Omega Therapeutics Reports Second Quarter 2024 Financial Results and Highlights Recent Company Progress
Omega Therapeutics (Nasdaq: OMGA) reported Q2 2024 financial results and company progress. Key highlights include:
1. Advancing MYCHELANGELO™ I trial for OTX-2002 in hepatocellular carcinoma, with plans to select recommended dose and initiate expansion cohorts in Q4 2024.
2. Presented preclinical data at ASGCT showing durable gene expression upregulation using epigenomic controllers.
3. Appointed Kaan Certel as Chief Business Officer and elected Richard N. Kender to Board of Directors.
4. Q2 2024 financials: $45.9M cash on hand, expected to fund operations into Q1 2025. R&D expenses decreased to $12.9M from $25.0M in Q2 2023. Net loss reduced to $16.3M from $29.7M in Q2 2023.
Omega Therapeutics (Nasdaq: OMGA) ha riportato i risultati finanziari del secondo trimestre del 2024 e i progressi aziendali. I principali punti salienti includono:
1. Avanzamento della trial MYCHELANGELO™ I per OTX-2002 nel carcinoma epatocellulare, con piani per selezionare la dose raccomandata e avviare coorti di espansione nel quarto trimestre del 2024.
2. Presentati dati preclinici all'ASGCT che mostrano un'espressione genica durevole mediante l'uso di controllori epigenomici.
3. Nomina di Kaan Certel come Chief Business Officer ed elezione di Richard N. Kender nel Consiglio di Amministrazione.
4. Risultati finanziari del secondo trimestre 2024: $45,9M di liquidità disponibile, prevista per finanziare le operazioni fino al primo trimestre del 2025. Le spese per R&S sono diminuite a $12,9M da $25,0M nel secondo trimestre del 2023. La perdita netta è stata ridotta a $16,3M da $29,7M nel secondo trimestre del 2023.
Omega Therapeutics (Nasdaq: OMGA) reportó los resultados financieros del segundo trimestre de 2024 y el progreso de la empresa. Los aspectos destacados incluyen:
1. Avance del ensayo MYCHELANGELO™ I para OTX-2002 en carcinoma hepatocelular, con planes para seleccionar la dosis recomendada e iniciar cohortes de expansión en el cuarto trimestre de 2024.
2. Presentación de datos preclínicos en ASGCT que muestran una regulación duradera de la expresión génica mediante el uso de controladores epigenómicos.
3. Nombramiento de Kaan Certel como Director de Negocios y elección de Richard N. Kender para la Junta Directiva.
4. Resultados financieros del segundo trimestre de 2024: $45.9M en efectivo disponible, previsto para financiar operaciones hasta el primer trimestre de 2025. Los gastos de I+D disminuyeron a $12.9M desde $25.0M en el segundo trimestre de 2023. La pérdida neta se redujo a $16.3M desde $29.7M en el segundo trimestre de 2023.
오메가 테라퓨틱스(Nasdaq: OMGA)가 2024년 2분기 재무 결과와 회사 진행 상황을 보고했습니다. 주요 사항은 다음과 같습니다:
1. OTX-2002의 간세포 암을 위한 MYCHELANGELO™ I 시험을 추진하며, 2024년 4분기에는 권장 용량을 선택하고 확장 코호트를 시작할 계획입니다.
2. ASGCT에서 에피유전학적 조절기를 사용하여 지속적인 유전자 발현 증가를 보여주는 전임상 데이터를 발표했습니다.
3. Kaan Certel을 최고 사업 책임자로 임명하고 Richard N. Kender를 이사회에 선출했습니다.
4. 2024년 2분기 재무: 현금 보유액은 4,590만 달러로, 2025년 1분기까지 운영 자금을 지원할 것으로 예상됩니다. 연구 및 개발 비용은 2023년 2분기 2,500만 달러에서 1,290만 달러로 감소했습니다. 순손실은 2023년 2분기 2,970만 달러에서 1,630만 달러로 줄어들었습니다.
Omega Therapeutics (Nasdaq: OMGA) a publié les résultats financiers du deuxième trimestre 2024 et les avancées de l'entreprise. Les points clés incluent :
1. Avancement de l'essai MYCHELANGELO™ I pour OTX-2002 dans le carcinome hépatocellulaire, avec des plans pour sélectionner la dose recommandée et initier les cohortes d'expansion au quatrième trimestre 2024.
2. Présentation de données précliniques à l'ASGCT montrant une régulation durable de l'expression génique grâce à des contrôleurs épigénomiques.
