Celcuity Inc.
For the period ended Sep 30, 2026. Filed Nov 5, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2026 · Filed Nov 5, 2026
CELC$66.79+4.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-13.
0001193125-26-349608
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-05.
0001193125-26-450161
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 166 previous paragraphs and 170 current paragraphs.
81 unchanged; 58 reworded; 29 added; 23 removed; 4 previous and 2 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (29)
Current report
Our Marketed Product: REVTORPYK
Current report
Shipments of REVTORPYK commenced on September 30, 2026. We recognize revenue when control of REVTORPYK transfers to the healthcare providers or pharmacies, which generally occurs upon delivery of REVTORPYK based on contractual shipping terms. Because no product was received by the healthcare providers or pharmacies until after September 30, 2026, we did not recognize any product revenue during the three and nine months ended September 30, 2026.
Current report
In August 2026, before REVTORPYK became commercially available, we opened an Expanded Access Program ("EAP") to provide gedatolisib to eligible patients through participating physicians. Nearly all patients enrolled in the EAP have now been transitioned to commercial product.
Current report
Second-Line Setting
Current report
First-Line Setting
Current report
Successful development in the first-line setting would offer the potential to advance the standard of care for approximately 90,000 patients who are diagnosed with late-stage HR+/HER2- ABC in the U.S., irrespective of their endocrine sensitivity or PIK3CA status. We estimate the total addressable market for gedatolisib in the first-line setting, using current WAC and a mean 36-month duration of treatment based on results from the Phase 1b study in this population, to be well over $10 billion annually.
Current report
We expect to provide further updates to results from both the MT and WT cohorts of the Phase 3 VIKTORIA-1 clinical trial at the San Antonio Breast Cancer Symposium in late 2026.
Current report
On October 24, 2026, at the ESMO Congress, we presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA WT cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- ABC. Eight studies were included in this network meta-analysis comparing PFS outcomes in randomized controlled trials of systemic treatments evaluated among patients with HR+/HER2- ABC with CDK4/6 inhibitor experience and PIK3CA WT tumors. This analysis found that the gedatolisib triplet and doublet each demonstrated statistically significant or numerically superior improvement in PFS and in the six-month PFS rate relative to the non-gedatolisib regimens evaluated. The analysis found that patients treated with the gedatolisib triplet and doublet were 2x and 1.5x more likely to survive without disease progression or death, respectively, compared to imlunestrant plus abemaciclib.
Current report
For the gedatolisib triplet, the ORR (confirmed and unconfirmed) was 59% compared to 33% for alpelisib plus fulvestrant, and the median DOR was 19.4 months compared to 7.5 months for alpelisib plus fulvestrant. The ORR of the gedatolisib doublet was 43%, and the median DOR was 27.8 months.
Current report
For patients with no liver metastases, the median PFS was 21.5 months with the gedatolisib triplet versus 9.1 months with alpelisib plus fulvestrant (HR=0.46; 90% CI: 0.30-0.72) and 11.5 months with the gedatolisib doublet versus alpelisib plus fulvestrant (HR=0.71; 90% CI: 0.41-1.25). For patients with liver metastases, the median PFS was 9.1 months with the gedatolisib triplet versus 4.6 months with alpelisib plus fulvestrant (HR=0.47; 90% CI: 0.34-0.65) and 11.1 months with the gedatolisib doublet versus alpelisib plus fulvestrant (HR=0.38; 90% CI: 0.23-0.62).
Current report
The mean duration of treatment for patients who received the gedatolisib triplet and the gedatolisib doublet was 10.0 and 11.3 cycles, respectively, with 22% (34) and 19% (10), respectively, of patients still receiving gedatolisib therapy in each arm.
Current report
Grade 3 stomatitis with gedatolisib was transient. By the second cycle of treatment, less than 3% of patients had Grade 3 stomatitis, and all Grade 3 events improved within 1-2 weeks. Discontinuations due to stomatitis for the gedatolisib triplet and gedatolisib doublet were minimal at 1% and 0%, respectively.
Current report
Key results reported across all arms included:
Current report
The median rPFS rate was 15.7 months with a six-month rPFS rate of 82.2% in patients with prior abiraterone exposure (22 patients).
Current report
The median rPFS rate was 9.1 months with a six-month rPFS rate of 62.5% in patients with prior enzalutamide exposure (18 patients).
Current report
Decreases in prostate-specific antigen (“PSA”) of at least 50% from baseline were observed in 36%, 47%, and 67% of patients at the 120 mg, 180 mg, and 240 mg gedatolisib dose levels, respectively, in patients with prior exposure to either abiraterone or enzalutamide.
Current report
Exploratory analyses of patients according to their PTEN status suggest activity is independent of PTEN status.
Current report
Gedatolisib plus darolutamide demonstrated a manageable safety profile across the evaluated dose levels (120 mg, 180 mg, 240 mg) with one dose limiting toxicity (Grade 3 rash), no Grade 4/5 TRAEs, and no TRAEs leading to treatment discontinuation or death. Grade 3 TRAEs occurred in 20% patients with only rash and pruritus occurring in more than one patient.
Current report
A randomized Phase 2 study is expected to evaluate two different groups of patients (Groups 1 and 2) with the objective of determining the recommended Phase 3 dose level. Subjects in Group 1 will be those who received prior abiraterone for either hormone-sensitive or castration-resistant prostate cancer. Subjects in Group 2 will be those who received prior enzalutamide or apalutamide for either hormone-sensitive or castration resistant prostate cancer. We anticipate initiating this study in the first half of 2027 after completion of the Phase 1b part of the study.
