New Risk • May 28
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 83% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 8.9% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (83% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$145m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Announcement • May 26
Editas Medicine Presents Preclinical Data For EDIT-401 Demonstrating Robust Reductions In LDL-C, Lp(a), And ApoB In Non-Human Primates Editas Medicine, Inc. presented new preclinical data for EDIT-401, its lead in vivo development candidate, in an oral presentation at the 94th European Atherosclerosis Society Congress in Athens, Greece on May 25, 2026. In the data presented, EDIT-401 achieved robust reductions in LDL-cholesterol (LDL-C), lipoprotein(a) (Lp(a)), and apolipoprotein B (ApoB) in non-human primates (NHPs), supporting its potential as a best-in-class medicine for hyperlipidemia. Key EDIT-401 preclinical data in NHPs presented include: A single dose of EDIT-401 achieved =90% mean reduction in LDL-C, with rapid and dose-dependent effect. EDIT-401 achieved rapid, dose dependent ~90% mean reduction in Lp(a), an independent risk factor for atherosclerotic cardiovascular disease (ASCVD). EDIT-401 achieved rapid, dose-dependent ~90% mean reduction in ApoB, a key measure of total plaque-causing cholesterol particles and predictive measure for ASCVD. Reductions in LDL-C, Lp(a), and ApoB were highly correlated, supporting a unified mechanism facilitated by LDLR upregulation. The abstract can be accessed on the EAS website, and the presentation is available on the Editas Medicine website. Editas continues to advance preclinical studies for EDIT-401, including an ongoing Good Laboratory Practice (GLP) toxicology study in NHPs. Interim results from this study demonstrated EDIT-401 was well-tolerated with no adverse clinical observations, no notable treatment-related liver enzyme elevations, and no liver histopathology findings in non-GLP toxicology at the therapeutically relevant dose of 1.5 mg/kg. The Company also received positive pre-IND feedback from the U.S. Food and Drug Administration (FDA) on its nonclinical package, CMC plans, and study design to support an Investigational New Drug Application (IND). The Company plans to submit a Clinical Trial Notification (CTN) in Australia to the Therapeutic Goods Administration (TGA) by mid-2026 to initiate a first-in-human clinical trial of EDIT-401 in patients with Heterozygous Familial Hypercholesterolemia (HeFH) later this year, and is on track to have early in vivo human proof-of-concept data for EDIT-401 by the end of 2026. Announcement • May 15
Editas Medicine Reports New Preclinical Data Demonstrating Progress of Edit-401 as Potential Treatment for Hyperlipidemia Editas Medicine, Inc. shared new preclinical data supporting the continued advancement of Editas’ lead in vivo development candidate, EDIT-401, and its potential as a one-time treatment for hyperlipidemia, as well as the broader potential of the Company’s differentiated upregulation strategy. The data is being presented this week at the 2026 Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in Boston, including one oral presentation and two poster presentations, as well as one oral presentation at TIDES USA 2026: Oligonucleotide and Peptide Therapeutics Conference. In an oral presentation at ASGCT, Editas reported that a single dose of EDIT-401 achieved =90% mean LDL-C reduction across all dose groups in non-human primates (NHPs). =90% mean LDL-C reduction was achieved with only moderate levels (10-40%) of functional editing of LDLR alleles and =6-fold mean increase in hepatic LDLR protein. LDL-C lowering was rapid and remained durable across evaluated dose levels (1.5 mg/kg-3.0 mg/kg) through ~6 months. Promising preclinical safety profile with no adverse clinical observations at therapeutically relevant dose (1.5 mg/kg). The highest delivery of EDIT-401 was observed in the hepatocytes as compared to other non-target tissues with undetectable oocyte delivery. In an oral presentation at TIDES, Editas presented data demonstrating EDIT-401 dose-dependent LDL-C reduction in NHPs. In a poster presentation at ASGCT, Editas reported that data evaluating pharmacokinetics and pharmacodynamics of a single dose of EDIT-401(mu) across multiple dose levels in heterozygous Ldlr loss-of-function mice and wildtype mice support that dose adjustments may not be needed to achieve LDL-C lowering in Heterozygous Familial Hypercholesterolemia (HeFH) patients. Additional in vivo upregulation findings from a poster presentation at ASGCT include: Data support leveraging DNA large language prediction models (DNA-LLM) to accelerate and streamline the pursuit of gene editing-based strategies designed to mitigate disease through augmentation of alternate or compensatory pathways and further highlight the broader potential of Editas’ in vivo gene upregulation platform. The presentation details are listed below. Abstracts can be accessed on the ASGCT website, and the presentations will be posted on the Editas Medicine website during the conferences. American Society of Gene and Cell Therapy (ASGCT) 2026 Annual Meeting, May 11-15 Oral Presentation: Title: Preclinical Development of EDIT-401, a Durable In Vivo CRISPR Gene Editing Therapy That Upregulates LDLR Protein to Lower LDL-C Session Date and Time: May 14, 3:30 p.m. – 5:00 p.m. EDT Session Title: Gene Therapy for Cardiovascular Diseases Presentation Room: 206AB Final Abstract Number: 380 Poster Presentations: Title: Pharmacokinetics and Pharmacodynamics of In Vivo Gene Editing Therapy for Lowering LDL-C in Mice Session Date and Time: May 14, 5:00 p.m. – 6:30 p.m. EDT Session Title: Thursday Poster Reception Presentation Room: Exhibit and Poster Hall Final Abstract Number: 3423 Title: In Vivo CRISPR-based Disruption of an Important Gene Repressor Element Upregulates a Compensatory Protein to Normalize Disease-Associated Biomarkers in a Knockout Mouse Disease Model Session Date and Time: May 13, 5:00 p.m. – 6:30 p.m. EDT Session Title: Poster Reception Presentation Room: Exhibit and Poster Hall Final Abstract Number: 2324 TIDES USA 2026: Oligonucleotide and Peptide Therapeutics Conference, May 11-14 Oral Presentation: Title: Transformative LDL Cholesterol Lowering In Vivo CRISPR Gene Editing Approach for Hyperlipidemia and Atherosclerotic Cardiovascular Disease Session Date and Time: May 13, 8:30 a.m. – 9:00 a.m. EDT Session Title: mRNA & Genome Editing: Technology & Applications. Price Target Changed • May 07
