What changed in this filing

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Item 2. Management’s Discussion and Analysis

2023-11-13 compared with 2023-08-11 · 266 added, 231 removed, 321 unchanged (61% of the section changed)

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results described in or implied by forward-looking statements.

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

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

Its mechanism of action and pharmacokinetic

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

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

is currently enrolling patients.

Its CELsignia companion diagnostic platform is uniquely able to analyze live patient tumor cells to

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

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

The Company’s lead therapeutic

candidate is gedatolisib, a pan-PI3K/mTOR inhibitor.

Its mechanism of action and pharmacokinetic properties are highly differentiated

from other currently approved and investigational therapies that target PI3K or mTOR alone or together.

The Company initiated VIKTORIA-1,

a Phase 3 study evaluating gedatolisib in patients with HR+/HER2- advanced breast cancer in 2022 and is currently enrolling patients.

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

Food and Drug Administration (“FDA”)

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

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

The Company expects

to initiate a Phase 1b/2 study, CELC-G-201, in the first quarter of 2024.

Its CELsignia companion diagnostic platform is uniquely able

to analyze live patient tumor cells to identify new groups of cancer patients likely to benefit from already approved targeted therapies.

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

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When a therapy only inhibits a single

Class 1 isoform (e.g., alpelisib, a PI3K-α inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor),

Class I isoform (e.g., alpelisib, a PI3K-α inhibitor) or only one mTOR kinase complex (e.g., everolimus, an mTORC1 inhibitor),

numerous feedforward and feedback loops between the PI3K isoforms and mTOR complexes cross-activate the uninhibited sub-units.

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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 10%

discontinued treatment.

of June 30, 2023, 492 patients with solid tumors have received gedatolisib in eight clinical trials sponsored by Pfizer.

Of the 492 patients,

129 were treated with gedatolisib as a single agent in three clinical trials.

The remaining 363 patients received gedatolisib in combination

with other anti-cancer agents in five clinical trials.

Additional patients received gedatolisib in combination with other anti-cancer

agents in nine investigator sponsored clinical trials.

portion of the Phase 1b (B2151009) clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less

than 10% discontinued treatment.

of September 30, 2023, 492 patients with solid tumors have received gedatolisib in eight completed clinical trials sponsored by Pfizer.

Of the 492 patients, 129 were treated with gedatolisib as a single agent in three clinical trials.

The remaining 363 patients received

gedatolisib in combination with other anti-cancer agents in five clinical trials.

Additional patients received gedatolisib in combination

with other anti-cancer agents in nine investigator sponsored clinical trials.

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

138 patients.

Seven patients from this study continue to receive study treatment, as of June 30, 2023, each of whom have received study

treatment for more than four 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).

Six patients from this study continue to receive study treatment, as of September 30, 2023, each of whom have received

study treatment for more than four years.

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

in combination with palbociclib (CDK4/6 inhibitor) and endocrine therapy (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.

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

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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%.

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 ranged from 36% to 77%.

Each arm achieved its primary

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

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

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

Median progression-free survival (PFS) was 12.9

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

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

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 (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).

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

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and 2) gedatolisib in combination with fulvestrant.

Two hundred clinical sites in North America, Europe, South America, Asia, and Australia have been selected to participate in the study.

The first clinical site was activated in the third quarter of 2022.

The first dosage of a subject in the trial occurred in December 2022.

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

Approximately two hundred clinical sites in North America, Europe, South America, Asia, and Australia have been selected to participate

in the study.

The first clinical site was activated in the third quarter of 2022, and the first patient was dosed in December 2022.

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

Subjects who meet eligibility

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

CELC-G-201 Phase 1b/2 clinical trial will enroll up to 54 participants with mCRPC who progressed after metastic castration resistant

prostate cancer (“mCRPC”) treatment with a next-generation androgen receptor inhibitor and have not received docetaxel

In the Phase 1b portion of the study, we expect 36 participants will be randomly assigned to receive 600 mg darolutamide

administered orally twice daily combined with either 120 mg gedatolisib in Arm 1 or 180 mg gedatolisib received intravenously in Arm

An additional 12 participants will then be enrolled in the Phase 2 portion of the study at the Recommended Phase 2 Dose (RP2D)

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

The primary objectives of the Phase 1b portion

of the trial include assessment of the safety and tolerability of gedatolisib in combination with darolutamide and determination of

the RP2D dose of gedatolisib.

