Celcuity Inc

Previous wording

Isoform-specific PI3K inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with isoform-specific inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis still leads to challenging toxicities. The experience with an FDA approved oral p110-α specific inhibitor, Piqray, illustrates the challenge. In its Phase 3 pivotal trial Piqray was found to induce a Grade 3 or 4 adverse event (AE) related to hyperglycemia in 39% of patients evaluated. In 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 9% discontinued treatment.

Current wording

Isoform-specific PI3K inhibitors administered orally were developed to reduce toxicities in patients. While the range of toxicities associated with isoform-specific inhibitors is narrower than oral pan-PI3K or PI3K/mTOR inhibitors, administering them orally on a continuous basis still leads to challenging toxicities. The experience with an FDA approved oral p110-α specific inhibitor, Piqray, illustrates the challenge. In its Phase 3 pivotal trial Piqray was found to induce a Grade 3 or 4 adverse event (“AE”) related to hyperglycemia in 39% of patients evaluated. In addition, 26% of patients discontinued alpelisib due to treatment related AEs. By contrast, in the 103-patient dose expansion portion of the Phase 1b clinical trial with gedatolisib, only 7% of patients experienced Grade 3 or 4 hyperglycemia and less than 9% discontinued treatment.

Previous wording

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

Current wording

High objective overall response rates (“ORR”) were observed in all four expansion arms and were comparable in each arm for PIK3CA wild-type (“WT”) and PIK3CA mutant (“MT”) patients. As of the data cut-off date, March 16, 2023, for treatment- naïve patients in Escalation Arm A and Expansion Arm A (n=41), median progression free survival (mPFS) was 48.6 months, median duration of response (mDOR) was 46.9 months, and ORR was 79%, respectively. This data compares favorably to published data for current first-line standard-of-care treatments for patients with HR+, HER2- advanced breast cancer. In patients who received prior hormonal therapy alone or in combination with a CDK4/6 inhibitor (Arms B, C, and D), ORR (including unconfirmed partial responses) ranged from 36% to 77%. Each arm achieved its primary endpoint target, which was reporting higher ORR in the study arm than ORR from either the PALOMA-2 (ORR=55%) study that evaluated palbociclib plus letrozole for Arm A or the PALOMA-3 study (ORR=25%) that evaluated palbociclib plus fulvestrant for Arms B, C, and D. For all enrolled patients, a clinical benefit rate (CBR) of ≥ 79% was observed. Median progression free survival was 12.9 months for patients who received a prior CDK4/6 inhibitor and were treated in the study with the Phase 3 dosing schedule (Arm D).

Previous wording

Gedatolisib combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity. The majority of treatment emergent adverse events were Grade 1 and 2. The most frequently observed adverse events included stomatitis/mucosal inflammation, the majority of which were Grade 1 and 2. The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed as related to treatment with palbociclib. No grade 5 events were reported in this study.

Current wording

Gedatolisib combined with palbociclib and endocrine therapy demonstrated a favorable safety profile with manageable toxicity. The majority of treatment emergent AEs were Grade 1 and 2. The most frequently observed AEs included stomatitis/mucosal inflammation, the majority of which were Grade 1 and 2. The most common Grade 4 AEs were neutropenia and neutrophil count decrease, which were assessed as related to treatment with palbociclib. No grade 5 AEs were reported in this study.

Previous wording

The 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). 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.

Current wording

The 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). Enrollment of the PIK3CA WT cohort is 100% enrolled and enrollment in the PIK3CA MT cohort is on plan. The PIK3CA WT cohort represents approximately 60% of the total patients enrolled to date in VIKTORIA-1. Based on our current forecast of reaching the event thresholds that will trigger primary analysis in both the PIKCA WT and MT cohorts, we expect to report topline data for the PIK3CA WT cohort sometime in late Q1 2025 or during Q2 2025 and to report topline data for the PIK3CA MT cohort in the second half of 2025. If the results from the PIK3CA wild-type patient cohort are positive, we would expect to file a new drug application, or NDA, with this data and follow-up with a supplemental NDA for the PIK3CA mutant cohort if those results are positive. If gedatolisib ultimately does receive FDA approval for both the PIK3CA wild-type and mutant populations, we estimate the peak revenue potential for this second-line indication could exceed $2 billion.

