PMV Pharmaceuticals Inc
For the period ended Mar 31, 2025. Filed May 9, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 9, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0000950170-24-122817
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-09.
0000950170-25-067513
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 86 previous paragraphs and 79 current paragraphs.
47 unchanged; 22 reworded; 10 added; 14 removed; 3 previous and 0 current paragraphs rearranged.
Tables are not compared: 6 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Interest Income, Net
Current report
Research and Development Expenses
Current report
$1.0 million decrease in personnel related costs and stock-based compensation as a result of the non-recurring charges from our reduction in force in 2024. Refer to Note 12 of the notes to our condensed consolidated financial statements in this Quarterly Report on Form 10-Q for details on the restructuring.
Current report
General and Administrative Expenses
Current report
Interest Income, Net
Current report
On August 5, 2024, we entered into a Lease Termination Agreement, or the Termination Agreement, with BMR-One Research Way LLC, or the Landlord, to terminate the One Research Way Lease, effective as of September 30, 2024. Pursuant to the Termination Agreement, we surrendered our then-current headquarters at One Research Way and paid a total termination fee of approximately $1.42 million to the Landlord in October 2024. No further amounts or payments related to the One Research Way Lease are owed. The foregoing descriptions of the Termination Agreement is not complete and is qualified in its entirety by reference to the full text of the Termination Agreement, a copy of which was filed as Exhibit 10.1 to our Form 8-K filed with the SEC on August 8, 2024.
Current report
For the three months ended March 31, 2025 and 2024, net cash provided by financing activities was zero.
Current report
Critical Accounting Policies and Estimates
Removed paragraphs (14)
Previous report
$4.1 million increase in research and development expenses associated with advancing our lead product candidate, PC14586, through the Phase 1/2 clinical trial; and
Previous report
$0.7 million decrease in expenses for personnel related costs and stock-based compensation, primarily driven by decreased headcount from our reduction in force initiated in January 2024.
Previous report
General and administrative expenses were $4.9 million for the three months ended September 30, 2024, compared to $6.0 million for the three months ended September 30, 2023. The decrease of $1.1 million, compared to the three months ended September 30, 2023, was primarily due to following:
Previous report
Comparison of the Nine Months Ended September 30, 2024 and 2023.
Previous report
Research and development expenses were $44.8 million for the nine months ended September 30, 2024, compared to $42.5 million for the nine months ended September 30, 2023. The increase of $2.3 million, compared to the nine months ended September 30, 2023, was primarily due to the following:
Previous report
$0.2 million decrease in expenses for personnel related costs and stock-based compensation as a result of reduced headcount from our reduction in force initiated in January 2024.
Previous report
General and administrative expenses were $15.5 million for the nine months ended September 30, 2024, compared to $18.7 million for the nine months ended September 30, 2023. The decrease of $3.2 million, compared to the nine months ended September 30, 2023, was primarily due to following:
Previous report
$1.8 million decrease in personnel expenses driven by a decrease in headcount, $1.1 million decrease in facility and equipment expenses due to expiration of three leases, and $0.5 million decrease in director and officer insurance fees and legal expenses; offset by
Previous report
$0.2 million increase in finance and legal support expenses.
Previous report
In January 2021, we signed a lease for 50,581 square feet of office and laboratory space at One Research Way in Princeton, New Jersey. That lease term extends through 2032 and has a five-year extension option. Amounts related to future lease payments as of September 30, 2024, totaled $13.9 million, with $1.9 million to be paid within the next 12 months. In August 2024, the Company entered into a Lease Termination Agreement with BMR-One Research Way LLC, in connection with the termination of the lease at One Research Way in Princeton, New Jersey. Pursuant to the Termination Agreement, the Company and the Landlord agreed to terminate the lease, contingent on the sale of the property by the Landlord to a prospective new buyer. The sale to the new buyer was completed on October 1, 2024 and the lease was terminated on such date.
Previous report
the costs involved in finalizing our announced reduction in force and related reorganization; and
Previous report
Our financing activities provided $0.1 million of cash during the nine months ended September 30, 2024. This consisted of $0.1 million of proceeds from the exercise of stock options.
