Celcuity (NASDAQ:CELC – Get Free Report) issued its quarterly earnings data on Thursday, August 13th. The company reported ($1.44) earnings per share for the quarter, missing the consensus estimate of ($1.16) by ($0.28), Zacks reports.
Here are the key takeaways from Celcuity’s conference call:
- REVTORPYK was FDA-approved for HR-positive, HER2-negative advanced breast cancer without detected PIK3CA mutations, and both its doublet and triplet regimens received preferred Category 1 recommendations in the NCCN guidelines.
- In the PIK3CA-mutant VIKTORIA-1 cohort, gedatolisib-based regimens significantly improved median progression-free survival to approximately 11 months versus 5.6 months for alpelisib plus fulvestrant, while treatment discontinuation due to adverse events was lower for gedatolisib. Celcuity plans to submit an sNDA in the third quarter of 2026.
- Celcuity remains confident that commercial shipments will begin in late Q3 2026. The company has completed its commercial infrastructure, deployed 88 oncology sales specialists, begun an expanded-access program, and estimates a U.S. addressable market exceeding $6 billion annually.
- The VIKTORIA-2 first-line breast cancer program has been expanded to include endocrine-sensitive patients, potentially broadening gedatolisib’s use across most newly diagnosed advanced HR-positive, HER2-negative patients. Celcuity also expects to provide additional prostate cancer data in Q4 2026.
- Second-quarter net loss widened to $78.9 million from $45.3 million year over year, while selling, general and administrative expenses rose sharply due to launch preparation. The company ended June with $754 million in cash and investments and expects funding into 2029, helped by a $575 million convertible-note offering.
Celcuity Stock Down 5.5%
Shares of CELC opened at $75.13 on Friday. The company’s 50-day simple moving average is $87.73 and its 200-day simple moving average is $103.15. The company has a debt-to-equity ratio of 6.04, a quick ratio of 8.93 and a current ratio of 8.93. Celcuity has a 1 year low of $44.42 and a 1 year high of $151.02. The stock has a market capitalization of $3.68 billion, a PE ratio of -17.47 and a beta of 0.11.
Analyst Upgrades and Downgrades
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About Celcuity
Celcuity, Inc is a clinical-stage biotechnology company that develops functional diagnostic tests designed to help identify patients who may benefit from targeted cancer therapies. The company’s technology is intended to measure the activity of cellular signaling networks in living tumor cells, rather than relying solely on the presence or absence of individual biomarkers.
Celcuity’s proprietary CELsignia platform analyzes patient tumor samples to identify abnormal signaling activity associated with cancer growth and treatment response.
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