Previous wording

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 recommended Phase 2 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.

Current wording

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 recommended Phase 2 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 report preliminary data in Q2 of 2025.

Previous wording

The 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 tested. Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant. The safety run-in will be completed, and gedatolisib’s Phase 3 dose confirmed, before enrolling patients in the Phase 3 portion of the study.

Current wording

The Phase 3 VIKTORIA-2 clinical trial, an open-label, randomized study to evaluate the efficacy and safety of gedatolisib combined with fulvestrant plus a CDK4/6 inhibitor in comparison to fulvestrant plus a CDK4/6 inhibitor as first-line treatment for patients with HR+/HER2- advanced breast cancer who are endocrine therapy resistant is on track to enroll its first Patient in Q2 2025. 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 tested. Therefore, a safety run-in of approximately 12-36 subjects will evaluate the safety profile of gedatolisib combined with ribociclib and fulvestrant. The safety run-in will be completed, and gedatolisib’s Phase 3 dose confirmed, before enrolling patients in the Phase 3 portion of the study.

Previous wording

The clinical trial primary endpoints are progression free survival (PFS), per RECIST 1.1 criteria, as assessed by blinded independent central review. The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA wild type and PI3KCA mutant.

Current wording

The clinical trial primary endpoints are progression free survival (PFS), per RECIST 1.1 criteria, as assessed by blinded independent central review. The primary PFS endpoints will be evaluated separately in subjects who are PI3KCA WT and PI3KCA MT.

Previous wording

The study’s design was reviewed and discussed with the U.S. Food and Drug Administration (FDA) during a Type C meeting. This 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.

Current wording

The study’s design was reviewed and discussed with the U.S. Food and Drug Administration (FDA) during a Type C meeting. This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, Latin America, and Asia. Site qualification activities to support activation for the 200 sites is on track.

Previous wording

We have not generated any revenue from sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception in 2012. 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.

Current wording

We have not generated any revenue from sales to date, and we continue to incur significant research and development and other expenses related to our ongoing operations. As a result, we are not and have never been profitable and have incurred losses in each period since our inception in 2012. For the three months ended September 30, 2024 and 2023, we reported a net loss of approximately $29.8 million and $18.4 million, respectively, and for the nine months ended September 30, 2024, we reported a net loss of approximately $75.1 million and $44.9 million, respectively. As of September 30, 2024, we had an accumulated deficit of approximately $235.2 million. As of September 30, 2024, we had cash and cash equivalents and short-term investments of approximately $264.1 million.

Previous wording

Internal and external research and development costs are expensed as they are incurred. As we continue development of gedatolisib and manage studies and clinical trials, including the VIKTORIA-1 Phase 3 trial, the CELC-G-201 Phase 1b/2 trial, and other clinical trials to evaluate the efficacy of targeted therapies in cancer patients selected with one of our CELsignia tests, the proportion of research and development expenses allocated to external spending will grow at a faster rate than expenses allocated to internal expenses.

Current wording

Internal and external research and development costs are expensed as they are incurred. As we continue development of gedatolisib and manage studies and clinical trials, including the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 clinical trial, and the VIKTORIA-2 Phase 3 clinical trial and other clinical trials to evaluate the efficacy of targeted therapies in cancer patients selected with one of our CELsignia tests, the proportion of research and development expenses allocated to external spending will grow at a faster rate than expenses allocated to internal expenses.

Previous wording

Sales and marketing expenses consist primarily of professional and consulting fees related to these functions. To date, we have incurred immaterial sales and marketing expenses as we continue to focus primarily on the development of our first drug, gedatolisib, managing the VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials. We would expect to begin to incur increased sales and marketing expenses in anticipation of the commercialization of our first drug, gedatolisib. These increased expenses are expected to include employee-related, consulting costs and professional fees.

