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Item 2. Management’s Discussion and Analysis

2025-05-15 compared with 2024-11-14 · 361 added, 415 removed, 223 unchanged (78% of the section changed)

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the forward-looking statements contained in the following discussion and analysis.

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

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.

In 2022, the Company began enrolling patients in VIKTORIA-1, a Phase 3 study evaluating gedatolisib and fulvestrant with and without

Ibrance® (palbociclib) as second line treatment for patients with HR+, HER2- advanced breast cancer.

In early 2024, the Company began

enrolling patients in CELC-G-201, a Phase 1b/2 study evaluating gedatolisib combined with Nubeqa® (darolutamide) in patients with

metastatic castration resistant prostate cancer (mCRPC).

In May 2024, the Company announced plans to initiate VIKTORIA-2, a Phase 3 trial

evaluating gedatolisib combined with fulvestrant plus a CDK 4/6 inhibitor as first-line treatment for patients with HR+, HER2- advanced

breast cancer.

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

The Company’s CELsignia companion diagnostic

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

approved targeted therapies.

is a potent, well-tolerated, reversible, ATP-competitive, pan-PI3K/mTOR inhibitor 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

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 kinase inhibitor of the phosphatidylinositol 3-kinase

(“PI3K”), serine/threonine-protein kinase protein kinase B (“AKT”), mechanistic target of rapamycin

(“mTOR”) pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2.

By targeting all

class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PI3K/AKT/mTOR (“PAM”) pathway.

Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational

therapies that target PI3K or mTOR alone or together.

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

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

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

We believe gedatolisib’s unique mechanism of action, differentiated chemical structure, favorable pharmacokinetic properties, and

intravenous route of administration offer distinct advantages over currently approved and investigational therapies that target PI3K,

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 mTORC1 and mTORC2 complexes.

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 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 can reduce the efficacy of isoform specific PI3K or single mTOR kinase complex

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

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.

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.

is administered intravenously on a four-week cycle of three weeks-on, one week-off, in contrast to the orally administered pan-PI3K or

dual PI3K/mTOR inhibitors that are no longer being clinically developed.

Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably been found

to induce significant side effects that were not well tolerated by patients.

This typically leads to a high proportion of patients requiring

dose reductions or treatment discontinuation.

The challenging toxicity profile of these drug candidates ultimately played a significant

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

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

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

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

Isoform-specific

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

While the range of toxicities associated with

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

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.

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.

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 September 30, 2024, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials.

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.

Of the 492 patients,

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agents in nine investigator sponsored clinical trials.

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 September 30, 2024, each of whom have received

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 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 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, D).

A total of 103 patients were

subsequently enrolled in one of four expansion arms (A, B, C, and D).

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.

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 D.

For all enrolled patients,

a clinical benefit rate (CBR) of ≥ 79% was observed.

Median progression free survival 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).

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%.

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.

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

The majority of treatment

emergent AEs were Grade 1 and 2.

The most frequently observed AEs 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.

No grade 5 AEs were reported in this study.

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:

related AEs were Grades 1 and 2.

The most frequently observed AEs included stomatitis/mucosal inflammation, the majority of which were

Grades 1 and 2.

The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed as related to treatment

with palbociclib.

No Grade 5 events were reported in this study.

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 clinical trial will enable separate evaluation of subjects according to their PIK3CA status.

and 2) gedatolisib in

combination with fulvestrant.

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.

VIKTORA-1 Phase 3 clinical trial enables 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).

Enrollment of the PIK3CA WT cohort is 100% enrolled and

enrollment in the PIK3CA MT cohort is on plan.

The PIK3CA WT cohort represents approximately 60% of the total patients enrolled to

date in VIKTORIA-1.

Based on our current forecast of reaching the event thresholds that will trigger primary analysis in both the

PIKCA WT and MT cohorts, we expect to report topline data for the PIK3CA WT cohort sometime in late Q1 2025 or during Q2 2025

and to report topline data for the PIK3CA MT cohort in the second half of 2025.

