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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): August 12, 2021

 

 

ANNEXON, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware	001-39402	27-5414423
(State or other jurisdiction	(Commission	(IRS Employer
of incorporation)	File Number)	Identification No.)

 

 

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:

 

☐	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, par value $0.001 per share		ANNX		The Nasdaq Stock 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.  ☐

 

 

 

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Item 2.02.

Results of Operations and Financial Condition.

On August 16, 2021, Annexon, Inc. (the “Company”) announced certain financial results for the second quarter ended June 30, 2021. A copy of the Company’s press release, titled “Annexon Biosciences Reports Second Quarter 2021 Financial Results and Provides Mid-Year Business Update,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, 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 in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission (the “SEC”) made by the Company, 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.

Item 5.02.

Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

(d) On August 12, 2021, the Board of Directors (the “Board”) of the Company appointed William D. Waddill to the Board and as chairperson of the Board’s Audit Committee (the “Audit Committee”), effectively immediately. Mr. Waddill will serve as a Class II director with a term expiring at the 2022 annual meeting of stockholders and until his successor has been elected and qualified.

Pursuant to the Company’s non-employee director compensation program, as a non-employee director, Mr. Waddill will receive (i) a $35,000 annual retainer for his service on the Board, prorated for the remainder of 2021, (ii) a $15,000 annual retainer for his service as chairperson of the Audit Committee, prorated for the remainder of 2021, (iii) an automatic initial grant of a stock option to purchase 20,000 shares of Common Stock under the Company’s 2020 Incentive Award Plan and (iv) on the date of each annual stockholder meeting, an automatic grant of a stock option to purchase 10,000 shares of Common Stock under the Company’s 2020 Incentive Award Plan. The foregoing description is qualified in its entirety by reference to the text of the Company’s non-employee director compensation program, the form of which was filed as Exhibit 10.12 to the Company’s Registration Statement on Form S-1 filed with the SEC on July 20, 2020.

In addition, Mr. Waddill will enter into the Company’s standard indemnification and advancement agreement for directors and executive officers, the form of which was filed as Exhibit 10.12 to the Company’s Registration Statement on Form S-1 filed with the SEC on July 2, 2020.

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits.

 

Exhibit		Description
99.1		Press Release, dated August 16, 2021, titled “Annexon Biosciences Reports Second Quarter 2021 Financial Results and Provides Mid-Year Business Update”
104.1		Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

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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.

 

Dated: August 16, 2021				Annexon, Inc.
		By:		/s/ Jennifer Lew
				Jennifer Lew
				Executive Vice President and Chief Financial Officer

 

 

Exhibit 99.1

 

 

Annexon Biosciences Reports Second Quarter 2021 Financial Results and Provides Mid-Year Business Update

 

– Recently expanded Autoimmune franchise with advancement of third clinical candidate, ANX009, and strategically expanded into additional autoantibody-driven diseases –  

– Continued progress in Neurodegeneration franchise with initial Phase 2 data results from ANX005 in Huntington’s disease expected in Q4 2021 and initiation of Phase 2 ANX005 trial in Amyotrophic Lateral Sclerosis –  

– Appointed William D. Waddill to the Board of Directors –

 

 

SOUTH SAN FRANCISCO, Calif., August 16, 2021 – Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), Annexon, a clinical-stage biopharmaceutical company developing a class of new complement medicines for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced second quarter 2021 financial results and provided a mid-year business update.

 

“We continue to make strong and consistent progress on our mission to deliver transformative therapies for patients suffering from classical complement-driven autoimmune and neurodegenerative diseases. With three clinical-stage drug candidates advancing in seven clinical trials, we remain laser-focused on developing game-changing therapies for patients in need while generating significant value for our shareholders,” said Douglas Love, Esq., president and chief executive officer of Annexon. “We also continue to expand our corporate capabilities and are pleased to announce the appointment of Will Waddill to our Board of Directors.  Will has extensive experience in biotech and finance, and will provide an invaluable perspective as we enter our next phase of growth and value creation.”

 

Therapeutic Franchise Highlights and Updates

 

Annexon is advancing a portfolio of innovative C1 inhibitors to stop classical complement-mediated diseases at the start of the pathway in three therapeutic franchise areas:  Autoimmune, Neurodegeneration and Ophthalmology.  

 

Autoimmune Franchise

 

Annexon is pursuing a range of carefully selected neuromuscular, hematologic and nephritic antibody-mediated autoimmune indications where excess classical complement activity is a key driver of disease. During its July 28th C1q R&D series presentation, Annexon showcased the rationale and potential of its anti-C1 approach in autoimmune disease.

 

Recent highlights and updates in the Autoimmune franchise include:

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Neurodegeneration Franchise

 

Annexon is pioneering an approach to stop complement-mediated neurodegeneration at the start, leveraging its original discoveries of the role of C1q as a major driver of synaptic loss and neurodegeneration. Blocking C1q potentially protects against functioning synapse loss and may provide functional benefit. Annexon is utilizing biomarkers of neuronal damage to measure impact on disease.

 

Recent highlights and updates in the Neurodegeneration franchise include:

 

Ophthalmology Franchise

 

Annexon is utilizing intravitreal administration of ANX007 to inhibit C1q, which is implicated in neurodegeneration in the retina. Selectively targeting C1q at the start of the classical pathway versus downstream approaches may enhance efficacy and safety for patients in ophthalmic disorders, including Geographic Atrophy (GA).  

Recent highlights and updates in the Ophthalmology franchise include:

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Corporate Update

 

 

Second Quarter 2021 Financial Results

 

 

 

 

 

About Annexon, Inc.

Annexon is a clinical-stage biopharmaceutical company developing a class of new complement medicines for patients with classical complement-mediated disorders of the body, brain and eye. The company’s pipeline is based on its platform technology addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway:  ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). Annexon is deploying a disciplined, biomarker-driven strategy designed to improve the probability of technical success of its portfolio. 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: continuing advancement of the company’s innovative portfolio; timing of data from clinical trials and peer reviewed forum 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

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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.

 

Investor Contacts:
Jennifer Lew, Chief Financial Officer

Annexon Biosciences

jlew@annexonbio.com

 

Sara Michelmore

MacDougall Advisors

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)

(unaudited)

 

 

 

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ANNEXON, INC.

Condensed Consolidated Balance Sheets

(in thousands)