Celcuity Inc.

Previous wording

Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) 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 PI3K/AKT/mTOR (“PAM”) pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3K, AKT, or mTOR alone or together. Our Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer has completed enrollment of and reported topline data for cohort 1, patients withPIK3CA wild-type (“WT”) tumors, and is continuing to enroll cohort 2, patients withPIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer is currently enrolling patients. The first patient was dosed in July of 2025. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer (“mCRPC”), is ongoing. An investigator sponsored trial has been initiated in collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.

Current wording

Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. The Company’s lead therapeutic candidate is gedatolisib, a kinase inhibitor of the phosphatidylinositol 3-kinase (“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin (“mTOR”) 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 PI3K/AKT/mTOR (“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 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer has completed enrollment of and reported detailed results for cohort 1, patients withPIK3CA wild-type (“WT”) tumors, and has completed enrollment of cohort 2, patients withPIK3CA mutant-type (“MT”) tumors. Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer is currently enrolling patients. The first patient was dosed in July of 2025. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer (“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 PI3K, AKT, or mTOR alone or together.

Current wording

In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer. We believe gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous route of administration offer distinct advantages over currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together.

Previous wording

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 PI3K-α 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 PI3K, 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.

Current wording

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.

Previous wording

High objective overall response rates (“ORR”) were observed in all four expansion arms and were comparable in each arm forPIK3CA wild type (“WT”) andPIK3CA mutant (“MT”) patients. In patients who received prior hormonal therapy alone or in combination with a CDK 4/6 inhibitor (Arms B, C, and D), the ORR (including unconfirmed partial responses) ranged from 36% to 77%. In patients who were treatment naïve in the advanced setting (Arm A), the ORR was 85%. Each arm achieved its primary endpoint target, which was reporting higher ORR in the study arm than the ORR from either the PALOMA-2 study (ORR=55%) that evaluated palbociclib plus letrozole for Arm A or the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D. For all patients enrolled in the expansion portion of the study who had evaluable tumors, the ORR observed was 63%.

Current wording

High objective overall response rates (“ORR”) were observed in all four expansion arms and were comparable in each arm forPIK3CA WT andPIK3CAMT patients. In patients who received prior hormonal therapy alone or in combination with a CDK 4/6 inhibitor (Arms B, C, and D), the ORR (including unconfirmed partial responses) ranged from 36% to 77%. In patients who were treatment naïve in the advanced setting (Arm A), the ORR was 85%. Each arm achieved its primary endpoint target, which was reporting higher ORR in the study arm than the ORR from either the PALOMA-2 study (ORR=55%) that evaluated palbociclib plus letrozole for Arm A or the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D. For all patients enrolled in the expansion portion of the study who had evaluable tumors, the ORR observed was 63%.

Previous wording

We are currently enrolling patients in a Phase 3, open-label, randomized clinical trial, VIKTORIA-1, to evaluate the efficacy and safety of two regimens in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK 4/6 therapy in combination with an aromatase inhibitor: 1) gedatolisib in combination with palbociclib and fulvestrant; and 2) gedatolisib in combination with fulvestrant. Over two hundred clinical sites in North America, Europe, Latin America, and Asia-Pacific are participating in the study. The first patient was dosed in this trial in December 2022.

Current wording

We have completed enrollment of our Phase 3, open-label, randomized clinical trial, VIKTORIA-1, to evaluate the efficacy and safety of gedatolisib treatment regimens in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK 4/6 therapy in combination with an aromatase inhibitor. Over two hundred clinical sites in North America, Europe, Latin America, and Asia-Pacific are participating in the study. The first patient was dosed in this trial in December 2022.

