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Annexon Reports Third Quarter 2024 Portfolio and Financial Results, and Key Anticipated Milestones

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Annexon reported Q3 2024 financial results and key milestones. The company expects topline Real-World Evidence data for ANX005 in Guillain-Barré Syndrome by year-end 2024, with BLA submission planned for H1 2025. The Phase 3 ARCHER II trial for ANX007 in Geographic Atrophy continues enrollment with topline data expected H2 2026. Their oral C1s inhibitor ANX1502 study data in Cold Agglutinin Disease is expected in Q1 2025.

Financial highlights include cash position of $340.1 million as of September 30, 2024, providing runway into H2 2026. Q3 2024 net loss was $34.8 million ($0.25 per share), with R&D expenses at $30.1 million and G&A expenses at $9.3 million.

Annexon ha riportato i risultati finanziari del terzo trimestre 2024 e i principali traguardi. L'azienda prevede il rilascio dei dati di Real-World Evidence per ANX005 nella Sindrome di Guillain-Barré entro la fine del 2024, con la presentazione della BLA pianificata per il primo semestre del 2025. Il trial di fase 3 ARCHER II per ANX007 nella Atrofia Geografica continua con l'arruolamento, con i dati attesi nella seconda metà del 2026. I dati dello studio del loro inibitore orale C1s ANX1502 nella Malattia da Agglutinina Fredda sono previsti per il primo trimestre del 2025.

I punti salienti finanziari includono una posizione di cassa di $340.1 milioni al 30 settembre 2024, garantendo fondi fino alla seconda metà del 2026. La perdita netta del terzo trimestre 2024 è stata di $34.8 milioni ($0.25 per azione), con spese per R&D pari a $30.1 milioni e spese generali e administrative di $9.3 milioni.

Annexon reportó los resultados financieros del tercer trimestre de 2024 y los hitos clave. La compañía espera datos de Real-World Evidence para ANX005 en el Síndrome de Guillain-Barré para finales de 2024, con la presentación de la BLA programada para el primer semestre de 2025. El ensayo de fase 3 ARCHER II para ANX007 en Atrofia Geográfica continúa con la inscripción, esperando datos en la segunda mitad de 2026. Se esperan datos del estudio de su inhibidor oral C1s ANX1502 en la Enfermedad por Agglutinina Fría para el primer trimestre de 2025.

Los puntos destacados financieros incluyen una posición de efectivo de $340.1 millones a fecha del 30 de septiembre de 2024, proporcionando recursos hasta la segunda mitad de 2026. La pérdida neta del tercer trimestre de 2024 fue de $34.8 millones ($0.25 por acción), con gastos de I+D de $30.1 millones y gastos de G&A de $9.3 millones.

Annexon은 2024년 3분기 재무 결과와 주요 이정표를 보고했습니다. 회사는 2024년 연말까지 기현상 증후군에 대한 ANX005의 실제 증거 데이터 공개를 기대하고 있으며, 2025년 상반기에는 BLA 제출이 계획되어 있습니다. 지리적 위축에 대한 ANX007의 3상 ARCHER II 시험은 계속 진행 중이며, 데이터는 2026년 하반기에 예상됩니다. 냉응집소병에서의 경구 C1s 억제제 ANX1502 연구 데이터는 2025년 1분기에 공개될 예정입니다.

재무 하이라이트에는 2024년 9월 30일 기준 $340.1 백만의 현금 보유가 포함되어 있으며, 2026년 하반기까지 자금을 제공합니다. 2024년 3분기 순손실은 $34.8 백만 ($0.25 per share)였으며, 연구개발비는 $30.1 백만, 일반관리비는 $9.3 백만이었습니다.

