Navacaprant Phase 3 KOASTAL program in major depressive disorder on track; planned initiation of Phase 2 bipolar depression trial in 1H24
Progressing NMRA-511 and NMRA-266 toward near-term clinical milestones and advancing multiple preclinical neuropsychiatric and neurodegeneration programs
Strong balance sheet with
“The third quarter of 2023 was momentous for Neumora with the achievement of several important clinical and corporate milestones, including our successful initial public offering and the initiation of our Phase 3 KOASTAL program for navacaprant. Additionally, we are on track to achieve the anticipated milestones for NMRA-511 and NMRA-266,” 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 KOASTAL Program On Track
Navacaprant (NMRA-140) is a highly selective, novel, once-daily kappa opioid receptor (KOR) antagonist being developed as a potential monotherapy treatment for major depressive disorder (MDD) and other neuropsychiatric disorders.
Neumora initiated the KOASTAL-1 study, a Phase 3 pivotal clinical trial designed to evaluate the efficacy and safety of navacaprant monotherapy for the treatment of MDD. This study is part of Neumora’s registrational Phase 3 KOASTAL program, which includes the KOASTAL-1, KOASTAL-2, and KOASTAL-3 studies. These replicate, randomized, placebo-controlled, double-blind studies are designed to evaluate the efficacy and safety of navacaprant monotherapy in adult patients with MDD.
The Company expects the following milestones for navacaprant in MDD:
- Initiate KOASTAL-3 study in the fourth quarter of 2023.
- Initiate KOASTAL-2 study in the first quarter of 2024.
- Report topline data from the KOASTAL-1 study in the second half of 2024.
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 clinical trial in BPD in the first half of 2024.
BUSINESS UPDATES
- Announced key leadership appointments: In
October 2023 , Neumora announced thatRobert Lenz , M.D., Ph.D., had joined Neumora as executive vice president, head of R&D.Dr. Lenz brings more than two decades of neuroscience drug development expertise, most recently serving as senior vice president and head of global development at Amgen. - Successfully completed initial public offering: In
September 2023 , Neumora completed its initial public offering of its common stock and shares began trading on the Nasdaq Global Select Market under the ticker symbol “NMRA.” Since its inception, Neumora has raised over$850 million to further its mission to confront the global brain disease crisis.
THIRD QUARTER 2023 FINANCIAL RESULTS
The Company reported a net loss of
Research and development expenses for the third quarter of 2023 were
General and administrative expenses for the third quarter of 2023 were
As of
About Neumora
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about
Financial Tables
Unaudited Consolidated Statement of Operations
(in thousands, except per-share data)
Three Months Ended | Nine Months Ended | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 41,601 | $ | 22,549 | $ | 103,855 | $ | 68,226 | |||||||
Acquired in-process research and development | — | — | — | 13,000 | |||||||||||
General and administrative | 15,263 | 8,053 | 34,239 | 23,926 | |||||||||||
Total operating expenses | 56,864 | 30,602 | 138,094 | 105,152 | |||||||||||
Loss from operations | (56,864 | ) | (30,602 | ) | (138,094 | ) | (105,152 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 3,838 | 1,406 | 10,965 | 2,276 | |||||||||||
Other income (expense), net | (1 | ) | (148 | ) | (66 | ) | 118 | ||||||||
Total other income | 3,837 | 1,258 | 10,899 | 2,394 | |||||||||||
Net loss | (53,027 | ) | (29,344 | ) | (127,195 | ) | (102,758 | ) | |||||||
Other comprehensive income (loss): | |||||||||||||||
Unrealized gain (loss) on marketable securities | 137 | (284 | ) | 463 | (1,154 | ) | |||||||||
Comprehensive loss | $ | (52,890 | ) | $ | (29,628 | ) | $ | (126,732 | ) | $ | (103,912 | ) | |||
Net loss per share, basic and diluted | $ | (1.14 | ) | $ | (1.06 | ) | $ | (3.59 | ) | $ | (3.83 | ) | |||
Weighted-average shares outstanding, basic and diluted | 46,691 | 27,646 | 35,428 | 26,841 | |||||||||||
Unaudited Consolidated Balance Sheets
(in thousands)
2023 | 2022 | ||||||
(unaudited) | |||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 412,284 | $ | 240,943 | |||
Short-term marketable securities | 97,281 | 130,941 | |||||
Restricted cash | — | 50 | |||||
Prepaid expenses and other current assets | 16,170 | 16,021 | |||||
Total current assets | 525,735 | 387,955 | |||||
Long-term marketable securities | 9,913 | 23,511 | |||||
Property and equipment, net | 1,934 | 2,411 | |||||
Operating lease right-of-use assets | 5,954 | 8,231 | |||||
Restricted cash | 1,213 | 1,213 | |||||
Other assets | — | 2,913 | |||||
Total assets | $ | 544,749 | $ | 426,234 | |||
Liabilities, Convertible Preferred Stock, and Stockholders’ Equity (Deficit) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,229 | $ | 7,147 | |||
Accrued liabilities | 23,347 | 11,536 | |||||
Early exercise liability, current portion | 149 | 1,644 | |||||
Operating lease liabilities, current portion | 3,398 | 3,370 | |||||
Total current liabilities | 29,123 | 23,697 | |||||
Operating lease liabilities, net of current portion | 2,745 | 5,072 | |||||
Early exercise liability, net of current portion | 188 | 628 | |||||
Total liabilities | 32,056 | 29,397 | |||||
Commitments and contingencies (Note 7) | |||||||
Convertible preferred stock | — | 843,687 | |||||
Stockholders’ equity (deficit): | |||||||
Common stock | 15 | 3 | |||||
Additional paid-in capital | 1,107,693 | 21,430 | |||||
Accumulated other comprehensive loss | (311 | ) | (774 | ) | |||
Accumulated deficit | (594,704 | ) | (467,509 | ) | |||
Total stockholders’ equity (deficit) | 512,693 | (446,850 | ) | ||||
Total liabilities, convertible preferred stock, and stockholders’ equity (deficit) | $ | 544,749 | $ | 426,234 | |||
Investors
+1 (315) 382-3979
Helen.Rubinstein@neumoratx.com
Source:
2023 GlobeNewswire, Inc., source