What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-08-14 compared with 2025-05-15 · 608 added, 373 removed, 211 unchanged (82% of the section changed)

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Its 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 site 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, are completed and site activities have begun.

The first patient is expected to be dosed in the

second quarter of 2025.

A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients

with metastatic castration resistant prostate cancer (“mCRPC”), is currently underway.

investigator sponsored trial has been initiated in collaboration with the Dana Farber Cancer Institute and Massachusetts General

Hospital to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial

therapies that target PI3K, AKT, or mTOR alone or together.

Our Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in

combination with fulvestrant with or without palbociclib in patients with hormone receptor-positive (HR+), human epidermal growth

factor receptor 2-negative (HER2-) (“HR+/HER2-”) advanced breast cancer has completed enrollment of and reported topline

data for cohort 1, patients with PIK3CA wild-type (“WT”) tumors, and is continuing to enroll cohort 2, patients

with PIK3CA mutant-type (“MT”) tumors.

Our Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib in

combination with a cyclin-dependent kinase (“CDK”) 4/6 inhibitor and fulvestrant as first-line treatment for patients

with endocrine treatment resistant HR+/HER2- advanced breast cancer is currently enrolling patients.

The first patient was dosed in

July of 2025.

A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with

metastatic castration resistant prostate cancer (“mCRPC”), is ongoing.

An investigator sponsored trial has been

initiated in collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital to evaluate gedatolisib in

combination with abemaciclib and letrozole in patients with endometrial cancer.

April 2021, we obtained exclusive global development and commercialization rights to gedatolisib under a license agreement with Pfizer.

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AKT, or mTOR alone or together.

limitations of therapies that only inhibit a single Class I PI3K isoform, AKT, or 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 the mTORC1 and mTORC2 complexes.

By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive

inhibition of the PAM pathway.

Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction

events that involve tumor cell survival, depending upon the aberrations associated with the linked pathway.

When a therapy only

inhibits a single Class I PI3K isoform (e.g., alpelisib, a PI3K-α inhibitor), AKT (e.g., capivasertib, an AKT inhibitor) or

only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the PI3K

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

This, in turn, induces compensatory resistance that reduces

the efficacy of isoform specific PI3K, AKT, or mTORC1 kinase inhibitors.

Inhibiting all four PI3K isoforms and both mTOR

complexes, as gedatolisib does, thus prevents the confounding effect of isoform interaction that may occur with isoform-specific

PI3K inhibitors and the confounding interaction between PI3K isoforms, AKT, and mTOR.

limitations of therapies that only inhibit a single Class I PI3K isoform, AKT, or 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 the mTORC1 and mTORC2 complexes.

By targeting all Class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition

of the PAM pathway.

Each PI3K isoform and mTOR complex is known to preferentially affect different signal transduction events that involve

tumor cell survival, depending upon the aberrations associated with the linked pathway.

When a therapy only inhibits a single Class I

PI3K isoform (e.g., alpelisib, a PI3K-α inhibitor), AKT (e.g., capivasertib, an AKT inhibitor) or only one mTOR kinase complex

(e.g., everolimus, an mTORC1 inhibitor), numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate

the uninhibited sub-units.

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

mTORC1 kinase inhibitors.

Inhibiting all four PI3K isoforms and both mTOR complexes, as gedatolisib does, thus prevents the confounding

effect of isoform interaction that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms,

AKT, and mTOR.

tolerated by patients than oral PI3K and mTOR drugs.

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role in the decisions to halt their development, despite showing promising efficacy.

By contrast, gedatolisib’s comprehensive inhibition of the PAM pathway at low nanomolar potency, IV route of administration,

and pharmacokinetic properties enables it to achieve optimal anti-proliferative effects on tumor cells without inducing the levels of

hyperglycemia, rash, and diarrhea typically associated with oral single-node inhibitors of the PAM pathway.

By contrast, gedatolisib’s comprehensive inhibition

of the PAM pathway at low nanomolar potency, IV route of administration, and pharmacokinetic properties enables it to achieve optimal

anti-proliferative effects on tumor cells without inducing the levels of hyperglycemia, rash, and diarrhea typically associated with

oral single-node inhibitors of the PAM pathway.

Isoform-specific

PI3K inhibitors administered orally were developed to reduce toxicities in patients.

While the range of toxicities associated with isoform-specific

inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis still leads to challenging

The experience with an FDA approved oral p110-α specific inhibitor, PIQRAY, illustrates the challenge.

3 pivotal trial, PIQRAY was found to induce a Grade 3 or 4 adverse event (“AE”) related to hyperglycemia in 39% of patients

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.

of March 31, 2025, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials.

While the range of toxicities associated with

isoform-specific inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis

can still lead to challenging toxicities.

The experience with an FDA approved oral p110-α specific inhibitor, PIQRAY,

illustrates the challenge.

In its Phase 3 pivotal trial, PIQRAY was found to induce a Grade 3 or 4 adverse event (“AE”)

related to hyperglycemia in 39% of patients evaluated.

In addition, 26% of patients discontinued alpelisib due to treatment related

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.

of June 30, 2025, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials.

Of the 492 patients, 129

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agents in nine investigator sponsored clinical trials.

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

enrolled 138 patients.

Four patients from this study continue to receive study treatment, as of March 31, 2025, each of whom has received

study treatment for more than five years.

The B2151009 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

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).

Phase 1b Trial

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

subsequently enrolled 138 patients.

Four patients from this study continue to receive study treatment, as of June 30, 2025, each of

whom has received study treatment for approximately five years.

The B2151009 clinical trial was an open label, multiple arm Phase 1b

clinical trial that evaluated gedatolisib in combination with palbociclib (CDK 4/6 inhibitor) and fulvestrant or letrozole in

patients with HR+/HER2- advanced breast cancer.

Thirty-five patients were enrolled in two dose escalation arms to evaluate the

safety and tolerability and to determine the maximum tolerated dose (“MTD”) of gedatolisib when used in combination with

the standard doses of palbociclib and endocrine therapy (letrozole or fulvestrant).

The MTD was determined to be 180 mg administered

intravenously once weekly.

A total of 103 patients were subsequently enrolled in one of four expansion arms (A, B, C, and

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 received prior hormonal therapy alone

or in combination with a CDK 4/6 inhibitor (Arms B, C, and D), the ORR (including unconfirmed partial responses) ranged from 36% to 77%.

In patients who were treatment naïve in the advanced setting (Arm A), the ORR was 85%.

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enrolled in the expansion portion of the study who had evaluable tumors, the ORR observed was 63%.

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 D).

For all treatment naïve patients who received gedatolisib combined with palbociclib

plus letrozole in Expansion Arm A and Escalation Arm A (N=41), median PFS was 48.6 months and ORR was 79%.

