What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-14 compared with 2024-08-14 · 253 added, 218 removed, 385 unchanged (55% of the section changed)

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

Company’s lead therapeutic candidate is gedatolisib, a pan-PI3K/mTOR inhibitor.

The Company’s lead therapeutic candidate is gedatolisib, a pan-PI3K/mTOR inhibitor.

Its mechanism of action and pharmacokinetic

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

In 2022, the Company began enrolling patients in VIKTORIA-1, a Phase 3 study evaluating gedatolisib and fulvestrant with

and without Ibrance® (palbociclib) as second line treatment for patients with HR+, HER2- advanced breast cancer.

In early 2024,

the Company began enrolling patients in CELC-G-201, a Phase 1b/2 study evaluating gedatolisib combined with Nubeqa®

(darolutamide) in patients with metastatic castration resistant prostate cancer (mCRPC).

In May 2024, the Company announced plans to

initiate VIKTORIA-2, a Phase 3 trial evaluating gedatolisib combined with fulvestrant plus a CDK 4/6 inhibitor as first-line

treatment for patients with HR+, HER2- advanced breast cancer.

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

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

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

In early 2024, the Company began

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

metastatic castration resistant prostate cancer (mCRPC).

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

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

breast cancer.

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

The Company’s CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify

new groups of cancer patients likely to benefit from already approved targeted therapies.

The Company’s CELsignia companion diagnostic

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

approved targeted therapies.

is a potent, well-tolerated, reversible, ATP-competitive, pan-PI3K/mTOR inhibitor that selectively targets all Class I isoforms of PI3K

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in 39% of patients evaluated.

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

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

in the 103-patient dose expansion portion of the Phase 1b clinical trial with gedatolisib, only 7% of patients experienced Grade

3 or 4 hyperglycemia and less than 9% discontinued treatment.

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

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

Of the 492 patients,

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138 patients.

Four patients from this study continue to receive study treatment, as of June 30, 2024, each of whom have received study

treatment for more than five years.

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

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

Four patients from this study continue to receive study treatment, as of September 30, 2024, each of whom have received

study treatment for more than five years.

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

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

patients were enrolled in two dose escalation arms to evaluate the safety and tolerability and to determine the maximum tolerated dose

(MTD) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapy (letrozole or fulvestrant).

(“MTD”) of gedatolisib when used in combination with the standard doses of palbociclib and endocrine therapy (letrozole or

fulvestrant).

The MTD was determined to be 180 mg administered intravenously once weekly.

A total of 103 patients were subsequently enrolled in one

of four expansion arms (A, B, C, D).

objective overall response rates (ORR) were observed in all four expansion arms and were comparable in each arm for PIK3CA WT and

PIK3CA MT patients.

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

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

and ORR was 79%, respectively.

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

patients with HR+, HER2- advanced breast cancer.

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

CDK4/6 inhibitor (Arms B, C, and D), ORR (including unconfirmed partial responses) ranged from 36% to 77%.

Each arm achieved its

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

evaluated palbociclib plus letrozole for Arm A or the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms

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

Median progression-free survival

(PFS) was 12.9 months for patients who received a prior CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing

schedule (Arm D).

A total of 103 patients were subsequently enrolled

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

objective overall response rates (“ORR”) were observed in all four expansion arms and were comparable in each arm for PIK3CA

wild-type (“WT”) and PIK3CA mutant (“MT”) patients.

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

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

79%, respectively.

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

HR+, HER2- advanced breast cancer.

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

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

Each arm achieved its primary endpoint target, which

was reporting higher ORR in the study arm than ORR from either the PALOMA-2 (ORR=55%) study that evaluated palbociclib plus letrozole

for Arm A or the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D.

For all enrolled patients,

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

Median progression free survival was 12.9 months for patients who received

a prior CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm D).

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

The majority of treatment

emergent adverse events were Grade 1 and 2.

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

emergent AEs were Grade 1 and 2.

The most frequently observed AEs included stomatitis/mucosal inflammation, the

majority of which were Grade 1 and 2.

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as related to treatment with palbociclib.

No grade 5 events were reported in this study.

No grade 5 AEs were reported in this study.

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

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

Enrollment of the PIK3CA wild-type cohort is more than

80% complete and expected to reach the enrollment target during Q4 2024.

The PIK3CA wild-type cohort represents approximately 60% of

the total patients enrolled to date in VIKTORIA-1 .

In light of this, we expect topline data for the PIK3CA WT cohort to shift

to sometime between late Q4 2024 and Q1 2025.

Enrollment of the PIK3CA WT cohort is 100% enrolled and

enrollment in the PIK3CA MT cohort is on plan.

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

date in VIKTORIA-1.

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

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

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

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

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

If gedatolisib ultimately does

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

indication could exceed $2 billion.

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

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

We expect to report preliminary data in Q2 of 2025.

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

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

HR+/HER2- advanced breast cancer who are endocrine therapy resistant, will be initiated in 2025.

For the CDK4/6 inhibitor,

investigators may choose either ribociclib or palbociclib.

The safety profile of gedatolisib combined with fulvestrant and

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

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

ribociclib and fulvestrant.

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

patients in the Phase 3 portion of the study.

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

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

The safety profile of gedatolisib combined with

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

clinically tested.

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

combined with ribociclib and fulvestrant.

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

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

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

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

The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA wild type and PI3KCA mutant.

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

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

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

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

Celcuity expects to enroll the first patient in the second quarter of 2025.

May 30, 2024, the Company announced plans to initiate a Phase 3 VIKTORIA-2 trial evaluating gedatolisib combined with fulvestrant plus

a CDK 4/6 inhibitor as first-line treatment for patients with HR+, HER2- advanced breast cancer.

The first patient is expected to be

enrolled in the second quarter of 2025.

expect to reach our enrollment target for VIKTORIA-1 PIK3CA WT cohort in Q4 2024 and report topline data for this cohort in late Q4

2024 or Q1 2025.

the quarter, the Company raised $129.0 million in gross proceeds from equity and debt financings, which will provide sufficient cash

to finance our operations and pay obligations when due through 2026.

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

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

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

The PIK3CA WT cohort is 100% enrolled, and enrollment

in the PIK3CA MT cohort is on plan.

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

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

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

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

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

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

Site qualification

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

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

place December 10-13, 2024.

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

will also be presented at the SABCS.

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

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

The published manuscript is available online and on the publications

section of Celcuity’s website .

of Operations

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

For the three months ended June 30, 2024 and 2023, we reported a net loss of approximately $23.7 million and $14.6 million,

respectively, and for the six months ended June 30, 2024, we reported a net loss of approximately $45.3 million and $26.5 million, respectively.

As of June 30, 2024, we had an accumulated deficit of approximately $205.4 million.

As of June 30, 2024, we had cash and cash

equivalents and short-term investments of approximately $283.1 million.

For the three months ended September 30, 2024 and 2023, we reported a net loss of approximately $29.8 million and $18.4 million,

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

respectively.

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

As of September 30, 2024,

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

of Operating Results

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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 trial, the CELC-G-201 Phase 1b/2 trial, and other clinical trials to evaluate the

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

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

As we continue development of gedatolisib and manage

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

VIKTORIA-2 Phase 3 clinical trial and other clinical trials to evaluate the efficacy of targeted therapies in cancer patients

selected with one of our CELsignia tests, the proportion of research and development expenses allocated to external spending will

grow at a faster rate than expenses allocated to internal expenses.

and Administrative

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

To date, we have incurred immaterial

sales and marketing expenses as we continue to focus primarily on the development of our first drug, gedatolisib, managing the VIKTORIA-1

Phase 3 and CELC-G-201 Phase 1b/2 trials.

We would expect to begin to incur increased sales and marketing expenses in anticipation of

the commercialization of our first drug, gedatolisib.

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

and professional fees.

To date, we have incurred

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

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

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

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

expense is primarily due to a Loan Agreement.

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of Operations

of the Three Months Ended June 30, 2024 and 2023

Statements of Operations

of the Three Months Ended September 30, 2024 and 2023

Three Months Ended

September 30,

Increase (Decrease)

Percent Change

Statements of Operations Data:

Operating expenses:

Research and development

General and administrative

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(18,898,037 )

Other income (expense)

(11,161,862 )

Other (expense) income

Interest expense

Interest income

Other income (expense),

loss before income taxes

Other income, net

Net loss before income taxes

(29,791,789 )

(18,404,540 )

(11,387,249 )

Income tax benefits

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$ (11,387,249 )

of the Six Months Ended June 30, 2024 and 2023

Statements of Operations

of the Nine Months Ended September 30, 2024 and 2023

Nine Months Ended

September 30,

Increase (Decrease)

Percent Change

Statements of Operations Data:

Operating expenses:

Research and development

General and administrative

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(30,335,761 )

Other income (expense)

Other (expense) income

Interest expense

Interest income

Other income (expense),

loss before income taxes

Other income, net

Net loss before income taxes

(75,126,064 )

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and Development

research and development expenses for the three months ended June 30, 2024 were approximately $22.5 million, representing an increase

of approximately $8.7 million, or 64%, compared to the same period in 2023.

Of the $8.7 million increase in research and development

expense, $2.1 million was related to increased employee and consulting expenses.

The remaining $6.6 million increase of research and

development costs are primarily related to costs supporting activities for the VIKTORIA-1 and CELC-G-201 pivotal trials.

research and development expenses for the six months ended June 30, 2024 were approximately $43.1 million, representing an increase of

approximately $18.1 million, or 72%, compared to the same period in 2023.

Of the $18.1 million increase in research and development expenses,

$3.5 million was related to increased employee and consulting expenses.

The remaining $14.6 million increase of research and development

expenses is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial and other existing clinical trials.

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

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

Of the $10.1 million increase in research and

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

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

The remaining $3.8 million was related to increased employee and

consulting expenses.

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

increase of approximately $28.2 million, or 66%, compared to the same period in 2023.

Of the $28.2 million increase in research and

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

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

The remaining $7.4 million was related to

increased employee and consulting expenses.

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

We plan to increase our research and development expenses

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

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

Phase 3 pivotal trial.

and Administrative

general and administrative expenses for the three months ended June 30, 2024 were approximately $1.8 million, representing an increase

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

of approximately $1.1 million, or 75%, compared to the same period in 2023.

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resulted from professional fees and other administrative expenses.

general and administrative expenses for the six months ended June 30, 2024 were approximately $3.6 million, representing an increase

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

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

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public company regulatory developments and other compliance matters.

expense for the three months ended June 30, 2024 was $2.3 million and represents an increase of $0.9 million, or 72%, compared to the

same period in 2023.

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

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

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

Term Loan C in May 2024.

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

to the same period in 2023.

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

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

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

of Term Loan C in May 2024.

The $3.3 million of interest expense includes $0.7 million of non-cash interest expense.

expense for the six months ended June 30, 2024 was $3.7 million and represents an increase of $1.1 million, or 43%, compared to the same

period in 2023.

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

the same period in 2023.

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

The $3.7 million of

interest expense includes $1.2 million of non-cash interest expense.

income for the three months ended June 30, 2024 was $2.8 million and represents an increase of $1.0 million compared to the same

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

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

period in 2023.

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

cash, cash equivalents and short-term investment balances.

income for the six months ended June 30, 2024 was $5.1 million and represents an increase of $1.5 million compared to the same

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

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

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

period in 2023.

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

cash, cash equivalents and short-term investment balances.

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

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

and Capital Resources

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

Through June 30, 2024, we have funded our

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

borrowings under loan agreements.

From inception through June 30, 2024, we raised an aggregate of approximately $367.8 million of net

proceeds through sales of our securities, and as of June 30, 2024 had $100.0 million of borrowings under loan agreements, not including

payable-in-kind interest.

As of June 30, 2024, our cash and cash equivalents and short-term investments were approximately $30.5 million

and $252.6 million, respectively, and we had an accumulated deficit of approximately $205.4 million.

Through September 30, 2024, we have funded

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

and borrowings under loan agreements.

From inception through September 30, 2024, we raised an aggregate of approximately $368.7 million

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

not including payable-in-kind interest.

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

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

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

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On February 4, 2022, we entered into an Open Market Sale Agreement with Jefferies LLC, as agent, pursuant

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

of up to $50,000,000.

On October 12, 2022, pursuant to this agreement, the Company sold 500,000 shares of common stock in a single

transaction at a price of $10.35 per share generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering

expenses) On December 1, 2023, pursuant to this agreement, the Company sold 1,034,500 shares of common stock in a single

transaction at a price of $14.50 per share, generating gross proceeds of $15 million ($14.4 million net of commissions and offering

In April 2024 and May 2024, pursuant to the Open Market Sale Agreement with Jefferies LLC, as agent, the Company sold

285,714 and 149,700 shares of common stock, respectively, at an average selling price of $ 17.55 per share, generating gross

proceeds of $7.6 million before deducting commissions and other offering expenses of $0.3 million.

At June 30, 2024, $22.2 million

of common stock remains available for sale under the Jefferies agreement.

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

up to $50,000,000.

On October 12, 2022, pursuant to this agreement, the Company sold 500,000 shares of common stock in a single transaction

at a price of $10.35 per share generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering expenses) On December

1, 2023, pursuant to this agreement, the Company sold 1,034,500 shares of common stock in a single transaction at a price of $14.50 per

share, generating gross proceeds of $15.0 million ($14.4 million net of commissions and offering expenses).

In April 2024 and May 2024,

pursuant to the Open Market Sale Agreement with Jefferies LLC, as agent, the Company sold 285,714 and 149,700 shares of common stock,

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

and other offering expenses of $0.3 million.

At September 30, 2024, $22.2 million of common stock remains available for sale under the

Jefferies agreement.

On May 30, 2024, the Company entered into an underwriting agreement with Leerink Partners LLC, TD Securities (USA) LLC

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The Company intends to use the net proceeds from the offering for working capital

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

expansion of business development activities and other general corporate purposes.

and general corporate purposes, which may include research and development expenditures, clinical trial expenditures, expansion of business

development activities and other general corporate purposes.

On May 30, 2024, the Company entered into an Amended and Restated Loan and Security Agreement (the “A&R Loan

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to other customary conditions and limits on when the Company can request funding for such tranches.

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

Costs associated with the new borrowings

was approximately $2.4 million.

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

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to liquidity and other financial measures.

Innovatus has the right, at its election and until August 9, 2025, to convert

up to 20% of the outstanding principal of the Term A Loan into shares of the Company’s common stock at a price per share of $10.00

(the “Conversion Right”).

Innovatus will continue to have the right to exercise a previously disclosed warrant granted to

it under the Prior Loan Agreement to purchase 26,042 shares of common stock at a price per share of $14.40 through April 8, 2031.

A&R Loan Agreement contains a Final Fee, which is equal to 4.5 %

of the initial funding of the agreement and is due on the earliest to occur of (a) the Maturity Date, (b) the acceleration of any

Term Loan, and (c) the prepayment of the Term Loans.

There is also a contingent non-utilization fee for both the Term D and Term E

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

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

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

fee of $ 900,000 ,

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

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

If the Company

achieves the Term E Milestone and (i) fails to draw the full amount of the Term E Loan during the Term E Draw Period and (ii) fails

to notify Collateral Agent, at any time before the date that is four weeks after the Company’s achievement of the Term E

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

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

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

After the 18-month

anniversary of the Effective Date, the Company shall have the option to prepay all, but not less than all, of the Term Loans

advanced by the Lenders under the A&R Loan Agreement, provided the Company (i) provides written notice to Collateral Agent of

its election to prepay the Term Loans at least seven Business Days prior to such prepayment, and (ii) pays to Lenders on the date of

such prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all

outstanding principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C)

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

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

At May 30, 2024, the Company

recognized the Final Fee of $ 4.5

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

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

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

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

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

A&R Loan Agreement contains a Final Fee, which is equal to 4.5% of the initial funding of the agreement and is due on the earliest

to occur of (a) the Maturity Date, (b) the acceleration of any Term Loan, and (c) the prepayment of the Term Loans.

There is also a contingent

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

If the Company achieves the Term D Milestone and (i) fails to draw the full

amount of the Term D Loan during the Term D Draw Period and (ii) fails to notify Collateral Agent, at any time before the date that is

four weeks after the Company’s achievement of the Term D Milestone, of the Company’s intent not to draw the full amount of

the Term D Loan, a non-utilization fee of $900,000, with respect to the Term D Loan shall become due and payable on the earliest of (i)

the termination of the Term D Draw Period, (ii) the Maturity Date, (iii) the acceleration of any Term Loan, and (iv) the prepayment in

whole of the Term Loans.

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

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

achievement of the Term E Milestone, of the Company’s intent not to draw the full amount of the Term E Loan, a non-utilization

fee of $1,500,000, with respect to the Term E Loan shall become due and payable on the earliest of (i) the termination of the Term E

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

the 18-month anniversary of the Effective Date, the Company shall have the option to prepay all, but not less than all, of the Term Loans

advanced by the Lenders under the A&R Loan Agreement, provided the Company (i) provides written notice to Collateral Agent of its

election to prepay the Term Loans at least seven Business Days prior to such prepayment, and (ii) pays to Lenders on the date of such

prepayment, payable to each Lender in accordance with its respective Pro Rata Share, an amount equal to the sum of (A) all outstanding

principal of the Term Loans plus accrued and unpaid interest thereon through the prepayment date, (B) the Final Fee, (C) the Prepayment

Fee, plus (D) all other outstanding Obligations that are due and payable, including, without limitation, Lenders’ Expenses and

interest at the Default Rate with respect to any past due amounts.

At May 30, 2024, the Company recognized the Final Fee of $4.5 million

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

connection with the funding of each of the Term C Loan, the Term D Loan, the Term E Loan and the Term F Loan, the Company agreed to issue

15 unchanged sentences

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

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

manage the VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials, conduct

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

We would also expect to incur sales and marketing

expenses as we commercialize gedatolisib.

We expect to use cash on hand, together with the funds to be received under the debt and equity

financings described above, to fund our research and development expenses, clinical trial costs, capital expenditures, working capital,

sales and marketing expenses, and general corporate expenses.

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

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

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

We would also expect to incur

sales and marketing expenses as we commercialize gedatolisib.

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

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

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

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

14 unchanged sentences

available on reasonable terms, or not 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:

September 30,

Net cash provided by (used in):

5 unchanged sentences

Financing activities

Net increase (decrease)

in cash and cash equivalents

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.

Net increase (decrease) in cash and cash equivalents

$ (18,059,485 )

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

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

items of approximately $5.5 million.

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

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

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

Non-cash expense items of

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

and depreciation expense of $0.1 million.

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

accrued expenses, accounts payable and other current assets.

cash used in operating activities was approximately $22.5 million for the six months ended June 30, 2023 and consisted primarily of a

net loss of approximately $26.5 million offset by non-cash expense items of approximately $3.7 million and working capital changes

of $0.3 million.

Non-cash expense items of approximately $3.7 million primarily consisted of $2.6 million of stock-based compensation

expense, non-cash interest expense of $1.0 million, and depreciation expense of $0.1 million.

The approximately $0.3 million of working

capital changes was primarily due to approximately $0.2 million net increase in accounts payable and accrued expenses and approximately

$0.1 million decrease in other assets.

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.

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

in other current assets.

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

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

Treasury Bills and U.S.

government agency).

cash provided by investing activities for the six months ended June 30, 2023 was approximately $30.0 million and consisted primarily

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

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

cash provided by investing activities for the nine months ended September

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

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

Treasury Bills and U.S.

government securities)

and minimal purchase of property and equipment.

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, $7.3 million from an at-the market

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.

cash provided by financing activities for the six months ended June 30, 2023 was approximately $0.2 million and primarily consisted of

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

registration and debt issuance costs.

government securities) partially offset by minimal purchase

of property and equipment.

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

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

from an at-the market offering.

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

of employee stock options and employee stock purchases.

cash provided by financing activities for the nine months ended September

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

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

Accounting Pronouncements

12 unchanged sentences

analyzed by us for changes in facts and circumstances, and material changes in these estimates could occur in the future.

estimates on historical experience and on various other factors that we believe are reasonable under the circumstances;

the results of

estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of

which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other

90 unchanged sentences

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

What changed 10-Q

Item 2. Management’s Discussion and Analysis