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IGM Biosciences Announces Third Quarter 2024 Financial Results and Provides Corporate Update

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IGM Biosciences reported Q3 2024 financial results and corporate updates. The company is advancing clinical trials for imvotamab in autoimmune diseases, with initial data expected by mid-2025. Cash position stands at $218.8M as of September 30, 2024. Q3 net loss was $61.4M ($1.01 per share). The company expects 2024 operating expenses of $215-225M and projects cash runway into 2027. IGM-2644 is expected to enter clinical trials for generalized myasthenia gravis by end of 2024. The company has successfully completed the third dose cohort for rheumatoid arthritis trials and continues enrollment in systemic lupus erythematosus and myositis studies.

IGM Biosciences ha riportato i risultati finanziari e gli aggiornamenti aziendali del terzo trimestre del 2024. L'azienda sta portando avanti gli studi clinici per imvotamab nelle malattie autoimmuni, con i dati preliminari attesi entro metà 2025. La posizione di cassa è di 218,8 milioni di dollari al 30 settembre 2024. La perdita netta del terzo trimestre è stata di 61,4 milioni di dollari (1,01 dollari per azione). L'azienda prevede spese operative per il 2024 comprese tra 215 e 225 milioni di dollari e stima di avere sufficiente liquidità fino al 2027. Si prevede che IGM-2644 entri in fase di sperimentazione clinica per la miastenia gravis generalizzata entro la fine del 2024. L'azienda ha completato con successo il terzo gruppo di dosaggio per gli studi sull'artrite reumatoide e continua l'arruolamento negli studi su lupus eritematoso sistemico e miosite.

IGM Biosciences informó los resultados financieros y las actualizaciones corporativas del tercer trimestre de 2024. La empresa está avanzando en ensayos clínicos para imvotamab en enfermedades autoinmunes, con datos iniciales esperados para mediados de 2025. La posición de efectivo es de 218,8 millones de dólares a fecha del 30 de septiembre de 2024. La pérdida neta del tercer trimestre fue de 61,4 millones de dólares (1,01 dólares por acción). La empresa espera gastos operativos de 215 a 225 millones de dólares para 2024 y prevé que su liquidez se extienda hasta 2027. Se espera que IGM-2644 ingrese a ensayos clínicos para la miastenia gravis generalizada a finales de 2024. La compañía ha completado con éxito el tercer grupo de dosis para los ensayos de artritis reumatoide y continúa reclutando participantes para los estudios de lupus eritematoso sistémico y miositis.

IGM 바이오사이언스는 2024년 3분기 재무 결과 및 기업 업데이트를 발표했습니다. 이 회사는 자가면역질환에 대한 임보타맙의 임상시험을 진행하고 있으며, 초기 데이터는 2025년 중반에 예상됩니다. 2024년 9월 30일 현재 현금 보유액은 2억 1,880만 달러입니다. 3분기 순손실은 6,140만 달러(주당 1.01 달러)였습니다. 이 회사는 2024년 운영 비용이 2억 1,500만에서 2억 2,500만 달러가 될 것으로 예상하고, 2027년까지 자금을 확보할 수 있을 것으로 예상하고 있습니다. IGM-2644는 2024년 말까지 일반화된 중증근무력증에 대한 임상시험에 진입할 것으로 예상됩니다. 이 회사는 류마티스 관절염 임상시험을 위한 세 번째 용량 집단을 성공적으로 완료했으며, 전신 홍반 루푸스 및 근염 연구에 대한 등록을 계속하고 있습니다.

IGM Biosciences a publié les résultats financiers et les mises à jour de l'entreprise pour le troisième trimestre 2024. L'entreprise fait progresser des essais cliniques pour imvotamab dans les maladies auto-immunes, avec des données préliminaires attendues d'ici mi-2025. La position de trésorerie s'élève à 218,8 millions de dollars au 30 septembre 2024. La perte nette du troisième trimestre était de 61,4 millions de dollars (1,01 dollar par action). L'entreprise prévoit des dépenses d'exploitation de 215 à 225 millions de dollars pour 2024 et projette une liquidité suffisante jusqu'en 2027. On s'attend à ce qu'IGM-2644 entre en essais cliniques pour la myasthénie généralisée d'ici fin 2024. L'entreprise a terminé avec succès le troisième groupe de doses pour les essais sur l'arthrite rhumatoïde et continue de recruter pour les études sur le lupus érythémateux systémique et la myosite.

