Generation Bio Reports Recent Business Highlights and First Quarter 2025 Financial Results
Generation Bio (GBIO) reported its Q1 2025 financial results and business updates. The company is developing first-in-class treatments for T cell-driven autoimmune diseases using its cell-targeted lipid nanoparticle (ctLNP) technology to deliver siRNA. The company plans to announce its lead target and portfolio strategy in mid-2025.
Financial highlights include a cash position of $157.6 million as of March 31, 2025, expected to fund operations into 2H 2027. Q1 2025 results showed R&D expenses of $15.4 million (up from $14.3M in Q1 2024), G&A expenses of $8.8 million (down from $10.4M), and a net loss of $14.8 million ($0.22 per share), significantly improved from a $74.5 million loss ($1.12 per share) in Q1 2024.
Generation Bio (GBIO) ha riportato i risultati finanziari e gli aggiornamenti aziendali del primo trimestre 2025. L'azienda sta sviluppando trattamenti innovativi per malattie autoimmuni guidate dalle cellule T utilizzando la sua tecnologia di nanoparticelle lipidiche mirate alle cellule (ctLNP) per la somministrazione di siRNA. La società prevede di annunciare il suo obiettivo principale e la strategia del portafoglio a metà del 2025.
I punti salienti finanziari includono una posizione di cassa di 157,6 milioni di dollari al 31 marzo 2025, che dovrebbe coprire le operazioni fino alla seconda metà del 2027. I risultati del primo trimestre 2025 mostrano spese di R&S di 15,4 milioni di dollari (in aumento rispetto a 14,3 milioni nel primo trimestre 2024), spese generali e amministrative di 8,8 milioni di dollari (in diminuzione rispetto a 10,4 milioni) e una perdita netta di 14,8 milioni di dollari (0,22 dollari per azione), migliorata significativamente rispetto alla perdita di 74,5 milioni (1,12 dollari per azione) nel primo trimestre 2024.
Generation Bio (GBIO) informó sus resultados financieros y actualizaciones comerciales del primer trimestre de 2025. La compañía está desarrollando tratamientos innovadores para enfermedades autoinmunes impulsadas por células T utilizando su tecnología de nanopartículas lipídicas dirigidas a células (ctLNP) para la entrega de siRNA. La empresa planea anunciar su objetivo principal y estrategia de cartera a mediados de 2025.
Los aspectos financieros destacados incluyen una posición de efectivo de 157,6 millones de dólares al 31 de marzo de 2025, que se espera financie las operaciones hasta la segunda mitad de 2027. Los resultados del primer trimestre de 2025 mostraron gastos de I+D de 15,4 millones de dólares (aumentando desde 14,3 millones en el primer trimestre de 2024), gastos administrativos y generales de 8,8 millones de dólares (disminuyendo desde 10,4 millones) y una pérdida neta de 14,8 millones de dólares (0,22 dólares por acción), mejorando significativamente desde una pérdida de 74,5 millones (1,12 dólares por acción) en el primer trimestre de 2024.
Generation Bio(GBIO)는 2025년 1분기 재무 실적 및 사업 업데이트를 발표했습니다. 회사는 세포 표적 지질 나노입자(ctLNP) 기술을 이용해 siRNA를 전달하는 T 세포 주도 자가면역 질환에 대한 혁신적인 치료제를 개발 중입니다. 주요 타깃과 포트폴리오 전략은 2025년 중반에 발표할 계획입니다.
재무 하이라이트로는 2025년 3월 31일 기준 1억 5,760만 달러의 현금 보유가 있으며, 이는 2027년 하반기까지 운영 자금을 지원할 것으로 예상됩니다. 2025년 1분기 실적은 연구개발비 1,540만 달러(2024년 1분기 1,430만 달러 대비 증가), 일반관리비 880만 달러(10,400만 달러에서 감소), 순손실 1,480만 달러(주당 0.22달러)로, 2024년 1분기 7,450만 달러(주당 1.12달러) 손실에 비해 크게 개선되었습니다.
Generation Bio (GBIO) a publié ses résultats financiers et mises à jour commerciales du premier trimestre 2025. La société développe des traitements innovants pour les maladies auto-immunes à médiation par les cellules T en utilisant sa technologie de nanoparticules lipidiques ciblant les cellules (ctLNP) pour la délivrance de siRNA. L'entreprise prévoit d'annoncer sa cible principale et sa stratégie de portefeuille à la mi-2025.
Les faits marquants financiers incluent une trésorerie de 157,6 millions de dollars au 31 mars 2025, censée financer les opérations jusqu'à la seconde moitié de 2027. Les résultats du premier trimestre 2025 montrent des dépenses en R&D de 15,4 millions de dollars (en hausse par rapport à 14,3 millions au T1 2024), des frais généraux et administratifs de 8,8 millions de dollars (en baisse par rapport à 10,4 millions) et une perte nette de 14,8 millions de dollars (0,22 dollar par action), une nette amélioration par rapport à la perte de 74,5 millions (1,12 dollar par action) au premier trimestre 2024.
