ADDED
As of March 2, 2026, there were 59,599,375 shares of the registrant s common stock, par value $0.001 per share, outstanding.
and Novartis Pharma AG and our licensee Alexion, AstraZeneca Rare Disease (successor-in-interest to former licensee Pfizer Inc.); our collaboration with Transition Bio, Inc.
VY7523, our anti-tau antibody candidate, is in early-stage clinical trials, and all of our other active product candidates, including VY1706, are currently in preclinical development.
We or our collaborators may encounter substantial delays or difficulties in the commencement, enrollment or completion of preclinical studies or clinical trials, or we or our collaborators may fail to demonstrate safety and efficacy sufficient to support further development or to satisfy the applicable regulatory authorities, any of which could prevent us or our collaborators from further developing or commercializing current and future product candidates on a timely basis, if at all.
We may seek to enter into collaborations and out-licensing transactions in the future with other third parties.
If we are unable to enter into such collaborations or out-licensing transactions, or if these collaborations or out-licensing transactions are not successful, our business could be adversely affected.
Our gene therapy approach utilizes vectors derived from viruses that are selectively engineered, which may be perceived as unsafe or may result in unforeseen adverse events.
Our relationships with healthcare providers, physicians and third-party payors will be subject, directly or indirectly, to applicable anti-kickback, fraud and abuse and other healthcare laws and regulations, which, in the event of a violation, could expose us to criminal sanctions, civil penalties, contractual damages, reputational harm and diminished profits and future earnings.
If we are unable to obtain and maintain patent protection for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products and technology may be adversely affected, which would have a material adverse impact on our business, results of operations, financial condition and prospects.
In 2025 and 2026, we reduced the size of our organization in connection with restructurings.
REMOVED
As of March 3, 2025, there were 55,206,885 shares of the registrant s common stock, par value $0.001 per share, outstanding.
This Annual Report on Form 10-K and the documents filed as exhibits to the Annual Report on Form 10-K contain references to trademarks, service marks and trade names referred to in this Annual Report on Form 10-K and the information incorporated herein, including logos, artwork, and other visual displays, that may appear without the or TM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks, service marks or trade names.
VY7523, our anti-tau antibody candidate, is in early-stage clinical trials, and all of our other active product candidates are currently in preclinical development.
We may encounter substantial delays or difficulties in commencement, enrollment or completion of our preclinical studies or clinical trials, or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, any of which could prevent us from commercializing our current and future product candidates on a timely basis, if at all.
Our future success depends on our ability to retain key members of our management and research and development teams, and to attract, retain and motivate qualified personnel.
If we are unable to obtain and maintain patent protection for our products and technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize our products and technology may be adversely affected.
Some of our programs are wholly-owned, and some are advancing with licensees and collaborators including Alexion, AstraZeneca Rare Disease, or Alexion; Novartis Pharma AG, or Novartis; and Neurocrine Biosciences, Inc., or Neurocrine.
We are advancing our own proprietary pipeline of drug candidates for neurological diseases, with a focus on AD, and particularly on tau, which we view as a critically important AD target.
Our wholly-owned prioritized pipeline includes two tau targeting programs: VY7523 (which we formerly referred to as VY-TAU01), an anti-tau antibody for AD, and VY1706, a tau silencing gene therapy for AD.
VY7523 is currently in a Phase 1, multiple ascending dose, or MAD, clinical trial in early AD patients, from which we expect initial tau positron emission tomography, or PET, imaging data in the second half of 2026.