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Item 2. Management’s Discussion and Analysis

2024-08-14 compared with 2024-05-15 · 375 added, 274 removed, 228 unchanged (74% of the section changed)

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

is a clinical-stage biotechnology company focused on the development of targeted therapies for 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 initiated a Phase

1b/2 study, CELC-G-201, in the first quarter of 2024 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 potent, well-tolerated, small molecule reversible dual inhibitor, administered intravenously, that selectively targets all Class

I isoforms of PI3K and mammalian target of rapamycin (mTOR).

In April 2021, we obtained exclusive global development and commercialization

rights to gedatolisib under a license agreement with Pfizer, Inc.

We believe gedatolisib’s unique mechanism of action, differentiated

chemical structure, favorable pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved

and investigational therapies that target PI3K or mTOR alone or together.

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

kinase complex.

is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ isoforms

and mTORC1 and mTORC2 complexes.

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

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

When a therapy only inhibits a single

Class 1 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.

in turn, induces compensatory resistance that can reduce the efficacy of isoform specific PI3K or single mTOR kinase complex inhibitors.

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

that may occur with isoform-specific PI3K inhibitors and the confounding interaction between PI3K isoforms and mTOR.

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.

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.

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

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

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

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

and mammalian target of rapamycin (mTOR).

In April 2021, we obtained exclusive global development and commercialization rights to gedatolisib

under a license agreement with Pfizer, Inc.

We believe gedatolisib’s unique mechanism of action, differentiated chemical structure,

favorable pharmacokinetic properties, and intravenous formulation offer distinct advantages over currently approved and investigational

therapies that target PI3K or mTOR alone or together.

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

is a pan-class I isoform PI3K inhibitor with low nanomolar potency for the p110α, p110β, p110γ, and p110δ

isoforms and mTORC1 and mTORC2 complexes.

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

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

When a therapy only inhibits

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

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

This, in turn, induces compensatory resistance that can reduce the efficacy of isoform specific PI3K or single mTOR kinase complex

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

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

tolerated by patients than oral PI3K and mTOR drugs.

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

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

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

This typically leads to a high proportion of patients

requiring dose reductions or treatment discontinuation.

The challenging toxicity profile of these drug candidates ultimately played a

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

By contrast, gedatolisib stabilizes

at lower concentration levels in plasma compared to orally administered PI3K inhibitors, resulting in less toxicity, while maintaining

concentrations sufficient to inhibit PI3K/mTOR signaling.

Oral pan-PI3K or PI3K/mTOR inhibitors have repeatably

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

This typically leads to a high proportion

of patients requiring dose reductions or treatment discontinuation.

The challenging toxicity profile of these drug candidates ultimately

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

By contrast, gedatolisib

stabilizes at lower concentration levels in plasma compared to orally administered PI3K inhibitors, resulting in less toxicity, while

maintaining concentrations sufficient to inhibit PI3K/mTOR signaling.

Isoform-specific

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

While the range of toxicities associated with isoform-specific

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

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

3 pivotal trial Piqray was found to induce a Grade 3 or 4 adverse event (AE) related to hyperglycemia in 39% of patients evaluated.

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

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 March 31, 2024, 492 patients with solid tumors have received gedatolisib in eight clinical trials sponsored by Pfizer.

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.

While the range of toxicities associated with

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

still leads to challenging toxicities.

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

the challenge.

In its Phase 3 pivotal trial Piqray was found to induce a Grade 3 or 4 adverse event (AE) related to hyperglycemia

in 39% of patients evaluated.

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

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 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.

Four patients from this study continue to receive study treatment, as of March 31, 2024, each of whom have received study

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.

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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

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

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

Subjects who meet eligibility

criteria and are PIK3CA WT will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant

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

Subjects who meet eligibility criteria and are PIK3CA MT will be

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

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

received approval from the FDA in mid-2023 to proceed with the clinical development

of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients

We have since initiated a Phase 1b/2 study (CELC-G-201) that will enroll up to 54 participants with mCRPC who progressed

after treatment with an androgen receptor inhibitor.

We dosed our first patient in this trial in February 2024.

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

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

An additional 12 participants will then be enrolled

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

with the RP2D of gedatolisib.

Subjects who meet

eligibility criteria and are PIK3CA WT will be randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib,

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

Subjects who meet eligibility criteria and are

PIK3CA MT will be randomly assigned (3:3:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant (Arm D) or

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

Enrollment of the PIK3CA 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.

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

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

We have since initiated a Phase 1b/2 study (CELC-G-201)

that will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor.