If the results from the PIK3CA wild-type patient cohort are positive, we would expect to file a new drug application, or NDA, with this

data and follow-up with a supplemental NDA for the PIK3CA mutant cohort if those results are positive.

If gedatolisib ultimately does

receive FDA approval for both the PIK3CA wild-type and mutant populations, we estimate the peak revenue potential for this second-line

indication could exceed $2 billion.

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).

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.

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 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.

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

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

An additional 12 participants will then be enrolled in the Phase

2 portion of the study at the recommended phase 2 dose (RP2D) level to enable evaluation of 30 participants treated with the RP2D of

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

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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.

We expect to report preliminary data in Q2 of 2025.

Phase 3 VIKTORIA-2 clinical trial, an open-label, randomized study to evaluate the efficacy and safety of gedatolisib combined with

fulvestrant plus a CDK4/6 inhibitor in comparison to fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with

HR+/HER2- advanced breast cancer who are endocrine therapy resistant is on track to enroll its first Patient in Q2 2025.

CDK4/6 inhibitor, investigators may choose either ribociclib or palbociclib.

The safety profile of gedatolisib combined with

fulvestrant and palbociclib is well described, but the investigational combination of gedatolisib with ribociclib has not yet been

clinically tested.

Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib

combined with ribociclib and fulvestrant.

The safety run-in will be completed, and gedatolisib’s Phase 3 dose confirmed,

before enrolling patients in the Phase 3 portion of the study.

the Phase 3 study, approximately 638 subjects who meet the eligibility criteria will be assigned to a cohort based on their PIK3CA mutation

After the investigator selects the CDK4/6 inhibitor for a subject, the subject will then be randomly assigned on a 1:1 basis

to either Arm A (gedatolisib, fulvestrant, and Investigator’s choice of ribociclib or palbociclib) or Arm B (fulvestrant and Investigator’s

choice of ribociclib or palbociclib).

clinical trial primary endpoints are progression free survival (PFS), per RECIST 1.1 criteria, as assessed by blinded independent central

The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA WT and PI3KCA MT.

study’s design was reviewed and discussed with the U.S.

Food and Drug Administration (FDA) during a Type C meeting.

trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia.

Site qualification activities to support activation for the 200 sites is on track.

Enrollment in our VIKTORIA-1 study remains robust and on-track.

The PIK3CA WT cohort is 100% enrolled, and enrollment

in the PIK3CA MT cohort is on plan.

Based on our current forecast of reaching the event thresholds that will trigger primary analysis

in both the PIK3CA WT and MT cohorts, we expect to report topline data for the PIK3CA WT cohort sometime in late Q1 2025 or during Q2

2025 and to report topline data for the PIK3CA MT cohort in the second half of 2025.

The Phase 1b/2 clinical trial, evaluating gedatolisib in combination with darolutamide for the treatment of patients

with metastatic castration resistant prostate cancer (mCRPC), is ongoing and expected to report preliminary data in Q2 2025

The VIKTORIA-2 Phase 3 clinical trial remains on track to enroll its first patient in Q2 2025.

Site qualification

activities to support activation of up to 200 sites across North America, Europe, Latin America, and Asia are on track.

survival data from the B2151009 Phase 1b clinical trial will be presented at the San Antonio Breast Cancer Symposium (SABCS), taking

place December 10-13, 2024.

nonclinical data further characterizing the mechanism of action of gedatolisib and its effect on breast cancer cell metabolic functions

will also be presented at the SABCS.

October, Cancers published results of nonclinical studies in gynecological cancer cell line models highlighting the differences between

single-node inhibitors of the PI3K/AKT/mTOR pathway and gedatolisib.

The published manuscript is available online and on the publications

section of Celcuity’s website .

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.

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 September 30, 2024 and 2023, we reported a net loss of approximately $29.8 million and $18.4 million,

respectively, and for the nine months ended September 30, 2024, we reported a net loss of approximately $75.1 million and $44.9 million,

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 September 30, 2024, we had an accumulated deficit of approximately $235.2 million.

As of September 30, 2024,

we had cash and cash equivalents and short-term investments of approximately $264.1 million.

