CAMBRIDGE, Mass., July 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, today announced that, on July 1, 2025, the company granted equity awards to one new employee, pursuant to the company’s 2025 Inducement Stock Incentive Plan, as an inducement material to such new employee’s entering into employment with the company in accordance with Nasdaq Listing Rule 5635(c)(4). The employ ...

Generation Bio (GBIO) 2025 Conference June 04, 2025 08:10 AM ET Speaker0 Good morning, everyone. I'm Farzin Hak, one of the biotech analysts at Jefferies. It's my pleasure to introduce Jeff McDonough, CEO of Generation Bio. He's going to talk about an exciting way to deliver siRNA to T cells for development of that approach for the treatment of autoimmune diseases. Welcome Jeff. Speaker1 Farzin, thank you and good morning everybody. It's really a pleasure to be here. Really appreciate the invitation to spea ...

Core Insights - Generation Bio Co. is focused on developing innovative therapeutics for T cell-driven autoimmune diseases [3] - The company will present at the Jefferies Global Healthcare Conference on June 4, 2025 [1] - A live webcast of the presentation will be available on the company's investor website [2] Company Overview - Generation Bio is developing redosable therapeutics that aim to reprogram T cells in vivo to combat autoimmune diseases [3] - The company utilizes cell-targeted lipid nanoparticles (ctLNP) for selective delivery of small interfering RNA (siRNA) to T cells [3] - This approach targets historically undruggable genes associated with autoimmune diseases, potentially unlocking new treatment avenues [3]

Financial Performance - For the three months ended March 31, 2025 and 2024, the company reported net losses of $14.8 million and $74.5 million, respectively, with an accumulated deficit of $717.8 million as of March 31, 2025[91]. - Net loss narrowed to $14.8 million in Q1 2025 compared to a net loss of $74.5 million in Q1 2024, reflecting an improvement of 80%[112]. - Collaboration revenue increased to $8.7 million for the three months ended March 31, 2025, up from $4.1 million in the same period of 2024, representing a growth of 115%[113]. - Total operating expenses decreased to $25.3 million in Q1 2025 from $81.7 million in Q1 2024, a reduction of 69%[112]. - General and administrative expenses decreased to $8.8 million in Q1 2025 from $10.4 million in Q1 2024, a decline of 15%[115]. - Research and development expenses rose to $15.4 million in Q1 2025, up from $14.3 million in Q1 2024, an increase of 7%[114]. - Net cash used in operating activities was $28.4 million in Q1 2025, compared to $31.7 million in Q1 2024, a decrease of 10.4%[120]. - Net cash provided by investing activities was $3.0 million in Q1 2025, primarily due to $45.0 million in maturities of marketable securities[124]. Future Expectations - The company expects to incur significant expenses and increasing operating losses for at least the next several years due to ongoing research programs, technology expansion, and clinical development[91]. - The company expects to announce the target and indication of its lead T cell-selective LNP-siRNA program for autoimmune disease by mid-year 2025[88]. - The company expects to submit its investigational new drug (IND) application for its lead program in the second half of 2026[88]. - The company believes its existing cash, cash equivalents, and marketable securities will fund operations into the second half of 2027[95]. - The company expects to fund its operating expenses into the second half of 2027 with existing cash and marketable securities[128]. - The company has not yet commercialized any product candidates and does not expect to generate revenue from sales for several years[118]. Collaboration and Revenue Generation - The collaboration with Moderna includes an upfront payment of $40.0 million and eligibility for up to $1.8 billion in milestone payments, along with tiered royalties on product sales[101]. - The company has not generated any revenue from product sales and expects future revenue primarily from the collaboration with Moderna[90]. Market and Financial Risks - The company may need to curtail or discontinue research or development programs if sufficient capital is not raised[129]. - Additional funds raised through collaborations or licensing may require relinquishing valuable rights to future revenue streams[129]. - The company is exposed to market risk related to changes in interest rates, primarily due to investments in short-term securities[133]. - A hypothetical increase in interest rates of 100 basis points would have resulted in a $0.4 million decrease in the fair value of the company's holdings[133]. - The company does not currently seek to hedge exposure to fluctuations in interest rates[133]. Accounting and Financial Management - There have been no material changes to the company's critical accounting policies and estimates from those disclosed in the 2024 Annual Report[132]. - The company evaluates its estimates and assumptions on an ongoing basis, which may differ from actual results under different conditions[132]. - The company incurs costs associated with acquisitions of in-licensed products and operating as a public company[131]. - There were no impairment charges recorded for marketable securities during the three months ended March 31, 2025[133]. - As of March 31, 2025, the company had marketable securities totaling $106.7 million[133].