We dosed our first

patient in this trial in February 2024.

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

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

An additional 12 participants will then be enrolled in the Phase

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

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

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

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

tumor cells to identify the specific abnormal cellular process driving a patient’s cancer and the targeted therapy that best treats

This enables us to identify patients whose tumors may respond to a targeted therapy, even though they lack a previously associated

molecular mutation.

By identifying cancer patients whose tumors lack an associated genetic mutation but have abnormal cellular activity

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.

While 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 three different targeted therapies, controlled by other pharmaceutical

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

Three 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

February 22, 2024, the Company announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib

in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with mCRPC.

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.

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

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

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

choice of ribociclib or palbociclib).

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

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

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.

of Operations

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

For the three months ended March 31, 2024 and 2023, we reported a net loss of approximately $21.6 million and $11.9 million,

respectively.

As of March 31, 2024, we had an accumulated deficit of approximately $181.7 million.

As of March 31, 2024, we had

cash and cash equivalents and short-term investments of approximately $177.7 million.

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.

of Operating Results

2 unchanged sentences

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

potential regulatory approval to market gedatolisib.

In August 2023, we announced plans to proceed with the clinical development of gedatolisib

in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with mCRPC.

we obtain regulatory approvals to market gedatolisib, we expect to initially generate revenue from sales of the drug for the treatment

of breast cancer patients.

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.

potential regulatory approval to market gedatolisib as a second line treatment for HR+, HER2- advanced breast cancer.

In August 2023,

we announced plans to proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved

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

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

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

advanced breast cancer who are endocrine therapy resistant.

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

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

and Development

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employee-related

expenses related to our research and development activities, including salaries, benefits,

recruiting, travel and stock-based compensation expenses;

expenses related to our research and development activities, including salaries, benefits, recruiting, travel and stock-based compensation

fees paid to third parties;

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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, 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, and CELsignia

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

expense is primarily due to a Loan Agreement and finance lease obligations.

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.

expense is primarily due to a Loan Agreement.

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

of Operations

of the Three Months Ended March 31, 2024 and 2023

Three Months Ended

Increase (Decrease)

Percent Change

Statements of Operations Data:

of the Three Months Ended June 30, 2024 and 2023

Statements of Operations

Operating expenses:

Research and development

General and administrative

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Interest income

Other income (expense), net

Net loss before income taxes

Other income (expense),

loss before income taxes

(23,721,820 )

4 unchanged sentences

$ (9,134,133 )

of the Six Months Ended June 30, 2024 and 2023

Statements of Operations

Operating expenses:

General and administrative

Total operating expenses

Loss from operations

(46,776,921 )

(27,603,022 )

(19,173,899 )

Other income (expense)

Interest expense

Interest income

Other income (expense),

loss before income taxes

(45,334,275 )

(26,526,104 )

(18,808,171 )

Income tax benefits

$ (45,334,275 )

$ (26,526,104 )

$ (18,808,171 )

and Development

research and development expenses for the three months ended March 31, 2024 were approximately $20.7 million, representing an increase

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.

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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.

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, 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.

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.

and Administrative

general and administrative expenses for the three months ended March 31, 2024 were approximately $1.8 million, representing an increase

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

of approximately $0.5 million, or 36%, compared to the same period in 2023.

3 unchanged sentences

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

of approximately $1.1 million, or 41%, compared to the same period in 2023.

Employee related expenses accounted for $0.6 million of the

$1.1 million increase.

The remaining $0.5 million of the increase resulted from professional fees and other administrative expenses.

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

with the potential future commercialization of gedatolisib and CELsignia tests, an expanding infrastructure, and increased professional

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

expense for the three months ended March 31, 2024 was $1.4 million and represents an increase of $0.2 million compared to the same

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

public company regulatory developments and other compliance matters.

expense for the three months ended 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.

The $2.3 million of interest expense includes $0.6 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.

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

The increase is due to the increase in prime interest rates.

The $1.4 million of interest expense includes $0.5 million

of non-cash interest expense.

income for the three months ended March 31, 2024 was $2.3 million and represents an increase of $0.4 million compared to the same period

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

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

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

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

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.

and Capital Resources

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

Through March 31, 2024, we have funded our

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 March 31, 2024, we raised an aggregate of approximately $303.7 million of net

proceeds through sales of our securities, and as of March 31, 2024 had $35.0 million of borrowings under loan agreements.

In March 2024,

an investor exercised 1,739,080 warrants at an exercise price of $8.05, which generated approximately $14 million in cash.

were issued pursuant to a previously reported private placement that closed and was funded on December 9, 2022.

