Announcement • Feb 10
Generation Bio Co.(NasdaqGS:GBIO) dropped from NASDAQ Composite Index Generation Bio Co. has been removed from NASDAQ Composite Index . Announcement • Dec 16
XOMA Royalty Corporation (NasdaqGM:XOMA) entered into an agreement to acquire Generation Bio Co. (NasdaqGS:GBIO) for $28.92 million. XOMA Royalty Corporation (NasdaqGM:XOMA) entered into an agreement to acquire Generation Bio Co. (NasdaqGS:GBIO) for $28.92 million on December 15, 2025. A cash consideration of $28.92 million valued at $4.2913 per share will be paid by XOMA Royalty Corporation. As part of consideration, $28.92 million is paid towards common equity of Generation Bio Co and one contingent value right per Company Share, which represents the right to receive certain payments in cash in accordance with the terms and subject to the conditions of a contingent value rights agreement to be entered into by the XOMA with Broadridge Corporate Issuer Solutions, LLC. In case of termination of transaction, Generation Bio will pay a termination fee of $0.84 million.
The transaction is subject to approval of merger agreement by target board. The deal has been unanimously approved by the board. The expected completion of the transaction is February 2026, subject to the satisfaction of customary closing conditions.
Gibson, Dunn & Crutcher LLP acted as legal advisor to XOMA Royalty. TD Cowen acted served as financial advisor and provided fairness opinion, and Wilmer Cutler Pickering Hale and Dorr LLP served as legal counsel, to Generation Bio. The Depository Trust Company acted as depository bank to Generation Bio. Board Change • Nov 12
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 11 experienced directors. 1 highly experienced director. Independent Director Ron Cooper was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Jul 18
Price target increased by 7.7% to US$7.00 Up from US$6.50, the current price target is an average from 4 analysts. New target price is 1,623% above last closing price of US$0.41. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$1.25 next year compared to a net loss per share of US$1.98 last year. Major Estimate Revision • May 14
Consensus revenue estimates increase by 163%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$5.68m to US$14.9m. EPS estimate fell from -US$1.02 to -US$1.10 per share. Biotechs industry in the US expected to see average net income decline 13% next year. Consensus price target down from US$6.75 to US$6.50. Share price was steady at US$0.38 over the past week. Reported Earnings • May 09
First quarter 2025 earnings: EPS and revenues exceed analyst expectations First quarter 2025 results: US$0.22 loss per share (improved from US$1.12 loss in 1Q 2024). Revenue: US$8.72m (up 115% from 1Q 2024). Net loss: US$14.8m (loss narrowed 80% from 1Q 2024). Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 24%. Revenue is forecast to grow 2.1% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 61% per year, which means it is significantly lagging earnings. Price Target Changed • May 08
Price target decreased by 7.1% to US$6.50 Down from US$7.00, the current price target is an average from 4 analysts. New target price is 1,707% above last closing price of US$0.36. Stock is down 89% over the past year. The company is forecast to post a net loss per share of US$0.94 next year compared to a net loss per share of US$1.98 last year. Announcement • Apr 14
Generation Bio Co., Annual General Meeting, Jun 04, 2025 Generation Bio Co., Annual General Meeting, Jun 04, 2025. Major Estimate Revision • Mar 20
Consensus revenue estimates fall by 20% The consensus outlook for revenues in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from US$7.11m to US$5.68m. Forecast losses increased from -US$1.08 to -US$1.14 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$7.00 to US$6.75. Share price rose 3.5% to US$0.54 over the past week. Reported Earnings • Mar 14
Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2024 results: US$1.98 loss per share (further deteriorated from US$1.96 loss in FY 2023). Revenue: US$19.9m (up 237% from FY 2023). Net loss: US$131.7m (loss widened 4.0% from FY 2023). Revenue exceeded analyst estimates by 9.7%. Earnings per share (EPS) missed analyst estimates by 7.8%. Revenue is forecast to grow 6.9% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 2% per year but the company’s share price has fallen by 56% per year, which means it is significantly lagging earnings. Announcement • Mar 02
Generation Bio Receives Written Notification from Nasdaq Regarding Non-Compliance with the Minimum Bid Price Requirement Under Nasdaq Listing Rule 5450(a)(1) On February 24, 2025, Generation Bio Co. (the ‘Company’) received written notification (the ‘Notice’) from the Listing Qualifications Department (the ‘Staff’) of the Nasdaq Stock Market (‘Nasdaq’) that, because the closing bid price for the Company’s common stock has fallen below $1.00 per share for 30 consecutive business days, the Company no longer complies with the minimum bid price requirement for continued listing on the Nasdaq Global Select Market, pursuant to Nasdaq Listing Rule 5450(a)(1) (the ‘Bid Price Requirement’). The Notice has no immediate effect on the listing of the Company’s common stock on the Nasdaq Global Select Market, which will continue to be listed and trade on Nasdaq subject to the Company’s continued compliance with the other listing requirements. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has an initial period of 180 calendar days, or until August 25, 2025 (the ‘Compliance Date’), to regain compliance with the Bid Price Requirement. To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of 10 consecutive business days prior to the Compliance Date, at which time the Staff will provide written notification to the Company that it complies with the Bid Price Requirement, unless the Staff exercises its discretion to extend this 10-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company does not regain compliance by the Compliance Date, it may be eligible for an additional 180 calendar day grace period. To qualify, the Company would be required to transfer the listing of its common stock to the Nasdaq Capital Market, provided that it meets the continued listing requirement for the market value of publicly held shares and all other initial listing standards of the Nasdaq Capital Market, with the exception of the Bid Price Requirement. To effect such a transfer, among other things, the Company would also need to pay an application fee to Nasdaq and provide written notice to the Staff of its intention to cure the deficiency during the additional compliance period by effecting a reverse stock split, if necessary. However, if it appears to the Staff that the Company will not be able to regain compliance with the Bid Price Requirement during the additional compliance period, or if the Company does not meet the other listing standards, the Staff could provide written notice that the Company’s common stock will be subject to delisting. Upon receipt of such notice, under Nasdaq rules, the Company may appeal the Staff’s delisting determination to a Nasdaq Listing Qualifications Panel (the ‘Panel’). The Company expects that its common stock would remain listed pending the Panel’s decision. However, there can be no assurance that, if the Company does appeal the delisting determination by the Staff to the Panel, that such appeal would be successful. The Company intends to monitor the closing bid price of its common stock and may, if appropriate, consider available options to regain compliance with the Bid Price Requirement. There can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or will otherwise remain in compliance with other Nasdaq listing criteria. Recent Insider Transactions • Jan 15
Independent Director recently bought US$203k worth of stock On the 13th of January, Anthony Quinn bought around 211k shares on-market at roughly US$0.96 per share. This transaction increased Anthony's direct individual holding by 1x at the time of the trade. This was the largest purchase by an insider in the last 3 months. This was the only on-market transaction from insiders over the last 12 months. New Risk • Nov 20
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$95.5m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$84m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (US$95.5m market cap). Major Estimate Revision • Nov 13
Consensus revenue estimates increase by 50% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$11.5m to US$17.3m. Forecast losses expected to reduce from -US$1.88 to -US$1.86 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target of US$7.50 unchanged from last update. Share price fell 24% to US$1.83 over the past week. Reported Earnings • Nov 07
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations Third quarter 2024 results: US$0.23 loss per share (improved from US$0.43 loss in 3Q 2023). Revenue: US$7.55m (up 252% from 3Q 2023). Net loss: US$15.3m (loss narrowed 46% from 3Q 2023). Revenue exceeded analyst estimates significantly. Earnings per share (EPS) also surpassed analyst estimates by 19%. Revenue is expected to decline by 16% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 21%. Over the last 3 years on average, earnings per share has fallen by 1% per year but the company’s share price has fallen by 52% per year, which means it is performing significantly worse than earnings. Major Estimate Revision • Aug 14
Consensus revenue estimates increase by 38%, EPS downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$8.37m to US$11.5m. EPS estimate fell from -US$1.79 to -US$1.86 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$7.50 unchanged from last update. Share price rose 5.0% to US$2.33 over the past week. Announcement • Aug 08
Generation Bio Co. has filed a Follow-on Equity Offering in the amount of $237 million. Generation Bio Co. has filed a Follow-on Equity Offering in the amount of $237 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Major Estimate Revision • May 20
Consensus revenue estimates increase by 29%, EPS downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$5.59m to US$7.18m. EPS estimate fell from -US$1.40 to -US$1.96 per share. Biotechs industry in the US expected to see average net income decline 11% next year. Consensus price target of US$7.50 unchanged from last update. Share price rose 29% to US$3.66 over the past week. Announcement • May 10
Generation Bio Co. Announces the Presentation of Preclinical Data on iqDNA and ctLNP Platforms At the ASGCT 27th Annual Meeting Generation Bio Co. presented five posters on its immune-quiet DNA (iqDNA) and cell-targeted lipid nanoparticle (ctLNP) platforms as well as its enzymatic synthesis manufacturing at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting. A sixth presentation on the company's ctLNP platform will be discussed in an oral presentation on May 11, 2024. Data included in the posters describe iqDNA as a modified, structured, partially single-stranded DNA that evades innate immunity while remaining transcriptionally active in the cell. In mouse studies, the immune profile of iqDNA is consistent with avoidance of key innate immune pathways such as cGAS-STING, which is known to have a significantly lower binding affinity for single-stranded DNA than double-stranded DNA. Given the non-immunogenic nature of iqDNA, Generation Bio believes it can now create novel therapies with a wide therapeutic index, which has been a major challenge to the development of in vivo DNA-based genetic medicines. The company invented iqDNA using its proprietary rapid enzymatic synthesis (RES) for DNA production. RES is a cell-free process that permits chemical and structural changes with a high degree of control, facilitating heightened DNA functionality through engineering molecular design and components. Because RES does not rely on cellular or viral components, it consistently produces 99% pure material in approximately