{ "@context": "https://frontierpicks.com/schemas/dossier.v1.json", "ticker": "COAG", "name": "Hemab Therapeutics Holdings, Inc.", "url": "https://frontierpicks.com/dossiers/COAG/", "json_url": "https://frontierpicks.com/dossiers/COAG.json", "status": "WATCHLIST", "current_conviction": "MEDIUM", "archetype": { "code": "a7", "n": 7 }, "current_thesis": "Hemab Therapeutics is modestly more likely than not to beat the S&P 500 over three months: its pivotal sutacimig trial has started and cash is guided into 2029. Updated Factor VII deficiency data at the ASH meeting on 14 December 2026 test whether the drug has a second indication.", "invalidation_trigger": "A daily close below $34.00, the first-day close after the April 2026 IPO, which would erase every gain since listing day. An FDA clinical hold on sutacimig or a drug-related clotting event of Grade 3 or higher would also show the case failing.", "catalyst_date": "2026-11-17", "portfolio": null, "pick": null, "themes": [ "rare-disease-gene-therapy" ], "tags": [], "sources": [], "caveats": [], "source_links": [ { "title": "SEC EDGAR", "url": "https://www.sec.gov/Archives/edgar/data/0002114044/000119312526454414/d22670dex991.htm", "date": "2026-11-10" }, { "title": "SEC EDGAR", "url": "https://www.sec.gov/Archives/edgar/data/0002114044/000119312526455376/coag-20260930.htm", "date": null }, { "title": "Hemab Therapeutics Initiates SOLARA, a Pivotal Phase 3 Trial of Sutacimig in Glanzmann Thrombasthenia", "url": "https://www.globenewswire.com/news-release/2026/11/09/3398220/0/en/hemab-therapeutics-initiates-solara-a-pivotal-phase-3-trial-of-sutacimig-in-glanzmann-thrombasthenia.html", "date": "2026-11-09" }, { "title": "Hemab Therapeutics to Participate in Upcoming Investor Conferences", "url": "https://www.globenewswire.com/news-release/2026/11/11/3400575/0/en/hemab-therapeutics-to-participate-in-upcoming-investor-conferences.html", "date": "2026-11-11" }, { "title": "Hemab Therapeutics to Present Clinical and Preclinical Data from Multiple Blood Coagulation Programs at the 68th ASH Annual Meeting and Exposition", "url": "https://www.globenewswire.com/news-release/2026/11/04/3395417/0/en/hemab-therapeutics-to-present-clinical-and-preclinical-data-from-multiple-blood-coagulation-programs-at-the-68th-ash-annual-meeting-and-exposition.html", "date": "2026-11-04" }, { "title": "Hemab Therapeutics Presents Clinical and Preclinical Data from Sutacimig in Glanzmann Thrombasthenia and Factor VII Deficiency at the ISTH 2026 Congress", "url": "https://www.biospace.com/press-releases/hemab-therapeutics-presents-clinical-and-preclinical-data-from-sutacimig-in-glanzmann-thrombasthenia-and-factor-vii-deficiency-at-the-isth-2026-congress", "date": null }, { "title": "Hemab Therapeutics (COAG) Launches Pivotal Phase III Trial for Sutacimig in Rare Bleeding Disorder", "url": "https://www.gurufocus.com/news/9189532/hemab-therapeutics-coag-launches-pivotal-phase-iii-trial-for-sutacimig-in-rare-bleeding-disorder", "date": null }, { "title": "MarketBeat", "url": "https://www.marketbeat.com/instant-alerts/hemab-therapeutics-nasdaqcoag-hits-new-1-year-high-time-to-buy-2026-08-06/", "date": "2026-08-06" } ], "evidence": [ { "claim": "Cash, cash equivalents and marketable securities totaled $430.2 million at 2026-09-30, down from $457.5 million at 2026-06-30; Hemab guides that cash funds operations into 2029.", "source": "Hemab Form 8-K, Exhibit 99.1 (third-quarter 2026 results)", "as_of": "2026-09-30" }, { "claim": "Third-quarter 2026 net loss was $27.3 million, or $0.58 per share; research and development expense was $24.6 million versus $14.6 million a year earlier.", "source": "Hemab Form 8-K, Exhibit 99.1 (third-quarter 2026 results)", "as_of": "2026-11-10" }, { "claim": "Third-quarter loss per share of $0.58 missed the $0.52 analyst estimate.", "source": "Benzinga", "as_of": "2026-11-10" }, { "claim": "Net cash used in operating activities was $72.5 million for the nine months ended 