Revolution Medicines Inc
For the period ended Jun 30, 2024. Filed Aug 7, 2024.
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.
Jun 30, 2024 · Filed Aug 7, 2024
RVMD$192.28+8.2%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-08.
0000950170-24-055655
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0000950170-24-092783
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 139 previous paragraphs and 142 current paragraphs.
97 unchanged; 31 reworded; 13 added; 9 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 3 previous and 3 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 (13)
Current report
On July 15, 2024, we reported updated clinical safety, tolerability and activity data from the RMC-6236-001 study, as of a May 11, 2024 cut-off date (the Data Cutoff Date), for patients with previously treated PDAC. In the RMC-6236-001 study, a total of 127 patients with PDAC treated across dose cohorts ranging from 160 mg daily to 300 mg daily were evaluated for safety and tolerability as of the Data Cutoff Date. As of the Data Cutoff Date, approximately 22% of these patients experienced a Grade 3 or higher treatment-related adverse event (TRAE), and 96% of these patients experienced a TRAE of any grade. The most common TRAEs that were observed were rash and gastrointestinal-related toxicities. We also reported TRAEs that led to dose modifications, where we observed dose interruption and/or reduction for 28% of these patients, but no TRAEs leading to discontinuation.
Current report
We also reported preliminary progression-free survival (PFS) data as of the Data Cutoff Date for patients with metastatic PDAC treated with RMC-6236 in the second-line (2L) setting across dose cohorts ranging from 160 mg daily to 300 mg daily. As of the Data Cutoff Date, the median PFS for these patients with tumors harboring KRAS G12X mutations was 8.1 months (95% confidence interval (CI): 5.9 months, not estimable), and the median PFS for these patients with tumors harboring G12X, G13X and Q61X mutations was 7.6 months (95% CI: 5.3 months, not estimable). We also reported preliminary PFS data as of the Data Cutoff Date for patients with tumors harboring KRAS G12X mutations who were treated with RMC-6236 in the third-line or later (3L+) setting across dose cohorts ranging from 160 mg daily to 300 mg daily. As of the Data Cutoff Date, the median PFS for these patients was 4.2 months (95% CI: 4.1 months, 6.4 months).
Current report
In addition, we reported best percentage change in tumor size from baseline for patients with PDAC treated with RMC-6236 in the 2L or later (2L+) setting as of the Data Cutoff Date. The ORR for these patients who received the first dose of RMC-6236 at least 14 weeks prior to the Data Cutoff Date was 20% for patients with tumors harboring KRAS G12X mutations and was 21% for patients with tumors harboring G12X, G13X and Q61X mutations. The ORR for these patients who received the first dose of RMC-6236 at least 20 weeks prior to the Data Cutoff Date was 27% for patients with tumors harboring KRAS G12X mutations and was 26% for patients with tumors harboring G12X, G13X and Q61X mutations. The DCR for these patients who received the first dose of RMC-6236 at least 14 weeks prior to the Data Cutoff Date was 87% for patients with tumors harboring KRAS G12X mutations and was 88% for patients with tumors harboring G12X, G13X and Q61X mutations.
Current report
We also reported interim observed overall survival, or OS, data as of the Data Cutoff Date for patients with metastatic PDAC who were treated with RMC-6236 in the 2L setting across dose cohorts ranging from 160 mg daily to 300 mg daily. The interim OS as of the Data Cutoff Date for these patients with tumors harboring KRAS G12X mutations was not estimable (95% CI: 8.5 months, not estimable) and for patients with tumors harboring G12X, G13X and Q61X mutations was also not estimable (95% CI: 8.5 months, not estimable).