These results compare favorably

to published data for current first-line standard-of-care treatments for patients with HR+/HER2-advanced breast cancer.

progression-free survival (“PFS”) was 12.9 months for patients who received a prior CDK 4/6 inhibitor and were treated

in the study with the Phase 3 dosing schedule (Arm D).

For all treatment naïve patients who received gedatolisib combined with

palbociclib plus letrozole in Expansion Arm A and Escalation Arm A (N=41), median PFS was 48.6 months and ORR was 79%.

These results

compare favorably to published data for current first-line standard-of-care treatments for patients with HR+/HER2-advanced breast

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

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No Grade 5 events were reported in this study.

Phase 3 Trial

are currently enrolling patients in a Phase 3, open-label, randomized clinical trial, VIKTORIA-1, to evaluate the efficacy and

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VIKTORA-1 Phase 3 clinical trial enables separate evaluation of subjects according to their PIK3CA status.

Subjects who meet

eligibility criteria and have PIK3CA WT tumors were randomly assigned (1:1:1) to receive a regimen of either gedatolisib,

palbociclib, and fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C).

During the fourth quarter of

2024, we achieved our enrollment goal of 351 subjects for the PIK3CA WT cohort.

Based on evaluation of blinded event rates, the

primary completion date is projected to occur in June 2025 with topline data now expected to be available in the third quarter of

2025 for this group.

Subjects who meet eligibility criteria and are PIK3CA MT are

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).

Subjects who meet eligibility

criteria and have PIK3CA WT tumors were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and

fulvestrant (Arm A), gedatolisib and fulvestrant (Arm B), or fulvestrant (Arm C).

During the fourth quarter of 2024, we achieved our

enrollment goal of 351 subjects for the PIK3CA WT cohort.

The primary completion date for this cohort was achieved in May 2025

and the database cut-off date for this cohort was May 30, 2025.

Topline data from the PIK3CA WT cohort was reported in July 2025.

See “Recent Developments,” below, for a summary of the topline data.

Subjects who meet eligibility criteria and are PIK3CA

MT are randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D), alpelisib and fulvestrant

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

Enrollment of up to 350 subjects who have PIK3CA MT tumors is ongoing.

We expect topline data for this group to be available in the fourth quarter of 2025.

topline data for this group to be available in the fourth quarter of 2025.

Phase 1b/2 Trial

received approval from the FDA in mid-2023 to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide),

an approved androgen receptor inhibitor, for the treatment of patients with mCRPC.

We have since initiated a Phase 1b/2 clinical trial, CELC-G-201, that is enrolling patients with mCRPC who progressed after treatment

with an androgen receptor inhibitor.

The first patient was dosed in this trial in February 2024.

the 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.

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 PFS at six months of patients who received the RP2D.

The study is expected to report topline data for the Phase 1b dose

escalation portion of the trial late in the second quarter of 2025.

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.

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.

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.

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

on evaluation of blinded event rates in the ongoing VIKTORIA-1 Phase 3 clinical trial, the primary completion date for the PIK3CA WT

patient cohort is projected to occur in June 2025 with topline data now anticipated to be available in the third quarter of 2025.

our topline data from the WT cohort is positive, we expect the data will support the filing of our first new drug application and, if

approved, our transition to a commercial stage company.

If gedatolisib ultimately does receive FDA approval for both the PIK3CA WT and

MT populations, we estimate the peak revenue potential for this second-line indication could exceed $2 billion with just 40% market penetration.

is ongoing in the PIK3CA MT of the VIKTORIA-1 trial and remains on track to report

topline data in the fourth quarter of 2025.

is a global Phase 3 study 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.

activation activities are underway globally for the VIKTORIA-2 Phase 3 clinical trial and dosing of the first patient is anticipated

to occur in the second quarter of 2025.

is a global, 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.

to initiating the Phase 3 portion of the study, a safety run-in will be conducted in 12-36

participants to assess the safety of gedatolisib in combination with ribociclib and fulvestrant.

CELC-G-201 study is on track to report topline data for the Phase 1b portion of the trial late in the second quarter of 2025.

is a Phase 1b/2 evaluating gedatolisib in combination with darolutamide for the treatment

of patients with metastatic castration resistant prostate cancer (mCRPC) whose disease progressed

while on or after treatment with an androgen receptor signaling inhibitor.

Phase 1b portion of the trial will assess the safety and tolerability of gedatolisib in combination with darolutamide and is expected

to identify the recommended phase 2 dose regimen.

Initiating a clinical trial collaboration with the Dana Farber Cancer Institute and Massachusetts General Hospital

to evaluate gedatolisib in combination with abemaciclib and letrozole in patients with endometrial cancer.

In a prior Phase 2 study, gedatolisib was evaluated as a monotherapy

in patients with endometrial cancer.

We have since initiated a Phase 1b/2 clinical trial,

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

The first patient

was dosed in this trial in February 2024.

The primary objectives of the Phase 1b portion of the trial include assessment of the safety and tolerability of gedatolisib in combination

with darolutamide and determination of the recommended Phase 2 dose (“RP2D”) of gedatolisib.

The primary objective of the

Phase 2 portion of the trial is to assess the radiographic PFS at six months of patients who received the RP2D.

the Phase 1b portion of the clinical trial, 38 patients with mCRPC were randomly assigned to receive 600 mg of darolutamide twice

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

In both arms, gedatolisib was

administered once weekly for three weeks, then one week off.

Additionally, all patients received prophylactic treatment for

June 30, 2025, we announced topline data for the CELC-G-201 Phase 1b trial, utilizing a May 30, 2025 data cut-off.

The preliminary

efficacy and safety analyses for the combined arms showed:

six-month radiographic PFS was 66%.

patients discontinued treatment due to a treatment-related AE and no dose reductions were required with gedatolisib or darolutamide.

Grade 3 hyperglycemia was reported.

2-3 stomatitis was reported in four (10.5%) patients - three (7.9%) Grade 2 and one (2.6%) Grade 3.

on these data, we have amended the clinical trial protocol to enable exploration of additional doses in the Phase 1b portion of this

clinical trial to determine the RP2D.

Once RP2D is determined, an additional 12 participants will then be enrolled in the Phase 2 portion

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

preliminary results for the Phase 1b portion of the clinical trial will be presented at a medical conference later this year.

Phase 3 Trial

Phase 3, open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with a CDK4/6 inhibitor

and fulvestrant as first-line treatment for patients with endocrine treatment resistant HR+/HER2- advanced breast cancer (“VIKTORIA-2”)

is currently enrolling patients.

The first patient was dosed in July of 2025.

For the CDK 4/6 inhibitor, investigators may choose either

ribociclib or palbociclib.

This multi-center, international trial is expected to enroll approximately 12–36 evaluable subjects

in the safety run-in portion of the study to evaluate the safety of gedatolisib when combined with ribociclib and fulvestrant.