2026-09-30.", "source": "Hemab third-quarter 2026 Form 10-Q", "as_of": "2026-09-30" }, { "claim": "SOLARA plans to enroll about 75 people aged 12 to 70; first participants enter the 24-week run-in in the fourth quarter of 2026, and adolescent enrollment is gated by the data safety monitoring committee.", "source": "Hemab Form 8-K, Exhibit 99.1 (third-quarter 2026 results)", "as_of": "2026-11-10" }, { "claim": "Hemab's 10-Q risk factors state that the FDA or other regulators may require additional clinical trials, including a randomized controlled trial.", "source": "Hemab third-quarter 2026 Form 10-Q", "as_of": "2026-11-10" }, { "claim": "Mean annualized treated bleed rate fell about 84% in the low-dose weekly sutacimig group across 34 participants at a median of 6.9 months; three participants had Grade 2 thromboembolic events.", "source": "Hemab press release, ISTH 2026 Congress", "as_of": "2026-11-06" }, { "claim": "HMB-002 VELORA data will be presented at EAHAD in February 2027; 8 of 9 evaluable single-dose participants had no treated bleeds in the 28 days after dosing.", "source": "Hemab Form 8-K, Exhibit 99.1 (third-quarter 2026 results)", "as_of": "2026-11-10" } ], "view_changes": [], "frame": null, "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": { "revenue": { "status": "not reported" }, "gross_margin": { "status": "not reported" }, "operating_margin": { "status": "not available" }, "pretax_income": { "status": "ok", "end": "2026-09-30", "filed": "2026-11-10", "value_musd": -26.6 }, "net_income": { "status": "ok", "end": "2026-09-30", "filed": "2026-11-10", "value_musd": -27.3 }, "operating_cash_flow": { "status": "not available" }, "capital_spending": { "status": "not available" }, "free_cash_flow": { "status": "not available" }, "diluted_share_change": { "status": "ok", "end": "2026-09-30", "filed": "2026-11-10", "base_end": "2025-09-30", "pct": 4837.8 }, "cash": { "status": "ok", "end": "2026-09-30", "filed": "2026-11-10", "value_musd": 430.2 }, "debt": { "status": "not available" }, "net_cash": { "status": "not available" }, "deferred_revenue": { "status": "not reported" }, "backlog": { "status": "not reported" }, "receivables": { "status": "not reported" }, "inventory": { "status": "not reported" }, "equity": { "status": "ok", "end": "2026-09-30", "filed": "2026-11-10", "value_musd": 429.3 }, "market_value": { "status": "ok", "close_date": "2026-11-13", "basis_end": "2026-10-30", "basis_filed": "2026-11-10", "value_musd": 1909.4 }, "enterprise_value": { "status": "not available" }, "ev_sales": { "status": "not available" }, "ev_ebit": { "status": "not available" }, "pe": { "status": "not available" }, "pb": { "status": "ok", "close_date": "2026-11-13", "basis_end": "2026-10-30", "basis_filed": "2026-11-10", "multiple": 4.4 }, "fcf_yield": { "status": "not available" } } }, "short_interest": { "status": "ok", "settlement": "2026-10-15", "published": "2026-10-26", "short_pct_of_outstanding": 6.76, "days_to_cover": 7.8, "change_pct": -6.8 }, "insiders": { "status": "ok", "as_of": "2026-11-15", "windows": [ { "days": 90, "status": "ok", "from": "2026-08-18", "bought_usd": 0, "sold_usd": 0, "bought_unpriced": 0, "sold_unpriced": 0 }, { "days": 365, "status": "ok", "from": "2025-11-16", "bought_usd": 55460170.87, "sold_usd": 0, "bought_unpriced": 0, "sold_unpriced": 0 } ] } }, "body_markdown": "## Current Thesis\n\nHemab Therapeutics is modestly more likely than not to beat the S&P 500 over the next three months. Its pivotal trial of sutacimig has started, and the company still guides that its cash lasts into 2029. Updated Factor VII deficiency data at the American Society of Hematology (ASH) meeting on 2026-12-14 test the second use for the drug. A clean safety record as SOLARA, the Phase 3 trial in Glanzmann thrombasthenia, begins dosing is the other half of the case.