IGM Biosciences hat die finanziellen Ergebnisse und Unternehmensaktualisierungen für das dritte Quartal 2024 bekannt gegeben. Das Unternehmen entwickelt klinische Studien für imvotamab bei Autoimmunerkrankungen und erwartet erste Daten bis Mitte 2025. Die Liquiditätsposition beläuft sich zum 30. September 2024 auf 218,8 Millionen Dollar. Der Nettoverlust im dritten Quartal betrug 61,4 Millionen Dollar (1,01 Dollar pro Aktie). Das Unternehmen rechnet 2024 mit Betriebskosten von 215 bis 225 Millionen Dollar und prognostiziert eine Liquidität bis 2027. IGM-2644 wird voraussichtlich bis Ende 2024 in klinische Studien zur generalisierten Myasthenia gravis eintreten. Das Unternehmen hat die dritte Dosisgruppe für klinische Studien zur rheumatoiden Arthritis erfolgreich abgeschlossen und setzt die Rekrutierung für Studien zu systemischem Lupus erythematodes und Myositis fort.

Positive
  • Cash runway expected to fund operations into 2027
  • Successfully completed third dose cohort in rheumatoid arthritis trials
  • Reduced R&D expenses to $46.1M from $54.8M year-over-year
Negative
  • Net loss of $61.4M in Q3 2024
  • Cash position decreased to $218.8M from $337.7M since December 2023
  • One-time expenses of $14M related to strategic pivot
  • Low collaboration revenue of only $0.5M

Insights

The Q3 financial results reveal a challenging period for IGM Biosciences with a net loss of $61.4 million ($1.01 per share). Cash position declined to $218.8 million from $337.7 million at year-end 2023. The company's strategic pivot to autoimmunity resulted in $14 million in one-time expenses across R&D and G&A. While revenue remains minimal at $0.5 million, the projected cash runway into 2027 provides operational stability.

The 2024 guidance forecasts operating expenses of $215-225 million with an expected year-end cash position of $180 million. The 15.9% reduction in R&D expenses year-over-year to $46.1 million reflects cost management efforts, though G&A expenses increased by 50.4% to $18.8 million.

The strategic pivot to autoimmune diseases represents a significant transformation in IGM's pipeline focus. Key developments include:

  • Imvotamab advancing through multiple trials with data expected by mid-2025
  • Completion of third dose cohort in rheumatoid arthritis
  • Progress in systemic lupus erythematosus trial with second dose cohort enrollment
  • Initiation of myositis trial
  • IGM-2644 program expanding into generalized myasthenia gravis by year-end
The company's focus on B-cell depletion through engineered IgM antibodies could offer a novel approach in treating autoimmune conditions, though clinical validation is still pending.

– Imvotamab (CD20 x CD3) trials in rheumatoid arthritis, systemic lupus erythematosus and myositis ongoing; initial clinical data expected by mid-2025 –

– IGM-2644 (CD38 x CD3) expected to enter clinical study for generalized myasthenia gravis by year-end 2024 –

– Cash runway expected to fund operations into 2027 –

MOUNTAIN VIEW, Calif., Nov. 08, 2024 (GLOBE NEWSWIRE) -- IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company creating and developing engineered IgM antibodies, today announced its financial results for the fiscal quarter ended September 30, 2024 and provided an update on recent developments.

“The third quarter was transformative for IGM, punctuated by the announcement of our strategic pivot to focus exclusively on autoimmunity,” said Mary Beth Harler, M.D., Chief Executive Officer of IGM Biosciences. "Our near-term focus for imvotamab remains generating robust initial data sets in rheumatoid arthritis, systemic lupus erythematosus and myositis. Based on enrollment timing, we expect to have sufficient information by the middle of 2025 to present initial imvotamab data at an appropriate venue as well as determine next steps to advance imvotamab in autoimmune indications.”

Pipeline Updates

Imvotamab (CD20 x CD3 T cell engager)

  • Clinical development of imvotamab in autoimmune diseases advances, with initial clinical data disclosure expected by mid-2025.
    • Third dose cohort in rheumatoid arthritis successfully completed. The Company has cleared the third dose cohort of its placebo-controlled clinical study testing imvotamab in severe rheumatoid arthritis.
    • Enrollment in second dose cohort in systemic lupus erythematosus ongoing. The Company has cleared the first dose cohort of its open-label clinical study testing imvotamab in severe systemic lupus erythematosus (SLE) and is currently enrolling patients in a second dose cohort.
    • First patient dosed in myositis. The Company has dosed the first patient in its single arm, open-label clinical study testing imvotamab in moderate-severe idiopathic inflammatory myopathies (myositis). Enrollment is ongoing in this study, which is being conducted in collaboration with Stanford University.
  • Imvotamab preclinical data selected for poster presentation at ACR Convergence 2024. The Company will present a poster titled "Imvotamab, a CD20-Targeted Bispecific IgM T Cell Engager, Effectively Depletes Low-Expressing CD20+ B Cells in Preclinical Models of Autoimmune Disease" at the American College of Rheumatology’s annual meeting, ACR Convergence 2024, taking place in Washington, D.C., on November 17, 2024.

