false 0001885522 0001885522 2023-11-01 2023-11-01

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): November 1, 2023

 

 

NEUMORA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-41802   84-4367680

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification Number)

490 Arsenal Way, Suite 200

Watertown, Massachusetts 02472

(Address of principal executive offices) (Zip Code)

(857) 760-0900

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

  ☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Trading

Symbol(s)

  

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   NMRA   The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

Item 2.02

Results of Operations and Financial Condition.

On November 1, 2023, Neumora Therapeutics, Inc. (“Neumora” or the “Company”) announced its financial results for the third quarter ended September 30, 2023. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information furnished pursuant to this Item 2.02 of this Current Report on Form 8-K, including the attached Exhibit 99.1, is being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01

Financial Statements and Exhibits.

 

Exhibit
No.

   

Description

99.1    Press Release dated November 1, 2023.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    NEUMORA THERAPEUTICS, INC.
Date: November 1, 2023     By:  

/s/ Joshua Pinto

      Joshua Pinto
      Chief Financial Officer

Exhibit 99.1

 

LOGO

Neumora Therapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update

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 $519.5 million in cash, cash equivalents and marketable securities expected to support operations into 2026

WATERTOWN, MA, November 1, 2023 – Neumora Therapeutics, Inc. (Nasdaq: NMRA), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced financial results for the third quarter ended September 30, 2023 and provided a general business update.

“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 Henry Gosebruch, chief executive officer, Neumora. “Looking forward, we have a strong balance sheet to support our continued focus on execution across our programs as we seek to pioneer a new era in brain diseases, which collectively represent one of the largest areas of unmet medical need, affecting upwards of 1.5 billion patients globally. I believe that we have the right combination of novel programs and capabilities to make a real difference for patients living with brain diseases and create significant value.”

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.

 

Page 1 of 4

LOGO

BUSINESS UPDATES

 

  •  

Announced key leadership appointments: In October 2023, Neumora announced that Robert 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 $53.0 million for the third quarter of 2023, as compared to $29.3 million for the same period in 2022.

Research and development expenses for the third quarter of 2023 were $41.6 million, as compared to $22.5 million for the same period in 2022. This increase was primarily due to advancement of clinical and preclinical programs and related start-up activities for Phase 3 clinical trials evaluating navacaprant as a monotherapy treatment for MDD.

General and administrative expenses for the third quarter of 2023 were $15.3 million, as compared to $8.1 million for the same period in 2022. This increase was primarily due to personnel-related costs and professional services to support the continued expansion of administrative functions.

As of September 30, 2023, Neumora had $519.5 million in cash, cash equivalents and marketable securities. The Company expects that its cash, cash equivalents and marketable securities as of September 30, 2023, will enable it to fund its operating plan into 2026.

About Neumora

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

 

Page 2 of 4

LOGO

 

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.

Financial Tables

Neumora Therapeutics, Inc.

Unaudited Consolidated Statement of Operations

(in thousands, except per-share data)

 

     Three Months Ended
September 30,		     Nine Months Ended
September 30,		  
     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  
  

 

 

    

 

 

    

 

 

    

 

 

  

 

Page 3 of 4

LOGO

 

Neumora Therapeutics, Inc.

Unaudited Consolidated Balance Sheets

(in thousands)

 

     September 30,
2023		     December 31,
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

Helen Rubinstein

+1 (315) 382-3979

Helen.Rubinstein@neumoratx.com

 

Page 4 of 4

v3.23.3
Document and Entity Information
Nov. 01, 2023
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Entity Central Index Key 0001885522
Document Type 8-K
Document Period End Date Nov. 01, 2023
Entity Registrant Name NEUMORA THERAPEUTICS, INC.
Entity Incorporation State Country Code DE
Entity File Number 001-41802
Entity Tax Identification Number 84-4367680
Entity Address, Address Line One 490 Arsenal Way
Entity Address, Address Line Two Suite 200
Entity Address, City or Town Watertown
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02472
City Area Code (857)
Local Phone Number 760-0900
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Security 12b Title Common Stock, $0.0001 par value per share
Trading Symbol NMRA
Security Exchange Name NASDAQ
Entity Emerging Growth Company true
Entity Ex Transition Period false
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