{
  "@context": "https://frontierpicks.com/schemas/dossier.v1.json",
  "ticker": "OBIO",
  "name": "Orchestra BioMed Holdings, Inc.",
  "url": "https://frontierpicks.com/dossiers/OBIO/",
  "json_url": "https://frontierpicks.com/dossiers/OBIO.json",
  "status": "DORMANT",
  "current_conviction": "MEDIUM",
  "archetype": {
    "code": "a5",
    "n": 5
  },
  "current_thesis": "Orchestra BioMed is modestly more likely to lead the S&P 500 over three months: the November offering funds it through 2028 and analysts lifted targets to $12; the BACKBEAT hypertension data planned for May 2027 settle the longer case.",
  "invalidation_trigger": "A daily close below $5.60, under every close since the 2026-11-06 offering pricing, which would erase the 2026-11-13 jump and show the shares lagging the S&P 500. A company statement moving the BACKBEAT presentation beyond the Heart Rhythm Society's May 2027 meeting would also break the case.",
  "catalyst_date": null,
  "portfolio": null,
  "pick": null,
  "themes": [
    "medtech-diagnostics",
    "binary-catalyst-biotech"
  ],
  "tags": [],
  "sources": [],
  "caveats": [
    {
      "claim": "AVIM Therapy is investigational and not approved for sale; Orchestra BioMed has no product revenue from it.",
      "source": "Form 10-Q for the third quarter of 2026",
      "as_of": "2026-11-10"
    },
    {
      "claim": "Medtronic, not Orchestra BioMed, plans to file the marketing application for AVIM Therapy if BACKBEAT results are positive.",
      "source": "Orchestra BioMed third-quarter 2026 results, 2026-11-10",
      "as_of": "2026-11-10"
    },
    {
      "claim": "The balance sheet carries a $36.8 million royalty purchase agreement and a $21.2 million note payable at 2026-09-30.",
      "source": "Form 10-Q for the third quarter of 2026",
      "as_of": "2026-11-10"
    },
    {
      "claim": "The offering of 17.25 million shares at $5.00 closed on 2026-11-09, enlarging the share count; per-share figures reflect the larger base.",
      "source": "Orchestra BioMed third-quarter 2026 results, 2026-11-10",
      "as_of": "2026-11-10"
    }
  ],
  "source_links": [
    {
      "title": "Black Friday Get Elite for just $149.00 Claim Now",
      "url": "https://finviz.com/news/420580/orchestra-biomed-reports-third-quarter-2026-financial-results-and-highlights-recent-business-updates",
      "date": null
    }
  ],
  "evidence": [
    {
      "claim": "BACKBEAT enrollment is complete with 349 patients randomized across 92 sites in 15 countries; three-month follow-up and database lock are under way.",
      "source": "Orchestra BioMed third-quarter 2026 results, 2026-11-10",
      "as_of": "2026-11-10"
    },
    {
      "claim": "Cash, cash equivalents and marketable securities were $101.9 million at 2026-09-30, before offering proceeds; the company says cash plus proceeds fund operations through 2028.",
      "source": "Orchestra BioMed third-quarter 2026 results, 2026-11-10",
      "as_of": "2026-09-30"
    },
    {
      "claim": "The public offering closed 2026-11-09: 17.25 million shares at $5.00, including the full underwriters' option, for net proceeds of about $80.5 million.",
      "source": "Orchestra BioMed third-quarter 2026 results, 2026-11-10",
      "as_of": "2026-11-09"
    },
    {
      "claim": "HC Wainwright and BTIG each maintained a Buy rating and raised their price target to $12.",
      "source": "Company news, 2026-11-13",
      "as_of": "2026-11-13"
    },
    {
      "claim": "Directors Fain, Pacitti and Hochman, the chief financial officer and 10% owner RTW Investments bought shares at $5.00 on 2026-11-09; RTW bought 1,200,000 shares.",
      "source": "SEC Form 4 filings, 2026-11-09 and 2026-11-12",
      "as_of": "2026-11-09"
    },
    {
      "claim": "Third-quarter research and development expense was $17.7 million against $14.0 million a year earlier; product revenue was $91,000.",
      "source": "Orchestra BioMed third-quarter 2026 results, 2026-11-10",
      "as_of": "2026-09-30"
    },
    {
      "claim": "Director Darren Sherman sold 15,000 shares at $5.74 on 2026-11-02 under a Rule 10b5-1 plan.",
      "source": "SEC Form 4 filing, 2026-11-03",
      "as_of": "2026-11-02"
    },
    {
      "claim": "Shares closed at $7.25 on 2026-11-13, above the 50-day average of $5.86 and the 200-day average of $4.63; the 52-week intraday high is $7.37 on 2026-11-13.",
      "source": "Adjusted daily closes",
      "as_of": "2026-11-13"
    }
  ],
  "view_changes": [
    {
      "date": "2026-11-15",
      "at": "2026-11-15T12:36:00Z",
      "from": "LOW",
      "to": "MEDIUM",
      "kind": "invalidation_fired",
      "fact_date": "2026-11-13",
      "fact": "On 2026-11-13 the shares closed at $7.25, above the $6.61 line published on 2026-11-11, their first completed close through it."
