# EDGAR Filing Document

**Accession Number:** 0001603454
**File Stem:** 0001493152-25-018565
**Filing Date:** 2025-10
**Character Count:** 39332
**Document Hash:** 20aff88488be101e36790a4827f326ba
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-018565.hdr.sgml**: 20251020

**ACCESSION NUMBER**: 0001493152-25-018565

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20251018

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251020

**DATE AS OF CHANGE**: 20251020

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Celcuity Inc.
- **CENTRAL INDEX KEY:** 0001603454
- **STANDARD INDUSTRIAL CLASSIFICATION:** SERVICES-MEDICAL LABORATORIES [8071]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38207
- **FILM NUMBER:** 251402276

**BUSINESS ADDRESS:**
- **STREET 1:** 16305 36TH AVENUE N
- **STREET 2:** SUITE 100
- **CITY:** MINNEAPOLIS
- **STATE:** MN
- **ZIP:** 55446
- **BUSINESS PHONE:** 763-392-0767

**MAIL ADDRESS:**
- **STREET 1:** 16305 36TH AVENUE N
- **STREET 2:** SUITE 100
- **CITY:** MINNEAPOLIS
- **STATE:** MN
- **ZIP:** 55446

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Celcuity LLC
- **DATE OF NAME CHANGE:** 20140324

?xml version='1.0' encoding='ASCII'?

**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**Washington, D.C. 20549**

**FORM 8-K**

**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of the**

**Securities Exchange Act of 1934**

**Date of Report (Date of earliest event reported): October 18, 2025**

**Celcuity Inc.**

**(Exact name of Registrant as Specified in its Charter)**

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-38207** | **82-2863566** |
| **(State or Other Jurisdiction**<br> **of Incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

**16305 36th Avenue North, Suite 100**

**Minneapolis** **, Minnesota 55446**

**(Address of Principal Executive Offices and Zip Code)**

**(763) 392-0767**

**(Registrant's telephone number, including area code)**

**Not Applicable**

**(Former Name or Former Address, if Changed Since Last Report)**

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | |
|:---|:---|
| Title of each class | Name of each exchange on which registered |
| Common Stock, $0.001 par value per share CELC | The Nasdaq Stock Market LLC |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

---

| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.** |

---

On October 18, 2025, in connection with a presentation at the ESMO Congress 2025, Celcuity Inc. (the "Company") issued press releases (i) announcing detailed results from the *PIK3CA* wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial (the "VIKTORIA-1 trial"), (ii) providing a status update on the *PIK3CA* mutant-type cohort of the VIKTORIA-1 trial, and (iii) disclosing additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with hormone receptor ("HR")-positive, human epidermal growth factor receptor 2 ("HER2")-negative advanced breast cancer ("ABC"). Copies of these press releases are furnished as Exhibit 99.1 and Exhibit 99.2 to this report and are incorporated herein by reference.

The information in this Item 7.01, including the accompanying exhibits, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that Section. The information in this Item 7.01 shall not be incorporated into any filing pursuant to the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.

---

| | |
|:---|:---|
| **Item 8.01** | **Other Events.** |

---

On October 18, 2025, the Company announced detailed topline results from the *PIK3CA* wild-type cohort of the VIKTORIA-1 trial evaluating gedatolisib plus palbociclib and fulvestrant (the "gedatolisib triplet") and gedatolisib plus fulvestrant (the "gedatolisib doublet") in adults with HR-positive, HER2-negative, *PIK3CA* wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor.

In the VIKTORIA-1 trial, median progression-free survival ("PFS") with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate ("ORR") of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response ("DOR") was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). 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 topline efficacy data from the VIKTORIA-1 *PIK3CA* wild-type cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

● The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.

● The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of an endocrine therapy-based regimen.

● Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR ("PAM") pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/ *PIK3CA* wild-type ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.

● The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- ABC.

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.

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%); rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). 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.

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, with less than one-half of the required number of events having occurred, showed promising trends for both the gedatolisib triplet and doublet.

The Company initiated a rolling New Drug Application ("NDA") submission in conjunction with the U.S. Food and Drug Administration's ("FDA") Real-Time Oncology Review program, based on data from the *PIK3CA* wild-type cohort of VIKTORIA-1. Completion of the NDA submission is targeted for the fourth quarter of 2025. The *PIK3CA* mutant cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled and is expected to report topline data for this cohort in late Q1 2026 or during Q2 2026.