Phase 3 portion of the study, approximately 638 subjects will be randomized and assigned to Cohort 1 (PIK3CA WT) or Cohort 2 ( PIK3CA

MT) based on their PIK3CA status.

Subjects in each cohort will be randomized on a 1:1 basis to either Arm A (gedatolisib with

fulvestrant and ribociclib or palbociclib) or Arm B (fulvestrant and ribociclib or palbociclib).

It is expected that approximately 200

clinical sites across North America, Europe, Latin America, and Asia-Pacific will participate.

Investigator-Sponsored

Phase 2 Trial

an investigator-sponsored Phase 2 clinical trial, 44 patients with HER2+/ PIK3CA mutated metastatic breast cancer were treated

with gedatolisib plus standard doses of trastuzumab-pkrb.

No prophylaxis for stomatitis was administered.

The median number of prior

anti-HER2 therapies enrolled patients received in the metastatic setting was four or more;

86% of patients had received at least three

prior anti-HER2 therapies.

The data cut-off was February 10, 2025.

efficacy and safety results, as presented at the American Society of Clinical Oncologists meeting in June 2025, showed:

ORR among all patients enrolled was 43%.

PFS was 6.0 months (95% CI, 5.0-7.7).

overall survival was 24.7 months (95% CI;

patients discontinued gedatolisib due to a treatment-related AE.

(2.3%) patient experienced Grade 3 hyperglycemia.

Patent Issuance

July 8, 2025, the U.S.

Patent and Trademark Office (“USPTO”) issued to the Company U.S.

12,350,276 covering the clinical dosing

regimen for gedatolisib in HR+/HER2- advanced breast cancer patients.

The patent extends our patent exclusivity in the U.S.

The USPTO previously issued five U.S.

patents directed to gedatolisib’s composition of matter, four U.S.

patents directed

to various formulations comprising gedatolisib, and three U.S.

patents directed to methods of using gedatolisib.

The worldwide gedatolisib-related

patent portfolio now comprises 13 granted gedatolisib-related patents in the U.S.

and 290 patents granted in foreign jurisdictions.

Topline Data for PIK3CA WT Cohort

July 28, 2025, we announced topline data from the PIK3CA WT cohort of the VIKTORIA-1 clinical trial.

The key efficacy and safety

data from the PIK3CA WT cohort showed:

gedatolisib triplet (gedatolisib, fulvestrant and palbociclib) demonstrated a statistically significant and clinically meaningful

improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard

ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35;

The median PFS, as assessed by blinded independent central

review (“BICR”), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement

of 7.3 months.

gedatolisib doublet (gedatolisib and fulvestrant) also demonstrated a statistically significant and clinically meaningful improvement

in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48;

The median PFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant,

an incremental improvement of 5.4 months.

hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients

with HR+/HER2- advanced breast cancer.

7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant,

respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- advanced breast cancer receiving

at least their second line of therapy.

is the first inhibitor targeting the PI3K/AKT/mTOR pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/ PIK3CA

wild-type advanced breast cancer whose disease progressed on or after treatment with a CDK 4/6 inhibitor.

gedatolisib regimens showed lower rates of hyperglycemia and stomatitis and the rate of discontinuation

of all treatment due to a treatment-related adverse event (“AE”), was lower than

was reported in a Phase 1b study in this patient population.

data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later

At the same time, we announced

that we expect to submit an NDA for gedatolisib to the FDA in the fourth quarter of 2 025.

Stock Offering

July 30, 2025, we entered into an underwriting agreement (the “Equity Underwriting Agreement”) with Jefferies LLC, TD Securities

(USA) LLC, and Leerink Partners LLC as representatives (the “Representatives”) of the several underwriters named therein

(collectively, the “Underwriters”) agreeing, subject to customary conditions, to issue and sell in a public offering (i)

1,836,842 shares (the “Shares”) of our common stock, at a price to the public of $38.00 per Share and (b) in lieu of Shares

to certain investors, pre-funded warrants to purchase up to 400,000 shares of common stock (the “Pre-Funded Warrants”), at

a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the

$0.001 per share exercise price for each such Pre-Funded Warrant (the “Equity Offering”).

In addition, pursuant to the Equity

Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 shares of common stock (the “Option

Shares”), less underwriting discounts and commissions.

The Underwriters exercised their option to purchase the Option Shares in

full on July 30, 2025.

The Equity Offering was completed on July 31, 2025.

net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were approximately

$91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the Option Shares.

may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.

We intend to use the net proceeds from the Equity

Offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures,

clinical trial expenditures, commercial launch expenditures, expansion of business development activities and other general corporate

Please see “ Liquidity and Capital Resources ” below for additional information regarding the Equity Offering.

Notes Offering

July 30, 2025, we also entered into an underwriting agreement (the “Note Underwriting Agreement”) with the Underwriters,

subject to customary conditions, to issue and sell in a public offering $175,000,000 aggregate principal amount of the Company’s

2.750% Convertible Senior Notes due 2031 (the “Notes”) to the Underwriters (the “Note Offering”).

pursuant to the Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26,250,000 aggregate

principal amount of Notes solely to cover over-allotments.

On July 30, 2025, the Underwriters exercised such option to purchase an additional

$26,250,000 aggregate principal amount of Notes.

The issuance of $201,250,000 aggregate principal amount of Notes was completed on August

The Notes were issued pursuant to, and are governed by, an indenture (the “Base Indenture”), dated as of August

1, 2025, between us and U.S.

Bank Trust Company, National Association, as trustee (the “Trustee”), as supplemented by a first

supplemental indenture (the “Supplemental Indenture,” and the Base Indenture, as supplemented by the Supplemental Indenture,

the “Indenture”), dated as of August 1, 2025, between us and the Trustee.

The net proceeds from the Note Offering, after

deducting underwriting discounts and commissions and offering expenses, were approximately $194.9 million, including the proceeds from

the Underwriters’ exercise of their over-allotment option in full.

We intend to use the net proceeds from the Note Offering for

working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical

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

Please see “ Liquidity and Capital Resources ” below for additional information regarding the Note Offering.

of Operations

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As a result, we are not and have never been profitable and have incurred losses in each period since our inception

For the three months ended March 31, 2025 and 2024, we reported a net loss of approximately $37.0 million and $21.6 million,

respectively.

As of March 31, 2025, we had an accumulated deficit of approximately $308.9 million.

As of March 31, 2025, we had

cash and cash equivalents and short-term investments of approximately $205.7 million.

For the three months ended June 30, 2025 and 2024, we reported a net loss of approximately $45.3 million and $23.7 million,

respectively, and for the six months ended June 30, 2025, we reported a net loss of approximately $82.3 million and $45.3 million, respectively.

As of June 30, 2025, we had an accumulated deficit of approximately $354.1 million.

As of June 30, 2025, we had cash and cash

equivalents and short-term investments of approximately $168.4 million.

of Operating Results

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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 the second quarter of 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.