    }
  ],
  "frame": {
    "as_of": "2026-11-15",
    "business": "Orchestra BioMed develops heart devices with partners, chiefly AVIM Therapy for hypertension with Medtronic and the Virtue sirolimus-eluting balloon. It earns milestones and royalties; third-quarter 2026 product revenue was $91,000 (company results, 2026-11-10).",
    "change": {
      "now": "On 2026-11-10 the company reported 349 patients randomized in BACKBEAT and cash funded through 2028; on 2026-11-13 HC Wainwright and BTIG raised targets to $12 and the shares closed at $7.25.",
      "next": "Research and development expense was $17.7 million in the third quarter of 2026 against $14.0 million a year earlier; operating activities and capital spending used $19.9 million (company results, 2026-11-10).",
      "linked": "Medtronic (MDT) plans to file the premarket approval supplement for AVIM Therapy if BACKBEAT results are positive; the company, not Orchestra, carries the filing and the launch."
    },
    "priced_in": "At the 2026-11-13 close (filed inputs to 2026-11-10) the shares trade at 16.2 times sales and 73.3 times book value, for an enterprise value of $504 million; that holds only if BACKBEAT succeeds and Medtronic's launch turns $91,000 of quarterly revenue into real sales while the free-cash-flow yield of −11.2% closes.",
    "links": {
      "customers": [
        {
          "ticker": "MDT",
          "url": null
        }
      ],
      "suppliers": [],
      "competitors": []
    }
  },
  "filed_numbers": {
    "as_of": "2026-11-13",
    "sector": "Healthcare",
    "financials": {
      "status": "ok",
      "reason": null,
      "close_date": "2026-11-13",
      "latest_quarter": "2026-09-30",
      "figures": {
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          "quarters": [
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              "pct": 69.2
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        "operating_margin": {
          "status": "ok",
          "quarters": [
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              "restated": null,
              "pct": -25600
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              "pct": -2311.8
            }
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        "pretax_income": {
          "status": "not reported"
        },
        "net_income": {
          "status": "ok",
          "end": "2026-09-30",
          "filed": "2026-11-10",
          "four_quarters_end": "2026-09-30",
          "value_musd": -18.8,
          "four_quarters_musd": -57
        },
        "operating_cash_flow": {
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          "end": "2026-09-30",
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          "value_musd": -63.3
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        "capital_spending": {
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          "end": "2026-09-30",
          "filed": "2026-11-10",
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          "value_musd": 0.9
        },
        "free_cash_flow": {
          "status": "ok",
          "end": "2026-09-30",
          "filed": "2026-11-10",
          "first_end": "2025-12-31",
          "value_musd": -64.2
        },
        "diluted_share_change": {
          "status": "ok",
          "end": "2026-09-30",
          "filed": "2026-11-10",
          "base_end": "2025-09-30",
          "pct": 23.8
        },
        "cash": {
          "status": "ok",
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          "value_musd": 101.9
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        "debt": {
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          "value_musd": 35.6,
          "composition": "convertible debt plus loans"
        },
        "net_cash": {
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          "value_musd": 66.3
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        "deferred_revenue": {
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          "end": "2025-09-30",
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          "value_musd": 13.3,
          "yoy_pct": -14.2
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          "status": "ok",
          "end": "2025-12-31",
          "filed": "2025-03-31",
          "value_musd": 11,
          "yoy_pct": 150
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        "receivables": {
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          "end": "2026-09-30",
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          "value_musd": 0.1
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        "inventory": {
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          "end": "2026-09-30",