Annexon a annoncé les résultats financiers du troisième trimestre 2024 et les jalons clés. La société s'attend à des données de Real-World Evidence pour ANX005 dans le syndrome de Guillain-Barré d'ici la fin de 2024, avec une soumission de BLA prévue pour le premier semestre 2025. L'essai de phase 3 ARCHER II pour ANX007 dans l'atrophie géographique continue son recrutement, avec des données attendues pour le second semestre 2026. Les données de leur étude sur l'inhibiteur oral C1s ANX1502 dans la maladie par agglutinine froide sont attendues pour le premier trimestre 2025.

Les faits saillants financiers comprennent une position de trésorerie de $340.1 millions au 30 septembre 2024, garantissant des fonds jusqu'au second semestre 2026. La perte nette du troisième trimestre 2024 s'élevait à $34.8 millions ($0.25 par action), avec des dépenses de R&D s'élevant à $30.1 millions et des dépenses générales et administratives de $9.3 millions.

Annexon hat die finanziellen Ergebnisse für das 3. Quartal 2024 und wichtige Meilensteine berichtet. Das Unternehmen erwartet, dass die Topline-Daten zur Real-World Evidence für ANX005 bei Guillain-Barré-Syndrom bis Ende 2024 vorliegen werden, und die Einreichung des BLA ist für das erste Halbjahr 2025 geplant. Die Phase-3-Studie ARCHER II für ANX007 bei geografischer Atrophie läuft weiterhin, und die Topline-Daten werden für die zweite Hälfte von 2026 erwartet. Die Studiendaten ihres oralen C1s-Inhibitors ANX1502 bei der kalten Agglutininkrankheit werden im 1. Quartal 2025 erwartet.

Die finanziellen Highlights umfassen eine Zahlungsmittelposition von $340.1 Millionen zum 30. September 2024, die Spielraum bis zur zweiten Hälfte von 2026 bietet. Der Nettoverlust im 3. Quartal 2024 betrug $34.8 Millionen ($0.25 pro Aktie), wobei die F&E-Ausgaben bei $30.1 Millionen und die allgemeinen Verwaltungsausgaben bei $9.3 Millionen lagen.

Positive
  • Strong cash position of $340.1 million providing runway into H2 2026
  • Positive Phase 3 data for ANX005 showing statistically significant effects in GBS treatment
  • Reduced net loss per share from $0.43 in Q3 2023 to $0.25 in Q3 2024
Negative
  • Increased R&D expenses from $27.9M in Q3 2023 to $30.1M in Q3 2024
  • Higher G&A expenses rising from $6.9M to $9.3M year-over-year
  • Net loss increased to $34.8M from $32.5M in previous year

Insights

The Q3 2024 results reveal a solid financial position with $340.1 million in cash and investments, providing runway into H2 2026. Key financial metrics show R&D expenses at $30.1 million (up from $27.9 million YoY) and G&A expenses at $9.3 million (up from $6.9 million YoY). Net loss was $34.8 million ($0.25 per share), compared to $32.5 million ($0.43 per share) in Q3 2023. The improved per-share metrics despite higher absolute losses reflect better capital efficiency.

The company's pipeline progress, particularly with ANX005's potential BLA submission in H1 2025, represents a significant near-term catalyst. The strengthened commercial team and robust cash position strategically position Annexon for potential commercialization efforts.

The clinical pipeline shows promising advancement across multiple indications. ANX005's positive Phase 3 data in GBS, demonstrating accelerated recovery and improved outcomes, positions it as a potential first-targeted therapy for this indication. The upcoming RWE data and BLA submission timeline provide near-term validation opportunities.

ANX007's Phase 3 ARCHER II trial in Geographic Atrophy represents a unique approach with demonstrated vision protection benefits. The ANX1502 program's transition to an enhanced tablet formulation for CAD shows strategic development in expanding the complement inhibition platform. The company's focus on C1q targeting across body, brain and eye indications demonstrates a cohesive scientific approach with multiple shots on goal.