Previous wording

The VIKTORA-1 Phase 3 clinical trial enables separate evaluation of subjects according to theirPIK3CA status. Subjects who meet eligibility criteria and havePIK3CA WT tumors 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). During the fourth quarter of 2024, we achieved our enrollment goal of 351 subjects for thePIK3CA WT cohort. The primary completion date for this cohort was achieved in May 2025 and the database cut-off date for this cohort was May 30, 2025. Topline data from thePIK3CA WT cohort was reported in July 2025. See “Recent Developments,” below, for a summary of the topline data. Subjects who meet eligibility criteria and arePIK3CA MT are 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). Enrollment of up to 350 subjects who havePIK3CA MT tumors is ongoing. We expect topline data for this group to be available in the fourth quarter of 2025.

Current wording

The VIKTORA-1 Phase 3 clinical trial involves two study cohorts that enable separate evaluation of subjects according to theirPIK3CA status. Subjects who met eligibility criteria and hadPIK3CA WT tumors (cohort 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). During the fourth quarter of 2024, we achieved our enrollment goal of 351 subjects for thePIK3CA WT cohort. The primary completion date for this cohort was achieved in May 2025 and the database cut-off date for this cohort was May 30, 2025. Subjects who met eligibility criteria and hadPIK3CA MT tumors (cohort 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). Enrollment of approximately 350 subjects who havePIK3CA MT tumors is complete. We expect topline data for this group to be available in late Q1 2026 or during Q2 2026.

Previous wording

On July 28, 2025, we announced topline data from thePIK3CAWT cohort of the VIKTORIA-1 clinical trial. The key efficacy and safety data from thePIK3CA WT cohort showed:

Current 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 was presented. The key efficacy and safety data from thePIK3CA WT cohort showed:

Previous wording

Additional preliminary results for the Phase 1b portion of the clinical trial will be presented at a medical conference later this year.

Current wording

Additional results from cohort 1 of the VIKTORIA-1 Phase 3 clinical trial will be presented at a medical conference later this year.

Previous wording

Based on these data, we have 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 will then 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 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 will then 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 July 30, 2025, we entered into an underwriting agreement (the “Equity Underwriting Agreement”) with Jefferies LLC, TD Securities (USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several underwriters named therein (collectively, the “Underwriters”) agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 shares (the “Shares”) of our common stock, at a price to the public of $38.00 per Share and (b) in lieu of Shares to certain investors, pre-funded warrants to purchase up to 400,000 shares of common stock (the “Pre-Funded Warrants”), at a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $0.001 per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”). In addition, pursuant to the Equity Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 shares of common stock (the “Option Shares”), less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025.

Current wording

On July 30, 2025, we entered into the Equity Underwriting Agreement with the Representatives of the Underwriters agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 Shares at a price to the public of $38.00 per Share and (ii) in lieu of Shares to certain investors, Pre-Funded Warrants to purchase up to 400,000 shares of common stock, at a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $0.001 per share exercise price for each such Pre-Funded Warrant. In addition, pursuant to the Equity Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 Option Shares, less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025. For a summary of the Equity Offering, see “Liquidity and Capital Resources” below.

Previous wording

On July 30, 2025, we also entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters, subject to customary conditions, to issue and sell in a public offering $175,000,000 aggregate principal amount of the Company’s 2.750% Convertible Senior Notes due 2031 (the “Notes”) to the Underwriters (the “Note Offering”). In addition, pursuant to the Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26,250,000 aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $26,250,000 aggregate principal amount of Notes. The issuance of $201,250,000 aggregate principal amount of Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August 1, 2025, between us and U.S. Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a first supplemental indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture, the “Indenture”), dated as of August 1, 2025, between us and the Trustee. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. We intend to use the net proceeds from the Note Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes. Please see “Liquidity and Capital Resources” below for additional information regarding the Note Offering.

Current wording

On July 30, 2025, we also entered into the Note Underwriting Agreement with the Underwriters, subject to customary conditions, to issue and sell in a public offering $175.0 million aggregate principal amount of Notes to the Underwriters. In addition, pursuant to the Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26.3 million aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $26.3 million aggregate principal amount of Notes. The issuance of $201.3 million aggregate principal amount of Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by the Indenture. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. We are using the net proceeds from the Note Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes. For a summary of the Note Offering, see “Liquidity and Capital Resources” below.