Current report
We are planning a global, randomized Phase 3 registrational trial of RMC-6236 in the 2L treatment of patients with metastatic PDAC, which we call the RASolute 302 study. In the RASolute 302 study, we plan to randomize patients in a 1:1 ratio to receive either RMC-6236 at a dose of 300 mg daily or the investigator’s choice of chemotherapy. The RASolute 302 study is further anticipated to have a nested trial design allowing for a hierarchical sequence of statistical analysis, with patients with tumors harboring RAS G12X mutations serving as the core population which will be tested first and all enrolled patients serving as the secondary population. We believe this nested design and hierarchical testing increases the probably of trial success based on the core population while creating an opportunity to gain approval for a broader population. Patients in the RASolute 302 study are expected to be evaluated for the dual primary endpoints of PFS and OS, with secondary endpoints including ORR and quality of life measures. The Company’s current planned trial design and dose selection for the RASolute 302 study are based on initial feedback from the U.S. Food and Drug Administration (FDA), including supportive discussions on high level trial design and dose, but are subject to finalization pending the Company’s final protocol submission and FDA review. We currently expect to initiate the RASolute 302 study in the second half of 2024.
Current report
Other income (expense), net
Current report
Research and development expenses increased by $86.0 million, or 52%, during the six months ended June 30, 2024 compared to the same period in 2023. The increase in research and development expenses during the six months ended June 30, 2024 was primarily due to a $22.5 million increase in RMC-6236 expenses, primarily attributable to clinical trial expenses; a $20.0 million increase in salaries and other employee-related expenses due to increased headcount to support our research and development programs; a $13.5 million increase in our preclinical research portfolio expenses; a $12.8 million increase in RMC-6291 expenses, primarily attributable to higher clinical trial expenses; a $9.7 million increase in stock-based compensation; a $7.6 million increase in other research and development expenses as a result of higher rent, utilities and information technology expenses associated with increased headcount; and a $6.3 million increase in RMC-9805 expenses primarily attributable to clinical trial expenses; partially offset by a $6.4 million decrease in other RAS companion inhibitor program expenses.
Current report
General and administrative expenses increased by $7.1 million, or 48%, during the three months ended June 30, 2024 compared to the same period in 2023. The increase in general and administrative expenses during the three months ended June 30, 2024 was primarily due to a $1.9 million increase in salaries and other employee-related expenses due to increased headcount; a $1.9 million increase in commercial preparation activities and a $1.7 million increase in stock-based compensation expense.
Current report
Other income (expense), net
Current report
We will require substantial additional financing for our development efforts for our current and future programs and to prepare for their potential commercialization. We do not have any committed external source of funds or other support for these activities, and we expect to finance our cash needs through a combination of public or private equity offerings, debt financings, credit or loan facilities, acquisitions, collaborations, strategic alliances, licensing arrangements and other marketing or distribution arrangements. In addition, we may seek additional capital due to favorable market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. If we need to raise additional capital to fund our operations, funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when needed, we may have to (i) delay, limit, reduce the scope of or terminate one or more of our preclinical studies, clinical trials, or other research and development programs altogether; or (ii) delay, limit, reduce or terminate our efforts to establish manufacturing and sales and marketing capabilities or other activities that may be necessary to commercialize any future approved products, or reduce our flexibility in developing or maintaining our sales and marketing strategy.
Current report
Cash used in investing activities
Current report
During the six months ended June 30, 2023, cash provided by financing activities of $388.8 million was primarily comprised of $323.7 million in net proceeds from issuance of common stock from the March 2023 underwritten public offering; $62.1 million in net proceeds from the issuance of common stock under the ATM and $2.1 million in proceeds from the issuance of common stock related to the ESPP.
Current report
Item 3. Quantitative and Qualitati
Removed paragraphs (9)
Previous report
On October 13, 2023, we reported updated interim safety, pharmacokinetic (PK) and circulating tumor DNA (ctDNA) data from the RMC-6236-001 study as of a September 11, 2023 data cut-off date. These data demonstrated that RMC-6236 was generally well tolerated across dose levels in patients with solid tumors. These data also demonstrated dose-dependent increases in exposure at a steady state with minimal accumulation after repeated daily oral dosing, which we believe is compatible with once-daily dosing. Reductions in ctDNA variant allele frequency were observed for multiple KRAS-mutated alleles in multiple tumor types, indicative of anti-tumor activity by RMC-6236.
Previous report
On January 9, 2024, we reported that relative to the October 13, 2023 report, the profile of RMC-6291 in the RMC-6291-001 study had remained relatively stable. We continue dosing patients at a 200 mg twice daily dose.
