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Item 7. Management’s Discussion and Analysis

2025-03-31 compared with 2024-03-27 · 524 added, 451 removed, 42 unchanged (96% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

should read the following discussion and analysis of our financial condition and results of operations together in conjunction with our

financial statements and the related notes included elsewhere in this Annual Report.

Some of the information contained in this discussion

and analysis or set forth elsewhere in this Annual 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 Item 1A of Part I of this Annual Report.

is a clinical-stage biotechnology company focused on the development of targeted therapies for oncology.

The Company ’ s

lead therapeutic candidate is gedatolisib, a pan-PI3K/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.

Company initiated VIKTORIA-1, a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022 and

is currently enrolling patients.

In addition to the Phase 3 study, the Company recently announced that it received U.S.

Drug Administration ( “ FDA ” )

clearance for its Investigational New Drug (IND) submission for the clinical development of gedatolisib in combination with

Nubeqa® (darolutamide), for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).

initiated a Phase 1b/2 study, CELC-G-201, in the first quarter of 2024 and is currently enrolling patients.

Its 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.

is a potent, well-tolerated, small molecule reversible dual inhibitor, administered intravenously, that selectively targets all Class

I isoforms of PI3K and mammalian target of rapamycin (mTOR).

In April 2021, we obtained exclusive global development and commercialization

rights to gedatolisib under a license agreement with Pfizer, Inc.

We believe gedatolisib’s unique mechanism of action, differentiated

chemical structure, favorable pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved

and investigational therapies that target PI3K or mTOR alone or together.

limitations of therapies that only inhibit a single Class I PI3K isoform or only one mTOR kinase complex.

is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ

isoforms and mTORC1 and mTORC2 complexes.

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 isoforms (e.g., alpelisib, a PI3K-α 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-activates the uninhibited

This, in turn, induces compensatory resistance that reduces the efficacy of isoform specific PI3K or single mTOR kinase

complex 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

tolerated by patients than oral PI3K and mTOR drugs.

is administered intravenously (IV) 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

stabilizes at lower concentration levels in plasma compared to orally administered PI3K inhibitors, resulting in less toxicity, while

maintaining concentrations sufficient to inhibit PI3K/mTOR signaling.

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

still leads 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 adverse events.

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 10% discontinued treatment.

of December 31, 2023, 492 patients with solid tumors have received gedatolisib in eight clinical trials sponsored by Pfizer.

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.

Phase 1b trial (B2151009) evaluating patients with ER+/HER2- metastatic breast cancer was initiated in 2016 and subsequently enrolled

138 patients.

Five patients from this study continue to receive study treatment, as of December 31, 2023, each of which have received

study treatment for more than five years.

The B2151009 clinical trial was an open label, multiple arm Phase 1b study that evaluated gedatolisib

in combination with palbociclib (CDK4/6 inhibitor) and fulvestrant or letrozole in patients with HR+/HER2- advanced breast cancer.

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, D).

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.

As of the data cut-off date, March 16, 2023, for treatment- naïve patients in Escalation Arm A and

Expansion Arm A(n=41), median progression free survival (mPFS) was 48.6 months, median duration of response (mDOR) was 46.9 months,

and ORR was 79%.respectively.

This data compares favorably to published data for current first-line standard-of-care treatments for

patients with HR+/HER2-advanced breast cancer.

In patients who received prior hormonal therapy alone or in combination with a CDK4/6

inhibitor (Arms B, C, and D), ORR (including unconfirmed partial responses) ranged from 36% to 77%.

Each arm achieved its primary

endpoint target, which was reporting higher ORR in the study arm than ORR from either the PALOMA-2 (ORR=55%) study 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

For all enrolled patients, a clinical benefit rate (CBR) of ≥79% was observed.

Median progression-free survival (PFS) was 12.9

months for patients who received a prior CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm

combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity.

The majority of treatment

emergent adverse events were Grade 1 and 2.

The most frequently observed adverse events included stomatitis/mucosal inflammation, the

majority of which were Grade 1 and 2.

The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed

as related to treatment with palbociclib.

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 in conjunction with our financial statements and the related notes included

elsewhere in this Annual Report.

Some of the information contained in this discussion and analysis or set forth elsewhere in this Annual

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 Item 1A of Part I of this

Annual Report.

Celcuity is a

clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor

The Company’s lead therapeutic candidate is gedatolisib, a potent, well-tolerated, small molecule reversible

inhibitor, administered intravenously, that selectively targets all Class I isoforms of phosphatidylinositol-3-kinase

(“PI3K”) and the two mechanistic targets of rapamycin (“mTOR”) sub-complexes, mTORC1 and mTORC2.

mechanism of action and pharmacokinetic properties are 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.

selection activities are completed and activation activities for a Phase 3 clinical trial, VIKTORIA-2, evaluating 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 has commenced, and the first patient is expected to be dosed in the second quarter of 2025.

1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with mCRPC, is currently

In April 2021, we obtained exclusive global development

and commercialization rights to gedatolisib under a license agreement with Pfizer Inc.

We believe gedatolisib’s unique mechanism

of action, differentiated chemical structure, favorable pharmacokinetic properties, and intravenous route of administration offer distinct

advantages over currently approved and investigational therapies that target PI3K, AKT, or mTOR alone or together.

● Overcomes limitations of therapies that only inhibit a single Class I PI3K isoform or only 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 mTORC1 and mTORC2 complexes.

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 isoform (e.g., alpelisib, a PI3K-α

inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the

PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units.

