Celcuity Inc.
11/13/2025 | Press release | Distributed by Public on 11/13/2025 16:15
Quarterly Report for Quarter Ending September 30, 2025 (Form 10-Q)
Management's Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations 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.
Overview
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 with PIK3CA wild-type ("WT") tumors, and has completed enrollment of cohort 2, patients with PIK3CA 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.
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.
| ● | Overcomes limitations of therapies that only inhibit a single Class I PI3K isoform, AKT, or one mTOR kinase complex. |
Gedatolisib is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms and the mTORC1 and mTORC2 complexes. By targeting all Class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PAM pathway. Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction events that involve tumor cell survival, depending upon the aberrations associated with the linked pathway. When a therapy only inhibits a single Class I PI3K isoform (e.g., alpelisib, a PI3Kα inhibitor), AKT (e.g., capivasertib, an AKT inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units. This, in turn, induces compensatory resistance that reduces the efficacy of isoform specific PI3Kα, AKT, or mTORC1 kinase inhibitors. Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding effect of isoform interaction that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms, AKT, and mTOR.
| ● | Better tolerated by patients than oral PI3K and mTOR drugs. |
Gedatolisib is administered intravenously on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or dual PI3K/mTOR inhibitors that are no longer being clinically developed. Oral pan-PI3K or PI3K/mTOR inhibitors have 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.
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.
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.
B2151009 Phase 1b Trial
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).
High objective overall response rates ("ORR") were observed in all four expansion arms and were comparable in each arm for PIK3CA WT and PIK3CA 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%.
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.
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.
In a presentation of results from the PIK3CA WT 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.
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 with PIK3CA MT tumors and 25% for those with PIK3CA WT tumors. The proportion of patients who received prior treatment with a CDK4/6 inhibitor was 73% for those with PIK3CA WT tumors, and 71% for those with PIK3CA MT tumors.
Median PFS and the ORR were assessed in sub-groups of patients according to their PIK3CA status (Table 1). For all analyzed patients with PIK3CA MT 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 with PIK3CA MT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study. For patients with PIK3CA WT 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 with PIK3CA WT tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study.
Table 1: Efficacy Analysis of Phase 1b Patients Treated with Gedatolisib Plus Palbociclib Plus Fulvestrant
| PIK3CA MT | PIK3CA WT | |||||||||||||||
| All |
Intermittent Dose |
All |
Intermittent dose |
|||||||||||||
| Sample size | 30 | 11 | 60 | 15 | ||||||||||||
| Median PFS (months) | 14.6 | 19.7 | 9.0 | 9.1 | ||||||||||||
| ORR | 48 | % | 64 | % | 41 | % | 53 | % | ||||||||
VIKTORIA-1 Phase 3 Trial
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.
The VIKTORA-1 Phase 3 clinical trial involves two study cohorts that enable separate evaluation of subjects according to their PIK3CA status. Subjects who met eligibility criteria and had PIK3CA 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 the PIK3CA 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 had PIK3CA 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 have PIK3CA MT tumors is complete. We expect topline data for this group to be available in late Q1 2026 or during Q2 2026.
On July 28, 2025, we announced topline data from the PIK3CA WT 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 the PIK3CA WT cohort showed:
| ● | The gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The median PFS, as assessed by blinded independent central review ("BICR"), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. | |
| ● | The gedatolisib doublet (gedatolisib and fulvestrant) also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The median PFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. | |
| ● |
The ORR of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response ("DOR") was 17.5 months. The ORR of the gedatolisib doublet was 28.3% and the median DOR was 12.0 months. The median DOR was not determinable for fulvestrant because there was only one objective response. |
|
| ● |
The gedatolisib triplet and doublet were generally well tolerated in the trial with mostly low-grade treatment-related adverse events ("TRAEs"). The most common Grade 3 TRAEs for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively); stomatitis (19.2%, 12.3%, and 0% of patients, respectively) rash (4.6%, 5.4%, and 0% of patients, respectively); and hyperglycemia (2.3%, 2.3%, and 0% of patients, respectively). The primary Grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia (10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group) and pneumonitis (0.8% in gedatolisib doublet group). TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet group, and 0% in the fulvestrant group. |
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:
| ● | The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- advanced breast cancer. | |
| ● | The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- advanced breast cancer receiving at least their second line of therapy. | |
| ● | Gedatolisib is the first inhibitor targeting the PAM pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA WT advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor. | |
| ● | The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- advanced breast cancer. |
The median PFS benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups with the gedatolisib triplet showing higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were pre/perimenopausal, endocrine therapy resistant, or had visceral metastases. For patients enrolled in the United States and Canada, median PFS was 19.3 months (HR=0.13; 90% CI: 0.07-0.29) for the gedatolisib triplet and 14.9 months (HR=0.35; 90% CI: 0.17-0.76) for the gedatolisib doublet.
