SEISMIC Pharmaceuticals
Transforming Early Cardiogenic Shock with First-in-Class Calcitropes
Istaroxime and second generation Calcitropes for Cardiogenic Shock, Acute and Chronic Heart Failure
Istaroxime and second generation Calcitropes for Cardiogenic Shock, Acute and Chronic Heart Failure
Rapid onset or worsening of HF requiring urgent hospitalization
4–10% in-hospital
15% 1-year
Rapid onset or worsening of HF that does not require hospitalization)
6–10% 1-year
25–30% 5-year
Most extreme type of Acute HF Critical state of systemic hypoperfusion and low blood pressure impairing the function of vital organs.
30–50% in-hospital
| Asset | Where it plays | Stage |
|---|---|---|
|
Istaroxime
|
Early cardiogenic shock / low-BP Acute HF; IV hospital use | In Phase 3 |
|
SEISMIC 101
|
Acute/Worsening HF With Low EF – transition to chronic therapy Similar mechanism as Istaroxime – Focused on advanced HF and HF with reduced EF |
Preclinical |
|
SEISMIC 102
|
Acute/Worsening HF with preserved/mid-range EF – transition to chronic therapy Oral SERCA2a-focused follow-on |
Preclinical |
|
SEISMIC 103
|
Group 1 PAH; oral add-on across risk strata; disease-modifying intent; First pan-SERCA oral agent | Preclinical |
Multiple programs with staged near-term readouts offer repeated opportunities for partnering, acquisition, or IPO
| 2026 | 2027 | 2028 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | Q1 | Q2 | Q3 | Q4 | |
| Istaroxime 1st-gen Calcitrope |
Marketing Authorization
Ph3 Interim
|
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|
SEISMIC101
Dual IV + Oral (2nd-gen, same mechanism as Ista.) |
101 IND
Phase 3 →
|
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|
SEISMIC102
Pure SERCA2a (2nd-gen) |
102 IND
Phase 3 →
|
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| SEISMIC103 Pan-SERCA |
102 IND
Phase 3 →
|
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FDA agreed on the overall design
Some discussions are ongoing on whether the QoL endpoint will be stand alone or part of hierarchical endpoint, other issues on endpoints agreed.
Stable HF patients on GDMT have materially lower annual event risk than patients after an Acute/Worsening HF episode.
Patients developing Worsening or Acute HF face a 30% risk of readmission or death during the first year after the event, mostly in the first 90 days – and up to 15% mortality in the first 6 – 12 months.
No therapy has been shown to improve 6 to 12-month outcomes in worsening or Acute HF. Rapid uptitration of GDMT remains the only available option — leaving a critical therapeutic gap.
Seismic 101 and 102, administered IV and orally, are specifically developed to reduce adverse outcomes after Worsening or Acute HF events — enabling IV-to-oral transition to long term chronic care.
Lead asset in early cardiogenic shock; Phase 3 readiness and FDA alignment drive near-term value.
IV/oral follow-on concept for systolic / advanced HF overarching acute to chronic or chronic therapy;
Biological effect value shown in small animal models,
Large animal HF models POC pending, IND-enabling, safety and label clarity.
SERCA2a-focused IV/oral option for diastolic / chronic-care biology if preclinical and clinical validation holds.
Biological effect value shown in small animal models,
HF large animal models POC pending, IND-enabling, safety and label clarity.
Istaroxime is the short-term financing thesis.
101/102 create strategic optionality and support a franchise story once the biology is further validated.
Gad Cotter, cardiologist, 25 years experience in leading successful phase 2-3 clinical studies in AHF and CS, leading to changes in guidelines, regulatory approvals and acquisitions by big pharma.
Beth Davison PhD, biostatistician and executive with >25 years clinical research experience in acute cardiovascular conditions with trials that led to practice guideline changes and successful M&A transactions.
Jed Latkin MBA from Columbia since 2002 has over 28 years in various roles as CEO, investment banker, research analyst, biotech and pharmaceuticals CEO. He has helped get products approved by the FDA and healthcare companies public.
Ameet Nathwani, Cardiologist, Biotech CEO, Pharma Executive. 30+ years of leadership and CV drug development at GSK, Novartis and Sanofi incl. development of multiple Heart Failure therapies (carvedilol, valsartan and Entresto).
Howard C Dittrich cardiologist, originally of UC San Diego, former CMO of various CV companies. Under his medical leadership, several of these companies gained both US and EU regulatory approval and several have been acquired by big pharma.
Rick Orr, JD, pharmaceutical and biotechnology executive with >25 years of experience creating and building life science companies that led to multiple successful M&A transactions and drug approvals
For more information please contact: Gad Cotter ( gadcotter@seismicrx.com )