Celcuity Inc.
For the period ended Mar 31, 2026. Filed May 14, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 14, 2026
CELC$66.79+4.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-13.
0001493152-25-022401
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-14.
0001493152-26-023180
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 144 previous paragraphs and 102 current paragraphs.
35 unchanged; 40 reworded; 27 added; 69 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 10 previous and 21 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (27)
Current report
A Phase 1b dose-finding trial with an expansion portion for safety and efficacy evaluated gedatolisib when added to either the standard doses of palbociclib plus letrozole or palbociclib plus fulvestrant in patients with HR+/HER2- ABC. PI3K mutation status was not used as an eligibility criterion. Patient enrollment for the trial is complete.
Current report
Source: Layman SABCS 2021
Current report
(1) ORR represents PR, except in Arm A, which had 1 CR = Complete response. Responses per RECIST 1.1; (2) Includes 2 unconfirmed PR
Current report
Abbreviations: 1L = first line; 2L = second line; mos = months; NR = not reached; ORR = objective response rate; PFS = progression free survival
Current report
Source: Layman R. et. al, Lancet Oncol., 2024
Current report
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 report
In March 2026, efficacy and safety results from Study 1 (PIK3CA WT cohort) of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib were published in the Journal of Clinical Oncology.
Current report
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 report
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 report
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 report
In July 2025, we dosed the first patient in VIKTORIA-2, a Phase 3, multi-center, open-label, randomized, clinical trial designed to evaluate the efficacy and safety of gedatolisib combined with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- endocrine-resistant ABC. Preceding commencement of the Phase 3 portion of the trial, a safety run-in study to evaluate the safety of gedatolisib combined with ribociclib and fulvestrant was initiated and completed in the first quarter of 2026. Based on the results of this safety run-in study, we have elected to remove ribociclib as a treatment partner with gedatolisib in the study treatment arm of the trial. Additionally, in light of the clinically meaningful improvement in PFS for patients treated with gedatolisib combined with palbociclib and fulvestrant compared to those treated with fulvestrant in thePIK3CA WT cohort of the VIKTORIA-1 study, we proposed to amend several important elements of the study design and clinical trial protocol for the VIKTORIA-2 study.
Current report
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 report
Study 1 is expected to enroll approximately 440 patients with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant (Arm A) compared to ribociclib combined with fulvestrant (Arm B). We expect topline data for this group to be available by the end of 2028. Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole (Arm C) compared to ribociclib combined with letrozole (Arm D). We expect topline data for this group to be available in 2030.
Current report
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 report
The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by BICR. The statistical analyses of Study 1 and Study 2 are each independent of the other. For Study 1, the primary objective is to compare the PFS of Arm A (gedatolisib + palbociclib + fulvestrant) to Arm B (ribociclib + fulvestrant). For Study 2, the primary objective is to compare the PFS of Arm C (gedatolisib + palbociclib + letrozole) to Arm D (ribociclib + letrozole).
Current report
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 report
Selling, General and Administrative
Current report
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 report
The following table summarizes our results of operations (in thousands):
Current report
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 report
Selling, General and Administrative
Current report
During the three months ended March 31, 2026, our selling, general and administrative expenses were $17.4 million, representing an increase of $11.1 million, or 174%, compared to the same period in 2025. The increase was primarily due to an $8.7 million increase in employee-related and consulting expenses, of which $6.6 million related to commercial headcount additions and other launch-related activities, and a $2.4 million increase primarily due to software costs, professional fees and other costs.
Current report
Liquidity
Current report
Capital Resources
Current report
To help meet our liquidity requirements, we have entered into various equity and financing arrangements. As of March 31, 2026, our material cash requirements for the operations of our business consisted primarily of the current and long-term liabilities noted on our condensed balance sheets, as well as other commitments, including the following notable items:
Current report
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 report
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.
Removed paragraphs (69)
Previous report
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 report
Median progression-free survival (“PFS”) was 12.9 months for patients who received a prior CDK 4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm D). For all treatment naïve patients who received gedatolisib combined with palbociclib plus letrozole in Expansion Arm A and Escalation Arm A (N=41), median PFS was 48.6 months and ORR was 79%. These results compare favorably to published data for current first-line standard-of-care treatments for patients with HR+/HER2-advanced breast cancer.