Previous wording

We have not generated any revenue from sales 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. For the three months ended June 30, 2025 and 2024, we reported a net loss of approximately $45.3 million and $23.7 million, respectively, and for the six months ended June 30, 2025, we reported a net loss of approximately $82.3 million and $45.3 million, respectively. As of June 30, 2025, we had an accumulated deficit of approximately $354.1 million. As of June 30, 2025, we had cash and cash equivalents and short-term investments of approximately $168.4 million.

Current wording

We have not generated any revenue from sales 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. For the three months ended September 30, 2025 and 2024, we reported a net loss of approximately $43.8 million and $29.8 million, respectively, and for the nine months ended September 30, 2025 and 2024, we reported a net loss of approximately $126.1 million and $75.1 million, respectively. As of September 30, 2025, we had an accumulated deficit of approximately $397.9 million. As of September 30, 2025, we had cash and cash equivalents and short-term investments of approximately $455.0 million.

Previous wording

To date, we have not generated any revenue. With the execution of the Pfizer license agreement in April 2021, whereby we acquired exclusive world-wide licensing rights to develop and commercialize gedatolisib, we initiated a Phase 3 clinical trial, VIKTORIA-1, in 2022 to support potential regulatory approval to market gedatolisib. In August 2023, we initiated a Phase 1b/2 clinical trial, CELC-G-201. In July 2025 we dosed our first patient and are currently enrolling patients in a second Phase 3 clinical trial, VIKTORIA-2. We expect to submit an NDA to the FDA in the fourth quarter of 2025 seeking approval for gedatolisib in combination with fulvestrant and with or without palbociclib for the treatment of adults with endocrine therapy resistant HR+/HER2- advanced breast cancer following progression on or after treatment with a CDK 4/6 inhibitor in combination with endocrine therapy. If we obtain regulatory approvals to market gedatolisib, we expect to generate revenue from sales of the drug for this and potentially additional breast cancer indications.

Current wording

To date, we have not generated any revenue. With the execution of the Pfizer license agreement in April 2021, whereby we acquired exclusive world-wide licensing rights to develop and commercialize gedatolisib, we initiated a Phase 3 clinical trial, VIKTORIA-1, in 2022 to support potential regulatory approval to market gedatolisib. In August 2023, we initiated a Phase 1b/2 clinical trial, CELC-G-201. In July 2025 we dosed our first patient and are currently enrolling patients in a second Phase 3 clinical trial, VIKTORIA-2.

Previous wording

General and administrative expenses consist primarily of salaries, benefits and stock-based compensation related to our executive, finance and support functions. Other general and administrative expenses include professional fees for auditing, tax, and legal services associated with being a public company, director and officer insurance, investor relations and travel expenses for our general and administrative personnel.

Current wording

General and administrative expenses consist primarily of salaries, benefits and stock-based compensation related to our executive, finance and support functions. Other general and administrative expenses include 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.

Previous wording

Interest expense to date is primarily related to the A&R Loan Agreement. Going forward, interest expense also will be related to the Notes.

Current wording

Interest expense to date is primarily related to the A&R Loan Agreement. During the three months ended September 30, 2025, interest expense included the Convertible Notes.

Previous wording

Comparison of the Six Months Ended June 30, 2025 and 2024 (in thousands)

Current wording

Comparison of the Nine Months Ended September 30, 2025 and 2024 (in thousands)

Previous wording

Our research and development expenses for the six months ended June 30, 2025 were approximately $72.4 million, representing an increase of approximately $29.3 million, or 68%, compared to the same period in 2024. Of the $29.3 million increase in research and development expenses, $12.5 million was related to increased employee and consulting expenses, $11.8 million was related to increased research and development costs primarily attributable to activities supportingour ongoing clinical trials, and $5.0 million is related to an anticipated development milestone payment under the license agreement with Pfizer.