one week, marking a significant improvement over biologic methods, which are often lengthy and complex. Further, due to the nature of enzymatic processes, iqDNA can be manufactured at scale to support clinical and global commercial demands without the challenges faced by cell-culture based production. Generation Bio continues to leverage RES to advance its iqDNA platform by optimizing various structural and chemical elements. In new data presented at ASGCT, a second generation of iqDNA achieved higher luciferase expression than first-generation iqDNA. The company is currently testing formulations of second-generation iqDNA encoding Factor VIII. The company’s ctLNP platform is designed to reach a broad set of target cell types and tissues with exquisite selectivity. Data presented at ASGCT describe the foundation of the platform, Generation Bio’s “stealth” LNP, which was engineered in part by making structural modifications to the parental ionizable lipid composition. Cell-specific targeting is achieved by optimizing ligand selection and linker chemistry. Additional data on T cell delivery, including the in vivo delivery of therapeutic transgenes via ctLNP, will be discussed in an oral presentation on May 11, 2024. Announcement • Apr 26
Generation Bio Co., Annual General Meeting, Jun 06, 2024 Generation Bio Co., Annual General Meeting, Jun 06, 2024, at 09:00 US Eastern Standard Time. Agenda: To elect three Class I directors to company board of directors, each to serve until the 2027 annual meeting of stockholders; to ratify of the appointment of Ernst & Young LLP as company independent registered public accounting firm for the fiscal year ending December 31, 2024; to approve, on an advisory basis, of the compensation of company named executive officers; and to transaction of any other business properly brought before the Annual Meeting or any adjournment or postponement of the Annual Meeting. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Independent Director Ron Cooper was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Major Estimate Revision • Mar 13
Consensus revenue estimates increase by 101% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$2.57m to US$5.17m. Forecast losses expected to reduce from -US$1.67 to -US$1.44 per share. Biotechs industry in the US expected to see average net income decline 8.5% next year. Consensus price target down from US$8.25 to US$7.25. Share price rose 8.4% to US$3.10 over the past week. Price Target Changed • Mar 07
Price target decreased by 16% to US$7.25 Down from US$8.66, the current price target is an average from 4 analysts. New target price is 146% above last closing price of US$2.95. Stock is down 24% over the past year. The company is forecast to post a net loss per share of US$1.47 next year compared to a net loss per share of US$1.96 last year. New Risk • Feb 23
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 1.8% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$126m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Shareholders have been diluted in the past year (11% increase in shares outstanding). Revenue is less than US$5m (US$3.0m revenue). Recent Insider Transactions • Dec 07
Independent Director recently bought US$478k worth of stock On the 4th of December, Charles Rowland bought around 343k shares on-market at roughly US$1.39 per share. This transaction increased Charles' direct individual holding by 2x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$747k more in shares than they have sold in the last 12 months. Announcement • Nov 30
Generation Bio Co. Announces Termination of Executives, Effective on January 28, 2024 Generation Bio Co. announced terminate the employment of Douglas Kerr, M.D., Ph.D., M.B.A., the Company’s Chief Medical Officer, and Tracy Zimmermann, Ph.D., the Company’s Chief Development Officer, effective as of January 28, 2024. Major Estimate Revision • Nov 16
Consensus revenue estimates increase by 51% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$2.52m to US$3.82m. EPS estimate reaffirmed at -US$1.92 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$8.66 unchanged from last update. Share price rose 13% to US$1.18 over the past week. Price Target Changed • Nov 02
Price target decreased by 17% to US$9.00 Down from US$10.83, the current price target is an average from 6 analysts. New target price is 799% above last closing price of US$1.00. Stock is down 81% over the past year. The company is forecast to post a net loss per share of US$1.92 next year compared to a net loss per share of US$2.35 last year. Announcement • Oct 27
Generation Bio Co. Announces Demonstration of Highly Selective T Cell Transduction in Vivo with Cell-Targeted Lnp Platform Generation Bio Co. announced that it has reached two significant achievements through in vivo studies, including results generated as part of its collaboration with Moderna Inc. First, Generation Bio has shown highly selective T cell targeting in vivo with its cell-targeted LNP (ctLNP) platform in a humanized mouse model. Separately, the company has confirmed the Stealth properties of its ctLNP platform in non-human primates (NHPs). Generation Bio will present these data at the European Society for Gene and Cell Therapy (ESGCT) 30th Annual Congress in Brussels, Belgium at 4:40 p.m. CEST today. The ctLNP platform is the foundation of the immune cell targeting programs in Generation Bio's collaboration with Moderna, which aims to leverage ctLNPs for in vivo delivery of nucleic acid therapies to select immune cell types, including T cells. As part of the company's collaboration with Moderna, Generation Bio has demonstrated that its T cell ctLNPs successfully drive highly selective receptor-mediated uptake and expression of mRNA in humanized mice upon systemic administration. In a separate NHP study, the company confirmed the properties of its stealth LNP, including long circulating half-life and very low off-target delivery to liver and spleen. New Risk • Oct 19