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.
Additional results from cohort 1 of the VIKTORIA-1 Phase 3 clinical trial will be presented at a medical conference later this year.
CELC-G-201 Phase 1b/2 Trial
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.
The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of the recommended Phase 2 dose ("RP2D") of gedatolisib. The primary objective of the Phase 2 portion of the trial is to assess the radiographic PFS at six months of patients who received the RP2D.
In the Phase 1b portion of the clinical trial, 38 patients with mCRPC were randomly assigned to receive 600 mg of darolutamide twice daily combined with either 120 mg of gedatolisib in Arm 1 or 180 mg of gedatolisib in Arm 2. In both arms, gedatolisib was administered once weekly for three weeks, then one week off. Additionally, all patients received prophylactic treatment for stomatitis.
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.
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.
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.
The combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs. No dose limiting toxicities were observed in either arm. The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and pruritus (2.6%); no Grade 3 hyperglycemia was reported. Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued study treatment due to a TRAE.
VIKTORIA-2 Phase 3 Trial
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 their PIK3CA 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.
Investigator-Sponsored Trials
In an investigator-sponsored Phase 2 clinical trial, 44 patients with HER2+/PIK3CA mutated metastatic breast cancer were treated with gedatolisib plus standard doses of trastuzumab-pkrb. No prophylaxis for stomatitis was administered. The median number of prior anti-HER2 therapies enrolled patients received in the metastatic setting was four or more; 86% of patients had received at least three prior anti-HER2 therapies. The data cut-off was February 10, 2025.
Key efficacy and safety results, as presented at the American Society of Clinical Oncologists meeting in June 2025, showed:
| ● | The ORR among all patients enrolled was 43%. | |
| ● | Median PFS was 6.0 months (95% CI, 5.0-7.7). | |
| ● | Median overall survival was 24.7 months (95% CI; 17.3-NA). | |
| ● | No patients discontinued gedatolisib due to a treatment-related AE. | |
| ● | One (2.3%) patient experienced Grade 3 hyperglycemia. |
An investigator sponsored trial has been initiated in collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.
Recent Developments
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.
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.
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.
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.
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.
Results of Operations
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.
Components of Operating Results
Revenue
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.
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.
Research and Development
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:
| ● | employee-related expenses related to our research and development activities, including salaries, benefits, recruiting, travel and stock-based compensation expenses; | |
| ● | laboratory supplies; | |
| ● | consulting fees paid to third parties; | |
| ● | clinical trial costs; | |
| ● | validation costs for gedatolisib; | |
| ● | facilities expenses; and | |
| ● | legal costs associated with patent applications. |
General and Administrative
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.
Sales and Marketing
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.
Interest Expense
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.
Interest Income
Interest income consists of interest income earned on our cash, cash equivalents, and investment balances.
