Tillkännagivande • Apr 01
Omega Therapeutics, Inc. Files Form 15 Omega Therapeutics, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.001 per share. Tillkännagivande • Feb 10
Omega Therapeutics, Inc. Filed for Bankruptcy Omega Therapeutics, Inc. filed a voluntary petition for reorganization under Chapter 11 in the US Bankruptcy Court for the District of Delaware on February 10, 2025. The debtor listed both its assets and liabilities in the range of $100 million to $500 million. The debtor is represented by Jonathan Michael Weyand, Daniel B. Butz, and Derek C. Abbott of Morris, Nichols, Arsht & Tunnell as its legal counsel. The debtor also hired Triple P RTS, LLC to act as restructuring advisor and Triple P Securities, LLC to act as investment banker to the Company, Latham & Watkins LLP, as special counsel to the Company; and Kroll Restructuring Administration LLC, as claims agent and administrative advisor. New Risk • Feb 07
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.8% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-US$58m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Earnings are forecast to decline by an average of 8.8% per year for the foreseeable future. Market cap is less than US$10m (US$6.92m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$76m net loss next year). New Risk • Feb 05
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 24% 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 Risk Share price has been highly volatile over the past 3 months (24% average weekly change). Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$58m). Currently unprofitable and not forecast to become profitable over next 3 years (US$49m net loss in 3 years). Market cap is less than US$100m (US$26.5m market cap). Tillkännagivande • Feb 04
Omega Therapeutics Receives Non-Compliance Letter Regarding Nasdaq Minimum Bid Price Requirement On January 29, 2025, Omega Therapeutics, Inc. received a written notice (the Notice") from The Nasdaq Stock Market, LLC (Nasdaq") notifying the Company that for the last 30 consecutive business days, the bid price for the Company's common stock, par value $0.001 per share (the Common Stock"), had closed below the $1.00 per share minimum bid price requirement for continued inclusion on The Nasdaq Global Market as set in Nasdaq Listing Rule 5450(a)(1) (the Minimum Bid Price Requirement"). The Notice has no effect at this time on the listing of the Common Stock, which continues to trade on The Nasdaq Global Market under the symbol OMGA". In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a period of 180 calendar days, or until July 28, 2025 (the Compliance Date"), to regain compliance with the Minimum Bid Price Requirement. To regain compliance with the Minimum Bid Price Requirement, the closing bid price of the Common Stock must be at least $1.00 per share for a minimum of 10 consecutive business days prior to the Compliance Date. If the Company does not regain compliance with the Minimum Bid Price Requirement by the Compliance Date, the Company may be eligible for a second 180 calendar day compliance period. To qualify, the Company must submit an application to transfer the listing of the Common Stock to The Nasdaq Capital Market, which requires the Company to meet the continued listing requirement for the market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement. The Company would also need to pay an application fee to Nasdaq and to provide written notice of its intention to cure the deficiency during the additional compliance period. As part of its review process, Nasdaq will make a determination of whether it believes the Company will be able to cure this deficiency. If the Company does not qualify for or fails to regain compliance during the additional compliance period, then Nasdaq will notify the Company of its determination to delist its Common Stock, at which point the Company would have an opportunity to appeal the delisting determination to a Nasdaq hearings panel. There can be no assurance that, if the Company decides to appeal any delisting determination, such appeal would be successful. Tillkännagivande • Jan 31
Omega Therapeutics, Inc. Announces Board Changes On January 22, 2025, Ravi Mehrotra, Ph.D. and Robert L. Rosiello each submitted their resignation as a member of the Board of Directors (the “Board”) of Omega Therapeutics, Inc. (the “Company”), effective immediately. On January 24, 2025, the Board appointed Jeffrey T. Varsalone as a Class I director of the Company, effective immediately Mr. Varsalone will also be entitled to indemnification pursuant to an agreement with the Company. There is no arrangement or understanding between Mr. Varsalone and any other person pursuant to which he was selected as a director of the Company, and there is no family relationship between either of Mr. Varsalone and any of the Company’s other directors or executive officers. On January 24, 2025, in order to achieve an equal balance of membership among the classes of directors, the Board determined to move Richard Kender from Class III with a term expiring at the 2027 Annual Meeting of Stock holders to Class II with a term expiring at the 2026 Annual Meeting of Stockholders. Accordingly, on the same date, Mr., Kender, who was a Class III Director, resigned as a director and was immediately elected by the Board as a Class II Director The Board now consists of two Class I Directors, two Class II Directors, and two Class III Directors. Tillkännagivande • Jan 13