Price target increased by 11% to US$6.38 Up from US$5.72, the current price target is an average from 8 analysts. New target price is 110% above last closing price of US$3.03. Stock is up 118% over the past year. The company is forecast to post a net loss per share of US$1.07 next year compared to a net loss per share of US$1.80 last year. Reported Earnings • May 06
First quarter 2026 earnings: EPS and revenues miss analyst expectations First quarter 2026 results: US$0.26 loss per share (improved from US$0.92 loss in 1Q 2025). Revenue: US$2.83m (down 39% from 1Q 2025). Net loss: US$25.0m (loss narrowed 67% from 1Q 2025). Revenue missed analyst estimates by 52%. Earnings per share (EPS) also missed analyst estimates by 2.0%. Revenue is expected to decline by 24% 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 increased by 13% per year but the company’s share price has fallen by 32% per year, which means it is significantly lagging earnings. Board Change • May 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. 6 experienced directors. 2 highly experienced directors. Independent Director Elliott Levy was the last director to join the board, commencing their role in 2023. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Announcement • Apr 29
Editas Medicine, Inc., Annual General Meeting, Jun 17, 2026 Editas Medicine, Inc., Annual General Meeting, Jun 17, 2026. Reported Earnings • Mar 10
Full year 2025 earnings: EPS and revenues exceed analyst expectations Full year 2025 results: US$1.80 loss per share (improved from US$2.88 loss in FY 2024). Revenue: US$40.5m (up 25% from FY 2024). Net loss: US$160.1m (loss narrowed 33% from FY 2024). Revenue exceeded analyst estimates by 69%. Earnings per share (EPS) also surpassed analyst estimates by 11%. Revenue is expected to decline by 15% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 19%. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 32% per year, which means it is significantly lagging earnings. New Risk • Mar 09
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 7.4% 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 7.4% per year for the foreseeable future. Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$181m). Currently unprofitable and not forecast to become profitable over next 3 years (US$145m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (18% increase in shares outstanding). New Risk • Feb 07
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$181m). Currently unprofitable and not forecast to become profitable over next 3 years (US$145m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (18% increase in shares outstanding). Price Target Changed • Nov 20
Price target increased by 32% to US$5.13 Up from US$3.88, the current price target is an average from 8 analysts. New target price is 107% above last closing price of US$2.47. Stock is up 4.2% over the past year. The company is forecast to post a net loss per share of US$2.02 next year compared to a net loss per share of US$2.88 last year. Reported Earnings • Nov 11
Third quarter 2025 earnings: EPS and revenues exceed analyst expectations Third quarter 2025 results: US$0.28 loss per share (improved from US$0.75 loss in 3Q 2024). Revenue: US$7.54m (up US$7.48m from 3Q 2024). Net loss: US$25.1m (loss narrowed 60% from 3Q 2024). Revenue exceeded analyst estimates by 53%. Earnings per share (EPS) also surpassed analyst estimates by 10%. Revenue is expected to decline by 39% 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 increased by 5% per year but the company’s share price has fallen by 41% per year, which means it is significantly lagging earnings. New Risk • Nov 11
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 18% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$205m). Currently unprofitable and not forecast to become profitable over next 3 years (US$150m 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 (18% increase in shares outstanding). Announcement • Oct 09
Editas Medicine Reports in Vivo Proof-Of-Concept Data for Edit-401 At the European Society of Gene and Cell Therapy (Esgct) 32Nd Annual Congress Editas Medicine, Inc. reported in vivo preclinical proof-of-concept data for EDIT-401, an experimental, potential best-in-class, one-time therapy to significantly reduce LDL-cholesterol (LDL-C), at the 32nd Annual European Society of Gene and Cell Therapy (ESGCT) Congress in Seville, Spain. The Company shared results from preclinical studies demonstrating potent and durable reductions in LDL-C through upregulation of the LDL receptor (LDLR). Key EDIT-401 Data Presented includes: Robust efficacy data: 90% LDL-C reduction in non-human primates achieved within 48 hours of a single dose of EDIT-401; 90% LDL-C reduction In mice with high baseline LDL-C and reduced LDLR function; Optimized therapeutic strategy: CRISPR/Cas9 nuclease and dual gRNAs with LNP delivery disrupt negative regulatory elements in the 3' UTR, increasing mRNA stability enabling potent LDLR upregulation; 6-fold mean increase in LDLR protein in the NHP liver, requiring only a moderate level of functional editing of LDLR alleles; Durable effect: LDL-C reduction maintained in mouse models in a three-month study. Major Estimate Revision • Aug 19
