false000152811500015281152023-08-072023-08-07

 

 

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 7, 2023

 

 

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.)

 

 

1400 Sierra Point Parkway, Bldg C, Suite 200

Brisbane, California 94005

(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 7, 2023, Annexon, Inc. (the “Company”) announced certain financial results for the second quarter ended June 30, 2023. A copy of the Company’s press release, titled “Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results,” 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 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 9.01. Financial Statements and Exhibits.

(d)

Exhibits.

 

Exhibit		Description
99.1		Press Release, dated August 7, 2023, titled “Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results”
104		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, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Dated: August 7, 2023				Annexon, Inc.
		By:		/s/ Jennifer Lew
				Jennifer Lew
				Executive Vice President and Chief Financial Officer

 

 

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Exhibit 99.1

 

 

Annexon Highlights Recent Pipeline and Business Progress and Reports Second Quarter 2023 Financial Results

ARCHER Trial Results Presented at ASRS Further Demonstrate Preservation of Visual Function in Patients with Geographic Atrophy; Company to Engage Regulatory Agencies to Determine Optimal Path Forward

 

Multiple Key Catalysts Expected in Second Half 2023, Including Completion of Enrollment in the Phase 3 Pivotal Trial of ANX005 in GBS and Phase 1 Data from ANX1502 Oral Small Molecule

 

Company to Provide Updates Across its Portfolio of Complement Therapies During R&D Day in Second Half 2023

Strong Financial Position with Operating Runway into 2025

BRISBANE, Calif., Aug. 7, 2023 – Annexon, Inc. (Nasdaq: ANNX), a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative and ophthalmic disorders, today highlighted recent progress across its business and portfolio of complement therapies and reported second quarter 2023 financial results.

“This quarter, we made meaningful progress across our clinical-stage portfolio of medicines, which are squarely focused on stopping classical complement’s aggressive inflammatory cascade where it starts on diseased tissue to provide the most complete protection against this harmful inflammation and its resulting damage,” said Douglas Love, president and CEO of Annexon. “Following our recent ARCHER data, we now have clinical proof-of-concept in three difficult-to-treat diseases: Guillain-Barré Syndrome (GBS), Huntington’s disease and geographic atrophy (GA). Together, these data demonstrate the differentiated mechanism of inhibiting C1q to provide functional benefits for patients living with complement-mediated diseases. As we look ahead, we remain focused on executing toward important near-term milestones, including for our pivotal GBS program and oral small molecule program, in the second half of 2023. We look forward to providing additional updates on our progress and plans at our R&D Day later this year.”

Recent Corporate and Pipeline Updates

Key 2023-2024 Anticipated Milestones

Corporate

 

Flagship Programs

 

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Next Wave Programs

Second Quarter 2023 Financial Results

About Annexon

Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company seeking to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement pathway within the immune system, when overactivated, drives inflammation in a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon is advancing a new class of complement medicines targeting the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of the other complement pathways. Annexon is rigorously developing a pipeline of diversified product candidates across multiple mid- to late-stage clinical trials, with clinical data anticipated throughout 2023 and beyond.

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,” “suggest,” “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: anticipated milestones; plans to engage with U.S. and EU regulatory agencies to determine the optimal path forward for ANX007; cash operating runway; the potential benefits from treatment with anti-C1q therapy; timing of data reports; and continuing advancement of the company’s portfolio. 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 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 Contact:

Chelcie Lister

THRUST Strategic Communications

chelcie@thrustsc.com

 

Media Contact:

Sheryl Seapy

Real Chemistry

949-903-4750

sseapy@realchemistry.com

 

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ANNEXON, INC.

Condensed Consolidated Statements of Operations

(in thousands, except share and per share amounts)

(unaudited)

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Operating expenses:
Research and development (1)		$	30,251			$	29,106			$	62,596			$	56,104
General and administrative (1)			7,440				8,303				16,337				16,731
Total operating expenses			37,691				37,409				78,933				72,835
Loss from operations			(37,691	)			(37,409	)			(78,933	)			(72,835	)
Interest and other income, net			2,503				272				5,069				325
Net loss		$	(35,188	)		$	(37,137	)		$	(73,864	)		$	(72,510	)
Net loss per share, basic and diluted		$	(0.47	)		$	(0.96	)		$	(0.99	)		$	(1.88	)
Weighted-average shares used in computing net loss per share,    basic and diluted			75,230,003				38,584,400				74,546,995				38,573,950

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(1) Includes the following stock-based compensation expense:
Research and development		$	2,307			$	2,117			$	4,558			$	4,076
General and administrative		$	2,353			$	2,403			$	4,709			$	4,696

 

 

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ANNEXON, INC.

Condensed Consolidated Balance Sheets

(in thousands)

 

		June 30,				December 31,
		2023				2022
		(Unaudited)
Assets
Current assets:
Cash and cash equivalents		$	113,614			$	140,020
Short-term investments			79,324				102,637
Prepaid expenses and other current assets			4,623				5,441
Total current assets			197,561				248,098
Restricted cash			1,032				1,032
Property and equipment, net			15,830				16,838
Operating lease right-of-use assets			18,590				19,128
Total assets		$	233,013			$	285,096
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable		$	7,161			$	7,416
Accrued liabilities			8,953				13,448
Operating lease liabilities, current			1,616				1,316
Other current liabilities			161				180
Total current liabilities			17,891				22,360
Operating lease liabilities, non-current			30,398				31,542
Total liabilities			48,289				53,902
Stockholders’ equity:
Common stock			53				48
Additional paid-in capital			696,968				669,780
Accumulated other comprehensive loss			(171	)			(372	)
Accumulated deficit			(512,126	)			(438,262	)
Total stockholders' equity			184,724				231,194
Total liabilities and stockholders’ equity		$	233,013			$	285,096

 

 

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