Current report
On August 26, 2026, we announced the submission of our sNDA to the FDA for REVTORPYK for the treatment of patients with HR+/HER2- ABC with a PIK3CA mutation, following progression on or after treatment with at least one line of endocrine therapy. The application to the FDA is supported by positive results from the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 clinical trial.
Current report
On September 30, 2026, we announced that REVTORPYK is now commercially available in the United States for eligible patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Current report
On October 23, 2026, at the ESMO Congress, we presented updated clinical results from the CELC-G-201 Phase 1b/2 study evaluating gedatolisib in patients with mCRPC. See the CELC-G-201 Phase 1b/2 Trial update above.
Current report
On October 24, 2026, at the ESMO Congress, we presented new subgroup analyses from the PIK3CAMT cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib in patients with HR+/HER2- ABC. See the PIK3CAMT Cohort update above. We also presented a comparative analysis of data for the gedatolisib regimens from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial and other regimens evaluated in patients with HR+/HER2- ABC. See the PIK3CAWT Cohort update above.
Current report
We commenced shipments of REVTORPYK on September 30, 2026. We expect our results of operations to vary from period to period depending on, among other factors, the level and timing of product sales, cost of sales, commercial activities, and expenses related to our ongoing operations. Although we have commenced shipments of REVTORPYK, we are not currently profitable and have incurred losses in each period since our inception in 2012.
Current report
costs related to the production of preclinical, clinical and pre-launch inventory, including fees paid to contract manufacturers, which are recorded as research and development expenses prior to the FDA Approval;
Current report
laboratory supplies; and
Current report
Loss on Debt Extinguishment
Current report
Comparison of the Nine Months Ended September 30, 2026 and 2025
Current report
Loss on Debt Extinguishment
Removed paragraphs (23)
Previous report
FDA Approval of REVTORPYK
Previous report
The build-out of the commercialization infrastructure needed to support a successful launch of REVTORPYK is complete and commercial launch activities for REVTORPYK commenced immediately after approval. Shipments of REVTORPYK are expected to begin late in the third quarter of 2026.
Previous report
To make gedatolisib available to patients prior to commercial availability of REVTORPYK, in August 2026, we opened an Expanded Access Program ("EAP") to participating physicians on behalf of eligible patients, and we have begun to distribute gedatolisib to those physicians.
Previous report
The median PFS benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups with the gedatolisib triplet showing higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were pre/perimenopausal, endocrine therapy resistant, or had visceral metastases. For patients enrolled in the United States and Canada, median PFS was 19.3 months (HR=0.13; 90% CI: 0.07-0.29) for the gedatolisib triplet and 14.9 months (HR=0.35; 90% CI: 0.17-0.76) for the gedatolisib doublet.
Previous report
In December 2025, we presented updated efficacy and safety results from the VIKTORIA-1 Phase 3 PIK3CA WT cohort at the 2025 San Antonio Breast Cancer Symposium including patient sub-group analyses, safety analyses and patient reported outcomes for well-being measures.
Previous report
For patients enrolled in the United States, Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months with the gedatolisib triplet and 7.1 months with the gedatolisib doublet versus 1.9 months for fulvestrant (HR=0.14; 95% CI: 0.08-0.28; p<0.0001).
Previous report
On June 30, 2025, we announced preliminary data for the CELC-G-201 Phase 1b/2 trial, utilizing a May 30, 2025, data cut-off. Based on these data, we amended the clinical trial protocol to enable exploration of additional doses in the Phase 1b portion of this clinical trial to determine the RP2D. Once RP2D is determined, an additional 12 participants are planned to be enrolled in the Phase 2 portion of the study at the RP2D level to enable evaluation of 30 participants treated with the RP2D of gedatolisib.
Previous report
On October 18, 2025, at the ESMO congress, we presented updated clinical results for the CELC-G-201 Phase 1b/2 trial based on an August 15, 2025, data cut-off. Among the 38 patients enrolled, 61% had received one line of prior systemic therapy and 39% had received at least two or more lines of prior therapy. Median duration of follow-up was 9.0 months.
Previous report
The six-month radiographic progression-free survival (“rPFS”) rate and median rPFS for patients from both arms combined was 67% and 9.1 months, respectively. For patients treated with 120 mg of gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg of gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.
Previous report
The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE.
Previous report
In the amended Phase 1/1b portion of the clinical trial, up to six patients are planned to be enrolled in up to three arms and treated with different doses. In the dose finding portion of the amended Phase 1/1b portion of the clinical trial, evaluation of a 240 mg dose of gedatolisib was completed. No AEs led to treatment discontinuation of gedatolisib and dose limiting toxicity criteria for dose reduction were not met. Evaluation of a 300 mg dose is ongoing. Once the Phase 1/1b portion of the study is completed, Celcuity expects to select the RP2D level(s) and control arm options for the randomized Phase 2 portion of the study. In the Phase 2 portion of the study, up to 84 additional subjects will be enrolled. All patients will also receive standard doses of darolutamide. We expect to provide updated clinical data and additional visibility into its mCRPC development strategy during the fourth quarter of 2026.