The Company also disclosed additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with HR-positive, HER2-negative ABC. The analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VIKTORIA-1 trial.

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 trial received. The proportion of patients who received the intermittent dose of gedatolisib was 37% for those with *PIK3CA* mutant-type tumors and 25% for those with *PIK3CA* wild-type tumors. The proportion of patients who received prior treatment with a CDK4/6 inhibitor was 73% for those with *PIK3CA* wild-type tumors, and 71% for those with *PIK3CA* mutant-type 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* mutant-type 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* mutant-type tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 trial. For patients with *PIK3CA* wild-type 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* wild-type tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 trial.

**Table 1: Efficacy Analysis of Phase 1b Patients Treated with Gedatolisib Plus Palbociclib Plus Fulvestrant**

---

| | | | | |
|:---|:---|:---|:---|:---|
|  | ***PIK3CA* Mutant Type** | ***PIK3CA* Mutant Type** | ***PIK3CA* Wild Type** | ***PIK3CA* Wild Type** |
|  | **All** | **Intermittent Dose** | **All** | **Intermittent dose** |
| **N** | 30 | 11 | 60 | 15 |
| **Median PFS (months)** | 14.6 | 19.7 | 9.0 | 9.1 |
| **ORR** | 48% | 64% | 41% | 53% |

---

**Forward-Looking Statements**

This Current Report on Form 8-K (including the exhibit thereto) contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; the ability of our data to support the filing of an NDA with the FDA; our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; and other expectations with respect to gedatolisib. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "confidence," "encouraged," "potential," "plan," "targets," "likely," "may," "will," "would," "should" and "could," and similar expressions or words identify forward-looking statements. The forward-looking statements included in this report are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that certain of our results are based on a preliminary analysis of key data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our planned NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this report to reflect events or circumstances after the date hereof.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.** |

---

**(d)** **Exhibits** 

99.1 [Press release dated October 18, 2025](ex99-1.htm) <br> 99.2 [Press release dated October 18, 2025](ex99-2.htm) <br> 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

**SIGNATURES**

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: October 20, 2025

---

| | |
|:---|:---|
| **CELCUITY INC.** | **CELCUITY INC.** |
| By: | */s/ Brian F. Sullivan* |
|  | Brian F. Sullivan |
|  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-2.jpg)

**Detailed Results from *PIK3CA* Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial Presented at 2025 ESMO Congress Demonstrate Potential for Gedatolisib Regimens to be Practice Changing for Patients with HR+/HER2- Advanced Breast Cancer**

---

| |
|:---|
| *Clinical benefit of the gedatolisib regimens was consistent across patient subgroups* |
| *Hyperglycemia was reported in only 9.2% of patients treated with gedatolisib + palbociclib + fulvestrant ("gedatolisib triplet") and in 11.5% of patients treated with gedatolisib + fulvestrant ("gedatolisib doublet")* |
| *Study treatment discontinuation due to treatment related adverse events was reported in 2.3% of patients treated with the gedatolisib triplet and 3.1% of patients with the gedatolisib doublet* |
| *Management to host webcast and conference call October 20, 2025, at 8:00 a.m. ET* |

---

**MINNEAPOLIS, October 18, 2025** — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced detailed efficacy and safety results from the *PIK3CA* wild-type ("WT") cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive ("HR+"), human epidermal growth factor receptor 2 negative ("HER2-"), *PIK3CA* WT, advanced breast cancer ("ABC"), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. As previously announced, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in median progression-free survival ("PFS") versus fulvestrant, reducing the risk of disease progression or death by 76%. The gedatolisib doublet reduced the risk of progression or death by 67% versus fulvestrant.

The detailed study results were presented at a late breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress today, Saturday, October 18 at 4:25 a.m. ET/10:25 a.m. CEST.

In the trial, median PFS with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months (HR=0.24; 95% CI: 0.17-0.35; p<0.0001). The objective response rate ("ORR") of the gedatolisib triplet was 31.5% compared to 1% with fulvestrant and the median duration of response ("DOR") was 17.5 months. For the gedatolisib doublet, the median PFS was 7.4 months versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months (HR=0.33; 95% CI: 0.24-0.48; p<0.0001). 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 topline efficacy data from the VIKTORIA-1 *PIK3CA* WT cohort established several new milestones in the history of drug development for HR+/HER2- ABC:

● The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC.