This, in turn, induces compensatory resistance that reduces

the efficacy of isoform specific PI3K or single mTOR kinase complex 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 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 stabilizes at lower concentration levels in plasma compared to orally administered

PI3K inhibitors, resulting in less toxicity, while maintaining concentrations sufficient to inhibit PI3K/mTOR signaling.

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 still leads 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 December 31, 2024, 492 patients with solid tumors

have received gedatolisib in eight clinical trials sponsored by Pfizer.

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

Additional patients received gedatolisib in combination with other anti-cancer agents in nine investigator sponsored clinical

A Phase 1b 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 December 31, 2024, each of whom have received study treatment for more than five years.

clinical trial was an open label, multiple arm Phase 1b clinical trial that evaluated gedatolisib in combination with palbociclib (CDK4/6

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 wild type (“WT”)

and PIK3CA mutant (“MT”) patients.

In patients who received prior hormonal therapy alone or in combination with a CDK4/6 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 CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule

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 emergent adverse events were Grade

The most frequently observed adverse events included stomatitis/mucosal inflammation, the majority of which were Grade 1 and

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.

We are currently enrolling patients in a Phase 3, open-label, randomized

clinical trial (VIKTORIA-1) to evaluate the efficacy and safety of two regimens in adults with HR+/HER2- advanced breast cancer whose

disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor:

1) gedatolisib in combination with palbociclib

and fulvestrant;

We are currently enrolling patients in a Phase 3,

open-label, randomized clinical trial,VIKTORIA-1, to evaluate the efficacy and safety of two regimens in adults with HR+/HER2- advanced

breast cancer whose disease has progressed after prior CDK4/6 therapy in combination with an aromatase inhibitor:

1) gedatolisib in combination

with palbociclib and fulvestrant;

and 2) gedatolisib in combination with fulvestrant.

Approximately two hundred clinical sites in North America, Europe,

South America, Asia, and Australia have been selected to participate in the study.

The first clinical site was activated in the third

quarter of 2022, and the first patient was dosed in December 2022.

VIKTORIA-1 Phase 3 clinical trial will enable separate evaluation of subjects according to their PIK3CA status.

Subjects who meet

eligibility criteria and are PIK3CA WT will be 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).

Subjects who meet eligibility criteria and are

PIK3CA MT will be randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), or

alpelisib and fulvestrant (Arm E), or gedatolisib and fulvestrant (Arm F).

received approval from the US 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 study (CELC-G-201) that will enroll up to 54 participants with mCRPC who progressed after treatment with an

androgen receptor inhibitor.

We dosed our first patient in this trial in February 2024.

In 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

An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the recommended phase 2 dose (RP2D) level

to enable evaluation of 30 participants treated with the RP2D of gedatolisib.

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 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.

proprietary CELsignia diagnostic platform is the only commercially ready technology we are aware of that uses a patient’s living

tumor cells to identify the specific abnormal cellular process driving a patient’s cancer and the targeted therapy that best treats

This enables us to identify patients whose tumors may respond to a targeted therapy, even though they lack a previously associated

molecular mutation.

By identifying cancer patients whose tumors lack an associated genetic mutation but have abnormal cellular activity

a matching targeted therapeutic is designed to inhibit, CELsignia CDx can expand the markets for a number of already approved targeted

Our current CDx identifies breast and ovarian cancer patients whose tumors have cancer drivers potentially responsive to treatment

with human epidermal growth factor receptor 2-negative (HER2), mesenchymal-epithelial transition factor (c-MET), or phosphatidylinositol

3-kinases (PI3K) targeted therapeutics.

Food and Drug Administration (“FDA”) approval or clearance is not currently

required for CELsignia tests offered as a stand-alone laboratory developed test, if we are partnered with a drug company to launch a

CELsignia test as a companion diagnostic for a new drug indication, we would be required to obtain premarket approval, or PMA, in conjunction

with the pharmaceutical company seeking a new drug approval for the matching therapy.

are supporting the advancement of new potential indications for three different targeted therapies, controlled by other pharmaceutical

companies, that would rely on a CELsignia CDx to select patients.

Three Phase 2 trials are underway to evaluate the efficacy and safety

of these therapies in CELsignia selected patients.

These patients are not currently eligible to receive these drugs and are not identifiable

with a molecular test.

the development of a potential first-in-class targeted therapy for breast cancer, like gedatolisib, with our CELsignia platform is a

natural extension of our strategy to use our CELsignia CDx to enable new indications for other companies’ targeted therapies.

combining companion diagnostics designed to enable proprietary new drug indications with targeted therapies that treat signaling dysregulation

our CDx identifies, we believe we are uniquely positioned to improve the standard-of-care for many early and late-stage breast cancer

Our goal is to play a key role in the multiple treatment approaches required to treat breast cancer patients at various stages

of their disease.

With each program, we are:

the proprietary insights CELsignia provides into live patient tumor cell function

a CELsignia CDx to identify new patients likely to respond to the paired targeted therapy

a new targeted therapeutic option for breast cancer patients

the probability of getting regulatory approval to market the targeted therapy indication

February 22, 2024, the Company announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib

in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with mCRPC.

In December 2023, Celcuity presented data from nonclinical studies

evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio

Breast Cancer Symposium (SABCS).

In a panel of breast cancer cell lines, gedatolisib was found to be more cytotoxic and at least 300-fold

more potent, on average, compared to the single node PAM inhibitors.

December 1, 2023, pursuant to an Open Market Sale Agreement SM with Jefferies LLC, as agent, the Company 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 million before deducting commissions

and other offering expenses of $0.6 million.