Current wording

Our research and development expenses for the nine months ended September 30, 2025 were approximately $107.4 million, representing an increase of approximately $36.6 million, or 52%, compared to the same period in 2024. Of the $36.6 million increase in research and development expenses, $18.1 million was related to increased employee and consulting expenses, $7.6 million of which related to commercial headcount additions and other launch activities. $13.1 million was attributable to activities supporting our ongoing clinical trials, $5.0 million was related to an anticipated development milestone payment under the license agreement with Pfizer, and $0.4 million was related to other costs.

Previous wording

Conducting a significant amount of research and development is central to our business model. We plan to increase our research and development expenses for the foreseeable future as we seek to continue to develop gedatolisib, including conducting the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 clinical trial and the VIKTORIA-2 Phase 3 clinical trial.

Current wording

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 seek to continue to develop gedatolisib, including conducting the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 clinical trial and the VIKTORIA-2 Phase 3 clinical trial.

Previous wording

Our general and administrative expenses for the three months ended June 30, 2025 were approximately $3.8 million, representing an increase of approximately $2.0 million, or 112%, compared to the same period in 2024. Of the $2.0 million increase in general and administrative expense, $1.6 million was related to increased employee and consulting expenses. The remaining $0.4 million of the $2.0 million increase resulted from professional fees, expanding infrastructure and other administrative expenses

Current wording

Our general and administrative expenses for the three months ended September 30, 2025 were approximately $7.9 million, representing an increase of approximately $5.4 million, or 221%, compared to the same period in 2024. Of the $5.4 million increase in general and administrative expense, $4.9 million was related to increased employee and consulting expenses. Of the $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation. The remaining $0.5 million of the $5.4 million increase resulted from professional fees, expanding infrastructure and other administrative expenses.

Previous wording

Our general and administrative expenses for the six months ended June 30, 2025 were approximately $7.7 million, representing an increase of approximately $4.1 million, or 112%, compared to the same period in 2024. Employee related expenses accounted for $3.2 million of the $4.1 million increase. The remaining $0.9 million of the increase resulted from professional fees, expanding infrastructure and other administrative expenses.

Current wording

Our general and administrative expenses for the nine months ended September 30, 2025 were approximately $15.6 million, representing an increase of under $9.5 million, or 156%, compared to the same period in 2024. Of the $9.5 million increase in general and administrative expense, $8.1 million was related to increased employee and consulting expenses. Of the $8.1 million increase, $5.0 million related to non-cash, stock-based compensation. The remaining $1.4 million of the $9.5 million increase was related to professional fees, expanding infrastructure and other administrative expenses.

Previous wording

We anticipate that our general and administrative expenses will 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 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.

Previous wording

Interest expense for the three months ended June 30, 2025 was $3.2 million and represents an increase of $0.9 million, or 42%, compared to the same period in 2024. Interest expense is the result of the A&R Loan Agreement. The increase is due primarily to the incremental $61.7 million funding of Term Loan C in May 2024. The $3.2 million of interest expense includes $0.8 million of non-cash interest expense.

Current wording

Interest expense for the three months ended September 30, 2025 was $4.6 million and represents an increase of $1.3 million, or 37%, compared to the same period in 2024. Interest expense is the result of Convertible Notes and the A&R Loan Agreement. The increase is due primarily to the issuance of the Convertible Notes in July 2025 and the distribution of the Term Loan D in September 2025. The $4.6 million of interest expense includes $1.1 million of non-cash interest expense.

Previous wording

Interest expense for the six months ended June 30, 2025 was $6.4 million and represents an increase of $2.7 million, or 74%, compared to the same period in 2024. Interest expense is the result of the A&R Loan Agreement. The increase is due primarily to the incremental $61.7 million funding of Term Loan C in May 2024. The $6.4 million of interest expense includes $1.6 million of non-cash interest expense.

