Exhibit 99.1
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
2026
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.”
KEY PIPELINE
HIGHLIGHTS
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.
Navacaprant
(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.
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In February 2024 following a Type D meeting, the U.S. Food and Drug Administration (FDA) provided written
feedback that there is no need for the Company to conduct further studies to assess physical dependence with navacaprant. |
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Navacaprant did not demonstrate properties associated with risks of opioid-related abuse in several mode of
action profiling studies. Data from these studies were presented at the Annual Meeting of the Society of Biological Psychiatry and College on Problems of Drug Dependence Annual Meeting in 2023. |
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Neumora expects to report topline data from the KOASTAL-1 study in the
second half of 2024, and topline data from the KOASTAL-2 and KOASTAL-3 studies in the first half of 2025. |
Neumora also intends to evaluate the potential of navacaprant as treatment for other neuropsychiatric populations beyond MDD, including bipolar depression
(BPD).
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The Company expects to initiate a Phase 2 clinical trial in BPD in the first half of 2024. |
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