Previous report
Gedatolisib combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity. The majority of treatment related AEs were Grades 1 and 2. The most frequently observed AEs included stomatitis/mucosal inflammation, the majority of which were Grades 1 and 2. The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed as related to treatment with palbociclib. No Grade 5 events were reported in this study.
Previous report
In a presentation of results from thePIK3CAWT cohort of the VIKTORIA-1 study at the European Society for Medical Oncology (“ESMO”) Congress, additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with HR+/HER2- ABC was included. The analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VIKTORIA-1 study, gedatolisib combined with fulvestrant and palbociclib. (Layman R., Lancet Oncol. 2024; 25:474-8). This included patients from Escalation Arm B and Expansion Arms B, C and D of the Phase 1b study.
Previous report
Patients in Escalation Arm B and Expansion Arms B and C received a 180 mg dose of gedatolisib once weekly (“weekly dose”). Patients in Expansion Arm D received a 180 mg dose of gedatolisib on days 1, 8, and 15 of a four-week cycle (“intermittent dose”), which was the same dose regimen patients in the VIKTORIA-1 study received. The proportion of patients who received the intermittent dose of gedatolisib was 37% for those withPIK3CAMT tumors and 25% for those withPIK3CAWT tumors. The proportion of patients who received prior treatment with a CDK4/6 inhibitor was 73% for those withPIK3CAWT tumors, and 71% for those withPIK3CAMT tumors.
Previous report
Median PFS and the ORR were assessed in sub-groups of patients according to theirPIK3CAstatus (Table 1). For all analyzed patients withPIK3CAMT tumors (n=30), median PFS was 14.6 months and the ORR in response evaluable patients was 48%. Median PFS was 19.7 months and the ORR was 64% in patients withPIK3CAMT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study. For patients withPIK3CAWT tumors (n=60), median PFS was 9.0 months and the ORR in response evaluable patients was 41%. Median PFS was 9.1 months and the ORR was 53% in patients withPIK3CAWT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study.
Previous report
Table 1: Efficacy Analysis of Phase 1b Patients Treated with Gedatolisib Plus Palbociclib Plus Fulvestrant
Previous report
Additional results from cohort 1 of the VIKTORIA-1 Phase 3 clinical trial will be presented at a medical conference later this year.
Previous report
A Phase 3, open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer (“VIKTORIA-2”) is currently enrolling patients. The first patient was dosed in July of 2025. For the CDK 4/6 inhibitor, investigators may choose either ribociclib or palbociclib. This multi-center, international trial is expected to enroll approximately 12–36 evaluable subjects in the safety run-in portion of the study to evaluate the safety of gedatolisib when combined with ribociclib and fulvestrant. In the Phase 3 portion of the study, approximately 638 subjects will be randomized and assigned to Cohort 1*(PIK3CA* WT) or Cohort 2 (PIK3CA MT) based on theirPIK3CA status. Subjects in each cohort will be randomized on a 1:1 basis to either Arm A (gedatolisib with fulvestrant and ribociclib or palbociclib) or Arm B (fulvestrant and ribociclib or palbociclib). It is expected that approximately 200 clinical sites across North America, Europe, Latin America, and Asia-Pacific will participate.
Previous report
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 report
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 report
On August 27, 2025, the FDA granted our request to submit the gedatolisib NDA via the FDA’s Real-Time Oncology Review (“RTOR”) program, and we made our first NDA pre-submission in September 2025. We expect to complete our final NDA submission to the FDA in the fourth quarter of 2025.
Previous report
On September 9, 2025, we entered into the Third Amendment to the Amended and Restated Loan and Security Agreement with Oxford Finance LLC, a Delaware limited liability company, as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership, as a lender, and the other lenders party thereto. For a summary of the Third Amendment to the A&R Loan Agreement, see “Liquidity and Capital Resources” below.** **
Previous report
On October 18, 2025, at the ESMO Congress, we presented (i) detailed efficacy and safety results from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib; (ii) additional data from our Phase 1b clinical trial that evaluated gedatolisib in patients with HR+/HER2- advanced breast cancer; and (iii) additional data from the CELC-G-201 Phase 1b clinical trial evaluating gedatolisib in combination with Nubeqa® (darolutamide), an androgen receptor inhibitor, in men with mCRPC whose disease had progressed on prior treatment with a next generation androgen receptor inhibitor. For a summary of the data presented, see “Overview” above. We also announced that the PIK3CA MT cohort of the VIKTORIA-1 Phase 3 trial was fully enrolled.