In August 2023, we initiated a Phase 1b/2 clinical trial, CELC-G-201.

we dosed our first patient and are currently enrolling patients in a second Phase 3 clinical trial, VIKTORIA-2.

We expect to submit an

NDA to the FDA in the fourth quarter of 2025 seeking approval for gedatolisib in combination with fulvestrant and with or without palbociclib

for the treatment of adults with endocrine therapy resistant HR+/HER2- advanced breast cancer following progression on or after treatment

with a CDK 4/6 inhibitor in combination with endocrine therapy.

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

generate revenue from sales of the drug for this and potentially additional breast cancer indications.

and Development

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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

laboratory supplies;

consulting fees paid to

third parties;

clinical trial costs;

validation costs for gedatolisib;

facilities expenses;

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.

10 unchanged sentences

and Marketing

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.

expense is primarily due to the A&R Loan Agreement (as defined below).

and costs related to marketing, supply chain, distribution, market access and other commercial operations related activities are being

incurred in anticipation of the commercialization of gedatolisib.

These expenses consist primarily of employee-related expenses, professional

and consulting fees related to these functions and operations, software costs, and the acquisition of data required to support our market

analysis for gedatolisib.

We expect sales and marketing expenses to increase as we get closer to a potential FDA approval date.

expense to date is primarily related to the A&R Loan Agreement.

Going forward, interest expense also will be related to the Notes.

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

of Operations

of the Three Months Ended March 31, 2025 and 2024

(in thousands)

Statements of Operations Data:

of the Three Months Ended June 30, 2025 and 2024 (in thousands)

of Operations Data:

and development

and administrative

operating expenses

from operations

(expense) income

(expense) income, net

loss before income taxes

of the Six Months Ended June 30, 2025 and 2024 (in thousands)

of Operations Data:

and development

and administrative

Total operating expenses

Loss from operations

Other (expense) income

Interest expense

Other (expense) income,

operating expenses

from operations

(expense) income

(expense) income, net

loss before income taxes

Income tax benefits

$ ( 3 6,997 )

and Development

research and development expenses for the three months ended March 31, 2025 were approximately $32.2 million, representing an

increase of approximately $11.6 million, or 56%, compared to the same period in 2024.

Of the $11.6 million increase in research and

development expense, $5.9 million was related to increased employee and consulting expenses.

The remaining $5.7 million was

primarily related to activities supporting our ongoing clinical trials.

research and development expenses for the three months ended June 30, 2025 were approximately $40.2 million, representing an increase

of approximately $17.7 million, or 79%, compared to the same period in 2024.

Of the $17.7 million increase in research and development

expense, $6.6 million was related to increased employee and consulting expenses, $6.1 million was related to increased research and development

costs primarily attributable to activities supporting our ongoing clinical trials, and

$5.0 million is related to an anticipated development milestone payment under the license agreement with Pfizer.

research and development expenses for the six months ended June 30, 2025 were approximately $72.4 million, representing an increase of

approximately $29.3 million, or 68%, compared to the same period in 2024.

Of the $29.3 million increase in research and development expenses,

$12.5 million was related to increased employee and consulting expenses, $11.8 million was related to increased research and development

costs primarily attributable to activities supporting our ongoing clinical trials , and $5.0

million is related to an anticipated development milestone payment under the license agreement with Pfizer.

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 conduct the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2

clinical trial and the VIKTORIA-2 Phase 3 clinical trial.

for the foreseeable future as we seek to continue to develop gedatolisib, including conducting the VIKTORIA-1 Phase 3 clinical trial,

the CELC-G-201 Phase 1b/2 clinical trial and the VIKTORIA-2 Phase 3 clinical trial.

and Administrative

general and administrative expenses for the three months ended March 31, 2025 were approximately $3.9 million, representing an increase

general and administrative expenses for the three months ended June 30, 2025 were approximately $3.8 million, representing an increase

of approximately $2.0 million, or 112%, compared to the same period in 2024.

3 unchanged sentences

resulted from professional fees, expanding infrastructure and other administrative expenses

general and administrative expenses for the six months ended June 30, 2025 were approximately $7.7 million, representing an increase

of approximately $4.1 million, or 112%, compared to the same period in 2024.

Employee related expenses accounted for $3.2 million of

the $4.1 million increase.

The remaining $0.9 million of the increase resulted from professional

fees, expanding infrastructure and other administrative expenses.

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

1 unchanged sentence

public company regulatory developments and requirements, and other compliance matters.

expense for the three months ended March 31, 2025 was $3.2 million and represents an increase of $1.8 million, or 127%, compared to the

expense for the three months ended June 30, 2025 was $3.2 million and represents an increase of $0.9 million, or 42%, compared to the

same period in 2024.

Interest expense is the result of the A&R Loan Agreement.

The increase is due primarily to the incremental

$61.7 million funding of Term Loan C in May 2024.

The $3.2 million of interest expense includes $0.8 million of non-cash interest expense.

income for the three months ended March 31, 2025 was $2.3 million which is flat compared to the same period in 2024.

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

The $3.2 million of interest expense includes $0.8

million of non-cash interest expense.

expense for the six months ended June 30, 2025 was $6.4 million and represents an increase of $2.7 million, or 74%, compared to the same

period in 2024.

Interest expense is the result of the A&R Loan Agreement.

The increase is due

primarily to the incremental $61.7 million funding of Term Loan C in May 2024.

The $6.4 million of interest expense includes $1.6 million

of non-cash interest expense.

income for the three months ended June 30, 2025 was $1.9 million and represents a decrease of $0.9 million compared to the same period

The decrease was primarily the result of lower market interest rates, as well as lower average cash, cash equivalent and investment balances in the current period.

income for the six months ended June 30, 2025 was $4.3 million and represents a decrease of $0.8 million compared to the same period

The decrease was primarily the result of lower market interest rates.

and Capital Resources

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

Through March 31, 2025, we have funded our

operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes, and

borrowings under loan agreements.

From inception through March 31, 2025, we raised an aggregate of approximately $374.6 million of net

proceeds through sales of our securities, and as of March 31, 2025 had $100.0 million of borrowings under loan agreements, not including

payable-in-kind interest.

As of March 31, 2025, our cash and cash equivalents and short-term investments were approximately $16.5 million

and $189.2 million, respectively, and we had an accumulated deficit of approximately $308.9 million.

As of June 30, 2025, our cash and cash equivalents

and short-term investments were approximately $46.4 million and $122.0 million, respectively, and we had an accumulated deficit of approximately

$354.1 million.

the date of this Quarterly Report, 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 the date of this Quarterly

Report, we raised an aggregate of approximately $478.7 million of net proceeds through sales of our equity securities,

approximately $194.9 million of net proceeds through the issuance of the Notes, and $100.0 million of borrowings under

loan agreements, not including payable-in-kind interest.

