UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 OR 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
|
|
|
|
|
(State or other jurisdiction |
(Commission |
(IRS Employer |
|
of incorporation) |
File Number) |
Identification No.) |
(Address of principal executive offices) (Zip Code)
Registrant’s telephone number, including area code:
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 |
|
|
|
|
|
|
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. ☐
|
Item 2.02. |
Results of Operations and Financial Condition. |
On March 1, 2022, Annexon, Inc. (the “Company”) announced certain financial results for the fourth quarter and the year ended December 31, 2021. A copy of the Company’s press release, titled “Annexon Biosciences Announces Program Highlights and Reports Fourth Quarter and Full Year 2021 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 |
|
|
|
104 |
|
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: March 1, 2022 |
|
|
|
Annexon, Inc. |
|
|
|
|
||||
|
|
|
By: |
|
/s/ Jennifer Lew |
|
|
|
|
|
|
Jennifer Lew |
|
|
|
|
|
|
Executive Vice President and Chief Financial Officer |
|
Exhibit 99.1
|
|
Annexon Biosciences Announces Program Highlights and Reports Fourth Quarter and Full Year 2021 Financial Results
Multiple Value-Creating Catalysts Across Complement-Targeted Portfolio Anticipated Through 2023
Encouraging Interim Data Reported from Phase 2 Study of ANX005 for Huntington’s Disease; Full Data Expected in the Second Quarter of 2022
$243 Million in Cash and Investments at End of 2021; Operating Runway into First Quarter of 2024
BRISBANE, Calif., March 1, 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 recent highlights and reported fourth quarter and full year 2021 financial results.
“2021 was a year of marked progress across our pipeline, which is uniquely designed to provide greater protection against complement-mediated disorders of the body, brain and eye by stopping the classical complement pathway at its start, C1q,” said Douglas Love, Esq., president and chief executive officer of Annexon. “The favorable early data generated with ANX005 in both Guillain-Barré Syndrome and Huntington’s disease – autoimmune and neurodegenerative diseases, respectively – support our approach to fully inhibiting C1q and support the ongoing development with our lead candidate. In addition, given the known role that aberrant activation of C1q plays in driving a wide range of diseases, we are actively advancing our pipeline across three therapeutic franchises, with numerous clinical data readouts and new study initiations anticipated over the course of 2022 and 2023. This is an exciting time for Annexon, and I am confident in our potential to deliver game-changing medicines to patients in need.”
Pipeline Highlights
|
|
• |
In January 2022, Annexon reported interim data from its ongoing, open-label Phase 2 clinical trial of ANX005 in patients with Huntington’s disease (HD) who completed the 24-week treatment period. Interim data showed that treatment with ANX005 had been generally well-tolerated and showed full target engagement of C1q in serum and cerebrospinal fluid (CSF), notable improvements in clinical measures relative to baseline and NfL levels consistent with levels reported in natural history studies. Annexon anticipates reporting data from all patients treated, including data from the three-month follow-up period, in the second quarter of 2022. |
|
|
• |
In December 2021 at the ASH Annual meeting, Annexon announced safety and dose-response data from its Phase 1 clinical trial of ANX009, the company’s subcutaneously administered product candidate that is designed to selectively inhibit C1q in vascular and blood-based autoimmune diseases. In addition, Annexon reported preclinical data supporting the potential role of the complement pathway in warm autoimmune hemolytic anemia (wAIHA). |
Corporate Highlights
|
|
• |
In February 2022, Dr. Bettina Cockroft joined the Annexon board of directors with over 20 years of experience in the biopharmaceutical industry. |
Key Anticipated Milestones
Autoimmune
|
|
• |
Report data from Phase 2 trial of ANX005 in patients with warm autoimmune hemolytic anemia (wAIHA) in the second half of 2022 |
|
|
• |
Report initial data from Phase 1b trial of ANX009, the company’s subcutaneously administered drug candidate, in patients with lupus nephritis in the second half of 2022 |
|
|
• |
Initiate first-in-human trial of ANX1502, a first-in-class oral small molecule drug candidate, in the second half of 2022, with data expected in 2023 |
|
|
• |
Report data from Phase 2/3 trial of ANX005 in patients with Guillain-Barré Syndrome (GBS) in 2023 |
|
|
Neurodegeneration
|
|
• |
Report data from Phase 2 trial of ANX005 in patients with HD, who completed the six-month treatment period and three-month follow-up period, in the second quarter of 2022 |
|
|
• |
Initiate first-in-human trial of ANX105, the company’s next generation monoclonal antibody formulated for IV administration, in the first half of 2022, with data anticipated in 2023 |
|
|
• |
Report data from Phase 2 trial of ANX005 in patients with ALS in 2023 |
Ophthalmology
|
|
• |
Report data from Phase 2 trial of ANX007, a monoclonal antibody antigen-binding fragment, in patients with geographic atrophy in 2023 |
Fourth Quarter and Full Year 2021 Financial Results
|
|
• |
Cash and operating runway: Cash and cash equivalents and short-term investments were $242.7 million as of December 31, 2021. Annexon continues to expect that its current cash position is sufficient to fund its operating plans into the first quarter of 2024. |
|
|
• |