Previous report
General and Administrative
Previous report
Sales and Marketing
Previous report
Comparison of the Nine Months Ended September 30, 2025 and 2024 (in thousands)
Previous report
Our research and development expenses for the three months ended September 30, 2025 were approximately $34.9 million, representing an increase of approximately $7.3 million, or 27%, compared to the same period in 2024. Of the $7.3 million increase in research and development expense, $5.6 million was related to increased employee and consulting expenses, $3.2 million of which related to commercial headcount additions and other launch activities. The remaining $1.7 million increase was primarily related to activities supporting our ongoing clinical trials.
Previous report
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 report
General and Administrative
Previous report
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 report
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 report
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 report
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 report
July 2025 Equity Offering
Previous report
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 report
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 report
Each Pre-Funded Warrant is exercisable for one share of common stock at an exercise price of $0.001 per share, or alternatively, at the election of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined according to the formula set forth in each Pre-Funded Warrant. The Pre-Funded Warrants are exercisable at any time after the date of issuance until all of the Pre-Funded Warrants are exercised. A holder (together with its “attribution parties,” as defined in the Pre-Funded Warrant) may not exercise any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together with its attribution parties), would beneficially own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise. However, a holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, which increase or decrease shall not become effective until 61 days after notice from the holder to us.
Previous report
July 2025 Convertible Notes Offering
Previous report
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 report
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 report
Noteholders may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $51.30 per share of common stock. The conversion rate is subject to customary adjustments upon the occurrence of certain events as described in the Indenture. In addition, if certain corporate events that constitute a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances, be increased for a specified period of time.
Previous report
The Notes will be redeemable, in whole or in part (subject to certain limitations described below), at our option at any time, and from time to time, on a redemption date on or after August 6, 2029 and on or before the 51st scheduled trading day immediately before the maturity date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date we send the related redemption notice; and (ii) the trading day immediately before the date we send such notice. However, we may not redeem less than all of the outstanding Notes unless at least $50.0 million aggregate principal amount of Notes are outstanding and not called for redemption as of the time we send the related redemption notice. In addition, calling any Note for redemption will constitute a Make-Whole Fundamental Change with respect to that Note, in which case the conversion rate applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption.
Previous report
If a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth in the Indenture, noteholders may require us to repurchase their Notes at a cash repurchase price equal to the principal amount of the Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date. The definition in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing events with respect to the common stock.
Previous report
Lastly, the Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert all or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect to such conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder or any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of our common stock outstanding immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes; provided, that such 4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder; provided further, that such limitation in no event can exceed 19.99%.
Previous report
Private Placement Warrants
Previous report
In March 2025, an investor exercised 695,650 warrants at an exercise price of $8.05, which generated approximately $5.6 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022.
Previous report
In July 2025, an investor exercised 1,286,960 warrants at an exercise price of $8.05, which generated approximately $10.4 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022.
Previous report
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 report
In September 2025, an investor exercised 104,340 warrants at exercise prices of $8.05, which generated approximately $0.8 million in cash. The warrants were issued pursuant to a private placement that closed on December 9, 2022. Also in September 2025, the placement agent from private placements that closed in January and May 2016 exercised 7,917 warrants at an exercise price of $7.56, which generated approximately $0.1 million in cash.
Showing the first 40 of 69 passages. Open the source sections for the rest.
Reworded paragraphs (40)
Previous wording
You should read the following discussion and analysis of our financial condition and results of operations together with our unaudited condensed financial statements and the related notes appearing under Item 1 of Part I of this Quarterly Report on Form 10-Q (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 our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, 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 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.
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 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.
Current 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.
Previous wording
Gedatolisib is administered intravenously on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably been found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion of patients requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately played a significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisib’s comprehensive inhibition of the PAM pathway at low nanomolar potency, IV route of administration, and pharmacokinetic properties enables it to achieve optimal anti-proliferative effects on tumor cells without inducing the levels of hyperglycemia, rash, and diarrhea typically associated with oral single-node inhibitors of the PAM pathway.
