Generation Bio Reports Recent Business Highlights and Third Quarter 2024 Financial Results
Generation Bio (GBIO) reported its Q3 2024 financial results and business highlights. The company presented data at ESGCT showing successful selective in vivo delivery of mRNA to T cells in non-human primates using their cell-targeted lipid nanoparticle platform. Financial highlights include a cash position of $199.8 million, expected to fund operations into 2H 2027. Q3 2024 showed reduced losses with net loss of $15.3 million ($0.23 per share) compared to $28.3 million ($0.43 per share) in Q3 2023. R&D expenses decreased to $15.1 million from $21.9 million, and G&A expenses reduced to $9.2 million from $11.6 million year-over-year.
Generation Bio (GBIO) ha riportato i risultati finanziari e i punti salienti aziendali per il terzo trimestre del 2024. L'azienda ha presentato dati all'ESGCT che mostrano una consegna selettiva in vivo di mRNA alle cellule T in primati non umani utilizzando la loro piattaforma di nanoparticelle lipidiche mirate alle cellule. Tra i principali risultati finanziari, si evidenzia una posizione di cassa di 199,8 milioni di dollari, che dovrebbe finanziare le operazioni fino alla seconda metà del 2027. Il terzo trimestre del 2024 ha mostrato perdite ridotte, con una perdita netta di 15,3 milioni di dollari (0,23 dollari per azione) rispetto ai 28,3 milioni di dollari (0,43 dollari per azione) nel terzo trimestre del 2023. Le spese per ricerca e sviluppo sono diminuite a 15,1 milioni di dollari rispetto ai 21,9 milioni di dollari, e le spese generali e amministrative sono scese a 9,2 milioni di dollari rispetto agli 11,6 milioni di dollari rispetto all'anno precedente.
Generation Bio (GBIO) informó sus resultados financieros y aspectos destacados del negocio para el tercer trimestre de 2024. La compañía presentó datos en el ESGCT que muestran una entrega selectiva in vivo de ARNm a células T en primates no humanos utilizando su plataforma de nanopartículas lipídicas dirigidas a células. Los aspectos financieros destacados incluyen una posición de efectivo de 199,8 millones de dólares, que se espera financie las operaciones hasta la segunda mitad de 2027. El tercer trimestre de 2024 mostró pérdidas reducidas con una pérdida neta de 15,3 millones de dólares (0,23 dólares por acción) en comparación con 28,3 millones de dólares (0,43 dólares por acción) en el tercer trimestre de 2023. Los gastos de I+D disminuyeron a 15,1 millones de dólares desde 21,9 millones de dólares, y los gastos generales y administrativos se redujeron a 9,2 millones de dólares desde 11,6 millones de dólares año tras año.
Generation Bio (GBIO)는 2024년 3분기 재무 결과와 비즈니스 주요 사항을 보고했습니다. 이 회사는 ESGCT에서 비인간 영장류에서 T 세포에 대한 mRNA의 선택적 생체 내 전달의 성공적인 데이터를 발표했습니다. 재무 주요 사항으로는 현금 보유액이 1억 9,980만 달러로, 2027년 하반기까지 운용 자금으로 활용될 것으로 예상됩니다. 2024년 3분기에는 순손실 1,530만 달러 ($0.23 주당)로 손실이 줄어들었으며, 2023년 3분기에는 2,830만 달러 ($0.43 주당)였습니다. 연구개발 비용은 2,190만 달러에서 1,510만 달러로 감소하였고, 관리 및 일반 비용은 1,160만 달러에서 920만 달러로 감소했습니다.