Current wording

Interest expense for the nine months ended September 30, 2025 was $11.0 million and represents an increase of $4.0 million, or 57%, compared to the same period in 2024. Interest expense is the result of the Convertible Notes and the A&R Loan Agreement. The increase is primarily due to the incremental $61.7 million funding of the Term Loan C in May 2024, the issuance of the Convertible Notes in July 2025 and the distribution of the Term Loan D in September 2025. The $11.0 million of interest expense includes $2.6 million of non-cash interest expense.

Previous wording

Interest income for the three months ended June 30, 2025 was $1.9 million and represents a decrease of $0.9 million compared to the same period in 2024. The decrease was primarily the result of lower market interest rates, as well as lower average cash, cash equivalent and investment balances in the current period.

Current wording

Interest income for the three months ended September 30, 2025 was $3.6 million and represents a decrease of under $0.1 million compared to the same period in 2024. The decrease was primarily the result of lower market interest rates offset largely by a higher invested cash balance.

Previous wording

Interest income for the six months ended June 30, 2025 was $4.3 million and represents a decrease of $0.8 million compared to the same period in 2024. The decrease was primarily the result of lower market interest rates.

Current wording

Interest income for the nine months ended September 30, 2025 was $7.9 million and represents a decrease of $0.8 million compared to the same period in 2024. The decrease was primarily the result of lower market interest rates offset partially by a higher invested cash balance.

Previous wording

Through the date of this Quarterly Report, we have funded our operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes, and borrowings under loan agreements. From inception through the date of this Quarterly Report, we raised an aggregate of approximately $478.7 million of net proceeds through sales of our equity securities, approximately $194.9 million of net proceeds through the issuance of the Notes, and $100.0 million of borrowings under loan agreements, not including payable-in-kind interest. Theterms of our more recent financings are described below.

Current wording

Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through September 30, 2025, we have funded our operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes, and borrowings under loan agreements. From inception through September 30, 2025, we raised an aggregate of approximately $481.7 million of net proceeds through sales of our securities, approximately $194.9 million of net proceeds through the issuance of the Notes, and had $130.0 million of borrowings under loan agreements, not including payable-in-kind interest. In October 2025, investors exercised 2,930,420 warrants at an exercise price of $8.05, which generated approximately $23.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. From September 30, 2025 through the report date, stock option exercises generated approximately $0.2 million in cash. As of September 30, 2025, our cash and cash equivalents and short-term investments were approximately $74.3 million and $380.7 million, respectively, and we had an accumulated deficit of approximately $397.9 million.

Previous wording

On July 30, 2025, we entered into the Equity Underwriting Agreement with the Representatives of the Underwriters agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 shares at a price to the public of $38.00 per Share and (b) in lieu of Shares to certain investors, Pre-Funded Warrants to purchase up to 400,000 shares of common stock, at a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $0.001 per share exercise price for each such Pre-Funded Warrant. In addition, pursuant to the Equity Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 Option Shares, less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025.

Current wording

On July 30, 2025, we entered into the Equity Underwriting Agreement with the Representatives of the Underwriters agreeing, subject to customary conditions, to issue and sell in a public offering (i) 1,836,842 Shares at a price to the public of $38.00 per Share and (ii) in lieu of Shares to certain investors, Pre-Funded Warrants to purchase up to 400,000 shares of common stock, at a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the $0.001 per share exercise price for each such Pre-Funded Warrant. In addition, pursuant to the Equity Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 Option Shares, less underwriting discounts and commissions. The Underwriters exercised their option to purchase the Option Shares in full on July 30, 2025. The Equity Offering was completed on July 31, 2025.

Previous wording

The net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares. We may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants. We intend to use the net proceeds from the Equity Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes.

Current wording

The net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares. We may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants. We are using the net proceeds from the Equity Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes.

