The 2032 Notes will be redeemable, in whole or in part (subject to certain limitations described below), at the Company’s option at any time, and from time to time, on a redemption date on or after August 6, 2029, and on or before the 31st scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the 2032 Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and (ii) the trading day immediately before the date the Company sends such notice. However, the Company may not redeem less than all of the outstanding 2032 Notes unless at least $50.0 million aggregate principal amount of the 2032 Notes are outstanding and not called for redemption as of the time the Company sends the related redemption notice. In addition, calling any 2032 Note for redemption will constitute a Make-Whole Fundamental Change with respect to that 2032 Note, in which case the conversion rate applicable to the conversion of that 2032 Note will be increased in certain circumstances if it is converted after it is called for redemption.
If a “Fundamental Change” (as defined in the 2032 Indenture) occurs, then, subject to certain conditions and except as set forth in the 2032 Indenture, noteholders may require the Company to repurchase their 2032 Notes at a cash repurchase price equal to the principal amount of the 2032 Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the 2032 Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock.
The fair value of the 2032 Notes, which differs from their carrying value, is influenced by interest rates, stock price and stock price volatility and is determined by prices for the 2032 Notes observed in market trading. The market for trading of the 2032 Notes is not considered to be an active market and therefore the fair value is determined using Level 2 inputs. As of September 30, 2026, the carrying value and fair value of the 2032 Notes was $557.9 million and $551.9 million, respectively.
The issuance costs attributed to the 2032 Notes amounted to $18.0 million and were discounted from the 2032 Notes. The issuance costs will be amortized to interest expense over the term of the 2032 Notes based on the effective interest rate method. During each of the three and nine months ended September 30, 2026, the effective interest rate was 0.8%. During the three and nine months ended September 30, 2026, interest expense related to the 2032 Notes was $1.1 million and $1.3 million, respectively, including $0.7 million and $0.9 million, respectively, related to the amortization of issuance costs.
As of September 30, 2026, the Company was in full compliance with all financial covenants under the 2032 Notes.
July 2025 Convertible Notes Offering
On July 30, 2025, the Company entered into an underwriting agreement (the “2031 Note Underwriting Agreement”) with the 2031 Underwriters, subject to customary conditions, to issue and sell in a public offering $175.0 million aggregate principal amount of the 2031 Notes to the 2031 Underwriters (the “2031 Note Offering”). In addition, pursuant to the 2031 Note Underwriting Agreement, the Company granted the 2031 Underwriters an option to purchase up to an additional $26.3 million aggregate principal amount of the 2031 Notes, solely to cover over-allotments. On July 30, 2025, the 2031 Underwriters exercised such option in full. The issuance of $201.3 million aggregate principal amount of the 2031 Notes was completed on August 1, 2025.
The 2031 Notes were issued pursuant to, and are governed by the Base Indenture, as supplemented by a first supplemental indenture (the “First Supplemental Indenture,” and the Base Indenture, as supplemented by the First Supplemental Indenture, the “2031 Indenture”), dated as of August 1, 2025, between the Company and the Trustee. The net proceeds from the 2031 Note Offering, after deducting underwriting discounts and commissions and offering expenses, were $194.9 million, including the proceeds from the 2031 Underwriters’ exercise of their over-allotment option in full.
The 2031 Notes are general, unsecured, senior obligations of the Company. The 2031 Notes accrue interest payable semi-annually in arrears on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750% per year. In addition, special interest will accrue on the 2031 Notes upon the occurrence of certain events relating to the Company’s failure to file certain reports with the SEC as provided in the 2031 Indenture and as described below. The 2031 Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the 2031 Indenture) with certain interest penalty provisions. The 2031 Notes mature on August 1, 2031, unless earlier converted, redeemed or repurchased by the Company.
Noteholders may convert their 2031 Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $1,000 principal amount of the 2031 Notes, which is equivalent to an initial conversion price of $51.30 per share of common stock. The conversion rate is subject to customary adjustments upon the occurrence of certain events as described in the 2031 Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the 2031 Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time.
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed financial statements and the related notes included elsewhere in this Quarterly Report. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and expected financial results, includes forward-looking statements that involve risks and uncertainties. You should review the “Risk Factors” discussed in Part I, Item 1A of the 2025 10-K, and the cautionary statements elsewhere in this Quarterly Report, for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the forward-looking statements contained in the following discussion and analysis.
Overview
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.
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.
Gedatolisib
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.