Previous report
Overview
Previous report
We and Sanofi, our former SHP2 development partner, sponsored several additional studies involving RMC-4630, all of which are being wound down.
Previous report
Other expense, net
Previous report
Benefit from income taxes
Previous report
Benefit from income taxes relates to net changes in the deferred tax liability associated with our Warp Drive acquisition resulting from changes in the effective state tax rate and changes in our valuation allowance.
Previous report
Other expense, net
Previous report
Cash provided by (used in) investing activities
Reworded paragraphs (31)
Previous wording
On October 22, 2023, we reported updated interim safety and anti-tumor activity data for dose levels of 80 mg daily and above from the RMC-6236-001 study as of an October 12, 2023 data cut-off date. These data demonstrated that RMC-6236 was generally well tolerated across the dose levels analyzed as of the cut-off date. These data also demonstrated preliminary evidence of clinical activity in pancreatic ductal adenocarcinoma (PDAC) patients and non-small cell lung cancer (NSCLC) patients.
Current wording
On October 22, 2023, we reported interim safety and anti-tumor activity data for dose levels of 80 mg daily and above from the RMC-6236-001 study as of an October 12, 2023 data cut-off date. These data demonstrated that RMC-6236 was generally well tolerated across the dose levels analyzed as of the cut-off date. These data also demonstrated preliminary evidence of clinical activity in pancreatic ductal adenocarcinoma (PDAC) patients and non-small cell lung cancer (NSCLC) patients.
Previous wording
On January 9, 2024, we reported that, with additional follow-up after the October 2023 data reports described above, the profile of RMC-6236 remained relatively consistent with the description in the October 2023 reports, the objective response rate (ORR) for both PDAC and NSCLC patients had improved, and the disease control rate (DCR) remained consistent.
Current wording
On January 9, 2024, we reported that, with additional follow-up after the October 2023 data report described above, the profile of RMC-6236 remained relatively consistent with the description in the October 2023 report, the objective response rate (ORR) for both PDAC and NSCLC patients had improved, and the disease control rate (DCR) remained consistent.
Previous wording
We currently expect to disclose updated RMC-6236 monotherapy clinical safety, tolerability and activity data for patients with PDAC and for patients with NSCLC in the second half of 2024.
Current wording
We currently expect to disclose updated RMC-6236 monotherapy clinical safety, tolerability and activity data for patients with NSCLC in the fourth quarter of 2024.
Previous wording
We are also planning a global randomized Phase 3 registrational trial comparing RMC-6236 against docetaxel in patients with RAS-mutated NSCLC who have been treated with immunotherapy and platinum-containing chemotherapy. The study design for this planned trial is subject to change based on regulatory authority feedback. We currently expect to initiate this study in the second half of 2024.
Current wording
We are also planning a global, randomized Phase 3 registrational trial comparing RMC-6236 against docetaxel in patients with RAS-mutated NSCLC who have been treated with immunotherapy and platinum-containing chemotherapy. The study design for this planned trial is subject to change based on regulatory authority feedback. We currently expect to initiate this study in the fourth quarter of 2024.
Previous wording
Based on our observations from the RMC-6236-001 study and our preclinical observations, we believe there is a potential opportunity to evaluate RMC-6236 as a first line therapy and are currently evaluating several exploratory combination regimens that include RMC-6236 in order to assess the potential for development in these settings. These combinations include RMC-6236 with pembrolizumab, RMC-6236 with RMC-6291, and RMC-6236 with standard of care chemotherapy agents. We currently expect to disclose initial clinical PK, safety, tolerability and activity data for the combination of RMC-6236 with pembrolizumab and for the combination of RMC-6236 with RMC-6291 in the second half of 2024.
Current wording
Based on our observations from the RMC-6236-001 study and our preclinical observations, we believe there is a potential opportunity to evaluate RMC-6236 in earlier lines of therapy and are currently evaluating several exploratory combination regimens that include RMC-6236 in order to assess the potential for development in these settings. These combinations include RMC-6236 with pembrolizumab, RMC-6236 with RMC-6291, and RMC-6236 with standard of care chemotherapy agents. We currently expect to disclose initial clinical pharmacokinetic (PK), safety, tolerability and activity data for the combination of RMC-6236 with pembrolizumab and for the combination of RMC-6236 with RMC-6291 in the fourth quarter of 2024.
