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 6, 2023, Annexon, Inc. (the “Company”) announced certain financial results for the fourth quarter and the year ended December 31, 2022. A copy of the Company’s press release, titled “Annexon Reports Fourth Quarter and Year-End 2022 Financial Results and Reiterates Anticipated Milestones,” 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 |
|
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 6, 2023 |
|
|
|
Annexon, Inc. |
|
|
|||
|
|
By: |
|
/s/ Jennifer Lew |
|
|
|
|
Jennifer Lew |
|
|
|
|
Executive Vice President and Chief Financial Officer |
Exhibit 99.1
|
Annexon Reports Fourth Quarter and Year-End 2022 Financial Results and Reiterates Anticipated Milestones
Initial Clinical Data from Phase 2 Trial of ANX007 in Patients with Geographic Atrophy On-track for Mid-2023
Oral Small Molecule ANX1502, for Autoimmune Indications, Advances into Multi-Ascending Dose Trial
Well-capitalized with Operating Runway into 2025, Including through Multiple Mid-stage and Pivotal Clinical Trial Readouts Anticipated in 2023 and 2024
BRISBANE, Calif., March 6, 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 outlined anticipated upcoming milestones across its portfolio of complement therapies and reported fourth quarter and full year 2022 financial results.
“2022 was a year of focused execution at Annexon, establishing a strong foundation on which to drive near- and long-term value across our deep portfolio of complement therapeutics,” said Douglas Love, president and CEO of Annexon. “We expect this year to be even stronger for Annexon, as we execute the pivotal and late-stage development of our four flagship programs across all three of our therapeutic franchises – autoimmune, ophthalmology and neurodegeneration. We’re prioritizing our focus and resources on well-supported, value creating programs, including our Phase 2 program for geographic atrophy with data anticipated mid-year, using our first-in-class up- and down-stream complement approach, and our potentially paradigm-shifting oral small molecule, ANX1502, for autoimmune indications. Overall, Annexon is well-positioned to continue executing our goals with a passionate and talented team, a strong balance sheet and multi-year runway, and a steady cadence of anticipated clinical catalysts over the next six to 18 months – all designed to deliver game-changing medicines to patients.”
Recent Pipeline Progress
Key 2023-2024 Anticipated Milestones
Flagship Programs
Additional Complement Programs
Fourth Quarter and Full Year 2022 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 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 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; cash operating runway; the potential benefits from treatment with anti-C1q therapy; timing of data reports; and continuing advancement of the company’s broad 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)
|
|
Three Months Ended |
|
|
Year Ended |
|
||||||||||
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
||||
|
|
(unaudited) |
|
|
(unaudited) |
|
|
|
|
|
|
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development (1) |
|
$ |
28,535 |
|
|
$ |
27,217 |
|
|
$ |
112,501 |
|
|
$ |
100,066 |
|
General and administrative (1) |
|
|
8,160 |
|
|
|
10,241 |
|
|
|
33,098 |
|
|
|
30,647 |
|
Total operating expenses |
|
|
36,695 |
|
|
|
37,458 |
|
|
|
145,599 |
|
|
|
130,713 |
|
Loss from operations |
|
|
(36,695 |
) |
|
|
(37,458 |
) |
|
|
(145,599 |
) |
|
|
(130,713 |
) |
Interest and other income (expense), net |
|
|
2,312 |
|
|
|
87 |
|
|
|
3,652 |
|
|
|
390 |
|
Net loss |
|
|
(34,383 |
) |
|
|
(37,371 |
) |
|
|
(141,947 |
) |
|
|
(130,323 |
) |
Net loss attributable to common stockholders |
|
$ |
(34,383 |
) |
|
$ |
(37,371 |
) |
|
$ |
(141,947 |
) |
|
$ |
(130,323 |
) |
Net loss per share attributable to common stockholders, basic and |
|
$ |
(0.48 |
) |
|
$ |
(0.97 |
) |
|
$ |
(2.60 |
) |
|
$ |
(3.40 |
) |
Weighted-average shares used in computing net loss per share |
|
|
72,368,539 |
|
|
|
38,479,221 |
|
|
|
54,673,572 |
|
|
|
38,316,273 |
|
_______________________
(1) Includes the following stock-based compensation expense: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
2,365 |
|
|
$ |
2,280 |
|
|
$ |
8,874 |
|
|
$ |
8,610 |
|
General and administrative |
|
$ |
2,468 |
|
|
$ |
2,075 |
|
|
$ |
9,642 |
|
|
$ |
7,652 |
|
ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)
|
|
December 31, |
|
|
December 31, |
|
||
|
|
2022 |
|
|
2021 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
140,020 |
|
|
$ |
74,843 |
|
Short-term investments |
|
|
102,637 |
|
|
|
167,872 |
|
Prepaid expenses and other current assets |
|
|
5,441 |
|
|
|
4,978 |
|
Total current assets |
|
|
248,098 |
|
|
|
247,693 |
|
Restricted cash |
|
|
1,032 |
|
|
|
1,166 |
|
Property and equipment, net |
|
|
16,838 |
|
|
|
17,848 |
|
Operating lease right-of-use assets |
|
|
19,128 |
|
|
|
20,333 |
|
Total assets |
|
$ |
285,096 |
|
|
$ |
287,040 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
7,416 |
|
|
$ |
11,153 |
|
Accrued liabilities |
|
|
13,448 |
|
|
|
9,250 |
|
Operating lease liabilities, current |
|
|
1,316 |
|
|
|
1,202 |
|
Other current liabilities |
|
|
180 |
|
|
|
139 |
|
Total current liabilities |
|
|
22,360 |
|
|
|
21,744 |
|
Operating lease liabilities, non-current |
|
|
31,542 |
|
|
|
33,387 |
|
Total liabilities |
|
|
53,902 |
|
|
|
55,131 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Common stock |
|
|
48 |
|
|
|
39 |
|
Additional paid-in capital |
|
|
669,780 |
|
|
|
528,365 |
|
Accumulated other comprehensive loss |
|
|
(372 |
) |
|
|
(180 |
) |
Accumulated deficit |
|
|
(438,262 |
) |
|
|
(296,315 |
) |
Total stockholders' equity |
|
|
231,194 |
|
|
|
231,909 |
|
Total liabilities and stockholders’ equity |
|
$ |
285,096 |
|
|
$ |
287,040 |
|