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$158.9m This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 15% per year for the foreseeable future. Revenue is less than US$1m (US$880k revenue). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$169m net loss in 3 years). Shareholders have been diluted in the past year (12% increase in shares outstanding). Market cap is less than US$100m (US$158.9m market cap). Announcement • Oct 19
Generation Bio Co. Announces Breakthrough in Its Non-Viral Genetic Medicine Platform with Novel "Immune-Quiet" Dna Generation Bio Co. announced the development of a proprietary, novel DNA called immune-quiet DNA (iqDNA). iqDNA is an optimized variant of the company's closed-ended DNA (ceDNA) that upon systemic administration with Generation Bio's lipid nanoparticle (LNP) delivery has shown cytokine levels and tolerability comparable to chemically modified messenger RNA (mRNA) in mice and non-human primates (NHPs). Generation Bio's non-viral genetic medicine platform aims to advance durable, redosable, and titratable therapies to reach potentially hundreds of millions of patients worldwide. The company has made deep investments in its three proprietary platform technologies, comprising novel DNA cargos, rapid enzymatic synthesis (RES) manufacturing, and cell-targeted LNP (ctLNP) delivery. Concurrent with extending its cash runway, the company is increasing investment in its iqDNA and ctLNP platforms. Systemic dosing in mouse and NHP studies demonstrates that iqDNA delivered via LNP evades detection by the key innate immune pathways that are reactive to DNA. Due to the superior tolerability profile of iqDNA, Generation Bio is discontinuing development of prior ceDNA constructs and is advancing iqDNA as the cargo for its lead program in hemophilia A as well as for all other programs. Scaling of iqDNA factor VIII for NHP testing is underway, leveraging existing RES systems and processes. Major Estimate Revision • Aug 17
Consensus revenue estimates increase by 270% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$2.52m to US$9.33m. Forecast losses expected to reduce from -US$2.01 to -US$1.90 per share. Biotechs industry in the US expected to see average net income decline 6.6% next year. Consensus price target broadly unchanged at US$10.85. Share price rose 4.1% to US$4.53 over the past week. Major Estimate Revision • Aug 09
Consensus revenue estimates decrease by 41%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$4.28m to US$2.52m. EPS estimate increased from -US$2.15 to -US$2.01 per share. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target down from US$12.33 to US$10.71. Share price was steady at US$4.49 over the past week. Price Target Changed • Aug 04
Price target decreased by 12% to US$11.42 Down from US$13.00, the current price target is an average from 7 analysts. New target price is 154% above last closing price of US$4.49. Stock is down 44% over the past year. The company is forecast to post a net loss per share of US$2.07 next year compared to a net loss per share of US$2.35 last year. New Risk • Jul 26
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 15% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (15% average weekly change). Earnings are forecast to decline by an average of 14% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$165m net loss in 3 years). Shareholders have been diluted in the past year (15% increase in shares outstanding). Price Target Changed • Feb 26
Price target decreased by 19% to US$13.00 Down from US$16.00, the current price target is an average from 6 analysts. New target price is 223% above last closing price of US$4.03. Stock is down 20% over the past year. The company is forecast to post a net loss per share of US$2.16 next year compared to a net loss per share of US$2.35 last year. Price Target Changed • Nov 16
Price target decreased to US$16.67 Down from US$19.40, the current price target is an average from 6 analysts. New target price is 164% above last closing price of US$6.32. Stock is down 69% over the past year. The company is forecast to post a net loss per share of US$2.35 next year compared to a net loss per share of US$2.12 last year. Board Change • Nov 16
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Kate Fitzgerald was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Price Target Changed • Nov 08
Price target decreased to US$16.67 Down from US$19.40, the current price target is an average from 6 analysts. New target price is 158% above last closing price of US$6.47. Stock is down 70% over the past year. The company is forecast to post a net loss per share of US$2.36 next year compared to a net loss per share of US$2.12 last year. Recent Insider Transactions Derivative • Oct 19
President exercised options and sold US$58k worth of stock On the 15th of October, Cameron McDonough exercised options to acquire 10k shares at no cost and sold these for an average price of US$5.61 per share. This trade did not impact their existing holding. For the year to December 2019, Cameron's total compensation was 10% salary and 90% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2022, Cameron's direct individual holding has increased from 1.68m shares to 1.71m. Company insiders have collectively bought US$170k more than they sold, via options and on-market transactions, in the last 12 months. Announcement • Sep 21
Generation Bio Co. Names Phillip Samayoa as Chief Strategy Officer Generation Bio Co. announced the promotion of Phillip Samayoa, Ph.D., to chief strategy officer. Dr. Samayoa has led strategy, corporate and portfolio development at Generation Bio since he joined the company in 2017, most recently serving as senior vice president. Phillip Samayoa co-founded Generation Bio as a principal at Atlas Venture, where he focused on genetic medicines and building novel platform therapeutics companies. While at Atlas, Dr. Samayoa also co-founded Dyne Therapeutics. Previously, he was director of MRL Ventures Fund at Merck, where he helped construct the strategic venture fund and led investments in early-stage companies including Alector, Translate Bio, and Spero Therapeutics. Prior to Merck, Dr. Samayoa was an associate at Flagship Pioneering where he was involved in building several startups, including Codiak BioSciences and Indigo Ag. Dr. Samayoa graduated from MIT with dual Bachelor of Science degrees in Biological Engineering and Physics, and earned his Ph.D. in Systems Biology from UC San Diego, where he was an NSF graduate research fellow. Recent Insider Transactions • Sep 16