3. Nommer Kaan Certel en tant que Directeur Commercial et élire Richard N. Kender au Conseil d'Administration.
4. Finances du deuxième trimestre 2024 : 45,9 millions de dollars de liquidités disponibles, prévus pour financer les opérations jusqu'au premier trimestre 2025. Les dépenses en R&D ont diminué à 12,9 millions de dollars contre 25,0 millions de dollars au deuxième trimestre 2023. La perte nette a été réduite à 16,3 millions de dollars contre 29,7 millions de dollars au deuxième trimestre 2023.
Omega Therapeutics (Nasdaq: OMGA) hat die Finanzergebnisse für das zweite Quartal 2024 und den Fortschritt des Unternehmens berichtet. Die wichtigsten Höhepunkte umfassen:
1. Vorantreibung der MYCHELANGELO™ I-Studie für OTX-2002 bei hepatozellulärem Karzinom, mit Plänen zur Auswahl der empfohlenen Dosis und zur Einleitung von Erweiterungskohorten im vierten Quartal 2024.
2. Präsentation präklinischer Daten auf ASGCT, die eine dauerhafte Hochregulierung der Genexpression mit epigenomischen Controllern zeigen.
3. Ernennung von Kaan Certel zum Chief Business Officer und Wahl von Richard N. Kender in den Vorstand.
4. Finanzen des zweiten Quartals 2024: 45,9 Mio. USD in bar, die voraussichtlich die Betriebe bis ins erste Quartal 2025 finanzieren werden. Die F&E-Ausgaben sanken von 25,0 Mio. USD im zweiten Quartal 2023 auf 12,9 Mio. USD. Der Nettoverlust wurde von 29,7 Mio. USD im zweiten Quartal 2023 auf 16,3 Mio. USD reduziert.
- Advanced MYCHELANGELO™ I trial, expecting to initiate expansion cohorts in Q4 2024
- Presented promising preclinical data demonstrating durable gene expression upregulation
- Reduced R&D expenses by $12.1M compared to Q2 2023
- Decreased net loss by $13.4M compared to Q2 2023
- Cash and cash equivalents of $45.9M only expected to fund operations into Q1 2025
Insights
Omega Therapeutics' Q2 2024 financials reveal a mixed picture. While the company has made progress in its clinical trials, its financial position remains challenging. The cash balance of
Positively, R&D expenses decreased by
Investors should monitor the company's cash burn rate and potential financing options closely, as well as progress in the MYCHELANGELO™ I trial, which could be a key value driver for the stock.
Omega Therapeutics' progress with its MYCHELANGELO™ I trial for OTX-2002 in HCC is promising. The advancement to Cohort 6 at 0.2 mg/kg dose level suggests positive safety profile thus far. The planned expansion into monotherapy and combination settings in Q4 2024 could provide crucial efficacy data.
The preclinical data presented at ASGCT demonstrating durable upregulation of gene expression is scientifically significant. It validates the potential of their OMEGA platform to create a novel therapeutic modality targeting disease drivers across various therapeutic areas.
However, investors should note that while preclinical results are encouraging, clinical success is not guaranteed. The company's ability to translate these findings into effective therapies will be critical. The diverse pipeline, including programs in NSCLC and liver regeneration, offers multiple shots on goal but also requires substantial resources to develop.
- Advanced MYCHELANGELO™ I trial; Company expects to select recommended dose for expansion and initiate monotherapy and combination expansion cohorts in fourth quarter of 2024
- Reinforced diverse capabilities of the OMEGA platform at scientific meetings, including demonstration of precise and durable upregulation of gene expression
- Strengthened leadership team with appointment of Kaan Certel, Ph.D., as Chief Business Officer and election of Richard N. Kender to Board of Directors
CAMBRIDGE, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines, today announced financial results for the second quarter ended June 30, 2024, and highlighted recent Company progress.
“We are excited by the meaningful progress achieved to date with our MYCHELANGELO™ I trial, having generated clinical proof-of-platform data that validates the potential of epigenomic controllers as a new class of programmable mRNA therapeutics. As we approach identification of the recommended dose for expansion for OTX-2002, we look forward to sharing updated dose escalation data and initiating expansion cohorts in monotherapy and combination settings in the fourth quarter of this year,” said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. “We are equally energized by the advances we have made with the OMEGA platform, including new preclinical data presented at this year’s ASGCT Annual Meeting showing durable and robust upregulation of gene expression with epigenomic controllers across a broad range of targets. We believe these achievements underscore the potential of our platform to create tremendous value through its ability to prospectively engineer epigenomic controllers with diverse and meaningful therapeutic applications across nearly any human disease.”