● The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of an endocrine therapy-based regimen.

● Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR ("PAM") pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/ *PIK3CA* WT ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor.

● The median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for an endocrine therapy-based regimen in 2L HR+/HER2- ABC.

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.

Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Smith Family Endowed Chair in Women's Health, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial, said: "VIKTORIA-1 is the first study to demonstrate a statistically significant and clinically meaningful improvement in median PFS with inhibition of the PI3K/AKT/mTOR pathway in patients with *PIK3CA* wild-type disease, all of whom previously received a CDK4/6 inhibitor. With these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+, HER2-negative, *PIK3CA* wild-type advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor."

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%) rash (4.6%, 5.4%, and 0%); and hyperglycemia (2.3%, 2.3%, and 0%). 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.

Overall survival, a key secondary endpoint in VIKTORIA-1, while immature at the time of the analysis, with less than one-half of the required number of events having occurred, showed promising trends for both the gedatolisib triplet and doublet.

Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity, said: "We are very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event. This safety profile combined with the 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens, offer potentially paradigm shifting results for patients with HR-positive, HER2-negative, *PIK3CA* wild-type advanced breast cancer."

Celcuity initiated a rolling New Drug Application ("NDA") submission in conjunction with the U.S. Food and Drug Administration's ("FDA") Real-Time Oncology Review program, based on data from the *PIK3CA* wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Completion of the NDA submission is targeted for the fourth quarter of 2025. The *PIK3CA* mutant cohort of the Phase 3 VIKTORIA-1 trial is 100% enrolled and is expected to report topline data for this cohort in late Q1 2026 or during Q2 2026.

**Webcast and Conference Call Information**

The Celcuity management team will host a webcast/conference call on Monday, October 20, 2025, at 8:00 a.m. ET to discuss the additional results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast <u>here</u> or register in advance for the teleconference <u>here</u>. A replay of the webcast will be available on the Celcuity website following the live event.

**<u>Notes</u>**

**HR+/HER2- Breast cancer** 

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.<sup>1</sup> More than two million breast cancer cases were diagnosed globally in 2022.<sup>1</sup> While survival rates are high for those diagnosed with early breast cancer, approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.<sup>2</sup> HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.<sup>2</sup>

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.<sup>3</sup> Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.<sup>4,5,6,7</sup> However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.<sup>8</sup> Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

**VIKTORIA-1**

VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is fully enrolled. The trial enrolled subjects regardless of *PIK3CA* status while enabling separate evaluation of subjects according to their *PIK3CA* status. Subjects who met eligibility criteria and did not have confirmed *PI3KCA* mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who met eligibility criteria and had confirmed *PI3KCA* mutations (MT) were randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet.

**Gedatolisib**

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.<sup>9,10,11</sup> As a multi-target PAM inhibitor, gedatolisib's mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.<sup>11</sup> Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib's comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in *PIK3CA*-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.<sup>11,12</sup>

**About Celcuity**

Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC has completed enrollment and reported topline data for the *PIK3CA* WT cohort and has completed enrollment of patients for the *PIK3CA* mutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity's active clinical trials can be found at <u>ClinicalTrials.gov</u>. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at <u>www.celcuity.com</u>. Follow us on <u>LinkedIn</u> and <u>X</u>.

**Forward-Looking Statements**

This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; and other expectations with respect to gedatolisib. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "confidence," "encouraged," "potential," "plan," "targets," "likely," "may," "will," "would," "should" and "could," and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials; and unanticipated developments that may impact the design of our clinical trials. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

**References:**

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 H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
 CA Cancer J Clin. 2021;10.3322/caac.21660.