Independent Director recently bought US$127k worth of stock On the 14th of September, Charles Rowland bought around 24k shares on-market at roughly US$5.22 per share. This transaction amounted to 24% of their direct individual holding at the time of the trade. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$177k more in shares than they have sold in the last 12 months. Board Change • Aug 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 12 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Kate Fitzgerald was the last director to join the board, commencing their role in 2019. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Jul 19
Generation Bio Co. Appoints Dannielle Appelhans as Class III Director and Member of N&G Committee Board of Directors of Generation Bio Co. appointed Dannielle Appelhans to fill the newly created vacancy as a Class III director and as a member of the Company’s N&G Committee, with a term of office to continue until the Company’s 2023 annual meeting of stockholders and until her successor has been duly elected and qualified, or until her earlier death, resignation or removal. Ms. Appelhans will receive compensation as a non-employee director in accordance with the Company’s non-employee director compensation program that the Board approved in April 2022 Pursuant to the Program, Ms. Appelhans will be entitled to receive a cash retainer of $40,000 per year for her service on the Board and $4,000 per year for her service as a member of the N&G Committee. This retainer is payable in arrears in four equal quarterly installments on the last day of each quarter, provided that the amount of such payment will be prorated for the third quarter of 2022. In addition, under the Program, Ms. Appelhans has received an initial grant of an option to purchase 38,400 shares of the Company’s common stock under the Company’s 2020 Stock Incentive Plan that will vest monthly over a three-year period, subject to Ms. Appelhans’ continued service as a director through each applicable vesting date. The option grant has an exercise price of $7.18, equal to the closing sales price of the Company’s common stock on July 15, 2022 as reported on The Nasdaq Global Select Market, and a term of 10 years, subject to earlier termination for cessation of continuous service. Further, under the Program, on the date of each annual meeting of stockholders commencing in 2023, Ms. Appelhans will be entitled to receive an option to purchase 19,200 shares of the Company’s common stock under the 2020 Plan that will vest in full on the earlier of the first anniversary of the grant date and the date of the annual meeting of stockholders in the year immediately following the year in which the option was granted, will be issued at an exercise price equal to the closing sales price of the Company’s common stock as reported on The Nasdaq Global Select Market on the date of grant and will have a term of ten years. In conjunction with Ms. Appelhans’ appointment, the Company and Ms. Appelhans entered into the Company’s standard indemnification agreement, a copy of which was filed as Exhibit 10.10 to the Company’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission on May 22, 2020. Announcement • Jun 26
Generation Bio Co.(NasdaqGS:GBIO) dropped from Russell 2000 Growth Index Generation Bio Co.(NasdaqGS:GBIO) dropped from Russell 2000 Growth Index Announcement • Jun 22
Generation Bio Co. Announces Update to its Good Manufacturing Process Manufacturing Strategy Generation Bio Co. announced that it is updating its Good Manufacturing Process manufacturing strategy to integrate efficiencies enabled by improvements to its proprietary rapid enzymatic synthesis process for the production of closed-ended DNA (ceDNA). RES is a cell-free process that delivers three key benefits compared to biologics-based DNA manufacturing approaches: consistent yields of highly pure ceDNA, potential to scale to hundreds of millions of doses, and short production cycles. In July 2021, Generation Bio announced plans to deploy RES for ceDNA across all of its portfolio programs and had entered into a lease agreement to build out a GMP facility in order to scale RES for clinical and initial commercial supply. Through further process development of RES, the company has achieved a significant increase in scale while maintaining high productivity and ceDNA purity, and now projects underutilization of the planned GMP facility. The company will seek to sublease this facility and intends to execute an alternative GMP approach that retains control over personnel, quality, infrastructure and process know-how. Price Target Changed • Apr 27
Price target decreased to US$20.40 Down from US$22.80, the current price target is an average from 6 analysts. New target price is 230% above last closing price of US$6.19. Stock is down 84% over the past year. The company is forecast to post a net loss per share of US$2.34 next year compared to a net loss per share of US$2.12 last year. Board Change • Apr 27
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 11 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Kate Fitzgerald was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Price Target Changed • Feb 27
Price target decreased to US$20.40 Down from US$22.80, the current price target is an average from 5 analysts. New target price is 303% above last closing price of US$5.06. Stock is down 86% over the past year. The company is forecast to post a net loss per share of US$2.35 next year compared to a net loss per share of US$2.12 last year. Announcement • Feb 11
