Celcuity Inc. has unveiled a corporate presentation highlighting the potential of their developmental therapy, gedatolisib, for treating cancers involving the PI3K/AKT/mTOR $(PAM)$ pathway. The presentation emphasizes the significant untapped opportunity in addressing breast and prostate cancers, which are associated with this oncogenic pathway. Gedatolisib's mechanism of action and pharmacokinetic profile contribute to its potency and tolerability as a PAM inhibitor. Ongoing clinical trials include a Phase 3 study for second-line (2L) patients with HR+/HER2- advanced breast cancer $(ABC.AU)$ and a recently initiated Phase 3 study for first-line (1L) patients. Celcuity Inc. is exploring potential applications of gedatolisib for prostate cancer, noting the parallels between breast and prostate cancer, particularly the interaction between PAM and hormonal pathways. With a substantial addressable patient population and limited market penetration of PAM drugs, the company is positioned to explore multiple indications. Celcuity's financial position includes $205 million in cash, cash equivalents, and short-term investments as of Q1 2025, supporting operations through 2026. You can access the full presentation through the link below.
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