Consensus revenue estimates increase by 35%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$15.2m to US$20.6m. EPS estimate fell from -US$1.90 to -US$2.08 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target up from US$3.38 to US$3.88. Share price rose 15% to US$2.63 over the past week. New Risk • Aug 13
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$205m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$205m). Currently unprofitable and not forecast to become profitable over next 3 years (US$147m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Reported Earnings • Aug 13
Second quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2025 results: US$0.63 loss per share (improved from US$0.82 loss in 2Q 2024). Revenue: US$3.58m (up US$3.07m from 2Q 2024). Net loss: US$53.2m (loss narrowed 21% from 2Q 2024). Revenue exceeded analyst estimates by 98%. Earnings per share (EPS) missed analyst estimates by 64%. Revenue is expected to decline by 27% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 19%. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. Announcement • Jun 12
Editas Medicine Reports Proprietary Targeted Lipid Nanoparticle Delivery in Non-Human Primates Enables in Vivo HBG1/2 Promoter Editing for Sickle Cell Disease and Beta Thalassemia At the European Hematology Association 2025 Congress in June Editas Medicine, Inc. shared new in vivo data demonstrating therapeutically relevant levels of HBG1/2 promoter editing in hematopoietic stem cells (HSCs) with a single dose of proprietary targeted lipid nanoparticle (tLNP) in non-human primates (NHPs). This clinically validated approach targeting HBG1/2 promoters to upregulate fetal hemoglobin (HbF) is in pre-clinical development as a potential transformative in vivo gene editing medicine for the treatment of sickle cell disease and beta thalassemia. The Company reported these data in a presentation available today and will detail the data in a poster session on Saturday, June 14th6:30 - 7:30 p.m. CEST (12:30 – 1:30 p.m. EDT) at the European Hematology Association (EHA) 2025 Congress in Milan, Italy. In this study, the Company’s proprietary tLNP formulation delivered HBG1/2 promoter editing cargo to HSCs in NHPs. Latest data from this ongoing NHP study showed that at five months a single intravenous administration of Editas’ tLNP resulted in mean on-target editing levels in the HBG1/2 promoter region of 58% in HSCs: well exceeding the predicted editing threshold of =25% required for therapeutic benefit. In addition to achieving therapeutically relevant editing levels, the biodistribution data in NHPs with Editas’ tLNP continue to show significant de-targeting of the liver in contrast to standard LNPs. Editas Medicine’s in vivo HSC program targets HBG1/2 promoters to mimic naturally occurring mechanisms of hereditary persistence of fetal hemoglobin (HPFH) and utilizes proprietary AsCas12a to edit with high efficiency and minimize off-target editing. Editing the HBG1/2 promoters with AsCas12a with the investigational medicine reni-cel led to robust increases in HbF and total hemoglobin (Hb) in clinical trials. Major Estimate Revision • May 19
Consensus revenue estimates increase by 17%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from US$10.6m to US$12.4m. EPS estimate fell from -US$1.59 to -US$1.88 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target down from US$4.00 to US$3.38. Share price was steady at US$1.51 over the past week. Announcement • May 14
Editas Medicine, Inc. Reports New in Vivo Proof of Concept Data in an Undisclosed Liver Target At the American Society of Gene and Cell Therapy Annual Meeting Editas Medicine, Inc. shared in vivo proof of concept data supporting the development of a potentially first-in-class treatment for an undisclosed liver target in a poster presentation at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in New Orleans. An in vivo editing strategy using lipid nanoparticles (LNPs) with CRISPR/Cas RNA cargo was employed for an undisclosed liver target gene. The strategy mimics a naturally occurring, protective variant, resulting in upregulation of the target gene. This resulted in meaningful reduction in the clinically relevant disease-specific biomarker in mice. Key findings include: An in vivo dose-response study in a disease-specific mouse model utilizing LNPs to deliver CRISPR/Cas-based cargo demonstrated maximal liver editing of the target gene (70%) and resulted in robust target protein upregulation with >80% disease biomarker reduction. Editing and subsequent upregulated expression of the target gene in cynomolgus monkey hepatocytes treated with CRISPR/Cas- based editing cargo also achieved >50% target gene editing and >15-fold protein upregulation. Additional data on the undisclosed liver target will be shared in an oral presentation on May 21 at TIDES USA 2025: Oligonucleotide & Peptide Therapeutics Conference in San Diego. Reported Earnings • May 13
First quarter 2025 earnings: Revenues exceed analysts expectations while EPS lags behind First quarter 2025 results: US$0.92 loss per share (further deteriorated from US$0.76 loss in 1Q 2024). Revenue: US$4.66m (up 310% from 1Q 2024). Net loss: US$76.1m (loss widened 23% from 1Q 2024). Revenue exceeded analyst estimates significantly. Earnings per share (EPS) missed analyst estimates by 60%. Revenue is expected to decline by 36% p.a. on average during the next 3 years, while revenues in the Biotechs industry in the US are expected to grow by 18%. Over the last 3 years on average, earnings per share has increased by 4% per year but the company’s share price has fallen by 49% per year, which means it is significantly lagging earnings. Announcement • May 06
Editas Medicine, Inc. to Report Q1, 2025 Results on May 12, 2025 Editas Medicine, Inc. announced that they will report Q1, 2025 results on May 12, 2025 Announcement • Apr 29
