OBIO — what changed in the latest 10-Q

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

• Effective June 26, 2026, following the annual reconstitution of the Russell indexes, we were added to the Russell 3000® Index and the Russell 2000® Index. The Russell indexes are reconstituted annually based primarily on market capitalization and other objective criteria established by FTSE Russell.…

• On July 31, 2025, we and our wholly-owned subsidiaries, Orchestra BioMed, Inc. and BackBeat, entered into a Loan Agreement with Medtronic (the “Medtronic Loan Agreement”), pursuant to which Medtronic agreed to extend a convertible loan to us in the aggregate original principal amount of $20.0 millio…

• The Medtronic Note does not allow for prepayment without the prior consent of Medtronic. Unless earlier converted, or redeemed, the Medtronic Note will mature on April 27, 2031 (the “Maturity Date”). In addition, the payment or other satisfaction of the obligations set forth in the Medtronic Loan Ag…

• The principal balance of the Medtronic Note, together with all accrued and unpaid interest thereon (collectively, the “Balance”) will automatically convert into a revenue share (the “Revenue Share Credit”), if FDA approval of a Medtronic device incorporating AVIM Therapy is achieved prior to the Mat…

• We recognize interest expense using the effective interest method over the estimated term of the arrangement. The effective interest rate is based on our estimate of the timing and amount of future payments expected to be made under the arrangement. The total interest expense associated with the Med…

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• Orchestra BioMed Presented AVIM Therapy Clinical and Mechanistic Data at HRS 2026

• On April 23, 2026, we announced the presentation of new clinical data related to our AVIM Therapy at the Heart Rhythm Society 2026 Annual Meeting. Data from the MODERATO II randomized, prospective, multi-center, double-blind, controlled pilot study demonstrated that activation of AVIM Therapy was as…

• Additional data presented from a pressure-volume loop analysis study in patients with uncontrolled hypertension indicated that AVIM Therapy reduced systolic blood pressure through decreases in cardiac preload and effective arterial elastance (afterload), without a significant reduction in left ventr…

• FDA Grants Orchestra BioMed Additional Breakthrough Device Designation for AVIM Therapy

• We now hold two Breakthrough Device Designations (“BDDs”) for AVIM Therapy. On April 30, 2026, we announced that the U.S. Food and Drug Administration (“FDA”) granted AVIM Therapy a second BDD for the treatment of patients with uncontrolled hypertension despite the use of anti-hypertensive medicatio…

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

• On June 23, 2026, we held our 2026 Annual Meeting of Stockholders (the “Annual Meeting”). At the Annual Meeting, our stockholders passed a proposal to approve the Orchestra BioMed Holdings, Inc. 2026 Employee Stock Purchase Plan (the “ESPP”). The ESPP was previously approved by our board of director…

• A more detailed description regarding the ESPP is set forth in our definitive proxy statement for the Annual Meeting on Schedule 14A, which was filed with the SEC on April 29, 2026 (the “Proxy Statement”), under the heading entitled, “Proposal No. 3 – The ESPP Proposal,” which is incorporated herein…

• On May 27, 2026, Andrew Taylor, our Chief Financial Officer, terminated his “Rule 10b5-1 trading arrangement,” as such term is defined in Item 408(c) of Regulation S-K, for the sale of up to 84,000 shares of our common stock, subject to certain conditions. The Rule 10b5-1 trading arrangement was ado…

• During the three months ended June 30, 2026, no other director or officer (as defined in Rule 16a-1(f) promulgated under the Exchange Act) informed us of the adoption or termination of a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement”, as those terms are defined in Item …

Text removed vs the prior filing · source: 10-Q · 2026-05-12

• During the three months ended March 31, 2026, no director or officer (as defined in Rule 16a-1(f) promulgated under the Exchange Act) informed us of the adoption or termination of a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement”, as each term is defined in Item 408(c) o…