•Overcomes limitations of therapies that only inhibit a single class I PI3K isoform, AKT, or one mTOR kinase complex.
Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms and the mTORC1 and mTORC2 complexes. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PAM pathway. Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction events that involve tumor cell survival, depending upon the aberrations associated with the linked pathway. When a therapy only inhibits a single class I PI3K isoform (e.g., alpelisib, a PI3Kα inhibitor), AKT (e.g., capivasertib, an AKT inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units. This, in turn, induces compensatory resistance that reduces the efficacy of isoform specific PI3Kα, AKT, or mTORC1 kinase inhibitors. Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms, AKT, and mTOR.
•Better tolerated by patients than oral PI3K and mTOR drugs.
Gedatolisib is administered intravenously on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatedly been found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion of patients requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately played a significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisib’s comprehensive inhibition of the PAM pathway at low nanomolar potency, IV route of administration, and pharmacokinetic properties enables it to achieve optimal anti-proliferative effects on tumor cells without inducing the levels of hyperglycemia, rash, and diarrhea typically associated with oral single-component inhibitors of the PAM pathway.
Isoform-specific PI3K or mTORC1 inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with single-component PAM inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis can still lead to challenging toxicities. The experience with an FDA-approved oral p110-α specific inhibitor, PIQRAY, illustrates the challenge. In its Phase 3 pivotal trial, PIQRAY was found to induce a Grade 3 or 4 adverse event (“AE”) related to hyperglycemia in 39% of patients evaluated. In addition, 26% of patients discontinued alpelisib due to AEs. By contrast, in the 103-patient dose expansion portion of the Phase 1b clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less than 9% discontinued treatment.
Our Marketed Product: REVTORPYK
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.
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.
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.
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.
Market Opportunity
Second-Line Setting
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, PIK3CA MT patients, is approximately $9 billion annually.
First-Line Setting
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.
Clinical Development
As of September 30, 2026, at least 1,130 patients and healthy volunteers have received gedatolisib in 12 completed or ongoing clinical trials. Of these, 123 patients with solid tumors were treated with gedatolisib as a single agent in two clinical trials, 36 healthy volunteers were treated in two clinical trials, and the remaining 971 patients received gedatolisib in combination with other anti-cancer agents in eight clinical trials. Additional patients received gedatolisib in combination with other anti-cancer agents in 10 investigator-sponsored clinical trials.
HR+/HER2- Advanced Breast Cancer
B2151009 Phase 1b Trial
A Phase 1b dose-finding trial with an expansion portion for safety and efficacy evaluated gedatolisib when added to either the standard doses of palbociclib plus letrozole or palbociclib plus fulvestrant in patients with HR+/HER2- ABC. PI3K mutation status was not used as an eligibility criterion. Patient enrollment for the trial is complete.
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.
•35 patients were enrolled in two dose escalation arms to evaluate the safety and tolerability and determine the maximum tolerable dose (“MTD”) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapies. The MTD was determined to be 180 mg administered intravenously once weekly.
•103 patients were enrolled in one of four expansion arms (A, B, C, D) to determine if the triplet combination of gedatolisib plus palbociclib and letrozole or gedatolisib plus palbociclib and fulvestrant produced a superior objective response (OR), compared to historical control data of the doublet combination (palbociclib plus endocrine therapy). All patients received gedatolisib in combination with standard doses of palbociclib and endocrine therapy (either letrozole or fulvestrant). In Arms A, B, and C, patients received an intravenous dose of 180 mg of gedatolisib once weekly. In Arm D, patients received an intravenous dose of 180 mg of gedatolisib on a four-week cycle of three-weeks-on, one-week-off. Objective response was determined using Response Evaluation Criteria in Solid Tumors v1.0, or RECIST v1.0.
Source: Layman R., et. al, Lancet Oncol., 2024
VIKTORIA-1 Phase 3 Trial (Second-Line Setting)
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.
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.
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.
PIK3CA Wild-Type Cohort
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:
•The “gedatolisib triplet” (gedatolisib, fulvestrant and palbociclib) demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The median PFS, as assessed by blinded independent central review (“BICR”), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months.
•The “gedatolisib doublet” (gedatolisib and fulvestrant) also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR = 0.33, 95% CI 0.24-0.48; p<0.0001). The median PFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months.
•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.
•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.
•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.
•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.
•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.
The detailed results from cohort 1, PIK3CA WT cohort, established several new milestones in the history of drug development for HR+/HER2- ABC:
•The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.