The terms of our more recent financings

are described below.

2025 Equity Offering

July 30, 2025, we entered into the Equity Underwriting Agreement with the Representatives of the Underwriters agreeing, subject to customary conditions, to issue and sell in a public offering (i)

1,836,842 shares at a price to the public of $38.00 per Share and (b) in lieu of Shares

to certain investors, Pre-Funded Warrants to purchase up to 400,000 shares of common stock, at

a price to the public of $37.999 per Pre-Funded Warrant, which represents the per share public offering price for the Shares less the

$0.001 per share exercise price for each such Pre-Funded Warrant.

In addition, pursuant to the Equity Underwriting

Agreement, we granted the Underwriters an option to purchase up to an additional 335,526 Option Shares,

less underwriting discounts and commissions.

The Underwriters exercised their option to purchase the Option Shares in full on July 30,

The Equity Offering was completed on July 31, 2025.

net proceeds from the Equity Offering, after deducting underwriting discounts and commissions and offering expenses, were

approximately $91.6 million, including the proceeds from the Underwriters’ exercise of their option in full to purchase the

Option Shares.

We may also receive nominal proceeds, if any, from the exercise of the Pre-Funded Warrants.

We intend to use the net

proceeds from the Equity Offering for working capital and general corporate purposes, which may include capital expenditures,

research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of business

development activities and other general corporate purposes.

Pre-Funded Warrant is exercisable for one share of common stock at an exercise price of $0.001 per share, or alternatively, at the election

of each holder, shares of common stock may be issued through a cashless exercise, with the net number of shares of common stock determined

according to the formula set forth in each Pre-Funded Warrant.

The Pre-Funded Warrants are exercisable at any time after the date of

issuance until all of the Pre-Funded Warrants

are exercised.

A holder (together with its “attribution parties,” as defined in the Pre-Funded Warrant) may not exercise

any portion of the Pre-Funded Warrants if immediately after exercise, the holder (together with its attribution parties), would beneficially

own in excess of 4.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise.

a holder may increase or decrease such percentage to any other percentage not in excess of 19.99%, which increase or decrease shall not

become effective until 61 days after notice from the holder to us.

2025 Convertible Notes Offering

July 30, 2025, we also entered into the Note Underwriting Agreement with the Underwriters, subject to customary conditions, to issue

and sell in a public offering $175,000,000 aggregate principal amount of the Notes to the Underwriters.

In addition, pursuant to the

Note Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26,250,000 aggregate principal

amount of Notes solely to cover over-allotments.

On July 30, 2025, the Underwriters exercised such option to purchase an additional

$26,250,000 aggregate principal amount of Notes.

The issuance of $201,250,000 aggregate principal amount of Notes was completed on

August 1, 2025.

The Notes were issued pursuant to, and are governed by the Indenture.

The net proceeds from the Note Offering, after deducting underwriting discounts and commissions and offering expenses, were

approximately $194.9 million, including the proceeds from the Underwriters’ exercise of their over-allotment option in full.

intend to use the net proceeds from the Note Offering for working capital and general corporate purposes, which may include capital

expenditures, research and development expenditures, clinical trial expenditures, commercial launch expenditures, expansion of

business development activities and other general corporate purposes.

Notes are our general, unsecured, senior obligations.

The Notes will accrue interest payable semiannually in arrears

on February 1 and August 1 of each year, beginning on February 1, 2026, at a rate equal to 2.750% per year.

In addition, special

interest will accrue on the Notes upon the occurrence of certain events relating to our failure to file certain reports with the SEC

as provided in the Indenture and as described below.

The Notes also have customary provisions relating to the occurrence of

“Events of Default” (as defined in the Indenture) with certain interest penalty provisions.

The Notes will mature on

August 1, 2031, unless earlier converted, redeemed or repurchased by us.

may convert their Notes at their option at any time prior to the close of business on the scheduled trading day immediately preceding

the maturity date based on an initial conversion rate of 19.4932 shares of common stock, per $1,000 principal amount of the Notes, which

is equivalent to an initial conversion price of approximately $51.30 per share of common stock.

The conversion rate is subject to customary

adjustments upon the occurrence of certain events as described in the Indenture.

In addition, if certain corporate events that constitute

a “Make-Whole Fundamental Change” (as defined in the Indenture) occur, then the conversion rate will, in certain circumstances,

be increased for a specified period of time.

Notes will be redeemable, in whole or in part (subject to certain limitations described below), at our option at any time, and from time

to time, on a redemption date on or after August 6, 2029 and on or before the 51st scheduled trading day immediately before the maturity

date, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any,

to, but excluding, the redemption date, but only if the last reported sale price per share of the common stock exceeds 130% of the conversion

price on (i) each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including,

the trading day immediately before the date we send the related redemption notice;

and (ii) the trading day immediately before the date

we send such notice.

However, we may not redeem less than all of the outstanding Notes unless at least $50.0 million aggregate principal

amount of Notes are outstanding and not called for redemption as of the time we send the related redemption notice.

In addition, calling

any Note for redemption will constitute a Make-Whole Fundamental Change with respect to that Note, in which case the conversion rate

applicable to the conversion of that Note will be increased in certain circumstances if it is converted after it is called for redemption.

a “Fundamental Change” (as defined in the Indenture) occurs, then, subject to certain conditions and except as set forth

in the Indenture, noteholders may require us to repurchase their Notes at a cash repurchase price equal to the principal amount of the

Notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the fundamental change repurchase date.

The definition

in the Indenture of a Fundamental Change includes certain business combination transactions involving the Company and certain de-listing

events with respect to the common stock.

Notes contain a beneficial ownership limitation, and as a result of such limitation, noteholders do not have the right to convert all

or any portion of the Notes held by such noteholder, to the extent that immediately prior to, or immediately after giving effect to such

conversion by such noteholder, together with its affiliates and any other persons acting as a group together with such noteholder or

any of such noteholder’s affiliates, would beneficially own in excess of 4.99% of the number of shares of our common stock outstanding

immediately prior to, and immediately after giving effect to, the conversion of all or any portion of the Notes;

provided, that such

4.99% beneficial ownership can be increased or decreased at the discretion of the noteholder;

provided further, that such limitation

in no event can exceed 19.99%.

Placement Warrants

March 2025, an investor exercised 695,650 warrants at an exercise price of $8.05, which generated approximately $5.6 million in cash.

The warrants were issued pursuant to a private placement that closed on December 9, 2022.

In July 2025, an

investor exercised 1,286,960 warrants at an exercise price of $8.05, which generated approximately $10.4 million in cash.

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

In August 2025, investors exercised

200,000 warrants at an exercise price of $8.05, which generated approximately $1.6 million in cash.