Omega Therapeutics, Inc. Announces Resignation of Christian S. Schade as Chair, Member of the Board of Directors, and as A Member of the Nominating, Corporate Governance and Compensation Committees of the Board On January 10, 2025, Christian S. Schade submitted his resignation as Chair and a member of the Board of Directors of Omega Therapeutics, Inc., and as a member of the Nominating and Corporate Governance and Compensation Committees of the Board, effective immediately. Tillkännagivande • Jan 02
Omega Therapeutics, Inc. Announces Resignation of Michelle C. Werner as Member of the Board of Directors and the Nominating and Corporate Governance Committee On December 30, 2024, Michelle C. Werner notified Omega Therapeutics, Inc. of her resignation as a member of the Board of Directors of the Company and the Nominating and Corporate Governance Committee of the Board, effective immediately. Reported Earnings • Nov 17
Third quarter 2024 earnings: EPS in line with analyst expectations despite revenue beat Third quarter 2024 results: US$0.30 loss per share (improved from US$0.40 loss in 3Q 2023). Net loss: US$16.4m (loss narrowed 26% from 3Q 2023). Revenue is forecast to grow 65% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Board Change • Nov 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Rob Rosiello was the last director to join the board, commencing their role in 2024. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Oct 07
Omega Therapeutics, Inc. Elects Robert L. Rosiello as Class I Director Omega Therapeutics, Inc. announced on October 2, 2024 (the effective date), the board of directors (the board) of the company elected Robert L. Rosiello as a Class I director of the company, effective immediately. Tillkännagivande • Sep 17
Omega Therapeutics, Inc. Announces Publication of Epigenomic Controller OTX-2002 Preclinical Data in Nature Communications Omega Therapeutics, Inc. announced the publication of preclinical data from studies of OTX-2002 in Nature Communications. The article highlights the potential of Omega’s approach to precision epigenomic control and the ability of OTX-2002 to controllably regulate the historically undruggable MYC gene in multiple models of hepatocellular carcinoma (HCC), the most common type of primary liver cancer. OTX-2002 is a first-in-class, bicistronic mRNA-encoded epigenomic controller (EC) delivered via liver-targeting lipid nanoparticles that is designed to durably downregulate MYC expression pre-transcriptionally via two different epigenetic modifications at two distinct genomic loci within the MYC gene. MYC is a master transcription factor that regulates cell proliferation, differentiation and apoptosis and plays a significant role in more than 50% of all human cancers. The publication, titled “Targeted Transcriptional Downregulation of MYC Using Epigenomic Controllers Demonstrates Antitumor Activity in Hepatocellular Carcinoma Models,” describes OTX-2002 and its effects on tumor growth in cellular and animal models of HCC. Treatment with OTX-2002 resulted in the following: Rapid reduction in both MYC mRNA and protein levels, Decreased viability of multiple HCC cell lines, Dose-dependent reduction in tumor size and growth rate in preclinical models of HCC, Antitumor activity and mechanism of action that is synergistic when combined with either tyrosine kinase inhibitors or immune checkpoint inhibitor agents, Beneficial impact on the tumor microenvironment in immune-competent mice bearing HCC tumors as evidenced by a decrease in inhibitory regulatory T cells. OTX-2002 is currently under clinical evaluation in the Phase 1/2 MYCHELANGELO™ I trial in adult patients with HCC and other MYC-associated solid tumors. Tillkännagivande • Aug 14
Omega Therapeutics, Inc. Announces Executive Changes Omega Therapeutics, Inc. announced the addition of Jennifer Nelson, Ph.D., to the Company’s executive leadership team in the role of Senior Vice President of Research. She brings over 20 years of experience working with RNA- and DNA-based therapies and technologies, and extensive expertise as a leader in building novel platforms. Prior to joining Omega, Dr. Nelson served as Vice President of Research at Flagship Pioneering, where she helped launch and develop bio-platform companies, including oversight of platform-related strategy and research. Previously, she served as Head of Vaccines at Laronde, having formerly led Platform Research, and played pivotal roles throughout her tenure advancing the company’s preclinical development, manufacturing capabilities and portfolio and IP strategy. Earlier in her career, Dr. Nelson held management positions of increasing responsibility at Moderna Therapeutics, culminating in a leading role advancing novel approaches to leveraging mRNA for therapeutic purposes. Dr. Nelson began her industry career at Archemix Therapeutics and later worked at GSK prior to joining Moderna. Dr. Nelson is an author on numerous articles and patents focused on various nucleic acid technologies, including mRNA, circular RNA, ribozymes and aptamers. She received a Ph.D. in Chemistry and Biochemistry from the University of Colorado Boulder, a Master of Liberal Arts in Extension Studies, field: Management from Harvard University, and a B.A. from Northwestern University. Thomas McCauley, Ph.D., who served as Chief Scientific Officer since 2019, will leave the company to pursue a new opportunity. Major Estimate Revision • Aug 13