Current wording

Sales and marketing expenses consist primarily of professional and consulting fees related to these functions. To date, we have incurred immaterial sales and marketing expenses as we continue to focus primarily on the development of our first drug, gedatolisib, managing the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 clinical trial, and the VIKTORIA-2 Phase 3 clinical trial. We would expect to begin to incur increased sales and marketing expenses in anticipation of the commercialization of our first drug, gedatolisib. These increased expenses are expected to include employee-related, consulting costs and professional fees.

Previous wording

Our research and development expenses for the three months ended June 30, 2024 were approximately $22.5 million, representing an increase of approximately $8.7 million, or 64%, compared to the same period in 2023. Of the $8.7 million increase in research and development expense, $2.1 million was related to increased employee and consulting expenses. The remaining $6.6 million increase of research and development costs are primarily related to costs supporting activities for the VIKTORIA-1 and CELC-G-201 pivotal trials.

Current wording

Our research and development expenses for the three months ended September 30, 2024 were approximately $27.6 million, representing an increase of approximately $10.1 million, or 58%, compared to the same period in 2023. Of the $10.1 million increase in research and development expense, $6.3 million was primarily related to costs supporting on-going activities for the VIKTORIA-1 and CELC-G-201 trials and the initiation of the VIKTORIA-2 Phase 3 pivotal trial. The remaining $3.8 million was related to increased employee and consulting expenses.

Previous wording

Conducting 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.

Current wording

Conducting a significant amount of research and development is central to our business model. We plan to increase our research and development expenses for the foreseeable future as we seek to develop gedatolisib and manage the VIKTORIA-1 Phase 3, the CELC-G-201 Phase 1b/2 and the VIKTORIA-2 Phase 3 pivotal trial.

Previous wording

Our 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. Of the $0.5 million increase in general and administrative expense, $0.3 million was related to increased employee and consulting expenses. The remaining $0.2 million of the $0.5 million increase resulted from professional fees and other administrative expenses.

Current wording

Our general and administrative expenses for the three months ended September 30, 2024 were approximately $2.5 million, representing an increase of approximately $1.1 million, or 75%, compared to the same period in 2023. Of the $1.1 million increase in general and administrative expense, $0.9 million was related to increased employee and consulting expenses. The remaining $0.2 million of the $1.1 million increase resulted from professional fees and other administrative expenses.

Previous wording

Our 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.

Current wording

Our general and administrative expenses for the nine months ended September 30, 2024 were approximately $6.1 million, representing an increase of approximately $2.1 million, or 53%, compared to the same period in 2023. Employee related expenses accounted for $1.5 million of the $2.1 million increase. The remaining $0.6 million of the increase resulted from professional fees and other administrative expenses.

Previous wording

Interest 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.

Current wording

Interest expense for the three months ended September 30, 2024 was $3.3 million and represents an increase of $2.0 million, or 144%, compared to the same period in 2023. Interest expense is the result of a Loan Agreement that was executed in April 2021, amended in August 2022 and March 2024, and further amended and restated in May 2024. The increase is due primarily to the incremental $61.7 million funding of Term Loan C in May 2024. The $3.3 million of interest expense includes $0.7 million of non-cash interest expense.

Previous wording

Interest 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. 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.

Current wording

Interest expense for the nine months ended September 30, 2024 was $7.0 million and represents an increase of $3.1 million, or 78%, compared to the same period in 2023. The increase is due primarily to the incremental $61.7 million funding of Term Loan C in May 2024. The $7.0 million of interest expense includes $1.9 million of non-cash interest expense.

Previous wording

Interest 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.

Current wording

Interest income for the three months ended September 30, 2024 was $3.6 million and represents an increase of $1.7 million compared to the same period in 2023. The increase was primarily from the closing of additional equity and debt financing activities in May 2024, leading to higher cash, cash equivalents and short-term investment balances.

Previous wording

Interest 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.