\n\nThe third-quarter report on 2026-11-10 left the case intact. Cash, cash equivalents and marketable securities were $430.2 million at 2026-09-30, against $457.5 million at 2026-06-30, per the company's 8-K. The net loss of $0.58 per share missed the $0.52 estimate, per Benzinga, as research spending rose with the Phase 3 start. Data for HMB-002 in von Willebrand disease moved to the European Association for Haemophilia and Allied Disorders (EAHAD) congress in February 2027.\n\nThe shares closed at $39.38 on 2026-11-12, above their 50-day moving average of $37.12, per adjusted daily closes. They are still down 28.3% over three months. The price reflects doubt about the Phase 3 design and safety more than the mid-stage bleed reduction: the shares fell 28.3% over the three months to 2026-11-12 while the trial started on schedule. The rating is Medium because the trial and the cash are in place, while the next hard data arrive only at ASH.\n\n## Bull Case\n\n- **Pivotal trial started on schedule.** The company's 2026-11-10 release says SOLARA plans to enroll about 75 people aged 12 to 70, with the first participants entering a 24-week run-in in the fourth quarter of 2026. Each then gets 48 weeks of 0.2 mg/kg sutacimig, injected under the skin once a week, and the primary endpoint compares the treated bleed rate on the drug with the run-in rate.\n- **Regulatory designations support a faster review.** Sutacimig holds Fast Track, Orphan Drug and Breakthrough Therapy designations from the Food and Drug Administration (FDA) for Glanzmann thrombasthenia, per coverage of the 2026-11-09 SOLARA announcement.\n- **Large bleed reduction in mid-stage testing.** At the 2026 congress of the International Society on Thrombosis and Haemostasis (ISTH), Hemab reported results from 34 participants at a median of 6.9 months. The mean annualized treated bleed rate fell about 84% in the low-dose weekly group.\n- **Second indication shows an early signal.** The 2026-11-10 release reports that two participants with severe Factor VII deficiency each got a single dose. Prothrombin time, a standard clotting test, shortened by more than 50% in both, and adverse events were low grade and judged unrelated to treatment.\n- **Cash covers the pivotal program.** The company held $430.2 million at 2026-09-30 and guides that cash funds operations into 2029, per the 2026-11-10 8-K. Net cash used in operations was $72.5 million over the first nine months of 2026, per the third-quarter 10-Q.\n- **Management is in front of investors twice before ASH.** The company's 2026-11-11 release schedules fireside chats at the Jefferies Global Healthcare Conference in London on 2026-11-17 and the Evercore Healthcare Conference on 2026-12-01.\n\n## Bear Case\n\n- **Clotting remains the central safety question.** Hemab's ISTH release reported three Grade 2 thromboembolic events in the long-term study. SOLARA doses more people for 48 weeks, and an independent data safety monitoring committee must clear dosing before adolescents enroll, per the 2026-11-10 release.\n- **The FDA wanted a randomized trial.** The FDA recommended that Hemab consider a randomized design before the company proceeded with a self-controlled single-arm trial, per the 2026-11-09 release. The third-quarter 10-Q risk factors say regulators may require additional trials, including a randomized controlled trial.\n- **Spending is rising.** Third-quarter research and development spending was $24.6 million, up from $14.6 million a year earlier, and the net loss was $27.3 million, per the 2026-11-10 8-K. Costs climb further as the Phase 3 trial enrolls.\n- **Second-program data moved later.** HMB-002 data are now set for EAHAD in February 2027. The early results are descriptive: 8 of 9 evaluable participants had no treated bleeds in the 28 days after one dose, per the 2026-11-10 release.\n- **Positive coverage has not lifted the shares.** Rodman & Renshaw, J.P. Morgan and LifeSci Capital started coverage with positive ratings between 2026-10-12 and 2026-11-09, and the shares still show a 28.3% three-month decline at the 2026-11-12 close.