Neumora Therapeutics, Inc.
For the period ended Mar 31, 2025. Filed May 12, 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 12, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-12.
0000950170-24-125437
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-12.
0000950170-25-069311
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 120 previous paragraphs and 107 current paragraphs.
78 unchanged; 24 reworded; 5 added; 13 removed; 5 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 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 (5)
Current report
ALS = Amyotrophic lateral sclerosis; CK1δ= Casein Kinase I Isoform delta; GCase = Glucocerebrosidase; IP = Intellectual Property; KOR = kappa opioid receptor; M4R = Muscarinic Acetylcholine Receptor M4; NLRP3 = Nucleotide-binding Domain, Leucine-rich–containing Family, Pyrin Domain–containing-3; NMDA = N-methyl-D-aspartate; V1aR = Vasopressin 1a Receptor.
Current report
Interest Income
Current report
General and administrative expenses increased by $4.5 million, or 31%, to $18.8 million for the three months ended March 31, 2025, from $14.3 million for the three months ended March 31, 2024 primarily attributable to higher personnel-related costs, including severance pay and one time bonus payments for key executives of $2.0 million and increased stock-based compensation expense of $1.0 million.
Current report
Interest Income
Current report
We were also a “smaller reporting company,” as defined in the Securities Exchange Act of 1934, as amended (Exchange Act) until December 31, 2024.
Removed paragraphs (13)
Previous report
Research and development expenses consist of external and internal expenses, and primarily relate to our discovery efforts and development of our precision neuroscience approach, programs, and product candidates. We account for acquired in-process research and development (IPR&D) expenses from our strategic acquisitions, which account for a significant portion of our operating expenses, separately from research and development expenses.
Previous report
Acquired In-Process Research and Development
Previous report
Acquired in-process research and development expenses consist of existing research and development projects at the time of the acquisition. Projects that qualify as IPR&D assets represent those that have not yet reached technological feasibility and have no alternative future use. Our acquisitions of assets have all included IPR&D assets that had not yet reached technological feasibility and had no alternative future use, which resulted in a write-off of these IPR&D assets to acquired in-process research and development expenses in our condensed consolidated statement of operations and comprehensive loss.
Previous report
General and administrative expenses increased by $0.7 million, or 5%, to $16.0 million for the three months ended September 30, 2024, from $15.3 million for the three months ended September 30, 2023 attributable to an increase in technology and insurance costs to support operations as a public company.
Previous report
For the Nine Months Ended September 30, 2024 and 2023
Previous report
Research and Development Expenses
Previous report
Research and development expenses increased by $51.2 million, or 49%, to $155.0 million for the nine months ended September 30, 2024, from $103.9 million for the nine months ended September 30, 2023, as we advanced our clinical trials. Direct external program expenses increased by $54.7 million, of which $56.0 million was related to the Phase 3 clinical trials for navacaprant, partially offset by a decrease of $1.3 million to the Phase 1 clinical trial costs for NMRA-266 due to the FDA clinical hold. Internal and unallocated expenses decreased by $3.6 million, which were primarily due to a decrease in contracted research and consulting activities of $14.2 million, primarily attributable to decreased activities under our research and collaboration agreements with Amgen and with other vendors, which was partially offset by an increase in personnel related costs of $10.6 million, including $8.7 million related to stock-based compensation. Stock-based compensation primarily increased due to stock modification expense of $3.7 million and the increased value of stock awards issued.
Previous report
General and Administrative Expenses
Previous report
General and administrative (G&A) expenses increased by $11.3 million, or 33%, to $45.5 million for the nine months ended September 30, 2024 from $34.2 million for the nine months ended September 30, 2023. The increase was primarily attributable to higher personnel-related costs, including $10.2 million related to stock-based compensation. The increase in stock based-compensation was due to the increased value of awards issued.
Previous report
Interest income increased by $4.9 million to $15.8 million for the nine months ended September 30, 2024 from $11.0 million for the nine months ended September 30, 2023, which was attributable to interest earned on our higher balances in cash equivalents and marketable securities.