The primary objective of the Phase 2 portion of the trial is to assess the

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

We expect to initiate the study in

the first quarter of 2024.

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

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

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

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

3-kinases (PI3K) targeted therapeutics.

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

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

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

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

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

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

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

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

of these therapies in CELsignia selected patients.

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

with a molecular test.

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

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

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

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

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

of their disease.

With each program, we are:

the proprietary insights CELsignia provides into live patient tumor cell function

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

a new targeted therapeutic option for breast cancer patients

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

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

these therapies in CELsignia selected patients.

The FACT-1 trial is expected to have interim results available in the first half of 2024

and final results approximately nine months later.

The FACT-2 trial, which was evaluating patients with early-stage triple negative breast

cancer, was terminated in the third quarter.

This decision was made in response to recent FDA approvals of new therapeutic options for

patients with early-stage triple negative breast cancer.

The availability of these new therapeutic options negatively impacted enrollment,

which led us to conclude that the study was no longer feasible.

our April 2021 license agreement with Pfizer to research, develop, manufacture and commercialize gedatolisib, we paid a $5.0 million

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in the event of specified insolvency events involving the other party.

May 2023, updated results from a Phase 1b trial evaluating gedatolisib, in combination with palbociclib and the aromatase inhibitor,

letrozole, were presented at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress, with data updated

as of March 16, 2023.

For treatment-naïve patients from Escalation Arm A and Expansion Arm A (n=41), mPFS was 48.6 months, mDOR was

46.9 months, and the ORR was 79%.

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

for patients with HR+/HER2- advanced breast cancer.

April 2023, Celcuity presented a poster at the American Association for Cancer Research (AACR) Annual Meeting demonstrating gedatolisib’s

superior therapeutic activity relative to the various PI3K, AKT, and mTOR inhibitors, regardless of the cell lines’ PTEN, PI3K,

or AKT mutational status in endometrial, ovarian and cervical cancer cell lines.

October 2023, Celcuity announced that it entered into a securities purchase agreement to sell pre-funded warrants at a price of $8.70

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

The closing of the private

placement occurred on October 20, 2023 and resulted in gross proceeds of approximately $50 million.

Each Warrant to purchase one share

has a purchase price of $8.699 per share, and an exercise price of $0.001 per share for the Common Stock issuable upon exercise of the

Warrant (for aggregate consideration equating to $8.70 per share).

The Company expects to use the net proceeds to advance clinical development

of gedatolisib and for general corporate purposes.

The Company has entered into a Registration Rights Agreement in connection with the

private placement, pursuant to which it has agreed to register for resale the shares issuable upon exercise or exchange of the Warrants.

August 2023, Celcuity announced it entered into a clinical trial collaboration and supply agreement with Bayer AG for Celcuity’s

Phase 1b/2 clinical trial of gedatolisib and Nubeqa® (darolutamide) in patients with metastatic castration resistant prostate cancer

As part of the supply agreement, Bayer will provide Nubeqa to Celcuity at no cost.

August 2023, Celcuity announced it was notified by the FDA that its Investigational New Drug (IND) submission has been reviewed, and

Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved

androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).

Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an

androgen receptor inhibitor.

The Company expects to begin enrolling patients in the Phase 1b/2 clinical trial in the first quarter

of COVID-19 on our Business

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the pandemic’s impact, and the potential adverse effects on the suppliers, labor market and general economic activity.

we continue to advance our clinical trial collaborations, we remain in close contact with our current clinical sponsors, and principal

investigators, as well as prospective pharmaceutical company and clinical collaborators, to monitor the impact of COVID-19 on our trial

enrollment timelines and collaboration discussions.

We experienced delays in the enrollment of patients in our ongoing clinical trials

and now expect interim results from the FACT-1 and FACT-2 trials to be delayed until the first half of 2024 and final results approximately

nine months later.

We could experience further delays in clinical trials and collaborations with pharmaceutical companies and sponsors

if new variants emerge or if the spread of COVID-19 once again accelerates.

Due to the inherent uncertainty associated with the COVID-19

pandemic, we are unable to predict the impact the pandemic may have on our clinical trial work and overall financial condition.

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, 2023 and 2022, we reported a net loss of approximately $14.6 million and $10.0 million,

respectively, and for the six months ended June 30, 2023 and 2022, we reported a net loss of approximately $26.5 million and $17.9 million,

respectively.

As of June 30, 2023, we had an accumulated deficit of approximately $122.8 million.

As of June 30, 2023, we had

cash and cash equivalents and short-term investments of approximately $146.2 million.

For the three months ended September 30, 2023 and 2022, we reported a net loss of approximately $18.4 million and $10.9 million,

respectively, and for the nine months ended September 30, 2023 and 2022, we reported a net loss of approximately $44.9 million and $28.8

million, respectively.

As of September 30, 2023, we had an accumulated deficit of approximately $141.2 million.

As of September

30, 2023, we had cash and cash equivalents and short-term investments of approximately $133.9 million.

of Operating Results

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

potential regulatory approval to market gedatolisib.

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

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

Additionally, we will seek to generate revenue from partnership agreements

with pharmaceutical companies to provide companion diagnostics for such pharmaceutical partners’ existing or investigational targeted

If a new drug indication is received that requires use of our companion diagnostic to identify eligible patients, we expect

to generate revenues from sales of tests to treating physicians.

potential regulatory approval to market gedatolisib for the treatment of breast cancer.

In August 2023, Celcuity announced its plans

to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor

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

If we obtain regulatory approvals

to market gedatolisib, we expect to generate revenue from sales of the drug for the treatment of patients who present with the forms

of breast or prostate cancer for which gedatolisib has been approved..

Additionally, we will seek to generate revenue from partnership

agreements with pharmaceutical companies to provide companion diagnostics for such pharmaceutical partners’ existing or investigational

targeted therapies.

If a new drug indication is received that requires use of our companion diagnostic to identify eligible patients,

we expect to generate revenues from sales of tests to treating physicians.

and Development

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

As we continue development of gedatolisib, manage the

VIKTORIA-1 Phase 3 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 to develop gedatolisib and manage studies

and clinical trials, including the VIKTORIA-1 Phase 3 trial, the CELC-G-201 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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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 trial, and development of our CELsignia platform and corresponding CELsignia tests.

We would expect to begin to incur increased

sales and marketing expenses in anticipation of the commercialization of our first drug, gedatolisib, and CELsignia tests.

These increased

expenses are expected to include payroll-related costs as we add employees in the commercial departments, costs related to the initiation

and operation of our sales and distribution network and marketing related costs.

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

3 trial, initiating the CELC-G-201 study, and developing our CELsignia platform and corresponding CELsignia tests.

We would expect to

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

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

expense is primarily due to a Loan Agreement.

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of Operations

of the Three Months Ended June 30, 2023 and 2022

of the Three Months Ended September 30, 2023 and 2022

Three Months Ended

September 30,

Increase (Decrease)

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(18,898,037 )

(10,643,555 )

Other income (expense)

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(18,404,540 )

(10,893,721 )

Income tax benefits

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$ (7,510,819 )

of the Six Months Ended June 30, 2023 and 2022

Six Months Ended

of the Nine Months Ended September 30, 2023 and 2022

Nine Months Ended

September 30,

Increase (Decrease)

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(28,788,694 )

(16,141,950 )

Income tax benefits

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and Development

research and development expenses for the three months ended June 30, 2023 were approximately $13.7 million, representing an increase

research and development expenses for the three months ended September 30, 2023 were approximately $17.5 million, representing an increase

of approximately $7.9 million, or 82%, compared to the same period in 2022.

Of the $7.9 million increase in research and development

expense, $0.5 million was related to increased employee and consulting expenses.

expense, $0.4 million was related to increased employee-related expenses.

The remaining $7.5 million increase of research and

development costs is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial.

research and development expenses for the six months ended June 30, 2023 were approximately $25.0 million, representing an increase

research and development expenses for the nine months ended September 30, 2023 were approximately $42.5 million, representing an increase

of approximately $17.8 million, or 72%, compared to the same period in 2022.

Of the $10.0 million increase in research and

development expenses, $1.3 million was related to increased employee and consulting expenses.

The remaining $8.7 million increase of

research and development expenses is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial.

Of the $17.8 million increase in research and development

expenses, $1.8 million was related to increased employee and consulting expenses.

The remaining $16.0 million increase of research and

development expenses is primarily related to costs supporting activities for the VIKTORIA-1 pivotal trial.

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

We plan to increase our research and development expenses

for the foreseeable future as we seek to develop gedatolisib, manage the VIKTORIA-1 Phase 3 trial, discover new cancer sub-types, and

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

We also expect to incur increased expenses to support companion

diagnostic business development activities with pharmaceutical companies as we develop additional CELsignia tests and manage the clinical

trial for gedatolisib.

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

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

We also expect to incur

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

CELsignia tests and manage the clinical trials for gedatolisib.

and Administrative

general and administrative expenses for the three months ended June 30, 2023 were approximately $1.3 million, representing an increase

general and administrative expenses for the three months ended September 30, 2023 were approximately $1.4 million, representing an increase

of approximately $0.4 million, or 38%, compared to the same period in 2022.

The $0.1 million increase resulted from professional fees

and other expenses associated with being a public company.

general and administrative expenses for the six months ended June 30, 2023 were approximately $2.6 million, representing an increase

Employee related expenses accounted for $0.3 million of the

The remaining $0.1 million increase resulted from professional fees and other expenses associated with being a public company.

general and administrative expenses for the nine months ended September 30, 2023 were approximately $4.0 million, representing an increase

of approximately $0.9 million, or 30%, compared to the same period in 2022.

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

expense for the three months ended June 30, 2023 was $1.3 million and represents an increase of $0.9 million, or 189%, compared to the

same period in 2022.

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

The increase is due to rising interest rates and the incremental $20 million funding of Term Loan B in December 2022.

expense for the three months ended September 30, 2023 was $1.4 million and represents an increase of $0.8 million, or 155%, compared

to the same period in 2022.

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

in August 2022.

The increase is primarily due to the incremental $20 million funding of Term Loan B in December 2022.

The $1.4 million

of interest expense includes $0.5 million of non-cash interest expense.

expense for the nine months ended September 30, 2023 was $3.9 million and represents an increase of $2.5 million, or 175%, compared to

the same period in 2022.

The increase is primarily due to the incremental $20 million funding of Term Loan B in December 2022.

million of interest expense includes $1.5 million of non-cash interest expense.

expense for the six months ended June 30, 2023 was $2.6 million and represents an increase of $1.7 million, or 187%, compared to the

same period in 2022.

The increase is due to rising interest rates and the incremental $20 million funding of Term Loan B in December

The $2.6 million of interest expense includes $1.0 million of non-cash interest expense.

income for the three months ended June 30, 2023 was $1.8 million and represents an increase of $1.7 million compared to the same period

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

cash, cash equivalents and short-term investment balances.

income for the six months ended June 30, 2023 was $3.6 million and represents an increase of $3.5 million compared to the same period

The increase was due to higher market interest rates and the closing of financing activities, leading to higher cash, cash equivalents

income for the three months ended September 30, 2023 was $1.9 million and represents an increase of $1.6 million compared to the same

period in 2022.

The increase was primarily the result of the closing of financing activities, leading to higher cash, cash equivalents

and short-term investment balances.

The $1.9 million of interest income includes $0.5 million of non-cash interest income.

income for the nine months ended September 30, 2023 was $5.5 million and represents an increase of $5.1 million compared to the same

period in 2022.

The increase was primarily due to the closing of financing activities, leading to higher cash, cash equivalents and short-term

investment balances.

The $5.5 million of interest income includes $0.4 million of non-cash interest income.

and Capital Resources

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

Through June 30, 2023, we have funded our

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

borrowings under loan agreements.

From inception through June 30, 2023, we raised an aggregate of approximately $223.7 million of net

proceeds through sales of our securities, and as of June 30, 2023 had $35.0 million of borrowings under loan agreements.

As of June 30,

2023, our cash and cash equivalents and short-term investments were approximately $32.2 million and $114.0 million, respectively, and

we had an accumulated deficit of approximately $122.8 million.

Through September 30, 2023, we have funded

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

and borrowings under loan agreements.

From inception through September 30, 2023, we raised an aggregate of approximately $223.7 million

of net proceeds through sales of our securities, and as of September 30, 2023 had $35.0 million of borrowings under loan agreements.

As of September 30, 2023, our cash and cash equivalents and short-term investments were approximately $25.8 million and $108.2 million,

respectively, and we had an accumulated deficit of approximately $141.2 million.

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

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offering expenses).

At June 30, 2023, $44.8 million of common stock remains available for sale under the Jefferies agreement.

At September 30, 2023, $44.8 million of common stock remains available for sale under the Jefferies agreement.

Loan Agreement.

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

As of June 30, 2023, term loans

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

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

described above.

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

of $20 million upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined on a

pro forma as-funded basis.

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

Company can request funding for such tranches.

As of September 30, 2023, term

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

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

placement described above.

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

tranche of $20 million upon achievement of certain clinical trial milestones and satisfaction of certain financial covenants determined

on a pro forma as-funded basis.

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

the Company can request funding for such tranches.

On October 20, 2023, we issued pre-funded warrants (the “Warrants”) to purchase 5,747,787 shares of common

stock in a private placement to certain institutional investors, pursuant to a securities purchase agreement entered into on October

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

share for the common stock issuable upon exercise of the Warrants (for aggregate consideration equating to $8.70 per share of common

The sale of the Warrants pursuant to the securities purchase agreement generated gross proceeds of approximately $50 million

before deducting offering expenses payable by the Company.

Please see “Management’s Discussion and Analysis of Financial

Condition and Results of Operations – Recent Developments” above for additional details.

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 trial, conduct research related to the discovery of new cancer sub-types, conduct clinical trials, and

pursue other business development activities.

We would also expect to incur sales and marketing expenses as we commercialize gedatolisib

and our CELsignia tests.

We expect to use cash on hand, which includes funds received under the Securities Purchase Agreement described

above, to fund our research and development expenses, clinical trial costs, capital expenditures, working capital, sales and marketing

expenses, and general corporate expenses.

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

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

next twelve months.

manage the VIKTORIA-1 Phase 3 trial, initiate the CELC-G-201 trial, conduct research related to the discovery of new cancer sub-types,

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

We would also expect to incur sales and

marketing expenses as we commercialize gedatolisib and our CELsignia tests.

We expect to use cash on hand, which includes funds received

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

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

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

borrowings under the Innovatus Loan Agreement, will provide sufficient cash to finance our operations and pay obligations when due for

at least the next twelve months.

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

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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):

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$ (26,802,605 )

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.

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 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, 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 operating activities was approximately $17.2 million for the six months ended June 30, 2022 and consisted primarily of a

net loss of approximately $17.9 million and working capital changes of approximately $2.1 million, offset by non-cash expense

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

The approximately $4.8 million of working capital

changes was primarily due to increases in accounts payable and accrued expenses of $3.0 million and $2.8 million, respectively, offset

by an approximately $1.0 million increase in other current assets.

cash used in operating activities was approximately $26.5 million for the nine months ended September 30, 2022 and consisted primarily

of a net loss of approximately $28.8 million and working capital changes of approximately $2.0 million, offset by non-cash expense

items of approximately $4.3 million.

The approximately $2.0 million of working capital changes was primarily due to an increase of approximately

$3.9 million in prepaid assets, partially offset by increases in accounts payable and accrued expenses of approximately $0.7 million

$5.9 million in other current assets, partially offset by increases in accounts payable and accrued expenses of approximately $1.6 million

and $2.3 million, respectively.

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$0.2 million.

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

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.

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government securities)

and minimal purchase of property and equipment.

Net cash used in investing for the six months ended June 30, 2022 were minimal and consisted

of purchases of property and equipment.

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.

Net cash used in financing activities was $0.1 million for the six months ended June 30, 2022 and

consisted of payments for secondary registration costs, offset partially by proceeds from the exercise of employee stock options and

proceeds from employee stock purchases.

partially offset by minimal purchase of property and equipment.

Net cash used in investing for the nine months ended September 30, 2022

were minimal and consisted of purchases of property and equipment.

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 costs.

Net cash used in financing activities was $0.2 million for the nine months ended September

30, 2022 and consisted of payments for secondary registration costs, offset partially by proceeds from the exercise of employee stock

options and proceeds from employee stock purchases.

