RNA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• We expect to generate revenue from research and development and clinical trial activities. This revenue comes from license and research collaboration agreements, including reimbursements for services, upfront payments, and milestone payments under current and future agreements.

• We do not expect to generate revenue from product sales until our candidates successfully advance through clinical development and receive regulatory approval,

• if ever. Consequently, our revenue may fluctuate quarterly, influenced by the timing and amounts of payments related to our services and milestones. Any setbacks in preclinical or clinical development, or failure to secure regulatory approval, could adversely affect our ability to generate future re…

• Research and development expenses increased by $2.1 million for the three months ended June 30, 2026, as compared to the same period in 2025. External costs decreased by $0.4 million primarily as a result of normal fluctuations in operating activities. Internal costs increased by $2.4 million primar…

• General and administrative expenses increased by $6.9 million for the three months ended June 30, 2026, as compared to the same period in 2025, primarily due to $2.3 million in higher personnel costs including salaries, wages and executive transition bonus award, and $4.0 million in external spend t…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• We expect to generate revenue from research and development and clinical trial activities. This revenue comes from license and research collaboration agreements, including reimbursements for services, upfront payments, and milestone payments under current and future agreements. As of March 31, 2026,…

• We do not expect to generate revenue from product sales until our candidates successfully advance through clinical development and receive regulatory approval, if ever. Consequently, our revenue may fluctuate quarterly, influenced by the timing and amounts of payments related to our services and mil…

• Research and development expenses increased by $9.7 million for the three months ended March 31, 2026, as compared to the same period in 2025. External costs increased $3.9 million primarily due to a $3.2 million increase in contract manufacturing costs and $0.7 million increase in other development…

• General and administrative expenses increased by $18.2 million for the three months ended March 31, 2026, as compared to the same period in 2025, primarily due to $6.4 million in higher personnel costs including salaries, wages and accelerated vesting of stock-based compensation, and $8.7 million in…

• We have incurred net losses and negative cash flow from operations since inception and we anticipate that we will continue to incur net losses for the foreseeable future. Historically, we have depended on Avidity to fund our operations as Avidity used a centralized approach to cash management and fi…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• that the initial request for designation was materially defective. In addition, orphan drug exclusivity does not prevent the FDA from approving competing drugs containing different active ingredients for the same or similar indication. In addition, if a subsequent drug is approved for marketing for …

• certain policies and executive orders directed toward reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA and the USPTO, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the ability of these agencie…

• Because we currently rely on third parties to manufacture our product candidates and to perform quality testing, we must, at times, share our proprietary technology and confidential information, including trade secrets, with them. We seek to protect our proprietary technology, in part, by entering i…

• third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by our competitors, are intentionally or inadvertently incorporated into the technology of others or are disclosed or used in violation of these agreements. Given…

• Furthermore, Avidity is now owned by Novartis, a large, well-capitalized pharmaceutical company with significant resources and experience in the development and commercialization of cardiology products. The Avidity License Agreement provides Avidity a non-exclusive, worldwide, irrevocable, royalty-f…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• on safety, efficacy or other regulatory considerations and may result in significant delays in obtaining regulatory approvals. Any delay in obtaining, or inability to obtain, applicable regulatory approvals could prevent us or any of our potential future collaborators from commercializing our produc…

• orphan drug exclusivity. Orphan drug designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.

• Because we currently rely on third parties to manufacture our product candidates and to perform quality testing, we must, at times, share our proprietary technology and confidential information, including trade secrets, with them. We seek to protect our proprietary technology, in part, by entering i…

• Furthermore, Avidity is now owned by Novartis, a large, well-capitalized pharmaceutical company with significant resources and experience in the development and commercialization of cardiology products. The Avidity License Agreement provides Avidity a non-exclusive, worldwide, irrevocable, royalty-f…

• marketing resources than we do, and may be able to devote substantially more resources to the development, commercialization, and marketing of competing products. This competition could limit our ability to successfully commercialize our product candidates, reduce our market share, and adversely imp…