October 18, 2023, the Company entered into a securities purchase agreement to sell pre-funded warrants at a price of $8.70 per warrant,

to purchase up to 5,747,787 shares of the Company’s common stock in a private placement.

The closing of the private placement occurred

on October 20, 2023 and resulted in gross proceeds of approximately $50 million, before deducting offering expenses of approximately

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 will enable separate

evaluation of subjects according to their PIK3CA status.

Subjects who meet eligibility criteria and are PIK3CA WT will be randomly assigned

(1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant

The WT enrollment target was achieved in the fourth quarter of 2024.

Subjects who meet eligibility criteria and are PIK3CA MT

will be 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).

Topline data from Arms A, B and C of this clinical trial are expected in Q2 2025.

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 metastatic castration resistant prostate cancer (“mCRPC”).

We have since initiated a Phase

1b/2 study, CELC-G-201, that is enrolling patients with mCRPC who progressed after treatment with an androgen receptor inhibitor.

first patient was dosed in this trial in February 2024.

In the Phase 1b portion of the clinical trial, Celcuity

expects approximately 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

recommended phase 2 dose (“RP2D”) level to enable evaluation of 30 participants treated with the RP2D of gedatolisib.

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 of gedatolisib.

The primary objective of the Phase 2 portion of the trial is to assess the radiographic progression-free

survival at six months of patients who received the RP2D.

Initial preliminary data for the Phase 1b dose escalation portion of the trial

is expected to be available by the end of the second quarter of 2025.

A Phase 3, open-label, randomized clinical trial to

evaluate the efficacy and safety of gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2-

advanced breast cancer that is endocrine treatment resistant (“VIKTORIA-2”) is currently activating clinical trial sites.

For the CDK4/6 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.

patient is expected to be dosed in the second quarter of 2025.

Recent Developments

The VIKTORIA-1 Phase 3 clinical trial evaluating

gedatolisib in combination with fulvestrant with and without palbociclib in adults with HR+, HER2- advanced breast cancer who have received

prior treatment with a CDK4/6 inhibitor is 100% enrolled for the PIK3CA wild-type cohort.

We expect to provide topline data in

VIKTORIA-2 Phase 3 open-label randomized study evaluating the efficacy and safety of gedatolisib in combination with fulvestrant plus

a CDK4/6 inhibitor, either ribociclib or palbociclib, in comparison to fulvestrant plus a CDK4/6 inhibitor as a first-line treatment

for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant remains on track to enroll its first patient in

December 2024, Celcuity presented overall survival data from a Phase 1b trial, which evaluated gedatolisib in combination with palbociclib

and either letrozole or fulvestrant, in patients with HR+, HER2- advanced or metastatic breast cancer during a poster session at the

2024 San Antonio Breast Cancer Symposium (SABCS).

Median overall survival was 77.3 months among patients with HR+, HER2- advanced breast

cancer who were treatment-naïve in the advanced setting and 33.9 months among patients previously treated with a CDK4/6 inhibitor.

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 we began operations in 2012.

For the years ended December

31, 2024 and 2023, we reported a net loss of approximately $111.8 million and $63.8 million, respectively.

As of December 31,

2024, our cash and cash equivalents and short-term investments were approximately $235.1 million, and we had an accumulated deficit of approximately

$271.9 million.

Each Warrant to purchase one share has a purchase price of $8.699 per share, and an exercise price of $0.001 per share

for the Common Stock issuable upon exercise of the Warrant (for aggregate consideration equating to $8.70 per share).

The Company expects

to use the net proceeds to advance clinical development of gedatolisib and for general corporate purposes.

The Company has entered into

a Registration Rights Agreement in connection with the private placement, pursuant to which it has agreed to register for resale the

shares issuable upon exercise or exchange of the Warrants.

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 we began

operations in 2012.

For the years ended December 31, 2023 and 2022, we reported a net loss of approximately $63.8 million and

$40.4 million, respectively.

As of December 31, 2023, our cash and cash equivalents and short-term investments were approximately $180.6

million, and we had an accumulated deficit of approximately $160.1 million.

OF OPERATIONS

of Operating Results

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 announced plans 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.

If we obtain regulatory approvals to market gedatolisib, we expect to generate

revenue from sales of the drug for the treatment of breast cancer patients.

Additionally, we will seek to generate revenue from

partnership agreements with pharmaceutical companies to provide companion diagnostics for such pharmaceutical partners’

existing or investigational targeted therapies.

If a new drug indication is received that requires use of our companion diagnostic

to identify eligible patients, we expect to generate revenues from sales of tests to treating physicians.

and Development

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

fees paid to third parties;

costs for gedatolisib;

costs associated with patent applications.

and external research and development costs are expensed as they are incurred.

As we continue to develop gedatolisib and manage

studies and clinical trials, including the VIKTORIA-1 Phase 3 trial, the CELC-G-201 Phase 1b/2 trial, and other clinical trials to

evaluate the efficacy of targeted therapies in cancer patients selected with one of our CELsignia tests, the proportion of research

and development expenses allocated to external spending will grow at a faster rate than expenses allocated to internal

and Administrative

and administrative expenses consist primarily of salaries, benefits and stock-based compensation related to our executive, finance and

support functions.

Other general and administrative expenses include professional fees for auditing, tax, and legal services associated

with being a public company, director and officer insurance, investor relations and travel expenses for our general and administrative

and Marketing

and marketing expenses consist primarily of professional and consulting fees related to these functions.