Topline Real-World Evidence (RWE) Comparability and Outcomes Data for ANX005 in Guillain-Barré Syndrome (GBS) Expected by Year-End 2024; Biologics License Application (BLA) Submission Targeted for First Half 2025

Ongoing Enrollment in Phase 3 ARCHER II Trial for ANX007 in Geographic Atrophy (GA); Topline Data Expected Second Half 2026

Proof-of-Concept Study with First-in-Kind Oral C1s Inhibitor ANX1502 Transitioned to an Enhanced Tablet Formulation; Data in Cold Agglutinin Disease (CAD) Expected in First Quarter 2025

Bolstered Commercial, Medical Affairs and Health Economics Senior Leadership in Preparation for Potential ANX005 Commercialization

Robust Balance Sheet with Cash, Cash Equivalents, and Short-term Investments of Approximately $340 Million as of September 30, 2024, and Anticipated Runway into Second Half 2026

BRISBANE, Calif., Nov. 14, 2024 (GLOBE NEWSWIRE) -- 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 third quarter 2024 financial results.

“We are executing toward a strong finish for the year to propel us into the start of an impactful 2025. The RWE data for our ANX005 GBS program expected by year end 2024 will be an important part of our first BLA submission as a company and a significant step toward providing GBS patients with a targeted and approved therapy. ARCHER II, our Phase 3 trial in GA, is actively enrolling and designed to provide the first significant data for protection of vision in a pivotal GA trial. Finally, we’re anticipating data from our first-in-kind oral C1s program, ANX1502, with an improved tablet formulation in patients with CAD in the first quarter of 2025,” said Douglas Love, president and chief executive officer of Annexon.

Mr. Love continued, “Our portfolio of programs has provided consistent support for our approach to target C1q, a key upstream driver of neuroinflammatory diseases of the body, brain and eye, and we’re encouraged by the outlook for our programs. With a strong balance sheet and runway into the second half of 2026, we are laser-focused to deliver on our near-term goals and achieve our mission of helping millions of patients live their best lives.”

Recent Corporate and Clinical Program Updates

Strengthened senior leadership team in commercial, medical affairs and health economics to advance global late-stage neuroinflammatory-targeted portfolio: Appointments include Shikhar Agarwal, M.B.A. as senior vice president, head of commercial, Sunil B. Mehta, Pharm.D as senior vice president of medical affairs and Myoung Kim, PhD, M.A., M.B.A. as vice president of health economics and outcomes research.

Flagship Programs

ANX005 in Guillain-Barré syndrome (GBS): First-in-kind monoclonal antibody designed to block C1q and the entire classical complement pathway in both the body and the brain has the potential to be the first targeted therapy for GBS, if approved.

  • Positive topline Phase 3 data demonstrated statistically significant effects of ANX005 treatment on multiple measures of GBS, including on the primary endpoint GBS-disability scale (GBS-DS)
    • Demonstrated higher likelihood of being in a better state of health as early as week 1, and observed through 26-weeks on the GBS-DS
    • Early, robust and durable treatment effects expedited recovery and led to patients walking and off ventilation for those requiring it approximately one month earlier
    • Single infusion of ANX005 was generally well-tolerated with a safety profile similar to placebo and balanced across groups
    • Patients with baseline characteristics similar to those of patients in North America and Europe had greater responses to ANX005 over placebo than were observed in the overall population of the study
  • Ongoing RWE study conducted by global experts in GBS using the International Guillain-Barré Syndrome Outcomes Study (IGOS)
    • Study will produce a cohort of patients from our GBS Phase 3 trial matched to patients in the IGOS registry based on key prognostic factors to support BLA submission
    • Study will compare outcomes of patients treated with ANX005 vs. patients treated with IVIg or plasma exchange assessed on the GBS-DS primary and other outcome measures, including impact on muscle strength

ANX007 in Geographic Atrophy (GA): First-in-kind, non-pegylated antigen-binding fragment (Fab) designed to block C1q and the classical complement cascade locally in the eye is the only investigational medicine to date to show significant protection against ≥15-letter loss (vision protection) on the endpoint of best corrected visual acuity (BCVA) in GA.

