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Annexon, Inc. (ANNX)

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Previous Close21.52
Open21.36
Bid21.72 x 800
Ask21.90 x 1000
Day's Range21.36 - 22.00
52 Week Range15.33 - 38.01
Volume8,769
Avg. Volume169,106
Market Cap826.494M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est37.00
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    • Annexon Biosciences Reports Fourth Quarter and Full-Year 2020 Financial Results with Recent Business Highlights
      GlobeNewswire

      Annexon Biosciences Reports Fourth Quarter and Full-Year 2020 Financial Results with Recent Business Highlights

      SOUTH SAN FRANCISCO, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Today 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 body, brain and eye, announced fourth quarter and full-year 2020 financial results and business highlights. Recent Business Highlights Annexon continues to make strong progress in advancing its broad and deep pipeline and clinical programs across a range of potential indications. Recent highlights include: ANX005 in Guillain-Barré Syndrome (GBS). In March 2021, the company completed evaluation of its drug-drug interaction (DDI) study of ANX005 co-administered with Intravenous Immunoglobulin (IVIg) in 14 patients with GBS. The DDI study was conducted to evaluate the safety and tolerability of ANX005 and IVIg co-administration in GBS patients, and measured pharmacokinetics (PK) and pharmacodynamics (PD) of ANX005 when administered in combination with IVIg. IVIg, though not FDA-approved in the United States for GBS, is currently the standard of care for GBS. Initial results from the DDI study included: Co-administration of IVIg-ANX005 was well-tolerated.Co-administration of IVIg-ANX005 achieved full C1q target engagement, and C1q suppression was maintained within the targeted range.The open-label DDI study was not placebo-controlled or powered for statistical significance on efficacy measures. A number of key GBS outcome measures were recorded from baseline, and early improvement was observed in GBS patients, including increased muscle strength, decreased neurofilament light chain (NfL) and improved GBS disability score. Full results from the DDI study are expected to be submitted to a peer-reviewed forum in 2021. A placebo-controlled Phase 2/3 trial is ongoing to evaluate the efficacy of ANX005 monotherapy in improving disability in GBS patients. Data from the Phase 2/3 trial is anticipated in 2023. ANX007 in Geographic Atrophy (GA). In February 2021, the company initiated a Phase 2 trial evaluating the efficacy of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA, which includes monthly and every other month dosing of ANX007. Data from this trial is anticipated in 2023.In February 2021, Annexon appointed William H. Carson, M.D. to the Board of Directors. Concurrent with Dr. Carson’s appointment, Thomas G. Wiggans was appointed as Annexon’s chairman. “We continue to make progress against our vision of building a leading, multi-faceted complement therapeutics company with an innovative portfolio for a broad range of autoimmune, neurodegenerative and ophthalmic diseases,” said Douglas Love, Esq., president and chief executive officer of Annexon. “The DDI data gives us further confidence in ANX005. We are rapidly advancing multiple Phase 2 clinical programs across a diverse set of potential indications, and accelerating development of a number of innovative, next generation product candidates. This clinical momentum coupled with our strong capital position positions us well to drive value in 2021 and beyond.” Fourth Quarter and Full-Year 2020 Financial Results Cash and cash equivalents and short-term investments: Cash and cash equivalents and short-term investments were $351.2 million as of December 31, 2020. Research and development (R&D) expenses: R&D expenses were $18.0 million for the quarter ended December 31, 2020 compared to $6.8 million for the quarter ended December 31, 2019. R&D expenses were $49.3 million for the year ended December 31, 2020 compared to $24.5 million for the year ended December 31, 2019.General and administrative (G&A) expenses: G&A expenses were $5.2 million for the quarter ended December 31, 2020 compared to $2.3 million for the quarter ended December 31, 2019. G&A expenses were $14.2 million for the year ended December 31, 2020 compared to $8.0 million for the year ended December 31, 2019.Net loss: Net loss was $23.2 million for the quarter ended December 31, 2020 compared to $8.9 million for the quarter ended December 31, 2019. Net loss was $63.4 million for the year ended December 31, 2020 compared to $37.2 million for the year ended December 31, 2019. 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 body, brain 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 strategy designed to select indications, identify patients and to measure target engagement and response to treatment with its drug candidates. 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; timing of data from clinical trials and submission of data to peer-reviewed forums; confidence in the company’s product candidates; the company’s ability to drive value in 2021 and beyond; 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. ANNEXON, INC.Condensed Consolidated Statements of Operations(in thousands, except share and per share amounts) Three Months EndedDecember 31, Year EndedDecember 31, 2020 2019 2020 2019 (unaudited) (unaudited) Operating expenses: Research and development (1) $17,992 $6,795 $49,271 $24,524 General and administrative (1) 5,199 2,334 14,198 7,994 Total operating expenses 23,191 9,129 63,469 32,518 Loss from operations (23,191) (9,129) (63,469) (32,518)Loss on remeasurement of redeemable convertible preferred stock liability — — — (5,670)Other (expense) income, net (7) 188 57 1,009 Net loss before taxes (23,198) (8,941) (63,412) (37,179)Provision for income taxes (5) 1 — 4 Net loss (23,193) (8,942) (63,412) (37,183)Accretion on redeemable convertible preferred stock — (280) (705) (1,095)Deemed dividend – beneficial conversion feature on redeemable convertible preferred stock — — (6,219) — Net loss attributable to common stockholders $(23,193) $(9,222) $(70,336) $(38,278)Net loss per share attributable to common stockholders, basic and diluted $(0.61) $(21.26) $(4.15) $(88.30)Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted 38,157,618 433,749 16,962,398 433,493 (1) Includes the following stock-based compensation expense: Research and development 990 230 2,274 713 General and administrative 1,001 294 2,614 1,324 ANNEXON, INC.Condensed Consolidated Balance Sheets(in thousands) December 31,2020 December 31,2019 Assets Current assets: Cash and cash equivalents $268,565 $43,931 Short-term investments 82,641 — Prepaid expenses and other current assets 2,805 1,475 Total current assets 354,011 45,406 Property and equipment 1,935 2,138 Other long-term assets — 2,354 Total assets $355,946 $49,898 Liabilities, Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable $3,734 $2,371 Accrued liabilities 6,497 2,194 Deferred rent, current 391 366 Total current liabilities 10,622 4,931 Deferred rent 1,046 1,437 Total liabilities 11,668 6,368 Redeemable convertible preferred stock — 143,984 Stockholders’ Equity (Deficit): Preferred stock — — Common stock 38 4 Additional paid-in capital 510,309 2,202 Accumulated other comprehensive loss (77) (80)Accumulated deficit (165,992) (102,580)Total stockholders’ equity (deficit) 344,278 (100,454)Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit) $355,946 $49,898 CONTACT: Investor Contacts: Jennifer Lew, Chief Financial Officer Annexon Biosciences jlew@annexonbio.com Sara Michelmore smichelmore@macbiocom.com Media Contacts: Miriam Mason Annexon Biosciences mmason@annexonbio.com Caroline Rufo, Ph.D. crufo@macbiocom.com