To date, we have incurred

immaterial sales and marketing expenses as we continue to focus primarily on developing our first drug, gedatolisib, managing the

VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials, and developing our CELsignia platform and corresponding CELsignia tests.

would expect to begin to incur increased sales and marketing expenses in anticipation of the commercialization of our first drug,

gedatolisib, and CELsignia tests.

These increased expenses are expected to include employee-related and consulting costs.

expense is primarily due to a Loan Agreement and finance lease obligations.

income consists of interest income earned on our cash, cash equivalents and investment balances.

of Operations

of the Years Ended December 31, 2023 and 2022

RESULTS OF OPERATIONS

Components of Operating Results

To date, we have not generated any revenue.

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, and we have initiated a second Phase 3 clinical trial, VIKTORIA-2,

with dosing of the first patient planned in Q2 2025 to support submission to the FDA seeking approval for this indication for gedatolisib.

If we obtain regulatory approvals to market gedatolisib, we expect to generate revenue from sales of the drug for the treatment of breast

cancer patients.

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.

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;

● legal costs associated with patent applications.

Internal and external research and development costs

are expensed as they are incurred.

As we continue development of gedatolisib and manage studies and clinical trials, including the VIKTORIA-1

Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 clinical trial, and the VIKTORIA-2 Phase 3 clinical trial, the proportion of research

and development expenses allocated to external spending will grow at a faster rate than expenses allocated to internal expenses.

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, investor relations and travel expenses for our general and administrative personnel.

Sales and Marketing

Expenses and costs related to the initiation and operation

of our medical and marketing teams, supply chain and distribution network are being incurred in anticipation of the commercialization

of our first drug candidate, 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 our drug product.

We would expect to begin to incur sales force,

sales support staff and marketing expenses closer to a potential FDA approval date.

Interest Expense

Interest expense is primarily due to a Loan Agreement.

Interest Income

Interest income consists of interest income earned

on our cash, cash equivalents and investment balances.

Results of Operations

Comparison of the Years Ended December 31, 2024 and 2023

Increase (Decrease)

3 unchanged sentences

Research and development

$ 104,203,230

General and administrative

4 unchanged sentences

(47,036,620 )

Other income (expense)

Other (expense) income

Interest expense

(10,280,445 )

Interest income

Other income (expense), net

Other income, net

Net loss before income taxes

6 unchanged sentences

$ (47,999,989 )

and Development

the year ended December 31, 2023, our research and development expenses were approximately $60.6 million, representing an increase

of approximately $25.3 million, or 72%, compared to the same period in 2022.

Of the $25.3 million increase in research and

development expense, $2.4 million was related to increased employee and consulting expenses.

The remaining $22.9 million increase of research and development costs are primarily related

to costs supporting activities for the VIKTORIA-1 pivotal trial.

a significant amount of research and development is central to our business model.

We plan to increase our research and development

expenses for the foreseeable future as we seek to develop gedatolisib, manage the VIKTORIA-1 Phase 3 and the CELC-G-201 Phase 1b/2 trials, discover new

cancer sub-types, and develop and validate additional CELsignia tests to diagnose such sub-types.

We also expect to incur increased

expenses to support companion diagnostic business development activities with pharmaceutical companies as we develop additional

CELsignia tests and manage the clinical trials for gedatolisib.

and Administrative

the year ended December 31, 2023, our total general and administrative expenses were $5.6 million, representing an increase of

approximately $1.5 million, or 37%, compared to the same period in 2022.

The increase primarily resulted from a $1.1 million

increase in employee and consulting expenses.

addition, other general and administrative expenses increased $0.4 million primarily due to professional fees and other expenses

associated with being a public company.

anticipate that our general and administrative expenses will increase in future periods, reflecting both increased costs in connection

with the potential future commercialization of gedatolisib and CELsignia tests, an expanding infrastructure, and increased professional

fees associated with public company regulatory developments and other compliance matters.

the year ended December 31, 2023, interest expense was $5.3 million and represents an increase of $3.2 million compared to the same

period in 2022.

The increase is due to the Loan Agreement that was executed in April 2021, amended in August 2022, and includes $2.1

million of non-cash interest expense.

The increase in interest expense is primarily due to the incremental $20 million funding of

Term Loan B in December 2022.

the year ended December 31, 2023, interest income was $7.8 million and represents an increase of $6.7 million compared to the same period

The increase was primarily the result of higher market interest rates and the closing of additional financing activities, leading

to higher cash, cash equivalents and short-term investment balances.

AND CAPITAL RESOURCES

our inception, we have incurred losses and cumulative negative cash flows from operations.

Through December 31, 2023, 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 December 31, 2023, we raised an aggregate of approximately $288.0 million

of net proceeds through sales of our securities, and as of December 31, 2023 had $35.0 million of borrowings under loan agreements.

Research and Development

For the year ended December 31, 2024, our research

and development expenses were approximately $104.2 million, representing an increase of approximately $43.6 million, or 72%, compared

Of the $43.6 million increase in research and development expense, $30.7 million was primarily related to costs supporting ongoing

activities for the VIKTORIA-1 and CELC-G-201 trials and the commencement of the VIKTORIA-2 Phase 3 pivotal trial.

The remaining $12.9

million was related to increased employee and consulting expenses, of which $0.1 million was in the form of non-cash stock-based compensation.

Conducting a significant amount of research and development

is central to our business model.

We plan to increase our research and development expenses for the foreseeable future as we seek to develop

gedatolisib and manage the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 clinical trial, and the VIKTORIA-2 Phase 3 clinical

General and Administrative

For the year ended December 31, 2024, our total general

and administrative expenses were $9.1 million, representing an increase of approximately $3.4 million, or 61%, compared to 2023.

related expenses accounted for $2.6 million of the $3.4 million increase.