Generation Bio (GBIO) veröffentlichte seine Finanzergebnisse und Geschäftsupdates für das erste Quartal 2025. Das Unternehmen entwickelt erstklassige Behandlungen für T-Zell-gesteuerte Autoimmunerkrankungen mithilfe seiner zellzielgerichteten Lipid-Nanopartikel (ctLNP)-Technologie zur siRNA-Lieferung. Das Unternehmen plant, Mitte 2025 sein Hauptziel und die Portfoliostrategie bekannt zu geben.
Finanzielle Höhepunkte umfassen eine Barmittelposition von 157,6 Millionen US-Dollar zum 31. März 2025, die voraussichtlich den Betrieb bis zur zweiten Hälfte 2027 finanzieren wird. Die Ergebnisse des ersten Quartals 2025 zeigten F&E-Ausgaben von 15,4 Millionen US-Dollar (gegenüber 14,3 Mio. im ersten Quartal 2024), Verwaltungs- und Allgemeinkosten von 8,8 Millionen US-Dollar (gegenüber 10,4 Mio. gesunken) und einen Nettoverlust von 14,8 Millionen US-Dollar (0,22 US-Dollar pro Aktie), was eine deutliche Verbesserung gegenüber dem Verlust von 74,5 Millionen US-Dollar (1,12 US-Dollar pro Aktie) im ersten Quartal 2024 darstellt.
- Cash runway extended into second half of 2027 with $157.6M in cash and equivalents
- Significant reduction in net loss to $14.8M from $74.5M year-over-year
- Decreased G&A expenses by 15.4% to $8.8M compared to Q1 2024
- Non-cash lease termination charge reduced substantially to $1.1M from $56.9M year-over-year
- Cash position decreased from $185.2M in December 2024 to $157.6M
- R&D expenses increased 7.7% to $15.4M compared to Q1 2024
- Lead target and portfolio strategy still pending announcement
- Continuing to operate at a loss ($14.8M net loss in Q1)
Insights
Generation Bio maintains $157.6M cash runway into 2H 2027, continues developing T cell-targeted autoimmune treatments with specific targets coming mid-2025.
Generation Bio's Q1 2025 results showcase a pre-clinical stage biotech with a healthy financial position. The $157.6M cash balance represents a $27.6M decrease from year-end 2024 ($185.2M), though the company notes this quarter included seasonal and non-recurring payments. This cash position is expected to fund operations into second half of 2027 - providing approximately 2+ years of runway, which is respectable for an early-stage biotech company.
The quarterly net loss of $14.8M (
The company's technology platform - cell-targeted lipid nanoparticles (ctLNP) delivering siRNA - aims to precisely modulate T cells involved in autoimmune diseases, potentially addressing previously "undruggable" intracellular targets. This approach could create differentiated treatments for conditions where T cells drive pathology, though specific disease targets remain undisclosed with announcements expected mid-2025.
Without specific disease targets or clinical data yet available, Generation Bio remains in early development stages. The consistent R&D investment demonstrates commitment to their technology platform, while the extended cash runway provides time to reach key developmental milestones without immediate financing pressure. This reflects steady execution of their stated strategy without significant deviations or surprises.
- Company continues to advance its strategy to develop first-in-class treatments for T cell-driven autoimmune diseases using its cell-targeted lipid nanoparticle (ctLNP) technology to deliver siRNA
- Lead target and portfolio strategy to be announced mid-2025
- Cash balance of
CAMBRIDGE, MASS., May 07, 2025 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq: GBIO), a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases, reported business highlights and first quarter 2025 financial results.
"Our selective, redosable cell-targeted lipid nanoparticle (ctLNP) delivery system enables precise modulation of T cells with siRNA, opening mechanisms that can powerfully reduce or eliminate autoreactive T cell activity while supporting immune balance,” said Geoffrey McDonough, M.D., chief executive officer of Generation Bio. “This innovative approach could allow us to address undruggable intracellular T cell targets, paving the way for first-in-class treatments that could meaningfully enhance the standard of care for T cell-driven autoimmune diseases.”
Generation Bio plans to develop its novel siRNA therapeutics for autoimmune diseases in indications where there is a prominent role of T cell pathology in disease progression and where current treatments have limitations in efficacy, safety, and patient experience. The company plans to announce the target and portfolio strategy for its lead ctLNP-siRNA program in mid-2025.