Editas Medicine to Present Preclinical Data Demonstrating Progress in the Development of an in vivo Gene Editing Pipeline at the American Society of Gene and Cell Therapy Annual Meeting Editas Medicine, Inc. announced that five abstracts have been accepted for presentation, including one oral presentation, at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) being held May 13 – 17, 2025, in New Orleans, LA, and virtually. The Company is presenting preclinical data to support its development of transformative in vivo gene editing medicines. Editas Medicine presentations at ASGCT include: Oral presentation of in vivo preclinical data from humanized mouse and non-human primate (NHP) studies using targeted lipid nanoparticles (tLNPs) to deliver HBG1/2 promoter editing cargo to hematopoietic stem and progenitor cells (HSPCs) and/or hematopoietic stem cells (HSCs) in bone marrow. Preclinical proof of concept for an undisclosed liver target using in vivo CRISPR editing to upregulate target protein expression and reduce a disease-associated biomarker in a relevant mouse disease model. Proof of concept results from the first in vivo mouse and NHP studies demonstrating high levels of target gene editing in the liver and corresponding biomarker response following intravenous administration of AsCas12a messenger RNA (mRNA) and chemically modified guide RNAs (gRNAs) delivered using LNPs from Genevant. Additional preclinical data demonstrating in vivo gene editing capabilities towards developing transformative in vivo medicines, including guide modification and targeting moiety optimizations to increase potency and improve gene editing outcomes in vivo. Announcement • Apr 07
Editas Medicine, Inc., Annual General Meeting, May 29, 2025 Editas Medicine, Inc., Annual General Meeting, May 29, 2025. New Risk • Apr 01
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$96.3m 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 Risk Share price has been highly volatile over the past 3 months (30% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$169m net loss in 3 years). Market cap is less than US$100m (US$96.3m market cap). Recent Insider Transactions Derivative • Mar 12
President notifies of intention to sell stock Gilmore O’Neill intends to sell 35k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of March. If the sale is conducted around the recent share price of US$1.86, it would amount to US$65k. For the year to December 2022, Gilmore's total compensation was 27% salary and 73% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2024, Gilmore's direct individual holding has increased from 106.88k shares to 129.12k. Company insiders have collectively sold US$92k more than they bought, via options and on-market transactions in the last 12 months. Announcement • Feb 24
Editas Medicine, Inc. to Report Q4, 2024 Results on Mar 05, 2025 Editas Medicine, Inc. announced that they will report Q4, 2024 results on Mar 05, 2025 Major Estimate Revision • Nov 11
Consensus revenue estimates increase by 78% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$22.8m to US$40.5m. Forecast losses expected to reduce from -US$2.96 to -US$2.65 per share. Biotechs industry in the US expected to see average net income decline 15% next year. Consensus price target down from US$11.63 to US$9.07. Share price rose 7.2% to US$3.12 over the past week. Reported Earnings • Nov 04
Second quarter 2024 earnings released: US$0.82 loss per share (vs US$0.56 loss in 2Q 2023) Second quarter 2024 results: US$0.82 loss per share (further deteriorated from US$0.56 loss in 2Q 2023). Revenue: US$513.0k (down 82% from 2Q 2023). Net loss: US$67.6m (loss widened 68% from 2Q 2023). Revenue is forecast to grow 19% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 59% per year, which means it is significantly lagging earnings. New Risk • Nov 04
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.1% 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 1.1% per year for the foreseeable future. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$253m net loss in 3 years). Price Target Changed • Oct 23
Price target decreased by 7.1% to US$13.00 Down from US$14.00, the current price target is an average from 16 analysts. New target price is 295% above last closing price of US$3.29. Stock is down 50% over the past year. The company is forecast to post a net loss per share of US$2.94 next year compared to a net loss per share of US$2.02 last year. Announcement • Oct 22
Editas Medicine, Inc. Announces Achievement of in Vivo Preclinical Proof of Concept Editas Medicine, Inc. announced its achievement of in vivo preclinical proof of concept of hematopoietic stem and progenitor cell (HSPC) editing and fetal hemoglobin (HbF) induction in humanized mice engrafted with human hematopoietic stem cells and lacking their own hematopoietic cells. The Company observed high levels of editing of the HBG1/2 promoter, leveraging clinically validated upregulation strategy, utilizing a novel and Editas-proprietary targeted lipid nanoparticle (tLNP) formulation for extrahepatic tissue delivery. The Company is also providing business development and financial updates, including that it initiated a process to partner or out-license reni-cel. In Vivo Proof of Concept Data Highlights: Achieved highly competitive level of in vivo hematopoietic stem and progenitor cell (HSPC) editing utilizing a novel, Editas-proprietary targeted lipid nanoparticle (t-LNP) for extrahepatic tissue delivery in a humanized mouse model, mice engrafted with human hematopoietic stem cells. Major Estimate Revision • Aug 14
Consensus revenue estimates fall by 13% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$27.6m to US$24.0m. Forecast losses increased from -US$2.69 to -US$2.92 per share. Biotechs industry in the US expected to see average net income decline 9.8% next year. Consensus price target down from US$14.27 to US$13.53. Share price fell 15% to US$3.99 over the past week. New Risk • Aug 11