Current wording
Gedatolisib is administered intravenously on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have repeatedly been found to induce significant side effects that were not well tolerated by patients. This typically leads to a high proportion of patients requiring dose reductions or treatment discontinuation. The challenging toxicity profile of these drug candidates ultimately played a significant role in the decisions to halt their development, despite showing promising efficacy. By contrast, gedatolisib’s comprehensive inhibition of the PAM pathway at low nanomolar potency, IV route of administration, and pharmacokinetic properties enables it to achieve optimal anti-proliferative effects on tumor cells without inducing the levels of hyperglycemia, rash, and diarrhea typically associated with oral single-component inhibitors of the PAM pathway.
Previous wording
Isoform-specific PI3K inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with isoform-specific 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 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.
Previous wording
As of September 30, 2025, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials. Of the 492 patients, 129 were treated with gedatolisib as a single agent in three clinical trials. The remaining 363 patients received gedatolisib in combination with other anti-cancer agents in five clinical trials. Additional patients received gedatolisib in combination with other anti-cancer agents in nine investigator sponsored clinical trials.
Current 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.
Previous wording
A Phase 1b clinical trial (B2151009) evaluating patients with HR+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled 138 patients. Four patients from this study continue to receive study treatment, as of September 30, 2025, each of whom has received study treatment for approximately five years. The B2151009 clinical trial was an open label, multiple arm Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib (CDK 4/6 inhibitor) and fulvestrant or letrozole in patients with HR+/HER2- advanced breast cancer. Thirty-five patients were enrolled in two dose escalation arms to evaluate the safety and tolerability and to determine the maximum tolerated dose (“MTD”) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapy (letrozole or fulvestrant). The MTD was determined to be 180 mg administered intravenously once weekly. A total of 103 patients were subsequently enrolled in one of four expansion arms (A, B, C, and D).
Current 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.
Previous 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.
Current 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.
Previous 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.
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 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.
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 was presented. 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 were presented. The key efficacy and safety data from thePIK3CA WT cohort showed:
Previous wording
The detailed results from cohort 1,PIK3CA WT cohort, established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer:
Current wording
The detailed results from cohort 1,PIK3CA WT cohort, established several new milestones in the history of drug development for HR+/HER2- ABC:
Previous wording
With these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+/HER2-,PIK3CA WT advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor.
Current 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.
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 is enrolling patients 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 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.
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 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 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 2 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 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
The six-month radiographic progression free survival (“rPFS”) rate and median rPFS for patients from both arms combined was 67 % and 9.1 months, respectively. For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.
Current wording
The six-month radiographic progression-free survival (“rPFS”) rate and median rPFS for patients from both arms combined was 67% and 9.1 months, respectively. For patients treated with 120 mg of gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months. For patients treated with 180 mg of gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.
Previous wording
Key efficacy and safety results, as presented at the American Society of Clinical Oncologists meeting in June 2025, showed:
Current wording
Key efficacy and safety results, as presented at the American Society of Clinical Oncology meeting in June 2025, showed:
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 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.
Current 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.
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.
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 potential regulatory approval to market gedatolisib. Our Phase 3 clinical trial, VIKTORIA-2, and Phase 1b/2 clinical trial, CELC-G-201, 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; we expect to complete the final NDA submission to the FDA in the fourth quarter of 2025. 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
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.
Previous wording
Since our inception, we have primarily focused on research and development of gedatolisib, a PI3K/mTOR targeted therapy, and our CELsignia platform and corresponding tests. Research and development expenses primarily include:
Current wording
Since our inception, we have primarily focused on research and development of gedatolisib, a PAM inhibitor. Research and development expenses primarily include:
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, software costs, investor relations and travel expenses for our general and administrative personnel.
Current 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.
Previous wording
Expenses and costs related to marketing, supply chain, distribution, market access and other commercial operations related activities are being incurred in anticipation of the commercialization of gedatolisib. These expenses consist primarily of employee-related expenses, professional and consulting fees related to these functions and operations, software costs, and the acquisition of data required to support our market analysis for gedatolisib. We expect sales and marketing expenses to increase as we get closer to a potential FDA approval date.
Current wording
We expect selling, general and administrative expenses to increase as we get closer to a potential FDA approval date for gedatolisib.
Previous 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.
Current wording
Interest expense to date is primarily related to the Amended A&R Loan Agreement and the Notes.