•The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of therapy.
•Gedatolisib is the first inhibitor targeting the PAM pathway to demonstrate positive Phase 3 results in patients with HR+/HER2- PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.
•The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- ABC.
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.
PIK3CA Mutant-Type Cohort
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.
•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.
•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).
•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.
•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).
•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.
•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.
•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.
•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.
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:
•First Phase 3 trial to demonstrate superiority of one PAM inhibitor versus another.
•The median PFS of 11.1 months for the gedatolisib triplet is the highest reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving a regimen including endocrine therapy as second-line treatment.
•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.
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.
VIKTORIA-2 Phase 3 Trial (First-Line Setting)
VIKTORIA-2 is evaluating the safety and efficacy of patients with endocrine-resistant and endocrine-sensitive HR+/HER2- ABC who are treatment-naïve in the metastatic setting. Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized to a treatment arm. Each study will have independent statistical analysis plans that will include separate primary endpoints. The primary efficacy analyses for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent-to-treat population enrolled in their respective study (combined WT and MT); primary endpoints for patient cohorts based on their PIK3CA status (e.g., WT or MT) are not included. The control arms for Study 1 and Study 2 will evaluate ribociclib combined with either fulvestrant (Study 1) or letrozole (Study 2).
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.
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.
The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by BICR. The statistical analyses of Study 1 and Study 2 are each independent of the other. For Study 1, the primary objective is to compare the PFS of Arm A (gedatolisib + palbociclib + fulvestrant) to Arm B (ribociclib + fulvestrant). For Study 2, the primary objective is to compare the PFS of Arm C (gedatolisib + palbociclib + letrozole) to Arm D (ribociclib + letrozole).
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.
Metastatic Castration-Resistant Prostate Cancer
CELC-G-201 Phase 1b/2 Trial
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.
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.
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.
Key results reported across all arms included:
•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).
•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).
•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.
•Exploratory analyses of patients according to their PTEN status suggest activity is independent of PTEN status.
•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.
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.
Collaborations
Investigator-Sponsored Trials
In an investigator-sponsored Phase 2 clinical trial, 44 patients with HER2+ PIK3CA mutated metastatic breast cancer were treated with gedatolisib plus standard doses of trastuzumab-pkrb. No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more; 86% of patients had received at least three prior anti-HER2 therapies. The data cut-off was February 10, 2025.
Key efficacy and safety results, as presented at the American Society of Clinical Oncology meeting in June 2025, showed:
•The ORR among all patients enrolled was 43%.
•Median PFS was 6.0 months (95% CI, 5.0-7.7).
•Median overall survival was 24.7 months (95% CI; 17.3-NA).
•No patients discontinued gedatolisib due to a treatment-related AE.
•One (2.3%) patient experienced Grade 3 hyperglycemia.
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.
Recent Developments
•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.
•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.
•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.
•On October 24, 2026, at the ESMO Congress, we presented new subgroup analyses from the PIK3CA MT cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib in patients with HR+/HER2- ABC. See the PIK3CA MT 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 PIK3CA WT Cohort update above.
Results of Operations
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.
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.
Components of Operating Results
Research and Development
Since our inception, we have primarily focused our research and development on gedatolisib. Research and development expenses primarily include:
•employee-related expenses related to our research and development activities, including compensation, benefits, recruiting and travel expenses;
•consulting fees paid to third parties;
•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;
•laboratory supplies; and
Conducting research and development is central to our business model. We plan to continue to increase our research and development expenses for the foreseeable future as we continue to develop gedatolisib, conduct the VIKTORIA-2 Phase 3 and CELC-G-201 Phase 1b/2 clinical trials, continue follow-up activities for the VIKTORIA-1 Phase 3 clinical trial, and conduct other studies and clinical trials.
Selling, General and Administrative
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.
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.
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.
Interest Expense
Interest expense to date is primarily related to the Amended A&R Loan Agreement, the 2031 Notes and the 2032 Notes.
Loss on Debt Extinguishment
The loss on debt extinguishments relates to the voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the Amended A&R Loan Agreement on June 8, 2026.
Interest Income
Interest income consists of interest income earned on our cash, cash equivalents, and investment balances.