Consensus revenue estimates increase by 30% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$5.72m to US$7.45m. Forecast losses expected to reduce from -US$1.30 to -US$1.19 per share. Biotechs industry in the US expected to see average net income decline 9.8% next year. Consensus price target broadly unchanged at US$11.13. Share price fell 8.8% to US$1.50 over the past week. New Risk • Aug 08
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.5% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-US$67m free cash flow). Earnings are forecast to decline by an average of 8.5% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$98m net loss in 3 years). Share price has been volatile over the past 3 months (14% average weekly change). Market cap is less than US$100m (US$84.4m market cap). Reported Earnings • Aug 07
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations Second quarter 2024 results: US$0.30 loss per share (improved from US$0.54 loss in 2Q 2023). Net loss: US$16.3m (loss narrowed 45% from 2Q 2023). Revenue exceeded analyst estimates by 113%. Earnings per share (EPS) also surpassed analyst estimates by 16%. Revenue is forecast to grow 62% 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 58% per year but the company’s share price has fallen by 55% per year, which means it is significantly lagging earnings. Tillkännagivande • Jun 24
Omega Therapeutics, Inc. Appoints Richard N. Kender to Board of Directors Omega Therapeutics, Inc. announced the election of Richard N. Kender to its Board of Directors following its annual meeting of stockholders. Mr. Kender’s industry knowledge and proven expertise in corporate finance and business development spanning both large pharmaceutical and emerging biotech companies will be instrumental in supporting the Company’s business objectives. Richard N. Kender is a recognized business leader with an extensive career in the pharmaceutical industry, including 35 years spent at Merck & Co., Inc. During his tenure at Merck, he held various roles across corporate development, including M&A, licensing, financial evaluation and analysis, and global competitive intelligence. Most recently, he served as Senior Vice President, Business Development and Corporate Licensing from 2000 until his retirement in 2013. Over his career, he has been involved in numerous strategic transactions and played an instrumental role in Merck’s acquisition of Schering Plough. Mr. Kender currently serves on the board of directors of Seres Therapeutics, POXEL SA, Longeveron Inc. and Bicycle Therapeutics. He received a Bachelor of Science in accounting from Villanova University and a Master of Business Administration from Fairleigh Dickinson University. Tillkännagivande • May 29
Omega Therapeutics, Inc. Appoints Kaan Certel, Ph.D., as Chief Business Officer Omega Therapeutics, Inc. announced the appointment of Kaan Certel, Ph.D., as Chief Business Officer. Dr. Certel brings to Omega extensive biopharmaceutical industry experience and will be responsible for global business development activities including strategic partnerships. Dr. Certel is a recognized business development leader with over 20 years of experience in the biopharmaceutical industry and academia. Most recently, he served as the Chief Business Officer at BioCity Biopharma, where he led the expansion of the global business development function and coordinated efforts to establish collaborations for the development of pipeline assets. Previously, Dr. Certel was the Global Head of Oncology External Innovation at Sanofi, where he played a pivotal role in strengthening the oncology portfolio by assessing in-licensing opportunities and spearheading numerous strategic collaborations. Notably, he also played a key role in the successful launch of X-Chem Pharmaceuticals’ immuno-oncology spin-off, overseeing scientific strategic development, pipeline generation, project management and talent acquisition. Dr. Certel received a Ph.D. in Genetics from the University of Iowa and completed a postdoctoral fellowship at the Koch Institute for Integrative Cancer Research at the Massachusetts Institute of Technology (MIT). Major Estimate Revision • May 13
Consensus revenue estimates increase by 24% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$3.37m to US$4.20m. Forecast losses expected to reduce from -US$1.26 to -US$1.24 per share. Biotechs industry in the US expected to see average net income decline 9.8% next year. Consensus price target of US$11.00 unchanged from last update. Share price fell 14% to US$1.96 over the past week. Reported Earnings • May 06
Full year 2023 earnings released: US$1.80 loss per share (vs US$2.15 loss in FY 2022) Full year 2023 results: US$1.80 loss per share (improved from US$2.15 loss in FY 2022). Net loss: US$97.4m (loss narrowed 5.1% from FY 2022). Products in clinical trials Phase I: 1 Revenue is forecast to grow 58% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. New Risk • May 06
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 6.8% 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 Risks Less than 1 year of cash runway based on free cash flow trend (-US$94m free cash flow). Earnings are forecast to decline by an average of 6.8% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$139m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Revenue is less than US$5m (US$3.1m revenue). Tillkännagivande • May 01