Recent Highlights and Key Anticipated Milestones
Development Pipeline and Platform
- Progressed dose escalation portion of Phase 1/2 MYCHELANGELO™ I clinical trial evaluating OTX-2002 in patients with hepatocellular carcinoma (HCC): Made steady progress towards identifying the recommended dose for expansion (RDE) of OTX-2002, with patient enrollment ongoing in Cohort 6 at the 0.2 mg/kg dose level across sites in the U.S. and Asia. The Company expects to report updated clinical data and is planning for expansion into monotherapy and combination settings in the fourth quarter of 2024.
- Presented new preclinical data demonstrating durable upregulation of gene expression at the American Society of Gene and Cell Therapy (ASGCT) 27th Annual Meeting: Data demonstrated durable and robust upregulation of gene expression across a diverse set of gene types and regulatory mechanisms, including turning on inactive genes, augmenting expression of genes with existing but low baseline expression levels, and increasing expression of poised genes that are typically only responsive to certain external stimuli. Additional data showed reversible downregulation and multiplexed upregulation of gene expression. These findings further demonstrate the OMEGA platform’s potential to engineer an entirely novel therapeutic modality to directly target key drivers of disease across therapeutic areas.
- Continued to advance and enhance the OMEGA platform: The Company is evaluating multiple epigenomic controller programs in preclinical studies, including OTX-2101 for non-small cell lung cancer (NSCLC), an HNF4A program in liver regeneration, and development of an epigenomic controller for the management of obesity in collaboration with Novo Nordisk. Core work on platform biology, epigenomic controller design, and characterization of LNP delivery to the lung and other high-value tissues continues to progress.
Corporate
- Strengthened leadership team with appointment of Kaan Certel, Ph.D., as Chief Business Officer and election of Richard N. Kender to Board of Directors: Dr. Certel is a seasoned biopharmaceutical leader and is responsible for Omega’s global business development activities, including strategic partnerships. Mr. Kender brings extensive expertise across corporate finance, business development and corporate licensing, among other roles he held during his career in the pharmaceutical industry, including 35 years spent at Merck & Co., Inc.
Second Quarter 2024 Financial Results
As of June 30, 2024, the Company had cash and cash equivalents totaling
Research and development (R&D) expenses for the second quarter of 2024 were
General and administrative (G&A) expenses for the second quarter of 2024 were
Net loss for the second quarter of 2024 was
About Omega Therapeutics
Omega Therapeutics is a clinical-stage biotechnology company pioneering the development of a new class of programmable epigenomic mRNA medicines to treat or cure a broad range of diseases. By pre-transcriptionally modulating gene expression, Omega’s approach enables precision epigenomic control of nearly all human genes, including historically undruggable and difficult-to-treat targets, without altering native nucleic acid sequences. Founded in 2017 by Flagship Pioneering following breakthrough research by world-renowned experts in the field of epigenetics, Omega is led by a seasoned and accomplished leadership team with a track record of innovation and operational excellence. The Company is committed to revolutionizing genomic medicine and has a pipeline of therapeutic candidates derived from its OMEGA platform spanning oncology, regenerative medicine, and multigenic diseases including inflammatory and cardiometabolic conditions.
For more information, visit omegatherapeutics.com, or follow us on X and LinkedIn.
About the OMEGA Platform
The OMEGA platform leverages the Company’s deep understanding of gene regulation, genomic architecture and epigenetic mechanisms to design programmable epigenomic mRNA medicines that precisely target and modulate gene expression at the pre-transcriptional level. Combining world-class data science capabilities with rational drug design and customized delivery, the OMEGA platform enables control of fundamental epigenetic processes and reprogramming of cellular physiology to address the root cause of disease. Omega’s modular and programmable mRNA medicines, called epigenomic controllers, target specific genomic loci within insulated genomic domains with high specificity to durably tune single or multiple genes to treat and cure diseases through unprecedented precision epigenomic control.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the timing, progress and design of our ongoing Phase 1/2 MYCHELANGELOTM I clinical trial and our preclinical studies, as well as the timing of announcements of data related thereto; the potential of the OMEGA platform to engineer programmable epigenomic mRNA therapeutics that successfully regulate gene expression by targeting insulated genomic domains; expectations surrounding the potential of our product candidates, including OTX-2002; expectations regarding our pipeline, including trial design, initiation of preclinical studies and advancement of multiple preclinical development programs in oncology, regenerative medicine, and multigenic diseases including inflammatory and cardiometabolic conditions; potential franchise opportunities; our anticipated cash runway into the first quarter of 2025; and upcoming events and presentations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the novel technology on which our product candidates are based makes it difficult to predict the time and cost of preclinical and clinical development and subsequently obtaining regulatory approval, if at all; the substantial development and regulatory risks associated with epigenomic controllers due to the novel and unprecedented nature of this new category of medicines; our limited operating history; the incurrence of significant losses and the fact that we expect to continue to incur significant additional losses for the foreseeable future; our need for substantial additional financing; volatility in capital markets and general economic conditions; our investments in research and development efforts that further enhance the OMEGA platform, and their impact on our results; uncertainty regarding preclinical development, especially for a new class of medicines such as epigenomic controllers; potential delays in and unforeseen costs arising from our clinical trials; the fact that our product candidates may be associated with serious adverse events, undesirable side effects or have other properties that could halt their regulatory development, prevent their regulatory approval, limit their commercial potential, or result in significant negative consequences; difficulties manufacturing the novel technology on which our epigenomic controller candidates are based; our ability to adapt to rapid and significant technological change; our reliance on third parties for the manufacture of materials; our ability to successfully acquire and establish our own manufacturing facilities and infrastructure; our reliance on a limited number of suppliers for lipid excipients used in our product candidates; our ability to advance our product candidates to clinical development; and our ability to obtain, maintain, enforce and adequately protect our intellectual property rights. These and other important factors discussed under the caption “Risk Factors” in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and our other filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
CONTACT
Investor contact:
Eva Stroynowski
617.949.4370
estroynowski@omegatx.com
Media contact:
Jason Braco, LifeSci Communications
646.751.4361
jbraco@lifescicomms.com
| Omega Therapeutics, Inc. Consolidated statements of operations and comprehensive loss (Unaudited, In thousands except share and per share data) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Collaboration revenue | $ | 2,134 | $ | 759 | $ | 4,494 | $ | 1,274 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 12,940 | 25,042 | 28,355 | 45,132 | |||||||||||
| General and administrative | 5,774 | 6,557 | 13,170 | 12,800 | |||||||||||
| Total operating expenses | 18,714 | 31,599 | 41,525 | 57,932 | |||||||||||
| Loss from operations | (16,580 | ) | (30,840 | ) | (37,031 | ) | (56,658 | ) | |||||||
| Other income (expense), net: | |||||||||||||||
| Interest income, net | 299 | 957 | 630 | 1,639 | |||||||||||
| Other income (expense), net | (24 | ) | 196 | (33 | ) | 53 | |||||||||
| Total other income, net | 275 | 1,153 | 597 | 1,692 | |||||||||||
| Net loss | $ | (16,305 | ) | $ | (29,687 | ) | $ | (36,434 | ) | $ | (54,966 | ) | |||
| Net loss per common stock attributable to common stockholders, basic and diluted | $ | (0.30 | ) | $ | (0.54 | ) | $ | (0.66 | ) | $ | (1.04 | ) | |||
| Weighted-average common stock used in net loss per share attributable to common stockholders, basic and diluted | 55,150,507 | 55,071,469 | 55,152,746 | 52,861,655 | |||||||||||
| Comprehensive loss: | |||||||||||||||
| Net loss | $ | (16,305 | ) | $ | (29,687 | ) | $ | (36,434 | ) | $ | (54,966 | ) | |||
| Other comprehensive income (loss): | |||||||||||||||
| Unrealized gain on marketable securities | — | 57 | 14 | 308 | |||||||||||
| Comprehensive loss | $ | (16,305 | ) | $ | (29,630 | ) | $ | (36,420 | ) | $ | (54,658 | ) | |||
| Omega Therapeutics, Inc. Condensed Consolidated Balance Sheets (Unaudited, In thousands) | ||||||
| June 30, | December 31, | |||||
| 2024 | 2023 | |||||
| Assets | ||||||
| Cash and cash equivalents | $ | 45,852 | $ | 68,443 | ||
| Marketable securities | — | 4,986 | ||||
| Other assets | 122,373 | 130,937 | ||||
| Total assets | $ | 168,225 | $ | 204,366 | ||
| Liabilities and stockholders’ equity | ||||||
| Liabilities | $ | 141,963 | $ | 146,350 | ||
| Stockholders’ equity | 26,262 | 58,016 | ||||
| Total liabilities and stockholders’ equity | $ | 168,225 | $ | 204,366 | ||
FAQ
What are the key financial results for Omega Therapeutics (OMGA) in Q2 2024?
When does Omega Therapeutics (OMGA) expect to initiate expansion cohorts for the MYCHELANGELO™ I trial?
What new preclinical data did Omega Therapeutics (OMGA) present at the ASGCT Annual Meeting?
How long is Omega Therapeutics' (OMGA) current cash expected to fund operations?
