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): May 17, 2021

 

 

ANNEXON, INC.

(Exact name of registrant as specified in its charter)

 

 

 

 

 

180 Kimball Way, Suite 200

South San Francisco, California 94080

(Address of principal executive offices) (Zip Code)

 

Registrant’s telephone number, including area code: (650) 822-5500

Not Applicable

(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:

 

 

 

 

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

 

 

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.  ☐

 

 

 

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On May 17, 2021, Annexon, Inc. (“Annexon”) announced certain financial results for the first quarter ended March 31, 2021. A copy of Annexon’s press release, titled “Annexon Biosciences Provides Business Update and Reports First Quarter 2021 Financial Results,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.

 

 

The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Annexon, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such a filing.

 

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SIGNATURES

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

 

 

 

Exhibit 99.1

 

 

Annexon Biosciences Provides Business Update and Reports First Quarter 2021 Financial Results

 

– ANX005 Huntington’s Disease Phase 2 trial fully enrolled with data anticipated 2H 2021 –

– ANX009 First-in-Human dose-ranging trial completed with data expected summer 2021 –

– Next generation drug candidates, ANX105 and ANX1502, on track to submit INDs by end of 2021 –

– Current cash position sufficient to fund operations through 2023 –

 

 

SOUTH SAN FRANCISCO, Calif., May 17, 2021 – Annexon, Inc.  (“Annexon”) (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, today announced first quarter 2021 financial results and business highlights.

 

Recent Business Highlights

 

Annexon is advancing a portfolio of innovative C1q inhibitors to stop classical complement-mediated autoimmune and neurodegenerative disease processes at the start in several indications.  Recent portfolio highlights include:

 

 

 

 

“We are pleased with the strong progress on our mission to deliver transformative therapies for patients suffering from complement-driven autoimmune and neurodegenerative diseases,” said Douglas Love, Esq., president and chief executive officer of Annexon.  “Annexon remains on track for another exciting year, and looking ahead, is sharply focused on effectively executing our several clinical programs while advancing multiple next generation drug candidates and driving our beachhead strategy to rapidly expand our platform into mechanistically related indications.”

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First Quarter 2021 Financial Results

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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About Annexon, Inc.

Annexon is a clinical-stage biopharmaceutical company developing a pipeline of novel therapies for patients with classical complement-mediated disorders of the body, brain and eye. The company’s pipeline is based on its platform technology addressing well-researched classical complement-mediated autoimmune and neurodegenerative disease processes, both of which are triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is deploying a disciplined, biomarker-driven strategy designed to select indications, identify patients and to measure target engagement and response to treatment with its drug candidates. For more information, visit www.annexonbio.com.

 

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “positioned,” “potential,” “predict,” “seek,” “should,” “target,” “on track,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology.  All statements other than statements of historical facts contained in this press release are forward-looking statements.  These forward-looking statements include, but are not limited to, statements about: sufficiency of the company’s cash to fund operations; continuing advancement of the company’s innovative portfolio; timing of data from clinical trials and regulatory submissions; timing of completion of clinical studies and clinical development milestones; the company’s ability to deliver on its objectives; and the implementation of the company’s business model and strategic plans for its business and product candidates, including potential treatment indications and additional indications that the company may pursue.  Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: the company’s history of net operating losses; the company’s ability to obtain necessary capital to fund its clinical programs; the early stages of clinical development of the company’s product candidates; the effects of COVID-19 or other public health crises on the company’s clinical programs and business operations; the company’s ability to obtain regulatory approval of and successfully commercialize its product candidates; any undesirable side effects or other properties of the company’s product candidates; the company’s reliance on third-party suppliers and manufacturers; the outcomes of any future collaboration agreements; and the company’s ability to adequately maintain intellectual property rights for its product candidates.  These and other risks are described in greater detail under the section titled “Risk Factors” contained in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and the company’s other filings with the SEC. Any forward-looking statements that the company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release.  Except as required by law, the company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.

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Investor Contacts:
Jennifer Lew, Chief Financial Officer

Annexon Biosciences

jlew@annexonbio.com

 

Sara Michelmore

smichelmore@macbiocom.com

 

Media Contacts:
Miriam Mason

Annexon Biosciences

mmason@annexonbio.com

 

 

 

 

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ANNEXON, INC.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

 

 

 

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ANNEXON, INC.

Condensed Consolidated Balance Sheets

(in thousands)