Full Press Release Details
Annexon Biosciences Announces Business and Program Highlights and Reports Third Quarter 2021 Financial Results
$271 Million Cash and Investments at End of Third Quarter 2021 Supports Operating Runway into 2024, Including Several Key Clinical Milestones across the Portfolio
SOUTH SAN FRANCISCO, Calif., Nov. 9, 2021 - 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 third quarter 2021 financial results.
"The third quarter marks another quarter of meaningful progress with our portfolio, including effectively advancing three clinical-stage product candidates in five clinical trials," said Douglas Love, Esq., president and chief executive officer of Annexon. "We're also pleased to have been granted Orphan Drug designation by the FDA for ANX005, underscoring the Agency's recognition of ANX005's potential as a novel therapy for the treatment of Huntington's disease. Additionally, in collaboration with multiple academic and physician key opinion leaders, we conducted two C1q Series R&D Events that highlighted the applicability of our platform and differentiated scientific approach targeting the classical complement cascade in a range of autoimmune and neurodegenerative diseases. The combination of a rich set of milestones, a strong balance sheet, and a talented team, lays the foundation for a transformational year ahead. We look forward to sharing the continued progress across our portfolio, including initial data from our Huntington's disease clinical trial, as we work to bring treatments to patients suffering from serious complement-mediated diseases."
Third Quarter 2021 Financial Results
Annexon (Nasdaq: ANNX) is a clinical-stage biopharmaceutical company developing a new class of complement medicines for patients with classical complement-mediated autoimmune, neurodegenerative, and ophthalmic disorders of the body, brain, and eye. The company's pipeline is based on its platform technology addressing a broad spectrum of well-researched classical complement-mediated autoimmune and neurodegenerative diseases triggered by aberrant activation of C1q, the initiating molecule of the classical complement pathway. Annexon is advancing a portfolio of innovative product candidates designed to block the activity of C1q and the entire classical complement pathway: ANX005 (intravenous administration), ANX007 (intravitreal administration), and ANX009 (subcutaneous administration). 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," "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: continuing advancement of the company's innovative portfolio; timing of data from clinical trials; timing of completion of clinical studies and clinical development milestones; the company's ability to deliver on its objectives and the potential for a transformational year ahead; 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; cash position sufficient to fund its operating plans into 2024; the benefits of Orphan Drug designation; and leadership team service. 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.
THRUST Strategic Communications
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 27,581 | $ | 11,775 | $ | 72,849 | $ | 31,279 | ||||||||
| General and administrative (1) | 8,099 | 3,810 | 20,406 | 8,999 | ||||||||||||
| Total operating expenses | 35,680 | 15,585 | 93,255 | 40,278 | ||||||||||||
| Loss from operations | (35,680 | ) | (15,585 | ) | (93,255 | ) | (40,278 | ) | ||||||||
| Other income (expense), net | 82 | (52 | ) | 303 | 64 | |||||||||||
| Net loss before taxes | (35,598 | ) | (15,637 | ) | (92,952 | ) | (40,214 | ) | ||||||||
| Provision for income taxes | - | 1 | - | 5 | ||||||||||||
| Net loss | (35,598 | ) | (15,638 | ) | (92,952 | ) | (40,219 | ) | ||||||||
| Accretion on redeemable convertible preferred stock | - | (145 | ) | - | (705 | ) | ||||||||||
| Deemed dividend - beneficial conversion feature on redeemable convertible preferred stock | - | (6,219 | ) | - | (6,219 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (35,598 | ) | $ | (22,002 | ) | $ | (92,952 | ) | $ | (47,143 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.93 | ) | $ | (0.77 | ) | $ | (2.43 | ) | $ | (4.79 | ) | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 38,341,110 | 28,465,156 | 38,261,359 | 9,845,754 | ||||||||||||
| (1) Includes the following stock-based compensation expense: | ||||||||||||||||
| Research and development | $ | 2,382 | $ | 624 | $ | 6,330 | $ | 1,284 | ||||||||
| General and administrative | $ | 2,046 | $ | 847 | $ | 5,577 | $ | 1,613 |
Condensed Consolidated Balance Sheets
| September 30, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 68,519 | $ | 268,565 | ||||
| Short-term investments | 202,848 | 82,641 | ||||||
| Prepaid expenses and other current assets | 4,131 | 2,805 | ||||||
| Total current assets | 275,498 | 354,011 | ||||||
| Restricted cash | 1,166 | - | ||||||
| Property and equipment, net | 12,219 | 1,935 | ||||||
| Operating lease right-of-use assets | 20,680 | - | ||||||
| Other assets | 593 | - | ||||||
| Total assets | $ | 310,156 | $ | 355,946 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,797 | $ | 3,734 | ||||
| Accrued liabilities | 7,059 | 6,497 | ||||||
| Deferred rent, current | - | 391 | ||||||
| Operating lease liabilities, current | 63 | - | ||||||
| Total current liabilities | 11,919 | 10,622 | ||||||
| Deferred rent | - | 1,046 | ||||||
| Operating lease liabilities, non-current | 33,760 | - | ||||||
| Total liabilities | 45,679 | 11,668 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock | 38 | 38 | ||||||
| Additional paid-in capital | 523,458 | 510,309 | ||||||
| Accumulated other comprehensive loss | (75 | ) | (77 | ) | ||||
| Accumulated deficit | (258,944 | ) | (165,992 | ) | ||||
| Total stockholders' equity | 264,477 | 344,278 | ||||||
| Total liabilities and stockholders' equity | $ | 310,156 | $ | 355,946 |