock Split.
The information in this Annual Report on Form 10-K as of and for the periods prior to the effective date of the Merger gives effect to the Reverse Stock Split.