The remaining $0.8 million of the increase resulted from professional

fees, expanding infrastructure and other administrative expenses.

We anticipate that our general

and administrative expenses will increase in future periods, reflecting both increased costs in connection with the potential future commercialization

of gedatolisib, an expanding infrastructure, and increased professional fees associated with public company regulatory developments and

requirements, and other compliance matters.

Interest Expense

For the year ended December 31, 2024, interest expense

was $10.3 million and represents an increase of $5.0 million compared to 2023.

The increase is due primarily to the increased debt balance

in 2024 compared to 2023 due to the incremental $61.7 million funding of Term Loan C in May 2024.

The $10.3 million of interest expense

includes $2.7 million of non-cash interest expense.

Interest Income

For the year ended December 31,

2024, interest income was $11.8 million and represents an increase of $4.0 million compared to 2023.

The increase was primarily the result

of closing on additional equity and debt financing activities in May 2024, leading to higher cash, cash equivalents and short-term investment

LIQUIDITY AND CAPITAL RESOURCES

Since our inception, we have incurred losses and cumulative

negative cash flows from operations.

Through December 31, 2024, 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

December 31, 2024, we raised an aggregate of approximately $369.0 million of net proceeds through sales of our securities, and as of December

31, 2024 had $100.0 million of borrowings under loan agreements, not including payable-in-kind interest.

In March 2024, an investor exercised

1,739,080 warrants at an exercise price of $8.05, which generated approximately $14 million in cash.

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 and was funded on December 9, 2022.

of December 31, 2023, our cash and cash equivalents and short-term investments were approximately $30.7 million and $149.9 million, respectively,

and we had an accumulated deficit of approximately $160.1 million.

Market Sale Offering SM .

On February 4, 2022, we entered into an Open Market Sale Agreement SM with Jefferies

LLC, 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 $50,000,000.

Pursuant to the Open Market Sale Agreement SM with Jefferies LLC, as agent, on December

1, 2023, the Company 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 million ($14.4 million net of commissions and offering expenses).

At December 31, 2023, $29.8 million of common stock remains

available for sale under the Jefferies agreement.

Warrants On October 18, 2023, the Company entered into a securities purchase agreement to sell pre-funded warrants at a price of

$8.70 per warrant, to purchase up to 5,747,787 shares of the Company’s common stock in a private placement.

The closing of the

private placement occurred on October 20, 2023, and resulted in gross proceeds of approximately $50 million, before deducting offering

expenses of approximately $0.1 million.

On December 9, 2022, we issued 6,182,574 shares of common stock, 1,120,873 shares of Series A Preferred Stock and warrants

exercisable for 6,956,450 shares of common stock to certain institutional and other accredited investors pursuant to a securities purchase

agreement entered into on May 15, 2022.

Pursuant to the securities purchase agreement, the closing (funding) of the private placement

occurred following dosage of the first patient in the Company’s Phase 3 study, VIKTORIA-1.

Investors purchased shares of common

stock and Series A Preferred Stock at a price of $5.75 per share (on an as converted to common stock basis), with forty percent (40%)

warrant coverage (on an as converted to common stock basis) and customary resale registration rights.

The warrants have an exercise price

of $8.05 per share.

The private placement generated gross proceeds of approximately $100 million before deducting placement agent fees

The warrants exercised in March 2024 and 2025 were issued pursuant

to a private placement that closed on December 9, 2022.

As of December 31, 2024, our cash and cash equivalents and short-term investments

were approximately $22.5 million and $212.6 million, respectively, and we had an accumulated deficit of approximately $271.9 million.

Open Market Sale Agreement℠.

4, 2022, we entered into an Open Market Sale Agreement SM with Jefferies LLC, 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 October 12, 2022, pursuant to this agreement, the Company 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, the Company 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, the Company 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.

Market Sale Agreement SM .

On October 12, 2022, pursuant to our Open Market Sale Agreement SM with Jefferies

LLC as agent, the Company 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).

At December 31, 2024, $125.0 million of common stock remains available for sale under the

Jefferies agreement.

Private Placement.

On December 9, 2022, we

issued 6,182,574 shares of common stock, 1,120,873 shares of Series A Preferred Stock and warrants exercisable for 6,956,450 shares of

common stock to certain institutional and other accredited investors pursuant to a securities purchase agreement entered into on May 15,

Pursuant to the securities purchase agreement, the closing (funding) of the private placement occurred following dosage of the first

patient in the Company’s Phase 3 study, VIKTORIA-1.

Investors purchased shares of common stock and Series A Preferred Stock at a

price of $5.75 per share (on an as converted to common stock basis), with forty percent (40%) warrant coverage (on an as converted to

common stock basis) and customary resale registration rights.

The warrants have an exercise price of $8.05 per share.

The private placement

generated gross proceeds of approximately $100.0 million before deducting placement agent fees and other offering expenses of $4.3 million.

Pre-funded Warrants.

On October 18, 2023, the Company entered into a securities purchase agreement to sell pre-funded warrants at a price of $8.70 per warrant,

to purchase up to 5,747,787 shares of the Company’s common stock in a private placement.

The closing of the private placement occurred

on October 20, 2023, and resulted in gross proceeds of approximately $50.0 million, before deducting offering expenses of approximately

$0.1 million.

Equity Offering .

On May 30, 2024, the Company

entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated

as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of common stock, at a price to the

public of $15.50, generating gross proceeds of approximately $60.0 million.

