Celcuity (CELC) Q2 2024 earnings summary

Executive summary

• Advanced clinical development of gedatolisib with robust enrollment in VIKTORIA-1 phase III, ongoing phase 1b/2 prostate cancer trial, and planned VIKTORIA-2 phase III for HR-positive, HER2-negative advanced breast cancer.

• No revenue generated to date; operations funded by equity and debt, with recent $129M in financings extending cash runway through 2026.

• Net loss widened to $23.7M for Q2 2024, driven by increased R&D for pivotal trials.

• Major clinical milestones include ongoing VIKTORIA-1, CELC-G-201, and planned VIKTORIA-2 trials, with key data expected late 2024 and 2025.

• Published multiple peer-reviewed manuscripts highlighting gedatolisib's superior activity in breast and prostate cancer models.

Financial highlights

• Q2 2024 net loss was $23.7M ($0.62/share) vs. $14.6M ($0.66/share) in Q2 2023; non-GAAP adjusted net loss was $22.2M ($0.58/share) vs. $11.1M ($0.51/share) year-over-year.

• R&D expenses rose to $22.5M from $13.8M, mainly due to VIKTORIA-1 and prostate trial activities; total operating expenses reached $24.3M.

• General and administrative expenses increased 36% to $1.8M for Q2.

• Interest expense for Q2 was $2.3M, up 72% year-over-year, reflecting new debt financing.

• Ended Q2 with $283.1M in cash, cash equivalents, and short-term investments.

Outlook and guidance

• Cash runway expected through 2026 based on current resources and available borrowings.

• VIKTORIA-1 wild type cohort enrollment target expected in Q4 2024, with topline data anticipated late Q4 2024 or Q1 2025; PIK3CA mutant cohort topline data expected in H1 2025.

• VIKTORIA-2 first patient enrollment anticipated in Q2 2025.

• Preliminary data from phase 1b/2 prostate trial expected in H1 2025.

• R&D and G&A expenses projected to increase as clinical programs expand and commercialization planning advances.