Previous report
Net cash provided by financing activities for the nine months ended September 30, 2023 was $232.4 million, which primarily consisted of $232.6 million in proceeds from the issuance of common stock upon the completion of our IPO, net of underwriting commissions and discounts and $2.5 million in proceeds from exercise of stock options, partially offset by $3.0 million in payments of issuance costs in connection with our IPO.
Previous report
We are also a “smaller reporting company,” as defined in the Exchange Act. We may continue to be a smaller reporting company even after we are no longer an emerging growth company.
Previous report
We have elected to take advantage of certain of the scaled disclosures available to smaller reporting companies, and will be able to take advantage of these scaled disclosures for so long as the market value of our voting and non-voting common stock held by non-affiliates is less than $250.0 million measured on the last business day of our second fiscal quarter, or our annual revenue is less than $100.0 million during the most recently completed fiscal year and the market value of our voting and non-voting common stock held by non- affiliates is less than $700.0 million measured on the last business day of our second fiscal quarter.
Reworded paragraphs (24)
Previous wording
We are a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. We have rapidly scaled our therapeutic pipeline, which currently consists of seven clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our most advanced product candidate, navacaprant (NMRA-140), is a novel once-daily oral kappa opioid receptor (KOR) antagonist that is being developed for the treatment of major depressive disorder (MDD), bipolar depression and other neuropsychiatric disorders, which we believe has the potential to provide significant advantages relative to the standard of care, if approved. In 2023, we initiated our pivotal Phase 3 KOASTAL program that is evaluating navacaprant monotherapy in patients with moderate to severe MDD. The KOASTAL program includes three replicate Phase 3 studies, KOASTAL-1, KOASTAL-2 and KOASTAL-3 as well as an open-label extension study, KOASTAL-LT, which is designed to evaluate the long-term safety of navacaprant. We anticipate releasing topline results from the KOASTAL-1 study around the end of 2024 and topline results from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025. Additionally, in May 2024 we initiated a Phase 2 study for navacaprant in bipolar depression and anticipates releasing results from that study in the second half of 2025.
Current wording
We are a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. We have rapidly scaled our therapeutic pipeline, which currently consists of seven neuroscience programs, including two clinical programs, that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our most advanced product candidate, navacaprant (NMRA-140), is a novel once-daily oral kappa opioid receptor (KOR) antagonist that is being developed for the treatment of major depressive disorder (MDD), which we believe has the potential to provide significant advantages relative to the standard of care, if approved. Navacaprant is being investigated in the KOASTAL pivotal Phase 3 program, evaluating navacaprant monotherapy in patients with moderate to severe MDD. We expect to report topline data from KOASTAL-3 in the first quarter of 2026 and KOASTAL-2 in the second quarter of 2026. Our next most advanced product candidate is NMRA-511, a highly selective, novel antagonist of the vasopressin 1a receptor (V1aR) being developed for the treatment of agitation associated with dementia due to Alzheimer’s disease (AD). We are advancing a Phase 1b signal-seeking study investigating NMRA-511 initially in healthy elderly adult participants and then people with agitation associated with dementia due to AD, and we expect to report data from this study around the end of 2025. Our M4 positive allosteric modular (PAM) franchise comprises multiple novel compounds that each have different chemical composition and what we believe are optimal pharmacological properties, which have demonstrated robust activity in preclinical efficacy models and high selectivity for the M4 receptor subtype. We expect to progress an M4 PAM into the clinic in mid-2025.
Previous wording
As shown in the table below, our current pipeline includes seven programs, three of which are in clinical development and four of which are in preclinical development.
Current wording
As shown in the table below, our current pipeline includes seven programs, two of which are in clinical development and five of which are in preclinical development.
Previous wording
We have assumed license arrangements with certain third parties as a result of our acquisitions and have entered into several additional agreements with various parties. For details regarding these agreements, see Note 8–Strategic License and Research and Collaboration Agreements to our condensed consolidated financial statements included elsewhere in this Quarterly Reporton Form 10-Q.