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.

of Operating Results

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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 as a second line treatment for HR+, HER2- advanced breast cancer.

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.

In May 2024, we announced plans to initiate a Phase 3 clinical

trial, VIKTORIA-2, to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for patients with HR+, HER2-,

advanced breast cancer who are endocrine therapy resistant.

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

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

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.

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.

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;

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;

costs associated with patent applications.

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 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 expenses.

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.

and Administrative

4 unchanged sentences

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 the development of our first drug, gedatolisib,

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

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

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

expense is primarily due to a Loan Agreement.

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).

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

of Operations

of the Three Months Ended September 30, 2024 and 2023

Three Months Ended

September 30,

Increase (Decrease)

Percent Change

of the Three Months Ended March 31, 2025 and 2024

(in thousands)

Statements of Operations Data:

Operating expenses:

Research and development

General and administrative

and administrative

Total operating expenses

Loss from operations

(30,059,899 )

(18,898,037 )

(11,161,862 )

Other (expense) income

Interest expense

Interest income

Other income, net

Net loss before income taxes

(29,791,789 )

(18,404,540 )

(11,387,249 )

Income tax benefits

$ (29,791,789 )

$ (18,404,540 )

$ (11,387,249 )

of the Nine Months Ended September 30, 2024 and 2023

Nine Months Ended

September 30,

Increase (Decrease)

Percent Change

Statements of Operations Data:

Operating expenses:

Research and development

General and administrative

Total operating expenses

Loss from operations

(76,836,820 )

(46,501,059 )

(30,335,761 )

Other (expense) income,

Interest expense

Interest income

Other income, net

Net loss before income taxes

(75,126,064 )

(44,930,644 )

(30,195,420 )

loss before income taxes

Income tax benefits

$ ( 3 6,997 )

$ (44,930,644 )

$ (30,195,420 )

and Development

research and development expenses for the three months ended September 30, 2024 were approximately $27.6 million, representing an

increase of approximately $10.1 million, or 58%, compared to the same period in 2023.

Of the $10.1 million increase in research and

development expense, $6.3 million was primarily related to costs supporting on-going activities for the VIKTORIA-1 and CELC-G-201

trials and the initiation of the VIKTORIA-2 Phase 3 pivotal trial.

The remaining $3.8 million was related to increased employee and

consulting expenses.

research and development expenses for the nine months ended September 30, 2024 were approximately $70.7 million, representing an

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 expenses, $20.8 was primarily related to costs supporting on-going activities for the VIKTORIA-1 and CELC-G-201 trials

and activities supporting the initiation of the VIKTORIA-2 Phase 3 pivotal trial.

The remaining $7.4 million was related to

increased employee and consulting expenses.

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.

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, the CELC-G-201 Phase 1b/2 and the VIKTORIA-2

Phase 3 pivotal trial.

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.

and Administrative

general and administrative expenses for the three months ended September 30, 2024 were approximately $2.5 million, representing an increase

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

of approximately $2.1 million, or 112%, compared to the same period in 2024.

2 unchanged sentences

The remaining $0.5 million of the $2.1 million increase

resulted from professional fees and other administrative expenses.

general and administrative expenses for the nine months ended September 30, 2024 were approximately $6.1 million, representing an increase

of approximately $2.1 million, or 53%, compared to the same period in 2023.

Employee related expenses accounted for $1.5 million of the

$2.1 million increase.

The remaining $0.6 million of the increase resulted from professional fees and other administrative expenses.

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

with the potential future commercialization of gedatolisib, an expanding infrastructure, and increased professional fees associated with

public company regulatory developments and other compliance matters.

expense for the three months ended September 30, 2024 was $3.3 million and represents an increase of $2.0 million, or 144%, compared

to the same period in 2023.

Interest expense is the result of a Loan Agreement that was executed in April 2021, amended in August 2022

and March 2024, and further amended and restated in May 2024.

The increase is due primarily to the incremental $61.7 million funding

of Term Loan C in May 2024.

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

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.

expense for the nine months ended September 30, 2024 was $7.0 million and represents an increase of $3.1 million, or 78%, compared to

the same period in 2023.

