Full Press Release Details
Annexon Biosciences Reports Second Quarter 2021 Financial Results and Provides Mid-Year Business Update
- Recently expanded Autoimmune franchise with advancement of third clinical candidate, ANX009, and strategically expanded into additional autoantibody-driven diseases -
- Continued progress in Neurodegeneration franchise with initial Phase 2 data results from ANX005 in Huntington's disease expected in Q4 2021 and initiation of Phase 2 ANX005 trial in Amyotrophic Lateral Sclerosis -
- Appointed William D. Waddill to the Board of Directors -
SOUTH SAN FRANCISCO, Calif., August 16, 2021 - Annexon, Inc. ("Annexon") (Nasdaq: ANNX), Annexon, a clinical-stage biopharmaceutical company developing a class of new complement medicines for patients with classical complement-mediated autoimmune and neurodegenerative disorders of the body, brain and eye, today announced second quarter 2021 financial results and provided a mid-year business update.
"We continue to make strong and consistent progress on our mission to deliver transformative therapies for patients suffering from classical complement-driven autoimmune and neurodegenerative diseases. With three clinical-stage drug candidates advancing in seven clinical trials, we remain laser-focused on developing game-changing therapies for patients in need while generating significant value for our shareholders," said Douglas Love, Esq., president and chief executive officer of Annexon. "We also continue to expand our corporate capabilities and are pleased to announce the appointment of Will Waddill to our Board of Directors. Will has extensive experience in biotech and finance, and will provide an invaluable perspective as we enter our next phase of growth and value creation."
Therapeutic Franchise Highlights and Updates
Annexon is advancing a portfolio of innovative C1 inhibitors to stop classical complement-mediated diseases at the start of the pathway in three therapeutic franchise areas: Autoimmune, Neurodegeneration and Ophthalmology.
Autoimmune Franchise
Annexon is pursuing a range of carefully selected neuromuscular, hematologic and nephritic antibody-mediated autoimmune indications where excess classical complement activity is a key driver of disease. During its July 28th C1q R&D series presentation, Annexon showcased the rationale and potential of its anti-C1 approach in autoimmune disease.
Recent highlights and updates in the Autoimmune franchise include:
Neurodegeneration Franchise
Annexon is pioneering an approach to stop complement-mediated neurodegeneration at the start, leveraging its original discoveries of the role of C1q as a major driver of synaptic loss and neurodegeneration. Blocking C1q potentially protects against functioning synapse loss and may provide functional benefit. Annexon is utilizing biomarkers of neuronal damage to measure impact on disease.
Recent highlights and updates in the Neurodegeneration franchise include:
Ophthalmology Franchise
Annexon is utilizing intravitreal administration of ANX007 to inhibit C1q, which is implicated in neurodegeneration in the retina. Selectively targeting C1q at the start of the classical pathway versus downstream approaches may enhance efficacy and safety for patients in ophthalmic disorders, including Geographic Atrophy (GA).
Recent highlights and updates in the Ophthalmology franchise include:
Second Quarter 2021 Financial Results
Annexon is a clinical-stage biopharmaceutical company developing a class of new complement medicines for patients with classical complement-mediated 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 and peer reviewed forum submissions; timing of completion of clinical studies and clinical development milestones; the company's ability to deliver on its objectives; and 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. 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.
Jennifer Lew, Chief Financial Officer
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development (1) | $ | 24,572 | $ | 9,287 | $ | 45,268 | $ | 19,504 | ||||||||
| General and administrative (1) | 6,801 | 2,950 | 12,307 | 5,189 | ||||||||||||
| Total operating expenses | 31,373 | 12,237 | 57,575 | 24,693 | ||||||||||||
| Loss from operations | (31,373 | ) | (12,237 | ) | (57,575 | ) | (24,693 | ) | ||||||||
| Other income, net | 79 | 1 | 221 | 116 | ||||||||||||
| Net loss before taxes | (31,294 | ) | (12,236 | ) | (57,354 | ) | (24,577 | ) | ||||||||
| Provision for income taxes | - | 4 | - | 4 | ||||||||||||
| Net loss | (31,294 | ) | (12,240 | ) | (57,354 | ) | (24,581 | ) | ||||||||
| Accretion on redeemable convertible preferred stock | - | 281 | - | 560 | ||||||||||||
| Net loss attributable to common stockholders | $ | (31,294 | ) | $ | (12,521 | ) | $ | (57,354 | ) | $ | (25,141 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.82 | ) | $ | (28.87 | ) | $ | (1.50 | ) | $ | (57.96 | ) | ||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 38,277,950 | 433,749 | 38,219,143 | 433,749 | ||||||||||||
| (1) Includes the following stock-based compensation expense: | ||||||||||||||||
| Research and development | $ | 2,402 | $ | 335 | $ | 3,948 | $ | 660 | ||||||||
| General and administrative | 2,115 | 428 | 3,531 | 766 |
Condensed Consolidated Balance Sheets
| June 30, 2021 | December 31, 2020 | |||||||
| (Unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 99,588 | $ | 268,565 | ||||
| Short-term investments | 202,798 | 82,641 | ||||||
| Prepaid expenses and other current assets | 2,007 | 2,805 | ||||||
| Total current assets | 304,393 | 354,011 | ||||||
| Restricted cash | 1,166 | - | ||||||
| Property and equipment, less accumulated depreciation of $3,047 and $1,971 as of June 30, 2021 and December 31, 2020, respectively | 5,129 | 1,935 | ||||||
| Operating lease right-of-use assets | 21,096 | - | ||||||
| Total assets | $ | 331,784 | $ | 355,946 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,184 | $ | 3,734 | ||||
| Accrued liabilities | 5,850 | 6,497 | ||||||
| Deferred rent, current | - | 391 | ||||||
| Operating lease liabilities, current | 250 | - | ||||||
| Total current liabilities | 10,284 | 10,622 | ||||||
| Deferred rent | - | 1,046 | ||||||
| Operating lease liabilities, non-current | 26,165 | - | ||||||
| Total liabilities | 36,449 | 11,668 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock | 38 | 38 | ||||||
| Additional paid-in capital | 518,708 | 510,309 | ||||||
| Accumulated other comprehensive loss | (65 | ) | (77 | ) | ||||
| Accumulated deficit | (223,346 | ) | (165,992 | ) | ||||
| Total stockholders' equity | 295,335 | 344,278 | ||||||
| Total liabilities and stockholders' equity | $ | 331,784 | $ | 355,946 |