ADDED
As of March 17, 2026, there were 48,336,675 shares of the registrant s common stock outstanding.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 91 Item 9A.
Forward-looking statements may include, among other things, statements relating to: our clinical trial plans and the estimated timelines and costs for such trials; our plans to develop and commercialize our products, and our expectations about the market opportunity for gedatolisib in the U.S.
( Pfizer ) with respect to gedatolisib; our expectations regarding the future payments that may be owed to Pfizer under our license agreement with them; our beliefs with respect to the potential rate and degree of market acceptance and clinical utility of gedatolisib, both in the U.S.
and internationally; our revenue expectations; our expectations regarding business development activities, including collaborations with pharmaceutical companies; our plans with respect to pricing in the U.S.
Because all drugs can have adverse effects, the data from our Phase 3 clinical study must demonstrate to the satisfaction of the FDA and other health authorities that the benefits of gedatolisib in combination with fulvestrant and with or without palbociclib, or gedatolisib in combination with fulvestrant plus a CDK4/6 inhibitor, outweigh its risks.
If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for, or commercialize, any potential product candidates; We may encounter difficulties in scaling production of, commercializing, marketing and distributing our products, including in hiring and retaining a qualified sales force.
Our lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase ( PI3K ), serine/threonine-protein kinase protein kinase B ( AKT ), mechanistic target of rapamycin ( mTOR ) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2.
By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR ( PAM ) pathway.
Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K , AKT, or mTORC1 alone or together.
REMOVED
As of March 24, 2025, there were 37,839,392 shares of the registrant s common stock outstanding.
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure s 67 Item 9A.
We have a limited operating history and we may never generate revenue or profit; Our inability to raise additional capital on acceptable terms in the future may limit our ability to develop and commercialize our drug candidate, gedatolisib; Future financing activities could dilute the percentage ownership of our stockholders and could cause our stock price to fall, or could result in operating or other restrictions; We are currently conducting and will continue to conduct clinical trials.
Clinical trials are expensive and complex with uncertain outcomes, which may prevent or delay commercialization of our products; Our near-term revenue prospects depend on the success of our initial drug product, gedatolisib.
Because all drugs can have adverse effects, the data from our Phase 3 clinical study must demonstrate to the satisfaction of the FDA and other health authorities that the benefits of gedatolisib in combination with palbociclib and fulvestrant, or gedatolisib in combination with fulvestrant, outweigh its risks.
Our lead therapeutic candidate is gedatolisib, a potent, well-tolerated, small molecule reversible inhibitor, administered intravenously, that selectively targets all Class I isoforms of phosphatidylinositol-3-kinase ( PI3K ) and the two mechanistic targets of rapamycin ( mTOR ) sub-complexes, mTORC1 and mTORC2.
Gedatolisib s mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.
We believe there is significant potential for gedatolisib to address breast and prostate cancer tumors, and it has the potential to be used in other tumor types where the PI3K/protein kinase B ( AKT )/mTOR ( PAM ) pathway is either: i) driving tumorigenesis directly; ii) cooperating with other dysregulated signaling pathways; or iii) a mechanism of resistance to other drug therapies.
Our initial clinical development programs for gedatolisib are focusing on the treatment of patients with hormone receptor positive ( HR+ ), human epidermal growth factor receptor 2 negative ( HER2- ), or HR+/HER2-, advanced or metastatic breast cancer ( ABC ), and patients with metastatic castration resistant prostate cancer ( mCRPC ).
In January 2022, gedatolisib was granted Fast Track designation for the treatment of patients with HR+/HER2- advanced breast cancer after progression on CDK4/6 therapy.