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          "value_musd": 0.2
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          "end": "2026-09-30",
          "filed": "2026-11-10",
          "value_musd": 7.8,
          "label": "including non-controlling interests"
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        "market_value": {
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          "close_date": "2026-11-13",
          "basis_end": "2026-11-09",
          "basis_filed": "2026-11-10",
          "value_musd": 570.6
        },
        "enterprise_value": {
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          "close_date": "2026-11-13",
          "basis_end": "2026-11-09",
          "basis_filed": "2026-11-10",
          "value_musd": 504.3
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        "ev_sales": {
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          "close_date": "2026-11-13",
          "basis_end": "2026-11-09",
          "basis_filed": "2026-11-10",
          "multiple": 16.2
        },
        "ev_ebit": {
          "status": "not meaningful"
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        "pe": {
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        "pb": {
          "status": "ok",
          "close_date": "2026-11-13",
          "basis_end": "2026-11-09",
          "basis_filed": "2026-11-10",
          "multiple": 73.3
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          "close_date": "2026-11-13",
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          "pct": -11.2
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    "short_interest": {
      "status": "ok",
      "settlement": "2026-10-15",
      "published": "2026-10-26",
      "short_pct_of_outstanding": 3.24,
      "days_to_cover": 9.7,
      "change_pct": 0.2
    },
    "insiders": {
      "status": "ok",
      "as_of": "2026-11-15",
      "windows": [
        {
          "days": 90,
          "status": "ok",
          "from": "2026-08-18",
          "bought_usd": 6188560,
          "sold_usd": 255600,
          "bought_unpriced": 0,
          "sold_unpriced": 0
        },
        {
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          "status": "ok",
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  },
  "body_markdown": "## Current Thesis\nOrchestra BioMed is modestly more likely to lead the S&P 500 over the next three months. The November offering funds operations through 2028, insiders bought in it, and two brokers raised price targets to $12 on 2026-11-13. The decisive BACKBEAT hypertension data, run with Medtronic, are planned for the Heart Rhythm Society's 2027 meeting in May and settle the longer case.\n\nThe $6.61 kill line was crossed on 2026-11-13, when the shares closed at $7.25 after a $6.15 close on 2026-11-12. That showed the shares leading the index without a trial result, so the case no longer rests on a lag. Adjusted daily closes show a 53.6% gain over three months from the $4.72 close of 2026-08-17.\n\nFunding is largely answered. The third-quarter results of 2026-11-10 report $101.9 million of cash, cash equivalents and marketable securities at 2026-09-30, before the offering. The offering closed on 2026-11-09 with 17.25 million shares at $5.00 and net proceeds of about $80.5 million. The company says cash plus proceeds fund operations through 2028.\n\nA common market view is that small-cap device and biotech shares tend to rise into a pivotal readout; that is a belief, not a finding here. With the data about six months away, the three-month window depends on whether buyers keep paying for the May 2027 outcome ahead of the result.\n\n## Bull Case\n- **Analysts raised targets on 2026-11-13.** HC Wainwright and BTIG each maintained Buy and raised their target to $12 (company news, 2026-11-13). The shares closed at $7.25 that day.\n- **Enrollment ended above target.** The third-quarter results report 349 patients randomized across 92 sites in 15 countries. The protocol needs 284 evaluable patients and was designed to detect a systolic blood pressure difference of at least 5 millimetres of mercury with more than 90% statistical power (company release, 2026-10-01).\n- **Medtronic carries the filing.** The company says the US Food and Drug Administration confirmed that Medtronic's submission will be a premarket approval supplement, filed promptly after data presentation if results are positive (third-quarter results, 2026-11-10).\n- **Insiders bought at the offering price.** SEC Form 4 filings show purchases at $5.00 on 2026-11-09 by directors Eric Fain (20,000 shares), David Pacitti (20,000) and David Hochman (5,000), by Chief Financial Officer Andrew Taylor (1,000), and by 10% owner RTW Investments (1,200,000 shares).