Current wording

Interest income for the nine months ended September 30, 2024 was $8.7 million and represents an increase of $3.2 million compared to the same period in 2023. The increase was primarily from the closing of additional equity and debt financing activities in May 2024, leading to higher cash, cash equivalents and short-term investment balances.

Previous wording

Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through June 30, 2024, we have funded our operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes, and borrowings under loan agreements. From inception through June 30, 2024, we raised an aggregate of approximately $367.8 million of net proceeds through sales of our securities, and as of June 30, 2024 had $100.0 million of borrowings under loan agreements, not including payable-in-kind interest. As of June 30, 2024, our cash and cash equivalents and short-term investments were approximately $30.5 million and $252.6 million, respectively, and we had an accumulated deficit of approximately $205.4 million.

Current wording

Since our inception, we have incurred losses and cumulative negative cash flows from operations. Through September 30, 2024, we have funded our operations primarily through private placements and registered offerings of our equity securities and unsecured convertible notes, and borrowings under loan agreements. From inception through September 30, 2024, we raised an aggregate of approximately $368.7 million of net proceeds through sales of our securities, and as of September 30, 2024 had $100.0 million of borrowings under loan agreements, not including payable-in-kind interest. As of September 30, 2024, our cash and cash equivalents and short-term investments were approximately $12.6 million and $251.5 million, respectively, and we had an accumulated deficit of approximately $235.2 million.

Previous wording

Pre-funded Warrants. On October 18, 2023, the Company entered into a securities purchase agreement to sell pre-funded warrants at a price of $8.70 per warrant, to purchase up to 5,747,787 shares of the Company’s common stock in a private placement. The closing of the private placement occurred on October 20, 2023, and resulted in gross proceeds of approximately $50 million, before deducting offering expenses of approximately $0.1 million.

Current wording

Pre-funded Warrants. On October 18, 2023, the Company entered into a securities purchase agreement to sell pre-funded warrants at a price of $8.70 per warrant, to purchase up to 5,747,787 shares of the Company’s common stock in a private placement. The closing of the private placement occurred on October 20, 2023, and resulted in gross proceeds of approximately $50.0 million, before deducting offering expenses of approximately $0.1 million.

Previous wording

*Open 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 expenses). In April 2024 and May 2024, pursuant to the Open Market Sale Agreement with Jefferies LLC, as agent, the Company sold 285,714 and 149,700 shares of common stock, respectively, at an average selling price of $ 17.55 per share, generating gross proceeds of $7.6 million before deducting commissions and other offering expenses of $0.3 million. At June 30, 2024, $22.2 million of common stock remains available for sale under the Jefferies agreement.

Current wording

*Open Market Sale Agreement.*On February 4, 2022, we entered into an Open Market Sale Agreement with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time, through Jefferies, shares of our common stock having an aggregate offering price of up to $50,000,000. On October 12, 2022, pursuant to this agreement, the Company sold 500,000 shares of common stock in a single transaction at a price of $10.35 per share generating gross proceeds of $5.2 million ($4.8 million net of commissions and offering expenses) On December 1, 2023, pursuant to this agreement, the Company sold 1,034,500 shares of common stock in a single transaction at a price of $14.50 per share, generating gross proceeds of $15.0 million ($14.4 million net of commissions and offering expenses). In April 2024 and May 2024, pursuant to the Open Market Sale Agreement with Jefferies LLC, as agent, the Company sold 285,714 and 149,700 shares of common stock, respectively, at an average selling price of $17.55 per share, generating gross proceeds of $7.6 million before deducting commissions and other offering expenses of $0.3 million. At September 30, 2024, $22.2 million of common stock remains available for sale under the Jefferies agreement.

Previous wording

Equity Offering: 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. The offering closed on May 31, 2024 and resulted in net proceeds to the Company of approximately $56.3 million after deducting underwriting discounts and other offering expenses payable by the Company. 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.

Current wording

Equity Offering: 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 $60.0 million. The offering closed on May 31, 2024 and resulted in net proceeds to the Company of approximately $56.3 million after deducting underwriting discounts and other offering expenses payable by the Company. 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.