Previous report
Our financing activities provided $35.3 million of cash during the nine months ended September 30, 2023. This consisted of $35.1 million of common stock issued under the ATM Program, net of issuance costs, and $0.2 million of proceeds from the exercise of stock options and issuance of common stock under the 2020 ESPP.
Previous report
Critical Accounting Policies and Significant Judgments and Estimates
Reworded paragraphs (22)
Previous wording
Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activities and raising capital. We are not profitable and have incurred losses in each year since our inception. During the three and nine months ended September 30, 2024, the Company incurred net losses of $19.2 million and $35.7 million, respectively. As of September 30, 2024, we had an accumulated deficit of $345.7 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, PC14586 (rezatapopt). In October 2020, we were granted FDA Fast Track Designation of PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we concluded our End of Phase 1 meeting with the FDA with alignment on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for PC14586 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We are continuing to dose patients in the pivotal Phase 2 monotherapy portion of our PYNNACLE trial, and have activated over 75% of sites globally across the U.S., Europe and Asia-Pacific. In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MD Anderson Cancer Center and the Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacytidine in patients harboring a TP53 Y220C mutation. We expect that enrollment for this Phase 1b study will begin in the first quarter of 2025. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025.
Current wording
Since our formation in March 2013, we have devoted substantially all of our time and efforts to performing research and development activities and raising capital. We are not profitable and have incurred losses in each year since our inception. During the three months ended March 31, 2025, we incurred net losses of $17.4 million. As of March 31, 2025, we had an accumulated deficit of $386.1 million. We do not currently have any product candidates approved for sale, and we continue to incur significant research and development and general administrative expenses related to our operations. We initiated a Phase 1/2 clinical trial, PYNNACLE, in October 2020 for our lead product candidate, rezatapopt. Our strategy is to seek approval under an accelerated pathway, and we believe our PYNNACLE clinical trial has the potential to serve as a pivotal study. In October 2020, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In July 2023, we met with the FDA at an End of Phase 1 meeting where alignment was obtained on the recommended Phase 2 dose and key elements of the single arm, Phase 2 registrational portion of the PYNNACLE study. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Annual Meeting. We dosed our first patient in the pivotal Phase 2 monotherapy portion of the PYNNACLE study in the first quarter of 2024. We are continuing to dose patients in the pivotal Phase 2 monotherapy portion of our PYNNACLE trial, and have activated over 90% of sites globally across the U.S., U.K., Europe and Asia-Pacific. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025, with interim analysis data for approximately 50 patients, of which approximately 40% are in the ovarian cancer cohort, who have been followed for at least 18 weeks. In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MD Anderson Cancer Center, or MDACC, and the Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacitidine in relapsed or refractory, or R/R, acute myeloid leukemia, or AML, and myelodysplastic syndromes, or MDS, patients harboring a TP53 Y220C mutation. MDACC dosed its first patient for this Phase 1b study in the first quarter of 2025.
Previous wording
We expect that our operating expenses will increase significantly as we advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, discover, validate, and develop additional product candidates; obtain, maintain, protect, and enforce our intellectual property portfolio; and hire additional personnel. Furthermore, we have incurred and will continue to incur additional costs associated with operating as a public company that we did not experience as a private company. We expect to continue to incur significant losses for the foreseeable future.
Current wording
We expect that our operating expenses will increase significantly as we advance our product candidates through preclinical and clinical development, seek regulatory approval, and prepare for and, if approved, proceed to commercialization; acquire, discover, validate, and develop additional product candidates; obtain, maintain, protect, and enforce our intellectual property portfolio; and hire additional personnel. We expect to continue to incur significant losses for the foreseeable future.
Previous wording
To date, we have not generated any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, or license agreements with third parties, we may generate revenue in the future from product sales. However, there can be no assurance as to when we will generate such revenue, if at all.
Current wording
To date, we have not generated any revenue from any sources, including from product sales, and we do not expect to generate any revenue from the sale of products in the foreseeable future. If our development efforts for our product candidates are successful and result in regulatory approval, or result in license agreements with third parties, we may generate revenue in the future from product sales or license agreements. However, there can be no assurance as to when we will generate such revenue, if at all.