Subsequent to March 31,

2024, pursuant to an Open Market Sale Agreement SM with Jefferies LLC, as agent, the Company sold 435,414 shares of common

stock 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 $0.2 million.

As of March 31, 2024, our cash and cash equivalents and short-term investments were approximately

$31.2 million and $146.5 million, respectively, and we had an accumulated deficit of approximately $181.7 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

exercisable for 6,956,450 shares of common stock to certain institutional and other accredited investors pursuant to a securities purchase

agreement entered into on May 15, 2022.

Pursuant to the securities purchase agreement, the closing (funding) of the private placement

occurred following dosage of the first patient in the Company’s Phase 3 study, VIKTORIA-1.

Investors purchased shares of common

stock and Series A Preferred Stock at a price of $5.75 per share (on an as converted to common stock basis), with forty percent (40%)

warrant coverage (on an as converted to common stock basis) and customary resale registration rights.

The warrants have an exercise price

of $8.05 per share.

The private placement generated gross proceeds of approximately $100 million before deducting placement agent fees

and other offering expenses of $4.3 million.

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

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.

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

$8.70 per warrant, to purchase up to 5,747,787 shares of the Company’s common stock in a private placement.

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expenses of approximately $0.1 million.

Market Sale Agreement SM .

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

At March 31, 2024, $29.8 million of common stock remains available for sale under the Jefferies agreement.

Loan Agreement.

On April 8, 2021, we entered into a Loan Agreement with Innovatus Life Sciences Lending Fund I, LP (“Innovatus”),

under which Innovatus agreed to loan up to $25 million in three tranches consisting of (i) a $15.0 million non-contingent Term A loan

that was funded on April 8, 2021, (ii) a $5 million Term B loan with a deadline of March 31, 2022, and (iii) a $5 million Term C loan

to be funded upon our request, subject to our ability to achieve certain milestones, no later than March 31, 2023.

On August 9, 2022,

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

As of March 31, 2024, 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 March 29, 2024, the Company entered into a Second Amendment to Loan Agreement with

Innovatus in order to extend the date through which the Company may draw on the Term C loan from April 1, 2024 to June 1, 2024.

than as set forth in the Second Amendment to Loan Agreement, the amended Loan Agreement shall continue in full force and effect without

alteration or amendment.

Market Sale Agreement.

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

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

of up to $50,000,000.

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

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

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

transaction at a price of $14.50 per share, generating gross proceeds of $15 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.

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

and Stifel, Nicolaus & Company, Incorporated as representatives of the several underwriters relating to the issuance and sale of

3,871,000 shares of common stock, at a price to the public of $15.50, generating gross proceeds of approximately $60 million.

closed on May 31, 2024 and resulted in net proceeds to the Company of approximately $56.3 million after deducting underwriting discounts

and other offering expenses payable by the Company.

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

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

expansion of business development activities and other general corporate purposes.

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

Agreement”) with Innovatus Life Sciences Lending Fund I, LP, a Delaware limited partnership (“Innovatus”), as collateral

agent, and the Lenders including Innovatus in its capacity as a Lender and Oxford Finance LLC (“Oxford”), pursuant to which

Innovatus and Oxford, as Lenders, have agreed to make certain term loans (“Term Loans”) to the Company in the aggregate principal

amount of up to $180 million.

The A&R Loan Agreement amends and restates, in its entirety, that certain Loan and Security Agreement,

dated April 8, 2021, as amended, between the Company and Innovatus, as collateral agent, and the Lenders named therein.

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

“Term A Loan”) and $21.5 million (the “Term B Loan”) reflecting repayment of the principal amount of loans under

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

The Company will be eligible to draw on a fourth tranche of $30 million (the “Term D Loan”) and fifth tranche of $50 million

(the “Term E Loan”), in each case upon achievement of certain clinical trial milestones and satisfaction of certain financial

covenants determined on a pro forma as-funded basis.

The Lenders may, in their sole discretion upon the Company’s request, make

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

Funding of these additional tranches is also subject

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

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

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

The Term Loans will mature on May 1, 2029 and will bear interest at a rate equal to the sum of (a) the greater of (i) the Prime Rate

(as defined in the A&R Loan Agreement) or (ii) 7.75%, plus (b) 2.85%, provided that 1.0% of such interest will be payable in-kind

by adding an amount equal to such 1.0% of the outstanding principal amount to the then outstanding principal balance on a monthly basis

through May 31, 2027.