Generation Bio (GBIO) a annoncé ses résultats financiers et ses points saillants pour le troisième trimestre de 2024. L'entreprise a présenté des données lors de l'ESGCT montrant une livraison sélective in vivo d'ARNm aux cellules T chez des primates non humains à l'aide de leur plateforme de nanoparticules lipidiques ciblées. Les points financiers saillants comprennent une position de trésorerie de 199,8 millions de dollars, qui devrait financer les opérations jusqu'au second semestre 2027. Le troisième trimestre 2024 a montré des pertes réduites avec une perte nette de 15,3 millions de dollars (0,23 dollars par action) par rapport à 28,3 millions de dollars (0,43 dollars par action) au troisième trimestre 2023. Les dépenses de R&D ont diminué à 15,1 millions de dollars contre 21,9 millions de dollars, et les dépenses générales et administratives ont été réduites à 9,2 millions de dollars contre 11,6 millions de dollars d'une année sur l'autre.
Generation Bio (GBIO) hat seine finanziellen Ergebnisse und wichtigen Geschäftspunkte für das dritte Quartal 2024 veröffentlicht. Das Unternehmen präsentierte Daten auf dem ESGCT, die eine erfolgreiche selektive In-vivo-Abgabe von mRNA an T-Zellen bei nichtmenschlichen Primaten mithilfe ihrer zellgerichteten Lipid-Nanopartikel-Plattform zeigen. Zu den finanziellen Höhepunkten gehört eine Liquiditätsposition von 199,8 Millionen US-Dollar, die voraussichtlich die Geschäfte bis zur zweiten Hälfte von 2027 finanzieren wird. Im dritten Quartal 2024 wurden die Verluste reduziert mit einem Nettoverlust von 15,3 Millionen US-Dollar (0,23 USD pro Aktie) im Vergleich zu 28,3 Millionen US-Dollar (0,43 USD pro Aktie) im dritten Quartal 2023. Die F&E-Ausgaben gingen auf 15,1 Millionen US-Dollar von 21,9 Millionen US-Dollar zurück, und die allgemeinen und administrativen Ausgaben reduzierten sich auf 9,2 Millionen US-Dollar von 11,6 Millionen US-Dollar im Jahresvergleich.
- Net loss improved significantly to $15.3M from $28.3M YoY
- Operating expenses decreased with R&D down to $15.1M from $21.9M
- Strong cash position of $199.8M providing runway into 2H 2027
- Successful preclinical results in non-human primate studies
- Cash position decreased from $264.4M to $199.8M since December 2023
- Continued quarterly net losses of $15.3M
Insights
Generation Bio's Q3 results show significant financial discipline with a
The successful demonstration of selective mRNA delivery to T cells in non-human primates marks a important technical milestone. The ctLNP platform showed impressive targeting efficiency, transducing a majority of circulating T cells with balanced distribution across CD4+ and CD8+ populations. Most notably, the minimal off-target distribution to LNP clearance tissues suggests a favorable safety profile. This advancement in T cell-targeting technology could be particularly valuable for treating autoimmune diseases, where precise immune cell modification is essential. The validation through the Moderna collaboration adds credibility to the platform's potential. However, significant work remains to translate these preclinical findings into human applications.
- Non-human primate data presented at ESGCT demonstrated selective in vivo delivery of mRNA with T cell-targeted lipid nanoparticle (ctLNP)
- Cash balance of
$199.8 million expected to fund operations into 2H 2027
CAMBRIDGE, Mass., Nov. 06, 2024 (GLOBE NEWSWIRE) -- Generation Bio Co. (Nasdaq:GBIO), a biotechnology company innovating genetic medicines for people living with rare and prevalent diseases, reported business highlights and third quarter 2024 financial results.
“There is immense potential for a new class of redosable, selectively targeted in vivo genetic medicines to fulfill the needs of people living with diseases that remain unaddressed by existing treatment options,” said Geoff McDonough, chief executive officer of Generation Bio. “Our cell-targeted lipid nanoparticle (ctLNP) platform has recently demonstrated highly selective in vivo delivery of mRNA to T cells in non-human primates (NHPs), a key milestone on the path to developing in vivo programs for T cell-mediated autoimmune diseases.”
Generation Bio recently presented data at the European Society of Gene and Cell Therapy (ESGCT) 31st Annual Congress from an NHP study showing that a single IV dose of a ctLNP delivering mRNA selectively to T cells transduced most circulating T cells with balanced distribution to CD4+ and CD8+ cells. These data confirm and improve on the potency and biodistribution profiles seen in previous murine and NHP studies, which have shown minimal off-target distribution to LNP clearance tissues. The NHP study was conducted as part of the company’s collaboration with Moderna, Inc.