    • Benzinga

      Annexon Shares Gain After Patient Dosing Starts In Mid-Stage Study For Vision Loss Disorder Therapy

      Annexon Inc (NASDAQ: ANNX) has commenced patient dosing in its Phase 2 ARCHER study evaluating ANX007 to treat Geographic Atrophy (GA). GA, also known as atrophic age-related macular degeneration (AMD) or dry AMD, can lead to blindness caused by damaged and dying retinal cells. The Phase 2 trial is designed to evaluate the efficacy and safety of ANX007. Monthly dosing schedules will be evaluated. ANX007 is a monoclonal antibody formulated for intravitreal administration. The drug candidate is designed to bind to C1q and inhibit activation of all downstream components of the classical complement cascade, including C3 and C5, but not to interfere with the normal function of C3 and C5. Price Action: ANNX shares gained 10.6% at $32.19 in market trading hours on the last check Monday. See more from BenzingaClick here for options trades from BenzingaOcular Therapeutix Shares Are Trading Higher As Company Starts Dosing In Mid-Stage Therapy Study For Dry Eye DiseaseFlexion Therapeutics To Start Testing FX301 For Post-Op Pain In Patients After Musculoskeletal Surgery© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

    • Annexon Advances Classical Complement Platform with Initiation of Global Phase 2 ARCHER Trial in Patients with Geographic Atrophy
      GlobeNewswire

      Annexon Advances Classical Complement Platform with Initiation of Global Phase 2 ARCHER Trial in Patients with Geographic Atrophy

      SOUTH SAN FRANCISCO, Calif., March 01, 2021 (GLOBE NEWSWIRE) -- Today, Annexon, Inc. (“Annexon”) (Nasdaq: ANNX), a clinical stage biopharmaceutical company developing novel therapies for patients with classical complement-mediated disorders of the body, brain and eye, announced that patient dosing has begun in its Phase 2 ARCHER study of its anti-C1q therapy, ANX007, to treat Geographic Atrophy (GA). GA, also known as atrophic age-related macular degeneration (AMD) or dry AMD, can lead to blindness caused by damaged and dying retinal cells. Currently, there are no approved treatment options to prevent onset or progression of GA. “We are pleased to have commenced this important Phase 2 trial, advancing ANX007 as a potential therapy for GA, a leading cause of blindness and highly burdensome disease which affects more than five million people worldwide,” said Douglas Love, Esq., president and chief executive officer of Annexon. “This program harnesses our targeted anti-C1q approach, fully inhibiting the classical complement pathway with the aim of halting the damaging immune response and nerve damage that occurs in the eye.” “Geographic atrophy can have a profound impact on patients who lose their ability to drive, read and carry out normal daily functions,” said Peter K. Kaiser, M.D., Professor of Ophthalmology, Cole Eye Institute, Cleveland Clinic. “Targeting aberrant complement activity associated with the GA process has demonstrated great promise. Evaluating treatments that may reduce the rate of GA lesions growth and preserve visual function is important for these patients that have no treatment options today.” About the Phase 2 ARCHER Clinical Trial and ANX007 The randomized, multi-center, double-masked Phase 2 trial is designed to evaluate the efficacy and safety of ANX007 in reducing the area of GA as evaluated by fundus autofluorescence (FAF) in patients with GA. Monthly and every other month dosing schedules will be evaluated. ANX007 is an investigational monoclonal antibody antigen-binding fragment for the treatment of patients with complement-mediated neurodegenerative ophthalmic diseases. Formulated for intravitreal administration, ANX007 is designed to potently bind to C1q and inhibit activation of all downstream components of the classical complement cascade, including C3 and C5, but not to interfere with the normal function of C3 and C5 as part of other complement pathways. In Phase 1 studies, intravitreal ANX007 demonstrated full C1q inhibition at 29 days and was well tolerated by patients. More information can be found at www.annexonbio.com. 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 body, brain 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 identify patients, and to measure target engagement and response to treatment. 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; timing of data from clinical trials; 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 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 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. CONTACT: Investor Contacts: Jennifer Lew, Chief Financial Officer Annexon Biosciences jlew@annexonbio.com Sara Michelmore smichelmore@macbiocom.com Media Contacts: Miriam Mason Annexon Biosciences mmason@annexonbio.com Caroline Rufo, Ph.D. crufo@macbiocom.com