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.3% 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 0.3% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$255m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Significant insider selling over the past 3 months (US$294k sold). Reported Earnings • Aug 08
Second quarter 2024 earnings: EPS and revenues miss analyst expectations Second quarter 2024 results: US$0.82 loss per share (further deteriorated from US$0.56 loss in 2Q 2023). Revenue: US$513.0k (down 82% from 2Q 2023). Net loss: US$67.6m (loss widened 68% from 2Q 2023). Revenue missed analyst estimates by 88%. Earnings per share (EPS) also missed analyst estimates by 19%. Revenue is forecast to grow 42% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 8% per year but the company’s share price has fallen by 60% per year, which means it is significantly lagging earnings. New Risk • Jul 28
New minor risk - Insider selling There has been significant insider selling in the company's shares over the past 3 months. Total value of shares sold: US$294k This is considered a minor risk. There are several reasons why an insider may be selling, including to cover a tax obligation or pay for some other expense. However, we generally consider it a negative if insiders have been selling, especially if they do so below the current price. It implies that they considered a lower price to be reasonable. This is a weak signal, but if there is a pattern of unexplained selling, it can be a sign the insider believes the company's stock is overpriced. Note: We only include open market transactions and private dispositions of directly owned stock by individuals, not by corporations or trusts. 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$251m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (3.4% increase in shares outstanding). Significant insider selling over the past 3 months (US$294k sold). Recent Insider Transactions • Jul 28
Executive VP & Chief Scientific Officer recently sold US$64k worth of stock On the 25th of July, Linda Burkly sold around 12k shares on-market at roughly US$5.42 per share. This transaction amounted to 14% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$125k. Insiders have been net sellers, collectively disposing of US$789k more than they bought in the last 12 months. Recent Insider Transactions Derivative • Jul 21
Executive VP & Chief Medical Officer notifies of intention to sell stock Baisong Mei intends to sell 14k shares in the next 90 days after lodging an Intent To Sell Form on the 19th of July. If the sale is conducted around the recent share price of US$5.61, it would amount to US$79k. Since March 2024, Baisong's direct individual holding has increased from 33.36k shares to 33.98k. Company insiders have collectively sold US$690k more than they bought, via options and on-market transactions in the last 12 months. New Risk • Jul 19
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10.0% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. 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$251m net loss in 3 years). Share price has been volatile over the past 3 months (10.0% average weekly change). Shareholders have been diluted in the past year (3.4% increase in shares outstanding). Announcement • Jun 15
Editas Medicine Announces New Safety and Efficacy Data from the Edithal Trial of Reni-Cel in 7 Patients with Transfusion-Dependent Beta Thalassemia, Presented At the European Hematology Association (Eha) Annual Congress Editas Medicine, Inc. announced new safety and efficacy data in 7 patients with transfusion-dependent beta thalassemia (TDT) treated with renizgamglogene autogedtemcel (reni-cel; formerly known as EDIT-301) in the Phase 1/2 EdiTHAL clinical trial. Reni-cel, the first investigational AsCas12a gene-edited cell therapy medicine, is being studied in the EdiTHAL trial as a potential one-time, durable gene editing medicine for people living with TDT. In the EdiTHAL trial to date, reni-cel was well-tolerated and continues to demonstrate a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all patients (N=7). Following treatment with reni-cel, all EdiTHAL patients had early and robust increase of total hemoglobin (Hb) and fetal hemoglobin (HbF) and remain transfusion-free at last follow-up for a range of 4.1 to 12.8 months (N=7). All patients in the EdiTHAL trial underwent 1.0 apheresis and mobilization cycle. Recent Insider Transactions • Jun 10
President recently sold US$67k worth of stock On the 4th of June, Gilmore O’Neill sold around 12k shares on-market at roughly US$5.50 per share. This transaction amounted to 10% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$125k. Gilmore has been a net seller over the last 12 months, reducing personal holdings by US$800k. Recent Insider Transactions Derivative • Jun 04
President notifies of intention to sell stock Gilmore O’Neill intends to sell 24k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of June. If the sale is conducted around the recent share price of US$5.32, it would amount to US$128k. For the year to December 2022, Gilmore's total compensation was 27% salary and 73% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2023, Gilmore's direct individual holding has increased from 15.18k shares to 94.28k. Company insiders have collectively sold US$721k more than they bought, via options and on-market transactions in the last 12 months. Recent Insider Transactions • May 23
CFO & Executive VP recently sold US$125k worth of stock On the 20th of May, Erick Lucera sold around 22k shares on-market at roughly US$5.61 per share. This transaction amounted to 16% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$733k. This was Erick's only on-market trade for the last 12 months. Recent Insider Transactions • May 16
Independent Lead Director recently bought US$254k worth of stock On the 13th of May, Jessica Hopfield bought around 45k shares on-market at roughly US$5.64 per share. This transaction increased Jessica's direct individual holding by 2x at the time of the trade. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold US$596k more in shares than they bought in the last 12 months. Major Estimate Revision • May 15