The offering closed on May 31, 2024 and resulted in net proceeds

to the Company of approximately $56.3 million after deducting underwriting discounts and other offering expenses payable by the Company.

The Company intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include research

and development expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes.

Loan Agreement.

On April 8, 2021, we entered into a Loan Agreement with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”),

under which Innovatus agreed to loan up to $25 million in three tranches consisting of (i) a $15.0 million non-contingent Term A loan

that was funded on April 8, 2021, (ii) a $5 million Term B loan with a deadline of March 31, 2022, and (iii) a $5 million Term C loan

to be funded upon our request, subject to our ability to achieve certain milestones, no later than March 31, 2023.

On August 9, 2022,

the Company amended the Loan Agreement with Innovatus to provide for up to $75 million in term loans.

As of December 31, 2023, term loans

totaling $35 million are outstanding under the Loan Agreement, including the initial Term A loan of $15 million which was funded on April

8, 2021, and a $20 million Term B loan which was funded on December 22, 2022 following the closing of the $100 million private placement

described above.

Additionally, the Company will be able to draw on two additional tranches of $10

million and one additional tranche of $20 million upon achievement of certain clinical trial milestones and satisfaction of certain financial

covenants determined on a pro forma as-funded basis.

Funding of these additional tranches is also subject to other customary conditions

and limits on when the Company can request funding for such tranches.

expect that our research and development and general and administrative expenses will increase as we continue to develop

gedatolisib, manage the VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials, conduct research related to the discovery of new cancer

sub-types, conduct other studies and clinical trials, and pursue other business development activities.

We would also expect to

incur sales and marketing expenses as we commercialize gedatolisib and our CELsignia tests.

We expect to use cash on hand, which

includes funds 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

on our current business plan, we believe that our current cash, cash equivalents and short-term investments together with available borrowings

under the Innovatus Loan Agreement will provide sufficient cash to finance our operations and pay obligations when due through at least

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 launch our integrated therapeutic and

companion diagnostic strategy and 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.

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 shares.

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 not at all.

following table sets forth the primary sources and uses of cash for the years ended December 31:

Net cash provided by (used in):

On May 30, 2024, the Company

entered into an Amended and Restated Loan and Security Agreement (the “A&R Loan Agreement”) with Innovatus Life Sciences

Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as collateral agent, and the Lenders including Innovatus

in its capacity as a Lender and Oxford Finance LLC (“Oxford”), pursuant to which Innovatus and Oxford, as Lenders, have agreed

to make certain term loans (“Term Loans”) to the Company in the aggregate principal amount of up to $180 million.

Loan Agreement amends and restates, in its entirety, that certain Loan and Security Agreement, dated April 8, 2021, as amended, between

the Company 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”).

The Company will be eligible to draw on a fourth

tranche of $30 million (the “Term D Loan”) and fifth tranche of $50 million (the “Term E Loan”), in each case

upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined on a pro forma as-funded

The Lenders may, in their sole discretion upon the Company’s request, make additional term loans to the Company of $45 million

(the “Term F Loan”).

Funding of these additional tranches is also subject to other customary conditions and limits on when

the Company can request funding for such tranches.

Costs associated with the new borrowings were approximately $2.4 million.

Pursuant to the A&R Loan Agreement, the Company

is entitled to make interest-only payments for thirty-six months, or up to forty-eight months if certain conditions are met.

Loans will mature on May 1, 2029 and will bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate (as defined

in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind by adding an

amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis through May

The A&R Loan Agreement is secured by all assets of the Company.

Proceeds will be used for working capital purposes and to

fund the Company’s general business requirements, including the Phase 3 VIKTORIA-2 clinical trial.

The A&R Loan Agreement contains

customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related to liquidity

and other financial measures.

Innovatus has the right, at its election and until August 9, 2025, to convert up to 20% of the outstanding

principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00 (the “Conversion Right”).

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 both the Term D and Term

If the Company achieves the Term D Milestone and (i) fails to draw the full amount of the Term D Loan during the Term D Draw

Period and (ii) fails to notify Collateral Agent, at any time before the date that is four weeks after the Company’s achievement

of the Term D Milestone, of the Company’s intent not to draw the full amount of the Term D Loan, a non-utilization fee of $900,000,

with respect to the Term D Loan shall become due and payable on the earliest of (i) the termination of the Term D Draw Period, (ii) the

Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in whole of the Term Loans.

If the Company achieves 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 the Company’s achievement of the Term E Milestone, of the Company’s

intent not to draw the full amount of the Term E Loan, a non-utilization fee of $1,500,000, 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, the Company 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

the Company (i) provides written notice to Collateral Agent of its election to prepay the Term Loans at least seven Business Days prior

to such prepayment, and (ii) pays 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.

2024, the Company 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, the Term D Loan, the Term E Loan and the Term F Loan, the Company agreed to issue to Innovatus and Oxford warrants to purchase

that number of shares of the Company’s common stock equal to 2.5% of the principal amount of the applicable Term Loan divided by

the exercise price, which shall, with respect to the Term C Loan, be equal to the lower of (i) the volume weighted average closing price

of the Company’s 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

Accordingly, on May 30, 2024, the Company issued 103,876 warrants with an exercise price of $14.84 per share.

fair value of the warrants was approximately $1.2 million.

For the additional Term Loans, the exercise price will be 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 the

Company’s common stock for the five-trading day period ending on the last trading day immediately preceding the applicable Term

Loan funding.

The Warrants may be exercised on a cashless basis and are exercisable through the tenth anniversary of the applicable funding

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.