Previous wording

On July 30, 2025, we also entered into the Note Underwriting Agreement with the Underwriters, subject to customary conditions, to issue and sell in a public offering $175,000,000 aggregate principal amount of the Notes to the Underwriters. In addition, pursuant to the Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26,250,000 aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $26,250,000 aggregate principal amount of Notes. The issuance of $201,250,000 aggregate principal amount of Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by the Indenture. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. We intend to use the net proceeds from the Note Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes.

Current wording

On July 30, 2025, we also entered into the Note Underwriting Agreement with the Underwriters, subject to customary conditions, to issue and sell in a public offering $175.0 million aggregate principal amount of Notes to the Underwriters. In addition, pursuant to the Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26.3 million aggregate principal amount of Notes solely to cover over-allotments. On July 30, 2025, the Underwriters exercised such option to purchase an additional $26.3 million aggregate principal amount of Notes. The issuance of $201.3 million aggregate principal amount of Notes was completed on August 1, 2025. The Notes were issued pursuant to, and are governed by the Indenture. The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full. We are using the net proceeds from the Note Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate purposes.

Previous wording

The Notes are our general, unsecured, senior obligations. The Notes will accrue interest payable semiannually 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 Notes upon the occurrence of certain events relating to our failure to file certain reports with the SEC as provided in the Indenture and as described below. The Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the Indenture) with certain interest penalty provisions. The Notes will mature on August 1, 2031, unless earlier converted, redeemed or repurchased by us.

Current wording

The Notes are our general, unsecured, senior obligations. The Notes will 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 Notes upon the occurrence of certain events relating to our failure to file certain reports with the SEC as provided in the Indenture and as described below. The Notes also have customary provisions relating to the occurrence of “Events of Default” (as defined in the Indenture) with certain interest penalty provisions. The Notes will mature on August 1, 2031, unless earlier converted, redeemed or repurchased by us.

Previous wording

In August 2025, investors exercised 200,000 warrants at an exercise price of $8.05, which generated approximately $1.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022.

Current wording

In August 2025, investors exercised 200,000 warrants at an exercise price of $8.05, which generated approximately $1.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. Also in August 2025, the underwriter of the Company’s initial public offering that closed on September 22, 2017 exercised its warrants on a cashless basis. As a result, the Company issued 55,592 shares of common stock upon the cashless exercise of 70,000 warrants.

Previous wording

On February 4, 2022, we entered into an Open Market Sale Agreement with Jefferies LLC (“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 $125.0 million on December 6, 2024. On July 29, 2025, prior to the pricing of the Equity Offering and the Note Offering, the aggregate offering price was reduced from $125.0 million to $50.0 million. On October 12, 2022, pursuant to this agreement, we sold 500,000 shares of common stock in a single transaction at a price of $10.35 per share, generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering expenses). On December 1, 2023, pursuant to this agreement, we sold 1,034,500 shares of common stock in a single transaction at a price of $14.50 per share, generating gross proceeds of $15.0 million ($14.4 million net of commissions and offering expenses). In April 2024 and May 2024, pursuant to this agreement, we sold 285,714 and 149,700 shares of common stock, respectively, at an average selling price of $17.55 per share, generating gross proceeds of $7.6 million before deducting commissions and other offering expenses of $0.3 million. At June 30, 2025, $125.0 million of common stock remains available for sale under the Open Market Sale Agreement with Jefferies.

Current wording

On February 4, 2022, we entered into an Open Market Sale Agreement with Jefferies LLC (“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 $125.0 million on December 6, 2024. On July 29, 2025, prior to the pricing of the Equity Offering and the Note Offering, the aggregate offering price was reduced from $125.0 million to $50.0 million. On October 12, 2022, pursuant to this agreement, we sold 500,000 shares of common stock in a single transaction at a price of $10.35 per share, generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering expenses). On December 1, 2023, pursuant to this agreement, we sold 1,034,500 shares of common stock in a single transaction at a price of $14.50 per share, generating gross proceeds of $15.0 million ($14.4 million net of commissions and offering expenses). In April 2024 and May 2024, pursuant to this agreement, we sold 285,714 and 149,700 shares of common stock, respectively, at an average selling price of $17.55 per share, generating gross proceeds of $7.6 million before deducting commissions and other offering expenses of $0.3 million. At September 30, 2025, $50.0 million of common stock remains available for sale under the Open Market Sale Agreement with Jefferies.