Accounting Pronouncements

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

but not limited to, (i) our clinical trial plans and the estimated costs for such trials, including the timing of launching a Phase 3

clinical trial for gedatolisib;

(ii) our expectations with respect to costs and timelines to develop, validate and launch CELsignia tests

and to continue to develop gedatolisib;

(iii) our beliefs related to the perceived advantages of our CELsignia tests compared to traditional

molecular or other diagnostic tests;

but not limited to, (i) our clinical trial plans and the estimated costs for such trials, including our ongoing VIKTORIA-1 Phase 3 clinical

trial and our expected Phase 1b/2 study and clinical trial for gedatolisib;

(ii) our expectations with respect to costs and timelines

to develop, validate and launch CELsignia tests and to continue to develop gedatolisib;

(iii) our beliefs related to the perceived advantages

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

(iv) the expected benefits of gedatolisib;

(v) our expectations regarding the timeline of patient

enrollment and results from clinical trials, including the existing clinical trial for gedatolisib;

(vi) the future payments that may

be owned to Pfizer under the license agreement;

(vii) our expectations regarding partnering with pharmaceutical companies and other third

(viii) our expectations regarding revenue from sales of CELsignia tests and revenue from milestone or other payment sources;

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

(x) our expectations regarding

business development activities, including companion diagnostic related activities with pharmaceutical companies, expanding our sales

and marketing functions and the costs associated with such activities;

(xi) our expectations with respect to the CELsignia tests and

the analytical capabilities and potential impact of such tests;

(xii) our beliefs regarding the ability of our cash on hand to fund our

research and development expenses, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses,

as well as the increased costs associated with being a public company;

(xiii) our plans with respect to potentially raising capital,

and (xiv) our expectations regarding the impact that the COVID-19 pandemic and related economic effects will have on our business and

results of operations.

expectations regarding the timeline of patient enrollment and results from clinical trials, including our existing and upcoming clinical

trials for gedatolisib;

(vi) the future payments that may be owned to Pfizer under the license agreement;

(vii) our expectations regarding

partnering with pharmaceutical companies and other third parties;

(viii) our expectations regarding revenue from sales of CELsignia tests

and revenue from milestone or other payment sources;

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

the foreseeable future;

(x) our expectations regarding business development activities, including companion diagnostic related activities

with pharmaceutical companies, expanding our sales and marketing functions and the costs associated with such activities;

(xi) our expectations

with respect to the CELsignia tests and the analytical capabilities and potential impact of such tests;

(xii) our beliefs regarding the

ability of our cash on hand to fund our research and development expenses, capital expenditures, working capital, sales and marketing

expenses, and general corporate expenses, as well as the increased costs associated with being a public company;

(xiii) our plans with

respect to potentially raising capital, and (xiv) our expectations regarding the impact that the COVID-19 pandemic and related economic

effects will have on our business and results of operations.

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

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our initial success being heavily dependent on the success of our CELsignia

HER2 Pathway Activity Test;

HER2 Pathway Activity Test and of gedatolisib;

our inability to develop and commercialize gedatolisib;

our inability to determine whether our CELsignia

tests are currently commercially viable;

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

our inability to determine whether

our CELsignia tests are currently commercially viable;

challenges we may face in developing and maintaining relationships with pharmaceutical

company partners;

the complexity and timeline for development of CELsignia tests and gedatolisib;

the uncertainty and costs associated with clinical

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;

the pricing of molecular and other diagnostic products and services that compete

uncertainty with insurance coverage and reimbursement for our CELsignia tests;

the uncertainty and costs associated

with clinical trials;

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

community, and regarding the size of market opportunities available to us;

the pricing of molecular and other diagnostic products and

services that compete with us;

uncertainty with insurance coverage and reimbursement for our products;

we may face in managing growth, such as hiring and retaining a qualified sales force and attracting and retaining key personnel;

in government regulations;

tightening credit markets and limitations on access to capital;

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, 2022 and elsewhere in this Quarterly Report.

of filings made with the SEC are available through the SEC’s electronic data gathering analysis and retrieval system (EDGAR) at

tightening credit markets, higher interest rates, and limitations on access to capital;

increasingly sophisticated

cybersecurity threats, 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

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, 2022 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