Celcuity Inc.

Previous wording

You should read the following discussion and analysis of our financial condition and results of operations together 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.

Current wording

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.

Previous wording

Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. Our lead therapeutic candidate is gedatolisib, a kinase inhibitor of the PI3K/AKT/mTOR (“PAM”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of 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 in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, has reported detailed results for Study 1, which evaluated patients withPIK3CA WT tumors, and announced topline results for Study 2, which evaluated patients withPIK3CA MT tumors. Our Phase 3 clinical trial, VIKTORIA-2, is ongoing and incorporates two independent studies, Study 1 and Study 2, evaluating two separate cohorts of patients with ABC who are treatment-naïve in the advanced setting. Study 1 is evaluating gedatolisib combined with palbociclib and fulvestrant as first-line treatment for patients with endocrine resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib combined 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 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.

Previous 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 currently approved and investigational therapies that target 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 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.

Previous wording

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 treatment related 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.

Current wording

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.

Previous wording

With these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+/HER2-PIK3CA WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor. In January 2026, the FDA accepted for filing 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.

Current 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.

Previous wording

As of March 31, 2026, 1,127 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 968 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.

Current wording

As of June 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.

Previous wording

A total of 138 patients with HR+/HER2- ABC were dosed in the clinical trial. Four patients from this study continue to receive study treatment, as of March 31, 2026, 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 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.

Previous wording

We have completed primary analysis of our Phase 3, open-label, randomized clinical trial, VIKTORIA-1, that is evaluating the efficacy and safety of gedatolisib treatment regimens in adults with HR+/HER2- ABC whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor. Over 200 clinical sites in North America, Europe, Latin America, and Asia-Pacific are participating in the study.

Current 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.

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 theirPIK3CA status. Subjects who met eligibility criteria and hadPIK3CA 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 hadPIK3CA 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 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.

Previous wording

On July 28, 2025, we announced topline data from thePIK3CAWT cohort of the VIKTORIA-1 clinical trial and on October 18, 2025, at the ESMO congress, additional efficacy and safety results from this cohort were presented. The key efficacy and safety data from thePIK3CA WT cohort showed:

Current 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:

Previous wording

In December 2025, updated efficacy and safety results from the Phase 3 VIKTORIA-1PIK3CA WT cohort were presented at the 2025 San Antonio Breast Cancer Symposium including patient sub-group analyses, safety analyses and patient reported outcomes for well-being measures.

Current wording

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 wording

On May 1, 2026, we announced positive topline results from Study 2 (PIK3CA MT cohort) of the VIKTORIA-1 Phase 3 clinical trial evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2-PIK3CA MT ABC, following progression on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Detailed results will be presented in a late-breaking abstract (“LBA”) oral session on June 2, 2026, at the American Society of Clinical Oncology (“ASCO”) Annual Meeting in Chicago, Illinois.

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 additional efficacy and safety results from this cohort.

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 no new safety signals.

Current 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.

Previous wording

We intend to submit these data to the FDA as an sNDA and to submit VIKTORIA-1 data to other regulatory authorities outside the U.S. following the sNDA submission.

Current 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.

Previous wording

In February 2026, we conducted a Type B meeting with the FDA in order to obtain the FDA’s feedback on our proposed study design changes. From this meeting, we gained general alignment with the FDA on our planned amendments to the VIKTORIA-2 study design and protocol. First, VIKTORIA-2 will now evaluate the safety and efficacy of patients with endocrine sensitive HR+/HER2- ABC, in addition to those with endocrine-resistant disease. 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. Second, 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 theirPIK3CA status (e.g., WT or MT) are no longer included. And third, the control arms for Study 1 and Study 2 will evaluate ribociclib combined with either fulvestrant (Study 1) or letrozole (Study 2); palbociclib will no longer be included as an option in the control arms.

Current wording

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).

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, 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 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.

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 a Phase 1b/2 clinical trial, CELC-G-201, 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 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.

Previous wording

On June 30, 2025, we announced preliminary data for the CELC-G-201 Phase 1b 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.

Current wording

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 wording

On October 18, 2025, at the ESMO congress, we presented updated clinical results for the CELC-G-201 Phase 1b 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.

Current wording

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 wording

In the amended Phase 1/1b portion of the clinical trial, up to six patients are planned to be enrolled in each of three arms and treated with different doses. Upon completion of Phase 1, up to an additional 24 patients will be randomly assigned to up to two Phase 1b cohorts to determine the RP2D. Dose levels will be selected based on the results from the Phase 1/1b clinical trial. In the Phase 2 dose expansion study, up to 84 additional subjects will be enrolled. All patients will also receive standard doses of darolutamide.