First Quarter 2025 Financial Results
- Cash Position: Cash, cash equivalents, and marketable securities were
$157.6 million as of March 31, 2025, compared to$185.2 million in cash, cash equivalents, and marketable securities as of December 31, 2024. Cash disbursements for the three months ended March 31, 2025 included seasonal and non-recurring payments. The company continues to believe that its cash, cash equivalents, and marketable securities will fund its operating expenditures and capital expenditure requirements into the second half of 2027. - R&D Expenses: Research and development (R&D) expenses were
$15.4 million for the quarter ended March 31, 2025, compared to$14.3 million for the quarter ended March 31, 2024. - G&A Expenses: General and administrative (G&A) expenses were
$8.8 million for the quarter ended March 31, 2025, compared to$10.4 million for the quarter ended March 31, 2024. - Loss on Lease Termination: Loss on lease termination was
$1.1 million non-cash charge for the quarter end March 31, 2025, compared to loss on lease termination of$56.9 million non-cash charge for the quarter end March 31, 2024. - Net Loss: Net loss was
$14.8 million , or$0.22 b asic and diluted net loss per share, for the quarter ended March 31, 2025, compared to a net loss of$74.5 million , or$1.12 b asic and diluted net loss per share, for the quarter ended March 31, 2024.
About Generation Bio
Generation Bio is a biotechnology company working to change what’s possible for people living with T cell-driven autoimmune diseases. The company is developing redosable therapeutics that reprogram T cells in vivo to reduce or eliminate the production and persistence of autoreactive T cells, which erroneously recognize and attack the body’s own tissues, causing autoimmune diseases. Generation Bio’s innovative approach leverages cell-targeted lipid nanoparticles (ctLNP) to selectively deliver small interfering RNA (siRNA) to T cells. This combination of selective delivery and an intracellular, genetically precise mechanism of target engagement could unlock a series of high-value, historically undruggable disease-driving genes in autoimmunity.
For more information, please visit www.generationbio.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for the company, including statements about the company’s strategic plans or objectives, cash resources, technologies, research and clinical development plans, and preclinical data, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the identification and development of product candidates, including the anticipated timing of identifying the company’s lead programs, the conduct of research activities, the initiation and completion of preclinical studies and clinical trials and clinical development of the company’s product candidates; uncertainties as to the availability and timing of results from preclinical studies and clinical trials; uncertainties regarding our novel technologies; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; whether the company’s cash resources are sufficient to fund the company’s operating expenses and capital expenditure requirements for the period anticipated; as well as the other risks and uncertainties set forth in the “Risk Factors” section of the company’s most recent annual report on Form 10-K, which is on file with the Securities and Exchange Commission, and in subsequent filings the company may make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the company’s views as of the date hereof. The company anticipates that subsequent events and developments will cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, the company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date on which they were made.
Investors and Media Contact
Maren Killackey
Generation Bio
mkillackey@generationbio.com
857-371-4638
| GENERATION BIO CO. CONSOLIDATED BALANCE SHEET DATA (Unaudited) (In thousands) | ||||||
| Earnings Release Balance Sheet | March 31, 2025 | December 31, 2024 | ||||
| Cash, cash equivalents and marketable securities | $ | 157,559 | $ | 185,223 | ||
| Working capital | 145,522 | 157,848 | ||||
| Total assets | 201,348 | 231,197 | ||||
| Total stockholders’ equity | 73,332 | 86,204 | ||||
| GENERATION BIO CO. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except share and per share data) | ||||||||
| Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenues: | ||||||||
| Collaboration revenue | $ | 8,723 | $ | 4,059 | ||||
| Operating expenses: | ||||||||
| Research and development | 15,357 | 14,335 | ||||||
| General and administrative | 8,834 | 10,428 | ||||||
| Loss on lease termination | 1,138 | 56,930 | ||||||
| Total operating expenses | 25,329 | 81,693 | ||||||
| Loss from operations | (16,606 | ) | (77,634 | ) | ||||
| Other income: | ||||||||
| Other income and interest income, net | 1,804 | 3,093 | ||||||
| Net loss | $ | (14,802 | ) | $ | (74,541 | ) | ||
| Net loss per share, basic and diluted | $ | (0.22 | ) | $ | (1.12 | ) | ||
| Weighted average common shares outstanding, basic and diluted | 67,002,511 | 66,433,640 | ||||||
| Comprehensive loss: | ||||||||
| Net loss | $ | (14,802 | ) | $ | (74,541 | ) | ||
| Other comprehensive loss: | ||||||||
| Unrealized losses on marketable securities | (74 | ) | (471 | ) | ||||
| Comprehensive loss | $ | (14,876 | ) | $ | (75,012 | ) | ||
FAQ
What is Generation Bio's (GBIO) cash runway as of Q1 2025?
How did GBIO's Q1 2025 net loss compare to Q1 2024?
What is Generation Bio's main therapeutic focus?
When will GBIO announce its lead target and portfolio strategy?
How much did Generation Bio spend on R&D in Q1 2025?