The warrants were issued pursuant

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

Market Sale Agreement

On February 4, 2022, we entered into an Open Market Sale Agreement with Jefferies LLC (“Jefferies”),

as agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate

offering price of up to $50.0 million, which amount was subsequently increased to $125.0 million on December 6, 2024.

On 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.

At March 31, 2025, $125.0 million

of common stock remains available for sale under the Open Market Sale Agreement with Jefferies.

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.

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.

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.

The A&R 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

February 4, 2022, we entered into an Open Market Sale Agreement with Jefferies LLC (“Jefferies”), as agent, pursuant to

which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate offering price of

up to $50.0 million, which amount was subsequently increased to $125.0 million on December 6, 2024.

On July 29, 2025, prior to the

pricing of the Equity Offering and the Note Offering, the aggregate offering price was

reduced from $125.0 million to $50.0 million.

On October 12, 2022, pursuant to this agreement, we sold 500,000 shares of common

stock in a single transaction at a price of $10.35 per share, generating gross proceeds of $5.2 million ($4.8 million net of

commissions and offering expenses).

On December 1, 2023, pursuant to this agreement, we sold 1,034,500 shares of common stock in a

single transaction at a price of $14.50 per share, generating gross proceeds of $15.0 million ($14.4 million net of commissions and

offering expenses).

In April 2024 and May 2024, pursuant to this agreement, we sold 285,714 and 149,700 shares of common stock,

respectively, at an average selling price of $17.55 per share, generating gross proceeds of $7.6 million before deducting

commissions and other offering expenses of $0.3 million.

At June 30, 2025, $125.0 million of common stock remains available for sale

under the Open Market Sale Agreement with Jefferies.

2024 Equity Offering

May 30, 2024, we entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus &

Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of 3,871,000 shares of common

stock, at a price to the public of $15.50, generating gross proceeds of approximately $60.0 million.

The offering closed on May 31, 2024

and resulted in net proceeds to the Company of approximately $56.3 million after deducting underwriting discounts and other offering

expenses payable by the Company.

Loan Agreement

May 30, 2024, we 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 us in the aggregate principal amount of up to $180 million.

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

between us and Innovatus, as collateral agent, and the Lenders named therein (the “Prior Loan Agreement”).

of the first $100 million under the A&R Loan Agreement occurred on May 30, 2024, including tranche payments of $16.8 million (the

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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 basis.

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.

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.

We became eligible to draw on a fourth tranche of $30 million (the “Term D Loan”) as of July 28, 2025 and will become eligible to draw on a fifth tranche of $50 million (the

“Term E Loan”), upon achievement of certain clinical trial milestones and satisfaction of certain financial

The Lenders may, in their sole discretion upon our request, make additional term

loans to us of $45 million (the “Term F Loan”).

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

and limits on when we can request funding for such tranches.

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

to the A&R Loan Agreement, we are entitled to make interest-only payments for thirty-six months, or up to forty-eight months if

certain conditions are met.

The Term Loans 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 31, 2027.

greater of (i) the Prime Rate (as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such

interest will be payable in-kind by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding

principal balance on a monthly basis through May 31, 2027.

The A&R Loan Agreement is secured by all 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

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.

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.

Proceeds will be used for working capital purposes and to fund our general business requirements, including the ongoing Phase 3

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

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 our common stock at a price per share of $10.00.

Innovatus will continue to have the right to exercise a previously disclosed warrant granted to it under the Prior Loan Agreement to

purchase 26,042 shares of common stock at a price per share of $14.40 through April 8, 2031.

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

2 unchanged sentences

non-utilization fee for both the Term D and Term E Loans.

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 $0.9 million, 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 $1.5 million 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.

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.

At May 30, 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.

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 Agreement.

Accordingly, on May 30, 2024, the Company issued 103,876 warrants with an exercise

price of $14.84 per share.

The relative fair value of the warrants was approximately $1.2 million.

For the 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

Because we achieved the Term D Milestone on July 28, 2025, if we (i) fail to

draw the full amount of the Term D Loan during the Term D Draw Period and (ii) fail to notify Collateral Agent, at any time before the

date that is four weeks after the our achievement of the Term D Milestone, of our intent not to draw the full amount of the Term D Loan,

a non-utilization fee of $0.9 million, 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

If we achieve the Term E Milestone and (i) fail to draw the full amount of the Term E Loan during the Term E Draw Period and (ii)

fail to notify Collateral Agent, at any time before the date that is four weeks after our achievement of the Term E Milestone, of our

intent not to draw the full amount of the Term E Loan, a non-utilization fee of $1.5 million with respect to the Term E Loan shall become

due and payable on the earliest of (i) the termination of the Term E Draw Period, (ii) the Maturity Date, (iii) the acceleration of any

Term Loan, and (iv) the prepayment in whole of the Term Loans.

After the 18-month anniversary of the Effective Date, we shall have the

option to prepay all, but not less than all, of the Term Loans advanced by the Lenders under the A&R Loan Agreement, provided we

(i) provide written notice to Collateral Agent of its election to prepay the Term Loans at least seven business days prior to such prepayment,

and (ii) pay to Lenders on the date of such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount

equal to the sum of (A) all outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date,

(B) the Final Fee, (C) the Prepayment Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation,

Lenders’ Expenses and interest at the Default Rate with respect to any past due amounts.

At May 30, 2024, we recognized the Final

Fee of $4.5 million as additional debt principal and a corresponding debt discount to be amortized over the life of the loan.

connection with the funding of each of the Term C Loan, the Term D Loan, the Term E Loan and the Term F Loan, we 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 applicable Term Loan funding.

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

of the applicable funding date.

The number of shares of common stock for which each Warrant is exercisable and the associated exercise

price are subject to certain proportional adjustments as set forth in such Warrant.

On May 13, 2025, we entered into the First Amendment (the “First

Amendment”) to the A&R Loan Agreement, pursuant to which we agreed to (i) pay Oxford an amendment fee of $40,000 on the effective

date of the First Amendment, (ii) extend to March 9, 2026 the expiration date of Innovatus’ right to convert up to 20% of the outstanding

principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00, (iii) extend the expiration

date of the Term D Draw Period to the earlier of (x) August 31, 2025 and (y) the occurrence of an Event of Default (as defined in

the A&R Loan Agreement), (iv) update the liquidity covenant to increase the Minimum Liquidity Percentage (as defined in the First

Amendment) to 50% if we fail to achieve the Term D Milestone prior to June 1, 2025 and to decrease the Minimum Liquidity Percentage back

to 30% if we subsequently achieve the Term D Milestone prior to the end of the Term D Draw Period, and (v) release Innovatus and the Lenders

from any and all claims arising out of or related to the A&R Loan Agreement, the First Amendment and related documentation.

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

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

trial, conduct other studies and clinical trials, and pursue other business development activities.

We would also expect to incur

sales and marketing expenses as we commercialize gedatolisib.