Current wording

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 wording

We have not generated any revenue from product sales or other sources to date, and we continue to incur significant research and development 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 March 31, 2026 and 2025, we reported a net loss of $52.8 million and $37.0 million, respectively. As of March 31, 2026, we had an accumulated deficit of $501.7 million and cash, cash equivalents and short-term investments of $387.1 million.

Current 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.

Previous wording

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 potential regulatory approval to market gedatolisib. Our Phase 3 clinical trial, VIKTORIA-2, and Phase 1b/2 clinical trial, CELC-G-201, are ongoing.

Current wording

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 wording

Pursuant to the FDA’s RTOR 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. If we obtain FDA approval to market gedatolisib, we expect to generate revenue from sales of the drug commencing in the second half of 2026.

Current wording

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 wording

Since our inception, we have primarily focused on research and development of gedatolisib, a PAM inhibitor. Research and development expenses primarily include:

Current wording

Since our inception, we have primarily focused on research and development of gedatolisib. Research and development expenses primarily include:

Previous wording

Selling, general and administrative expenses primarily consist of salaries and employee-related costs, including stock-based compensation, for personnel in our executive, commercial, market access, marketing, legal, finance, human resources and support functions.

Current 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.

Previous wording

Non-employee-related selling expenses consist primarily of professional and consulting fees, software costs, the acquisition of data, and other commercial operations related activities incurred in anticipation of the commercialization of gedatolisib. Non-employee-related general and administrative expenses primarily consist of professional fees for auditing, tax, and legal services associated with being a public company, director and officer insurance, software costs, investor relations, and travel expenses for our general and administrative personnel.

Current 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.

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 potential future commercialization of gedatolisib, 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 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.

Previous wording

Interest expense to date is primarily related to the Amended A&R Loan Agreement and the Notes.

Current wording

Interest expense to date is primarily related to the Amended A&R Loan Agreement, the 2031 Notes and the 2032 Notes.

Previous wording

During the three months ended March 31, 2026, our research and development expenses were $33.1 million, representing an increase of $3.3 million, or 11%, compared to the same period in 2025. The increase was primarily due to a $3.0 million increase in employee-related and consulting expenses, of which $0.9 million related to stock-based compensation. The remaining increase was primarily due to a $5.4 million increase in manufacturing and other costs, partially offset by a $5.1 million decrease in clinical trial costs, which was primarily driven by decreased costs for the VIKTORIA-1 Phase 3 clinical trial.

Current 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.

Previous wording

During the three months ended March 31, 2026, our interest expense was $6.1 million, and represents an increase of $2.9 million, or 91%, compared to the same period in 2025. Interest expense during the three months ended March 31, 2026, is attributable to the Notes and the Amended A&R Loan Agreement. Interest expense during the three months ended March 31, 2025, is attributable to the A&R Loan Agreement. The increase was primarily due to the issuance of $201.3 million aggregate principal amount of the Notes in July 2025 and the $30.0 million distribution of the Term Loan D in September 2025. The $6.1 million of interest expense includes $1.6 million of non-cash interest expense.

Current 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.

Previous wording

During the three months ended March 31, 2026, our interest income was $3.8 million, and represents an increase of $1.4 million, or 62%, 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 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.

Previous wording

Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through March 31, 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 March 31, 2026, we raised aggregate net proceeds of $507.3 million through sales of our securities, $194.9 million through the issuance of the Notes, and $120.8 million through borrowings under the Amended A&R Loan Agreement. As of March 31, 2026, we had an accumulated deficit of $501.7 million, our cash and cash equivalents were $145.2 million, and our short-term investments were $241.9 million.

Current wording

Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through June 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 June 30, 2026, we raised aggregate net proceeds of $473.0 million through sales of our securities and $752.1 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 June 30, 2026, we had an accumulated deficit of $580.6 million, cash and cash equivalents were $182.0 million, and our short-term investments were $572.0 million.

Previous wording

We expect that our research and development and selling, general and administrative expenses will increase 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, conduct other studies and clinical trials, and pursue other business development activities. We also expect sales and marketing expenses to increase as we prepare for and support the planned commercialization of gedatolisib. We expect to use cash on hand, together with the funds received or to be received under the debt and equity financings described above, to fund our research and development expenses, clinical trial costs, sales and marketing expenses, general corporate expenses, capital expenditures and working capital.

Current wording

We expect that our research and development and selling, general and administrative expenses will increase as we support 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 any future revenue received 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.