Previous wording
Comparison of the Three Months Ended September 30, 2025 and 2024 (in thousands)
Current wording
Comparison of the Three Months Ended March 31, 2026 and 2025
Previous 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.
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 continue to develop gedatolisib, conduct the VIKTORIA-2 Phase 3 and CELC-G-201 Phase 1b/2 clinical trials, continue follow-up activities for the VIKTORIA-1 Phase 3 clinical trial, and conduct other studies and clinical trials.
Previous 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.
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 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 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous wording
We expect that our research and development and general and administrative expenses will increase as we continue to develop gedatolisib, conduct the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 trial, and the VIKTORIA-2 Phase 3 clinical trial, conduct other studies and clinical trials, and pursue other business development activities. We would also expect to incur sales and marketing expenses as we prepare for commercial launch and then commercialize 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, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses.
Current 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.
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 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, together with available borrowings under the Amended A&R Loan Agreement, will provide sufficient cash to finance our operations through 2027.
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 to 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 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.
Previous wording
The following table sets forth the primary sources and uses of cash for the nine months ended September 30:
Current wording
The following table summarizes the primary sources and uses of cash and cash equivalents (in thousands):
Previous wording
Net cash used in operating activities was approximately $55.7 million for the nine months ended September 30, 2024 and consisted primarily of a net loss of approximately $75.1 million, partially offset by working capital changes of $13.9 million and non-cash expense items of approximately $5.5 million. Non-cash expense items of approximately $5.5 million primarily consisted of $4.7 million of stock-based compensation expense and net non-cash interest of $0.8 million. The approximately $13.9 million of working capital changes was primarily due to increases in accrued expenses and accounts payable, and a decrease in other current assets.
Current 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.
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2024 was approximately $100.6 million and consisted primarily of net purchases of short-term investments in government securities (U.S. Treasury Bills and U.S. government securities), partially offset by purchases of property and equipment.
Current 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.
Previous wording
Net cash used in investing activities for the nine months ended September 30, 2025 was approximately $167.5 million and consisted primarily of net purchases of short-term investments in government securities (U.S. Treasury Bills and U.S. government agency), partially offset by purchases of property and equipment.
Current 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.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $138.3 million and primarily consisted of net proceeds of approximately $59.2 million from incremental debt financing, $56.3 million from an equity offering and $7.3 million from an at-the market offering. The remaining $15.4 million consisted of proceeds from the exercise of common stock warrants, the exercise of employee stock options and employee stock purchases.
Current wording
Net cash provided by financing activities was $5.6 million during the three months ended March 31, 2025, and consisted of net proceeds of $5.6 million from the exercise of common stock warrants.
Previous wording
From time-to-time new accounting pronouncements are issued by the Financial Accounting Standards Board or other standard setting bodies and adopted by us as of the specified effective date. Unless otherwise discussed in Note 2 to our unaudited condensed financial statements included in Item 1 of Part I of this Quarterly Report, we believe that the impact of recently issued standards that are not yet effective will not have a material impact on our financial position or results of operations upon adoption.
Current wording
From time-to-time new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by us as of the specified effective date. These pronouncements are more fully described in Note 2 to our unaudited condensed financial statements included in Part I, Item 1 of this Quarterly Report. We are currently evaluating the method of adoption and the impact of any recent accounting pronouncements not yet adopted on our unaudited condensed financial statements and related disclosures.
Previous wording
Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results for the period in which they become known. Actual results may differ materially from these estimates.
Current wording
Our management’s discussion and analysis of financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these unaudited condensed financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed financial statements, as well as the reported expenses during the reporting periods. These items are monitored and analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Changes in estimates are reflected in reported results during the period in which they become known. Actual results may differ materially from these estimates.
Previous wording
Our significant accounting policies are more fully described in Note 2 to our unaudited condensed financial statements included in Item 1 of Part I of this Quarterly Report.
Current wording
Our significant accounting policies are more fully described in the 2025 10-K and in Note 2 to our unaudited condensed financial statements included in Part I, Item 1 of this Quarterly Report. There were no changes to our critical accounting estimates, as disclosed in the 2025 10-K, during the three months ended March 31, 2026. Of our significant accounting policies, we believe that the following reflect the critical accounting estimates used in the preparation of our unaudited condensed financial statements: