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Item 2. Management’s Discussion and Analysis

2025-11-13 compared with 2025-08-14 · 643 added, 517 removed, 302 unchanged (79% of the section changed)

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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, 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.

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 PI3Kα, AKT, or mTORC1 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 detailed results for cohort 1, patients with PIK3CA wild-type (“WT”)

tumors, and has completed enrollment of 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.

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

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intravenous route of administration offer distinct advantages over currently approved and investigational therapies that target PI3Kα,

AKT, or mTOR alone or together.

AKT, or mTORC1 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.

Gedatolisib 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 PI3Kα 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 PI3Kα, 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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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

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.

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

Of the 492 patients,

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

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 September 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.

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

High objective overall response rates (“ORR”) were observed in all

four expansion arms and were comparable in each arm for PIK3CA WT and PIK3CA MT patients.

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%.

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 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

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,

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 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 cancer.

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.

a presentation of results from the PIK3CA WT cohort of the VIKTORIA-1 study at the European Society for Medical Oncology

(“ESMO”) Congress, additional data from a Phase 1b clinical trial that evaluated gedatolisib in patients with HR+/HER2- ABC

was included.

The analyses reported efficacy data from patients who were treated with the same drug regimen evaluated in the VIKTORIA-1

study, gedatolisib combined with fulvestrant and palbociclib.

(Layman R., Lancet Oncol.

This included patients from

Escalation Arm B and Expansion Arms B, C and D of the Phase 1b study.

in Escalation Arm B and Expansion Arms B and C received a 180 mg dose of gedatolisib once weekly (“weekly dose”).

in Expansion Arm D received a 180 mg dose of gedatolisib on days 1, 8, and 15 of a four-week cycle (“intermittent dose”),

which was the same dose regimen patients in the VIKTORIA-1 study received.

The proportion of patients who received the intermittent dose

of gedatolisib was 37% for those with PIK3CA MT tumors and 25% for those with PIK3CA WT tumors.

proportion of patients who received prior treatment with a CDK4/6 inhibitor was 73% for those with PIK3CA WT tumors,

and 71% for those with PIK3CA MT tumors.

PFS and the ORR were assessed in sub-groups of patients according to their PIK3CA status (Table 1).

For all analyzed

patients with PIK3CA MT tumors (n=30), median PFS was 14.6 months and the ORR in response evaluable patients was 48%.

Median PFS was 19.7 months and the ORR was 64% in patients with PIK3CA MT tumors who received the intermittent dose

of gedatolisib used in the VIKTORIA-1 study.

For patients with PIK3CA WT tumors (n=60), median PFS was 9.0 months and

the ORR in response evaluable patients was 41%.

Median PFS was 9.1 months and the ORR was 53% in patients with PIK3CA WT

tumors who received the intermittent dose of gedatolisib used in the VIKTORIA-1 study.

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

Median PFS (months)

Phase 3 Trial

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 CDK 4/6 therapy in

have completed enrollment of our Phase 3, open-label, randomized clinical trial, VIKTORIA-1, to evaluate the efficacy and safety of gedatolisib

treatment regimens in adults with HR+/HER2- advanced breast cancer whose disease has progressed after prior CDK 4/6 therapy in

combination with an aromatase inhibitor.

1) gedatolisib in combination with palbociclib and fulvestrant;

and 2) gedatolisib in

combination with fulvestrant.

Over two hundred clinical sites in North America, Europe, Latin America, and Asia-Pacific are

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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 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.

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

VIKTORA-1 Phase 3 clinical trial involves two study cohorts that enable separate evaluation of subjects according to their PIK3CA

Subjects who met eligibility criteria and had PIK3CA WT tumors (cohort 1) 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).

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.

Subjects who met eligibility

criteria and had PIK3CA MT tumors (cohort 2) were 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 approximately 350 subjects

who have PIK3CA MT tumors is complete.

We expect topline data for this group to be available in late Q1 2026 or during Q2

July 28, 2025, we announced topline data from the PIK3CA WT cohort of the VIKTORIA-1 clinical trial and on October 18, 2025,

at the ESMO Congress, additional efficacy and safety results from this cohort was presented.

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.

The ORR of the gedatolisib triplet was 31.5%

compared to 1% with fulvestrant and the median duration of response (“DOR”) was 17.5 months.

The ORR of the gedatolisib doublet

was 28.3% and the median DOR was 12.0 months.

The median DOR was not determinable for fulvestrant because there was only one objective

The gedatolisib triplet and doublet were generally

well tolerated in the trial with mostly low-grade treatment-related adverse events (“TRAEs”).

The most common Grade 3 TRAEs

for the gedatolisib triplet, gedatolisib doublet, and fulvestrant groups included neutropenia (52.3%, 0%, and 0.8% of patients, respectively);

stomatitis (19.2%, 12.3%, and 0% of patients, respectively) rash (4.6%, 5.4%, and 0% of patients, respectively);

and hyperglycemia (2.3%,

2.3%, and 0% of patients, respectively).

The primary Grade 4 TRAEs for the gedatolisib triplet and gedatolisib doublet groups were neutropenia

(10.0% and 0.8%, respectively), leukopenia (0.8% in the gedatolisib triplet group) and pneumonitis (0.8% in gedatolisib doublet group).

TRAEs led to the discontinuation of study treatment in 2.3% of patients in the gedatolisib triplet group, 3.1% in the gedatolisib doublet

group, and 0% in the fulvestrant group.

detailed results from cohort 1, PIK3CA WT cohort, established several new milestones in the history of drug development for

HR+/HER2- advanced breast cancer:

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 PAM pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/ PIK3CA WT

advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor.

median DOR and incremental ORR improvement relative to control for the gedatolisib triplet and doublet are the highest reported for

an endocrine therapy-based regimen in 2L HR+/HER2- advanced breast cancer.

median PFS benefit of the gedatolisib triplet and doublet compared to fulvestrant was consistent across subgroups with the gedatolisib

triplet showing higher clinical benefit in nearly all subgroups compared to the gedatolisib doublet, particularly for patients who were

pre/perimenopausal, endocrine therapy resistant, or had visceral metastases.

For patients enrolled in the United States and Canada, median

PFS was 19.3 months (HR=0.13;

0.07-0.29) for the gedatolisib triplet and 14.9 months (HR=0.35;

0.17-0.76) for the gedatolisib

these results, the gedatolisib regimens represent a new potential standard of care for patients with HR+/HER2-, PIK3CA WT

advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor.

results from cohort 1 of the VIKTORIA-1 Phase 3 clinical trial will be presented at a medical conference later this year.

Phase 1b/2 Trial

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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

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.

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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

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 stomatitis.

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

on these data, we 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.

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.

On October 18, 2025, at the

ESMO Congress, we presented updated clinical results for the CELC-G-201 Phase 1b trial based on an August 15, 2025 data cut-off.

the 38 patients enrolled, 61% had received one line of prior systemic th erapy

and 39% had received at least 2 or more lines of prior therapy.

Median duration of follow-up was 9.0 months.

six-month radiographic progression free survival (“rPFS”) rate and median rPFS for patients from both arms combined was 67 %

and 9.1 months, respectively.

For patients treated with 120 mg gedatolisib, the six-month rPFS rate was 74% and median rPFS was 9.5 months.

For patients treated with 180 mg gedatolisib, the six-month rPFS rate was 61% and the median rPFS was 7.4 months.

combination of gedatolisib and darolutamide was generally well tolerated in the trial with mostly low-grade TRAEs.

No dose limiting toxicities

were observed in either arm.

The only Grade 3 TRAEs for patients from both arms combined included rash (5.3%), stomatitis (2.6%), and

pruritus (2.6%);

no Grade 3 hyperglycemia was reported.

Additionally, no Grade 4 or 5 TRAEs were observed, and no patients discontinued

study treatment due to a TRAE.

Phase 3 Trial

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Investigator-Sponsored

Phase 2 Trial

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

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(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.

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.

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 (ii) 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

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, 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.

For a summary of the Equity Offering, see “Liquidity

and Capital Resources” below.

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 $175.0 million aggregate principal amount of Notes to the Underwriters.

In addition, pursuant to the Note

Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26.3 million 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.

$26.3 million aggregate principal amount of Notes.

The issuance of $201.3 million 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.

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.

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 are using 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.

For a summary of the Note Offering, see “Liquidity and Capital Resources” below.

On August 27, 2025, the FDA granted our

request to submit the gedatolisib NDA via the FDA’s Real-Time Oncology Review (“RTOR”) program, and we made our first

NDA pre-submission in September 2025.

We expect to complete our final NDA submission to the FDA in the fourth quarter of 2025.

On September 9, 2025, we entered

into the Third Amendment to the Amended and Restated Loan and Security Agreement with Oxford Finance LLC, a Delaware limited liability

company, as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership, as a lender, and

the other lenders party thereto.

For a summary of the Third Amendment to the A&R Loan Agreement, see “Liquidity and Capital

Resources” below.

October 18, 2025, at the ESMO Congress, we presented (i) detailed efficacy and safety results from the PIK3CA WT cohort of the Phase

3 VIKTORIA-1 clinical trial of gedatolisib;

(ii) additional data from our Phase 1b clinical trial that evaluated gedatolisib in patients

with HR+/HER2- advanced breast cancer;

and (iii) additional data from the CELC-G-201 Phase 1b clinical trial evaluating gedatolisib in

combination with Nubeqa® (darolutamide), an androgen receptor inhibitor, in men with mCRPC whose disease had progressed on prior

treatment with a next generation androgen receptor inhibitor.

For a summary of the data presented, see “Overview” above.

We also announced that the PIK3CA MT cohort of the VIKTORIA-1 Phase 3 trial was fully enrolled.

of Operations

2 unchanged sentences

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 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.

For the three months ended September 30, 2025 and 2024, we reported a net loss of approximately $43.8 million and $29.8 million,

respectively, and for the nine months ended September 30, 2025 and 2024, we reported a net loss of approximately $126.1 million and $75.1

million, respectively.

As of September 30, 2025, we had an accumulated deficit of approximately $397.9 million.

As of September

30, 2025, we had cash and cash equivalents and short-term investments of approximately $455.0 million.

of Operating Results

date, we have not generated any revenue.

With the execution of the Pfizer license agreement in April 2021, whereby we acquired exclusive

world-wide licensing rights to develop and commercialize gedatolisib, we initiated a Phase 3 clinical trial, VIKTORIA-1, in 2022 to support

potential regulatory approval to market gedatolisib.

In August 2023, we 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.

With the execution of the Pfizer license agreement in April 2021, whereby we acquired

exclusive world-wide licensing rights to develop and commercialize gedatolisib, we initiated a Phase 3 clinical trial, VIKTORIA-1,

in 2022 to support potential regulatory approval to market gedatolisib.

In August 2023, we initiated a Phase 1b/2 clinical trial,

In July 2025 we dosed our first patient and are currently enrolling patients in a second Phase 3 clinical trial,

Pursuant to the FDA’s RTOR program, in September 2025 we made the first pre-submission of our NDA to the FDA;

we expect to complete the final NDA submission to the FDA in the fourth quarter of 2025.

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

7 unchanged sentences

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, 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

2 unchanged sentences

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

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

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

administrative personnel.

and Marketing

6 unchanged sentences

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

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

During the three months ended September 30, 2025, interest expense

included the Convertible Notes.

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

of Operations

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

of Operations Data:

and development

and administrative

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

Three Months Ended

September 30,

Statements of Operations Data:

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

Research and development

General and administrative

Total operating expenses

Loss from operations

Other (expense) income

Interest expense

Interest income

Other (expense) income, net

Net loss before income taxes

Income tax benefits

of the Nine Months Ended September 30, 2025 and 2024 (in thousands)

Nine Months Ended

September 30,

Statements of Operations Data:

Operating expenses:

from operations

(expense) income

(expense) income, net

loss before income taxes

Research and development

General and administrative

Total operating expenses

Loss from operations

Other (expense) income

Interest expense

Interest income

Other (expense) income, net

Net loss before income taxes

Income tax benefits

and Development

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 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.

Our research and development expenses for the three months ended September 30,

2025 were approximately $34.9 million, representing an increase of approximately $7.3 million, or 27%, compared to the same period in

Of the $7.3 million increase in research and development expense, $5.6 million was related to increased employee and consulting

expenses, $3.2 million of which related to commercial headcount additions and other launch activities.

The remaining $1.7 million increase

was primarily related to activities supporting our ongoing clinical trials.

Our research and development expenses for the nine months ended September 30, 2025

were approximately $107.4 million, representing an increase of approximately $36.6 million, or 52%, compared to the same period in 2024.

Of the $36.6 million increase in research and development expenses, $18.1 million was related to increased employee and consulting expenses,

$7.6 million of which related to commercial headcount additions and other launch activities.

$13.1 million was attributable to activities

supporting our ongoing clinical trials, $5.0 million was related to an anticipated development milestone payment under the license agreement

with Pfizer, and $0.4 million was related to other costs.

research and development is central to our business model.

We plan to continue to increase our research and development expenses 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 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.

Of the $2.0 million increase in general and administrative

expense, $1.6 million was related to increased employee and consulting expenses.

The remaining $0.4 million of the $2.0 million increase

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

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

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

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

Our general and administrative expenses for the three months ended September 30,

2025 were approximately $7.9 million, representing an increase of approximately $5.4 million, or 221%, compared to the same period in

Of the $5.4 million increase in general and administrative expense, $4.9 million was related to increased employee and

consulting expenses.

Of the $4.9 million increase, $4.0 million was related to non-cash, stock-based compensation.

The remaining $0.5

million of the $5.4 million increase resulted from professional fees, expanding infrastructure and other administrative expenses.

general and administrative expenses for the nine months ended September 30, 2025 were approximately $15.6 million, representing an increase

of under $9.5 million, or 156%, compared to the same period in 2024.

Of the $9.5 million increase in general and administrative expense,

$8.1 million was related to increased employee and consulting expenses.

Of the $8.1 million increase, $5.0 million related

to non-cash, stock-based compensation.

The remaining $1.4 million of the $9.5 million increase was related to professional fees, expanding

infrastructure and other administrative expenses.

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

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

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

expense for the three months ended September 30, 2025 was $4.6 million and represents an increase of $1.3 million, or 37%, compared to

the same period in 2024.

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

The increase is due primarily

to the issuance of the Convertible Notes in July 2025 and the distribution of the Term Loan D in September 2025.

The $4.6 million of

interest expense includes $1.1 million of non-cash interest expense.

expense for the nine months ended September 30, 2025 was $11.0 million and represents an increase of $4.0 million, or 57%, compared to

the same period in 2024.

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

The increase is primarily

due to the incremental $61.7 million funding of the Term Loan C in May 2024, the issuance of the Convertible Notes in July 2025 and the

distribution of the Term Loan D in September 2025.

The $11.0 million of interest expense includes $2.6 million of non-cash interest expense.

income for the three months ended September 30, 2025 was $3.6 million and represents a decrease of under $0.1 million compared to the

same period in 2024.

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

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.

The decrease was primarily the result of lower market interest rates offset largely by a higher invested cash balance.

income for the nine months ended September 30, 2025 was $7.9 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 offset partially by a higher invested cash balance.

and Capital Resources

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

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.

Through September 30, 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 September 30, 2025, we raised an aggregate of approximately $481.7 million

of net proceeds through sales of our securities, approximately $194.9 million of net proceeds through the issuance of the Notes, and

had $130.0 million of borrowings under loan agreements, not including payable-in-kind interest.

In October 2025, investors exercised 2,930,420 warrants

at an exercise price of $8.05, which generated approximately $23.6 million in cash.

The warrants were issued pursuant to a private

placement that closed on December 9, 2022.

From September 30, 2025 through the report date, stock option exercises generated approximately

$0.2 million in cash.

As of September 30, 2025, our cash and cash equivalents and short-term investments were approximately $74.3 million

and $380.7 million, respectively, and we had an accumulated deficit of approximately $397.9 million.

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,

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 (ii) 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, 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.

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.

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 are using 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

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

2 unchanged sentences

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.

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.

However, 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

and sell in a public offering $175.0 million aggregate principal amount of Notes to the Underwriters.

In addition, pursuant to the Note

Underwriting Agreement, we granted the Underwriters an option to purchase up to an additional $26.3 million aggregate principal amount

of Notes solely to cover over-allotments.

On July 30, 2025, the Underwriters exercised such option to purchase an additional $26.3 million

aggregate principal amount of Notes.

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

August 1, 2025.

The issuance of $201.3 million 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.

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 are using 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.

The Notes will accrue interest payable semi-annually 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

25 unchanged sentences

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

the 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;

6 unchanged sentences

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.

July 2025, an investor exercised 1,286,960 warrants at an exercise price of $8.05, which generated approximately $10.4 million in cash.

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

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.

Also in August 2025, the underwriter of the

Company’s initial public offering that closed on September 22, 2017 exercised its warrants on a cashless basis.

As a result, the

Company issued 55,592 shares of common stock upon the cashless exercise of 70,000 warrants.

In September 2025, an investor exercised 104,340 warrants at exercise prices of

$8.05, which generated approximately $0.8 million in cash.

The warrants were issued pursuant to a private placement that closed on December

Also in September 2025, the placement agent from private placements that closed in January and May 2016 exercised 7,917 warrants

at an exercise price of $7.56, which generated approximately $0.1 million in cash.

October 2025, investors exercised 2,930,420 warrants at an exercise price of $8.05, which generated approximately $23.6 million

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

Market Sale Agreement

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.

