Celcuity ended the second quarter of 2026 with $754 million of cash, cash equivalents and short-term investments, giving the biotechnology company what it expects to be sufficient capital to fund operations at least into 2029 as it prepares to commercialize REVTORPYK and expand the potential market for gedatolisib.
The balance-sheet strength comes at a pivotal point for Celcuity. The FDA approved REVTORPYK, or gedatolisib, on July 14 for certain patients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation. Celcuity expects commercial shipments to begin late in the third quarter of 2026.
Celcuity said the commercialization infrastructure required to support the REVTORPYK launch is complete, with launch activities beginning immediately following FDA approval. The company has also opened an Expanded Access Program and begun distributing gedatolisib to participating physicians for eligible patients ahead of commercial availability.
At the same time, new Phase 3 VIKTORIA-1 results could significantly expand the opportunity beyond the initial approved population. In patients with PIK3CA-mutant disease, the gedatolisib triplet consisting of gedatolisib, fulvestrant and palbociclib reduced the risk of disease progression or death by 50% compared with alpelisib plus fulvestrant.
Median progression-free survival for patients receiving the gedatolisib triplet reached 11.1 months compared with 5.6 months for alpelisib plus fulvestrant, representing nearly a doubling of the amount of time patients lived without disease progression or death.
The gedatolisib doublet also performed strongly. Gedatolisib plus fulvestrant reduced the risk of disease progression or death by 49%, with median progression-free survival reaching 11.3 months compared with 5.6 months for the alpelisib combination.
Response durability provided another positive signal. The gedatolisib triplet produced a 49% objective response rate and a median duration of response of 15.7 months. The doublet achieved a 36% objective response rate with median duration of response of 24.2 months.
Updated safety data also showed substantially lower treatment discontinuation rates with gedatolisib. Among patients receiving the triplet, 5.2% discontinued gedatolisib because of an adverse event, while 3.8% of patients receiving the doublet discontinued treatment. By comparison, 19.1% of patients receiving alpelisib discontinued that therapy because of an adverse event.
Celcuity plans to submit the PIK3CA-mutant VIKTORIA-1 results to the FDA as a supplemental New Drug Application during the third quarter of 2026. After the U.S. submission, the company also intends to submit VIKTORIA-1 data to regulatory authorities outside the U.S.
The company is simultaneously attempting to move gedatolisib into earlier lines of therapy. Celcuity expanded its Phase 3 VIKTORIA-2 program during Q2 to include a second study evaluating gedatolisib with palbociclib and letrozole in treatment-naive patients with endocrine-sensitive HR+/HER2- advanced breast cancer. An existing VIKTORIA-2 study is evaluating gedatolisib with palbociclib and fulvestrant in treatment-naive patients with endocrine-resistant disease.
Management believes the expanded development strategy could potentially position gedatolisib regimens across nearly all patients in first- and second-line HR+/HER2- advanced breast cancer, regardless of endocrine sensitivity or PIK3CA mutation status.
Celcuity has substantially strengthened its financial resources to support those programs and the commercial launch. The company completed a $575 million convertible senior note offering in June that generated $557.2 million of net proceeds. Celcuity used $137 million of the proceeds to prepay term-loan debt.
At June 30, Celcuity held $182 million of cash and cash equivalents and approximately $572 million of investments, bringing combined cash, equivalents and short-term investments to approximately $754 million. Management expects those resources to finance operations at least into 2029.
Celcuity is spending significantly to build out its commercial organization ahead of the REVTORPYK launch. Q2 SG&A expenses increased to $35 million from $7.6 million a year earlier. Of the $27.4 million increase, approximately $23.4 million was associated with commercial headcount additions and other launch-related activities.
R&D expenses declined to $31.1 million from $36.4 million, primarily because of lower VIKTORIA-1 clinical trial costs and reduced license milestone costs, partially offset by higher employee, consulting and manufacturing expenses.
Celcuity reported a Q2 net loss of $78.9 million, or $1.44 per share, compared with a $45.3 million loss, or $1.04 per share, a year earlier. Net cash used in operating activities increased to $55.4 million from $36.2 million as the company invested in its transition from clinical development toward commercialization.
Beyond breast cancer, Celcuity continues evaluating gedatolisib in metastatic castration-resistant prostate cancer and is developing a subcutaneous formulation intended to support potential future indications involving treatment periods that could extend for several years.
KEY QUOTES:
“Celcuity made monumental progress these past few months, achieving critical clinical and regulatory milestones related to gedatolisib.”
“We are on track to begin shipping REVTORPYK late in the third quarter of 2026.”
Brian Sullivan, CEO and Co-Founder of Celcuity