\n\n## Setup & Price Structure\n\nThe shares closed at $39.38 on 2026-11-12. The 50-day moving average stood at $37.12 on the same date, so the price sits above its recent average after a 28.3% fall over three months, per adjusted daily closes. The shares set a then-new one-year high on 2026-08-06, per MarketBeat, and most of the three-month decline came after that high.\n\nThe initial public offering (IPO) priced at $18.00 on 2026-04-30. The level the case turns on below the price is the first-day close after the listing. A close beneath it would erase every gain made since the first trading day and would show that the trial start and the cash guidance have the market's support. The quarterly report has passed, so the next scheduled company events are the two investor conferences and the ASH posters.\n\n## Catalyst Calendar\n\n- **2026-11-17:** Fireside chat at the 2026 Jefferies Global Healthcare Conference in London. It is management's first public forum after the third-quarter report and can update SOLARA site activation and the timing of first run-in enrollment.\n- **2026-12-01:** Fireside chat at the 9th Annual Evercore Healthcare Conference. It is the last scheduled management appearance before the ASH posters and can confirm SOLARA is on track for first participants in the fourth quarter of 2026.\n- **2026-12-13:** HMB-003 preclinical poster at the ASH Annual Meeting. It shows animal results for the weekly plasmin inhibitor ahead of first human data guided for mid-2027.\n- **2026-12-14:** Sutacimig Factor VII deficiency poster at the ASH Annual Meeting. Updated results test whether the two-participant prothrombin-time signal holds and supports a second indication for sutacimig.\n- **~2026-12-31 (est.):** First SOLARA participants enter the 24-week run-in period, guided for the fourth quarter of 2026. It confirms the pivotal trial is enrolling on the timeline the company set in its 2026-11-10 report.\n- **~2027-02-15 (est.):** HMB-002 VELORA Phase 1/2 data at the EAHAD Congress. It shows whether Hemab's von Willebrand disease program adds value beyond sutacimig.\n\n## What Would Change Our Mind\n\nA daily close below $34.00, the first-day close after the April 2026 IPO, which would erase every gain since listing day. An FDA clinical hold on sutacimig or a drug-related clotting event of Grade 3 or higher would also show the case failing.\n\nThe risks this note tracks, each with what would confirm it:\n\n- Clotting events limit sutacimig's use or slow SOLARA. Confirmed by: An FDA clinical hold, or a drug-related thromboembolic event of Grade 3 or higher disclosed in a company update.\n- The self-controlled single-arm design weakens the pivotal result in regulators' eyes. Confirmed by: Company disclosure of an FDA request to add a randomized control arm, run a second trial or extend SOLARA.\n- SOLARA enrollment runs slow in a rare disease. Confirmed by: Company guidance moving the first run-in start past the fourth quarter of 2026 or pushing enrollment completion later.\n- The early Factor VII signal fades in more patients. Confirmed by: ASH results on 2026-12-14 showing smaller prothrombin-time improvement or shorter Factor VII exposure than the earlier two-participant data.\n- Rising Phase 3 spending forces new share issuance. Confirmed by: A follow-on offering announcement or a cut to the runway guidance of into 2029.\n\n## Correlation Notes\n\nHemab has no product revenue. Its shares move on its own clinical and regulatory news more than on the economy. As a small clinical-stage biotech, it also tends to move with sector-wide shifts in demand for early-stage drug developers. The ASH meeting in December brings out hematology data from many companies at once, so peer results in bleeding disorders can move the shares in the same week as Hemab's posters.", "first_seen": "2026-11-10", "last_analyzed": "2026-11-13T00:04:26+00:00", "last_synthesized": "2026-11-13", "date_modified": "2026-11-13", "license": "Content © FrontierPicks. Cite the canonical URL." }