Previous wording
We do not allocate our costs by product candidate or development program, as a significant amount of research and development expenses include compensation costs, materials, supplies, depreciation on and maintenance of research equipment, and the cost of services provided by outside contractors, which are not tracked by product candidate or development program. In particular, with respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. Substantially all of our research and development costs are associated with our lead product candidate, PC14586 (rezatapopt). We initiated a Phase 1/2 clinical trial in October 2020 for our lead product candidate, PC14586. In October 2020, we were granted FDA Fast Track Designation of PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In October 2023, we presented our updated Phase 1 clinical data for PC14586 at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We are continuing to dose patients, and have activated over 60% of sites globally across the US, Europe and Asia-Pacific, in the registrational, tumor-agnostic PYNNACLE Phase 2 trial of PC14586 in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type (WT). In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MD Anderson Cancer Center and the Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacytidine in patients harboring a TP53 Y220C mutation. We expect that enrollment for this Phase 1b study will begin in the first quarter of 2025. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025.
Current wording
We do not allocate our costs by product candidate or development program, as a significant amount of research and development expenses include compensation costs, materials, supplies, depreciation on and maintenance of research equipment, and the cost of services provided by outside contractors, which are not tracked by product candidate or development program. In particular, with respect to internal costs, several of our departments support multiple product candidate research and development programs, and therefore the costs cannot be allocated to a particular product candidate or development program. Substantially all of our research and development costs are associated with our lead product candidate, rezatapopt. We initiated our Phase 1/2 PYNNACLE clinical trial in October 2020, and on that date, we were granted FDA Fast Track designation of rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation. In October 2023, we presented our updated Phase 1 clinical data for rezatapopt at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics Meeting. We are continuing to dose patients and have activated over 90% of sites globally across the U.S., U.K., Europe and Asia-Pacific, in the registrational, tumor-agnostic PYNNACLE Phase 2 trial of rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation and KRAS wild-type. We also expect to provide interim data on the Phase 2 monotherapy registrational portion of the PYNNACLE trial by mid-2025, with interim analysis data for approximately 50 patients, of which approximately 40% are in the ovarian cancer cohort, who have been followed for at least 18 weeks. In October 2024, we discontinued enrollment in the Phase 1b combination arm of the PYNNACLE trial evaluating rezatapopt in combination with Merck and Co.’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors harboring a TP53 Y220C mutation. Additionally, we announced that we are collaborating with the MDACC and MSK to support an investigator-initiated Phase 1b study, which is designed to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of rezatapopt monotherapy in combination with azacitidine in R/R AML and MDS patients harboring a TP53 Y220C mutation. MDACC dosed its first patient for this Phase 1b study in the first quarter of 2025.
Previous wording
General and administrative expenses include personnel costs, expenses for outside professional services and other allocated expenses. Personnel costs consist of salaries, bonuses, benefits, and stock-based compensation. Outside professional services consist of legal, accounting and audit services and other consulting fees. Allocated expenses consist of rent expense related to our office and research and development facilities. We also expect to increase our general and administrative expenses as we advance our product candidates through preclinical research and development, manufacturing, clinical development, and commercialization.
Current wording
General and administrative expenses include personnel costs, expenses for outside professional services and other allocated expenses. Personnel costs consist of salaries, bonuses, benefits, and stock-based compensation. Outside professional services consist of legal, accounting and audit services and other consulting fees. Allocated expenses consist of rent expense related to our office and research and development facilities. We have incurred expenses related to compliance with the rules and regulations of the SEC, and those of any national securities exchange on which our securities are traded, additional insurance expenses, investor relations activities and other administrative and professional services. We also expect to increase our general and administrative expenses as we advance our product candidates through preclinical research and development, manufacturing, clinical development, and commercialization.
Previous wording
Research and development expenses were $16.9 million for the three months ended September 30, 2024, compared to $13.6 million for the three months ended September 30, 2023. The increase of $3.3 million, compared to the three months ended September 30, 2023, was primarily due to the following:
Current wording
Research and development expenses were $17.4 million for the three months ended March 31, 2025, compared to $13.2 million for the three months ended March 31, 2024. The increase of $4.2 million, compared to the three months ended March 31, 2024, was primarily due to the following:
Previous wording
$2.5 million increase in research and development expenses, largely driven by increased contractual research organization costs; offset by
Current wording
$5.2 million increase in research and development expenses largely driven by increased contractual research organization costs for the advancement of the rezatapopt program; offset by
Previous wording
$0.9 million decrease in personnel expenses driven by a decrease in headcount and $0.2 million decrease in director and officer insurance fees.
