Exhibit 99.1
Annexon Reports Fourth Quarter and Year-End 2023 Financial Results and Key Anticipated Milestones
Pivotal Phase 3 Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected in Second Quarter 2024
Initiation of Pivotal Phase 3 ANX007 ARCHER II Trial in Geographic Atrophy (GA) Expected in mid-2024, a Global Sham-Controlled Trial Using Vision Preservation as Primary Outcome Measure
Clinical Proof-of-Concept Data with ANX1502 Oral Inhibitor of the Classical Pathway Expected in Second Half of 2024
Robust Balance Sheet with Cash, Cash Equivalents, and Short-term Investments of Approximately $260 Million as of December 31, 2023, and Anticipated Runway into mid-2026
BRISBANE, Calif., Mar. 26, 2024 – Annexon, Inc. (Nasdaq: ANNX), a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye, today highlighted portfolio progress and reported fourth quarter and full year 2023 financial results.
“Our strong execution in 2023 across our three priority programs successfully achieved key clinical and regulatory milestones and created a solid foundation from which to reach several important upcoming catalysts in 2024,” said Douglas Love, president and chief executive officer of Annexon. “Importantly, our approach in blocking C1q to stop classical complement-driven neuroinflammation in diseases of the body, brain and eye continues to show unique and consistent functional outcomes across our pipeline programs.”
Mr. Love continued, “In the year ahead, we are excited by ANX005’s near-term potential to be the first targeted treatment for GBS, and we are on track to report topline data from our pivotal, placebo-controlled trial in the second quarter. For our global registrational program in GA, we plan to initiate two pivotal trials in 2024 to underscore the unique mechanism of action of ANX007 and its competitive differentiation in visual function. Finally, we anticipate clinical proof-of-concept data from our novel oral inhibitor ANX1502 later in the year. With our balance sheet strengthened and anticipated runway into mid-2026, we are poised to generate significant near- to mid-term value for patients and our shareholders.”
Recent Corporate and Clinical Program Updates
Successful $125 Million Financing: In December 2023, Annexon announced a $125 million financing and extension of operating runway into mid-2026.
Flagship Programs
ANX005 in GBS: First-in-class monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain.
ANX007 in GA: First-in-class, non-pegylated antigen-binding fragment (Fab) designed to block C1q and activation of the classical complement cascade locally in the eye with an intravitreal formulation.
ANX1502 in Cold Agglutinin Disease (CAD): First-in-class oral small molecule inhibitor of the classical complement pathway designed to target chronic autoimmune diseases.
Next Wave Programs
ANX005 in Amyotrophic Lateral Sclerosis (ALS): First-in-class monoclonal antibody designed to block C1q and the entire classical complement pathway.
Key 2024 Anticipated Milestones for Flagship Programs
Fourth Quarter and Full Year 2023 Financial Results
About Annexon
Annexon Biosciences (Nasdaq: ANNX) is a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Annexon’s novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, Annexon is rigorously advancing its mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. To learn more visit 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: the timing of completion of Phase 3 trial of ANX005 in patients with GBS; the potential therapeutic benefit of ANX005; potential benefit of ANX005, if approved, compared to existing therapies; anticipated timing of the completion of a RWE comparability study and BLA submission for ANX005; timing of initiation of the ARCHER II and ARROW trials; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; timing of proof-of-concept data for ANX1502;; continued development of ANX007 and ANX1502;; anticipated cash runway into mid-2026; the potential benefits from treatment with anti-C1q therapy; 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 ongoing off-treatment follow-up portion of the ARCHER trial and final results from the ARCHER trial; 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.
Investor Contact:
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.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 |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
|
|
(unaudited) |
|
|
|
|
|
|
|
|||||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development (1) |
|
$ |
23,267 |
|
|
$ |
28,535 |
|
|
$ |
113,756 |
|
|
$ |
112,501 |
|
General and administrative (1) |
|
|
6,742 |
|
|
|
8,160 |
|
|
|
29,967 |
|
|
|
33,098 |
|
Total operating expenses |
|
|
30,009 |
|
|
|
36,695 |
|
|
|
143,723 |
|
|
|
145,599 |
|
Loss from operations |
|
|
(30,009 |
) |
|
|
(36,695 |
) |
|
|
(143,723 |
) |
|
|
(145,599 |
) |
Interest and other income, net |
|
|
2,118 |
|
|
|
2,312 |
|
|
|
9,486 |
|
|
|
3,652 |
|
Net loss |
|
$ |
(27,891 |
) |
|
$ |
(34,383 |
) |
|
$ |
(134,237 |
) |
|
$ |
(141,947 |
) |
Net loss per share, basic and diluted |
|
$ |
(0.36 |
) |
|
$ |
(0.48 |
) |
|
$ |
(1.77 |
) |
|
$ |
(2.60 |
) |
Weighted-average shares used in computing net loss per share, |
|
|
78,217,945 |
|
|
|
72,368,539 |
|
|
|
75,673,081 |
|
|
|
54,673,572 |
|
_______________________
(1) Includes the following stock-based compensation expense: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
2,077 |
|
|
$ |
2,365 |
|
|
$ |
8,878 |
|
|
$ |
8,874 |
|
General and administrative |
|
$ |
2,290 |
|
|
$ |
2,468 |
|
|
$ |
9,305 |
|
|
$ |
9,642 |
|
ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)
|
|
December 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
225,110 |
|
|
$ |
140,020 |
|
Short-term investments |
|
|
34,606 |
|
|
|
102,637 |
|
Prepaid expenses and other current assets |
|
|
4,144 |
|
|
|
5,441 |
|
Total current assets |
|
|
263,860 |
|
|
|
248,098 |
|
Restricted cash |
|
|
1,032 |
|
|
|
1,032 |
|
Property and equipment, net |
|
|
14,773 |
|
|
|
16,838 |
|
Operating lease right-of-use assets |
|
|
18,009 |
|
|
|
19,128 |
|
Total assets |
|
$ |
297,674 |
|
|
$ |
285,096 |
|
Liabilities and Stockholders' Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
5,487 |
|
|
$ |
7,416 |
|
Accrued liabilities |
|
|
10,235 |
|
|
|
13,448 |
|
Operating lease liabilities, current |
|
|
2,165 |
|
|
|
1,316 |
|
Other current liabilities |
|
|
41 |
|
|
|
180 |
|
Total current liabilities |
|
|
17,928 |
|
|
|
22,360 |
|
Operating lease liabilities, non-current |
|
|
29,190 |
|
|
|
31,542 |
|
Total liabilities |
|
|
47,118 |
|
|
|
53,902 |
|
Stockholders’ equity: |
|
|
|
|
|
|
||
Common stock |
|
|
78 |
|
|
|
48 |
|
Additional paid-in capital |
|
|
823,029 |
|
|
|
669,780 |
|
Accumulated other comprehensive loss |
|
|
(52 |
) |
|
|
(372 |
) |
Accumulated deficit |
|
|
(572,499 |
) |
|
|
(438,262 |
) |
Total stockholders' equity |
|
|
250,556 |
|
|
|
231,194 |
|
Total liabilities and stockholders’ equity |
|
$ |
297,674 |
|
|
$ |
285,096 |
|