Previous wording

We expect that our research and development and general and administrative expenses will increase as we continue to develop gedatolisib, manage the VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials, conduct other studies and clinical trials, and pursue other business development activities. We would also expect to incur sales and marketing expenses as we commercialize gedatolisib. We expect to use cash on hand, together with the funds to be received under the debt and equity financings described above, to fund our research and development expenses, clinical trial costs, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses.

Current wording

We expect that our research and development and general and administrative expenses will increase as we continue to develop gedatolisib, manage the VIKTORIA-1 Phase 3 clinical trial, the CELC-G-201 Phase 1b/2 trial and the VIKTORIA-2 Phase 3 pivotal trial, conduct other studies and clinical trials, and pursue other business development activities. We would also expect to incur sales and marketing expenses as we commercialize gedatolisib. We expect to use cash on hand, together with the funds to be received under the debt and equity financings described above, to fund our research and development expenses, clinical trial costs, capital expenditures, working capital, sales and marketing expenses, and general corporate expenses.

Previous wording

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

Current wording

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

Previous wording

Net cash used in operating activities was approximately $35.1 million for the six months ended June 30, 2024 and consisted primarily of a net loss of approximately $45.3 million, offset by working capital changes of $6.9 million and non-cash expense items of approximately $3.3 million. Non-cash expense items of approximately $3.3 million primarily consisted of $2.7 million of stock-based compensation expense and net non-cash interest of $0.5 million. The approximately $6.9 million of working capital changes was primarily due to increases in accrued expenses, accounts payable and other current assets.

Current wording

Net cash used in operating activities was approximately $55.7 million for the nine months ended September 30, 2024 and consisted primarily of a net loss of approximately $75.1 million, partially offset by working capital changes of $13.9 million and non-cash expense items of approximately $5.5 million. Non-cash expense items of approximately $5.5 million primarily consisted of $4.7 million of stock-based compensation expense and net non-cash interest of $0.8 million. The approximately $13.9 million of working capital changes was primarily due to increases in accrued expenses and accounts payable, and a decrease in other current assets.

Previous wording

Net 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.

Current wording

Net cash used in operating activities was approximately $35.3 million for the nine months ended September 30, 2023 and consisted primarily of a net loss of approximately $44.9 million partially offset by non-cash expense items of approximately $4.8 million and working capital changes of $4.8 million. Non-cash expense items of approximately $4.8 million primarily consisted of $3.7 million of stock-based compensation expense, net non-cash interest of $1.0 million and depreciation expense of $0.1 million. The approximately $4.8 million of working capital changes was primarily due to increases in accounts payable and accrued expenses of $3.0 million and $2.8 million, respectively, offset by an approximately $1.0 million increase in other current assets.

Previous wording

Net cash used in investing activities for the six months ended June 30, 2024 was approximately $102.5 million and consisted primarily ofnet purchases of short-term investments in government securities (U.S. Treasury Bills and U.S. government agency).

Current wording

Net cash used in investing activities for the nine months ended September 30, 2024 was approximately $100.6 million and consisted primarily ofnet purchases of short-term investments in government securities (U.S. Treasury Bills and U.S. government securities), partially offset by purchases of property and equipment.

Previous wording

Net 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 and U.S. government securities) and minimal purchase of property and equipment.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2023 was approximately $36.2 million and consisted primarily of net proceeds from maturities of short-term investments in government securities (U.S. Treasury Bills and U.S. government securities) partially offset by minimal purchase of property and equipment.

Previous wording

Net 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 offering. The remaining $14.7 million consisted of proceeds from the exercise of common stock warrants, the exercise of employee stock options and employee stock purchases.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was approximately $138.2 million and primarily consisted of net proceeds of approximately $59.2 million from incremental debt financing, $56.3 million from an equity offering and $7.3 million from an at-the market offering. The remaining $15.4 million consisted of proceeds from the exercise of common stock warrants, the exercise of employee stock options and employee stock purchases.

Previous wording

Net 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.

Current wording

Net 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.