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

million of interest expense includes $1.9 million of non-cash interest expense.

income for the three months ended September 30, 2024 was $3.6 million and represents an increase of $1.7 million compared to the same

period in 2023.

The increase was primarily from the closing of additional equity and debt financing activities in May 2024, leading to

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

income for the nine months ended September 30, 2024 was $8.7 million and represents an increase of $3.2 million compared to the same

period in 2023.

The increase was primarily from the closing of additional equity and debt financing activities in May 2024, leading to

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

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

and Capital Resources

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

Through September 30, 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 September 30, 2024, we raised an aggregate of approximately $368.7 million

of net proceeds through sales of our securities, and as of September 30, 2024 had $100.0 million of borrowings under loan agreements,

not including payable-in-kind interest.

As of September 30, 2024, our cash and cash equivalents and short-term investments were approximately

$12.6 million and $251.5 million, respectively, and we had an accumulated deficit of approximately $235.2 million.

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.

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.

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.

Market Sale Agreement.

On February 4, 2022, we entered into an Open Market Sale Agreement 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.

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 the Open Market Sale Agreement with Jefferies LLC, as agent, 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 September 30, 2024, $22.2 million of common stock remains available for sale under the

Jefferies 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

12 unchanged sentences

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.

dated April 8, 2021, as amended, between the Company 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

9 unchanged sentences

Costs associated with the new borrowings

was approximately $2.4 million.

Company is 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.

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.

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.

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

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 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.

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

5 unchanged sentences

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.

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

1 unchanged sentence

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

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.

25 unchanged sentences

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

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.

1 unchanged sentence

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.

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 operations and pay obligations when due through 2026.

under the Innovatus Loan Agreement will provide sufficient cash to finance our clinical development program activities through 2026.

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

11 unchanged sentences

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 nine months ended September 30:

September 30,

Net cash provided by (used in):

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:

(in thousands)

Net cash (used in) provided by:

Operating activities

$ (55,696,760 )

$ (35,276,332 )

Investing activities

(100,627,800 )

Financing activities

Net increase (decrease) in cash and cash equivalents

$ (18,059,485 )

cash used in operating activities was approximately $55.7 million for the nine months ended September 30, 2024 and consisted primarily

of a net loss of approximately $75.1 million, partially offset by working capital changes of $13.9 million and non-cash expense

items of approximately $5.5 million.

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 and net non-cash interest of $0.8 million.

The approximately $13.9 million of working capital changes was primarily

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

cash used in operating activities was approximately $35.3 million for the nine months ended September

30, 2023 and consisted primarily of a net loss of approximately $44.9 million partially

offset by non-cash expense items of approximately $4.8 million and working capital changes of $4.8 million.

Non-cash expense items of

approximately $4.8 million primarily consisted of $3.7 million of stock-based compensation expense, net non-cash interest of $1.0 million

and depreciation expense of $0.1 million.

The approximately $4.8 million of working capital changes was primarily due to increases in

accounts payable and accrued expenses of $3.0 million and $2.8 million, respectively, offset by an approximately $1.0 million increase

in other current assets.

cash used in investing activities for the nine months ended September 30, 2024 was approximately $100.6 million and consisted primarily

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

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.

Non-cash expense items of approximately $1.7 million primarily consisted of $1.3

million of stock-based compensation expense and net non-cash interest of $0.4 million.

The approximately $2.8 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.

Treasury Bills and U.S.

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

cash provided by investing activities for the nine months ended September

30, 2023 was approximately $36.2 million and consisted primarily of net proceeds from maturities

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 and U.S.

government securities) partially offset by minimal purchase

of property and equipment.

cash provided by financing activities for the nine months ended September 30, 2024 was approximately $138.2 million and primarily consisted

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

from an at-the market offering.

The remaining $15.4 million consisted of proceeds from the exercise of common stock warrants, the exercise

of employee stock options and employee stock purchases.

cash provided by financing activities for the nine months ended September

30, 2023 was approximately $0.3 million and primarily consisted of proceeds from the exercise of

employee stock options and proceeds from employee stock purchases, partially offset by payments for secondary registration and debt issuance

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.

