Q2 2024 Celcuity Inc Earnings Call Transcript
Key Points
- Celcuity Inc (CELC) made significant progress in advancing the clinical development of gedatolisib, with robust enrollment in their Phase 3 study, Victoria one.
- The company initiated efforts to launch Victoria two, a Phase 3 study for gedatolisib as a first-line treatment, potentially expanding the eligible patient population.
- Celcuity Inc (CELC) raised $129 million in gross proceeds from equity and debt offerings, strengthening their balance sheet and accelerating trial initiation.
- Preliminary clinical data from a Phase 1b trial showed promising results for gedatolisib in combination therapies, with a median progression-free survival of 48.6 months.
- Non-clinical research published in leading journals demonstrated gedatolisib's potent antitumor activity compared to single node inhibitors, supporting its therapeutic potential.
- Celcuity Inc (CELC) reported a net loss of $23.7 million for the second quarter of 2024, an increase from the previous year's loss.
- Research and development expenses rose significantly, primarily due to activities supporting ongoing trials and increased employee and consulting expenses.
- The proportion of patients with wild-type tumors in the Victoria one study shifted lower than initially estimated, affecting enrollment timelines.
- The company anticipates a delay in reaching the primary analysis event threshold for the wild-type cohort, now expected between late Q4 2024 and Q1 2025.
- General and administrative expenses increased, driven by higher employee and consulting-related costs, as well as professional fees.
Good afternoon, ladies and gentlemen, and welcome to the Celcuity Second Quarter 2024 financial results conference call. (Operator Instructions) This call is being recorded today, August 14, 2024.
I would now like to turn the conference over to Maria Yonkoski with ICR Westwicke. Please go ahead.
Thank you, operator, and good afternoon to everyone on the call. Thank you for joining us to review so Celcuity's Second Quarter 2024 financial results and business update. Earlier today, Celcuity released financial results for the quarter ending June 30, 2024 the press release can be found on the Investors section of the website.
Joining me on the call today are Brian Sullivan, Celcuity's Chief Executive Officer and Co-Founder; Vicky Hahne, Chief Financial Officer; as well as Igor Gorbatchevsky, Chief Medical Officer, who will be available during Q&A.
Before we begin, I would like to remind listeners that our comments today will include some forward-looking statements. These statements
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