Consensus revenue estimates fall by 16% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from US$34.3m to US$28.8m. Forecast losses increased from -US$2.45 to -US$2.63 per share. Biotechs industry in the US expected to see average net income decline 10% next year. Consensus price target broadly unchanged at US$15.13. Share price was steady at US$5.68 over the past week. Reported Earnings • May 08
First quarter 2024 earnings: EPS and revenues miss analyst expectations First quarter 2024 results: US$0.76 loss per share (further deteriorated from US$0.71 loss in 1Q 2023). Revenue: US$1.14m (down 89% from 1Q 2023). Net loss: US$62.0m (loss widened 26% from 1Q 2023). Revenue missed analyst estimates by 84%. Earnings per share (EPS) also missed analyst estimates by 31%. Revenue is forecast to grow 39% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 3% per year but the company’s share price has fallen by 46% per year, which means it is significantly lagging earnings. Announcement • Apr 17
Editas Medicine, Inc., Annual General Meeting, May 30, 2024 Editas Medicine, Inc., Annual General Meeting, May 30, 2024, at 08:30 US Eastern Standard Time. Agenda: To consider election of three Class II directors to board of directors, each to serve until the 2027 annual meeting of stockholders; to approve the compensation paid to named executive officers; to ratify the appointment of Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to transact any other business matters. Recent Insider Transactions • Mar 10
President recently sold US$733k worth of stock On the 5th of March, Gilmore O’Neill sold around 78k shares on-market at roughly US$9.42 per share. This transaction amounted to 45% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Gilmore has been a net seller over the last 12 months, reducing personal holdings by US$795k. Recent Insider Transactions Derivative • Mar 06
President notifies of intention to sell stock Gilmore O’Neill intends to sell 140k shares in the next 90 days after lodging an Intent To Sell Form on the 4th of March. If the sale is conducted around the recent share price of US$8.86, it would amount to US$1.2m. For the year to December 2022, Gilmore's total compensation was 4% salary and 96% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2023, Gilmore has owned 15.18k shares directly. Company insiders have collectively sold US$134k more than they bought, via options and on-market transactions in the last 12 months. Major Estimate Revision • Mar 06
Consensus revenue estimates increase by 49%, EPS downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$23.0m to US$34.3m. EPS estimate fell from -US$2.41 to -US$2.45 per share. Biotechs industry in the US expected to see average net income decline 8.7% next year. Consensus price target up from US$14.87 to US$15.40. Share price rose 3.2% to US$9.14 over the past week. Reported Earnings • Feb 29
Full year 2023 earnings: EPS and revenues exceed analyst expectations Full year 2023 results: US$2.02 loss per share (improved from US$3.21 loss in FY 2022). Revenue: US$78.1m (up 296% from FY 2022). Net loss: US$153.2m (loss narrowed 31% from FY 2022). Revenue exceeded analyst estimates by 177%. Earnings per share (EPS) also surpassed analyst estimates by 10%. Revenue is forecast to grow 37% 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 fallen by 4% per year but the company’s share price has fallen by 35% per year, which means it is performing significantly worse than earnings. Major Estimate Revision • Dec 14
Consensus revenue estimates increase by 25% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$22.1m to US$27.6m. Forecast losses expected to reduce from -US$2.43 to -US$2.36 per share. Biotechs industry in the US expected to see average net income growth of 8.2% next year. Consensus price target up from US$13.53 to US$14.53. Share price was steady at US$10.84 over the past week. Announcement • Dec 12
Editas Medicine, Inc. Announces New EDIT-301 Safety And Efficacy Data In 17 Patients, Presented At The American Society Of Hematology (ASH) Annual Meeting And In A Company-Sponsored Webinar Editas Medicine, Inc. announced new safety and efficacy data in 17 patients treated with EDIT-301, now known as renizgamglogene autogedtemcel (reni-cel), in the RUBY trial for severe sickle cell disease (SCD) (n=11) and in the EdiTHAL trial for transfusion-dependent beta thalassemia (TDT) (n=6). The total dataset of 17 treated patients includes 12 additional patients since the data presentation at the European Hematology Association (EHA) Annual Congress and in a Company-sponsored webinar this past June. Reni-cel is being investigated in the RUBY and EdiTHAL clinical trials as a potential one-time, durable gene editing medicine for people living with severe SCD and TDT. Editas Medicine will present the RUBY and EdiTHAL trial data on December 11, 2023 at 1 p.m. ET in a Company-sponsored webinar. The data will also be presented in a poster presentation at the American Society of Hematology (ASH) Annual Meeting in San Diego, CA, at 6:00 p.m. PT (9:00 p.m. ET). In both the RUBY and EdiTHAL trials to date, reni-cel was well-tolerated and continues to demonstrate a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all patients in the two trials (n=17). Since treatment with reni-cel, all RUBY patients are free of vaso-occlusive events (VOEs) (n=11). All RUBY patients with =5 months follow-up have maintained a normal hemoglobin level and a fetal hemoglobin level of >40%. All EdiTHAL patients had early and robust increase of total hemoglobin, above the transfusion independence threshold of 9 g/dl (n=6). Safety: Reni-cel was well-tolerated and demonstrated a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all patients in the RUBY and EdiTHAL trials (n=17). After reni-cel infusion, all treated patients with >2 months follow-up demonstrated successful neutrophil engraftment within one month and platelet engraftment within 1.6 months. No serious adverse events (SAEs) related to reni-cel treatment have been reported. Efficacy: RUBY Trial in Severe Sickle Cell Disease: In the RUBY trial, all treated patients are free of VOEs since reni-cel infusion. Reni-cel treatment drives early, robust increase of total hemoglobin and fetal hemoglobin. The patients with =5 months follow-up have maintained a normal hemoglobin level and a fetal hemoglobin level of >40% (n=6; range 5-18 months follow-up). All treated RUBY patients with >1 month of follow-up followed a similar trajectory of total hemoglobin and fetal hemoglobin increases (n=10). EdiTHAL Trial in Transfusion-dependent Beta Thalassemia: In the EdiTHAL trial, patients with >1 month follow-up (n=5) demonstrated early and robust total hemoglobin and fetal hemoglobin increases, with total hemoglobin rising above the transfusion independence threshold of 9 g/dL. Reni-cel, formerly known as EDIT-301, is an experimental gene editing medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). Reni-cel consists of patient-derived CD34+ hematopoietic stem and progenitor cells edited at the gamma globin gene (HBG1 and HBG2) promoters, where naturally occurring fetal hemoglobin (HbF) inducing mutations reside, by AsCas12a, a novel, proprietary, highly efficient, and specific gene editing nuclease. Red blood cells derived from reni-cel CD34+ cells demonstrate a sustained increase in fetal hemoglobin production, which has the potential to provide a one-time, durable treatment benefit for people living with severe SCD and TDT. The RUBY trial is a single-arm, open-label, multi-center Phase 1/2 study designed to assess the safety and efficacy of reni-cel in patients with severe sickle cell disease. Enrolled patients will receive a single administration of reni-cel. The RUBY trial marks the first time AsCas12a was used to successfully edit human cells in a clinical trial. The EdiTHAL trial is a single-arm, open label, multi-center Phase 1/2 study designed to assess the safety and efficacy of reni-cel in patients with transfusion-dependent beta thalassemia. Patients will receive a single administration of reni-cel. New Risk • Nov 15
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. 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$226m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Shareholders have been diluted in the past year (21% increase in shares outstanding). Major Estimate Revision • Nov 10
Consensus revenue estimates increase by 21% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$18.3m to US$22.1m. EPS estimate unchanged at -US$2.43. Biotechs industry in the US expected to see average net income growth of 1.4% next year. Consensus price target of US$13.53 unchanged from last update. Share price rose 12% to US$7.87 over the past week. Reported Earnings • Nov 05
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$0.55 loss per share (improved from US$0.81 loss in 3Q 2022). Revenue: US$5.34m (up US$5.29m from 3Q 2022). Net loss: US$45.0m (loss narrowed 19% from 3Q 2022). Revenue exceeded analyst estimates by 56%. Earnings per share (EPS) also surpassed analyst estimates by 3.5%. Revenue is forecast to grow 48% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has fallen by 35% per year, which means it is performing significantly worse than earnings. Announcement • Nov 03
Editas Medicine, Inc. to Present Clinical Data from the Rubber and Edithal Trials of Edit-301 At the Ash 2023 Annual Meeting and in A Company-Sponsored Webinar Editas Medicine, Inc. announced that a scientific abstract detailing safety and efficacy clinical data from the RUBY trial of EDIT-301 in patients with severe sickle cell disease and from the EdiTHAL trial of EDIT-301 in patient with transfusion-dependent beta thalassemia has been accepted for a poster presentation at the 65thAmerican Society of Hematology (ASH) Annual Meeting and Exposition being held December 9-12, 2023, in San Diego, CA, and online. Key data from patients treated in the RUBY trial and in the EdiTHAL trial will be shared, including: RUBY; Clinical data on 11 patients, including two patients with at least 12 months follow-up and an additional four patients with at least five months follow-up; Efficacy data, including total hemoglobin, fetal hemoglobin, and vaso-occlusive events, or VOEs. Higher levels of fetal hemoglobin (HbF) inhibit HbS polymerization, thus reducing the manifestation of sickling. About EDIT-301: EDIT-301 is an experimental gene editing medicine under investigation for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thAL trial. Enrolled patients will receive a single administration of EDIT-301. Announcement • Oct 11
Editas Medicine, Inc. Announces Bruce E. Eaton Will Step Down as Chief Technology Officer and Chief Business Officer, Effective January 2, 2024 On October 3, 2023, Editas Medicine, Inc. and Bruce E. Eaton, Ph.D., Executive Vice President, Chief Technology Officer and Chief Business Officer of the Company, agreed that Dr. Eaton will step down as Chief Technology Officer and Chief Business Officer effective January 2, 2024. Announcement • Sep 26