Results of Operations
Comparison of the Three Months Ended September 30, 2026 and 2025
The following table summarizes our results of operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Increase (Decrease) |
|
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
Percent Change |
|
Statements of operations data: |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
37,519 |
|
|
$ |
30,425 |
|
|
$ |
7,094 |
|
|
|
23 |
% |
Selling, general and administrative |
|
|
39,800 |
|
|
|
12,424 |
|
|
|
27,376 |
|
|
|
220 |
|
Total operating expenses |
|
|
77,319 |
|
|
|
42,849 |
|
|
|
34,470 |
|
|
|
80 |
|
Loss from operations |
|
|
(77,319 |
) |
|
|
(42,849 |
) |
|
|
(34,470 |
) |
|
|
80 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(2,691 |
) |
|
|
(4,595 |
) |
|
|
1,904 |
|
|
|
(41 |
) |
Interest income |
|
|
6,673 |
|
|
|
3,640 |
|
|
|
3,033 |
|
|
|
83 |
|
Other (expense) income, net |
|
|
3,982 |
|
|
|
(955 |
) |
|
|
4,937 |
|
|
|
(517 |
) |
Net loss before income taxes |
|
|
(73,337 |
) |
|
|
(43,804 |
) |
|
|
(29,533 |
) |
|
|
67 |
|
Income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(73,337 |
) |
|
$ |
(43,804 |
) |
|
$ |
(29,533 |
) |
|
|
67 |
% |
Research and Development
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.
Selling, General and Administrative
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.
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.
Interest Expense
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.
Interest Income
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.
Comparison of the Nine Months Ended September 30, 2026 and 2025
The following table summarizes our results of operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
Increase (Decrease) |
|
|
|
2026 |
|
|
2025 |
|
|
$ |
|
|
Percent Change |
|
Statements of operations data: |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
101,659 |
|
|
$ |
96,598 |
|
|
$ |
5,061 |
|
|
|
5 |
% |
Selling, general and administrative |
|
|
92,285 |
|
|
|
26,393 |
|
|
|
65,892 |
|
|
|
250 |
|
Total operating expenses |
|
|
193,944 |
|
|
|
122,991 |
|
|
|
70,953 |
|
|
|
58 |
|
Loss from operations |
|
|
(193,944 |
) |
|
|
(122,991 |
) |
|
|
(70,953 |
) |
|
|
58 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (expense) income: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(14,199 |
) |
|
|
(10,982 |
) |
|
|
(3,217 |
) |
|
|
29 |
|
Interest income |
|
|
14,578 |
|
|
|
7,904 |
|
|
|
6,674 |
|
|
|
84 |
|
Loss on debt extinguishment |
|
|
(11,477 |
) |
|
|
— |
|
|
|
(11,477 |
) |
|
NM |
|
Other expense, net |
|
|
(11,098 |
) |
|
|
(3,078 |
) |
|
|
(8,020 |
) |
|
|
261 |
|
Net loss before income taxes |
|
|
(205,042 |
) |
|
|
(126,069 |
) |
|
|
(78,973 |
) |
|
|
63 |
|
Income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
|
$ |
(205,042 |
) |
|
$ |
(126,069 |
) |
|
$ |
(78,973 |
) |
|
|
63 |
% |
NM indicates that the percentage change is not meaningful.
Research and Development
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.
Selling, General and Administrative
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.
In the aggregate, $57.0 million of the $65.9 million of selling, general and administrative increase related to commercial headcount additions and other activities to support the commercialization of REVTORPYK.
Interest Expense
During the nine months ended September 30, 2026, our interest expense was $14.2 million, and represents an increase of $3.2 million, or 29%, compared to the same period in 2025. Interest expense during the nine months ended September 30, 2026, was attributable to the 2031 Notes, the 2032 Notes and the Amended A&R Loan Agreement. Interest expense during the nine months ended September 30, 2025, was attributable to the 2031 Notes and 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, 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 increase was partially offset by the payoff of the Amended A&R Loan Agreement in June 2026. The $14.2 million of interest expense includes $4.0 million of amortization of debt issuance costs and discount and payment of in-kind interest.
Interest Income
During the nine months ended September 30, 2026, our interest income was $14.6 million, and represents an increase of $6.7 million, or 84%, compared to the same period in 2025. The increase was primarily the result of a higher invested cash balance and higher market interest rates.
Loss on Debt Extinguishment
During the nine months ended September 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.