Previous wording
On October 13, 2023, we reported interim preliminary safety and anti-tumor data from the RMC-6291-001 study as of an October 5, 2023 data cut-off date. The data demonstrated that RMC-6291 was generally well tolerated across dose levels. These data also demonstrated preliminary evidence of clinical activity in patients with KRAS G12C NSCLC previously treated with, or naïve to, a KRAS(OFF) G12C inhibitor and preliminary evidence of clinical activity in patients with KRAS G12C CRC who were naïve to treatment with a KRAS(OFF) G12C inhibitor. We observed that RMC-6291 was orally bioavailable and demonstrated dose-dependent pharmacokinetics and that reduction in ctDNA of the KRAS G12C allele across doses was correlated with clinical response. We believe these data provide preliminary evidence of clinically meaningful differentiation of RMC-6291 from KRAS(OFF) G12C inhibitors.
Current wording
On October 13, 2023, we reported interim preliminary safety and anti-tumor data from the RMC-6291-001 study as of an October 5, 2023 data cut-off date. The data demonstrated that RMC-6291 was generally well tolerated across dose levels. These data also demonstrated preliminary evidence of clinical activity in patients with KRAS G12C NSCLC previously treated with, or naïve to, a KRAS(OFF) G12C inhibitor and preliminary evidence of clinical activity in patients with KRAS G12C CRC who were naïve to treatment with a KRAS(OFF) G12C inhibitor. We observed that RMC-6291 was orally bioavailable and demonstrated dose-dependent pharmacokinetics and that reduction in circulating tumor DNA (ctDNA) of the KRAS G12C allele across doses was correlated with clinical response. We believe these data provide preliminary evidence of clinically meaningful differentiation of RMC-6291 from KRAS(OFF) G12C inhibitors.
Previous wording
We are also evaluating several exploratory combination regimens that include RMC-6291 in order to assess the potential for development in earlier lines of therapy. These combinations include RMC-6291 with pembrolizumab and, as discussed in the “RMC-6236” section above, RMC-6291 with RMC-6236. We are also planning a combination study of RMC-6291 with both RMC-6236 and pembrolizumab. We currently expect to disclose initial clinical PK, safety, tolerability and activity data for the combination of RMC-6236 with RMC-6291 in the second half of 2024 and for the combination of RMC-6291 with pembrolizumab in the first half of 2025.
Current wording
We are evaluating several exploratory combination regimens that include RMC-6291 in order to assess the potential for development in earlier lines of therapy. These combinations include RMC-6291 with pembrolizumab and, as discussed in the “RMC-6236” section above, RMC-6291 with RMC-6236. We are also planning a combination study of RMC-6291 with both RMC-6236 and pembrolizumab. We currently expect to disclose initial clinical PK, safety, tolerability and activity data for the combination of RMC-6236 with RMC-6291 in the fourth quarter of 2024 and for the combination of RMC-6291 with pembrolizumab in the first half of 2025.
Previous wording
We currently expect to disclose initial RMC-9805 monotherapy clinical PK, safety, tolerability and activity data in the second half of 2024.
Current wording
We currently expect to disclose initial RMC-9805 monotherapy clinical PK, safety, tolerability and activity data in the fourth quarter of 2024.
Previous wording
We are also planning an exploratory combination study of RMC-9805 with RMC-6236.
Current wording
In addition, an exploratory combination study of RMC-9805 with RMC-6236 is ongoing.
Previous wording
RMC-0708 is designed as a RAS(ON) oral Q61H-selective inhibitor. It is designed to exhibit picomolar potency for suppressing RAS pathway signaling and growth of RAS Q61H-bearing cancer cells and is engineered for selective inhibition of RAS Q61H over other RAS isoforms via non-covalent binding interactions. Clinical development of RMC-0708 is subject to our continuing assessment of our portfolio priorities.