\n- **Runway reaches 2028.** The company's guidance moved from the fourth quarter of 2027 (second-quarter results, 2026-08-10) to through 2028 after the November offering.\n\n## Bear Case\n- **The result sits outside the window.** Three-month patient follow-up and database lock are still under way, and the company targets a late-breaking presentation in May 2027 (third-quarter results, 2026-11-10).\n- **The price pays for a success already.** The filed valuation at the 2026-11-13 close is 16.2 times sales and 73.3 times book value, on product revenue of $91,000 in the third quarter (filed financials to 2026-11-10).\n- **Shareholders were diluted.** The offering added 17.25 million shares at $5.00, closing on 2026-11-09; the shares closed at $7.25 four sessions after it was priced on 2026-11-06.\n- **Cash use is rising.** Operating activities and fixed-asset purchases used $19.9 million in the third quarter against $14.9 million a year earlier, and research and development expense was $17.7 million against $14.0 million (third-quarter results, 2026-11-10).\n- **The balance sheet carries obligations.** Total liabilities were $89.0 million at 2026-09-30, including a $36.8 million royalty purchase agreement and a $21.2 million note payable, against stockholders' equity of $7.8 million before the offering (quarterly report, 2026-11-10).\n- **A director sold on the way up.** Darren Sherman sold 15,000 shares at $6.36 on 2026-10-01 and 15,000 at $5.74 on 2026-11-02, both under a Rule 10b5-1 trading plan (SEC Form 4 filings).\n\n## Setup & Price Structure\nThe shares closed at $7.25 on 2026-11-13. The 52-week intraday high is $7.37, set the same day, and the last close is 1.6% below it. The 52-week closing low is $3.49 on 2026-01-30.\n\nThe 50-day average is $5.86 and the 200-day average is $4.63, both as of the 2026-11-13 close. The last close sits well above both. Closes from 2026-11-06 to 2026-11-12 ranged from $5.68 to $6.15, so the 2026-11-13 close is a break above the whole post-offering range.\n\nThe previous 52-week intraday high of $6.50 on 2026-10-01 is now behind the shares. The three-month reference close is $4.72 on 2026-08-17.\n\n## Catalyst Calendar\n\n- **~2027-05-31 (est.):** BACKBEAT primary-endpoint data, planned as a late-breaking presentation at the Heart Rhythm Society's 2027 meeting in May. Settles whether AVIM Therapy lowers 24-hour ambulatory systolic blood pressure enough to support Medtronic's premarket approval supplement.\n\n## What Would Change Our Mind\n\nA daily close below $5.60, under every close since the 2026-11-06 offering pricing, which would erase the 2026-11-13 jump and show the shares lagging the S&P 500. A company statement moving the BACKBEAT presentation beyond the Heart Rhythm Society's May 2027 meeting would also break the case.\n\nThe line before it, a daily close above $6.61 set on 2026-11-11, was crossed on 2026-11-13: the shares closed at $7.25.\n\nThe risks this note tracks, each with what would confirm it:\n\n- The BACKBEAT primary efficacy endpoint misses, removing the main source of value. Confirmed by: Primary-endpoint data showing a between-group systolic blood pressure difference below the trial's 5 millimetre of mercury design threshold.\n- The data timeline slips and the gap before the readout lengthens. Confirmed by: Company guidance moving the BACKBEAT presentation beyond the Heart Rhythm 2027 meeting in May.\n- Cash use keeps rising and forces another raise before the readout. Confirmed by: A quarterly report showing operating cash use above the $19.9 million of the third quarter of 2026, or a new share offering announcement.\n- The 2026-11-13 jump on analyst target raises fades because no efficacy result is due for months. Confirmed by: Closes falling back below the 50-day average of $5.86 without new company news.\n- Regulatory review of Medtronic's filing is slower or narrower than the company expects. Confirmed by: Medtronic or the FDA indicating that the premarket approval supplement needs additional data after the BACKBEAT presentation.\n\n## Correlation Notes\nThe shares trade on one trial result, so their moves have followed company events and analyst actions, such as the 2026-10-01 enrollment news, the 2026-11-06 offering pricing and the 2026-11-13 target raises, more than index direction. Medtronic's partnership means large device peers share the read-through on AVIM Therapy only after the data publish. Small clinical-stage device and biotech names that raised equity after a rally are the closest comparison for the financing reaction.",
  "first_seen": "2026-11-10",
  "last_analyzed": "2026-11-15T12:36:43+00:00",
  "last_synthesized": "2026-11-15",
  "date_modified": "2026-11-15",
  "license": "Content © FrontierPicks. Cite the canonical URL."
}