Liquidity and Capital Resources
Liquidity
Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through September 30, 2026, we have funded our operations primarily through private placements, registered offerings of our equity securities, convertible notes, and borrowings under loan agreements. From inception through September 30, 2026, we raised aggregate net proceeds of $475.1 million through sales of our securities and $751.9 million through the issuance of our convertible notes. Additionally, prior to its payoff, we raised aggregate net proceeds of $120.8 million through borrowings under the Amended A&R Loan Agreement. As of September 30, 2026, we had an accumulated deficit of $653.9 million and our cash, cash equivalents and short-term investments were $642.7 million.
Capital Resources
To help meet our liquidity requirements, we have entered into various equity and financing arrangements. As of September 30, 2026, our material cash requirements for the operations of our business consisted primarily of the current and long-term liabilities noted on our condensed balance sheets, as well as other commitments, including the following notable items:
•In February 2022, we entered into an Open Market Sale Agreement with Jefferies, as agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate offering price of up to $50.0 million, which amount was subsequently increased to $400.0 million on January 9, 2026. During the nine months ended September 30, 2026 and 2025, we did not sell any shares pursuant to the Open Market Sale Agreement.
•In May 2024, we entered into the A&R Loan Agreement, which amended and restated, in its entirety, the Prior Loan Agreement. In May 2025, we entered into the First Amendment to the A&R Loan Agreement; in July 2025, we entered into the Second Amendment to the A&R Loan Agreement; and in September 2025, we entered into the Third Amendment to the A&R Loan Agreement.
In September 2025, we received funding of the $30.0 million Term D Loan (as defined in the Amended A&R Loan Agreement) upon achievement of the Term D Milestone (as defined in the Amended A&R Loan Agreement), resulting in net proceeds of $27.7 million. In connection with the funding of the Term D Loan, we issued warrants with an exercise price of $14.84 per share to purchase an aggregate of 50,537 shares of our common stock to Innovatus, Oxford, and certain of its affiliates.
In June 2026, we completed a voluntary prepayment of all outstanding principal, accrued and unpaid interest, fees, costs and expenses under the Amended A&R Loan Agreement, resulting in a payment of $137.4 million (see Note 10. Debt).
•In July 2025, we issued and sold 2,172,368 Shares and Pre-Funded Warrants to purchase up to 400,000 shares of common stock pursuant to the Equity Underwriting Agreement with the Representatives of the 2031 Underwriters, resulting in net proceeds of $91.6 million (see Note 8. Stockholders' Equity (Deficit)).
•In August 2025, we issued $201.3 million aggregate principal amount of convertible notes, resulting in net proceeds of $194.9 million (see Note 10. Debt).
•In June 2026, we issued $575.0 million aggregate principal amount of convertible notes, resulting in net proceeds of $557.0 million (see Note 10. Debt).
•During the nine months ended September 30, 2026 and 2025, investors exercised 45,788 and 2,294,867 warrants, net of shares withheld for exercise price, respectively, which generated less than $0.1 million and $18.5 million in cash, respectively (see Note 8. Stockholders' Equity (Deficit)). During the three months ended September 30, 2025, investors exercised 1,654,809 warrants, net of shares withheld for exercise price, which generated $12.9 million in cash. There were no warrant exercises during the three months ended September 30, 2026.
Liquidity and capital resource requirements
We expect that our research and development and selling, general and administrative expenses will increase as we ramp up the commercialization of REVTORPYK, continue to develop gedatolisib, conduct the VIKTORIA-2 Phase 3 and CELC-G-201 Phase 1b/2 clinical trials, continue follow-up activities for the VIKTORIA-1 Phase 3 clinical trial, conduct other studies and clinical trials, and pursue other business development activities. We expect to use cash on hand, together with the funds received under the debt and equity financings described above, and cash generated from commercial sales of REVTORPYK, to fund our research and development expenses, clinical trial costs, sales and marketing expenses, general corporate expenses, capital expenditures and working capital.
Based on our current business plan, we believe that our current cash, cash equivalents and short-term investments, will provide sufficient cash to finance our operations through 2029.
Our expectations as to how long our current capital resources will be sufficient to fund our operations are based on assumptions that may not be accurate, and we could use our current capital resources sooner than we expect. In addition, we may seek to raise additional capital to finance capital expenditures and operating expenses over the next several years as we ramp up the commercialization of REVTORPYK, expand our infrastructure, commercial operations and research and development activities, pursue other business development activities, and take advantage of financing or other opportunities that we believe to be in the best interests of the Company and our stockholders. Additional capital may be raised through the sale of common or preferred equity or convertible debt securities, entry into debt facilities or other third-party funding arrangements. The sale of equity and convertible debt securities may result in dilution to our stockholders and those securities may have rights senior to those of our common stock. Agreements entered into in connection with such capital raising activities could contain covenants that would restrict our operations or require us to relinquish certain rights. Additional capital may not be available on reasonable terms, or at all.