Previous wording

Based on our current business plan, we believe that our current cash, cash equivalents and short-term investments, together with available borrowings under the Amended A&R Loan Agreement, will provide sufficient cash to finance our operations through 2027.

Current wording

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 at least into 2029.

Previous wording

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 currently expect. In addition, we may seek to raise additional capital to finance capital expenditures and operating expenses over the next several years as we seek to obtain approval for and launch gedatolisib; expand our infrastructure, commercial operations and research and 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.

Current wording

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 support the commercialization of REVTORPYK, expand our infrastructure, commercial operations and research and 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.

Previous wording

Net cash used in operating activities was $55.1 million during the three months ended March 31, 2026, and consisted of a net loss of $52.8 million and working capital changes of $8.3 million, partially offset by non-cash expenses of $6.0 million. The $8.3 million decrease in working capital was primarily due to a $14.9 million decrease in accrued clinical trial costs and other accrued expenses, partially offset by a $4.1 million increase in accounts payable and a $2.5 million decrease in prepaid clinical trial costs and other current assets. The $6.0 million of non-cash expenses consisted of $5.3 million of stock-based compensation expense and $0.7 million of net non-cash interest expense.

Current wording

Net cash used in operating activities was $110.5 million during the six months ended June 30, 2026, and consisted primarily of a net loss of $131.7 million and a decrease in working capital of $5.2 million, partially offset by non-cash expenses of $26.4 million. The $5.2 million decrease in working capital was primarily due to a $7.5 million decrease in accounts payable and accrued expenses, partially offset by a $2.3 million decrease in prepaid expenses and other current assets. The $26.4 million of non-cash expenses consisted of $12.2 million of stock-based compensation expense, $11.5 million loss on debt extinguishment, $2.6 million of net non-cash interest expense and $0.1 million of depreciation expense.

Previous wording

Net cash used in operating activities was $35.9 million during the three months ended March 31, 2025, and consisted of a net loss of $37.0 million and working capital changes of $1.2 million, partially offset by non-cash expenses of $2.3 million. The $1.2 million decrease in working capital was primarily due to a $2.4 million increase in prepaid clinical trial costs and other current assets, partially offset by a $0.6 million increase in accounts payable and a $0.6 million increase in accrued clinical trial costs and other accrued expenses. The $2.3 million of non-cash expenses consisted of $2.4 million of stock-based compensation expense, partially offset by net non-cash interest income of $0.1 million.

Current wording

Net cash used in operating activities was $72.1 million during the six months ended June 30, 2025, and consisted primarily of a net loss of $82.3 million, partially offset by non-cash expenses of $7.2 million and an increase in working capital of $3.0 million. The $7.2 million of non-cash expenses consisted of $5.1 million of stock-based compensation expense, $2.0 million of net non-cash interest expense and $0.1 million of depreciation expense. The $3.0 million increase in working capital was primarily due to an $8.2 million increase in accounts payable and accrued expenses, partially offset by a $5.2 million increase in prepaid expenses and other current assets.

Previous wording

Net cash provided by investing activities was $34.5 million during the three months ended March 31, 2026, and consisted of $34.8 million of net purchases of short-term investments in U.S. treasury securities, partially offset by $0.3 million in purchases of property and equipment and capitalized software.

Current wording

Net cash used in investing activities was $296.1 million during the six months ended June 30, 2026, and consisted of $295.7 million of net purchases of short-term investments in U.S. treasury securities and $0.4 million in purchases of property and equipment and capitalized software.

Previous wording

Net cash provided by investing activities was $24.3 million during the three months ended March 31, 2025, and consisted of $24.4 million of net purchases of short-term investments in U.S. treasury securities, partially offset by $0.1 million in purchases of property and equipment.

Current wording

Net cash provided by investing activities was $90.1 million during the six months ended June 30, 2025, and consisted of $90.2 million of net proceeds from short-term investments in U.S. treasury securities, partially offset by $0.1 million in purchases of property and equipment.

Previous wording

Net cash provided by financing activities was less than $0.1 million during the three months ended March 31, 2026, and consisted of $0.2 million of proceeds from the exercise of employee stock options, partially offset by $0.2 million of payments for secondary registration statement costs.

Current wording

Net cash provided by financing activities was $5.8 million during the six months ended June 30, 2025, and consisted of net proceeds of $5.6 million from the exercise of common stock warrants and $0.3 million from the exercise of employee stock options and employee stock purchases, partially offset by $0.1 million of debt issuance costs and payments for secondary registration statement costs.