Previous wording

On May 30, 2024, we entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of common stock, at a price to the public of $15.50, generating gross proceeds of approximately $60.0 million. The offering closed on May 31, 2024 and resulted in net proceeds to the Company of approximately $56.3 million after deducting underwriting discounts and other offering expenses payable by the Company.

Current wording

On May 30, 2024, we entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of common stock, at a price to the public of $15.50, generating gross proceeds of approximately $60.0 million. The offering closed on May 31, 2024 and resulted in net proceeds to us of approximately $56.3 million after deducting underwriting discounts and other offering expenses payable by us.

Previous wording

On May 30, 2024, we entered into an Amended and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford Finance LLC (“Oxford”), pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to us in the aggregate principal amount of up to $180 million. The A&R Loan Agreement amends and restates, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between us and Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”).

Current wording

Amended and Restated Loan and Security Agreement

Previous wording

On July 28, 2025, we entered into the Second Amendment to the A&R Loan Agreement, pursuant to which we agreed to (i) subject to certain terms and conditions, permit the issuance of the Notes and certain transactions in connection therewith, including the conversion thereof settled solely in common stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit the capped call transactions in connection with the pricing of the Notes, (iii) require an amendment fee payable by us to Oxford in the amount of $25,000, which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00.

Current wording

On July 28, 2025, we entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with Innovatus, as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford, pursuant to which Innovatus and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to us in the aggregate principal amount of up to $180 million. The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the Notes discussed above and certain transactions in connection therewith, including the conversion thereof settled solely in common stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit capped call transactions in connection with the pricing of the Notes, (iii) require an amendment fee payable by us to Oxford in the amount of $25,000, which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00.

Previous wording

In connection with the release of the topline data from the WT cohort of the VIKTORIA-1 Phase 3 clinical trial, we achieved the Term D Milestone (as defined in the A&R Loan Agreement) and therefore are eligible to draw down an additional $30.0 million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). We intend to draw down such $30.0 million in late August 2025 prior to the expiration of the Term D Draw Period (as defined in the A&R Loan Agreement) on August 31, 2025.

Current wording

Further, in connection with the release of the topline data from the wild-type cohort of the VIKTORIA-1 Phase 3 clinical trial, we achieved the Term D Milestone (as defined in the A&R Loan Agreement) and therefore became eligible to draw an additional $30.0 million of indebtedness under the Term D Loan (as defined in the A&R Loan Agreement). As described above, the Term D Loan was disbursed to us in connection with the Third Amendment.

Previous wording

On May 13, 2025, we entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant to which we agreed to (i) pay Oxford an amendment fee of $40,000 on the effective date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if we fail to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if we subsequently achieve the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation.

Current wording

On May 13, 2025, we entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant to which we agreed to (i) pay Oxford an amendment fee of $40,000 on the effective date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if we had failed to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if we subsequently achieves the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation.

Previous wording

Funding of the first $100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $16.8 million (the “Term A Loan”) and $21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $61.7 million of new borrowings (the “Term C Loan”). We became eligible to draw on a fourth tranche of $30 million (the “Term D Loan”) as of July 28, 2025 and will become eligible to draw on a fifth tranche of $50 million (the “Term E Loan”), upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants. The Lenders may, in their sole discretion upon our request, make additional term loans to us of $45 million (the “Term F Loan”). Funding of these additional tranches is also subject to other customary conditions and limits on when we can request funding for such tranches. Costs associated with the new borrowings were approximately $2.4 million.