Current wording
General and administrative expenses were $4.1 million for the three months ended March 31, 2025, compared to $5.0 million for the three months ended March 31, 2024. The decrease of $0.9 million, compared to the three months ended March 31, 2024, was primarily due to a $0.8 million decrease in personnel expenses driven by a decrease in headcount, and a $0.1 million decrease in facility and equipment expenses primarily due to reduced lease costs.
Previous wording
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $2.6 million for the three months ended September 30, 2024. The decrease of $0.4 million compared to the three months ended September 30, 2023, is driven by less cash and investments in marketable securities and U.S treasuries during the three months ended September 30, 2024.
Current wording
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents, and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $1.9 million for the three months ended March 31, 2025, compared to $3.0 million for the three months March 31, 2024. The decrease of $1.1 million compared to the three months ended March 31, 2024, was driven by decreased interest rates from cash and investments in marketable securities and U.S treasuries during the three months ended March 31, 2025.
Previous wording
As of September 30, 2024, the Company received $16.2 million of cash for the NOL and R&D tax credit sales related to the tax years ended December 31, 2015 to 2022. The sale of the NOLs and R&D tax credits have been recorded as an income tax benefit within the condensed consolidated statement of operations.
Current wording
The State of New Jersey’s Technology Business Tax Certificate Program allows certain high technology and biotechnology companies to sell NOL carryforwards and R&D tax credits to other New Jersey-based corporate taxpayers. As of March 31, 2025, we received $18.4 million of cash for the NOL and R&D tax credit sales related to the tax years ended December 31, 2015 to 2023. The sale of the NOLs and R&D tax credits have been recorded as an income tax benefit within the condensed consolidated statement of operations. As of March 31, 2025, we had reached the sale limit established by the program. For the three months ended March 31, 2025, we received a benefit for income taxes of $2.2 million. We did not receive any benefit for income taxes for the three months ended March 31, 2024.
Previous wording
Since our inception, we have not generated any revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all. As of September 30, 2024, we had cash, cash equivalents, and marketable securities of $197.9 million and an accumulated deficit of $345.7 million.
Current wording
Since our inception, we have not generated any revenue from any product sales or any other sources and have incurred significant operating losses and negative cash flows from our operations. We have not yet commercialized any of our product candidates and we do not expect to generate revenue from sales of any product candidates for several years, if at all. As of March 31, 2025, we had cash, cash equivalents, and marketable securities of $165.8 million and an accumulated deficit of $386.1 million. We have financed our operations primarily through issuance and sales of our equity securities.
Previous wording
On October 4, 2021, we filed a shelf registration statement on Form S-3, as amended, (File No. 333-260012) with the SEC, or the Prior Shelf Registration Statement, which registered the offering, issuance, and sale of up to $200 million of various equity and debt securities and up to $150 million of common stock pursuant to an at-the-market equity offering program with Jefferies LLC, dated October 4, 2021, or the ATM Program. The Prior Shelf Registration Statement expired on October 4, 2024 and no shares of our common stock were able to be sold pursuant to the ATM Program following such date. We expect to file a new shelf registration statement on Form S-3 in order to, amongst other things, issue and sell common stock pursuant to the ATM Program. During the three and nine months ended September 30, 2024, we did not sell any shares of its common stock under the ATM Program. As of September 30, 2024, we have approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
Current wording
On November 20, 2024 we filed a shelf registration statement on Form S-3 (File No. 333-283349) with the SEC and a prospectus supplement, which registered the offering, issuance and sale of up to $200.0 million of various equity and debt securities and up to $113.8 million of common stock pursuant to an at-the-market equity offering program with Jefferies LLC, dated October 4, 2021, or the ATM Program. The SEC declared the registration statement effective on November 27, 2024. During the three months ending March 31, 2025, we did not sell any shares of our common stock pursuant to the ATM Program. As of March 31, 2025, we had approximately $113.8 million remaining in gross proceeds available for future issuances of common stock under the ATM Program.
Previous wording
In September 2024, we signed two subleases, one for 14,201 square feet of office space at 400 Alexander Park Drive, Suite 301, in Princeton, New Jersey, to be used as our new headquarters (“400 Alexander Sublease”), and the other for 3,025 square feet of office and laboratory space at 311 Pennington Rocky Hill in Hopewell, New Jersey, to be used for our new laboratory space (“311 Pennington Sublease”). The 400 Alexander Sublease term extends until February 28, 2027, and the 311 Pennington Sublease term extends until December 2029 and has a three-year extension option. Amounts related to future lease payments for 311 Pennington Sublease as of September 30, 2024, totaled $0.8 million with $0.1 million to be paid within the next 12 months. Amounts related to future lease payments for 400 Alexander Sublease as of October 1, 2024 totaled $0.8 million with $0.3 million to be paid within the next 12 months.
Current wording
In September 2024, we signed two subleases, one for 14,201 square feet of office space at 400 Alexander Park Drive, Suite 301, in Princeton, New Jersey, to be used as our new headquarters, or the 400 Alexander Sublease, and the other for 3,205 square feet of office and laboratory space at 311 Pennington Rocky Hill in Hopewell, New Jersey, to be used for our new laboratory space, or the 311 Pennington Sublease. The 400 Alexander Sublease term extends until February 2027, and the 311 Pennington Sublease term extends until December 2029 and has a three-year extension option. Amounts related to future lease payments for 311 Pennington Sublease as of March 31, 2025, totaled $0.7 million with $0.2 million to be paid within the next 12 months. Amounts related to future lease payments for 400 Alexander Sublease as of March 31, 2025, totaled $0.7 million with $0.3 million to be paid within the next 12 months.
Previous wording
We use our capital resources primarily to fund operating expenses, mainly research and development expenditures. On January 18, 2024, we announced a restructuring plan involving the reduction of our workforce by approximately 30% of our employees. All of the costs under the restructuring plan were incurred during the nine months ended September 30, 2024. We undertook these steps in order to streamline operations, reduce costs and preserve capital as we advance our lead candidate, PC14586, into late-stage development. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Current wording
We use our capital resources primarily to fund operating expenses, mainly research and development expenditures. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval and commercialize our current product candidates or any future product candidates, if at all. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.
Previous wording
Due to our significant research and development expenditures, we have generated substantial operating losses in each period since inception. We have incurred an accumulated deficit of $345.7 million through September 30, 2024. We expect to incur substantial additional losses in the future as we expand our research and development activities. For the nine months ended September 30, 2024 and 2023, our cash operating expenditures were $34.6 million and $43.6 million, respectively. Based on our research and development plans, we expect that our cash, cash equivalents and marketable securities as of September 30, 2024 will be sufficient to fund our operations to the end of 2026.
Current wording
Due to our significant research and development expenditures, we have generated substantial operating losses in each period since inception. We have incurred an accumulated deficit of $386.1 million through March 31, 2025. We expect to incur substantial additional losses in the future as we expand our research and development activities. For the three months ended March 31, 2025 and 2024, our cash operating expenditures were $18.3 million and $16.2 million, respectively. Based on our research and development plans, we expect that our cash, cash equivalents, and marketable securities as of March 31, 2025 will be sufficient to fund our planned operations at least through the end of 2026.
Previous wording
the cost and timing of regulatory approvals;
Current wording
the cost and timing of regulatory approvals; and
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2023, was $43.6 million, which consisted primarily of net loss of $53.2 million partially offset by non-cash charges of $6.5 million. Changes in our net operating assets increased operating cash by $3.1 million. The non-cash charges primarily consisted of stock-based compensation of $9.4 million, accretion of premiums on marketable securities of $3.5 million, depreciation of $0.9 million, and non-cash lease income of $0.3 million. The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expenses and other assets, a decrease in outstanding payables and an increase in accrued expenses.
Current wording
Net cash used in operating activities for the three months ended March 31, 2025, was $18.3 million, which consisted primarily of net loss of $17.4 million partially offset by non-cash charges of $0.7 million. Changes in our net operating assets decreased operating cash by $1.5 million. The non-cash charges primarily consisted of stock-based compensation of $1.5 million, and accretion of discounts on marketable securities of $0.8 million. The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expenses and other assets, an increase in outstanding payables and a decrease in accrued expenses.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2024, was $34.6 million, which consisted primarily of net loss of $35.7 million partially offset by non-cash charges of $4.1 million. Changes in our net operating assets decreased operating cash by $3.0 million. The non-cash charges primarily consisted of stock-based compensation of $7.6 million, accretion of discounts on marketable securities of $4.2 million, depreciation of $1.1 million, and non-cash lease income of $0.3 million. The change in our net operating assets and liabilities was primarily due to an increase in prepaid expenses and other assets, and a decrease in outstanding payables and accrued expenses.
Current wording
Net cash used in operating activities for the three months ended March 31, 2024, was $16.2 million, which consisted primarily of net loss of $15.3 million partially offset by non-cash charges of $1.3 million. Changes in our net operating assets decreased operating cash by $2.2 million. The non-cash charges primarily consisted of stock-based compensation of $2.6 million, accretion of discounts on marketable securities of $1.6 million, depreciation of $0.4 million, and non-cash lease income of $0.1 million. The change in our net operating assets and liabilities was primarily due to an increase in prepaid expenses and other assets, a decrease in outstanding payables and an increase in accrued expenses.
Previous wording
Our investing activities used $48.0 million of cash during nine months ended September 30, 2023, which consisted primarily of purchases of marketable securities of $187.1 million, along with purchases of property and equipment of $0.8 million, partially offset by maturities of marketable securities of $140.0 million.
Current wording
Our investing activities provided $28.7 million of cash during the three months ended March 31, 2025, which consisted primarily of maturities of marketable securities of $44.4 million, partially offset by purchases of marketable securities of $15.7 million.
Previous wording
Our investing activities provided $45.6 million of cash during the nine months ended September 30, 2024, which consisted primarily of maturities of marketable securities of $157.0 million, partially offset by purchases of marketable securities of $110.8 million, along with purchases of property and equipment of $0.6 million.
Current wording
Our investing activities provided $26.2 million of cash during the three months ended March 31, 2024, which consisted primarily of maturities of marketable securities of $57.2 million, partially offset by purchases of marketable securities of $30.5 million, along with purchase of property and equipment of $0.6 million.
Previous wording
We believe that the accounting policies described below involve a high degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our financial condition and results of our operations. During the nine-month period ended September 30, 2024, there were no material changes to our critical accounting policies from those described in our audited condensed consolidated financial statements for the year ended December 31, 2023, included in our Annual Report on Form 10-K filed with the SEC on February 29, 2024, except as noted below.
Current wording
We believe that the accounting policies described below involve a high degree of judgment and complexity. Accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our financial condition and results of our operations. During the three-month period ended March 31, 2025, there were no material changes to our critical accounting policies from those described in our audited condensed consolidated financial statements for the year ended December 31, 2024, included in our Annual Report on Form 10-K filed with the SEC on March 3, 2025, except as noted below.
Previous wording
For a description of recent accounting pronouncements, see Note 2 of the notes to our unaudited condensed consolidated financial statements for the nine months ended September 30, 2024 included elsewhere in this Quarterly Report on Form 10-Q.
Current wording
For a description of recent accounting pronouncements, see Note 2 of the notes to our unaudited condensed consolidated financial statements for the three months ended March 31, 2025 included elsewhere in this Quarterly Report on Form 10-Q.
Rearranged previous paragraphs (3)
Previous report — wording carried elsewhere
The following table summarizes our results of operations (in thousands):
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses incurred during the periods indicated (in thousands):
Previous report — wording carried elsewhere
Interest income, net primarily consists of interest income from our interest-bearing cash, cash equivalents and marketable securities and interest costs related to accretion and amortization of discounts and premiums on marketable securities. Interest income, net was $8.4 million for the nine months ended September 30, 2024. The increase of $0.4 million compared to the nine months ended September 30, 2023, is driven by increased interest rates from cash and investments in marketable securities and U.S treasuries during the nine months ended September 30, 2024.