Neumora Therapeutics Inc
For the period ended Sep 30, 2024. Filed Nov 12, 2024.
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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.
Sep 30, 2024 · Filed Nov 12, 2024
NMRA$0.50+3.3%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-06-30; filed 2024-08-06.
0000950170-24-091737
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 52 previous paragraphs and 120 current paragraphs.
49 unchanged; 3 reworded; 64 added; 0 removed; 0 previous and 4 current paragraphs rearranged.
Tables are not compared: 0 previous and 5 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 (64)
Current report
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Current report
Results of Operations
Current report
The following table summarizes our result of operations for the periods presented:
Current report
Research and Development Expenses
Current report
The following table summarizes our research and development expenses by program for the periods presented:
Current report
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 report
General and Administrative Expenses
Current 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.
Current report
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 report
For the Nine Months Ended September 30, 2024 and 2023
Current report
The following table summarizes our result of operations for the periods presented:
Current report
Research and Development Expenses
Current report
The following table summarizes our research and development expenses by program for the periods presented:
Current 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.
Current report
General and Administrative Expenses
Current 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.
Current 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.
Current report
Liquidity and Capital Resources
Current report
Sources of Liquidity
Current report
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 report
Future Funding Requirements
Current report
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 report
the scope, timing, progress, costs and results of discovery, preclinical development and clinical trials for our current or future product candidates;
Current report
the number of clinical trials required for regulatory approval of our current or future product candidates;
Current report
the costs, timing and outcome of regulatory review of any of our current or future product candidates;
Current report
the costs associated with acquiring or licensing additional product candidates, technologies or assets, including the timing and amount of any milestones, royalties or other payments due in connection with our acquisitions and licenses;
Current report
the cost of manufacturing clinical and commercial supplies of our current or future product candidates;
Current report
the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims, including any claims by third parties that we are infringing upon their intellectual property rights;
Current report
our ability to maintain existing, and establish new, strategic collaborations or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such agreement;
Current report
our ability to access additional multimodal patient datasets;
Current report
the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
Current report
the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;
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expenses to attract, hire and retain skilled personnel;
Current report
the costs of operating as a public company;
Current report
our ability to establish a commercially viable pricing structure and obtain approval for coverage and adequate reimbursement from third-party and government payers;
Current report
the effect of macroeconomic trends including inflation and rising interest rates;
Current report
addressing any potential supply chain interruptions or delays, including those related to geopolitical issues;
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the effect of competing technological and market developments; and
Current report
the extent to which we acquire or invest in business, products and technologies.
Current report
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.
Showing the first 40 of 64 passages. Open the source sections for the rest.
Reworded paragraphs (3)
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 in the fourth quarter 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 anticipate 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 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.
Previous wording
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 June 30, 2024, we had $371.6 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.
Current wording
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 wording
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 $58.7 million and $38.5 million for the three months ended June 30, 2024 and 2023. Our net losses were $112.4 million and $74.2 million for the six months ended June 30, 2024 and 2023. As of June 30, 2024, we had an accumulated deficit of $815.9 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.
Current wording
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.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
For the Three Months Ended September 30, 2024 and 2023
Current report — wording carried from elsewhere
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 report — wording carried from elsewhere
the effectiveness of our precision neuroscience approach at identifying target patient populations and utilizing our approach to enrich our patient population in our clinical trials;
Current report — wording carried from 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.