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 September 30, 2025, $50.0 million of common stock remains

available for sale under the Open Market Sale Agreement with Jefferies.

2024 Equity Offering

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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”).

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

payable by us.

and Restated Loan and Security Agreement

September 9, 2025, we entered into the Third Amendment (the “Third Amendment”) to the Amended and Restated Loan and Security

Agreement (the “A&R Loan Agreement”) with Oxford Finance LLC, a Delaware limited liability company (“Oxford”),

as collateral agent and a lender, Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”),

as a lender, and the other lenders party thereto (together with Oxford and Innovatus, the “Lenders”), pursuant to which the

A&R Loan Agreement was amended to (i) replace Innovatus with Oxford as collateral agent;

(ii) recognize the achievement of the Term

D Milestone (as defined in the A&R Loan Agreement, as amended by the Third Amendment (the “Amended A&R Loan Agreement”))

and provide for the immediate disbursement of the $30.0 million Term D Loan (as defined in the Amended A&R Loan Agreement);

increase the size of the Term E Loan (as defined in the Amended A&R Loan Agreement) from $50.0 million to up to $100.0 million, which

Term E Loan may only be drawn upon FDA approval of gedatolisib in second line wild-type advanced breast cancer patients post CDK4/6 inhibitor

(iv) add three new up to $40.0 million Term F Loans (as defined in the Amended A&R Loan Agreement), which may only be drawn

upon achievement of certain trailing three months’ product revenue thresholds;

(v) replace the prior $45.0 million Term F Loan

(as defined in the A&R Loan Agreement) with a new $150.0 million Term G Loan (as defined in the Amended A&R Loan Agreement),

which continues to be available only in the Lenders’ sole discretion upon our request;

(vi) require an amendment fee payable by

us to the Lenders in the amount of $50,000, which was paid at the closing of the Third Amendment;

(vii) make certain revisions to the

non-utilization fee for the Term E Loan, and add a new non-utilization fee for the Term F Loans, in each case equal to 3.0% of the applicable

unfunded commitment, after taking into consideration any reductions to the applicable term loan commitment that we may make by notice

to the collateral agent before the date that is eight weeks after the achievement of any applicable milestones;

and (viii) extend the

maturity date of the term loans to November 1, 2029.

The Term E Loan and each Term F Loan also are subject to other customary conditions

and limits on when we can request funding.

With the disbursement of the $30.0 million Term D Loan, the Company received net proceeds

of approximately $27.8 million.

In accordance with the A&R Loan Agreement, a Final Fee

equal to 4.5% of the $30.0 million Term D Loan was recognized and an additional $1.4 million was added to debt principal and a corresponding

debt discount to be amortized over the life of the loan.

connection with the Third Amendment, we issued warrants with an exercise price of $14.84 per share to purchase an aggregate of 50,537

shares of our common stock to Innovatus, Oxford, and certain of its affiliates (the “Third Amendment Warrants”).

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

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

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

A portion of the proceeds from the Term D Loan in the amount of $2.8 million was

allocated to the Third Amendment Warrants based on their relative fair value to the underlying Term D Loan.

The proceeds allocated to

the Third Amendment Warrants were recorded as additional paid in capital in the accompanying condensed consolidated balance sheets and

were discounted from the Term D Loan.

The relative fair value of the Third Amendment Warrants was based on the Black-Scholes method with

the following assumptions:

risk-free interest rate of 4.08%;

expected volatility of 74.4%;

expected life of 10.0 years;

and expected dividend

The underlying stock price used in the analysis was the traded market price.

The discount related to the Third Amendment Warrants

is being amortized to interest expense ratably over the term of the Term D Loan.

July 28, 2025, we entered into the Second Amendment (the “Second Amendment”) to the A&R Loan Agreement with Innovatus,

as collateral agent, and the Lenders including Innovatus in its capacity as a Lender and 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.

The A&R Loan Agreement was amended to (i) subject to certain terms and conditions, permit the issuance of the Notes discussed above

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 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.

in connection with the release of the topline data from the wild-type 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 became eligible to draw an additional $30.0 million of indebtedness

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

As described above, the Term D Loan was disbursed to us in connection

with the Third Amendment.

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 our 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 had failed to achieve the Term D Milestone prior to

June 1, 2025 and to decrease the Minimum Liquidity Percentage back to 30% if we subsequently achieves 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.

30, 2024 Amendment and Restatement

May 30, 2024, we entered into the A&R Loan Agreement.

