Celcuity Inc. ((CELC)) has held its Q2 earnings call. Read on for the main highlights of the call.
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The recent earnings call for Celcuity Inc. highlighted a robust set of achievements, underscored by significant clinical trial advancements, patent extensions, and a fortified financial position. However, these positives were tempered by increased losses and rising expenses, painting a balanced picture of the company’s current standing.
Significant Milestones Achieved
Celcuity reported promising top-line data from the PIK3CA wild-type cohort of the Phase III VIKTORIA-1 clinical trial. The results showed notable improvements in progression-free survival (PFS) for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer patients. The gedatolisib triplet achieved a median PFS of 9.3 months with a hazard ratio of 0.24, while the doublet reached 7.4 months with a hazard ratio of 0.33.
Phase III VIKTORIA-2 Clinical Trial Progress
The company marked a significant step forward with the dosing of the first patient in the Phase III VIKTORIA-2 trial. This trial aims to evaluate gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR-positive, HER2-negative advanced breast cancer.
Favorable Preliminary Results from Early-Phase Trials
Preliminary top-line results from early-phase trials were encouraging. Trials evaluating gedatolisib with darolutamide in prostate cancer and with a trastuzumab biosimilar in HER2-positive breast cancer showed favorable outcomes. Notably, the prostate cancer trial demonstrated a 66% 6-month radiographic PFS rate.
Patent Extension for Gedatolisib
Celcuity successfully extended patent exclusivity for gedatolisib into 2042, thanks to a new dosing regimen patent. This extension strengthens the company’s intellectual property portfolio and provides a longer runway for market exclusivity.
Strong Financial Position
The company bolstered its financial standing by raising approximately $287 million through public offerings. This brings their cash, cash equivalents, and investments to $455 million on a pro forma basis, ensuring funding through 2027.
Increased Net Loss
Celcuity reported a net loss of $45.3 million for Q2 2025, a significant increase from $23.7 million in Q2 2024. This was primarily due to increased R&D expenses and anticipated milestone payments.
Increased R&D and Administrative Expenses
R&D expenses rose to $40.2 million from $22.5 million year-over-year, and general administrative expenses increased to $3.8 million from $1.8 million. These increases were driven by higher employee, consulting, and development costs.
Forward-Looking Guidance
Celcuity provided extensive guidance on their future directions, highlighting the positive top-line data from the VIKTORIA-1 trial and the commencement of the VIKTORIA-2 trial. Financially, the company ended the quarter with $168.4 million in cash and a pro forma cash total of approximately $455 million post-financing activities. Celcuity is preparing for a potential FDA approval and market launch of gedatolisib, estimating an addressable market of $5 billion and projecting sufficient resources to fund operations through 2027.
In conclusion, Celcuity Inc.’s earnings call presented a mixed yet promising outlook. The company showcased significant clinical advancements and a strong financial position, albeit with increased losses and expenses. As Celcuity gears up for potential FDA approval and market launch, the future looks promising for this innovative biotech firm.