Results of Operations
Comparison of the Three Months Ended September 30, 2025 and 2024 (in thousands)
| Three Months Ended | ||||||||||||||||
| September 30, | Change | |||||||||||||||
| 2025 | 2024 | $ | Percent | |||||||||||||
| Statements of Operations Data: | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 34,915 | $ | 27,588 | $ | 7,327 | 27 | % | ||||||||
| General and administrative | 7,934 | 2,472 | 5,462 | 221 | ||||||||||||
| Total operating expenses | 42,849 | 30,060 | 12,789 | 43 | ||||||||||||
| Loss from operations | (42,849 | ) | (30,060 | ) | (12,789 | ) | 43 | |||||||||
| Other (expense) income | ||||||||||||||||
| Interest expense | (4,595 | ) | (3,344 | ) | (1,251 | ) | 37 | |||||||||
| Interest income | 3,640 | 3,612 | 28 | 1 | ||||||||||||
| Other (expense) income, net | (955 | ) | 268 | (1,223 | ) | (456 | ) | |||||||||
| Net loss before income taxes | (43,804 | ) | (29,792 | ) | (14,012 | ) | 47 | |||||||||
| Income tax benefits | - | - | - | - | ||||||||||||
| Net loss | $ | (43,804 | ) | $ | (29,792 | ) | $ | (14,012 | ) | 47 | % | |||||
Comparison of the Nine Months Ended September 30, 2025 and 2024 (in thousands)
| Nine Months Ended | ||||||||||||||||
| September 30, | Change | |||||||||||||||
| 2025 | 2024 | $ | Percent | |||||||||||||
| Statements of Operations Data: | ||||||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 107,364 | $ | 70,732 | $ | 36,632 | 52 | % | ||||||||
| General and administrative | 15,627 | 6,105 | 9,522 | 156 | ||||||||||||
| Total operating expenses | 122,991 | 76,837 | 46,154 | 60 | ||||||||||||
| Loss from operations | (122,991 | ) | (76,837 | ) | (46,154 | ) | 60 | |||||||||
| Other (expense) income | ||||||||||||||||
| Interest expense | (10,982 | ) | (7,005 | ) | (3,977 | ) | 57 | |||||||||
| Interest income | 7,904 | 8,716 | (812 | ) | (9 | ) | ||||||||||
| Other (expense) income, net | (3,078 | ) | 1,711 | (4,789 | ) | (280 | ) | |||||||||
| Net loss before income taxes | (126,069 | ) | (75,126 | ) | (50,943 | ) | 68 | |||||||||
| Income tax benefits | - | - | - | - | ||||||||||||
| Net loss | $ | (126,069 | ) | $ | (75,126 | ) | $ | (50,943 | ) | 68 | % | |||||
Research and Development
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.
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.
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.
General and Administrative
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.
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.
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.
Interest Expense
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.
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.
Interest Income
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.
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.
Liquidity and Capital Resources
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.
July 2025 Equity Offering
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.
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.
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.
July 2025 Convertible Notes Offering
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.
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.
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.
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.
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.
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%.
Private Placement Warrants
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.
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.
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.
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.
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.
Open Market Sale Agreement
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.
May 2024 Equity Offering
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.
Amended and Restated Loan and Security Agreement
Third Amendment
On September 9, 2025, we entered into the Third Amendment (the "Third Amendment") to the Amended and Restated Loan and Security Agreement (the "A&R Loan Agreement") with Oxford Finance LLC, a Delaware limited liability company ("Oxford"), as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership ("Innovatus"), as a lender, and the other lenders party thereto (together with Oxford and Innovatus, the "Lenders"), pursuant to which the A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral agent; (ii) recognize the achievement of the Term D Milestone (as defined in the A&R Loan Agreement, as amended by the Third Amendment (the "Amended A&R Loan Agreement")) and provide for the immediate disbursement of the $30.0 million Term D Loan (as defined in the Amended A&R Loan Agreement); (iii) increase the size of the Term E Loan (as defined in the Amended A&R Loan Agreement) from $50.0 million to up to $100.0 million, which Term E Loan may only be drawn upon FDA approval of gedatolisib in second line wild-type advanced breast cancer patients post CDK4/6 inhibitor therapy; (iv) add three new up to $40.0 million Term F Loans (as defined in the Amended A&R Loan Agreement), which may only be drawn upon achievement of certain trailing three months' product revenue thresholds; (v) replace the prior $45.0 million Term F Loan (as defined in the A&R Loan Agreement) with a new $150.0 million Term G Loan (as defined in the Amended A&R Loan Agreement), which continues to be available only in the Lenders' sole discretion upon our request; (vi) require an amendment fee payable by us to the Lenders in the amount of $50,000, which was paid at the closing of the Third Amendment; (vii) make certain revisions to the non-utilization fee for the Term E Loan, and add a new non-utilization fee for the Term F Loans, in each case equal to 3.0% of the applicable unfunded commitment, after taking into consideration any reductions to the applicable term loan commitment that we may make by notice to the collateral agent before the date that is eight weeks after the achievement of any applicable milestones; and (viii) extend the maturity date of the term loans to November 1, 2029. The Term E Loan and each Term F Loan also are subject to other customary conditions and limits on when we can request funding. With the disbursement of the $30.0 million Term D Loan, the Company received net proceeds of approximately $27.8 million.
In accordance with the A&R Loan Agreement, a Final Fee equal to 4.5% of the $30.0 million Term D Loan was recognized and an additional $1.4 million was added to debt principal and a corresponding debt discount to be amortized over the life of the loan.