Omega Therapeutics, Inc., Annual General Meeting, Jun 20, 2024 Omega Therapeutics, Inc., Annual General Meeting, Jun 20, 2024, at 14:30 US Eastern Standard Time. Agenda: To elect Rainer J. Boehm, M.D., Richard N. Kender and Elliott M. Levy, M.D. as Class III Directors to serve until the 2027 Annual Meeting of Stockholders, and until their respective successors shall have been duly elected and qualified; to ratify the appointment of Deloitte & Touche LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; to approve an amendment to Restated Certificate of Incorporation to provide for exculpation of officers from breaches of fiduciary duty to the fullest extent permitted by the General Corporation Law of the State of Delaware; and to consider and approve other matters of business. Tillkännagivande • Apr 09
Omega Therapeutics, Inc. Presents New Preclinical Data At AACR 2024 Supporting the Potential of Precision Epigenomic Control Omega Therapeutics, Inc. announced the presentation of new preclinical data demonstrating the anti-tumor effect of a MYC-targeting epigenomic controller (MYC-EC) in models of EGFR inhibitor (EGFRi)-resistant non-small cell lung cancer (NSCLC) at the American Association for Cancer Research Annual Meeting 2024, taking place in San Diego, California, April 5 - 10. The Company also presented preclinical data validating a novel pharmacodynamic biomarker assay for monitoring on-target engagement and activity of its clinical-stage EC candidate, OTX-2002. Key Findings: The combination of a MYC-directed EC (NSCLC MYC-EC) with osimertinib, a third generation EGFRi blocker, led to enhanced downregulation of MYC protein levels and synergistically inhibited viability of EGFR-T790M mutation or epithelial to mesenchymal transition (EMT) retained sensitivity to epigenomic downregulation of MYC expression with NSCLC MYC MYC MYC-EC in multiple in vitro models; These results support potential development of a NSCLC MYC MYR-EC in EGFR-mutant NSCLC as a combination therapy with o Simertinib, and as a monotherapy in osimertinib-resistant NSCLC. Key Findings: Development of a new DNA methylation assay consisting of a minimal hybridization capture panel to evaluate CpG methylation events across a 50 kilobase target region; Ultra-sensitive detection of methylation events at the MYC locus down to the theoretical limit of 1 in 104 copies of MYC. Demonstration of highly specific on-target engagement and methylation by OTX-2002 in liquid biopsies from mice bearing human hepatocellular carcinoma (HCC) xenografts. Major Estimate Revision • Apr 04
Consensus revenue estimates increase by 43% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$1.23m to US$1.77m. Forecast losses expected to reduce from -US$1.83 to -US$1.26 per share. Biotechs industry in the US expected to see average net income decline 9.6% next year. Consensus price target down from US$12.20 to US$11.00. Share price fell 19% to US$2.89 over the past week. Price Target Changed • Apr 01
Price target decreased by 9.2% to US$11.20 Down from US$12.33, the current price target is an average from 5 analysts. New target price is 250% above last closing price of US$3.20. Stock is down 47% over the past year. The company is forecast to post a net loss per share of US$1.31 next year compared to a net loss per share of US$1.80 last year. Reported Earnings • Mar 28
Full year 2023 earnings released: US$1.80 loss per share (vs US$2.15 loss in FY 2022) Full year 2023 results: US$1.80 loss per share (improved from US$2.15 loss in FY 2022). Net loss: US$97.4m (loss narrowed 5.1% from FY 2022). Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Major Estimate Revision • Nov 16
Consensus revenue estimates increase by 26% The consensus outlook for revenues in fiscal year 2023 has improved. 2023 revenue forecast increased from US$2.08m to US$2.61m. Forecast losses expected to reduce from -US$2.14 to -US$1.85 per share. Biotechs industry in the US expected to see average net income growth of 5.7% next year. Consensus price target of US$12.20 unchanged from last update. Share price rose 10% to US$1.86 over the past week. Tillkännagivande • Nov 15
Omega Therapeutics, Inc. Showcases Bidirectional and Multiplexed Epigenomic Control of Gene Expression in Preclinical Models of Liver Inflammation and Fibrosis Omega Therapeutics, Inc. announced the presentation of new preclinical data from two different programs that demonstrated sustained upregulation of gene expression and coordinated pre-transcriptional downregulation of multiple genes in models of liver fibrosis and inflammation, respectively, at the American Association for the Study of Liver Diseases' (AASLD) The Liver Meeting 2023, taking place in Boston, Massachusetts, November 10 - 14. Poster 3444-A: Induction of Hepatocyte Nuclear Factor 4 alpha (HNF4a) using novel epigenomic controllers. Key Findings: Human cell lines treated with an epigenomic controller (EC) engineered to modulate the epigenetic profile of the P1 promoter of the HFN4a gene, a master regulator of liver development and function, showed strong increases of mRNA and protein levels. Upregulation of HFN4a expression following a single EC treatment persisted for =10 days and induced strong and durable increases in HNF4a mRNA levels in primary human hepatocytes. EC-mediated upregulation of HNF4a expression correlated with significantly reduced expression of clinically relevant fibrotic genes in vitro. Single