On-track to report topline Phase 3 data from KOASTAL-1 study with navacaprant in MDD; guidance narrowed to fourth quarter of 2024
Multiple clinical study initiations planned in second quarter of 2024, including Phase 2 study in bipolar depression with navacaprant and Phase 1b study in Alzheimer's disease agitation with NMRA-511
Strong financial position with
“We are laser focused on high-quality clinical execution as we advance toward the Phase 3 topline data readout for navacaprant in the fourth quarter,” said
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 Data from KOASTAL-1 Study in Major Depressive Disorder (MDD) Expected in the Fourth Quarter of 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.
- The KOASTAL studies are progressing well, and Neumora remains on-track to report data within previously guided timeframes. Neumora expects to report topline data from the KOASTAL-1 study in the fourth quarter 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).
- The Company expects to initiate a Phase 2 clinical trial in BPD in the second quarter of 2024.
NMRA-511: Plan to Initiate Phase 1b Study in Alzheimer’s Disease Agitation in the Second Quarter of 2024
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 anxiety response.
- The Phase 1 single ascending dose / multiple ascending dose (SAD / MAD) study evaluating NMRA-511 in healthy adult participants is complete. NMRA-511 was generally well-tolerated in the study, and results support advancement of the program in people with Alzheimer’s disease agitation. Neumora looks forward to sharing more data from the Phase 1 SAD / MAD study in the future.
- Neumora expects to initiate a Phase 1b study in Alzheimer's disease agitation in the second quarter of 2024, with data from that study anticipated in 2025.
M4 Positive Allosteric Modulator (PAM) Franchise: Advancing Preclinical Work Across Compounds
Neumora’s M4 franchise is comprised of multiple novel compounds that each have different properties and chemical composition, including NMRA-266.
- Neumora recently announced that the Phase 1 single ascending dose / multiple ascending dose study with NMRA-266 has been paused following a clinical hold determination by the FDA. Neumora is working with the FDA to evaluate the potential to resolve the clinical hold and will provide an update when available.
Beyond NMRA-266, additional compounds in Neumora’s M4 PAM franchise also demonstrated robust activity in preclinical efficacy models, as well as high selectivity for the M4 receptor subtype and the potential for an oral once-daily dosing profile.
- Neumora is advancing pre-clinical safety and toxicology work with its additional M4 PAM compounds and expects to submit an IND in 2025.
BUSINESS UPDATES
- In
March 2024 , Neumora entered into a funding agreement with Parkinson’sUK for £2.1 million to support the advancement of NMRA-NLRP3, an NLRP3 inhibitor with the potential to reduce inflammation and protect brain cells in Parkinson’s. Neumora is advancing preclinical work for this program.
FOURTH QUARTER AND FULL YEAR FINANCIAL RESULTS
- Cash Position: As of
March 31, 2024 , Neumora had cash, cash equivalents and marketable securities of$423.0 million . - Financial Guidance: The Company expects that its cash, cash equivalents and marketable securities as of
March 31, 2024 , will enable it to fund its operating plan into 2026.
R&D Expense: Research and development expenses for the first quarter of 2024 were
- G&A Expense: General and administrative expenses for the first quarter of 2024 were
$14.3 million , as compared to$9.7 million for the same period in 2023. This increase was primarily due to personnel-related costs, including stock-based compensation and professional services to support the continued expansion of administrative functions. - Net Loss: The Company reported a net loss of
$53.7 million for the first quarter of 2024, as compared to$35.6 million for the same period in 2023.
About Neumora
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about
Financial Tables
Unaudited Consolidated Statements of Operations and Comprehensive Loss | |||||||||
(in thousands, except per share amounts) | |||||||||
Three Months Ended | |||||||||
2024 | 2023 | ||||||||
Operating expenses: | |||||||||
Research and development | $ | 45,757 | $ | 29,485 | |||||
General and administrative | 14,317 | 9,683 | |||||||
Total operating expenses | 60,074 | 39,168 | |||||||
Loss from operations | (60,074 | ) | (39,168 | ) | |||||
Other income (expense): | |||||||||
Interest income | 6,365 | 3,569 | |||||||
Other expense, net | (12 | ) | (26 | ) | |||||
Total other income | 6,353 | 3,543 | |||||||
Net loss | (53,721 | ) | (35,625 | ) | |||||
Other comprehensive income (loss): | |||||||||
Unrealized gain (loss) on marketable securities | (72 | ) | 476 | ||||||
Comprehensive loss | $ | (53,793 | ) | $ | (35,149 | ) | |||
Net loss per share, basic and diluted | $ | (0.34 | ) | $ | (1.22 | ) | |||
Weighted-average shares outstanding, basic and diluted | 157,943 | 29,277 | |||||||
Unaudited Condensed Consolidated Balance Sheets | |||||||||
(in thousands) | |||||||||
2024 | 2023 | ||||||||
Cash, cash equivalents and marketable securities | $ | 423,017 | $ | 463,827 | |||||
Total assets | $ | 450,211 | $ | 496,195 | |||||
Total liabilities | $ | 25,669 | $ | 27,119 | |||||
Total stockholders’ equity | $ | 424,542 | $ | 469,076 | |||||
Neumora Contact
+1 (315) 382-3979
Helen.Rubinstein@neumoratx.com
Source:
2024 GlobeNewswire, Inc., source