Cash Flows
The following table summarizes the primary sources and uses of cash and cash equivalents (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended September 30, |
|
|
|
2026 |
|
|
2025 |
|
Net cash and cash equivalents provided by (used in): |
|
|
|
|
|
|
Operating activities |
|
$ |
(176,717 |
) |
|
$ |
(116,881 |
) |
Investing activities |
|
|
(235,424 |
) |
|
|
(167,493 |
) |
Financing activities |
|
|
424,603 |
|
|
|
336,111 |
|
Net change in cash and cash equivalents |
|
$ |
12,462 |
|
|
$ |
51,737 |
|
Operating Activities
Net cash used in operating activities was $176.7 million during the nine months ended September 30, 2026, and consisted primarily of a net loss of $205.0 million and a net change of $5.7 million in our operating assets and liabilities, partially offset by non-cash expenses of $34.0 million. The $5.7 million net change in our operating assets and liabilities was primarily due to a $5.6 million increase in prepaid expenses and other current assets and a $1.5 million increase in inventory, partially offset by a $1.4 million increase in accounts payable and accrued expenses. The $34.0 million of non-cash expenses consisted of $22.3 million of stock-based compensation expense, $11.5 million loss on debt extinguishment and $0.2 million of depreciation expense.
Net cash used in operating activities was $116.9 million during the nine months ended September 30, 2025, and consisted primarily of a net loss of $126.1 million and a net change of $4.6 million in our operating assets and liabilities, partially offset by non-cash expenses of $13.8 million. The $13.8 million of non-cash expenses consisted of $11.9 million of stock-based compensation expense and $1.9 million of net non-cash interest expense. The $4.6 million net change in our operating assets and liabilities was primarily due to a $10.7 million increase in prepaid expenses and other current assets, partially offset by a $6.1 million increase in accounts payable and accrued expenses.
Investing Activities
Net cash used in investing activities was $235.4 million during the nine months ended September 30, 2026, and consisted of $184.7 million of net purchases of short-term investments in U.S. treasury securities, $50.0 million in purchases of intangible assets and $0.7 million in purchases of property and equipment and capitalized software.
Net cash used in investing activities was $167.5 million during the nine months ended September 30, 2025, and consisted of $167.3 million of net purchases of short-term investments in U.S. treasury securities and $0.2 million in purchases of property and equipment.
Financing Activities
Net cash provided by financing activities was $424.6 million during the nine months ended September 30, 2026, and consisted of $557.0 million of net proceeds from the 2032 Notes, $4.8 million of proceeds from the exercise of employee stock options and employee stock purchases, partially offset by $137.0 million of payments for the extinguishment of the Amended A&R Loan Agreement and $0.2 million of payments for secondary registration statement costs.
Net cash provided by financing activities was $336.1 million during the nine months ended September 30, 2025, and consisted of net proceeds of $195.5 million from the 2031 Notes, net proceeds of $91.8 million from the Equity Underwriting Agreement and net proceeds of $27.8 million from the Term D Loan. In addition, cash provided by financing activities included $18.5 million from the exercise of common stock warrants and $2.5 million from the exercise of employee stock options and employee stock purchases.
Recent Accounting Pronouncements
From time-to-time new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. These pronouncements are more fully described in Note 2 to our unaudited condensed financial statements included in Part I, Item 1 of this Quarterly Report. We are currently evaluating the method of adoption and the impact of any recent accounting pronouncements not yet adopted on our unaudited condensed financial statements and related disclosures.
Critical Accounting Policies and Use of Estimates
Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements, as well as the reported expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results during the period in which they become known. Actual results may differ materially from these estimates.
Our significant accounting policies are more fully described in the 2025 10-K and in Note 2 to our unaudited condensed financial statements included in Part I, Item 1 of this Quarterly Report. There were no changes to our critical accounting estimates, as disclosed in the 2025 10-K, during the nine months ended September 30, 2026. Of our significant accounting policies, we believe that the following reflect the critical accounting estimates used in the preparation of our unaudited condensed financial statements:
•Stock-based compensation; and