Generation Bio Co. Appoints Antoinette Paone as Chief Operating Officer Generation Bio Co. appointed Antoinette Paone, M.S., MBA, as Chief Operating Officer of the Company, effective as of February 10, 2022. Prior to being appointed as the Company’s Chief Operating Officer, Ms. Paone, age 44, served as the Company’s Senior Vice President, Regulatory and Quality, from February 2020 to February 2022 and its Vice President, Regulatory Affairs from October 2018 to February 2020. Before joining the Company, Ms. Paone served as Vertex Pharmaceuticals Inc.’s Vice President of Global Regulatory Affairs from October 2013 to September 2017 and its Head of Regulatory Affairs CMC from October 2011 to September 2013. She received her B.S. in chemistry at Fordham University, her M.S. in organic chemistry at Yale University and her MBA from Bentley College. Announcement • Dec 15
Generation Bio Provides Update on Preclinical Studies for Hemophilia A Program Generation Bio Co. provided an update on factor VIII expression from a series of mouse and companion non-human primate (NHP) studies in hemophilia A, as well as an update on the development of its non-viral genetic medicine platform. Generation Bio’s proprietary genetic medicine technology comprises a closed-ended DNA (ceDNA) delivered via a novel, cell-targeted lipid nanoparticle (ctLNP). In July 2021 the company announced that it would incorporate its novel, proprietary rapid enzymatic synthesis (RES) for ceDNA production into its pipeline programs. RES has improved ceDNA purity to 99%. In mouse studies, RES-derived ceDNA delivered by ctLNP generated peak mean human factor VIII expression of 205% of normal at 2.0 mg/kg. This is compared to peak mean human factor VIII expression of 23% of normal at 2.0 mg/kg using ceDNA produced by the company’s prior Sf9-based manufacturing process. In addition to the increased potency attributed to the RES-produced ceDNA and to ctLNP production process innovations, the company observed lower variability of factor VIII expression and of tolerability within and between mouse studies. Findings from companion studies in NHPs demonstrated human factor VIII expression of up to 2% of normal at 2.0 mg/kg, with higher-than-expected variability in both factor VIII expression and tolerability within and across studies. Additional optimization is needed to translate the improvement in potency and reduction in variability observed in mice to NHP, and to support nomination of a development candidate for the company’s hemophilia A program. Price Target Changed • Dec 15
Price target decreased to US$33.40 Down from US$41.17, the current price target is an average from 6 analysts. New target price is 458% above last closing price of US$5.99. Stock is down 83% over the past year. The company is forecast to post a net loss per share of US$2.18 next year compared to a net loss per share of US$2.95 last year. Board Change • Nov 03
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 11 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Kate Fitzgerald was the last director to join the board, commencing their role in 2019. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Recent Insider Transactions Derivative • Sep 15
Chief Scientific Officer exercised options and sold US$64k worth of stock On the 10th of September, Matthew Stanton exercised 3k options at a strike price of around US$4.59 and sold these shares for an average price of US$25.97 per share. This trade did not impact their existing holding. Since December 2020, Matthew has owned 198.15k shares directly. Company insiders have collectively sold US$4.8m more than they bought, via options and on-market transactions in the last 12 months. Announcement • Jul 15
Generation Bio Announces Plan to Scale Next-Generation Rapid Enzymatic Manufacturing Process Across Portfolio and Provides Pipeline Update Generation Bio Co. announced that it plans to deploy next-generation rapid enzymatic synthesis (RES) for manufacturing of its closed-ended DNA (ceDNA) constructs across all portfolio programs. RES is a cell-free process that has the following advantages over cell-based manufacturing: Quality: Consistently yields highly pure ceDNA and reduces the variability inherent in cell-based manufacturing, which may have important regulatory and clinical benefits for Generation Bio’s entire pipeline, including its lead hemophilia A program; Scale: Potential to expand ceDNA manufacturing scale to hundreds of millions of doses, supporting the company’s intention to develop programs for prevalent diseases; Speed: Shortens the ceDNA production cycle from 28 days to one day, which will accelerate preclinical research and development across the company’s portfolio. The company has signed a lease agreement to build out a state-of-the-art cGMP (current good manufacturing practice) facility of approximately 104,000 square feet in Waltham, Mass. to scale RES for clinical and initial commercial supply. The facility is expected to be operational in 2023, enabling an Investigational New Drug (IND) application and clinical development for the company’s lead hemophilia A program. The company is using existing infrastructure for RES production of research material. Generation Bio anticipates incurring net lease costs of $104 million over a 12-year period and investing up to $45 million in the new manufacturing facility over the next two years. The company plans to continue partnering with contract manufacturing organizations during and after construction to ensure redundancy and secure additional ceDNA supply. Expenditures on the new facility are not expected to impact Generation Bio’s cash runway, which is sufficient to fund key milestones into 2024. As Generation Bio transitions to RES, it expects to update its program development strategy and timelines across its pipeline. Generation Bio is currently advancing its liver-directed, cell-targeted lipid nanoparticle delivery system with RES for the lead hemophilia A program. The company expects to report factor VIII expression data using RES-produced drug product in non-human primates by year-end. Recent Insider Transactions Derivative • Jul 11