2. National
 Cancer Institute. Surveillance, Epidemiology and End Results Program (Accessed July 2025). <u>https://seer.cancer.gov/statfacts/html/breast-subtypes.html</u> 

3. Alves,
 C. L., & Ditzel, H. J. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer. Int J Mol Sci, 2023;24(5),4522. https://doi.org/10.3390/ijms24054522

4. United
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5. United
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6. United
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7. United
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8. Lloyd
 M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging
 Therapeutic Opportunities. Clin Cancer Res. 2022;28(5):821-30

9. Venkatesan,
 A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5'-triphosphate competitive phosphatidylinositol-3-kinase/mammalian
 target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6),
 2636-2645. https://doi.org/10.1021/jm901830p

10. Mallon,
 R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203.
 https://doi.org/10.1158/1078-0432.CCR-10-1694

11. Rossetti,
 S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ
 Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0

12. Layman,
 R., et al. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative
 advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol, 2024;25(4), 474-487.
 https://doi.org/10.1016/S1470-2045(24)00034-2

<u>View source version of release on GlobeNewswire.com</u>

**Contacts:**

Celcuity Inc.

Brian Sullivan, bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

(763) 392-0123

ICR Healthcare

Patti Bank, patti.bank@icrhealthcare.com

(415) 513-1284

## Exhibit 99.2

**Exhibit 99.2**

![](ex99-2.jpg)

**Celcuity Provides Update on Status of the *PIK3CA* Mutated Cohort of Phase 3 VIKTORIA-1 Trial and Releases Additional Data Analysis From Phase 1b Clinical Trial** 

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| |
|:---|
| *PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial is fully enrolled* |
| *Additional analysis of data from a Phase 1b clinical trial that included all patients treated with gedatolisib combined with fulvestrant and palbociclib showed median progression-free survival ("PFS") of 14.6 months in patients with HR+/HER2-/PIK3CA-mutated advanced breast cancer ("ABC")* |

---

 

**MINNEAPOLIS, October 18, 2025** — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced updates on the status of the *PIK3CA* mutant cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus alpelisib and fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, *PIK3CA* mutant ("MT") tumors, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. Analysis of data from a Phase 1b clinical trial that evaluated gedatolisib combined with palbociclib and fulvestrant in the same population was also provided.

"We are pleased to announce that the *PIK3CA* mutant cohort of the VIKTORIA-1 study is 100% enrolled," said Brian Sullivan, CEO and co-founder of Celcuity. "Based on our current forecast of reaching the event threshold that will trigger primary analysis in the *PIK3CA* mutant cohort, we expect to report topline data sometime in late Q1 2026 or during Q2 2026."

**Updated Analysis of Data from the Phase 1b Trial**

In a presentation of results from the *PIK3CA* wild-type ("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.<sup>1</sup> 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 objective response rate ("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**

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| | | | | |
|:---|:---|:---|:---|:---|
|  | ***PIK3CA MT*** | ***PIK3CA MT*** | ***PIK3CA WT*** | ***PIK3CA WT*** |
|  | **All** | **Intermittent Dose** | **All** | **Intermittent dose** |
| **N** | 30 | 11 | 60 | 15 |
| **Median PFS (months)** | 14.6 | 19.7 | 9.0 | 9.1 |
| **ORR** | 48% | 64% | 41% | 53% |

---

"We are very encouraged by the median PFS of 14.6 months found in the entire *PIK3CA* mutant patient subgroup," said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. "While the sample size is small, the median PFS from patients whose tumors had *PIK3CA* mutations and who received the Phase 3 intermittent gedatolisib dose is promising and consistent with the results from the overall group. We are looking forward to reporting Phase 3 data for this patient subgroup in 2026."

**About Celcuity**

Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC has completed enrollment and reported topline data for the *PIK3CA* WT cohort and has completed enrollment of patients for the *PIK3CA* mutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity's active clinical trials can be found at <u>ClinicalTrials.gov</u>. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at <u>www.celcuity.com</u>. Follow us on <u>LinkedIn</u> and <u>X</u>.

**Forward-Looking Statements**

This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials, including the release of topline data; our interpretation of topline clinical trial data; and other expectations with respect to gedatolisib. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "confidence," "encouraged," "potential," "plan," "targets," "likely," "may," "will," "would," "should" and "could," and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials; and unanticipated developments that may impact the design of our clinical trials. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

<u>View source version of release on GlobeNewswire.com</u>

**Reference:**

1. Layman R., Lancet Oncol. 2024;25:474-8

**Contacts:**

Celcuity Inc.

Brian Sullivan, bsullivan@celcuity.com

Vicky Hahne, vhahne@celcuity.com

(763) 392-0123

ICR Healthcare

Patti Bank, patti.bank@icrhealthcare.com

(415) 513-1284