Current wording
We have assumed license arrangements with certain third parties as a result of our acquisitions and have entered into several additional license, research and collaboration agreements with various parties. For details regarding these agreements, see Note 8–Strategic License and Research and Collaboration Agreements to our condensed consolidated financial statements included elsewhere in this Quarterly Reporton Form 10-Q.
Previous wording
Pursuant to the terms of the BlackThorn Merger Agreement, we are required to pay the former stockholders of BlackThorn contingent consideration (i) with respect to navacaprant, in the form of development and regulatory approval milestones of up to an aggregate amount of $365.0 million, which includes a milestone payment that became due and was paid in the fourth quarter of 2023 upon dosing the first patient in the Phase 3 clinical trial for navacaprant, and sales-based milestones of up to an aggregate amount of $450.0 million and (ii) with respect to NMRA-511, in the form of development and regulatory approval milestones of up to an aggregate amount of $100.0 million, and sales-based milestones of up to an aggregate amount of $100.0 million (BlackThorn Milestones). At the Company’s sole discretion, the BlackThorn Milestone payments may be settled in cash or shares of the Company, or a combination of both, subject to the provisions of the BlackThorn Merger Agreement, other than one development milestone in the amount of $10.0 million, which must be settled in cash. In December 2023, we issued 6,072,445 shares of common stock based on the volume weighted average price per share prior to the date the milestone was met and paid $2.3 million in cash in satisfaction of the Phase 3 navacaprant milestone to the former stockholders of BlackThorn and participants in the carveout plan. As of September 30, 2024, none of the other BlackThorn Milestones have been achieved and no such related amounts were deemed due or payable.
Current wording
Pursuant to the terms of the BlackThorn Merger Agreement, we are required to pay the former stockholders of BlackThorn contingent consideration (i) with respect to navacaprant, in the form of development and regulatory approval milestones of up to an aggregate amount of $365.0 million, which includes a milestone payment that became due and was paid in the fourth quarter of 2023 upon dosing the first patient in the Phase 3 clinical trial for navacaprant, and sales-based milestones of up to an aggregate amount of $450.0 million and (ii) with respect to NMRA-511, in the form of development and regulatory approval milestones of up to an aggregate amount of $100.0 million, and sales-based milestones of up to an aggregate amount of $100.0 million (BlackThorn Milestones). At our sole discretion, the BlackThorn Milestone payments may be settled in cash or shares of our common stock, or a combination of both, subject to the provisions of the BlackThorn Merger Agreement, other than one development milestone in the amount of $10.0 million, which must be settled in cash. In December 2023, we issued 6,072,445 shares of common stock based on the volume weighted average price per share prior to the date the milestone was met and paid $2.3 million in cash in satisfaction of the Phase 3 navacaprant milestone to the former stockholders of BlackThorn and participants in the carveout plan. As of March 31, 2025, none of the other BlackThorn Milestones have been achieved and no such related amounts were deemed due or payable.
Previous wording
External research and development expenses include, among others, amounts incurred with contract research organizations (CROs), contract manufacturing organizations (CMOs), preclinical testing organizations and other vendors that conduct research and development activities on our behalf. Internal research and development expenses include, among others, personnel-related costs, including salaries, benefits and stock-based compensation for employees engaged in research and development functions, laboratory supplies and other non-capital equipment utilized for in-house research, software development costs and allocated expenses including facilities costs and depreciation and amortization.
Current wording
Research and development expenses consist of external and internal expenses, and primarily relate to our discovery efforts and development of our precision neuroscience approach, programs, and product candidates. External research and development expenses include, among others, amounts incurred with contract research organizations (CROs), contract manufacturing organizations (CMOs), preclinical testing organizations and other vendors that conduct research and development activities on our behalf. Internal research and development expenses include, among others, personnel-related costs, including salaries, benefits and stock-based compensation for employees engaged in research and development functions, laboratory supplies and other non-capital equipment utilized for in-house research, software development costs and allocated expenses including facilities costs and depreciation and amortization.