Current wording

Funding of the first $100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $16.8 million (the “Term A Loan”) and $21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $61.7 million of new borrowings (the “Term C Loan”). As described above, the Term D Loan was disbursed to us in connection with the Third Amendment. Prior to the Third Amendment, we also would have become eligible to draw on a fifth tranche of $50 million (the “Term E Loan”), upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants. The Lenders also could have, in their sole discretion upon our request, made additional term loans to us of $45 million (the “Term F Loan”). Funding of these additional tranches was also subject to other customary conditions and limits on when we could have requested funding for such tranches. Costs associated with the new borrowings were approximately $2.4 million.

Previous wording

Pursuant to the A&R Loan Agreement, we are entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans will mature on May 1, 2029 and will bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. The A&R Loan Agreement is secured by all assets of the Company. Proceeds will be used for working capital purposes and to fund our general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201 clinical trial, and the Phase 3 VIKTORIA-2 clinical trial. The A&R Loan Agreement contains customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity and other financial measures. Innovatus has the right, at its election and until August 9, 2025, to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00. Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase 26,042 shares of common stock at a price per share of $14.40 through April 8, 2031.

Current wording

Pursuant to the A&R Loan Agreement, we are entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met. The Term Loans bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May 31, 2027. The A&R Loan Agreement is secured by all of our assets. Proceeds are being used for working capital purposes and to fund our general business requirements, including the ongoing Phase 3 VIKTORIA-1 clinical trial, the Phase 1b/2 CELC-G-201 clinical trial, and the Phase 3 VIKTORIA-2 clinical trial. The A&R Loan Agreement contains customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity and other financial measures. Prior to the Second Amendment, Innovatus also had the right, at its election and until August 9, 2025, to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00. Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to purchase 26,042 shares of common stock at a price per share of $14.40 through April 8, 2031.

Previous wording

The A&R Loan Agreement contains a Final Fee, which is equal to 4.5% of the initial funding of the agreement and is due on the earliest to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans. There is also a contingent non-utilization fee for both the Term D and Term E Loans. Because we achieved the Term D Milestone on July 28, 2025, if we (i) fail to draw the full amount of the Term D Loan during the Term D Draw Period and (ii) fail to notify Collateral Agent, at any time before the date that is four weeks after the our achievement of the Term D Milestone, of our intent not to draw the full amount of the Term D Loan, a non-utilization fee of $0.9 million, with respect to the Term D Loan shall become due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. If we achieve the Term E Milestone and (i) fail to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fail to notify Collateral Agent, at any time before the date that is four weeks after our achievement of the Term E Milestone, of our intent not to draw the full amount of the Term E Loan, a non-utilization fee of $1.5 million with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. After the 18-month anniversary of the Effective Date, we shall have the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided we (i) provide written notice to Collateral Agent of its election to prepay the Term Loans at least seven business days prior to such prepayment, and (ii) pay to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. At May 30, 2024, we recognized the Final Fee of $4.5 million as additional debt principal and a corresponding debt discount to be amortized over the life of the loan.

Current wording

The A&R Loan Agreement contains a Final Fee, which is equal to 4.5% of the initial funding of the agreement and is due on the earliest to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans. There is also a contingent non-utilization fee for the Term E Loans. Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization provisions related to the Term D Loan are no longer operative. The Term D Loan shall become due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. If we achieve the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fails to notify Collateral Agent, at any time before the date that is four weeks after our achievement of the Term E Milestone, of our intent not to draw the full amount of the Term E Loan, a non-utilization fee with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans. After the 18-month anniversary of the Effective Date, we shall have the option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided we (i) provide written notice to Collateral Agent of its election to prepay the Term Loans at least seven business days prior to such prepayment, and (ii) pay to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation, Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts. At May 30, 2024, we recognized the Final Fee of $4.5 million as additional debt principal and a corresponding debt discount to be amortized over the life of the loan.