In connection with the Third Amendment, we issued warrants with an exercise price of $14.84 per share to purchase an aggregate of 50,537 shares of our common stock to Innovatus, Oxford, and certain of its affiliates (the "Third Amendment Warrants"). The Third Amendment Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the funding date of the Term D Loan. The number of shares of common stock for which each Third Amendment Warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such Third Amendment Warrant.
A portion of the proceeds from the Term D Loan in the amount of $2.8 million was allocated to the Third Amendment Warrants based on their relative fair value to the underlying Term D Loan. The proceeds allocated to the Third Amendment Warrants were recorded as additional paid in capital in the accompanying condensed consolidated balance sheets and were discounted from the Term D Loan. The relative fair value of the Third Amendment Warrants was based on the Black-Scholes method with the following assumptions: risk-free interest rate of 4.08%; expected volatility of 74.4%; expected life of 10.0 years; and expected dividend yield 0%. The underlying stock price used in the analysis was the traded market price. The discount related to the Third Amendment Warrants is being amortized to interest expense ratably over the term of the Term D Loan.
Second Amendment
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.
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.
First Amendment
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.
May 30, 2024 Amendment and Restatement
On May 30, 2024, we entered into the A&R Loan Agreement. The A&R Loan Agreement amended and restated, 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").
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.
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.
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.
In connection with the funding of each of the Term C Loan and the Term D Loans, we agreed to issue to Innovatus and Oxford warrants to purchase that number of shares of our common stock equal to 2.5% of the principal amount of the applicable Term Loan divided by the exercise price, which was, with respect to the Term C Loan, equal to the lower of (i) the volume weighted average closing price of our common stock for the five-trading day period ending on the last trading day immediately preceding the execution of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution of the A&R Loan Agreement. Accordingly, on May 30, 2024, we issued 103,876 warrants with an exercise price of $14.84 per share. The relative fair value of the warrants was approximately $1.2 million. For the Term D Loans, the exercise price was based on the lower of (i) the exercise price for the warrants issued pursuant to the Term C Loan or (ii) the volume weighted average closing price of our common stock for the five-trading day period ending on the last trading day immediately preceding the Term D Loan funding. Prior to the Third Amendment, we also were required to issue warrants to Innovatus and Oxford in connection with the funding of the Term E Loan and the Term F Loan. The warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding date. The number of shares of common stock for which each warrant is exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in such warrant.
Liquidity and capital resource requirements
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.
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.
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.
Cash Flows
The following table sets forth the primary sources and uses of cash for the nine months ended September 30:
| 2025 | 2024 | |||||||
| (in thousands) | ||||||||
| Net cash (used in) provided by: | ||||||||
| Operating activities | $ | (116,881 | ) | $ | (55,697 | ) | ||
| Investing activities | (167,493 | ) | (100,628 | ) | ||||
| Financing activities | 336,111 | 138,265 | ||||||
| Net increase (decrease) in cash and cash equivalents | $ | 51,737 | $ | (18,060 | ) | |||
Operating Activities
Net cash used in operating activities was approximately $116.9 million for the nine months ended September 30, 2025 and consisted primarily of a net loss of approximately $126.1 million, partially offset by non-cash expense items of approximately $13.8 million and by a working capital net cash use of $4.6 million. Non-cash expense items of approximately $13.8 million primarily consisted of $11.9 million of stock-based compensation expense and non-cash amortization of debt issuance costs and discount and payment-in-kind interest of $2.6 million in the aggregate, offset partly by non-cash interest accretion of $0.8 million. The approximately $4.7 million of working capital changes were primarily due to increases in other current assets, partly offset by increases in both accounts payable and accrued expenses.
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.
Investing Activities
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.
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.
Financing Activities
Net cash provided by financing activities for the nine months ended September 30, 2025 was approximately $336.1 million and consisted of net proceeds from the Note Offering of $195.5 million, net proceeds from the Equity Offering of approximately $91.8 million and net proceeds from the Term D Loan of $27.8 million. In addition, cash provided by financing activities included the exercise of common stock warrants in the amount of $18.5 million and from the exercise of employee stock options and employee stock purchases in the amount of $2.6 million, offset in part by registration costs of $47 thousand.
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.
Recent Accounting Pronouncements
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.
Critical Accounting Policies and Use of Estimates
Our management's discussion and analysis of financial condition and results of operations is based on our unaudited condensed financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these 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.
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.
