ADDED
This number does not include 16,935,665 shares of common stock issuable upon the exercise of pre-funded warrants outstanding as of March 16, 2026 (which are immediately exercisable at an exercise price of $0.0001 per share of common stock, subject to beneficial ownership limitations).
These forward-looking statements concern our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition.
The following is a summary of the principal risks that could seriously harm our business, all of which are more fully described in Part I.
iii Our clinical trials may fail to demonstrate substantial evidence of the safety and efficacy of our product candidates, which would prevent, delay or limit the scope of regulatory approval and commercialization, which could seriously harm our business.
Our rights to develop and commercialize our product candidates are subject in part to the terms and conditions of licenses granted to us by others, and the patent protection, prosecution and enforcement for some of our product candidates may be dependent on our licensors.
Our employees, independent contractors, consultants, research or commercial partners or collaborators and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
Our products are developed with customized and evolved adeno-associated virus ( AAV ) vectors invented from our proprietary vector discovery platform, Therapeutic Vector Evolution ( TVE ) which was designed to generate vectors with properties that overcome the limitations of conventional AAV vectors.
TVE applies the principles of directed evolution in non-human primate ( NHP ) models to select vectors that target tissues of diseases with high unmet need using routine and local routes of administration.
We are focused on clinical-stage product candidates in retina and lung utilizing vectors invented with TVE and believe the clinical results to date validate the platform.
Our lead product candidate 4D-150 utilizes our proprietary R100 vector and a transgene encoding anti-VEGF biologics (inhibitors of vascular endothelial growth factor): aflibercept (targeting VEGF-A, VEGF-B and placental growth factor) and an RNA interference (RNAi) approach targeting VEGF-C.
REMOVED
This number does not include 3,075,000 shares of common stock issuable upon the exercise of pre-funded warrants outstanding as of February 26, 2025 (which are immediately exercisable at an exercise price of $0.0001 per share of common stock, subject to beneficial ownership limitations) sold in the registrant s public offering in February 2024.
Additionally, this number does not include 6,310,000 shares of our common stock issuable upon the exercise of pre-funded warrants outstanding as of February 26, 2025, (which are both immediately exercisable at an exercise price of $0.0001 per share of common stock, subject to beneficial ownership limitations) issued in exchange for 5,775,000 shares of our common stock in November 2024 and 535,000 shares of our common stock in December 2024, respectively.
See Note 13, Common Stock Warrants, to the Registrant s financial statements.
Our products are developed with customized and evolved adeno-associated virus ( AAV ) vectors invented from our proprietary synthetic vector discovery platform, Therapeutic Vector Evolution ( TVE ).
TVE was designed to invent AAV vectors with properties that overcome the limitations of conventional AAV vectors by applying the principles of directed evolution in non-human primate ( NHP ) models to select vectors that target tissues of diseases with high unmet need using routine routes of administration.
We have developed clinical-stage product candidates based on three vectors invented with TVE and believe the clinical results to date validate the platform.
Our lead product candidate 4D-150 utilizes our proprietary R100 vector and a transgene cassette encoding aflibercept and inhibitory miRNA targeting vascular endothelial growth factor-C ( VEGF-C ).
4D-150 was designed to become the first backbone therapy for the treatment of retinal vascular diseases by providing multi-year sustained production of anti-VEGF from the retina with a single, safe, intravitreal injection, substantially reducing treatment burden and improving long-term patient outcomes.
Our second priority product candidate is 4D-710, which we believe is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis ("CF").
We believe we are positioned to invent, develop, manufacture and, if approved, effectively commercialize targeted genetic medicines with the potential to transform the lives of patients suffering from debilitating diseases.