  • Ongoing global registrational Phase 3 ARCHER II trial, a well-powered, randomized, double masked, sham-controlled trial that will include a robust safety database expected to enroll approximately ~630 patients
  • Regulatory alignment with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the primary outcome measure for the Phase 3 program, BCVA protection against ≥15-letter loss
  • New Phase 2 ARCHER data on the protection of vision and vision-related retinal structure presented at the 2024 American Society of Retina Specialists Annual Scientific meeting, at the Retina Society’s 57th annual scientific meeting, at the 24th annual Euretina Congress, at the American Academy of Ophthalmology (AAO) 2024 annual meeting and at the Eyecelerator conference at AAO. Highlighted data with ANX007 treatment included:
    • Significant vision protection in both standard and low light conditions, and protection of photoreceptor integrity in the central fovea, the region of the retina most important for activities such as reading, driving and recognizing faces
    • Enhanced protection of vision in healthier eyes and greater preservation of central photoreceptor cells in patients with less advanced GA, as measured by the photoreceptor ellipsoid zone (EZ) in the central fovea

ANX1502 for Autoimmune Conditions: First-in-kind oral C1s inhibitor has the potential to offer the advantages of selective upstream classical complement inhibition with the convenience and flexibility of oral administration.

  • Completed bridging study in healthy volunteers from a liquid suspension formulation to a twice daily tablet with safety and pharmacokinetic profile similar or better than previous studies
  • Created an enteric-coated tablet formulation to enhance the patient experience and provide improved tolerability, for use in the proof-of-concept (POC) study in CAD
  • Ongoing open label single arm study in CAD patients will evaluate enteric-coated tablet formulation of ANX1502 administered twice daily for up to 4 weeks. The study will characterize the pharmacodynamics of ANX1502 on objective and established markers of complement activation and disease-related hemolysis
    • POC study is designed to enable advancement in multiple antibody-mediated autoimmune indications, including those with clinical validation and where approved treatments require weekly or every other week infusions

Key Anticipated Milestones for Flagship Programs

  • ANX005 in GBS: Initial topline data from RWE comparability protocol with IGOS expected by year-end 2024 to support a planned BLA submission in the first half of 2025
  • ANX007 in GA: Phase 3 ARCHER II trial topline data expected in the second half of 2026. Plans for an injection-controlled study, ARROW, to assess the prevention of ≥15-letter loss of BCVA, are being assessed
  • ANX1502 in CAD: Initial data from POC trial evaluating the pharmacodynamics of an oral tablet formulation in CAD expected in the first quarter of 2025

Third Quarter 2024 Financial Results

  • Cash and operating runway: Cash, cash equivalents and short-term investments were $340.1 million as of September 30, 2024. Annexon continues to expect its cash, cash equivalents and short-term investments as of September 30, 2024, to be sufficient to fund the company’s planned operating expenses into the second half of 2026
  • Research and development (R&D) expenses: R&D expenses were $30.1 million for the quarter ended September 30, 2024, reflecting the advancement of the Company’s priority programs, including GBS, GA and ANX1502, compared to $27.9 million for the quarter ended September 30, 2023
  • General and administrative (G&A) expenses: G&A expenses were $9.3 million for the quarter ended September 30, 2024, compared to $6.9 million for the quarter ended September 30, 2023
  • Net loss: Net loss was $34.8 million or $0.25 per share for the quarter ended September 30, 2024, compared to $32.5 million or $0.43 per share for the quarter ended September 30, 2023