Financial Performance - Cash balance as of March 31, 2025, was $157.6 million, down from $185.2 million as of December 31, 2024, expected to fund operations into the second half of 2027[6] - Net loss for Q1 2025 was $14.8 million, or $0.22 per share, compared to a net loss of $74.5 million, or $1.12 per share, in Q1 2024, indicating a substantial improvement[11] - Total operating expenses for Q1 2025 were $25.3 million, down from $81.7 million in Q1 2024, a decrease of 69.0%[16] - Loss on lease termination was $1.1 million in Q1 2025, significantly lower than $56.9 million in Q1 2024[11] Revenue and Expenses - Research and development (R&D) expenses for Q1 2025 were $15.4 million, compared to $14.3 million in Q1 2024, reflecting a year-over-year increase of 7.7%[7] - General and administrative (G&A) expenses decreased to $8.8 million in Q1 2025 from $10.4 million in Q1 2024, a reduction of 15.4%[7] - Collaboration revenue for Q1 2025 was $8.7 million, significantly higher than $4.1 million in Q1 2024, representing a 114.6% increase[16] Assets and Future Plans - Total assets as of March 31, 2025, were $201.3 million, down from $231.2 million as of December 31, 2024[14] - The company plans to announce the target and portfolio strategy for its lead ctLNP-siRNA program in mid-2025[4] - Generation Bio is focused on developing first-in-class treatments for T cell-driven autoimmune diseases using its innovative ctLNP technology[6]

Core Insights - Generation Bio Co. is focused on developing innovative treatments for T cell-driven autoimmune diseases using a novel cell-targeted lipid nanoparticle (ctLNP) delivery system for siRNA [2][4] Business Highlights - The company aims to address limitations in current treatments for autoimmune diseases by targeting T cell pathology, with plans to announce its lead ctLNP-siRNA program strategy in mid-2025 [2][7] Financial Results - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities of $157.6 million, down from $185.2 million as of December 31, 2024 [8][11] - Research and development expenses for Q1 2025 were $15.4 million, compared to $14.3 million in Q1 2024 [8][13] - General and administrative expenses decreased to $8.8 million in Q1 2025 from $10.4 million in Q1 2024 [8][14] - The net loss for Q1 2025 was $14.8 million, or $0.22 per share, significantly improved from a net loss of $74.5 million, or $1.12 per share, in Q1 2024 [8][14]

Company Overview - Generation Bio is a biotechnology company focused on developing therapeutics for T cell-driven autoimmune diseases [3] - The company aims to reprogram T cells in vivo to reduce or eliminate autoreactive T cells that attack the body's own tissues [3] - Generation Bio utilizes cell-targeted lipid nanoparticles (ctLNP) for selective delivery of small interfering RNA (siRNA) to T cells, potentially addressing previously undruggable genes in autoimmunity [3] Upcoming Events - Geoff McDonough, M.D., the president and CEO of Generation Bio, will participate in a fireside chat at the 24th Annual Needham Virtual Healthcare Conference on April 9th at 12:45 p.m. ET [1] - A live webcast of the presentation will be available on the investor section of the company's website, with a replay accessible for 30 days post-event [2]

