Scientific Co-Founder Dr. Ben Barres
– Cash balance of $370.7 million as of September 30, 2020 bolstered by July IPO –
– Recently expanded ANX005 clinical program into neurodegeneration, with initiation of Phase 2 in Huntington’s Disease –
– Fully enrolled Phase 1b DDI trial in Guillain-Barré Syndrome –
SOUTH SAN FRANCISCO, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) -- 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 brain, body and eye, today announced third quarter 2020 financial results and recent business highlights.
“We continue to make strong progress across our classical complement platform, including expanded development of ANX005 in Huntington’s Disease, and advancement of our subcutaneous formulation, ANX009, into the clinic,” said Douglas Love, Esq., president and chief executive officer of Annexon. “Our unique focus on C1q allows us to address a diverse set of classical complement-mediated autoimmune and neurodegenerative diseases, and we’re well capitalized to conduct several promising near- and mid-term Phase 2 clinical trials in these devastating diseases.”
Program Highlights
Anticipated Upcoming Milestones
Third Quarter 2020 Financial Results
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 brain, body 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 development strategy designed to establish that its product candidates are engaging the target at a well-tolerated therapeutic dose in the intended tissue compartments. 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; the company’s capital position and ability to conduct promising near- and mid-term Phase 2 clinical trials; timing and commencement of future nonclinical studies and clinical trials and research and development programs; and the implementation of the company’s business model and strategic plans for its business and product candidates, including additional indications which 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 Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020 filed with the Securities and Exchange Commission (SEC) on November 16, 2020 pursuant to Rule 424(b) under the Securities Act 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.
ANNEXON, INC.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(Unaudited)
| Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
| 2020 | 2019 | 2020 | 2019 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 11,775 | $ | 7,089 | $ | 31,279 | $ | 17,729 | ||||||||
| General and administrative (1) | 3,810 | 1,981 | 8,999 | 5,660 | ||||||||||||
| Total operating expenses | 15,585 | 9,070 | 40,278 | 23,389 | ||||||||||||
| Loss from operations | (15,585 | ) | (9,070 | ) | (40,278 | ) | (23,389 | ) | ||||||||
| Loss on remeasurement of redeemable convertible preferred stock liability | — | (1,340 | ) | — | (5,670 | ) | ||||||||||
| Other (expense) income, net | (52 | ) | 224 | 64 | 821 | |||||||||||
| Net loss before taxes | (15,637 | ) | (10,186 | ) | (40,214 | ) | (28,238 | ) | ||||||||
| Provision for income taxes | 1 | 2 | 5 | 3 | ||||||||||||
| Net loss | (15,638 | ) | (10,188 | ) | (40,219 | ) | (28,241 | ) | ||||||||
| Accretion on redeemable convertible preferred stock | (145 | ) | (281 | ) | (705 | ) | (815 | ) | ||||||||
| Deemed dividend – beneficial conversion feature on redeemable convertible preferred stock | (6,219 | ) | — | (6,219 | ) | — | ||||||||||
| Net loss attributable to common stockholders | $ | (22,002 | ) | $ | (10,469 | ) | $ | (47,143 | ) | $ | (29,056 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.77 | ) | $ | (24.14 | ) | $ | (4.79 | ) | $ | (67.04 | ) | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
28,465,156 | 433,749 | 9,845,754 | 433,406 | ||||||||||||
| (1) Includes the following stock-based compensation expense: | ||||||||||||||||
| Research and development | 624 | 159 | 1,284 | 391 | ||||||||||||
| General and administrative | 847 | 451 | 1,613 | 1,122 | ||||||||||||
ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)
(Unaudited)
| September 30, 2020 |
December 31, 2019 |
|||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 370,686 | $ | 43,931 | ||||
| Prepaid expenses and other current assets | 2,889 | 1,475 | ||||||
| Total current assets | 373,575 | 45,406 | ||||||
| Property and equipment, net | 2,039 | 2,138 | ||||||
| Other long-term assets | — | 2,354 | ||||||
| Total assets | $ | 375,614 | $ | 49,898 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 3,954 | $ | 2,371 | ||||
| Accrued liabilities | 4,649 | 2,194 | ||||||
| Deferred rent, current | 385 | 366 | ||||||
| Total current liabilities | 8,988 | 4,931 | ||||||
| Deferred rent | 1,147 | 1,437 | ||||||
| Total liabilities | 10,135 | 6,368 | ||||||
| Redeemable convertible preferred stock | — | 143,984 | ||||||
| Stockholders’ Equity (Deficit): | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 38 | 4 | ||||||
| Additional paid-in capital | 508,318 | 2,202 | ||||||
| Accumulated other comprehensive loss | (78 | ) | (80 | ) | ||||
| Accumulated deficit | (142,799 | ) | (102,580 | ) | ||||
| Total stockholders’ equity (deficit) | 365,479 | (100,454 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) | $ | 375,614 | $ | 49,898 | ||||
Investor Contact:
Sylvia Wheeler
swheeler@wheelhouselsa.com
Alexandra Santos
asantos@wheelhouselsa.com
Media Contact:
Caroline Rufo, Ph.D.
crufo@macbiocom.com