Financial Data and Key Metrics Changes - The net loss for Q3 2024 was $29.8 million or $0.70 per share, compared to a net loss of $18.4 million or $0.83 per share for Q3 2023 [32] - The non-GAAP adjusted net loss was $27.6 million or $0.65 per share for Q3 2024, compared to a non-GAAP adjusted net loss of $17.3 million or $0.78 per share for Q3 2023 [33] - Cash, cash equivalents, and short-term investments at the end of Q3 2024 were approximately $264.1 million, up from $180.6 million at December 31, 2023 [36] Business Line Data and Key Metrics Changes - Research and development expenses increased to $27.6 million in Q3 2024 from $17.5 million in Q3 2023, primarily due to activities supporting the VIKTORIA-1 and VIKTORIA-2 trials [34] - General and administrative expenses rose to $2.5 million in Q3 2024 from $1.4 million in Q3 2023, driven by employee and consulting-related expenses [35] Market Data and Key Metrics Changes - The company is on track to enroll the first patient in the VIKTORIA-2 Phase III trial in Q2 2025, with site qualification activities ongoing across multiple regions [24][25] Company Strategy and Development Direction - The company aims to establish a triplet regimen that includes gedatolisib to optimize antitumor control in HR-positive, HER2-negative advanced breast cancer [19][21] - Feedback from oncologists indicates a preference for delaying chemotherapy until the benefits of endocrine therapies are exhausted, which may favor gedatolisib's positioning [16][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential for gedatolisib, particularly regarding its IV administration route and its expected peak revenue potential exceeding $2 billion [23] - The company is focused on the evolving treatment landscape and believes that simultaneous blockade of key signaling pathways is essential for improving patient outcomes [19] Other Important Information - The company plans to present clinical and non-clinical data at the San Antonio Breast Cancer Symposium in December, highlighting the progress made in clinical development [30] Q&A Session Summary Question: Insights on event rate and enrollment - Management noted that the higher proportion of mutated patients affected the enrollment rate for the wild-type population, but overall enrollment is ahead of expectations [40] Question: Impact of Roche's approval on gedatolisib - Management believes that the approval of inavolisib will not significantly reduce the patient population for gedatolisib, as their target population is different [43] Question: Expectations for mPFS numbers - Management indicated a desire to see two years of median progression-free survival (mPFS) and noted that a three-month delta relative to control would be meaningful [56][59] Question: Enrollment expectations for VIKTORIA-2 - Management is optimistic about enrollment rates for VIKTORIA-2, expecting them to be at least as good as VIKTORIA-1 due to the experience gained [65]
Celcuity(CELC) - 2024 Q3 - Earnings Call Transcript