Group 1 - Generation Bio Co. reported a quarterly loss of $0.32 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.28, and an improvement from a loss of $0.53 per share a year ago, indicating an earnings surprise of -14.29% [1] - The company posted revenues of $4.19 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 6.95%, and showing an increase from year-ago revenues of $2.88 million [2] - Generation Bio shares have declined approximately 50.5% since the beginning of the year, contrasting with the S&P 500's decline of -4.8% [3] Group 2 - The earnings outlook for Generation Bio is mixed, with the current consensus EPS estimate for the coming quarter at -$0.28 on revenues of $0.86 million, and for the current fiscal year at -$0.95 on revenues of $9.52 million [7] - The Medical - Biomedical and Genetics industry, to which Generation Bio belongs, is currently ranked in the top 26% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Financial Performance - Generation Bio reported a cash balance of $185.2 million as of December 31, 2024, down from $264.4 million as of December 31, 2023, expected to fund operations into the second half of 2027[5][11]. - The net loss for Q4 2024 was $21.4 million, or $0.32 per share, compared to a net loss of $35.2 million, or $0.53 per share, in Q4 2023[6][12]. - The total operating expenses for the year ended December 31, 2024, were $162.3 million, an increase from $144.5 million in 2023[6][12]. - A non-cash charge of $3.6 million was recognized in Q4 2024 related to the termination of the lease for the manufacturing facility, totaling $63.2 million for the year[6][12]. - Total assets decreased to $231.2 million as of December 31, 2024, from $374.8 million as of December 31, 2023[11]. Research and Development - Research and development (R&D) expenses for Q4 2024 were $15.5 million, a decrease from $27.9 million in Q4 2023, while total R&D expenses for the year were $61.3 million compared to $93.6 million in 2023[6][12]. - Generation Bio achieved approximately 98% knockdown of the B2M protein in human T cells using its T cell-selective lipid nanoparticle (LNP) in both in vitro and mouse studies[4]. - The company plans to announce the target and indication for its lead ctLNP-siRNA program in mid-2025 and submit an investigational new drug (IND) application in the second half of 2026[4][5]. General and Administrative Expenses - General and administrative (G&A) expenses for Q4 2024 were $8.7 million, down from $13.4 million in Q4 2023, with total G&A expenses for the year at $37.8 million compared to $50.9 million in 2023[6][12]. Collaboration Revenue - Collaboration revenue for Q4 2024 was $4.2 million, compared to $2.9 million in Q4 2023, with total collaboration revenue for the year at $19.9 million versus $5.9 million in 2023[6][12].

Core Insights - Generation Bio is developing T cell-selective lipid nanoparticles (LNP) for siRNA therapeutics targeting T cell-driven autoimmune diseases, with a lead target and indication expected to be announced by mid-2025 [1][3][4] - The company reported a cash balance of $185.2 million as of December 31, 2024, which is projected to fund operations into the second half of 2027 [4][5] Business Highlights - The T cell-selective LNP is designed to deliver siRNA specifically to T cells, achieving approximately 98% knockdown of the B2M protein in human T cells in studies [2][3] - This innovative approach aims to selectively modulate T cell activity involved in autoimmune diseases while minimizing off-target effects on the broader immune system [2][3] - Generation Bio plans to submit an investigational new drug (IND) application in the second half of 2026 [3] Financial Results - Cash, cash equivalents, and marketable securities decreased from $264.4 million in 2023 to $185.2 million in 2024 [4][9] - Research and development (R&D) expenses for Q4 2024 were $15.5 million, down from $27.9 million in Q4 2023, while total R&D expenses for the year were $61.3 million compared to $93.6 million in 2023 [4][11] - General and administrative (G&A) expenses for Q4 2024 were $8.7 million, down from $13.4 million in Q4 2023, with total G&A expenses for the year at $37.8 million compared to $50.9 million in 2023 [4][11] - The net loss for Q4 2024 was $21.4 million, or $0.32 per share, compared to a net loss of $35.2 million, or $0.53 per share, in Q4 2023 [5][11]