IGM-2644 (CD38 x CD3 T cell engager)

  • Clinical development of IGM-2644 in autoimmune diseases to be initiated. The Company continues to make significant progress towards initiating clinical development of IGM-2644, a CD38 x CD3 T cell engager antibody, in the treatment of autoimmune diseases. The Company expects to enter IGM-2644 into a single arm, open-label clinical study for generalized myasthenia gravis (gMG) by the end of 2024.

Corporate Updates

  • Peer-reviewed article titled “Cutting-edge Approaches to B-cell Depletion in Autoimmune Diseases” published in Frontiers in Immunology. IGM co-authored this article with Bill Robinson, M.D., Ph.D., et al. and the article can be found online here. Dr. Robinson is Chief of the Division of Immunology and Rheumatology at Stanford University.
  • Eric Humke, M.D., Ph.D., Senior Vice President, appointed as Head of Clinical Research and Development. Dr. Humke joined IGM in 2019 as Vice President, Clinical Development. Prior to IGM, he spent eight years at Genentech, most recently serving as Senior Medical Director, where he led the early clinical development of multiple first-in-human therapeutics. Prior to joining Genentech, he was an Instructor of Medicine at the Stanford University School of Medicine, where he conducted basic science research and cared for patients.

Third Quarter 2024 Financial Results

  • Cash and Investments: Cash and investments as of September 30, 2024 were $218.8 million, compared to $337.7 million as of December 31, 2023.
  • Collaboration Revenue: For the third quarter of 2024, collaboration revenues were $0.5 million, compared to $0.5 million for the third quarter of 2023.
  • Research and Development (R&D) Expenses: For the third quarter of 2024, R&D expenses were $46.1 million, compared to $54.8 million for the third quarter of 2023. R&D expenses for the third quarter of 2024 included $5.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
  • General and Administrative (G&A) Expenses: For the third quarter of 2024, G&A expenses were $18.8 million, compared to $12.5 million for the third quarter of 2023. G&A expenses for the third quarter of 2024 included $8.5 million in one-time expenses related to the strategic pivot to focus exclusively on autoimmunity.
  • Net Loss: For the third quarter of 2024, net loss was $61.4 million, or a loss of $1.01 per share, compared to a net loss of $62.0 million, or a loss of $1.04 per share, for the third quarter of 2023.

2024 Financial Guidance
The Company expects full year 2024 GAAP operating expenses of $215 million to $225 million including estimated non-cash stock-based compensation expense of approximately $40 million, and full year collaboration revenue of approximately $2 million related to the Sanofi agreement. The Company expects to end 2024 with a balance of approximately $180 million in cash and investments and for the balance to enable it to fund its operating expenses and capital expenditure requirements into 2027.