Research and development (R&D) expenses: R&D expenses were $27.2 million for the quarter ended December 31, 2021, and $100.0 million for the year ended December 31, 2021, compared to $18.0 million for the quarter ended December 31, 2020, and $49.3 million for the year ended December 31, 2020. |
|
|
• |
General and administrative (G&A) expenses: G&A expenses were $10.2 million for the quarter ended December 31, 2021, and $30.6 million for the year ended December 31, 2021, compared to $5.2 million for the quarter ended December 31, 2020, and $14.2 million for the year ended December 31, 2020. |
|
|
• |
Net loss: Net loss was $37.4 million for the quarter ended December 31, 2021, and $130.3 million for the year ended December 31, 2021, compared to $23.2 million for the quarter ended December 31, 2020, and $63.4 million for the year ended December 31, 2020. |
About Annexon
Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company pioneering a new class of complement medicines designed to stop the classical complement pathway at its start, C1q, to bring therapies to patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders. The company’s proprietary complement-targeting platform utilizes well-researched classical complement-mediated autoimmune and neurodegenerative processes triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a broad portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway, which may provide more complete protection against complement-mediated disorders of the body, brain and eye. The company’s pipeline includes three clinical-stage drug candidates, ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration), as well as a robust early-stage pipeline of preclinical and discovery stage programs. 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,” “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; initial findings and observations related to the interim data from the company’s ongoing, open-label Phase 2 clinical trial of ANX005 in patients with HD; the potential benefits from treatment with anti-C1q therapy; timing of data reports and study initiation; 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:
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)
|
|
|
Three Months Ended December 31, |
|
|
Year Ended December 31, |
|
||||||||||
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
||||
|
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
||
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (1) |
|
$ |
27,217 |
|
|
$ |
17,992 |
|
|
$ |
100,066 |
|
|
$ |
49,271 |
|
|
General and administrative (1) |
|
|
10,241 |
|
|
|
5,199 |
|
|
|
30,647 |
|
|
|
14,198 |
|
|
Total operating expenses |
|
|
37,458 |
|
|
|
23,191 |
|
|
|
130,713 |
|
|
|
63,469 |
|
|
Loss from operations |
|
|
(37,458 |
) |
|
|
(23,191 |
) |
|
|
(130,713 |
) |
|
|
(63,469 |
) |
|
Interest and other income (expense), net |
|
|
87 |
|
|
|
(7 |
) |
|
|
390 |
|
|
|
57 |
|
|
Net loss before taxes |
|
|
(37,371 |
) |
|
|
(23,198 |
) |
|
|
(130,323 |
) |
|
|
(63,412 |
) |
|
Provision for income taxes |
|
|
— |
|
|
|
(5 |
) |
|
|
— |
|
|
|
— |
|
|
Net loss |
|
|
(37,371 |
) |
|
|
(23,193 |
) |
|
|
(130,323 |
) |
|
|
(63,412 |
) |
|
Accretion on redeemable convertible preferred stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(705 |
) |
|
Deemed dividend – beneficial conversion feature on redeemable convertible preferred stock |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,219 |
) |
|
Net loss attributable to common stockholders |
|
$ |
(37,371 |
) |
|
$ |
(23,193 |
) |
|
$ |
(130,323 |
) |
|
$ |
(70,336 |
) |
|
Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.97 |
) |
|
$ |
(0.61 |
) |
|
$ |
(3.40 |
) |
|
$ |
(4.15 |
) |
|
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
|
|
38,479,221 |
|
|
|
38,157,618 |
|
|
|
38,316,273 |
|
|
|
16,962,398 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes the following stock-based compensation expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
2,280 |
|
|
$ |
990 |
|
|
$ |
8,610 |
|
|
$ |
2,274 |
|
|
General and administrative |
|
$ |
2,075 |
|
|
$ |
1,001 |
|
|
$ |
7,652 |
|
|
$ |
2,614 |
|
ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)
|
|
|
December 31, |
|
|||||
|
|
|
2021 |
|
|
2020 |
|
||
|
Assets |
|
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
74,843 |
|
|
$ |
268,565 |
|
|
Short-term investments |
|
|
167,872 |
|
|
|
82,641 |
|
|
Prepaid expenses and other current assets |
|
|
4,978 |
|
|
|
2,805 |
|
|
Total current assets |
|
|
247,693 |
|
|
|
354,011 |
|
|
Restricted cash |
|
|
1,166 |
|
|
|
— |
|
|
Property and equipment, net |
|
|
17,848 |
|
|
|
1,935 |
|
|
Operating lease right-of-use assets |
|
|
20,333 |
|
|
|
— |
|
|
Total assets |
|
$ |
287,040 |
|
|
$ |
355,946 |
|
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
11,153 |
|
|
$ |
3,734 |
|
|
Accrued liabilities |
|
|
9,250 |
|
|
|
6,497 |
|
|
Deferred rent, current |
|
|
— |
|
|
|
391 |
|
|
Operating lease liabilities, current |
|
|
1,202 |
|
|
|
— |
|
|
Other current liabilities |
|
|
139 |
|
|
|
— |
|
|
Total current liabilities |
|
|
21,744 |
|
|
|
10,622 |
|
|
Deferred rent |
|
|
— |
|
|
|
1,046 |
|
|
Operating lease liabilities, non-current |
|
|
33,387 |
|
|
|
— |
|
|
Total liabilities |
|
|
55,131 |
|
|
|
11,668 |
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
|
Common stock |
|
|
39 |
|
|
|
38 |
|
|
Additional paid-in capital |
|
|
528,365 |
|
|
|
510,309 |
|
|
Accumulated other comprehensive loss |
|
|
(180 |
) |
|
|
(77 |
) |
|
Accumulated deficit |
|
|
(296,315 |
) |
|
|
(165,992 |
) |
|
Total stockholders' equity |
|
|
231,909 |
|
|
|
344,278 |
|
|
Total liabilities and stockholders’ equity |
|
$ |
287,040 |
|
|
$ |
355,946 |
|