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): March 25, 2021
ANNEXON, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction
of incorporation)
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001-39402 |
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27-5414423 |
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(Commission File No.) |
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(IRS Employer Identification No.) |
180 Kimball Way, Suite 200
South San Francisco, California
(Address of principal executive offices)
94080
(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 (see General Instruction A.2. below):
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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Common Stock, par value $0.001 per share |
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ANNX |
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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 March 25, 2021, Annexon, Inc. (“Annexon”) announced certain financial results for the quarter and the year ended December 31, 2020. A copy of Annexon’s press release, titled “Annexon Biosciences Reports Fourth Quarter and Full-Year 2020 Financial Results and Business Highlights,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.
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Item 9.01. |
Financial Statements and Exhibits. |
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(d) |
Exhibits. |
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Exhibit |
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Description |
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99.1 |
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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 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.
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.
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Dated: March 25, 2021 |
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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 |
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Exhibit 99.1
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Annexon Biosciences Reports Fourth Quarter and Full-Year 2020 Financial Results
with Recent Business Highlights
SOUTH SAN FRANCISCO, Calif., March 25, 2021 – Today 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, announced fourth quarter and full-year 2020 financial results and business highlights.
Recent Business Highlights
Annexon continues to make strong progress in advancing its broad and deep pipeline and clinical programs across a range of potential indications. Recent highlights include:
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ANX005 in Guillain-Barré Syndrome (GBS). In March 2021, the company completed evaluation of its drug-drug interaction (DDI) study of ANX005 co-administered with Intravenous Immunoglobulin (IVIg) in 14 patients with GBS. The DDI study was conducted to evaluate the safety and tolerability of ANX005 and IVIg co-administration in GBS patients, and measured pharmacokinetics (PK) and pharmacodynamics (PD) of ANX005 when administered in combination with IVIg. IVIg, though not FDA-approved in the United States for GBS, is currently the standard of care for GBS. Initial results from the DDI study included: |
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Co-administration of IVIg-ANX005 was well-tolerated. |
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Co-administration of IVIg-ANX005 achieved full C1q target engagement, and C1q suppression was maintained within the targeted range. |
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The open-label DDI study was not placebo-controlled or powered for statistical significance on efficacy measures. A number of key GBS outcome measures were recorded from baseline, and early improvement was observed in GBS patients, including increased muscle strength, decreased neurofilament light chain (NfL) and improved GBS disability score. |
Full results from the DDI study are expected to be submitted to a peer-reviewed forum in 2021. A placebo-controlled Phase 2/3 trial is ongoing to evaluate the efficacy of ANX005 monotherapy in improving disability in GBS patients. Data from the Phase 2/3 trial is anticipated in 2023.
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ANX007 in Geographic Atrophy (GA). In February 2021, the company initiated a Phase 2 trial evaluating the efficacy of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA, which includes monthly and every other month dosing of ANX007. Data from this trial is anticipated in 2023. |
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In February 2021, Annexon appointed William H. Carson, M.D. to the Board of Directors. Concurrent with Dr. Carson’s appointment, Thomas G. Wiggans was appointed as Annexon’s chairman. |
“We continue to make progress against our vision of building a leading, multi-faceted complement therapeutics company with an innovative portfolio for a broad range of autoimmune, neurodegenerative and ophthalmic diseases,” said Douglas Love, Esq., president and chief executive officer of Annexon. “The DDI data gives us further confidence in ANX005. We are rapidly advancing multiple Phase 2 clinical programs across a diverse set of potential indications, and accelerating development of a number of innovative, next generation product candidates. This clinical momentum coupled with our strong capital position positions us well to drive value in 2021 and beyond.”