We expect to use cash on hand, together with the funds received or to

be received under the debt and equity financings described above, to fund our research and development expenses, clinical trial

preceding the execution of the A&R Loan Agreement or (ii) the closing price on the last trading day immediately preceding the execution

of the A&R Loan Agreement.

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

relative 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 date.

The number of shares of common stock for which each Warrant is exercisable and the associated exercise price are subject

to certain proportional adjustments as set forth in such Warrant.

May 13, 2025, we entered into the First Amendment (the “First Amendment”) to the A&R Loan Agreement, pursuant to which

we agreed to (i) pay Oxford an amendment fee of $40,000 on the effective date of the First Amendment, (ii) extend to March 9, 2026 the

expiration date of Innovatus’ right to convert up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s

common stock at a price per share of $10.00, (iii) extend the expiration date of the Term D Draw Period to the earlier of (x) August

31, 2025 and (y) the occurrence of an Event of Default (as defined in the A&R Loan Agreement), (iv) update the liquidity covenant

to increase the Minimum Liquidity Percentage (as defined in the First Amendment) to 50% if we fail to achieve the Term D Milestone prior

to June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if we subsequently achieve the Term D Milestone prior to

the end of the Term D Draw Period, and (v) release Innovatus and the Lenders from any and all claims arising out of or related to the

A&R Loan Agreement, the First Amendment and related documentation.

July 28, 2025, we entered into the Second Amendment to the A&R Loan Agreement, pursuant to which we agreed to (i) subject to certain

terms and conditions, permit the issuance of the Notes and certain transactions in connection therewith, including the conversion thereof

settled solely in common stock (together with cash in lieu of the issuance of any fractional share of common stock), (ii) permit the

capped call transactions in connection with the pricing of the Notes, (iii) require an amendment fee payable by us to Oxford in the amount

of $25,000, which was paid upon execution of the Second Amendment, and (iv) extend to May 9, 2026 the expiration date of Innovatus’

right to convert up to 20% of the outstanding principal of the Term A Loan into shares of our common stock at a price per share of $10.00.

connection with the release of the topline data from the WT cohort of the VIKTORIA-1 Phase 3 clinical trial, we achieved the Term D

Milestone (as defined in the A&R Loan Agreement) and therefore are eligible to draw down an additional $30.0 million of

indebtedness under the Term D Loan (as defined in the A&R Loan Agreement).

We intend to draw down such $30.0 million in late

August 2025 prior to the expiration of the Term D Draw Period (as defined in the A&R Loan Agreement) on August 31,

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

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

studies and clinical trials, and pursue other business development activities.

We would also expect to incur sales and marketing expenses

as we prepare for commercial launch and then commercialize gedatolisib.

We expect to use cash on hand, together with the funds received

or to be received under the debt and equity financings described above, to fund our research and development expenses, clinical trial

costs, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses.

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.

on our current business plan, we believe that our current cash, cash equivalents and short-term investments, including amounts received

upon the closing of the Equity Offering and Note Offering, together with available borrowings under the A&R Loan Agreement, will

provide sufficient cash to finance our operations through 2027.

expectations as to how long our current capital resources will be sufficient to fund our operations are based on assumptions that may

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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 at all.

following table sets forth the primary sources and uses of cash for the three months ended March 31:

capital to finance capital expenditures and operating expenses over the next several years as we seek to obtain approval for and launch

expand our infrastructure, commercial operations and research and development activities;

and to take advantage of financing

or other opportunities that we believe to be in the best interests of the Company and our stockholders.

Additional capital may be raised

through the sale of common or preferred equity or convertible debt securities, entry into debt facilities or other third-party funding

arrangements.

The sale of equity and convertible debt securities may result in dilution to our stockholders and those securities may

have rights senior to those of our common stock.

Agreements entered into in connection with such capital raising activities could contain

covenants that would restrict our operations or require us to relinquish certain rights.

Additional capital may not be available on reasonable

terms, or at all.

following table sets forth the primary sources and uses of cash for the six months ended June 30:

(in thousands)

Net cash (used in) provided by:

Operating activities

Investing activities

Net (decrease) increase

in cash and cash equivalents

cash used in operating activities was approximately $35.9 million for the three months ended March 31, 2025 and consisted primarily of

a net loss of approximately $37.0 million and working capital changes of $1.2 million, partially offset by non-cash expense items

of approximately $2.3 million.

Non-cash expense items of approximately $2.3 million primarily consisted of $2.4 million of stock-based

compensation expense, partially offset by net non-cash interest of $0.1 million.

The approximately $1.2 million of working capital changes

was primarily due to an increase in other current assets and amortization of debt issuance costs and discount, partially offset by increases

in accrued expenses and accounts payable.

cash used in operating activities was approximately $17.1 million for the three months ended March 31, 2024 and consisted primarily

of a net loss of approximately $21.6 million, partially offset by working capital changes of $2.8 million and non-cash

expense items of approximately $1.7 million.

cash (used in) provided by:

increase (decrease) in cash and cash equivalents

cash used in operating activities was approximately $72.1 million for the six months ended June 30, 2025 and consisted primarily of

a net loss of approximately $82.3 million, partially offset by non-cash expense items of approximately $7.2 million and

decreased working capital changes of $3.0 million.

Non-cash expense items of approximately $7.2 million primarily consisted of $5.1

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The approximately $3.0 million of working

capital changes was primarily due to increases in accrued expenses and accounts payable and a decrease in other current

cash provided by investing activities for the three months ended March 31, 2025 was approximately $24.3 million and consisted primarily

of net proceeds from short-term investments in government securities (U.S.

capital changes was primarily due to increases in accrued expenses and accounts payable, partially offset by increases in other

current assets,

cash used in operating activities was approximately $35.1 million for the six months ended June 30, 2024 and consisted primarily of a

net loss of approximately $45.3 million, offset by working capital changes of $6.9 million and non-cash expense items of approximately

$3.3 million.

Non-cash expense items of approximately $3.3 million primarily consisted of $2.7 million of stock-based compensation expense

and net non-cash interest of $0.5 million.

The approximately $6.9 million of working capital changes was primarily due to increases in

accrued expenses, accounts payable and other current assets.

cash provided by investing activities for the six months ended June 30, 2025 was approximately $90.1 million and consisted primarily

of net proceeds from the maturities of short-term investments in government securities (U.S.

Bills and U.S.

government agency).

cash used in investing activities for the six months ended June 30, 2024 was approximately $102.5 million and consisted primarily of

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

Treasury Bills and U.S.

government securities), partially offset by purchases of property and equipment.