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

Proceeds will be used for working capital purposes

and to fund the Company’s general business requirements, including the Phase 3 VIKTORIA-2 clinical trial.

The A&R Loan Agreement

contains customary representations and warranties and covenants, subject to customary carve-outs, and includes financial covenants related

to liquidity and other financial measures.

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

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

(the “Conversion 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.

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

to Innovatus and Oxford warrants to purchase that number of shares of the Company’s common stock equal to 2.5% of the principal

amount of the applicable Term Loan divided by the exercise price, which shall, with respect to the Term C Loan, be equal to the lower

of (i) the volume weighted average closing price of the Company’s common stock for the five-trading day period ending on the last

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

preceding the execution of the A&R Loan Agreement.

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

price of $14.84 per share.

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

For the additional Term Loans, the

exercise price will be based on the lower of (i) the exercise price for the Warrants issued pursuant to the Term C Loan or (ii) the volume

weighted average closing price of the Company’s common stock for the five-trading day period ending on the last trading day immediately

preceding the applicable Term Loan funding.

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

of the applicable funding date.

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

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

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 research related to the discovery of new cancer sub-types, conduct

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 and our CELsignia tests.

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.

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

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

under the Innovatus Loan Agreement will provide sufficient cash to finance our operations and pay obligations when due through 2026.

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 three months ended March 31:

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

Net cash provided by (used in):

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Investing activities

(102,531,391 )

Financing activities

Net increase (decrease) in cash and cash equivalents

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

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

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.

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

accrued expenses and accounts payable and a decrease in other current assets.

The net cash used in operating activities was approximately

$12.9 million for the three months ended March 31, 2023 and consisted primarily of a net loss of approximately $11.9 million and

working capital changes of $1.0 million, offset by non-cash expense items of $0.1 million.

Non-cash expense items of approximately $0.1

million primarily consisted of $1.3 million of stock-based compensation expense and non-cash interest expense of $0.5 million, offset

by $1.7 million of non-cash interest income.

The approximately $1.0 million of working capital changes was primarily due to a decrease

in accrued expenses.

cash provided by investing activities for the three months ended March 31, 2024 was approximately $3.5 million and consisted primarily

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.

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.

Treasury Bills), partially offset by $0.1 million

purchases of property and equipment.

Net cash provided by investing activities for the three months ended March 31, 2023 was approximately

$21.9 million and consisted of net proceeds from maturities of short-term investments in government securities (U.S.

Treasury Bills and

government securities) and minimal purchases of property and equipment.

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

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

registration costs.

The net cash provided by financing activities for the three months ended March 31, 2023 was minimal and primarily

consisted of the exercise of employee stock options offset by payments for secondary registration and debt issuance costs.

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.

Accounting Pronouncements

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

(ii) our expectations with respect to our

competitive advantages, including the potential efficacy of gedatolisib in various patient types alone or in combination with other treatments;

(iii) our expectations regarding the timeline of patient enrollment and results from clinical trials, including our existing Phase 3

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

(iv) our expectations regarding our ability to obtain

FDA approval to commercialize gedatolisib;

(v) our expectations with respect to the development, validation, required approvals, costs

and timelines of gedatolisib and our CELsignia tests;

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

the foreseeable future;

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

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

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

the license agreement;

(ix) our beliefs related to the perceived advantages of our CELsignia tests compared to traditional molecular or

other diagnostic tests;

(ii) our expectations with respect to our competitive

advantages, including the potential efficacy of gedatolisib in various patient types alone or in combination with other treatments;

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

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

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

(v) our expectations with

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

(vi) our plans

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

(vii) our beliefs about our ability to capitalize

on the exclusive global development and commercialization rights obtained from our license agreement with Pfizer with respect to gedatolisib;

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

(ix) our beliefs related to the perceived advantages

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

(x) our revenue expectations;

(xi) our expectations regarding business development activities, including collaborations

with pharmaceutical companies;

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

(xiii) our 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;

our plans with respect to potentially raising capital.

(xi) our expectations

regarding business development activities, including collaborations with pharmaceutical companies;

(xii) our expectations as to the use

of proceeds from our recent financing activities;

(xiii) our expectations with respect to availability of capital, including accessing

our current debt facility or any other debt facility or other capital sources in the future, and our assumption that we will have adequate

authorized shares for future equity issuances;

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

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

costs associated with being a public company;

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

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

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limitations on access to capital;

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

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

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

10-K for the year ended December 31, 2023 and elsewhere in this Quarterly Report.

Copies of filings made with the SEC are available through

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

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

terms or at all;

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

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

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

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

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

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

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