Generation Bio(GBIO)

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Generation Bio Co. (GBIO) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2025-08-12 22:31
Generation Bio Co. (GBIO) came out with a quarterly loss of $3.12 per share versus the Zacks Consensus Estimate of a loss of $2.8. This compares to a loss of $3.1 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -11.43%. A quarter ago, it was expected that this company would post a loss of $2.5 per share when it actually produced a loss of $2.2, delivering a surprise of +12%.Over the last four quarters, the company has surpasse ...
Generation Bio(GBIO) - 2025 Q2 - Quarterly Report
2025-08-12 20:15
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR For the transition period from to Commission File Number: 001-39319 GENERATION BIO CO. (Exact name of registrant as specified in its charter) Delaware 81-4301284 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification Number) 301 Binne ...
Generation Bio(GBIO) - 2025 Q2 - Quarterly Results
2025-08-12 20:10
Generation Bio Announces New Data for Its Novel ctLNP Delivery System and Early T Cell Programs and Reports Second Quarter 2025 Financial Results CAMBRIDGE, MASS., August 12, 2025 -- 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 new data demonstrating that its cell-targeted lipid nanoparticle (ctLNP) system selectively delivered siRNA to T cells in non-human primates, reinforcing the comp ...
Generation Bio Announces 1-for-10 Reverse Stock Split
GlobeNewswire· 2025-07-18 12:35
Core Viewpoint - Generation Bio Co. announced a 1-for-10 reverse stock split to increase the per-share market price and regain compliance with Nasdaq listing requirements [1][3]. Group 1: Reverse Stock Split Details - The reverse stock split will be effective at 5:00 pm Eastern Time on July 21, 2025, and trading on a split-adjusted basis will begin on July 22, 2025 [1][2]. - The number of issued and outstanding shares will decrease from approximately 67.3 million to approximately 6.7 million [3]. - No fractional shares will be issued; instead, stockholders will receive cash payments for any fractional shares [4]. Group 2: Company Background - Generation Bio is focused on developing therapeutics for T cell-driven autoimmune diseases using cell-targeted lipid nanoparticles to deliver small interfering RNA to T cells [7]. - The company's innovative approach aims to address historically undruggable disease-driving genes in autoimmunity [7].
Generation Bio Announces Inducement Grant under Nasdaq Listing Rule 5635(c)(4)
Globenewswire· 2025-07-07 20:05
Company Overview - Generation Bio is a biotechnology company focused on developing therapeutics for T cell-driven autoimmune diseases [3] - The company aims to create redosable therapeutics that reprogram T cells in vivo to reduce or eliminate autoreactive T cells, which attack the body's own tissues [3] - Generation Bio utilizes cell-targeted lipid nanoparticles (ctLNP) to deliver small interfering RNA (siRNA) selectively to T cells, potentially addressing previously undruggable disease-driving genes in autoimmunity [3] Recent Developments - On July 1, 2025, Generation Bio granted equity awards to a new employee as part of its 2025 Inducement Stock Incentive Plan [1] - The employee received non-statutory stock options to purchase 128,600 shares of common stock at an exercise price of $0.32 per share, equal to the closing price on the grant date [2] - The options have a 10-year term and will vest over four years, with 25% vesting on the first anniversary and 6.25% vesting quarterly thereafter, contingent on the employee's continued service [2]
Generation Bio (GBIO) 2025 Conference Transcript
2025-06-04 13:10
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 ...
Generation Bio to Present at the 2025 Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 10:59
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]
Generation Bio(GBIO) - 2025 Q1 - Quarterly Report
2025-05-07 20:15
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].
Generation Bio(GBIO) - 2025 Q1 - Quarterly Results
2025-05-07 20:10
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]
Generation Bio Reports Recent Business Highlights and First Quarter 2025 Financial Results
Globenewswire· 2025-05-07 20:05
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]