Chief Medical Officer notifies of intention to sell stock Douglas Kerr intends to sell 4k shares in the next 90 days after lodging an Intent To Sell Form on the 8th of July. If the sale is conducted around the recent share price of US$24.20, it would amount to US$85k. Since March 2021, Douglas has owned 326.56k shares directly. Company insiders have collectively sold US$4.5m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Jun 12
Chief Scientific Officer exercised options and sold US$136k worth of stock On the 10th of June, Matthew Stanton exercised 6k options at a strike price of around US$4.59 and sold these shares for an average price of US$27.23 per share. This trade did not impact their existing holding. Since December 2020, Matthew has owned 198.15k shares directly. Company insiders have collectively sold US$4.5m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • May 31
Chief Scientific Officer notifies of intention to sell stock Matthew Stanton intends to sell 27k shares in the next 90 days after lodging an Intent To Sell Form on the 27th of May. If the sale is conducted around the recent share price of US$32.96, it would amount to US$890k. Since June 2020, Matthew has owned 198.15k shares directly. Company insiders have collectively sold US$4.4m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • May 14
Chief Scientific Officer exercised options and sold US$269k worth of stock On the 11th of May, Matthew Stanton exercised 9k options at a strike price of around US$0.60 and sold these shares for an average price of US$30.51 per share. This trade did not impact their existing holding. Since June 2020, Matthew has owned 198.15k shares directly. Company insiders have collectively sold US$4.3m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • May 07
Chief Development Officer notifies of intention to sell stock Tracy Zimmermann intends to sell 3k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of May. If the sale is conducted around the recent share price of US$36.72, it would amount to US$92k. Since December 2020, Tracy has not owned shares directly (This sale likely refers to shares that have not yet been received). Company insiders have collectively sold US$4.0m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Apr 24
Chief Scientific Officer exercised options and sold US$96k worth of stock On the 22nd of April, Matthew Stanton exercised 3k options at a strike price of around US$0.60 and sold these shares for an average price of US$32.55 per share. This trade did not impact their existing holding. Since June 2020, Matthew has owned 198.15k shares directly. Company insiders have collectively sold US$4.0m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Apr 08
Chief Medical Officer exercised options and sold US$351k worth of stock On the 5th of April, Douglas Kerr exercised 14k options at a strike price of around US$5.16 and sold these shares for an average price of US$30.09 per share. This trade did not impact their existing holding. Since June 2020, Douglas has owned 326.56k shares directly. Company insiders have collectively sold US$3.6m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Mar 04
President notifies of intention to sell stock Cameron McDonough intends to sell 30k shares in the next 90 days after lodging an Intent To Sell Form on the 1st of March. If the sale is conducted around the recent share price of US$35.82, it would amount to US$1.1m. For the year to December 2020, Cameron's total compensation was 27% salary and 73% non-salary (Indicating these sales could comprise a meaningful part of their income for the year). Since June 2020, Cameron has owned 1.71m shares directly. Company insiders have collectively sold US$2.5m more than they bought, via options and on-market transactions in the last 12 months. Announcement • Feb 19
Generation Bio Co. Appoints Ron Cooper to its Board of Directors, Effective March 1, 2021 Generation Bio Co. announced that Ron Cooper has been appointed to its Board of Directors. The appointment is effective March 1, 2021. Ron Cooper is a global biopharmaceutical executive who currently serves as president, chief executive officer and board member of Albireo Pharma Inc. He has successfully matured Albireo Pharma Inc. to a clinical-stage public company on the verge of its first drug approval. Prior to joining Albireo Pharma Inc., Cooper had a 25-year career at Bristol Myers Squibb, during which time he held multiple leadership roles in sales, marketing and general management, culminating in his role as president of Europe. Executive Departure • Feb 08
Co-Founder & COO Mark Angelino has left the company On the 5th of February, Mark Angelino's tenure as Co-Founder & COO ended after 4.4 years in the role. As of September 2020, Mark personally held 515.48k shares (US$16m worth at the time). Mark is the only executive to leave the company over the last 12 months. Recent Insider Transactions Derivative • Feb 05
Chief Development Officer exercised options and sold US$71k worth of stock On the 2nd of February, Tracy Zimmermann exercised 3k options at a strike price of around US$4.59 and sold these shares for an average price of US$33.05 per share. This trade did not impact their existing holding. As of today, Tracy currently holds no shares directly. Company insiders have collectively sold US$1.7m more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions Derivative • Jan 14
Chief Medical Officer notifies of intention to sell stock Douglas Kerr intends to sell roughly 47.87k shares in the next 90 days after lodging an Intent To Sell Form on the 11th of January. If the sale is conducted around the recent share price of US$27.61, it would amount to US$1.3m. Since June 2020, Douglas has owned 326.56k shares directly. Company insiders have collectively sold US$1.2m more than they bought, via options and on-market transactions in the last 12 months. Announcement • Jan 06
Generation Bio Announces Two Non-Viral Gene Therapy Achievements: Target Levels of Factor VIII Expression in Hemophilia A Mice and Translation of Expression from Mice to Non-Human Primates Generation Bio Co. announced data from a study achieving tolerability and targeted factor VIII expression levels in hemophilia A mice with a single dose of closed-ended DNA (ceDNA) delivered via the company’s novel, cell-targeted lipid nanoparticle (ctLNP) system. In this study, conducted with a ceDNA development construct, a dose response was observed across three cohorts, with the highest dose of 2.0 mg/kg yielding a mean human factor VIII expression of 23% of normal. The company also announced data from studies conducted with a ceDNA research construct delivered via ctLNP demonstrating approximately 2:1 species translation from mice to non-human primates (NHPs). All doses in mice and NHPs were well-tolerated up to the highest dose of 2.0 mg/kg. These data confirm delivery of ceDNA to the liver via ctLNPs in higher species. Generation Bio has previously demonstrated in immunocompetent mice that its ceDNA constructs with human factor IX achieved durable expression for months and that expression increased proportionately with redosing. In parallel with hemophilia A, Generation Bio plans to advance programs in phenylketonuria (PKU) as well as in additional rare and prevalent diseases that are addressable using the company’s liver-specific ctLNP delivery system and established, capsid-free manufacturing. Translation from mouse to NHP was established by delivering the same weight-adjusted dose of ceDNA-ctLNP in each species. Two separate studies were conducted. In the first study, a mean human factor VIII expression level of ~1% of normal was observed in mice at day 7 following a single dose of a ceDNA research construct delivered systemically via a liver-directed ctLNP at 1 mg/kg. This translated to a mean human factor VIII expression level of ~1% of normal in NHPs at day 5 using identical material and weight-adjusted dosing (1 mg/kg). In a second study employing a similar ctLNP, a mean human factor VIII expression level of ~3% of normal was observed in mice at day 5 following a single dose of a ceDNA research construct at 2 mg/kg. This translated to a mean factor VIII expression level of 1% of normal in NHPs at day 5 using identical material and weight-adjusted dosing at 2 mg/kg. In totality, the 2:1 expression ratio from mice to NHPs is similar to that observed across other modalities delivered via LNPs, including RNAi and mRNA, and establishes a basis for final development candidate selection. The expression levels in mice using a ceDNA development construct, coupled with the 2:1 expression ratio from mice to NHPs and expected 1:1 translation from NHPs to humans, support selection of a final hemophilia A clinical development candidate this year. The observed expression levels in mice with a ceDNA development construct may correspond to or exceed the 5% of normal threshold in humans that has been clinically proven to prevent serious bleeds in patients. Doses of ceDNA-ctLNP in both mice and NHPs were well tolerated up to 2 mg/kg, the highest dose evaluated. There were no adverse clinical observations, changes in clinical pathology, or histopathology findings including in the liver and spleen in NHPs. Generation Bio’s ctLNP employs N-acetyl galactosamine, or GalNAc, as the ligand for targeting of liver cells via the asialoglycoprotein receptor, or ASGPr. GalNAc-ASGPr is a well-validated, selective ligand-receptor pair for systemic delivery to hepatocytes. In previously released data from a study in immunocompetent mice, a single intravenous dose of ceDNA formulated in an LNP yielded long-term expression in the liver for months using the reporter protein luciferase and human factor IX. LNP delivery does not stimulate an antibody response, thereby enabling redosing and overcoming a major limitation of viral gene therapy. Generation Bio has previously released data showing that ceDNA delivered in an LNP does not induce neutralizing antibodies and can be redosed in mice with normal immune systems. Redosing five weeks after the initial dose proportionately increased expression using both the reporter protein luciferase and human factor IX in mice. After the first administration of a factor IX ceDNA research construct in an LNP, mice demonstrated 5% to 10% activity levels of factor IX protein in the blood. After repeat administration at the same dose, the activity levels rose to 10% to 20%. These results support the potential of Generation Bio’s non-viral gene therapy platform to safely titrate patients to the desired level of protein expression and to enable repeat dosing if needed to maintain expression over a lifetime. Recent Insider Transactions Derivative • Dec 13
Chief Scientific Officer notifies of intention to sell stock Matthew Stanton intends to sell roughly 43.63k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of December. If the sale is conducted around the recent share price of US$38.50, it would amount to US$1.7m. Since June 2020, Matthew has owned 198.15k shares directly. This was the only transaction from an insider over the last 12 months. Is New 90 Day High Low • Nov 14
New 90-day high: US$32.04 The company is up 63% from its price of US$19.70 on 14 August 2020. The American market is up 6.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Biotechs industry, which is up 5.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Nov 11
Generation Bio Co. Announces Resignation of Mark Angelino as Chief Operating Officer Generation Bio Co. announced that Mark Angelino informed the Company of his intention to resign from his role as the Chief Operating Officer of the Company, effective as of early February 2021.