Accounting Pronouncements

21 unchanged sentences

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

Such forward-looking

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

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

Forward-looking statements include all statements

based on future expectations.

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

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

(ii) 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;

our expectations regarding the timeline of patient enrollment and results from clinical trials, including our existing Phase 3 VIKTORIA-1

clinical trial and Phase 1b/2 study and clinical trial for gedatolisib, as well as our planned Phase 3 VIKTORIA-2 clinical trial for

(iv) our expectations regarding our ability to obtain FDA approval to commercialize gedatolisib;

(v) our expectations with

respect to the development, validation, required approvals, costs and timelines of gedatolisib and our CELsignia tests;

(vi) our plans

with respect to research and development and related expenses for the foreseeable future;

(vii) 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;

(viii) the future payments that may be owed to Pfizer under the license agreement;

(ix) our beliefs related to the perceived advantages

of our CELsignia tests compared to traditional molecular or other diagnostic tests;

(x) our revenue expectations;

(xi) our expectations

regarding business development activities, including collaborations with pharmaceutical companies;

(xii) our expectations as to the use

of proceeds from our recent financing activities;

(xiii) 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;

(xiv) our beliefs regarding the ability of our cash on hand to fund our research and development

expenses, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses, as well as the increased

costs associated with being a public company;

and (xv) our plans with respect to potentially raising capital.

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.

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;

(xiii) our revenue expectations;

(xiv) our expectations regarding business

development activities, including collaborations with pharmaceutical companies;

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

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

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

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

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

(xvii) our expectations with respect to availability

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

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

(xviii) our beliefs regarding the adequacy of

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

as the increased costs associated with being a public company;

(xix) our plans with respect to potentially raising capital;

our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, including

our gedatolisib drug candidate and our CELsignia platform and tests.

some cases, you can identify forward-looking statements by the following words:

17 unchanged sentences

we may face in developing and maintaining relationships with pharmaceutical company partners;

the complexity and timeline for development

of CELsignia tests;

the uncertainty and costs associated with clinical trials;

the uncertainty regarding market acceptance by physicians,

patients, third-party payors and others in the medical community, and with the size of market opportunities available to us;

of molecular and other diagnostic products and services that compete with us;

uncertainty with insurance coverage and reimbursement for

our CELsignia tests;

difficulties we may face in managing growth, such as hiring and retaining

a qualified sales force and attracting and retaining key personnel;

the uncertainty and costs associated with

clinical trials;

the uncertainty regarding market acceptance by physicians, patients, third-party payors and others in the medical community,

and with the size of market opportunities available to us;

difficulties we may face in managing

growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel;

changes in government regulations;

tightening credit markets and

limitations on access to capital;

stock market volatility or other factors that may affect our ability to access capital on favorable

terms or at all;

and obtaining and maintaining intellectual property protection for our technology and time and expense associated with

defending third-party claims of intellectual property infringement, investigations or litigation threatened or initiated against us.

These and additional risks, uncertainties and other factors are described more fully in our Annual Report on Form 10-K for the

year ended December 31, 2023 and elsewhere in this Quarterly Report.

Copies of filings made with the SEC are available through the SEC’s

electronic data gathering analysis and retrieval system (EDGAR) at www.sec.gov.

tightening credit markets and limitations on access to capital;

stock market volatility or other factors that may affect our ability

to access capital on favorable terms or at all;

and obtaining and maintaining intellectual property protection for our technology and

time and expense associated with defending third-party claims of intellectual property infringement, investigations or litigation threatened

or initiated against us.

These and additional risks, uncertainties and other factors are described more fully in our Annual Report

on Form 10-K for the year ended December 31, 2024 and elsewhere in this Quarterly Report.

Copies of filings made with the SEC are available

through the SEC’s electronic data gathering, analysis, and retrieval system (EDGAR) at www.sec.gov.

should read the cautionary statements made in this Quarterly Report as being applicable to all related forward-looking statements wherever

9 unchanged sentences

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