About Annexon

Annexon Biosciences (Nasdaq: ANNX) is harnessing classical complement-driven neuroinflammation to advance potentially first-in-kind treatments for millions of people living with serious neuroinflammatory diseases of the body, brain and eye. Our novel scientific approach focuses on C1q, the initiating molecule of classical complement’s potent inflammatory pathway that when misdirected can lead to tissue damage and loss. By targeting C1q, our immunotherapies are designed to stop neuroinflammatory diseases where they start. Our pipeline spans three diverse therapeutic areas – autoimmune, neurodegenerative and ophthalmic diseases – and includes targeted investigational drug candidates designed to address the unmet needs of over 8 million people worldwide. Annexon’s mission is to deliver game-changing therapies to patients so that they can live their best lives. When they thrive, we thrive. 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 potential therapeutic benefit of ANX005, if approved, compared to existing therapies; anticipated timing of the completion of a RWE comparability study and BLA submission for ANX005; the potential for the RWE comparability study to show that ANX005 treatment is comparable or better than treatment with IVIg/plasma exchange; the company’s ability to achieve regulatory approval for ANX005; the potential therapeutic benefit of ANX007; timing of the ARCHER II trial and initiation of ARROW trial; ANX007’s distinct potential neuroprotective mechanism of action and potential to provide protection from vision loss; timing of proof-of-concept data for ANX1502; the company’s ability to commercialize its product candidates, if approved; continued development of ANX007 and ANX1502; anticipated cash runway into the second half of 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)
(unaudited)
 
  Three Months Ended
September 30,
  Nine Months Ended
September 30,
 
  2024  2023  2024  2023 
Operating expenses:            
Research and development (1) $30,105  $27,893  $76,094  $90,489 
General and administrative (1)  9,337   6,888   25,500   23,225 
Total operating expenses  39,442   34,781   101,594   113,714 
Loss from operations  (39,442)  (34,781)  (101,594)  (113,714)
Interest and other income, net  4,618   2,299   11,984   7,368 
Net loss $(34,824) $(32,482) $(89,610) $(106,346)
Net loss per share, basic and diluted $(0.25) $(0.43) $(0.68) $(1.42)
Weighted-average shares used in computing net loss per share,
basic and diluted
  139,933,019   75,342,495   130,945,980   74,815,274 


_________________________
(1) Includes the following stock-based compensation expense:
            
Research and development $2,325  $2,243  $6,918  $6,801 
General and administrative $2,284  $2,306  $7,293  $7,015 


ANNEXON, INC.
Condensed Consolidated Balance Sheets
(in thousands)
       
  September 30,  December 31, 
  2024  2023 
  (unaudited)    
Assets      
Current assets:      
Cash and cash equivalents $79,540  $225,110 
Short-term investments  260,576   34,606 
Prepaid expenses and other current assets  4,176   4,144 
Total current assets  344,292   263,860 
Restricted cash  1,032   1,032 
Property and equipment, net  13,169   14,773 
Operating lease right-of-use assets  17,050   18,009 
Other non-current assets  3,233    
Total assets $378,776  $297,674 
Liabilities and Stockholders' Equity      
Current liabilities:      
Accounts payable $6,748  $5,487 
Accrued and other current liabilities  10,861   10,276 
Operating lease liabilities, current  2,437   2,165 
Total current liabilities  20,046   17,928 
Operating lease liabilities, non-current  27,170   29,190 
Total liabilities  47,216   47,118 
Stockholders’ equity:      
Common stock  106   78 
Additional paid-in capital  993,486   823,029 
Accumulated other comprehensive loss  77   (52)
Accumulated deficit  (662,109)  (572,499)
Total stockholders' equity  331,560   250,556 
Total liabilities and stockholders’ equity $378,776  $297,674 

FAQ

What were Annexon's (ANNX) Q3 2024 financial results?

Annexon reported a net loss of $34.8 million ($0.25 per share), R&D expenses of $30.1 million, and G&A expenses of $9.3 million. The company had $340.1 million in cash and investments as of September 30, 2024.

When will Annexon (ANNX) release topline data for ANX005 in GBS?

Annexon expects to release topline Real-World Evidence (RWE) data for ANX005 in Guillain-Barré Syndrome by the end of 2024.

What is the cash runway for Annexon (ANNX) as of Q3 2024?

Annexon's cash position of $340.1 million as of September 30, 2024, is expected to fund operations into the second half of 2026.

Annexon, Inc.

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