UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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).
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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 May 9, 2022, Annexon, Inc. (the “Company”) announced certain financial results for the first quarter ended March 31, 2022. A copy of the Company’s press release, titled “Annexon Biosciences Highlights Portfolio Progress and Key Anticipated Milestones, and Reports First Quarter 2022 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.
Exhibit |
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Description |
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99.1 |
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104 |
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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.
Dated: May 9, 2022 |
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Annexon, Inc. |
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By: |
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/s/ Jennifer Lew |
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Jennifer Lew |
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Executive Vice President and Chief Financial Officer |
Exhibit 99.1
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Annexon Biosciences Highlights Portfolio Progress and Key Anticipated Milestones, and Reports First Quarter 2022 Financial Results
Pioneering Upstream Complement-Targeted Platform with Broad Portfolio of Five Differentiated Product Candidates
Anticipating Eight Clinical Catalysts Across Robust Pipeline throughout 2022 and 2023
BRISBANE, Calif., May 9, 2022 - 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 announced progress across its broad pipeline of product candidates and reported first quarter 2022 financial results.
The classical complement cascade is a seminal pathway within the immune system that anchors and drives a host of autoimmune, neurodegenerative and ophthalmic diseases. Annexon’s unique platform targets C1q, the initiator of the pathway that localizes on disease tissue and triggers complement’s harmful inflammation and tissue-damaging activity. The company’s product candidates are designed to block the early classical cascade and all downstream pathway components that contribute to disease, while selectively preserving the beneficial immune functions of other complement pathways.
“I am very proud of the strong execution by the Annexon team in advancing our classical complement platform across multiple indications driven by aberrant complement activity. In doing so, we’re actively building on the learnings and momentum from the first two clinical datasets generated with our lead product candidate, ANX005, which showed rapid improvement in clinical measures in two historically challenging diseases – Guillain-Barré Syndrome and Huntington’s disease,” said Douglas Love, Esq., president and chief executive officer of Annexon. “After years of research and development across our platform, and with eight clinical datasets anticipated throughout 2022 and 2023, we’re reaching a significant inflection point in proving our founding thesis: stopping the classical complement cascade at its start has the potential to provide more complete protection against inappropriate complement activity, and thereby provide important benefit to patients. We’re excited by the promise of our pioneering upstream complement platform, and we are well-positioned to create meaningful near-term value for patients, our supporters and for the business.”
Portfolio Highlights and Key Anticipated Milestones
Annexon is rigorously advancing five drug candidates, each with distinct routes of administration and dosing schedules, and a fit-for-purpose design to selectively inhibit the classical complement pathway in specific compartments of the body, brain or eye.
To date, ANX005 has been evaluated in more than 170 patients with autoimmune and neurodegenerative diseases and was generally well-tolerated, demonstrated full target engagement in the periphery and central nervous system, and in two distinct indications – GBS and HD – showed rapid and meaningful improvement in clinical measures.
Key ANX005 Updates and Anticipated Milestones
- Phase 2 trial in patients with HD has completed the six-month treatment period and three-month follow-up period, with data anticipated in the second quarter of 2022
- Phase 2 trial in patients with wAIHA was initiated, with initial data anticipated in the second half of 2022
- Phase 2/3 trial in patients with GBS is underway, with data anticipated in 2023
- Phase 2 trial in patients with ALS is underway, with data anticipated in 2023
Key ANX007 Updates and Anticipated Milestones
- Phase 2 ARCHER trial fully enrolled ahead of schedule with a total of 270 patients; initial data is anticipated in the first half of 2023, with full data expected after the conclusion of the six-month off-treatment period
Key ANX009 Anticipated Milestones
- Initial data from Phase 1b trial in patients with LN is anticipated in the second half of 2022
Key ANX105 Updates and Anticipated Milestones
- First-in-human trial of ANX105 was initiated in the second quarter of 2022, following clearance of the clinical trial application (CTA) by Dutch regulatory authorities, with data expected in 2023
Key ANX1502 Updates and Anticipated Milestones
- Preclinical activities for ANX1502 have been completed, enabling a planned CTA submission in the Netherlands
- Initiation of the first-in-human trial of ANX1502 is anticipated in the second half of 2022, with data expected in 2023
First Quarter 2022 Financial Results
About Annexon
Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company that aims to bring game-changing medicines to patients with classical complement-mediated diseases of the body, brain and eye. The classical complement cascade is a seminal pathway within the immune system that anchors and drives 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 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 2022 and 2023. 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,” “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; cash operating runway; the potential benefits from treatment with anti-C1q therapy; timing of data reports and trial initiation and design; and continuing advancement of the company’s innovative 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 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.
Investor Contact:
Chelcie Lister
THRUST Strategic Communications
chelcie@thrustsc.com
Media Contact:
Sheryl Seapy
Real Chemistry
949-903-4750
sseapy@realchemistry.com
ANNEXON, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
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Three Months Ended |
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2022 |
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2021 |
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(As restated) |
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Operating expenses: |
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Research and development (1) |
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$ |
26,998 |
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$ |
20,696 |
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General and administrative (1) |
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8,428 |
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5,506 |
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Total operating expenses |
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35,426 |
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26,202 |
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Loss from operations |
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(35,426 |
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(26,202 |
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Interest and other income (expense), net |
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53 |
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142 |
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Net loss |
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(35,373 |
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(26,060 |
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Net loss attributable to common stockholders |
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$ |
(35,373 |
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$ |
(26,060 |
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Net loss per share attributable to common stockholders, basic and |
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$ |
(0.92 |
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$ |
(0.68 |
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Weighted-average shares used in computing net loss per share |
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38,563,384 |
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38,163,062 |
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_______________________
(1) Includes the following stock-based compensation expense: |
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Research and development |
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$ |
1,959 |
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$ |
1,546 |
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General and administrative |
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$ |
2,293 |
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$ |
1,416 |
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ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)
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March 31, |
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December 31, |
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2022 |
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2021 |
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(Unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
112,828 |
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$ |
74,843 |
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Short-term investments |
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93,831 |
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167,872 |
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Prepaid expenses and other current assets |
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4,595 |
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4,978 |
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Total current assets |
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211,254 |
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247,693 |
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Restricted cash |
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1,166 |
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1,166 |
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Property and equipment, net |
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17,805 |
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17,848 |
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Operating lease right-of-use assets |
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20,103 |
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20,333 |
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Other non-current assets |
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241 |
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— |
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Total assets |
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$ |
250,569 |
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$ |
287,040 |
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Liabilities and Stockholders' Equity |
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Current liabilities: |
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Accounts payable |
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$ |
9,378 |
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$ |
11,153 |
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Accrued liabilities |
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6,211 |
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9,250 |
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Operating lease liabilities, current |
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1,275 |
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1,202 |
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Other current liabilities |
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189 |
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139 |
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Total current liabilities |
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17,053 |
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21,744 |
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Operating lease liabilities, non-current |
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32,902 |
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33,387 |
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Total liabilities |
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49,955 |
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55,131 |
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Stockholders’ equity: |
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Common stock |
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39 |
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39 |
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Additional paid-in capital |
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532,636 |
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528,365 |
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Accumulated other comprehensive loss |
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(373 |
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(180 |
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Accumulated deficit |
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(331,688 |
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(296,315 |
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Total stockholders' equity |
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200,614 |
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231,909 |
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Total liabilities and stockholders’ equity |
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$ |
250,569 |
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$ |
287,040 |
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