Previous wording
We expense research and development costs as incurred. Amounts recorded for external goods or services incurred for research and development activities that have not yet been invoiced are included in accrued liabilities in our condensed consolidated balance sheets and often represent estimates. We estimate accrued expenses and the related research and development expense based on the level of services performed but not yet invoiced pursuant to agreements established with our service providers, according to the progress of preclinical studies, clinical trials or related activities, and discussions with applicable personnel and service providers as to the progress or state of consummation of goods and service. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our condensed consolidated financial statements as prepaid expenses or other current assets or accrued liabilities. Nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered.
Current wording
We expense research and development costs as incurred. Amounts recorded for external goods or services incurred for research and development activities that have not yet been invoiced are included in accrued liabilities in our consolidated balance sheets and often represent estimates. We estimate accrued expenses and the related research and development expense based on the level of services performed but not yet invoiced pursuant to agreements established with our service providers, according to the progress of preclinical studies, clinical trials or related activities, and discussions with applicable personnel and service providers as to the progress or state of consummation of goods and service. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our consolidated financial statements as prepaid expenses or other current assets or accrued liabilities. Nonrefundable advance payments that we make for goods or services to be received in the future for use in research and development activities are recorded as prepaid expenses. Such amounts are recognized as an expense as the goods are delivered or the related services are performed, or until it is no longer expected that the goods will be delivered, or the services rendered.
Previous wording
We expect our research and development expenses to increase substantially for the foreseeable future as we incur costs to further develop our precision neuroscience approach and advance our programs and product candidates through clinical development and pursue regulatory approval of our product candidates. The process of conducting the necessary clinical and preclinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result of the uncertainties discussed below, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates.
Current wording
We expect to continue to incur significant research and development expenses for the foreseeable future as we further develop our precision neuroscience approach and advance our programs and product candidates through clinical development and pursue regulatory approval of our product candidates. The process of conducting the necessary clinical and preclinical research to obtain regulatory approval is costly and time-consuming, and the successful development of our product candidates is highly uncertain. As a result of the uncertainties discussed below, we are unable to determine the duration and completion costs of our research and development projects or when and to what extent we will generate revenue from the commercialization and sale of our product candidates.
Previous wording
Research and development expenses increased by $19.0 million, or 46%, to $60.6 million for the three months ended September 30, 2024, from $41.6 million for the three months ended September 30, 2023 as we ramped up our clinical and preclinical programs and related activities. Direct external program expenses increased by $14.1 million, of which $14.9 million was related to the Phase 3 clinical trials for navacaprant, partially offset by a decrease of $1.1 million to the Phase 1 clinical trial costs for NMRA-266 due to the FDA clinical hold. Internal and unallocated expenses increased by $4.9 million, which were primarily due to an increase in external research and development activities of $3.7 million, attributable to increased activities under our research and collaboration agreements with Amgen and an increase in personnel related costs of $1.2 million, primarily attributable to an increase in stock-based compensation. Stock-based compensation primarily increased due to the increased value of stock awards issued.
Current wording
Research and development expenses increased by $6.4 million, or 14%, to $52.2 million for the three months ended March 31, 2025, from $45.8 million for the three months ended March 31, 2024 primarily due to the final $6.3 million of costs incurred under the Amgen Collaboration Agreement. Direct external program expenses decreased by $1.2 million, primarily due to a decrease in pre-clinical program research. Internal and unallocated expenses increased by $7.6 million, primarily due to an increase in external research and development activities of $6.1 million, attributable to the final costs incurred under the Amgen Collaboration Agreement and an increase in personnel related costs of $1.5 million, primarily attributable to an increase in stock-based compensation and a one time bonus payment for a key executive.
Previous wording
Interest income increased by $0.4 million to $4.2 million for the three months ended September 30, 2024 from $3.8 million for the three months ended September 30, 2023, which was attributable to interest earned on our higher balances in cash equivalents and marketable securities.
Current wording
Interest income decreased by $3.3 million to $3.1 million for the three months ended March 31, 2025 from $6.4 million for the three months ended March 31, 2024, which was attributable to less interest earned on our lower balances in cash equivalents and marketable securities.
Previous wording
As of September 30, 2024, we had $341.3 million of cash, cash equivalents and marketable securities. Prior to our IPO we primarily funded our operations with the net proceeds from the sale and issuance of our convertible preferred stock and convertible promissory notes and raised gross cash proceeds of over $600 million including from the sale of convertible preferred stock, borrowings pursuant to convertible promissory notes and cash acquired in our acquisitions of assets. On September 19, 2023, we completed our IPO pursuant to which we issued and sold an aggregate of 14,710,000 shares of common stock at a price to the public of $17.00 per share. We received aggregate net proceeds of $226.5 million after deducting underwriting discounts and commissions of $17.5 million and other offering expenses of $6.0 million. Since our IPO, in October 2024 we entered into a sales agreement (the Sales Agreement) with Leerink Partners LLC (Leerink) to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an at-the-market equity offering program (the ATM Program) with Leerink as the sales agent.
Current wording
As of March 31, 2025, we had $249.4 million of cash, cash equivalents and marketable securities. Prior to our IPO we primarily funded our operations with the net proceeds from the sale and issuance of our convertible preferred stock and convertible promissory notes and raised gross cash proceeds of over $600 million including from the sale of convertible preferred stock, borrowings pursuant to convertible promissory notes and cash acquired in our acquisitions of assets. In September, 2023, we completed our IPO pursuant to which we issued and sold an aggregate of 14,710,000 shares of common stock at a price to the public of $17.00 per share. We received aggregate net proceeds of $226.5 million after deducting underwriting discounts and commissions of $17.5 million and other offering expenses of $6.0 million. Since our IPO, in October 2024 we entered into a sales agreement with Leerink to sell shares of our common stock, from time to time, with aggregate gross sales proceeds of up to $300.0 million, through an at-the-market equity offering program (ATM) with Leerink as the sales agent. We received aggregate net proceeds of $13.7 million under the ATM after deducting commissions and offering expenses of $0.8 million during the year ended December 31, 2024. There were no sales under the ATM during the three months ended March 31, 2025.
Previous wording
Since our inception, we have not generated any revenue from the sale of products and we have incurred significant net losses and negative cash flows from operations. Our primary use of our capital resources is to fund our operating expenses, which consist primarily of expenditures related to identifying, acquiring, developing, and in-licensing our precision neuroscience approach, programs, and product candidates, and conducting preclinical studies and clinical trials, and to a lesser extent, general and administrative expenditures. We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. As of September 30, 2024, we had an accumulated deficit of $888.4 million.
Current wording
Since our inception, we have not generated any revenue from the sale of products and we have incurred significant net losses, which are primarily attributable to acquired intangible in-process research and development intangible asset (IPR&D) costs pursuant to our acquisitions, which occurred in 2020 and were accounted for as an acquisition of assets, and negative cash flows from operations. Our primary use of our capital resources is to fund our operating expenses, which consist primarily of expenditures related to identifying, acquiring, developing, and in-licensing our precision neuroscience approach, programs, and product candidates, and conducting preclinical studies and clinical trials, and to a lesser extent, general and administrative expenditures. We have not yet commercialized any products and we do not expect to generate revenue from sales of any product candidates for a number of years, if ever. As of March 31, 2025, we had an accumulated deficit of $1,015.2 million.
Previous wording
We expect our expenses and operating losses will increase substantially over the foreseeable future as we continue our research and development efforts, advance our product candidates through clinical and preclinical development, enhance our precision neuroscience approach and programs, expand our product pipeline, seek regulatory approval, prepare for commercialization, hire additional personnel and protect our intellectual property, Furthermore, as a result of the completion of our IPO on September 19, 2023, we have incurred and will continue to incur additional costs associated with being a public company. We also expect to increase the size of our administrative function to support the growth of our business. Our net losses may fluctuate significantly from period to period, depending on the factors described below. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. The expected increase in expenses will be driven in large part by our ongoing activities, and our future capital requirements will depend on many factors, including:
Current wording
We expect our expenses and operating losses will increase substantially over the foreseeable future as we continue our research and development efforts, advance our product candidates through clinical and preclinical development, enhance our precision neuroscience approach and programs, expand our product pipeline, seek regulatory approval, prepare for commercialization, as well as hire additional personnel and protect our intellectual property. Furthermore, since our IPO, we have incurred and will continue to incur additional costs associated with being a public company. Our net losses may fluctuate significantly from period to period, depending on the factors described below. We are subject to the risks typically related to the development of new products, and we may encounter unforeseen expenses, difficulties, complications, delays, and other unknown factors that may adversely affect our business. The expected increase in expenses will be driven in large part by our ongoing activities, and our future capital requirements will depend on many factors, including:
Previous wording
the effect of macroeconomic trends including inflation and rising interest rates;
Current wording
the effect of macroeconomic trends including tariffs, trade controls, inflation and rising interest rates;
Previous wording
Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the issuance of the condensed consolidated financial statements. However, we anticipate that we will need to raise additional financing in the future to fund our operations, including the commercialization of any approved product candidates. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We may also raise additional financing on an opportunistic basis in the future. We expect to continue to expend significant resources for the foreseeable future.
Current wording
Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the issuance of the condensed consolidated financial statements. However, we anticipate that we will need to raise additional financing in the future to fund our operationsand pursue our long-term business plan, including the development and commercialization of our product candidates, if approved. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we expect. We may also raise additional financing on an opportunistic basis in the future. We expect to continue to expend significant resources for the foreseeable future.
Previous wording
We will need substantial additional funding to support our continuing operations and pursue our long-term business plan, including to complete the development and commercialization of our product candidates, if approved. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through public or private equity offerings or debt financings or other capital sources, which may include strategic collaborations or other arrangements with third parties, or other sources of financing. We may not be able to raise additional capital on terms acceptable to us or at all. If we are unable to raise additional capital on acceptable terms when needed, our business, results of operations, and financial condition would be adversely affected. The amount and timing ofour future funding requirements will depend on many factors including the successful advancement of our precision neuroscience approach, programs, and product candidates. Our ability to raise additional funds may also be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide.
Current wording
To complete the development and commercialization of our product candidates, if approved, we will require substantial additional funding. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through public or private equity offerings or debt financings or other capital sources, which may include strategic collaborations or other arrangements with third parties, or other sources of financing. We may not be able to raise additional capital on terms acceptable to us or at all. If we are unable to raise additional capital on acceptable terms when needed, our business, results of operations, and financial condition would be adversely affected. The amount and timing ofour future funding requirements will depend on many factors including the successful advancement of our precision neuroscience approach, programs, and product candidates. Our ability to raise additional funds may also be adversely impacted by potential worsening global economic conditions and disruptions to, and volatility in, the credit and financial markets in the United States and worldwide.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2023 was $111.8 million, which consisted of a net loss of $127.2 million, which was partially offset by $11.1 million in noncash charges and a change in our net operating assets and liabilities of $4.2 million. The noncash charges primarily consisted of $11.2 million of stock-based compensation, $2.5 million of noncash operating lease expense and $0.5 million of depreciation and amortization, partially offset by $3.1 million of net accretion of discounts on marketable securities. The change in our net operating assets and liabilities primarily resulted from an increase of $10.0 million in accounts payable and accrued liabilities due to increased activities and the timing of our accounts payable, partially offset by an increase of $3.3 million in prepaid expenses and other current assets related to our clinical programs and collaboration with Amgen and a decrease of $2.5 million in operating lease liabilities.
Current wording
Net cash used in operating activities for thethree months ended March 31, 2025 was $59.4 million, which consisted of a net loss of $68.0 million and a change in our net operating assets and liabilities of $0.5 million, partially offset by noncash charges of $9.1 million. The change in our net operating assets and liabilities primarily resulted from an a decrease in accounts payable of $2.3 million due to the timing of our accounts payable and a decrease in current operating lease liabilities of $0.9 million due to the upcoming expiration of our office and lab lease agreement, partially offset by a decrease in prepaid expenses and other current assets of $1.0 million due to less interest receivable on our cash and marketable securities and an increase in accrued liabilities of $1.7 million related to our ongoing clinical trials. The noncash charges primarily consisted of $9.3 million of stock-based compensation, $$0.9 million of noncash operating lease expense, partially offset by $1.3 million on of net accretion of discounts on marketable securities.
Previous wording
Net cash used in operating activities for thenine months ended September 30, 2024 was $132.6 million, which consisted of a net loss of $185.0 million, partially offset by a change in our net operating assets and liabilities of $24.0 million and noncash charges of $28.4 million. The change in our net operating assets and liabilities primarily resulted from a decrease of $15.3 million in prepaid expenses and other current assets related to our clinical programs and the Amgen Collaboration Agreement, an increase of $5.4 million and $5.8 million in accrued liabilities and accounts payable, respectively, primarily related to our clinical programs and timing of our accounts payable, partially offset by a decrease in operating lease liabilities of $2.5 million. The noncash charges primarily consisted of $30.1 million of stock-based compensation, $2.4 million of noncash operating lease expense, partially offset by $4.6 million of net accretion of discounts on marketable securities.
Current wording
Net cash used in operating activities for the three months ended March 31, 2024 was $43.0 million, which consisted of a net loss of $53.7 million, which was partially offset by a change in our net operating assets and liabilities of $3.6 million and $7.2 million in noncash charges. The change in our net operating assets and liabilities primarily resulted from a decrease of $7.4 million in prepaid expenses and other current assets related to our clinical programs and an increase of $1.2 million in accounts payable primarily due to the timing of our accounts payable, partially offset by a decrease in accrued liabilities related to our clinical programs and a decrease in operating lease liabilities of $0.8 million. The noncash charges primarily consisted of $7.4 million of stock-based compensation, $0.8 million of noncash operating lease expense and $0.2 million of depreciation and amortization, partially offset by $1.1 million of net accretion of discounts on marketable securities.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2023 was $50.7 million, which primarily consisted of $139.8 million in proceeds from sales and maturities of marketable securities, partially offset by $89.0 million in purchases of marketable securities.
Current wording
Net cash provided by investing activities for thethree months ended March 31, 2025 was $44.2 million, which primarily consisted of $88.6 million in proceeds from maturities of marketable securities, partially offset by $44.4 million in purchases of marketable securities.
Previous wording
Net cash used in investing activities for thenine months ended September 30, 2024 was $28.2 million, which primarily consisted of $205.3 million in purchases of marketable securities, partially offset by $234.3 million in proceeds from sales and maturities of marketable securities.
Current wording
Net cash used in investing activities for the three months ended March 31, 2024 was $150.0 million, which primarily consisted of $185.8 million in purchases of marketable securities, partially offset by $36.6 million in proceeds from maturities of marketable securities.
Previous wording
Net cash provided by financing activities for thenine months ended September 30, 2024 was $6.0 million, which consisted of proceeds from the exercise of stock options.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2024 was $1.8 million, which consisted of proceeds from the exercise of stock options.
Previous wording
We have entered into a number of acquisitions of assets that are summarized in Note 6 – Acquisitions of Assets to our condensed consolidated financial statements. As part of these acquisitions of assets, we are obligated to pay cash and/or stock for future contingent payments that are dependent upon future events, and in some cases, vesting by the recipient of the contingent payment, such as our achievement of certain development, regulatory, and commercial milestones. We have also assumed license arrangements with various third parties, primarily as a result of our acquisitions, and have entered into additional agreements that are summarized in Note 8 –Strategic License and Research and Collaboration Agreements to our condensed consolidated financial statements. In accordance with these agreements, we are obligated to pay, among other items, future contingent payments that are uncertain and dependent upon future events such as our achievement of certain development, regulatory, and commercial milestones royalties, and sublicensing revenue in the future, as applicable. For example, in October 2023, in connection with our acquisition of BlackThorn, a milestone became due upon dosing the first patient in the Phase 3 clinical trial for navacaprant, which was settled in stock and cash in December 2023. In October 2023, in connection with our Vanderbilt License Agreement, a development milestone of $2.0 million became due, which was paid in cash in November 2023.
Current wording
We have entered into a number of acquisitions of assets that are summarized in Note 6 – Acquisitions of Assets to our condensed consolidated financial statements. As part of these acquisitions of assets, we are obligated to pay cash and/or stock for future contingent payments that are dependent upon future events, and in some cases, vesting by the recipient of the contingent payment, such as our achievement of certain development, regulatory, and commercial milestones. We have also assumed license arrangements with various third parties, primarily as a result of our acquisitions, and have entered into additional agreements that are summarized in Note 8 –Strategic License and Research and Collaboration Agreements to our condensed consolidated financial statements. In accordance with these agreements, we are obligated to pay, among other items, future contingent payments that are uncertain and dependent upon future events such as our achievement of certain development, regulatory, and commercial milestones royalties, and sublicensing revenue in the future, as applicable.
Previous wording
Our management’s discussion and analysis of the financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with the U.S. generally accepted accounting principles, or GAAP. The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosures. Our estimates are based on historical experience and on various other factors that 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 the financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with the U.S. generally accepted accounting principles (GAAP). The preparation of our condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, expenses, and related disclosures. Our estimates are based on historical experience and on various other factors that 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.
Previous wording
We are an “emerging growth company,” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until those standards apply to private companies.
Current wording
We were an “emerging growth company,” as defined in the JOBS Act until December 31, 2024. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until those standards apply to private companies.
Previous wording
We have elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our consolidated financial statements and our interim condensed consolidated financial statements may or may not be comparable to companies that comply with new or revised accounting pronouncements as of public companies’ effective dates.
Current wording
We elected to use this extended transition period for complying with certain new or revised accounting standards that have different effective dates for public and private companies until the date we lost emerging growth company status. As a result, our condensed consolidated financial statements may or may not be comparable to companies that comply with new or revised accounting pronouncements as of public companies’ effective dates.
Rearranged previous paragraphs (5)
Previous report — wording carried elsewhere
In September 2023, we completed our initial public offering (IPO) pursuant to which we issued and sold an aggregate of 14,710,000 shares of our common stock at a price to the public of $17.00 per share. We received aggregate net proceeds of $226.5 million after deducting underwriting discounts and commissions of $17.5 million and other offering expenses of $6.0 million. As of September 30, 2024, we had $341.3 million in cash, cash equivalents and marketable securities. Based upon our current operating plan, we believe that our existing cash, cash equivalents and marketable securities, will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months following the issuance of the condensed consolidated financial statements.
Previous report — wording carried elsewhere
Since our inception, we have incurred significant net losses, which are primarily attributable to acquired intangible in-process research and development intangible asset (IPR&D) costs pursuant to our acquisitions, which occurred in 2020 and were accounted for as an acquisition of assets. We expect to continue to incur significant losses for the foreseeable future as we continue to advance the development of our product candidates and approach, and incur additional costs associated with being a public company. Our net losses were $72.5 million and $53.0 million for the three months ended September 30, 2024 and 2023. Our net losses were $185.0 million and $127.2 million for the nine months ended September 30, 2024 and 2023. As of September 30, 2024, we had an accumulated deficit of $888.4 million. Our primary use of our capital resources is to fund our operating expenses, which consist primarily of expenditures related to identifying, acquiring, developing, and in-licensing our precision neuroscience approach and product candidates, and conducting preclinical studies and clinical trials, and to a lesser extent, general and administrative expenditures. Our net losses may fluctuate significantly from period to period, depending on the timing of our clinical trials and our expenditures on research and development activities.
Previous report — wording carried elsewhere
The following table summarizes our result of operations for the periods presented:
Previous report — wording carried elsewhere
The following table summarizes our research and development expenses by program for the periods presented:
Previous report — wording carried elsewhere
To complete the development and commercialization of our product candidates, if approved, we will require substantial additional funding. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our operations through public or private equity offerings or debt financings or other capital sources, which may include strategic collaborations or other arrangements with third parties, or other sources of financing.