administration of an EC in the humanized FRG mouse model resulted in induction of HNF4a mRNA levels compared to untreated FRG mice. EC-mediated induction of HNF4a expression in vivo in a mouse model of liver fibrosis led to decreased collagen deposition, a key marker of fibrosis. Regulation of HNF4a also led to changes in expression of other fibrosis-associated genes. Poster 2621-A: Targeting CXCL9/CXCL10/CXCL11 using novel epigenomic controllers for the treatment of inflammatory liver disease. Key Findings: Treatment of mouse and human liver cells with ECs engineered to pre-transcriptionally downregulate the expression CXCL9, CXCL10 and CXCL11 resulted in robust mRNA downregulation and decreased protein levels of all three chemokines. Primary human hepatocytes stimulated with interferon gamma (INFG) and treated with a single EC targeting CXCL9-11 resulted in a statistically significant decrease in mRNA expression and protein levels of each chemokine compared to INFG stimulation alone. Human T cells exposed to conditioned media from primary human hepatocytes treated with INFG and an EC targeting CXCL9-11 displayed 75% reduced migration compared to cells treated with INFG alone. Reported Earnings • Nov 10
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$0.40 loss per share (improved from US$0.54 loss in 3Q 2022). Net loss: US$22.2m (loss narrowed 14% from 3Q 2022). Revenue exceeded analyst estimates by 117%. Earnings per share (EPS) also surpassed analyst estimates by 27%. Revenue is forecast to grow 75% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. Tillkännagivande • Oct 17
Omega Therapeutics, Inc. Presents New Preclinical Data Supporting the Potential of OTX-2101 in Combination Settings for Treatment of NSCLC Omega Therapeutics, Inc. announced new preclinical data supporting the potential of OTX-2101, a c-MYC-targeting epigenomic controller (MYC-EC) being developed for the treatment of non-small cell lung cancer (NSCLC), in combination with immune checkpoint inhibitors or EGFR inhibitors at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics which took place in Boston, Mass., October 11 -- 15, 2023. These new data build on previous results demonstrating anti-tumor activity of OTX-2101 as a monotherapy in preclinical NSCLC models and highlight its potential ability to synergize with clinically validated strategies. These encouraging results give confidence in OTX-2101's potential as meaningful new treatment option for patients living with NSCLC. New Risk • Oct 05
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: US$95.1m 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 (15% average weekly change). Earnings are forecast to decline by an average of 3.1% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$177m net loss in 3 years). Shareholders have been diluted in the past year (15% increase in shares outstanding). Revenue is less than US$5m (US$2.6m revenue). Market cap is less than US$100m (US$95.1m market cap). Tillkännagivande • Sep 27
Omega Therapeutics Announces Promising Preliminary Clinical Data for OTX-2002 from Ongoing MYCHELANGELO I Trial Omega Therapeutics, Inc. announced encouraging preliminary safety, tolerability, pharmacokinetic and translational data from the initial two dose level cohorts (n=8) from Part 1 of its ongoing Phase 1/2 MYCHELANGELO™ I study evaluating OTX-2002 in patients with hepatocellular carcinoma (HCC) and other solid tumors associated with the c-MYC (MYC) gene. OTX-2002, the Company’s lead development candidate, is designed to pre-transcriptionally downregulate MYC, a master oncogene implicated in more than 50% of all cancers and approximately 70% of HCC cases. MYCHELANGELO I (NCT05497453) is an ongoing Phase 1/2 open label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of OTX-2002 as a monotherapy (Part 1) and in combination with standard of care therapies (Part 2) in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. These preliminary data cover the first two dose cohorts from the monotherapy dose escalation portion of the trial, which is currently being conducted at clinical sites across the United States and Asia. Patients were treated intravenously with either 0.02 mg/kg (n=4) or 0.05 mg/kg (n=4) of OTX-2002 once every two weeks. Changes in MYC DNA methylation and mRNA levels were analyzed through measurements of cell-free DNA and exosomal mRNA, respectively. As of the data cut-off date of September 18, 2023, one HCC patient in the 0.05 mg/kg dose level cohort remained on treatment. Based on these encouraging data, OTX-2002 continues to advance in monotherapy dose escalation. Following the identification of a recommended dose, the Company expects to initiate expansion cohorts in monotherapy and in combination with standard of care therapies. Price Target Changed • Sep 12
Price target increased by 8.6% to US$13.40 Up from US$12.33, the current price target is an average from 5 analysts. New target price is 306% above last closing price of US$3.30. Stock is down 50% 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$2.14 last year. Board Change • Sep 03
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Director Michelle Werner was the last director to join the board, commencing their role in 2023. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Reported Earnings • Aug 04
Second quarter 2023 earnings: Revenues exceed analysts expectations while EPS lags behind Second quarter 2023 results: US$0.54 loss per share. Net loss: US$29.7m (loss widened 15% from 2Q 2022). Revenue exceeded analyst estimates by 77%. Earnings per share (EPS) missed analyst estimates by 7.6%. Revenue is forecast to grow 73% p.a. on average during the next 3 years, compared to a 16% growth forecast for the Biotechs industry in the US. Tillkännagivande • Jul 13
Omega Therapeutics Appoints Chris Schade to Its Board of Directors Omega Therapeutics, Inc. announced the appointment of Chris Schade to its Board of Directors. Mr. Schade brings over 30 years of experience across the biopharma industry to support the Company’s long-term growth objectives. Mr. Schade is a seasoned executive with over 30 years of experience across private and public biopharma companies, including proven leadership in several executive roles. He joined Flagship Pioneering as a Growth Partner in January of this year. Previously, he was President and Chief Executive Office of Aprea Therapeutics, where he has been serving as a member of the board since 2016 and as Chairman of the board since 2020. Prior to Aprea, he held leadership positions at Novira, Omthera Pharmaceuticals and Medarex. In addition to industry expertise, Schade brings extensive corporate finance and capital markets experience from the investment banking industry, with roles at Merrill Lynch and JP Morgan Chase & Co. He also serves on the board of directors of Sapience Therapeutics, Inc., Integra LifeSciences, Inc., Ring Therapeutics and Alltrna Therapeutics. He received a Master of Business Administration from the Wharton School at the University of Pennsylvania and a Bachelor of Arts from Princeton University. Price Target Changed • May 26
Price target decreased by 9.0% to US$11.83 Down from US$13.00, the current price target is an average from 6 analysts. New target price is 49% above last closing price of US$7.96. Stock is up 259% over the past year. The company is forecast to post a net loss per share of US$2.05 next year compared to a net loss per share of US$2.14 last year. Major Estimate Revision • May 11
Consensus EPS estimates upgraded to US$2.23 loss The consensus outlook for fiscal year 2023 has been updated. 2023 losses forecast to reduce from -US$2.49 to -US$2.23 per share. Revenue forecast steady at US$1.21m. Biotechs industry in the US expected to see average net income decline 50% next year. Consensus price target of US$12.33 unchanged from last update. Share price rose 3.1% to US$7.96 over the past week. Breakeven Date Change • May 10
Forecast to breakeven in 2025 The 4 analysts covering Omega Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$91.5m in 2025. Average annual earnings growth of 21% is required to achieve expected profit on schedule. Price Target Changed • May 06
Price target increased by 14% to US$14.80 Up from US$13.00, the current price target is an average from 5 analysts. New target price is 68% above last closing price of US$8.82. Stock is up 147% over the past year. The company is forecast to post a net loss per share of US$2.10 next year compared to a net loss per share of US$2.14 last year. Major Estimate Revision • Mar 26
Consensus revenue estimates increase by 57% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from US$780.0k to US$1.22m. EPS estimate unchanged at -US$2.49. Biotechs industry in the US expected to see average net income decline 50% next year. Consensus price target of US$13.00 unchanged from last update. Share price fell 30% to US$6.84 over the past week. Recent Insider Transactions Derivative • Mar 23
Board Member notifies of intention to sell stock Richard Young intends to sell 10k shares in the next 90 days after lodging an Intent To Sell Form on the 17th of March. If the sale is conducted around the recent share price of US$8.00, it would amount to US$80k. Since June 2022, Richard's direct individual holding has decreased from 794.12k shares to 764.12k. There have been no trades via on-market transactions or options from company insiders in the last 12 months. Breakeven Date Change • Mar 02
Forecast to breakeven in 2025 The 4 analysts covering Omega Therapeutics expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$88.1m in 2025. Average annual earnings growth of 26% is required to achieve expected profit on schedule. Price Target Changed • Feb 12
Price target decreased by 17% to US$13.00 Down from US$15.60, the current price target is an average from 6 analysts. New target price is 119% above last closing price of US$5.94. Stock is down 54% over the past year. The company is forecast to post a net loss per share of US$2.12 next year compared to a net loss per share of US$3.05 last year. Recent Insider Transactions Derivative • Jan 14
Board Member notifies of intention to sell stock Richard Young intends to sell 20k shares in the next 90 days after lodging an Intent To Sell Form on the 10th of January. If the sale is conducted around the recent share price of US$8.00, it would amount to US$160k. Since June 2022, Richard's direct individual holding has decreased from 794.12k shares to 764.12k. There has only been one transaction (US$6.0k purchase) from insiders over the last 12 months. Major Estimate Revision • Nov 16
Consensus revenue estimates increase by 62% The consensus outlook for revenues in 2022 has improved. 2022 revenue forecast increased from US$930.0k to US$1.50m. Forecast losses expected to reduce from -US$2.23 to -US$2.13 per share. Biotechs industry in the US expected to see average net income decline 93% next year. Consensus price target broadly unchanged at US$15.80. Share price rose 34% to US$6.20 over the past week. Price Target Changed • Nov 09