We expect that our research and development and general

and administrative expenses will increase as we continue to develop gedatolisib, manage the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201

Phase 1b/2 trial, and the VIKTORIA-2 Phase 3 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 commercialize gedatolisib.

We expect to use cash on hand, together with

the funds 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 Innovatus Loan Agreement will

provide sufficient cash to finance our clinical development program activities through 2026.

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 launch our integrated therapeutic and companion diagnostic strategy and 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 shares.

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.

The following table sets forth the primary sources

and uses of cash for the years ended December 31:

Net cash (used in) provided by:

Operating activities

4 unchanged sentences

Financing activities

Net increase (decrease) in cash and cash equivalents

Net (decrease) increase in cash and cash equivalents

$ (8,147,951 )

cash used in operating activities was approximately $53.8 million for the year ended December 31, 2023 and consisted primarily of a net

loss of approximately $63.8 million, offset by working capital changes of $3.9 million and non-cash expense items of approximately

$6.1 million.

Non-cash expense items of approximately $6.1 million primarily consisted of $4.9 million of stock-based compensation expense,

non-cash interest expense of $2.1 million and depreciation expense of $0.1 million, offset by $1.0 accrued interest income.

Operating Activities

Net cash used in operating activities was approximately

$83.5 million for the year ended December 31, 2024 and consisted primarily of a net loss of approximately $111.8 million, partially

offset by working capital changes of $18.3 million and non-cash expense items of approximately $10.0 million.

Non-cash expense items of

approximately $10.0 million primarily consisting of $7.0 million of stock-based compensation expense, net non-cash interest income and

expense of $2.8 million, and depreciation expense of $0.1 million.

The approximately $18.3 million of working capital changes was primarily

due to increases in accrued expenses and accounts payable, and a decrease in other current assets.

Net cash used in operating activities

was approximately $53.8 million for the year ended December 31, 2023 and consisted primarily of a net loss of approximately $63.8 million,

partially offset by working capital changes of $3.9 million and non-cash expense items of approximately $6.1 million.

Non-cash expense

items of approximately $6.1 million primarily consisted of $4.9 million of stock-based compensation expense, non-cash interest expense

of $2.1 million and depreciation expense of $0.1 million, partially offset by $1.0 million of accrued interest income.

The approximately

1 unchanged sentence

in other current assets.

cash used in operating activities was approximately $36.0 million for the year ended December 31, 2022 and consisted primarily of a net

loss of approximately $40.4 million and working capital changes of $1.2 million, offset by non-cash expense items of approximately

$5.6 million.

Non-cash expense items of approximately $5.6 million primarily consisted of $4.6 million of stock-based compensation expense,

non-cash interest expense of $0.9 million and depreciation expense of $0.2 million.

The approximately $1.2 million of working capital

changes was primarily due to an increase in other current assets, somewhat offset by increases in accounts payable and accrued expenses.

cash used in investing activities for the year ended December 31, 2023 was approximately $5.0 million and consisted of approximately

$4.9 million of net purchases of short-term investments in government securities (U.S.

Investing Activities

Net cash used in investing activities for the year

ended December 31, 2024 was approximately $63.1 million and consisted of approximately $62.8 million of net purchases of short-term investments

in government securities (U.S.

Treasury Bills and U.S.

government agency securities)

and approximately $0.1 million in purchases of property and equipment.

cash used in investing activities for the year ended December 31, 2022 was approximately $144.0 million and consisted of approximately

$143.9 million of short-term investments in government securities (U.S.

government securities) and approximately $0.3 million in purchases of property

and equipment.

Net cash used in investing activities for the year

ended December 31, 2023 was approximately $5.0 million and consisted of approximately $4.9 million of net purchases of short-term investments

in government securities (U.S.

Treasury Bills and U.S.

government agency securities) and approximately

$0.1 million in purchases of property and equipment.

cash provided by financing activities for the year ended December 31, 2023 was approximately $64.9 million.

The $64.9 million primarily

consisted of net proceeds from a pre-funded warrants offering and ATM offering, collectively totaling $64.4 million.

The remaining $0.5

million was the result of proceeds from the exercise of employee stock options, the exercise of warrants, and proceeds from employee

stock purchases, slightly offset by payments for secondary registration and debt issuance costs.

cash provided by financing activities for the year ended December 31, 2022 was approximately $120.3 million.

The $120.3 million primarily

consisted of net proceeds from a private placement offering and ATM offering, collectively totaling $100.5 million, and $19.5 million

from net proceeds related to the closing of a Loan Agreement.

government securities) and approximately $0.1 million in purchases of property

and equipment.

Financing Activities

Net cash provided by financing

activities for the year ended December 31, 2024 was approximately $138.4 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 $15.6 million consisted of proceeds from the exercise of common stock warrants, the exercise of employee stock options and

employee stock purchases, slightly offset by payments for a secondary registration statement costs.

Net cash provided by financing activities for the

year ended December 31, 2023 was approximately $64.9 million and primarily consisted of net proceeds from a pre-funded warrant offering

and at-the-market offering, collectively totaling $64.4 million.

The remaining $0.5 million was the result of proceeds from the exercise

of employee stock options and proceeds from employee stock purchases.

ACCOUNTING PRONOUNCEMENTS

time-to-time new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard setting

bodies and adopted by us as of the specified effective date.

Unless otherwise discussed in Note 2 to our financial statements included

elsewhere in this Annual 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.

ACCOUNTING POLICIES AND USE OF ESTIMATES

management’s discussion and analysis of financial condition and results of operations is based on our financial statements, which

have been prepared in accordance with accounting principles generally accepted in the United States, or Generally Accepted Accounted

Principles (“U.S.