Net cash provided by investing

activities for the three months ended March 31, 2024 was approximately $3.5 million and consisted primarily of net proceeds from maturities

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

Treasury Bills), partially offset by $0.1 million purchases of property and

cash provided by financing activities for the three months ended March 31, 2025 was approximately $5.6 million and primarily consisted

of net proceeds from the exercise of 695,650 common stock warrants at an exercise price of $8.05.

cash provided by financing activities for the three months ended March 31, 2024 was approximately $14.1 million and primarily consisted

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

registration costs.

government agency).

cash provided by financing activities for the six months ended June 30, 2025 was approximately $5.8 million and consisted of proceeds

of approximately $5.6 million from the exercise of common stock warrants and $0.3 million from the exercise of exercise of employee stock

options and employee stock purchases, offset slightly by debt and equity issuance costs of $0.1 million in the aggregate.

cash provided by financing activities for the six months ended June 30, 2024 was approximately $137.5 million and consisted of net

proceeds of approximately $56.3 million from an equity offering, $59.2 million from incremental debt financing, and $7.3 million

from an at-the market offering.

The remaining $14.7 million consisted of proceeds from the exercise of common stock warrants, the

exercise of employee stock options and employee stock purchases.

Accounting Pronouncements

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Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements.

forward-looking information is included in this Quarterly Report and in other materials filed or to be filed by us with the SEC (as

well as information included in oral statements or other written statements made or to be made by us).

Forward-looking statements

include all statements based on future expectations.

This Quarterly Report contains forward-looking statements that involve risks

and uncertainties including, but not limited to, (i) our clinical trial plans and the estimated timelines and costs for such trials;

(ii) our plans to develop and commercialize our products, and our expectations about the market opportunity for gedatolisib and our

ability to serve that market;

(iii) our expectations with respect to our competitive advantages, including the potential efficacy of

gedatolisib in various patient types alone or in combination with other treatments;

(iv) our expectations regarding the timeline of

patient enrollment and results from clinical trials, including our ongoing Phase 3 VIKTORIA-1 clinical trial, ongoing Phase 3

VIKTORIA-2 clinical trial, and ongoing Phase 1b/2 clinical trial for gedatolisib;

(v) our expectations regarding our ability to

obtain FDA approval to commercialize gedatolisib;

(vi) our expectations regarding governmental laws and regulations affecting our

operations, including, without limitation, developments in laws and regulations or their interpretation, including, among others,

changes in tax laws and regulations internationally and in the U.S.

Such forward-looking

information is included in this Quarterly Report and in other materials filed or to be filed by us with the SEC (as well as information

included in oral statements or other written statements made or to be made by us).

Forward-looking statements include all statements

based on future expectations.

This Quarterly Report contains forward-looking statements that involve risks and uncertainties including,

but not limited to, (i) our clinical trial plans and the estimated timelines and costs for such trials;

(ii) our plans to develop and

commercialize our products, and our expectations about the market opportunity for gedatolisib and our ability to serve that market;

our expectations with respect to our competitive advantages, including the potential efficacy of gedatolisib in various patient types

alone or in combination with other treatments, and our interpretation of the topline data from the PIK3CA WT cohort of the Phase

3 VIKTORIA-1 clinical trial;

(iv) our expectations regarding the timeline of patient enrollment and results from clinical trials, including

our ongoing Phase 3 VIKTORIA-1 clinical trial, ongoing Phase 3 VIKTORIA-2 clinical trial, and ongoing Phase 1b/2 clinical trial for gedatolisib;

(v) our expectations regarding the timing of submitting an NDA for, and our ability to obtain FDA approval to commercialize, gedatolisib;

(vi) our expectations regarding governmental laws and regulations affecting our operations, including, without limitation, developments

in laws and regulations or their interpretation, including, among others, changes in tax laws and regulations internationally and in

and laws that affect our operations and our laboratory;

our expectations with respect to the development, validation, required approvals, costs and timelines of our drug candidate

(viii) our beliefs related to the potential benefits resulting from Breakthrough Therapy designation for gedatolisib;

(ix) our plans with respect to research and development and related expenses for the foreseeable future;

(x) our beliefs about our

ability to capitalize on the exclusive global development and commercialization rights obtained from our license agreement with

Pfizer with respect to gedatolisib;

(xi) our expectations regarding the future payments that may be owed to Pfizer under the license

agreement with them;

(xii) our beliefs with respect to the potential rate and degree of market acceptance, both in the United States

and internationally, and clinical utility of gedatolisib;

(vii) our expectations with respect to the development, validation,

required approvals, costs and timelines of our drug candidate gedatolisib;

(viii) our beliefs related to the potential benefits resulting

from Breakthrough Therapy designation for gedatolisib;

(ix) our plans with respect to research and development and related expenses for

the foreseeable future;

(x) our beliefs about our ability to capitalize on the exclusive global development and commercialization rights

obtained from our license agreement with Pfizer with respect to gedatolisib;

(xi) our expectations regarding the future payments that

may be owed to Pfizer under the license agreement with them;

(xii) our beliefs with respect to the potential rate and degree of market

acceptance, both in the United States and internationally, and clinical utility of gedatolisib;

(xiii) our revenue expectations;

(xiv) our expectations regarding business

development activities, including collaborations with pharmaceutical companies;

(xv) our plans with respect to pricing in the United

States and internationally, and our ability to obtain reimbursement for our drug candidate, gedatolisib, including expectations as

to our ability or the amount of time it will take to achieve successful reimbursement from third-party payors, such as commercial

insurance companies and health maintenance organizations, and from government insurance programs, such as Medicare and Medicaid;

our expectations regarding business development activities, including collaborations with pharmaceutical companies;

(xv) our plans with

respect to pricing in the United States and internationally, and our ability to obtain reimbursement for our drug candidate, gedatolisib,

including expectations as to our ability or the amount of time it will take to achieve successful reimbursement from third-party payors,

such as commercial insurance companies and health maintenance organizations, and from government insurance programs, such as Medicare

and Medicaid;

(xvi) our expectations as to the use of proceeds from our financing activities;

(xvii) our expectations with respect to availability

of capital, including accessing our current debt facility or any other debt facility or other capital sources in the future, and our

assumption that we will have adequate authorized shares for future equity issuances;

(xviii) our beliefs regarding the adequacy of

our cash on hand to fund our clinical trials, capital expenditures, working capital, and other general corporate expenses, as well

(xvii) our expectations with respect to

availability of capital, including accessing our current debt facility or any other debt facility or other capital sources in the future,

and our assumption that we will have adequate authorized shares for future equity issuances;

(xviii) our beliefs regarding the adequacy

of our cash on hand to fund our clinical trials, capital expenditures, working capital, and other general corporate expenses, as well

as the increased costs associated with being a public company;

15 unchanged sentences

Certain risks, uncertainties and other factors include, but are not limited to, our limited operating history;

our potential inability to develop, validate and commercialize gedatolisib on a timely basis or at all;

our potential inability to develop, validate, obtain regulatory approval for and commercialize gedatolisib on a timely basis or at all;

the uncertainties and costs associated

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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-Q

Item 2. Management’s Discussion and Analysis