Fourth Quarter and Full-Year 2020 Financial Results
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Cash and cash equivalents and short-term investments: Cash and cash equivalents and short-term investments were $351.2 million as of December 31, 2020. |
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Research and development (R&D) expenses: R&D expenses were $18.0 million for the quarter ended December 31, 2020 compared to $6.8 million for the quarter ended December 31, 2019. R&D expenses were $49.3 million for the year ended December 31, 2020 compared to $24.5 million for the year ended December 31, 2019. |
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General and administrative (G&A) expenses: G&A expenses were $5.2 million for the quarter ended December 31, 2020 compared to $2.3 million for the quarter ended December 31, 2019. G&A expenses were $14.2 million for the year ended December 31, 2020 compared to $8.0 million for the year ended December 31, 2019. |
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Net loss: Net loss was $23.2 million for the quarter ended December 31, 2020 compared to $8.9 million for the quarter ended December 31, 2019. Net loss was $63.4 million for the year ended December 31, 2020 compared to $37.2 million for the year ended December 31, 2019. |
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,” “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: advancement of the company’s clinical and preclinical programs; timing of data from clinical trials and submission of data to peer-reviewed forums; confidence in the company’s product candidates; the company’s ability to drive value in 2021 and beyond; 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.
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
Caroline Rufo, Ph.D.
crufo@macbiocom.com
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
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Three Months Ended December 31, |
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Year Ended December 31, |
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2020 |
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2019 |
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2020 |
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2019 |
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(unaudited) |
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(unaudited) |
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Operating expenses: |
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Research and development (1) |
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$ |
17,992 |
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$ |
6,795 |
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$ |
49,271 |
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$ |
24,524 |
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General and administrative (1) |
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5,199 |
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2,334 |
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14,198 |
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7,994 |
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Total operating expenses |
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23,191 |
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9,129 |
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63,469 |
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32,518 |
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Loss from operations |
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(23,191 |
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(9,129 |
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(63,469 |
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(32,518 |
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Loss on remeasurement of redeemable convertible preferred stock liability |
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— |
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— |
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— |
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(5,670 |
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Other (expense) income, net |
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(7 |
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188 |
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57 |
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1,009 |
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Net loss before taxes |
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(23,198 |
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(8,941 |
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(63,412 |
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(37,179 |
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Provision for income taxes |
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(5 |
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1 |
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— |
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4 |
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Net loss |
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(23,193 |
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(8,942 |
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(63,412 |
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(37,183 |
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Accretion on redeemable convertible preferred stock |
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— |
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(280 |
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(705 |
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(1,095 |
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Deemed dividend – beneficial conversion feature on redeemable convertible preferred stock |
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— |
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— |
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(6,219 |
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— |
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Net loss attributable to common stockholders |
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$ |
(23,193 |
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$ |
(9,222 |
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$ |
(70,336 |
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$ |
(38,278 |
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Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.61 |
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$ |
(21.26 |
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$ |
(4.15 |
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$ |
(88.30 |
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Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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38,157,618 |
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433,749 |
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16,962,398 |
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433,493 |
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(1) Includes the following stock-based compensation expense: |
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Research and development |
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990 |
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230 |
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2,274 |
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713 |
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General and administrative |
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1,001 |
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294 |
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2,614 |
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1,324 |
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ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)
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December 31, 2020 |
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December 31, 2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
268,565 |
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$ |
43,931 |
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Short-term investments |
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82,641 |
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— |
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Prepaid expenses and other current assets |
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2,805 |
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1,475 |
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Total current assets |
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354,011 |
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45,406 |
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Property and equipment |
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1,935 |
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2,138 |
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Other long-term assets |
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— |
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2,354 |
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Total assets |
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$ |
355,946 |
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$ |
49,898 |
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Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
3,734 |
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$ |
2,371 |
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Accrued liabilities |
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6,497 |
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2,194 |
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Deferred rent, current |
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391 |
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366 |
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Total current liabilities |
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10,622 |
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4,931 |
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Deferred rent |
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1,046 |
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1,437 |
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Total liabilities |
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11,668 |
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6,368 |
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Redeemable convertible preferred stock |
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— |
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143,984 |
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Stockholders’ Equity (Deficit): |
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Preferred stock |
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— |
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— |
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Common stock |
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38 |
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4 |
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Additional paid-in capital |
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510,309 |
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2,202 |
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Accumulated other comprehensive loss |
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(77 |
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(80 |
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Accumulated deficit |
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(165,992 |
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(102,580 |
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Total stockholders’ equity (deficit) |
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344,278 |
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(100,454 |
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Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) |
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$ |
355,946 |
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$ |
49,898 |
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