Editas Medicine, Inc. Appoints Caren Deardorf as Chief Commercial and Strategy Officer Editas Medicine, Inc. announced the appointment of Caren Deardorf as the Company’s first Chief Commercial and Strategy Officer. Ms. Deardorf will build and lead Editas Medicine’s commercial organization, strategy, and execution to support all launch, commercialization, and lifecycle management activities of the Company’s current and future pipeline of products. Caren Deardorf brings to Editas more than 25 years of international biotechnology leadership across a range of companies and therapeutic areas. Most recently, Ms. Deardorf served as the Chief Commercial Officer of Magenta Therapeutics. Prior to Magenta, she served as the Chief Commercial Officer of Ohana Biosciences where she was responsible for developing a commercial strategy, including planning for the company’s first product launch. Earlier in her career, Ms. Deardorf held a variety of commercial roles of increasing responsibility at Biogen, most recently serving as Vice President, Product Development & Commercialization, leading and executing a highly successful global launch of SPINRAZA, a treatment for children and adults with spinal muscular atrophy. During her tenure at Biogen, Ms. Deardorf was instrumental in building the multiple sclerosis (MS) franchise and helping to establish Biogen’s global leadership through US and worldwide brand management, including leading the brand and launch strategy for TECFIDERA and the successful US and EU launches of TYSABRI and AVONEX. Ms. Deardorf holds a Bachelor of Science degree in biology from Tufts University and a Master of Business Administration from the Olin Graduate School of Business at Babson College. Ms. Deardorf serves on the Boards of Directors for Crinetics Pharmaceuticals and for NeuroSense Therapeutics. She is also a board member for the Pan-Mass Challenge, a non-profit organization that raises funds for Dana-Farber Center Institute. Major Estimate Revision • Aug 09
Consensus revenue estimates decrease by 13%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$21.2m to US$18.4m. EPS estimate increased from -US$3.01 to -US$2.41 per share. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target broadly unchanged at US$13.18. Share price fell 2.6% to US$8.90 over the past week. Reported Earnings • Aug 02
Second quarter 2023 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2023 results: US$0.56 loss per share (improved from US$0.78 loss in 2Q 2022). Revenue: US$2.89m (down 55% from 2Q 2022). Net loss: US$40.3m (loss narrowed 25% from 2Q 2022). Revenue missed analyst estimates by 34%. Earnings per share (EPS) exceeded analyst estimates by 27%. Revenue is forecast to grow 49% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has fallen by 14% per year but the company’s share price has fallen by 34% per year, which means it is performing significantly worse than earnings. Announcement • Jul 25
Editas Medicine, Inc. Announces Appointment of Linda C. Burkly as Executive Vice President and Chief Scientific Officer Editas Medicine, Inc. announced the appointment of Linda C. Burkly, Ph.D., as the Company's Executive Vice President and Chief Scientific Officer. Dr. Burkly will lead Editas' drug discovery team and activities related to Editas Medicine's pipeline of experimental medicines across all therapeutic areas and indications. Dr. Burkly brings to Editas more than 35 years of experience in biotechnology as a research leader spanning the breadth of the drug discovery and development value chain. Her experience encompasses therapeutic areas of immunological, neurological, and rare genetic disorders. Linda also has a track record of contributing to the foundations of approved medicines and late-stage clinical candidates including Trogarzo(R), Tysabri(R), and Dapirolizumab (Phase 3), her role ranging across inventing therapeutic compositions, discovering novel pathway biology and uses of therapeutic compositions, co-authoring INDs, and leading project teams. Prior to joining Editas, Dr. Burkly held positions of increasing responsibility over a 37-year tenure at Biogen, most recently leading neuroscience-focused research teams as Vice President and Senior Distinguished Investigator from 2014 to 2022. At Biogen, Dr. Burkly invented a novel anti-CD4 mAb that was developed into Trogarzo(R), discovered novel VLA- 4/VCAM biology and uses of VLA-4 blockers including for Crohn's disease, an indication of Tysabri(R), and was Biogen lead on a partnered collaboration with UCB and therein an inventor of Dapirolizumab.Dr. Burkly holds a Ph.D. from Tufts University Graduate School of Biomedical Sciences, Boston, MA, and a B.S. from Fairfield University. She completed a Postdoctoral Fellowship in the laboratory of Richard A. Flavell, Biogen Research Corp. New Risk • Jun 16
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 14% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. 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$251m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (14% increase in shares outstanding). Announcement • Jun 10
Editas Medicine, Inc. Announces Positive Initial Edit-301 Safety and Efficacy Data from the First Four Patients Treated in the Phase I/II Clinical Trial Editas Medicine, Inc. announced positive Initial EDIT-301 Safety and Efficacy Data from the First Four Patients Treated in the RUBY Trial and the First Patient Treated in the EdiTHAL Trial. These promising data support the belief that EDIT-301 can be a clinically differentiated, one-time, durable medicine that can provide life changing clinical benefits to patients with sickle cell disease and beta thalassemia long term, specifically driving early and robust correction of anemia and sustained increases in fetal hemoglobin. EDIT-301 uses AsCas12a, a novel, proprietary, highly efficient, and specific gene editing nuclease, to edit the promoter regions of gamma globin gene 1 and 2 to increase the expression of HbF to mimic the naturally occurring mechanism of hereditary persistence of fetal hemoglobin to treat SCD. The RUBY trial marks the first time AsCas12a was used to successfully edit human cells in a clinical trial. EHA Oral Presentation Details: Title: EDIT-301 Shows Promising Preliminary Safety and Efficacy Results in the Phase I/II Clinical Trial (RUBY) of Patients with Severe Sickle Cell Disease Using Highly Specific and Efficient AsCas12a Enzyme. Presenting Author: Rabi Hanna, M.D., Department of Pediatric Hematology Oncology and Blood and Marrow Transplantation, Cleveland Clinic Children's, Cleveland, OH, United States.