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.

of employee stock options, the exercise of warrants, and proceeds from employee stock purchases, slightly offset by payments for secondary

registration statement and debt issuance costs.

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 financial statements included elsewhere in this Annual 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 financial statements, which have been prepared in accordance with accounting

principles generally accepted in the United States, or Generally Accepted Accounted Principles (“U.S.

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

Actual results may differ materially from these estimates.

significant accounting policies are more fully described in Note 2 to our financial statements included elsewhere in this Annual Report.

Of our significant accounting policies, we believe that the following are the most critical:

stock-based compensation consists of common stock options and restricted stock issued to certain employees and nonemployees and our Employee

Stock Purchase Plan (“ESPP”).

We recognize compensation expense based on an estimated grant date fair value using the Black-Scholes

option-pricing method.

We have elected to account for forfeitures as they occur.

inputs for the Black-Scholes valuation model require management’s significant assumptions.

Prior to our IPO, the price per share

of common stock was determined by our board based on recent prices of common stock sold in private offerings.

Subsequent to the IPO,

the price per share of common stock is determined by using the closing market price on the Nasdaq Capital Market on the grant date.

risk-free interest rates are based on the rate for U.S.

Treasury securities at the date of grant with maturity dates approximately equal

to the expected life at the grant date.

The expected life was based on the simplified method in accordance with SEC Staff Accounting

Bulletin Nos.

The expected volatility was estimated based on historical volatility information of peer companies that are

publicly available in combination with our calculated volatility since being publicly traded.

assumptions used to calculate the grant date fair value of nonemployee options are generally consistent with the assumptions used for

options granted to employees.

In the event we terminate any of our consulting agreements, the unvested options issued in connection with

such agreements would also be cancelled.

grants of restricted stock, we record compensation expense based on the quoted fair value of the shares on the grant date over the requisite

service period.

Compensation expense for ESPP rights is recorded in line with each respective offering period.

Company records prepaid assets or accrued expenses for prepaid or estimated clinical trial costs conducted by third-party service

providers, which includes the conduct of preclinical studies and clinical trials.

These costs can be a significant component of the

Company’s research and development expenses.

The Company primarily relies on a compilation of progress reports from

third-party service providers, including the respective invoicing, to record actual expenses, along with determining changes to

prepaid assets and accrued liabilities.

To date, the Company believes utilization of third-party reports most accurately reflects

expenses incurred.

As the current VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials ramp up site activation and patient

enrollment, the Company’s estimated expenses in future periods and the actual services performed may vary from these

estimates, and these estimates may become more significant.

Changes in these estimates that result in material changes to the

Company’s prepaid assets or accrued expenses could materially affect the Company’s results of operations.

Our significant accounting policies are more fully

described in Note 2 to our financial statements included elsewhere in this Annual Report.

Of our significant accounting policies, we believe

that the following are the most critical:

Stock-Based Compensation

Our stock-based compensation

consists of common stock options and restricted stock issued to certain employees and non-employees and our Employee Stock Purchase Plan

We recognize compensation expense based on an estimated grant date fair value using the Black-Scholes option-pricing

method for equity-based awards and the Monte Carlo simulation model for the performance-based awards.

We have elected to account for forfeitures

as they occur.

The inputs for the Black-Scholes valuation model require

management’s significant assumptions.

Prior to our IPO, the price per share of common stock was determined by our board based on

recent prices of common stock sold in private offerings.

Subsequent to the IPO, the price per share of common stock is determined by using

the closing market price on the Nasdaq Capital Market on the grant date.

The risk-free interest rates are based on the rate for U.S.

securities at the date of grant with maturity dates approximately equal to the expected life at the grant date.

The expected life was

based on the simplified method in accordance with SEC Staff Accounting Bulletin Nos.

The expected volatility was estimated

based on historical volatility information of peer companies that are publicly available in combination with our calculated volatility

since being publicly traded.

All assumptions used to calculate the grant date fair

value of non-employee options are generally consistent with the assumptions used for options granted to employees.

In the event we terminate

any of our consulting agreements, the unvested options issued in connection with such agreements would also be cancelled.

For grants of restricted stock, we record compensation

expense based on the quoted fair value of the shares on the grant date over the requisite service period.

Compensation expense for ESPP

rights is recorded in line with each respective offering period .

Clinical Trial Costs

The Company records prepaid assets or accrued expenses

for prepaid or estimated clinical trial costs conducted by third-party service providers, which includes the conduct of preclinical studies

and clinical trials.

These costs can be a significant component of the Company’s research and development expenses.

Company primarily relies on a compilation of progress reports from third-party service providers, including the respective invoicing,

to record actual expenses, along with determining changes to prepaid assets and accrued liabilities.

To date, the Company believes utilization

of third-party reports most accurately reflects expenses incurred.

With the ongoing VIKTORIA-1 Phase 3 trial and the CELC-G-201 Phase

1b/2 trial, and the commencement of the VIKTORIA-2 Phase 3 trial site activation and patient enrollment ,

the Company’s estimated expenses in future periods and the actual services performed may vary from these estimates, and these

estimates may become more significant.

Changes in these estimates that result in material changes to the Company’s prepaid assets

or accrued expenses could materially affect the Company’s results of operations.

Quantitative and Qualitative Disclosures About Market Risk

a smaller reporting company, we are not required to provide disclosure pursuant to this item.

As a smaller reporting company, we are not required

to provide disclosure pursuant to this item.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis