Full Press Release Details
Neumora Therapeutics Reports Fourth Quarter and Full Year 2023
Financial Results and Provides Business Update
On-track to report topline Phase 3 data from the KOASTAL-1
study with navacaprant in MDD in the second half of 2024 and Phase 1 data with NMRA-266 in healthy adult participants mid-2024
Strong financial position with $463.8 million in cash, cash equivalents and marketable securities expected to support operations into
WATERTOWN, Mass., March 7, 2024 Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage
biopharmaceutical company redefining neuroscience drug development, today announced financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.
2023 was a watershed year for Neumora as we transitioned to a publicly traded company, advanced our KOR antagonist, navacaprant, into three Phase 3
registrational studies, and brought our M4 PAM, NMRA-266, into the clinic ahead of schedule, said Henry Gosebruch, chief executive officer, Neumora. We have an exciting year ahead as we look
forward to a data-rich 2024 including anticipated readouts from two clinically validated programs our Phase 3 navacaprant program in major depressive disorder and Phase 1 data from our NMRA-266 program
and the initiation of several key clinical studies. Additionally, we continue to build on our leadership position in brain disorders with an industry-leading pipeline of seven clinical and preclinical programs all targeting novel mechanisms
of action. We believe we are well on our way to redefine treatment options for people suffering from debilitating brain diseases.
Neumora is advancing a therapeutic pipeline of seven clinical and preclinical neuroscience programs that target novel mechanisms of action
for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases.
(NMRA-140): Phase 3 KOASTAL Program On-Track with Major Depressive Disorder (MDD) Data Expected in 2024
Navacaprant (NMRA-140) is a highly selective, novel, once-daily kappa opioid receptor (KOR) antagonist being developed
as a potential monotherapy treatment for MDD and other neuropsychiatric disorders. The KOR antagonist approach has been clinically validated in three independent studies.
Neumora is currently enrolling the registrational Phase 3 KOASTAL program, which is designed to evaluate the efficacy and safety of navacaprant monotherapy
for the treatment of MDD. KOASTAL-1, KOASTAL-2, and KOASTAL-3 are replicate Phase 3, randomized, placebo-controlled, double-blind
studies in adult patients with MDD.
Neumora also intends to evaluate the potential of navacaprant as treatment for other neuropsychiatric populations beyond MDD, including bipolar depression
NMRA-266: Phase 1 Study Underway with Data in Healthy Adult
Participants Expected mid-2024
NMRA-266 is a highly selective
positive allosteric modulator (PAM) of the M4 muscarinic receptor that Neumora is developing as a treatment for schizophrenia and other neuropsychiatric disorders.
NMRA-511: Phase 1b Study in Alzheimer s Disease
NMRA-511 is an antagonist of the vasopressin 1a receptor (V1aR), with high selectivity
over V1b, V2 (greater than 3,000-fold) and oxytocin receptors (approximately 300-fold). Vasopressin plays a role in the regulation of aggression, affiliation, stress and
Announced Key Leadership Appointments
FOURTH QUARTER AND FULL YEAR FINANCIAL RESULTS
Neumora Therapeutics, Inc. is 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. Our therapeutic pipeline 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 work is supported by an integrated suite of translational,
clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved
treatment outcomes and quality of life for patients suffering from brain diseases.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Neumora Therapeutics, Inc. (the Company, we, us, or
our ) within the meaning of the federal securities laws, including statements related to: Neumora s intention to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved
treatment outcomes and quality of life for patients suffering from brain diseases; the timing, progress and plans for its therapeutic development programs, including the timing of initiation and data read outs for its programs and studies, as well
as its clinical trial and development plans; timing and expectations related to regulatory filings and interactions; expectations and projections regarding future operating results and financial performance, including the sufficiency of its cash
resources and expectation of the timing of its cash runway; its ability to create significant value and; other statements identified by words such as could, expects, intends, may, plans,
potential, should, will, would, or similar expressions and the negatives of those terms. Other than statements of historical facts, all statements contained in this press release, are forward-looking
statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are subject to risks and uncertainties that could cause the actual results or to be materially
different from the information expressed or implied by these forward-looking statements, including, among others: the risks related to the inherent uncertainty of clinical drug development and unpredictability and lengthy process for obtaining
regulatory approvals; risks related to the timely initiation and enrollment in our clinical trials; risks related to our reliance on third parties, including CROs; risks related to serious or undesirable side effects of our therapeutic candidates;
risks related to our ability to utilize and protect our intellectual property rights; and other matters that could affect sufficiency of capital resources to fund operations. For a detailed discussion of the risks and uncertainties that could cause
actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Neumora s business in general, please refer to the risk factors identified in the Company s filings with the Securities and
Exchange Commission (SEC), including but not limited to its Registration Statement on Form S-1, as amended (File No. 333-274229), filed with the SEC on
September 11, 2023, and related Prospectus dated September 14, 2023 filed under 424(b)(4) of the Securities Act of 1933, as amended. Forward-looking statements speak only as of the date hereof, and, except as required by law, Neumora
undertakes no obligation to update or revise these forward-looking statements.
NEUMORA THERAPEUTICS, INC.
Unaudited Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share amounts)
| Three months ended December 31, | Year ended December 31, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 38,864 | $ | 23,523 | $ | 142,719 | $ | 91,749 | ||||||||
| Acquired in-process research and development | 63,904 | 63,904 | 13,000 | |||||||||||||
| General and administrative | 11,236 | 7,195 | 45,475 | 31,121 | ||||||||||||
| Total operating expenses | 114,004 | 30,718 | 252,098 | 135,870 | ||||||||||||
| Loss from operations | (114,004 | ) | (30,718 | ) | (252,098 | ) | (135,870 | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | 5,646 | 2,285 | 16,611 | 4,561 | ||||||||||||
| Other income (expense), net | (104 | ) | 287 | (170 | ) | 405 | ||||||||||
| Total other income | 5,542 | 2,572 | 16,441 | 4,966 | ||||||||||||
| Net loss before income taxes | (108,462 | ) | (28,146 | ) | (235,657 | ) | (130,904 | ) | ||||||||
| Provision for income taxes | 268 | 268 | ||||||||||||||
| Net loss | (108,730 | ) | (28,146 | ) | (235,925 | ) | (130,904 | ) | ||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Unrealized gain (loss) on marketable securities | 235 | 380 | 698 | (774 | ) | |||||||||||
| Comprehensive loss | $ | (108,495 | ) | $ | (27,766 | ) | $ | (235,227 | ) | $ | (131,678 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.71 | ) | $ | (0.99 | ) | $ | (3.63 | ) | $ | (4.81 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 152,832 | 28,293 | 65,021 | 27,207 |
Unaudited Condensed Consolidated Balance Sheets
| December 31, 2023 | December 31, 2022 | |||||||
| Cash, cash equivalents and marketable securities | $ | 463,827 | $ | 395,395 | ||||
| Total assets | 496,195 | 426,234 | ||||||
| Total liabilities | 27,119 | 29,397 | ||||||
| Total stockholders equity (deficit) | 469,076 | (446,850 | ) |