Current wording
RMC-0708 is designed as a RAS(ON) oral Q61H-selective inhibitor. It is designed to exhibit picomolar potency for suppressing RAS pathway signaling and growth of RAS Q61H-bearing cancer cells and is engineered for selective inhibition of RAS Q61H over other
Previous wording
Interest income primarily consists of interest earned on and accretion of our cash equivalents and marketable securities.
Current wording
Interest income primarily consists of interest earned on accretion of our cash equivalents and marketable securities.
Previous wording
Other expense, net, consists of miscellaneous income and expenses unrelated to our core operations, including the impacts of foreign currency exchange differences.
Current wording
Other income (expense), net, consists of miscellaneous income and expenses unrelated to our core operations, including the impacts of foreign currency exchange differences.
Previous wording
Comparison of the three months ended March 31, 2024 and 2023
Current wording
Comparison of the three and six months ended June 30, 2024 and 2023
Previous wording
Collaboration revenue consisted of revenue under the Sanofi Agreement, which terminated in June 2023. Collaboration revenue decreased by $7.0 million, or 100%, during the three months ended March 31, 2024 compared to the same period in 2023. The decrease in collaboration revenue in 2024 was a result of the termination of the Sanofi Agreement.
Current wording
Collaboration revenue consisted of revenue under the Sanofi Agreement, which terminated in June 2023. Collaboration revenue decreased by $3.8 million to zero during the three months ended June 30, 2024 compared to the same period in 2023. Collaboration revenue decreased by $10.8 million to zero during the six months ended June 30, 2024 compared to the same period in 2023. The decrease in collaboration revenue in 2024 was a result of the termination of the Sanofi Agreement.
Previous wording
Our research and development efforts during the three months ended March 31, 2024 and 2023 were focused on our clinical development programs and our preclinical programs. The following table sets forth the components of our research and development expenses for the periods indicated:
Current wording
Our research and development efforts during the three and six months ended June 30, 2024 and 2023 were focused on our clinical development programs and our preclinical programs. The following table sets forth the components of our research and development expenses for the periods indicated:
Previous wording
Research and development expenses increased by $49.1 million, or 71%, during the three months ended March 31, 2024 compared to the same period in 2023. The increase in research and development expenses during the three months ended March 31, 2024 was primarily due to a $17.5 million increase in RMC-6236 costs, primarily attributable to clinical trial and clinical supply manufacturing expenses; a $10.0 million increase in salaries and other employee-related expenses due to increased headcount to support our research and development programs; a $7.4 million increase in our preclinical research portfolio costs; a $4.5 million increase in stock-based compensation; a $4.4 million increase in RMC-9805 costs, which commenced clinical trials in the third quarter of 2023; a $4.3 million increase in RMC-6291 costs, primarily attributable to higher clinical trial costs; and a $3.7 million increase in other research and development costs as a result of higher rent, utilities and information technology expenses associated with increased headcount; partially offset by a $2.7 million decrease in other RAS companion inhibitor program costs.
Current wording
Research and development expenses increased by $37.0 million, or 38%, during the three months ended June 30, 2024 compared to the same period in 2023. The increase in research and development expenses during the three months ended June 30, 2024 was primarily due to a $10.0 million increase in salaries and other employee-related expenses due to increased headcount to support our research and development programs; a $8.6 million increase in RMC-6291 expenses, primarily attributable to higher clinical trial expenses; a $6.1 million increase in preclinical research portfolio expenses; a $5.1 million increase in stock-based compensation; a $5.0 million increase in RMC-6236 expenses, primarily attributable to clinical trial expenses; a $3.9 million increase in other research and development expenses as a result of higher rent, utilities and information technology expenses associated with increased headcount; and a $1.9 million increase in RMC-9805 expenses primarily attributable to clinical trial expenses; partially offset by a $3.6 million decrease in other RAS companion inhibitor program expenses.
Previous wording
General and administrative expenses increased by $9.6 million, or 73%, during the three months ended March 31, 2024 compared to the same period in 2023. The increase in general and administrative expenses during the three months ended March 31, 2024 was primarily due to a $3.1 million increase in salaries and other employee-related expenses due to increased headcount; a $2.0 million increase in stock-based compensation expense; a $1.6 million increase in facilities and other allocated expenses as a result of higher rent, utilities and information technology expenses associated with increased headcount; a $1.4 million increase in pre-commercial development expenses; and a $1.3 million increase in legal and accounting fees.
Current wording
General and administrative expenses increased by $16.7 million, or 60%, during the six months ended June 30, 2024 compared to the same period in 2023. The increase in general and administrative expenses during the six months ended June 30, 2024 was primarily due to a $5.0 million increase in salaries and other employee-related expenses due to increased headcount; a $3.6 million increase in stock-based compensation expense; a $3.4 million increase in commercial preparation activities; a $2.3 million increase in facilities and other allocated expenses as a result of higher rent, utilities and information technology expenses associated with increased headcount and a $1.7 million increase in legal and accounting fees.
Previous wording
Interest income increased by $16.7 million during the three months ended March 31, 2024 compared to the same period in 2023 due to a larger cash, cash equivalents and marketable securities balance and higher interest rates.
Current wording
Interest income increased by $11.0 million and $27.7 million during the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023 due to a larger cash, cash equivalents and marketable securities balance and higher interest rates.
Previous wording
Other expense increased by $2.8 million during the three months ended March 31, 2024 compared to the same period in 2023 due to a $2.8 million impairment of a long term asset acquired as part of the EQRx Acquisition.
Current wording
Other income (expense) increased by less than $0.1 million and decreased by $2.8 million during the three and six months ended June 30, 2024, respectively, compared to the same periods in 2023 due to a $2.8 million impairment in the first quarter of 2024 of a long term asset acquired as part of the EQRx Acquisition.
Previous wording
In November 2021, we entered into a sales agreement (ATM Sales Agreement) with Cowen and Company, LLC (Cowen) to sell shares of our common stock, from time to time, with aggregate gross proceeds of up to $250 million, through an at-the-market equity offering program (ATM) under which Cowen agreed to act as our sales agent. During the year ended December 31, 2021, we sold an aggregate of 339,302 shares of common stock under the ATM resulting in gross proceeds to us of $10.4 million. After deducting commissions and expenses of $0.3 million, our net proceeds under the ATM were $10.1 million during the year ended December 31, 2021. During the year ended December 31, 2022, we sold an aggregate of 2,385,846 shares of common stock under the ATM resulting in gross proceeds to us of $51.3 million. After deducting commissions and expenses of $1.4 million, our net proceeds under the ATM were $49.9 million during the year ended December 31, 2022. During the year ended December 31, 2023, we sold an aggregate of 2,482,880 shares of common stock under the ATM resulting in gross proceeds to us of $63.5 million. After deducting commissions and expenses of $1.4 million, our net proceeds under the ATM were $62.1 million during the year ended December 31, 2023. The ATM Sales Agreement was amended in March 2024. During the three months ended March 31, 2024, we did not issue shares of our common stock under the ATM.
Current wording
In November 2021, we entered into a sales agreement with Cowen and Company, LLC (Cowen) to sell shares of our common stock, from time to time, with aggregate gross proceeds of up to $250 million, through an at-the-market equity offering program (the 2021 ATM) under which Cowen agreed to act as our sales agent. Since then, we have sold an aggregate of 6,502,078 shares of our common stock under the 2021 ATM resulting in gross proceeds to us of $186.0 million. During the three and six months ended June 30, 2024, we did not sell any shares of our common stock under the ATM. In August 2024, we terminated the 2021 ATM and entered into a new sales agreement with TD Securities (USA) LLC (TD Cowen) to sell shares of our common stock, from time to time, with aggregate gross proceeds of up to $500 million, through an at-the-market equity offering program (the 2024 ATM) under which TD Cowen agreed to act as our sales agent.
Previous wording
As of March 31, 2024, we had $1.7 billion in cash, cash equivalents and marketable securities.
Current wording
As of June 30, 2024, we had $1.6 billion in cash, cash equivalents and marketable securities.
Previous wording
As of March 31, 2024, we had an accumulated deficit of $1.3 billion. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures related to our product candidates and our pre-clinical research portfolio, and to a lesser extent, general and administrative expenditures. We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we continue to advance our product candidates and pre-clinical research portfolio.
Current wording
As of June 30, 2024, we had an accumulated deficit of $1.4 billion. Our primary use of cash is to fund operating expenses, which consist primarily of research and development expenditures related to our product candidates and our pre-clinical research portfolio, and to a lesser extent, general and administrative expenditures. We expect our expenses to continue to increase in connection with our ongoing activities, particularly as we continue to advance our product candidates and pre-clinical research portfolio.
Previous wording
the timing of, and the costs involved in, obtaining marketing approvals for product candidates we develop if clinical trials are successful;
Current wording
the timing of, and the costs involved in, obtaining marketing approvals for our product candidates if clinical trials are successful;
Previous wording
the cost of commercialization activities for any product candidates, whether alone or in collaboration, including marketing, sales and distribution costs if any product candidate is approved for sale;
Current wording
the cost of commercialization activities for any of our product candidates, whether alone or in collaboration, including marketing, sales and distribution costs if any product candidate is approved for sale;
Previous wording
We will need to obtain substantial additional funding in the future to continue the preclinical and clinical development of our current and future programs and to prepare for their potential commercialization. If we need to raise additional capital to fund our operations, funding may not be available to us on acceptable terms, or at all. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our clinical trials, research and development programs or commercialization efforts. We may seek to raise any necessary additional capital through a combination of public or private equity offerings, debt financings, acquisitions and collaborations or licensing arrangements. If we do raise additional capital through public or private equity offerings or acquisitions using our common stock, the ownership interest of our existing stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, and if the debt is convertible into our common stock, the ownership interest of our stockholders may be diluted. If we are unable to raise capital, we may need to delay, reduce or terminate planned activities to reduce costs. Doing so will likely harm our ability to execute our business plans.
Current wording
If we do raise additional capital through public or private equity offerings or acquisitions using our common stock, the ownership interest of our existing stockholders will be diluted, and the terms may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends, and if the debt is convertible into our common stock, the ownership interest of our stockholders may be diluted. If we are unable to raise capital, we may need to delay, reduce or terminate planned activities to reduce costs. Doing so will likely harm our ability to execute our business plans.
Previous wording
During the three months ended March 31, 2024, cash used in operating activities of $160.6 million was attributable to a net loss of $116.0 million and a net change of $47.2 million in our operating assets and liabilities and $2.7 million in non-cash charges. The change in operating assets and liabilities was primarily due to a $29.0 million decrease in accounts payable; a $21.3 million decrease in accrued expenses and other current liabilities, a $0.6 million decrease in prepaid expenses and other current assets; a $2.1 million increase in noncurrent liabilities; and a $1.3million decrease in accounts receivable. The non-cash charges primarily consisted of stock-based compensation expense of $16.2 million, a $2.8 million impairment of a long term asset acquired as part of the EQRx Acquisition, depreciation and amortization of $1.8 million, amortization of operating lease right-of-use asset of $1.0 million offset by net amortization of premium on marketable securities of $15.2 million and a $3.9 million change in fair value of warrant liabilities and contingent earn-out shares.
Current wording
During the six months ended June 30, 2024, cash used in operating activities of $288.7 million was attributable to a net loss of $249.2 million and a net change of $52.0 million in our operating assets and liabilities and $12.5 million in non-cash charges. The change in operating assets and liabilities was primarily due to a $33.0 million decrease in accounts payable; an $8.9 million increase in prepaid expenses and other current assets; a $6.6 million decrease in accrued expenses and other current liabilities; and an increase in other noncurrent assets by $4.0 million, offset by a $1.3 million decrease in accounts receivable. The non-cash charges primarily consisted of stock-based compensation expense of $36.0 million; depreciation and amortization of $3.7 million; a $2.8 million impairment of a long term asset acquired as part of the EQRx Acquisition; amortization of operating lease right-of-use asset of $1.8 million, offset by net amortization of premium on marketable securities of $26.1 million and a $5.8 million change in fair value of warrant liabilities and contingent earn-out shares.
Previous wording
During the three months ended March 31, 2023, cash used in operating activities of $62.4 million was attributable to a net loss of $68.1 million and a net change of $2.9 million in our operating assets and liabilities offset by $8.7 million in non-cash charges. The non-cash charges primarily consisted of stock-based compensation expense of $9.7 million, depreciation and amortization of $1.5 million, amortization of operating lease right-of-use asset of $1.1 million and net amortization of premium on marketable securities of $3.6 million. The change in operating assets and liabilities was primarily due to a $3.0 million decrease in deferred revenue associated with the Sanofi agreement; a $0.9 million decrease in operating lease liability; a $1.1 million decrease in accounts payable; a $1.8 million decrease in accrued expenses and other current liabilities, offset by $1.6 million decrease in prepaid expenses and other current assets; a $0.7 million decrease in accounts receivable; and a $1.4 million increase in other noncurrent liabilities.
Current wording
During the six months ended June 30, 2023, cash used in operating activities of $129.5 million was attributable to a net loss of $166.4 million offset by $18.6 million in non-cash charges and a net change of $18.3 million in our operating assets and liabilities. The non-cash charges primarily consisted of stock-based compensation expense of $22.7 million; depreciation and amortization of $3.0 million and amortization of operating lease right-of-use asset of $1.3 million, offset by net amortization of premium on marketable securities of $8.4 million. The change in operating assets and liabilities was primarily due to a $7.6 million increase in accounts payable; a $13.4 million increase in accrued expenses and other current liabilities; and a $2.2 million decrease in accounts receivable, offset by a $4.5 million decrease in deferred revenue associated with the Sanofi Agreement.
Previous wording
During the three months ended March 31, 2023, cash provided by investing activities of $4.0 million was comprised of maturities of marketable securities of $198.9 million partially offset by purchases of marketable securities of $193.1 million and purchases of property and equipment of $1.8 million.
Current wording
During the six months ended June 30, 2024, cash used in investing activities of $140.0 million was comprised of maturities of marketable securities of $942.1 million partially offset by purchases of marketable securities of $1.1 billion and purchases of property and equipment of $5.6 million.
Previous wording
During the three months ended March 31, 2024, cash used in investing activities of $248.0 million was comprised of maturities of marketable securities of $456.9 million partially offset by purchases of marketable securities of $701.7 million and purchases of property and equipment of $3.2 million.
Current wording
During the six months ended June 30, 2023, cash used in investing activities of $39.5 million was comprised of purchases of marketable securities of $369.3 million and purchases of property and equipment of $2.9 million offset by maturities of marketable securities of $332.6 million.
Previous wording
During the three months ended March 31, 2023, cash provided by financing activities of $324.2 million was comprised of $323.7 million in proceeds from the March 2023 underwritten public offering and $0.5 million in proceeds from the issuance of common stock upon the exercise of stock options.
Current wording
During the six months ended June 30, 2024, cash provided by financing activities comprised of $5.2 million in proceeds from the issuance of common stock upon the exercise of stock options and $3.2 million in proceeds from the issuance of common stock related to our 2020 Employee Stock Purchase Plan (the ESPP).
Previous wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles (U.S. GAAP). The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Current wording
Our management’s discussion and analysis of our financial condition and results of operations is based on our unaudited condensed consolidated financial statements, which have been prepared in accordance with United States generally accepted accounting principles. The preparation of these unaudited condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the unaudited condensed consolidated financial statements, as well as the reported expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
RAS isoforms via non-covalent binding interactions. Clinical development of RMC-0708 is subject to our continuing assessment of our portfolio priorities.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
We are planning a global randomized registrational trial comparing RMC-6236 against a physician’s choice of chemotherapy regimens in patients with previously treated PDAC. The study design for this planned trial is subject to change based on regulatory authority feedback. We currently expect to initiate this study in the second half of 2024.
Previous report — wording carried elsewhere
During the three months ended March 31, 2024, cash provided by financing activities comprised of $0.8 million in proceeds from the issuance of common stock upon the exercise of stock options.