Price target increased to US$18.50 Up from US$16.25, the current price target is an average from 5 analysts. New target price is 303% above last closing price of US$4.59. Stock is down 79% over the past year. The company is forecast to post a net loss per share of US$2.27 next year compared to a net loss per share of US$3.05 last year. Tillkännagivande • Nov 03
Omega Therapeutics Receives Orphan Drug Designation for OTX-2002 for the Treatment of Hepatocellular Carcinoma Omega Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OTX-2002, the company's first-in-class epigenomic controller engineered to downregulate c-Myc (MYC), for the treatment of hepatocellular carcinoma (HCC). The company recently announced that the first patient had been dosed in its Phase 1/2 MYCHELANGELO(TM) I clinical trial investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy and in combination with standard of care therapies in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. Tillkännagivande • Oct 28
Omega Therapeutics, Inc. Announces First Patient Dosed in Landmark MYCHELANGELO(TM) I Trial of OTX-2002 in Hepatocellular Carcinoma and Other Solid Tumor Types Associated with the MYC Oncogene Omega Therapeutics, Inc. announced dosing of the first patient in its Phase 1/2 MYCHELANGELO™ I trial evaluating OTX-2002 for the treatment of relapsed or refractory hepatocellular carcinoma (HCC) and other solid tumor types associated with c-Myc (MYC) oncogene overexpression. OTX-2002, a novel epigenomic controller, is an mRNA therapeutic designed to downregulate MYC expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The Phase 1/2 MYCHELANGELO I trial (NCT05497453) will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a monotherapy (Part 1) and in combination with standard of care therapies (Part 2) in patients with relapsed or refractory HCC and other solid tumor types known for association with the MYC oncogene. The study is expected to enroll approximately 190 patients at clinical trial sites in the United States, Asia, and Europe. Omega has previously announced preclinical data supporting OTX-2002's mechanism of action and antitumor activity in multiple in vitro and in vivo models. The Company demonstrated OTX-2002's ability to modulate the epigenetic profile of MYC and control its expression pre-transcriptionally in multiple in vitro studies. Preclinical studies also showed that OTX-2002 induced robust antitumor activity alone and in combination with standard of care therapies in multiple in vivo HCC models. Additionally, treatment with OTX-2002 resulted in successful pre-transcriptional downregulation of hepatocyte MYC expression in non-human primates. Cumulatively, these preclinical data support the clinical potential of OTX-2002 to provide a novel treatment strategy for patients with HCC. Tillkännagivande • Oct 13
Omega Therapeutics, Inc. Unveils New Epigenomic Controller Development Candidate Targeting MYC Driven Non-Small Cell Lung Cancer Omega Therapeutics, Inc. announced that it has selected OTX-2101 as the next Omega Epigenomic Controller(TM) (OEC) development candidate to advance into Investigational New Drug (IND)-enabling studies for the treatment of non-small cell lung cancer (NSCLC). Omega scientists rationally engineered OTX-2101 to control the expression of the c-Myc (MYC) oncogene, a historically undruggable target in NSCLC. MYC is a master transcription factor that regulates cell proliferation, differentiation and apoptosis and plays a significant role in more than 50% of all human cancers. Genetic analysis has revealed that MYC overexpression is present in approximately 60% of NSCLC. Preclinical data presented at the 2022 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting showed that OTX-2101 potently down-regulates MYC in multiple NSCLC cell lines. OTX-2101 effectively reduced tumor growth in vivo and was well tolerated in murine xenograft models, further supporting its clinical potential. IND-enabling activities for OTX-2101 are underway. The OTX-2101 clinical development program will utilize a lung tissue-targeting lipid nanoparticle (LNP) technology exclusively licensed from Nitto Denko Corporation ("Nitto"). This represents the first option exercised by the Company as part of an existing arrangement that provides Omega the option to exclusively license Nitto's LNP technology for therapeutic development across multiple targets and tissue types. Tillkännagivande • Sep 02
Omega Therapeutics, Inc. Announces Appointment of Rainer Boehm to its Board of Directors Omega Therapeutics, Inc. announced the appointment of Rainer Boehm as an independent director to its Board of Directors. Mr. Boehm will serve on Omega's audit and compensation committees. Mr. Boehm brings over 30 years of clinical and managerial experience to Omega. He held several senior management positions during his extensive tenure at Novartis Pharma AG and its predecessor, CIBA-Geigy, spanning from 1988 to 2017, most recently as Chief Commercial & Medical Affairs Officer. He was a key figure in the successful establishment of Novartis Oncology. He oversaw the launch and life cycle management of many blockbuster brands in different geographies globally, amongst them Femara, Zometa and Glivec in oncology, as well as Cosentyx and Entresto and the immunology and cardiovascular disease areas. Prior to joining Novartis, he served as unit head at the Psychiatric Hospital in Zwiefalten, Germany. Mr. Boehm serves on the boards of Cellectis SA, Humanigen Inc., BioCopy, AG (private) and Berlin Cures, AG (private). He holds a medical degree from the University of Ulm in Germany, and a Master of Business Administration from Schiller University, Strasbourg Campus in France. Recently he commenced a Master of Public Health program at the Universities of Basel /Bern /Zurich in Switzerland. Major Estimate Revision • Aug 11
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast increased from US$360.0k to US$840.0k. EPS estimate fell from -US$2.17 to -US$2.25 per share. Biotechs industry in the US expected to see average net income decline 46% next year. Consensus price target of US$16.50 unchanged from last update. Share price was steady at US$4.67 over the past week. Price Target Changed • Aug 05
Price target increased to US$20.67 Up from US$16.25, the current price target is an average from 4 analysts. New target price is 320% above last closing price of US$4.92. Stock is down 70% over the past year. The company is forecast to post a net loss per share of US$2.24 next year compared to a net loss per share of US$3.05 last year. Board Change • Jul 31
High number of new directors Independent Director Luke Beshar was the last director to join the board, commencing their role in 2021. Tillkännagivande • Jul 15
Omega Therapeutics, Inc. Announces U.S. Food and Drug Administration Clearance of IND Application for OTX-2002 Omega Therapeutics, Inc. announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1/2, first-in-human, clinical study of OTX-2002 for the treatment of hepatocellular carcinoma (HCC). OTX-2002, an Omega Epigenomic Controller (OEC), is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. Tillkännagivande • Jul 01
Omega Therapeutics, Inc. Presents New Preclinical Data Supporting the First Epigenomic Controller, Otx-2002, as A Potential Therapeutic Approach in Hepatocellular Carcinoma At the Esmo 2022 World Congress on Gastrointestinal Cancer Omega Therapeutics, Inc. announced the presentation of new preclinical data on its lead product candidate, OTX-2002, to regulate expression of the c-Myc (MYC) oncogene through epigenetic modulation in multiple models of hepatocellular carcinoma (HCC) in a poster presentation at the European Society of Medical Oncology (ESMO) 2022 World Congress on Gastrointestinal (GI) Cancer, taking place in Barcelona, Spain, June 29 – July 2, 2022. Key findings:In non-human primates, treatment with OTX-2002 resulted in durable reduction of MYC mRNA levels in liver consistent with previous in vitro and in vivo studies, OTX-2002 treatment decreased MYC mRNA and protein levels and cell viability in multiple HCC cell lines, while sparing normal cells, OTX-2002 significantly reduced tumor growth in HCC xenografts models, OTX-2002 treatment is associated with decreased expression of the immune checkpoint factor PD-L1 in HCC cells, suggesting a potential role for combination therapy with immune checkpoint inhibitors, Combining OTX-2002 with existing standard of care therapies for HCC resulted in further reduction of cell viability and tumor burden in both in vitro and in vivo HCC models, respectively, OTX-2002 treatment demonstrated synergistic activity with AKT inhibition in HCC cells, highlighting additional possible combination approaches. Tillkännagivande • Jun 16
Omega Therapeutics, Inc. Announces Submission of Investigational New Drug Application for Otx-2002 Omega Therapeutics, Inc. announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company's lead product candidate, OTX-2002, for the treatment of hepatocellular carcinoma (HCC). OTX-2002, an Omega Epigenomic Controller, is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The Company plans to initiate a Phase 1 clinical trial in the U.S. to evaluate OTX-2002, following FDA clearance. Board Change • Apr 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Luke Beshar was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Tillkännagivande • Mar 31
Omega Therapeutics Inc. Announces Executive Changes Omega Therapeutics, Inc. announced the appointment of Kevin McManus as Chief Human Resources Officer and Ling Zeng, Esq., as Chief Legal and Administrative Officer. Mr. McManus has extensive experience developing and implementing strategies to enhance growth and attract and retain talent while strengthening company culture. Ms. Zeng has deep experience in the healthcare industry, navigating a myriad of responsibilities around corporate governance, compliance, reputation, intellectual property, and operations. Mr. McManus most recently served as Senior Vice President and Chief Human Resources Officer at Acceleron Pharma, where he was responsible for leading human resources, information technology and facilities functions. During his time at Acceleron. Ms. Zeng most recently served as Chief Legal Officer and Secretary at Dicerna Pharmaceuticals where she worked alongside other executives, the board of directors and their committees to develop and implement company strategy, policy, compliance, and governance activities. Board Change • Jan 01
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Luke Beshar was the last director to join the board, commencing their role in 2021. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model.