The A&R Loan Agreement amended and restated, 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

1 unchanged sentence

the Prior Loan Agreement plus accrued payment-in-kind interest, in addition to $61.7 million of new borrowings (the “Term C Loan”).

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.

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

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.

As described above, the Term D Loan was disbursed to us in connection with the Third Amendment.

Prior to the Third Amendment, we also

would have 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 covenants.

The Lenders also could have, in their sole discretion upon our request,

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

Funding of these additional tranches was also subject

to other customary conditions and limits on when we could have requested 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 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 of our assets.

Proceeds are being 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.

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.

Prior to the Second Amendment, Innovatus

also had 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

1 unchanged sentence

There is also a contingent

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

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 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,

non-utilization fee for the Term E Loans.

Following the disbursement of the Term D Loan in connection with the Third Amendment, the non-utilization

provisions related to the Term D Loan are no longer operative.

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 we achieve 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 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 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.

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 and the Term D Loans, we agreed to issue to Innovatus and Oxford warrants to purchase

that number of shares of our common stock equal to 2.5% of the principal amount of the applicable Term Loan divided by the exercise price,

which was, with respect to the Term C Loan, equal to the lower of (i) the volume weighted average closing price of our 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, we 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 Term D Loans, the exercise price was 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 our common stock for the five-trading day period ending on the

last trading day immediately preceding the Term D Loan funding.

Prior to the Third Amendment, we also were required to issue warrants

to Innovatus and Oxford in connection with the funding of the Term E Loan and the Term F Loan.

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.

and capital resource requirements

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

6 unchanged sentences

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, 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.

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

14 unchanged sentences

terms, or at all.

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

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

(in thousands)

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

million of stock-based compensation expense and net non-cash interest of $2.0 million.

The approximately $3.0 million of working

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.

Net cash (used in) provided by:

Operating activities

Investing activities

Financing activities

Net increase (decrease) in cash and cash equivalents

cash used in operating activities was approximately $116.9 million for the nine months ended September 30, 2025 and consisted primarily

of a net loss of approximately $126.1 million, partially offset by non-cash expense items of approximately $13.8 million and by

a working capital net cash use of $4.6 million.

Non-cash expense items of approximately $13.8 million primarily consisted of $11.9 million

of stock-based compensation expense and non-cash amortization of debt issuance costs and discount and payment-in-kind interest of $2.6

million in the aggregate, offset partly by non-cash interest accretion of $0.8 million.

The approximately $4.7 million of working capital

changes were primarily due to increases in other current assets, partly offset by increases in both accounts payable and accrued expenses.

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.

Non-cash expense items of approximately $5.5 million primarily consisted of $4.7 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 investing activities for the nine months ended September 30, 2025 was approximately $167.5 million and consisted primarily

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

Treasury Bills and U.S.

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

government agency), partially offset

by purchases of property and equipment.

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.

Treasury Bills and U.S.

government securities), partially offset

by purchases of property and equipment.

cash provided by financing activities for the nine months ended September 30, 2025 was approximately $336.1 million and consisted of

net proceeds from the Note Offering of $195.5 million, net proceeds from the Equity Offering of approximately $91.8 million and net proceeds

from the Term D Loan of $27.8 million.

In addition, cash provided by financing activities included the exercise of common stock warrants

in the amount of $18.5 million and from the exercise of employee stock options and employee stock purchases in the amount of $2.6 million,

offset in part by registration costs of $47 thousand.

cash provided by financing activities for the nine months ended September 30, 2024 was approximately $138.3 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 $14.7 million consisted of proceeds from the exercise of common stock warrants, the

exercise of employee stock options and employee stock purchases.

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.

Accounting Pronouncements

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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;

alone or in combination with other treatments, and our interpretation of the 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;

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assumptions, which in turn are based on their interpretation of currently available information.

statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s actual

results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these

forward-looking statements.

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

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

with clinical studies and with developing and commercializing biopharmaceuticals;

the complexity and difficulty of demonstrating the

safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib and other products we may develop;

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

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;

These statements involve known and unknown risks, uncertainties and other factors that may cause our results or our industry’s

actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied

by these forward-looking statements.

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

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

the uncertainties and costs associated with clinical studies and with developing and commercializing biopharmaceuticals;

complexity and difficulty of demonstrating the safety and sufficient magnitude of benefit to support regulatory approval of gedatolisib

and other products we may develop;

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

including our current and any future suppliers of our product candidate;

the uncertainty and costs associated with clinical trials;

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, 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.

tightening credit markets and limitations on access

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

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

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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