Private Securities Litigation Reform Act
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Such forward-looking information is included in this Quarterly Report and in other materials filed or to be filed by us with the SEC (as well as information included in oral statements or other written statements made or to be made by us). Forward-looking statements include all statements based on future expectations. This Quarterly Report contains forward-looking statements that involve risks and uncertainties including, but not limited to, (i) our clinical trial plans and the estimated timelines and costs for such trials; (ii) our plans to develop and commercialize our products, and our expectations about the market opportunity for gedatolisib and our ability to serve that market; (iii) our expectations with respect to our competitive advantages, including the potential efficacy of gedatolisib in various patient types alone or in combination with other treatments, and our interpretation of the data from the PIK3CA WT cohort of the Phase 3 VIKTORIA-1 clinical trial; (iv) our expectations regarding the timeline of patient enrollment and results from clinical trials, including our ongoing Phase 3 VIKTORIA-1 clinical trial, ongoing Phase 3 VIKTORIA-2 clinical trial, and ongoing Phase 1b/2 clinical trial for gedatolisib; (v) our expectations regarding the timing of submitting an NDA for, and our ability to obtain FDA approval to commercialize, gedatolisib; (vi) our expectations regarding governmental laws and regulations affecting our operations, including, without limitation, developments in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in the U.S. and laws that affect our operations and our laboratory; (vii) our expectations with respect to the development, validation, required approvals, costs and timelines of our drug candidate gedatolisib; (viii) our beliefs related to the potential benefits resulting from Breakthrough Therapy designation for gedatolisib; (ix) our plans with respect to research and development and related expenses for the foreseeable future; (x) our beliefs about our ability to capitalize on the exclusive global development and commercialization rights obtained from our license agreement with Pfizer with respect to gedatolisib; (xi) our expectations regarding the future payments that may be owed to Pfizer under the license agreement with them; (xii) our beliefs with respect to the potential rate and degree of market acceptance, both in the United States and internationally, and clinical utility of gedatolisib; (xiii) our revenue expectations; (xiv) our expectations regarding business development activities, including collaborations with pharmaceutical companies; (xv) our plans with respect to pricing in the United States and internationally, and our ability to obtain reimbursement for our drug candidate, gedatolisib, including expectations as to our ability or the amount of time it will take to achieve successful reimbursement from third-party payors, such as commercial insurance companies and health maintenance organizations, and from government insurance programs, such as Medicare and Medicaid; (xvi) our expectations as to the use of proceeds from our financing activities; (xvii) our expectations with respect to availability of capital, including accessing our current debt facility or any other debt facility or other capital sources in the future, and our assumption that we will have adequate authorized shares for future equity issuances; (xviii) our beliefs regarding the adequacy of our cash on hand to fund our clinical trials, capital expenditures, working capital, and other general corporate expenses, as well as the increased costs associated with being a public company; (xix) our plans with respect to potentially raising capital; and (xx) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, including our gedatolisib drug candidate and our CELsignia platform and tests.
In some cases, you can identify forward-looking statements by the following words: "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "should," "will," "would," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are only predictions and are not guarantees of performance. These statements are based on our management's beliefs and assumptions, which in turn are based on their interpretation of currently available information.
These statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry's actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Certain risks, uncertainties and other factors include, but are not limited to, our limited operating history; our potential inability to develop, validate, obtain regulatory approval for and commercialize gedatolisib on a timely basis or at all; the uncertainties and costs associated with clinical studies and with developing and commercializing biopharmaceuticals; the complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib and other products we may develop; challenges we may face in developing and maintaining relationships with pharmaceutical company partners, including our current and any future suppliers of our product candidate; the uncertainty and costs associated with clinical trials; the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical community, and with the size of market opportunities available to us; difficulties we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel; changes in government regulations; tightening credit markets and limitations on access to capital; stock market volatility or other factors that may affect our ability to access capital on favorable terms or at all; and obtaining and maintaining intellectual property protection for our technology and time and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us. These and additional risks, uncertainties and other factors are described more fully in our Annual Report on Form 10-K for the year ended December 31, 2024 and elsewhere in this Quarterly Report. Copies of filings made with the SEC are available through the SEC's electronic data gathering, analysis, and retrieval system (EDGAR) at www.sec.gov.
You should read the cautionary statements made in this Quarterly Report as being applicable to all related forward-looking statements wherever they appear in this Quarterly Report. We cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. You should read this Quarterly Report completely. Other than as required by law, we undertake no obligation to update these forward-looking statements, even though our situation may change in the future.
Celcuity Inc. published this content on November 13, 2025, and is solely responsible for the information contained herein. Distributed via Edgar on November 13, 2025 at 22:16 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]