Previous report
Recent Developments
Previous report
On June 8, 2026, we completed the issuance of $575.0 million aggregate principal amount of the 2032 Notes, including the Underwriters’ exercise of their over-allotment option in full. The net proceeds from the 2032 Note Offering, after deducting underwriting discounts and commissions and offering expenses, were $557.2 million. See Note 9. Debt for additional information.
Previous report
On June 8, 2026, we utilized $137.4 million of the net proceeds from the 2032 Notes to complete a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the Amended A&R Loan Agreement. See Note 9. Debt for additional information.
Previous report
On July 14, 2026, we announced that the FDA approved REVTORPYK for the treatment of patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval. The approval of REVTORPYK (gedatolisib) is based on positive clinical results from the PIK3CA WT cohort of the VIKTORIA-1 Phase 3 trial. See the VIKTORIA-1 Phase 3 Trial update above for additional information.
Previous report
On July 30, 2026, we announced that REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, is recommended by the NCCN® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred Category 1 second-line and/or subsequent-line therapy following progression on or after treatment with at least one line of endocrine therapy.
Previous report
In August 2026, to make gedatolisib available to patients prior to commercial availability of REVTORPYK, Celcuity opened an EAP to participating physicians on behalf of eligible patients, and we have begun to distribute gedatolisib to those physicians.
Previous report
Revenue
Previous report
To date, we have not generated any revenue. Upon the execution of the Pfizer license agreement in April 2021, we acquired exclusive world-wide licensing rights to develop and commercialize gedatolisib. In 2022, we initiated VIKTORIA-1, a Phase 3 clinical trial, to support regulatory approval to market gedatolisib. The VIKTORIA-2 Phase 3 trial and CELC-G-201 Phase 1b/2 trial are ongoing.
Previous report
Pursuant to the FDA’s Real-Time Oncology Review program, in September 2025 we made the first pre-submission of our NDA to the FDA and completed the final NDA submission to the FDA on November 17, 2025. The FDA formally accepted our NDA submission on January 16, 2026, designated it for Priority Review, and assigned a PDUFA target goal date of July 17, 2026. On July 14, 2026, we received the FDA Approval, and we expect to generate revenue from sales of the drug commencing in the third quarter of 2026.
Previous report
laboratory supplies;
Previous report
validation costs for gedatolisib; and
Previous report
Comparison of the Six Months Ended June 30, 2026 and 2025
Reworded paragraphs (58)
Previous wording
We are a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Our first FDA-approved product is REVTORPYKTM (gedatolisib), a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1 alone or together. Our Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC. Data from this trial is the basis for FDA approval of REVTORPYK for use in adult patients with HR+/HER2- ABC without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. Results for the PIK3CA mutant cohort of the VIKTORIA-1 study have been released. Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naïve in the advanced setting. Study 1 is evaluating gedatolisib in combination with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib in combination with palbociclib and letrozole as first-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with mCRPC, is ongoing.
Current wording
We are a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications. Our first FDA-approved product is REVTORPYK, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blocks the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT or mTORC1, alone or together. Our Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib plus fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, supported the FDA Approval. Results for the PIK3CA MT cohort of the VIKTORIA-1 clinical trial have been released.
Previous wording
In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer. We believed gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous route of administration offered distinct advantages over currently approved and investigational therapies that targeted PI3Kα, AKT, or mTORC1, alone or together.
Current wording
In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer. We believe gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous route of administration, offer distinct advantages over other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1, alone or together.
Previous wording
In January 2026, the FDA accepted the submission of our NDA for gedatolisib in HR+/HER2-PIK3CA WT ABC. The FDA granted Priority Review and assigned a PDUFA goal date of July 17, 2026. On July 14, 2026, the FDA approved the Company’s NDA for REVTORPYK (gedatolisib) in HR+/HER2- ABC, for use in adult patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Current wording
On July 14, 2026, the FDA approved our NDA for REVTORPYK in HR+/HER2- ABC, for use in adult patients without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.
Previous wording
The NCCN Guidelines® play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, diagnosis, and treatment, as well as cancer care options, and are utilized in cancer treatment decision-making to drive positive patient outcomes. NCCN® is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
Current wording
We subsequently announced that REVTORPYK plus fulvestrant, with or without palbociclib, was recommended by the National Comprehensive Cancer Network® (“NCCN®”) as a preferred Category 1 second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy. The NCCN Guidelines® play a pivotal role in decision-making processes for individuals involved in cancer care all over the world, including physicians, nurses, pharmacists, payers, and patients and their families. The guidelines present expert recommendations for cancer screening, diagnosis, and treatment, as well as cancer care options, and are utilized in cancer treatment decision-making to drive positive patient outcomes. NCCN is a not-for-profit alliance of 33 leading cancer centers devoted to patient care, research, and education. NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.
Previous wording
Based on our analysis of published epidemiological data, we estimate that approximately 37,000 patients in the U.S. are receiving second-line treatment for HR+/HER2- ABC. Using internal duration of treatment estimates and Wholesale Acquisition Cost (WAC) of REVTORPYK, we estimate the total addressable market for gedatolisib in the second-line setting is potentially more than $6.0 billion annually.
Current wording
The Wholesale Acquisition Cost (“WAC”) of REVTORPYK, which has been reported to the drug pricing compendia, is $10,000 per vial, or $30,000 per 28-day cycle of treatment. Based on our analysis of published epidemiological data, we estimate that approximately 37,000 patients in the U.S. are receiving second-line treatment for HR+/HER2- ABC. Based on recently released Phase 3 VICTORIA-1 clinical trial data, we expect the mean duration of treatment for patients receiving the gedatolisib regimen in this setting to be approximately 10 treatment cycles. Assuming net receipt of 80% of our $30,000 WAC per cycle, we estimate the total addressable market for gedatolisib in the second-line setting, including PIK3CA WT patients and, if approved by the FDA, PIK3CAMT patients, is approximately $9 billion annually.
Previous wording
A total of 138 patients with HR+/HER2- ABC were dosed in the clinical trial. As of June 30, 2026, four patients from this study continue to receive study treatment, each of whom has received study treatment for more than six years.
Current wording
A total of 138 patients with HR+/HER2- ABC were dosed in the clinical trial. As of September 30, 2026, four patients from this study continue to receive study treatment, each of whom has received study treatment for more than seven years.
Previous wording
Our Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib in combination with fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC, and is the basis for the FDA Approval. Over 200 clinical sites in North America, Europe, South America, and Asia-Pacific participated in the study.
Current wording
Our Phase 3 clinical trial, VIKTORIA-1, evaluated gedatolisib plus fulvestrant, with or without palbociclib, for the treatment of patients with HR+/HER2- ABC, and is the basis for the FDA Approval. Over 200 clinical sites in North America, Europe, South America, and Asia-Pacific participated in the study.
Previous wording
The VIKTORIA-1 Phase 3 clinical trial involves two independent studies (Study 1 and Study 2) that enable separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and had PIK3CA WT tumors (Study 1) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). The primary completion date and the database cut-off date for Study 1 was May 30, 2025. Subjects who met eligibility criteria and had PIK3CA MT tumors (Study 2) were randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), alpelisib and fulvestrant (Arm E), or gedatolisib and fulvestrant (Arm F). The primary completion date and the database cut-off date for Study 2 was March 9, 2026.
Current wording
The VIKTORIA-1 Phase 3 clinical trial involved two independent studies (Study 1 and Study 2) that enabled separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and had PIK3CA wild-type tumors (Study 1) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C). The primary completion date and the database cut-off date for Study 1 was May 30, 2025. Subjects who met eligibility criteria and had PIK3CA MT tumors (Study 2) were randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), alpelisib and fulvestrant (Arm E), or gedatolisib and fulvestrant (Arm F). The primary completion date and the database cut-off date for Study 2 was March 9, 2026.
Previous wording
On July 28, 2025, we announced topline data from the PIK3CAWT cohort of the VIKTORIA-1 Phase 3 clinical trial and on October 18, 2025, at the ESMO congress, we presented additional efficacy and safety results from this cohort. The key efficacy and safety data from the PIK3CA WT cohort showed:
Current wording
On July 28, 2025, we announced topline data from the WT cohort of the VIKTORIA-1 Phase 3 clinical trial and on October 18, 2025, at the European Society of Medical Oncology ("ESMO") Congress, we presented additional efficacy and safety results from this cohort. The key efficacy and safety data from the PIK3CA WT cohort showed:
Previous wording
The ORR of the gedatolisib triplet was 31% compared to 1% with fulvestrant and the median duration of response (“DOR”) was 17.5 months. The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response.
Current wording
Analyses of the objective response rate ("ORR") and median duration of response ("DOR") for patients with evaluable disease were updated on October 24, 2026, in a presentation at the ESMO Congress. The ORR (confirmed and unconfirmed) of the gedatolisib triplet was 39% compared to 1% with fulvestrant and the median DOR was 19.2 months. The ORR of the gedatolisib doublet was 34% and the median DOR was 13.8 months. The median DOR was not determinable for fulvestrant because there was only one objective response.
Previous wording
Analyses of the mean number of gedatolisib treatment cycles patients received in the PIK3CAWT and MT cohorts of VIKTORIA-1 were also updated as of August 2, 2026, with a median follow-up period of approximately 21 months and 17 months for the PIK3CA WT and MT cohorts, respectively. For patients who received the gedatolisib triplet, the mean number of treatment cycles on gedatolisib was 9.0 and 10.0 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (16) and 22% (34) of patients still receiving gedatolisib therapy in each cohort, respectively. For patients who received the gedatolisib doublet, the mean number of treatment cycles on gedatolisib was 9.7 and 11.3 cycles in the PIK3CA WT and MT cohorts, respectively, with 12% (15) and 19% (10) of patients still receiving gedatolisib therapy in each cohort, respectively.
Current wording
The mean duration of treatment for patients who received the gedatolisib triplet and the gedatolisib doublet, was 9.0 and 9.7 cycles, respectively, with 12% (16) and 12% (15), respectively, of patients still receiving gedatolisib therapy in each arm.
Previous wording
The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade TRAEs. The most common Grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0% of patients, respectively) rash (4.6%, 5.4%, and 0% of patients, respectively); and hyperglycemia (2.3%, 2.3%, and 0% of patients, respectively). The primary Grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group) and pneumonitis (0.8% in the gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.
Current wording
The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade adverse reactions ("ARs"). The most clinically significant Grade 3 ARs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included stomatitis (22%, 12%, and 0% of patients, respectively); rash (6%, 5%, and 0% of patients, respectively); and hyperglycemia (0.9%, 1.8%, and 0% of patients, respectively). Serious ARs for the gedatolisib triplet and gedatolisib doublet groups included pneumonia (3.8% in the triplet and doublet group), thrombosis (3.8% and 2.3%, respectively), stomatitis (1.5% in the triplet group), pleural effusion (1.5% in the doublet group), and pneumonitis (1.5% in the doublet group). ARs led to the discontinuation of study treatment in 12% of patients in the gedatolisib triplet group, 9% in the gedatolisib doublet group, and 0% in the fulvestrant group. TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group.
Previous wording
Both gedatolisib regimens delayed time to definitive deterioration versus fulvestrant according to patient reported outcomes for well-being measures that included mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (the EQ-5D-5L score). The median time to definitive deterioration was 23.7 months (HR=0.39; 95% CI: 0.25-0.67; p = 0.0003) for patients treated with the gedatolisib triplet and not reached for the gedatolisib doublet (HR=0.37; 95% CI: 0.24-0.66; p = 0.0003) versus 4.0 months for fulvestrant. Additionally, for the first eight cycles of treatment, the patients’ assessment of their well-being remained stable relative to their assessment prior to starting treatment with gedatolisib.
Current wording
At the San Antonio Breast Cancer Symposium in 2025, data was reported that showed both gedatolisib regimens delayed time to definitive deterioration versus fulvestrant according to patient reported outcomes for well-being measures that included mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (the EQ-5D-5L score). The median time to definitive deterioration was 23.7 months (HR=0.39; 95% CI: 0.25-0.67; p = 0.0003) for patients treated with the gedatolisib triplet and not reached for the gedatolisib doublet (HR=0.37; 95% CI: 0.24-0.66; p = 0.0003) versus 4.0 months for fulvestrant. Additionally, for the first eight cycles of treatment, the patients’ assessment of their well-being remained stable relative to their assessment prior to starting treatment with gedatolisib.
Previous wording
The primary efficacy analysis of the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. The secondary endpoint comparing the gedatolisib doublet versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and presented no new safety signals.
Current wording
On May 1, 2026, we announced positive topline results from Study 2 (the PIK3CA MT cohort) of the VIKTORIA-1 Phase 3 trial, and on June 2, 2026, in a late-breaking abstract oral session at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, we presented detailed efficacy and safety results from this cohort. Additional efficacy and safety data for this cohort was presented at ESMO Congress on October 24, 2026. The primary efficacy analysis of the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib, a PI3Kα inhibitor, and fulvestrant. The secondary endpoint comparing the gedatolisib doublet versus alpelisib plus fulvestrant, which was not part of the primary efficacy analysis in the hierarchical order, also demonstrated a statistically significant and clinically meaningful improvement in PFS compared to alpelisib and fulvestrant. Efficacy was consistent across various sub-groups. Both gedatolisib regimens were generally well tolerated, with manageable safety profiles, and presented no new safety signals.
Previous wording
In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median PFS among patients, increasing the likelihood of survival without disease progression or death by two times compared to alpelisib plus fulvestrant (based on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed by blinded independent central review, was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant. The ORR of the gedatolisib-triplet was 49% compared to 26% with alpelisib plus fulvestrant, and the median DOR for the gedatolisib-triplet was 15.7 months compared to 7.5 months for alpelisib plus fulvestrant.
Current wording
In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median PFS among patients, increasing the likelihood of survival without disease progression or death by two times compared to alpelisib plus fulvestrant (based on a hazard ratio [HR] of 0.50; 95% CI: 0.37-0.68; p<0.0001). The median PFS, as assessed by blinded independent central review, was nearly two-times longer, 11.1 months versus 5.6 months, compared to alpelisib plus fulvestrant.
Previous wording
For the gedatolisib doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013). The ORR of the gedatolisib doublet was 36%, and the median DOR was 24.2 months.
Current wording
For the gedatolisib doublet, the median PFS was more than two-times longer, 11.3 months versus 5.6 months, compared to alpelisib plus fulvestrant (HR=0.51; 95% CI: 0.33-0.79; descriptive p=0.0013).
Previous wording
The gedatolisib triplet and gedatolisib doublet were generally well tolerated in the trial with mostly low-grade TRAEs. The most common Grade 3+ TRAEs for the gedatolisib triplet, the gedatolisib doublet, and alpelisib plus fulvestrant groups included neutropenia (58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients, respectively); rash (6.5%, 5.8%, and 15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively). For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8%, respectively, of patients discontinued gedatolisib due to an AE. For patients who received alpelisib, 19.1% discontinued treatment with alpelisib due to an AE. One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib, was reported; no Grade 5 TRAEs were reported in the gedatolisib-doublet group, and two Grade 5 TRAEs were reported in the alpelisib plus fulvestrant group.
Current wording
The gedatolisib triplet and gedatolisib doublet were generally well tolerated in the trial with mostly low-grade TRAEs. The most common Grade 3+ TRAEs for the gedatolisib triplet, the gedatolisib doublet, and alpelisib plus fulvestrant groups included neutropenia (58.8%, 0%, and 0.7% of patients, respectively); stomatitis (16.3%, 5.8%, and 5.3% of patients, respectively); rash (6.5%, 5.8%, and 15.1% of patients, respectively); and hyperglycemia (2.6%, 0%, and 14.5% of patients, respectively). For patients who received the gedatolisib triplet and gedatolisib doublet, 5.2% and 3.8%, respectively, of patients discontinued gedatolisib due to an AE. For patients who received alpelisib, 19.1% discontinued treatment with alpelisib plus fulvestrant due to an AE. One Grade 5 TRAE in the gedatolisib-triplet group, which was related to palbociclib, was reported; no Grade 5 TRAEs were reported in the gedatolisib-doublet group, and two Grade 5 TRAEs were reported in the alpelisib plus fulvestrant group.
Previous wording
The topline gedatolisib triplet efficacy data from the VIKTORIA-1 Phase 3 PIK3CA MT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:
Current wording
The efficacy data for the gedatolisib triplet from the VIKTORIA-1 Phase 3 PIK3CA MT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:
Previous wording
The ORR of 49% for the gedatolisib triplet is the highest reported by any Phase 3 clinical trial for a regimen including endocrine therapy in second-line HR+/HER2- ABC.
Current wording
The ORR of 59% for the gedatolisib triplet is the highest reported by any Phase 3 clinical trial for a regimen including endocrine therapy in second-line HR+/HER2- ABC.
Previous wording
We intend to submit the data from Study 2, the MT cohort, of the VIKTORIA-1 Phase 3 clinical trial to the FDA in the third quarter of 2026 as an sNDA. We intend to submit VIKTORIA-1 Phase 3 clinical trial data to other regulatory authorities outside the U.S. following the sNDA submission.
Current wording
On August 26, 2026, we submitted the data from Study 2, the MT cohort, of the VIKTORIA-1 Phase 3 clinical trial to the FDA as an sNDA. We intend to submit VIKTORIA-1 Phase 3 clinical trial data to other regulatory authorities outside the U.S. later this year or early next year.
Previous wording
Study 1 is expected to enroll approximately 440 patients with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant (Arm A) compared to ribociclib combined with fulvestrant (Arm B). We expect topline data for this group to be available by the end of 2028. Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole (Arm C) compared to ribociclib combined with letrozole (Arm D). We expect topline data for this group to be available in 2030.
Current wording
Study 1 is expected to enroll approximately 440 patients with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant (Arm A) compared to ribociclib combined with fulvestrant (Arm B). We expect topline data for this group to be available by the end of 2028 or the first half of 2029. Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole (Arm C) compared to ribociclib combined with letrozole (Arm D). We expect topline data for this group to be available in 2030.
Previous wording
Subjects in each study will be randomized 1:1 to either investigational treatment (Arm A, Study 1; Arm C, Study 2) or standard-of-care control (Arm B, Study 1; Arm D, Study 2). Approximately 200 clinical sites in North America, Europe, South America and Asia-Pacific will participate in the study, including many sites included in the VIKTORIA-1 clinical trial.
Current wording
Subjects in each study will be randomized 1:1 to either investigational treatment (Arm A, Study 1; Arm C, Study 2) or standard-of-care control (Arm B, Study 1; Arm D, Study 2). Approximately 250 clinical sites in North America, Europe, South America and Asia-Pacific will participate in the study, including many sites included in the VIKTORIA-1 clinical trial.
Previous wording
Development of the subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.
Current wording
Development of a subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.
Previous wording
We received approval from the FDA in mid-2023 to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with mCRPC. We have since initiated the CELC-G-201 Phase 1b/2 trial, that will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor. The first patient was dosed in this trial in February 2024.
Current wording
We received approval from the FDA in mid-2023 to proceed with the clinical development of gedatolisib plus Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with mCRPC. We have since initiated the CELC-G-201 Phase 1b/2 trial, that will enroll up to 210 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor. The first patient was dosed in this trial in February 2024.
Previous wording
The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the recommended Phase 2 dose (“RP2D”) of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic PFS at six months of patients who received the RP2D.
Current wording
The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib plus darolutamide and determination of the recommended Phase 2 dose (“RP2D”) of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic PFS at six months of patients who received the RP2D.
Previous wording
In the Phase 1b portion of the clinical trial, 38 patients with mCRPC were randomly assigned to receive 600 mg of darolutamide twice daily combined with either 120 mg of gedatolisib in Arm 1 or 180 mg of gedatolisib in Arm 2. In both arms, gedatolisib was administered once weekly for three weeks, then one week off. Additionally, all patients received prophylactic treatment for stomatitis.
Current wording
On October 23, 2026, at the ESMO Congress, we presented clinical results for the CELC-G-201 Phase 1b/2 trial based on an August 14, 2026, data cut-off. In the Phase 1b/2 portion of the clinical trial, 45 patients with mCRPC were randomly assigned to receive 600 mg of darolutamide twice daily combined with either 120 mg of gedatolisib in Arm 1, 180 mg of gedatolisib in Arm 2 or 240 mg of gedatolisib in Arm 3. In all arms, gedatolisib was administered intravenously on days 1, 8, and 15 of a 28-day treatment cycle, then two weeks off. Additionally, all patients received prophylactic treatment for stomatitis. Baseline characteristics were generally consistent across dose cohorts; over 50% had bone disease and 33% had phosphatase and tensin homolog (“PTEN”) loss.
Previous wording
An investigator-sponsored trial has been initiated in collaboration with the Dana-Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.
Current wording
An investigator-sponsored trial has been initiated in collaboration with the Dana-Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib plus abemaciclib and letrozole in patients with endometrial cancer.
Previous wording
We have not generated any revenue from product sales or other sources to date, and we continue to incur significant operating and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception in 2012. During the three months ended June 30, 2026 and 2025, we reported a net loss of $78.9 million and $45.3 million, respectively. During the six months ended June 30, 2026 and 2025, we reported a net loss of $131.7 million and $82.3 million, respectively. As of June 30, 2026, we had an accumulated deficit of $580.6 million and cash, cash equivalents and short-term investments of $754.0 million.
Current wording
During the three months ended September 30, 2026 and 2025, we reported a net loss of $73.3 million and $43.8 million, respectively. During the nine months ended September 30, 2026 and 2025, we reported a net loss of $205.0 million and $126.1 million, respectively. As of September 30, 2026, we had an accumulated deficit of $653.9 million and cash, cash equivalents and short-term investments of $642.7 million.
Previous wording
Since our inception, we have primarily focused on research and development of gedatolisib. Research and development expenses primarily include:
Current wording
Since our inception, we have primarily focused our research and development on gedatolisib. Research and development expenses primarily include:
Previous wording
employee-related expenses related to our research and development activities, including salaries, benefits, recruiting, travel and stock-based compensation expenses;
Current wording
employee-related expenses related to our research and development activities, including compensation, benefits, recruiting and travel expenses;
Previous wording
Selling, general and administrative expenses primarily consist of employee-related costs, including salaries, benefits, stock-based compensation and recruiting costs for personnel in our executive, sales, market access, marketing, commercial operations, legal, finance and support functions.
Current wording
Selling, general and administrative expenses primarily consist of employee-related costs, including compensation, benefits, recruiting and travel costs for personnel in our executive, sales, market access, marketing, commercial operations, legal, finance and support functions.
Previous wording
Non-employee-related expenses consist primarily of professional and consulting fees, software costs, the acquisition of data and other launch-related activities incurred to support the commercialization of REVTORPYK, legal services associated with being a public company, director and officer insurance, investor relations and travel expenses for our selling, general and administrative personnel.
Current wording
Non-employee-related expenses consist primarily of professional and consulting fees, launch-related activities incurred to support the commercialization of REVTORPYK, software costs, legal services associated with being a public company, director and officer insurance, investor relations and travel expenses for our selling, general and administrative personnel.
Previous wording
We anticipate that our selling, general and administrative expenses will continue to increase in future periods, reflecting both increased costs in connection with the commercialization of REVTORPYK, an expanding infrastructure, and increased professional fees associated with public company regulatory developments and requirements, and other compliance matters.
Current wording
We anticipate that our selling, general and administrative expenses will continue to increase in future periods, reflecting the continued commercialization of REVTORPYK, investments in our commercial infrastructure, and increased professional fees associated with public company regulatory developments and requirements, and other compliance matters.
Previous wording
During the three months ended June 30, 2026, our research and development expenses were $31.1 million, representing a decrease of $5.3 million, or 15%, compared to the same period in 2025. The decrease was primarily due to a $7.0 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial, and a $5.0 million decrease in license milestone costs. These decreases were partially offset by a $3.8 million increase in employee-related and consulting expenses, of which $0.9 million related to stock-based compensation, and a $2.9 million increase in manufacturing and other costs.
Current wording
During the three months ended September 30, 2026, our research and development expenses were $37.5 million, representing an increase of $7.1 million, or 23%, compared to the same period in 2025. The increase was primarily due to a $5.3 million increase in employee-related and consulting expenses, of which $1.5 million related to stock-based compensation, and a $2.1 million increase in manufacturing and other costs. These increases were partially offset by a $0.3 million decrease in clinical trial costs.
Previous wording
During the three months ended June 30, 2026, our selling, general and administrative expenses were $35.0 million, representing an increase of $27.4 million, or 361%, compared to the same period in 2025. The increase was primarily due to a $14.5 million increase in employee-related expenses, of which $3.3 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel within our commercial function to support the anticipated launch of REVTORPYK. The remaining $12.9 million increase was primarily due to a $10.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees and expanding infrastructure costs, and a $2.1 million increase in other administrative expenses.
Current wording
During the three months ended September 30, 2026, our selling, general and administrative expenses were $39.8 million, representing an increase of $27.4 million, or 220%, compared to the same period in 2025. The increase was primarily due to a $14.4 million increase in employee-related expenses, of which $1.7 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel to support the commercialization of REVTORPYK. The remaining $13.0 million increase was primarily due to an $11.1 million increase in costs to support the commercialization of REVTORPYK, including consulting expenses and expanding infrastructure costs, and a $1.9 million increase in other administrative expenses.
Previous wording
In the aggregate, $23.4 million of the $27.4 million selling, general and administrative increase related to commercial headcount additions and other launch-related activities.
Current wording
In the aggregate, $25.3 million of the $27.4 million of selling, general and administrative increase related to commercial headcount additions and other activities to support the commercialization of REVTORPYK.
Previous wording
During the three months ended June 30, 2026, our interest expense was $5.4 million, and represents an increase of $2.2 million, or 69%, compared to the same period in 2025. Interest expense during the three months ended June 30, 2026, was attributable to the 2031 Notes, the 2032 Notes and the Amended A&R Loan Agreement. Interest expense during the three months ended June 30, 2025, was attributable to the Amended A&R Loan Agreement. The increase was primarily due to the issuance of $201.3 million aggregate principal amount of the 2031 Notes in July 2025 and $575.0 million aggregate principal amount of the 2032 Notes in June 2026, and the $30.0 million distribution of the Term D Loan in September 2025. The increase was partially offset by the payoff of the Amended A&R Loan Agreement in June 2026. The $5.4 million of interest expense includes $1.5 million of non-cash interest expense.
Current wording
During the three months ended September 30, 2026, our interest expense was $2.7 million, and represents a decrease of $1.9 million, or 41%, compared to the same period in 2025. Interest expense during the three months ended September 30, 2026, was attributable to the 2031 Notes and the 2032 Notes. Interest expense during the three months ended September 30, 2025, was attributable to the 2031 Notes and the Amended A&R Loan Agreement. The decrease was primarily due to the payoff of the Amended A&R Loan Agreement in June 2026, partially offset by the issuance of $201.3 million aggregate principal amount of the 2031 Notes in August 2025, the issuance of $575.0 million aggregate principal amount of the 2032 Notes in June 2026, and the $30.0 million distribution of the Term D Loan in September 2025. The $2.7 million of interest expense includes $1.0 million of amortization of debt issuance costs.
Previous wording
During the three months ended June 30, 2026, our interest income was $4.2 million, and represents an increase of $2.2 million, or 114%, compared to the same period in 2025. The increase was primarily the result of a higher invested cash balance, partially offset by lower market interest rates.
Current wording
During the three months ended September 30, 2026, our interest income was $6.7 million, and represents an increase of $3.0 million, or 83%, compared to the same period in 2025. The increase was primarily the result of a higher invested cash balance and higher market interest rates.
Previous wording
During the six months ended June 30, 2026, our research and development expenses were $64.1 million, representing a decrease of $2.0 million, or 3%, compared to the same period in 2025. The decrease was primarily due to a $12.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial, and a $5.0 million decrease in license milestone costs. These decreases were partially offset by a $7.0 million increase in employee-related and consulting expenses, of which $2.0 million related to stock-based compensation, and an $8.1 million increase in manufacturing and other costs.
Current wording
During the nine months ended September 30, 2026, our research and development expenses were $101.7 million, representing an increase of $5.1 million, or 5%, compared to the same period in 2025. The increase was primarily due to a $12.1 million increase in employee-related and consulting expenses, of which $3.4 million related to stock-based compensation, and a $10.4 million increase in manufacturing and other costs. These increases were partially offset by a $12.4 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial, and a $5.0 million decrease in license milestone costs.
Previous wording
During the six months ended June 30, 2026, our selling, general and administrative expenses were $52.5 million, representing an increase of $38.5 million, or 276%, compared to the same period in 2025. The increase was primarily due to a $20.4 million increase in employee-related expenses, of which $5.2 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel within our commercial function to support the anticipated launch of REVTORPYK. The remaining $18.1 million increase was primarily due to a $14.8 million increase in costs to support pre-commercial launch activities, including consulting expenses, professional fees and expanding infrastructure costs, and a $3.3 million increase in other administrative expenses.
Current wording
During the nine months ended September 30, 2026, our selling, general and administrative expenses were $92.3 million, representing an increase of $65.9 million, or 250%, compared to the same period in 2025. The increase was primarily due to a $34.8 million increase in employee-related expenses, of which $6.9 million related to stock-based compensation. The increase in employee-related expenses was primarily driven by the hiring of additional personnel to support the commercialization of REVTORPYK. The remaining $31.1 million increase was primarily due to a $26.1 million increase in costs to support the commercialization of REVTORPYK, including consulting expenses and expanding infrastructure costs, and a $5.0 million increase in other administrative expenses.
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Rearranged current paragraphs (2)
Current report — wording carried from elsewhere
Our Phase 3 clinical trial, VIKTORIA-2, is an ongoing trial incorporating two independent studies, Study 1 and Study 2, in two separate cohorts of patients with ABC who are treatment-naïve in the advanced setting. Study 1 is evaluating gedatolisib plus palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib plus palbociclib and letrozole as first-line treatment for patients with endocrine- sensitive HR+/HER2- ABC. Our Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib plus darolutamide in patients with mCRPC, is ongoing.
Current report — wording carried from elsewhere
Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, showed promising trends for both the gedatolisib triplet and the gedatolisib doublet.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
We subsequently announced that REVTORPYK in combination with fulvestrant, with or without palbociclib, was recommended by the National Comprehensive Cancer Network® (“NCCN®”) as a preferred Category 1 second-line and/or subsequent-line therapy for the treatment of patients with HR+/HER2- breast cancer without a PIK3CA mutation following progression on or after treatment with at least one line of endocrine therapy.
Previous report — wording carried elsewhere
On May 1, 2026, we announced positive topline results from Study 2 (the PIK3CA MT cohort) of the VIKTORIA-1 Phase 3 trial, and on June 2, 2026, in a late-breaking abstract oral session at the American Society of Clinical Oncology (“ASCO”) Annual Meeting, we presented additional efficacy and safety results from this cohort.
Previous report — wording carried elsewhere
NM indicates that the percentage change is not meaningful.
Previous report — wording carried elsewhere
During the six months ended June 30, 2026, we recognized an $11.5 million non-cash loss on debt extinguishment related to the voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the Amended A&R Loan Agreement.