ADDED
As of February 27, 2026, the registrant had 3,560,410 shares of common stock, par value $0.001 per share, issued and outstanding.
or hereinafter LigaChem ), Simcere Zaiming Pharmaceutical Co, Ltd.
(formerly known as Hainan Simcere Zaiming Pharmaceutical, Ltd.
or hereinafter Zaiming ), and other third-party vendors and collaborators; our ability to retain key personnel; our intended reliance on and the performance of third parties, including collaborators, contract research organizations and third-party manufacturers; changes in international relations, tariffs, and other trade regulations between the U.S.
and China; our ability to protect and enforce our intellectual property protection and the scope and duration of such protection; developments and projections relating to our competitors and our industry, including competing therapies; and the impact of current and future laws and regulations.
RISK FACTOR SUMMARY The following is a summary of the principal risk factors that make an investment in our common stock speculative or risky.
We depend on third-party suppliers for key materials used in our manufacturing process, and the loss of these third-party suppliers, their inability to comply with applicable regulatory requirements, or their inability to supply us with adequate materials could harm our business.
Risks Related to Our Business There is substantial doubt as to our ability to continue as a going concern, which may affect our ability to obtain future financing and may require us to curtail or cease our operations.
We will require substantial additional funding in the immediate term to continue operations as planned.
Our product candidate SIM0505 is a novel ADC candidate developed by Simcere Zaiming Pharmaceutical Co., Ltd.
REMOVED
As of March 3, 2025, the registrant had 28,006,684 shares of common stock, par value $0.001 per share, issued and outstanding.
We may be unable to secure sufficient quantities of our product candidates economically, or at the necessary scale, whether through use of a third party, by scaling up our paused manufacturing operations, or by otherwise failing to source adequate supply of our product candidates which would delay or prevent us from developing and, if approved, commercializing our product candidates.
We are currently not in compliance with the continued listing standards of the Nasdaq Global Select Market, and if we are unable to regain compliance, our common stock will be delisted from the exchange.
Since inception, we have devoted substantially all of our efforts and financial resources to discovery, research and development activities for our product candidates, identifying business development opportunities, raising capital and securing intellectual property rights related to our product candidates.
B7-H4, a clinically validated target, is a cell surface protein expressed on multiple tumor types including breast, ovarian and endometrial cancers, that we believe represents a large market opportunity.
We believe LNCB74 will be positioned as a promising B7-H4 ADC with both potential improved safety and efficacy compared to other ADCs targeting B7-H4.
LNCB74 is being advanced under a November 2022 Research Collaboration and Co-Development Agreement (the LigaChem Agreement ) with LigaChem Biosciences, Inc.
formerly known as LegoChem Biosciences, Inc., or ( LigaChem ).
Food and Drug Administration (the FDA ) accepted an Investigational New Drug ( IND ) application for initiation of a Phase 1 clinical trial to evaluate LNCB74 for treating multiple cancers known to have high B7-H4 expression.
We announced in January 2025 that the first patient had been dosed in our Phase 1 trial of LNCB74, and we are currently within cohort 2 of the dose escalation portion of the Phase 1 trial, enrolling patients with various tumor types, including breast, ovarian, and endometrial cancers.