Celcuity Announces Plan to Conduct Phase 1b/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer - Received FDA clearance of IND for gedatolisib in combination with darolutamide - Virtual Science Day to be

Announces Plan to Conduct Phase 1b/2 Clinical Trial in

Castration Resistant Prostate Cancer

August 22, 2023 - Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies

for oncology, has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) submission has

been reviewed, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa (darolutamide),

an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).

Celcuity's Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen

receptor inhibitor as first-line treatment for mCRPC. The Company anticipates initiating this Phase 1b/2 clinical trial in the first

are excited to initiate the clinical development of gedatolisib in prostate cancer," said Brian Sullivan, Chief Executive Officer

and co-founder of Celcuity. "Gedatolisib's highly differentiated mechanism of action makes it uniquely suited to address

the complex PI3K/mTOR activity involved in this disease."

the Phase 1b portion of the study, Celcuity expects that 36 participants will be randomly assigned to receive 600 mg darolutamide combined

with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib in Arm 2. 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.

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 of gedatolisib. The primary objective of the Phase 2 portion of the

trial is to assess the radiographic progression-free survival (rPFS) at six months of patients who received the RP2D.

options for patients with mCRPC whose disease progressed on or after treatment with an androgen receptor inhibitor are limited, and there

is an urgent need for new drugs to treat this patient population," said Karim Fizazi, MD, PhD, Professor of Medicine at Institute Gustave Roussy and GETUG President. Professor K. Fizazi,

who is one of the primary principal investigators for this study, further stated:

"Since PI3K/mTOR and androgen receptor signaling are commonly aberrantly activated in mCRPC, combining gedatolisib with the approved

androgen receptor inhibitor darolutamide represents a potentially promising treatment option for these patients."

Information for the Virtual Science Day

will host a Virtual Science Day for analysts and investors on Thursday, September 21, 2023, from 10:00 a.m. - 12:00 p.m. ET, featuring

presentations by key opinion leaders and Celcuity's leadership. During this meeting, Celcuity will provide an in-depth scientific

overview of gedatolisib, the importance of comprehensive, rather than selective, inhibition of the PI3K/mTOR pathway, and review its

clinical development strategy, including a discussion about its Phase 1b/2 study in mCRPC.

live chat-based Q&A session will follow the formal presentations. To register for the event, please click here. A replay of

the webcast will be available on the "Events & Presentations" section of Celcuity's website for a limited time

following the event.

is a potent inhibitor that selectively targets all Class I isoforms of PI3K and mTOR. Its mechanism of action and pharmacokinetic properties

are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together. Inhibiting

all four PI3K isoforms, as gedatolisib does, limits the potential confounding effect of isoform interaction that may occur with isoform-specific

PI3K inhibitors. Inhibiting mTOR also addresses potential resistance mechanisms that can result when PI3K isoforms are targeted in the

absence of mTOR inhibition.

is a clinical-stage biotechnology company pursuing development of targeted therapies for oncology. The company's lead therapeutic

candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic properties are highly differentiated

from other currently approved and investigational therapies that target PI3K or mTOR 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- advanced breast cancer

is currently enrolling patients. More detailed information about the VIKTORIA-1 study can be found at ClinicalTrials.gov. A Phase

1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant

prostate cancer, is planned to begin enrolling patients in the first quarter of 2024. The company's CELsignia companion diagnostic

platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already

approved targeted therapies. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at Celcuity.com.

press release contains statements that constitute "forward-looking statements" including, but not limited to, the timing

of initiating and enrolling patients in, and receiving results from, clinical trials, such as Celcuity's Phase 3 VIKTORIA-1 and

Phase 1b/2 CELC-G-201 clinical trial, the scope, protocol, costs and expected results from ongoing and planned clinical trials, the skills

and experience of investigators involved with Celcuity's Phase 1b/2 CELC-G-201 clinical trial, the impact on gedatolisib and Celcuity

of preliminary clinical trial results, the market opportunity for gedatolisib in the prostate cancer market, and other expectations with

respect to Celcuity's lead product candidate, gedatolisib, and Celcuity's CELsignia platform. In some cases, you can identify

forward-looking statements by terminology such as "may," "will," "should," "expects,"

"plans," "anticipates," "believes," "estimates," "predicts," "potential,"

"intends," "goal," or "continue," and other similar expressions that are predictions of or indicate

future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject

to numerous risks, uncertainties, and conditions, many of which are beyond the control of Celcuity. These include, but are not limited

to, delays, disruptions or adverse results in the CELC-G-201 clinical trial and those risks set forth in the Risk Factors section in

Celcuity's Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on

March 23, 2023, and our subsequent Quarterly Reports on Form 10-Q. Readers are cautioned not to place undue reliance on these forward-looking

statements, which speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes

after the date of this press release, except as required by law.