Third Quarter 2024 Financial Results
- Cash Position: Cash, cash equivalents, and marketable securities were
$199.8 million as of September 30, 2024, compared to$264.4 million in cash, cash equivalents, and marketable securities as of December 31, 2023. The company continues to believe that its cash, cash equivalents, and marketable securities will fund its operating expenses and capital expenditures into the second half of 2027. - R&D Expenses: Research and development (R&D) expenses were
$15.1 million for the quarter ended September 30, 2024, compared to$21.9 million for the quarter ended September 30, 2023. - G&A Expenses: General and administrative (G&A) expenses were
$9.2 million for the quarter ended September 30, 2024, compared to$11.6 million for the quarter ended September 30, 2023. - Net Loss: Net loss was
$15.3 million , or$0.23 b asic and diluted net loss per share, for the quarter ended September 30, 2024, compared to a net loss of$28.3 million , or$0.43 b asic and diluted net loss per share, for the quarter ended September 30, 2023.
About Generation Bio
Generation Bio is innovating non-viral genetic medicines to provide durable and redosable treatments for hundreds of millions of patients living with rare and prevalent diseases. The company is developing two distinct and complementary platforms: a potent, highly selective cell-targeted lipid nanoparticle (ctLNP) delivery system and a novel immune-quiet DNA (iqDNA) cargo produced by a scalable capsid-free manufacturing process that uses proprietary cell-free rapid enzymatic synthesis (RES). With these platforms, Generation Bio aims to develop the next wave of non-viral genetic medicines to support its mission to extend the reach of genetic medicine to more people living with more diseases, around the world.
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, technology platforms, 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 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 the company’s novel platforms and related technologies; whether results from preclinical studies will be predictive of the results of later preclinical studies and clinical trials; challenges in the manufacture of genetic medicine products; 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 and quarterly report on Form 10-Q, which are 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 | September 30, 2024 | December 31, 2023 | |||||||||
| Cash, cash equivalents and marketable securities | $ | 199,812 | $ | 264,364 | |||||||
| Working capital | 161,089 | 232,704 | |||||||||
| Total assets | 248,784 | 374,758 | |||||||||
| Total stockholders’ equity | 104,442 | 203,128 | |||||||||
| GENERATION BIO CO. CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except share and per share data) | |||||||||||
| Three Months Ended September 30, | |||||||||||
| 2024 | 2023 | ||||||||||
| Revenues: | |||||||||||
| Collaboration Revenue | $ | 7,554 | $ | 2,146 | |||||||
| Operating expenses: | |||||||||||
| Research and development | 15,088 | 21,862 | |||||||||
| General and administrative | 9,181 | 11,641 | |||||||||
| Loss on lease termination | 1,169 | — | |||||||||
| Total operating expenses | 25,438 | 33,503 | |||||||||
| Loss from operations | (17,884 | ) | (31,357 | ) | |||||||
| Other income: | |||||||||||
| Other income and interest income, net | 2,571 | 3,091 | |||||||||
| Net loss | $ | (15,313 | ) | $ | (28,266 | ) | |||||
| Net loss per share, basic and diluted | $ | (0.23 | ) | $ | (0.43 | ) | |||||
| Weighted average common shares outstanding, basic and diluted | 66,738,468 | 65,907,000 | |||||||||
| Comprehensive loss: | |||||||||||
| Net loss | $ | (15,313 | ) | $ | (28,266 | ) | |||||
| Other comprehensive loss: | |||||||||||
| Unrealized gains on marketable securities | 599 | 19 | |||||||||
| Comprehensive loss | $ | (14,714 | ) | $ | (28,247 | ) | |||||
FAQ
What was Generation Bio's (GBIO) net loss in Q3 2024?
How long will GBIO's current cash position last?
What were the key findings from GBIO's non-human primate study presented at ESGCT?
