PMV Pharmaceuticals Inc

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 six months ended June 30, 2024, the Company incurred net losses of $1.2 million and $16.5 million, respectively. As of June 30, 2024, we had an accumulated deficit of $326.5 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 60% of sites globally across the US, Europe and Asia-Pacific. In addition, for the separate Phase 1b arm of the PYNNACLE trial, which combines rezatapopt with KEYTRUDA® (pembrolizumab) in collaboration with Merck and Co, we have updated patient eligibility criteria to exclude patients with KRAS single-nucleotide variant, consistent with the Phase 2 monotherapy eligibility criteria, and are continuing to identify the optimal combination dose. We 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 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.

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 addition, for the separate Phase 1b arm of the PYNNACLE trial, which combines rezatapopt with KEYTRUDA® (pembrolizumab) in collaboration with Merck and Co., we have updated patient eligibility criteria to exclude patients with KRAS single-nucleotide variant, consistent with the Phase 2 monotherapy eligibility criteria, and are continuing to identify the optimal combination dose. We 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, 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.

Previous wording

Research and development expenses were $14.6 million for the three months ended June 30, 2024, compared to $13.8 million for the three months ended June 30, 2023. The increase of $0.8 million, compared to the three months ended June 30, 2023, was primarily due to the following:

Current 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:

Previous wording

$1.3 million increase in development expenses associated with advancing our lead product candidate, PC14586, through the Phase 1/2 clinical trial; and

Current wording

$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 wording

$0.1 million decrease in expenses for personnel related costs and stock-based compensation, primarily driven by decreased headcount.

Current wording

$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 wording

General and administrative expenses were $5.5 million for the three months ended June 30, 2024, compared to $6.3 million for the three months ended June 30, 2023. The decrease of $0.8 million, compared to the three months ended June 30, 2023, was primarily due to following:

Current wording

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 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 $5.8 million for the six months ended June 30, 2024. The increase of $0.7 million compared to the six months ended June 30, 2023, is driven by increased interest rates from cash and investments in marketable securities and U.S treasuries during the six months ended June 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 $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.

Previous wording

Research and development expenses were $27.8 million for the six months ended June 30, 2024, compared to $28.9 million for the six months ended June 30, 2023. The decrease of $1.1 million, compared to the six months ended June 30, 2023, was primarily due to the following:

Current wording

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 wording

$1.6 million decrease in research and development expenses, largely driven by decreased contractual research organization costs; offset by

Current wording

$2.5 million increase in research and development expenses, largely driven by increased contractual research organization costs; offset by

Previous wording

$0.5 million increase in expenses for personnel related costs and stock-based compensation as a result of the non-recurring charges from our reduction in force initiated in January 2024.

Current wording

$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 wording

General and administrative expenses were $10.6 million for the six months ended June 30, 2024, compared to $12.7 million for the six months ended June 30, 2023. The decrease of $2.1 million, compared to the six months ended June 30, 2023, was primarily due to following:

Current wording

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 wording

$0.6 million decrease in personnel expenses driven by a decrease in headcount, $0.3 million decrease in facility and equipment expenses due to expiration of three leases, and $0.2 million decrease in director and officer insurance fees, offset by a $0.3 million increase in finance and legal support expenses

Current wording

$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 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 $2.8 million for the three months ended June 30, 2024. The increase of $0.1 million compared to the three months ended June 30, 2023, is driven by increased interest rates from cash and investments in marketable securities and U.S treasuries during the three months ended June 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 $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.

Previous wording

As of June 30, 2024, the Company received $16,176 of cash for the NOL and R&D tax credit sales related to the tax years ended December 31, 2015 to 2020. 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

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.

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 June 30, 2024, we had cash, cash equivalents, and marketable securities of $212.9 million and an accumulated deficit of $326.5 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 September 30, 2024, we had cash, cash equivalents, and marketable securities of $197.9 million and an accumulated deficit of $345.7 million.

Previous wording

We have a shelf registration statement on Form S-3 on file with the SEC, which registers 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 our at-the-market equity offering program, dated October 4, 2021, or the ATM Program. During the three and six months ended June 30, 2024, the Company did not sell any shares of its common stock under the ATM Program. As of June 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 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.

Previous wording

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 June 30, 2024, totaled $14.3 million, with $1.8 million to be paid within the next 12 months.

Current wording

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 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. Substantially all of the costs under the restructuring plan were incurred during the six months ended June 30, 2024. The remaining expected costs are not expected to be material and will be complete by September 30, 2024. As announced, we are taking 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. 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.

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 $326.5 million through June 30, 2024. We expect to incur substantial additional losses in the future as we expand our research and development activities. For the six months ended June 30, 2024 and 2023, our cash operating expenditures were $17.8 million and $27.9 million, respectively. Based on our research and development plans, we expect that our cash, cash equivalents and marketable securities as of June 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 $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.

Previous wording

the costs involved in implementing our announced reduction in force and related reorganization; and

Current wording

the costs involved in finalizing our announced reduction in force and related reorganization; and

Previous wording

Net cash used in operating activities for the six months ended June 30, 2024, was $17.8 million, which consisted primarily of net loss of $16.5 million partially offset by non-cash charges of $2.9 million. Changes in our net operating assets decreased operating cash by $4.2 million. The non-cash charges primarily consisted of stock-based compensation of $5.4 million, accretion of discounts on marketable securities of $3.0 million, depreciation of $0.7 million, and non-cash lease income of $0.2 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 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.

Previous wording

Net cash used in operating activities for the six months ended June 30, 2023, was $27.9 million, which consisted primarily of net loss of $36.6 million partially offset by non-cash charges of $4.8 million. Changes in our net operating assets increased operating cash by $3.9 million. The non-cash charges primarily consisted of stock-based compensation of $6.1 million, accretion of premiums on marketable securities of $1.7 million, depreciation of $0.5 million, and non-cash lease income of $0.2 million. The change in our net operating assets and liabilities was primarily due to a decrease in prepaid expenses and other assets, and an increase in outstanding payables and accrued expenses.

Current 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.

Previous wording

Our investing activities provided $28.5 million of cash during the six months ended June 30, 2024, which consisted primarily of maturities of marketable securities of $100.5 million, partially offset by purchases of marketable securities of $71.4 million, along with purchase of property and equipment of $0.6 million.

Current 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.

Previous wording

Our investing activities used $14.3 million of cash during the six months ended June 30, 2023, which consisted primarily of purchases of marketable securities of $129.6 million, along with purchase of property and equipment of $0.7 million, partially offset by maturities of marketable securities of $116.0 million.

Current 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.

Previous wording

Our financing activities provided $0.1 million of cash during the six months ended June 30, 2024. This consisted of $0.1 million of proceeds from the exercise of stock options.

Current wording

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 wording

Our financing activities provided $2.1 million of cash during the six months ended June 30, 2023. This consisted of $2.0 million of common stock issued under the ATM Program, net of issuance costs, and $0.1 million of proceeds from the exercise of stock options.

Current wording

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 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 six-month period ended June 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 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.

Previous wording

For a description of recent accounting pronouncements, see Note 2 of the notes to our unaudited condensed consolidated financial statements for the six months ended June 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 nine months ended September 30, 2024 included elsewhere in this Quarterly Report on Form 10-Q.