About IGM Biosciences, Inc.
IGM Biosciences is a clinical-stage biotechnology company committed to developing and delivering a new class of medicines to treat patients with autoimmune and inflammatory diseases. IGM’s pipeline of clinical and preclinical assets is based on the IgM antibody, which has 10 binding sites compared to conventional IgG antibodies with only 2 binding sites. IGM also has an exclusive worldwide collaboration agreement with Sanofi to create, develop, manufacture, and commercialize IgM antibody agonists against immunology and inflammation targets. For more information, please visit www.igmbio.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements. Such forward-looking statements are not based on historical fact and include, but are not limited to: the potential of, and expectations regarding, IGM’s technology platform and its IgM antibodies and product candidates, including imvotamab and IGM-2644; IGM’s plans and expectations regarding its clinical development efforts and activities; statements regarding the clinical development of imvotamab and IGM-2644, including with respect to patient enrollment, dosing, and the timing of the release of data; IGM’s expectations regarding its financial position and results, including its operating expenses, stock-based compensation expense, collaboration revenue, and projected cash runway; and statements by IGM’s Chief Executive Officer. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially, including but not limited to: IGM’s early stages of clinical drug development; risks related to the use of engineered IgM antibodies, which is a novel and unproven therapeutic approach; IGM’s ability to demonstrate the safety and efficacy of its product candidates; IGM's ability to successfully and timely advance its product candidates through clinical trials; IGM’s ability to enroll patients in its clinical trials; the potential for the results of clinical trials to differ from preclinical, preliminary, initial or expected results; the risk of significant adverse events, toxicities or other undesirable side effects; IGM's ability to successfully manufacture and supply its product candidates for clinical trials; the potential impact of continuing or worsening supply chain constraints; the risk that all necessary regulatory approvals cannot be obtained; the potential market for IGM’s product candidates; IGM’s ability to obtain additional capital to finance its operations; uncertainties related to the projections of the size of patient populations suffering from the diseases IGM is targeting; IGM’s ability to obtain, maintain and protect its intellectual property rights; developments relating to IGM’s competitors and its industry, including competing product candidates and therapies; any potential delays or disruptions resulting from catastrophic events, including epidemics or other outbreaks of infectious disease; general economic and market conditions, including inflation; uncertainties related to IGM's ability to realize the contemplated benefits of its pipeline prioritization efforts and related reduction in force; uncertainties related to IGM’s ability to realize the contemplated benefits of its strategic pivot and pipeline transformation and related reduction in force; and other risks and uncertainties, including those more fully described in IGM’s filings with the Securities and Exchange Commission (SEC), including IGM’s Quarterly Report on Form 10-Q filed with the SEC on November 8, 2024 and in IGM’s future reports to be filed with the SEC. Any forward-looking statements contained in this press release speak only as of the date hereof, and IGM specifically disclaims any obligation to update any forward-looking statement, except as required by law.

This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Contact:
Argot Partners
David Pitts
212-600-1902
igmbio@argotpartners.com


 IGM Biosciences, Inc.
 Selected Statement of Operations Data
 (unaudited)
 (in thousands, except share and per share data)
          
   Three Months Ended Nine Months Ended
   September 30, September 30,
    2024   2023   2024   2023 
 Collaboration revenue $516  $509  $2,267  $1,479 
          
 Operating expenses:        
 Research and development (1)  46,142   54,762   131,919   161,329 
 General and administrative (1)  18,761   12,507   39,948   38,492 
 Total operating expenses  64,903   67,269   171,867   199,821 
 Loss from operations  (64,387)  (66,760)  (169,600)  (198,342)
          
 Other income (expense):        
 Interest income  2,957   5,011   10,452   13,077 
 Other expense           (20)
 Total other income (expense)  2,957   5,011   10,452   13,057 
 Loss before income tax expense  (61,430)  (61,749)  (159,148)  (185,285)
 Income tax expense     (240)     (436)
 Net loss $(61,430) $(61,989) $(159,148) $(185,721)
          
 Net loss per share, basic and diluted $(1.01) $(1.04) $(2.63) $(3.73)
 Weighted-average common shares outstanding, basic and diluted  60,657,797   59,580,402   60,403,056   49,778,716 
          
          
(1) Amounts include stock-based compensation expense as follows:        
 Research and development $5,792  $7,391  $14,961  $22,078 
 General and administrative  10,410   4,563   17,591   15,232 
 Total stock-based compensation expense $16,202  $11,954  $32,552  $37,310 
          


IGM Biosciences, Inc.
Selected Balance Sheet Data
(unaudited)
(in thousands)
     
     
  September 30, December 31,
   2024   2023 
Cash and investments $218,787  $337,677 
Total assets  304,508   423,411 
Accounts payable  3,545   1,326 
Accrued liabilities  31,071   31,544 
Deferred revenue  144,534   146,801 
Total liabilities  225,561   220,177 
Accumulated deficit  (980,390)  (821,242)
Total stockholders' equity  78,947   203,234 
     

FAQ

What was IGM Biosciences (IGMS) net loss in Q3 2024?

IGM Biosciences reported a net loss of $61.4 million, or $1.01 per share, in Q3 2024.

When does IGMS expect initial clinical data for imvotamab?

IGM Biosciences expects to present initial clinical data for imvotamab by mid-2025.

What is IGMS's cash runway projection?

The company expects its current cash position to fund operations into 2027.

What are IGMS's expected operating expenses for 2024?

IGM Biosciences expects full year 2024 GAAP operating expenses of $215-225 million.

IGM Biosciences, Inc.

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