The 20-Year Gap in Heart Disease Treatment & the Startup Closing It | Auxilius Pharma

What happens when a corporate finance executive from Poland walks away from everything, moves his family to the United States, enrolls at Columbia University's School of Public Health — and decides to build the cardiovascular drug the U.S. healthcare system has been missing for 20 years? That's the story of Jed Litwiniuk, co-founder and CEO of Auxilius Pharma. In this episode of the Pulse Check, Jed joins host Ryan Sabbatini for an honest, wide-ranging conversation about what it really takes to build a clinical-stage biotech from scratch — the capital constraints, the regulatory navigation, the relationship-building, and the population health mission driving all of it. What we cover: 🫀 The treatment gap nobody is talking about — 11 million Americans live with chronic stable angina. A third of them still have symptoms despite taking multiple medications. And no new anti-anginal drug has been approved in the United States in nearly 20 years. 💊 AUX-001 and the nicorandil story — Auxilius is developing an optimized, once-daily version of a molecule called nicorandil — widely used in Europe, Japan, Australia, and China for decades, but never approved here. Jed breaks down the science in plain language and explains why this drug's mechanism of action is genuinely different from anything currently available in the U.S. 🏥 The ER problem nobody is solving — Angina patients flooding emergency rooms, unnecessary stenting procedures, and a healthcare system spending enormous resources on a chronic condition that could be better managed with the right medication. Jed explains the real cost to the system — and to patients. ⚖️ The 505(b)(2) regulatory strategy — How Auxilius is using the FDA's existing framework to leverage decades of global clinical data, skip Phase 2 entirely, and target U.S. market authorization as early as 2028. 💰 Doing more with less — Auxilius completed Phase 1A for $3.5 million. Large pharma companies guessed it would cost $15–20 million. Jed talks about what it actually means to run a lean, virtual biotech — and the mindset behind it. 🌍 Fundraising across an ocean — Why over 90% of Auxilius's funding has come from Central Europe, what it's like to build investor trust without a pre-existing U.S. network, and what the path to U.S. pharma partnerships looks like from here. 🎯 The project of a lifetime — Jed's closing words on what drives him, what he wishes someone had told him before he started, and why seven years in, he's more optimistic than ever. ---------------------------------------- About Auxilius Pharma Auxilius Pharma is a clinical-stage biotech company developing AUX-001 for the treatment of chronic stable angina. Learn more at 👉 http://www.auxiliuspharma.com ---------------------------------------- About PulsePoint AI PulsePoint AI works with healthcare organizations — from hospitals and private practices to biotech and pharmaceutical companies — to streamline operations, eliminate inefficiencies, and drive growth through custom AI-powered systems. We help healthcare leaders do more with less, so they can focus on what matters most: delivering better outcomes for patients and building stronger businesses. The Pulse Check podcast is an extension of that mission — bringing real conversations with healthcare founders, executives, and innovators to a wider audience, so the industry can learn from one another. 🌐 Website: http://www.pulse-point-ai.com 📺 YouTube:    / @pulse-check-podcast   📧 Contact: mailto:ryan@pulse-point-ai.com ---------------------------------------- Timestamps:00:00 — Introduction & pre-show chat 03:24 — Welcome to the Pulse Check — Ryan's host intro 05:40 — Jed responds & reflects on his journey 08:22 — Why biotechnology? The case for a global, scalable business 08:54 — Building at population scale — why Auxilius went against the trend 09:26 — The population health perspective & why costly therapies don't scale 11:14 — AUX-001 explained — the nicorandil story & the U.S. approval gap 12:34 — The chronic angina patient — symptoms, ER visits & quality of life 14:25 — Refractory angina & why physicians are running out of options 16:21 — The microvascular angina frontier 16:45 — Nicorandil's dual mechanism of action — what makes it different 19:00 — Why stenting failed to solve angina — and why that stalled drug development 21:03 — The 505(b)(2) regulatory strategy & FDA engagement 28:00 — Phase 1A for $3.5M — how Auxilius does more with less 34:06 — The budget accountability advantage of being small 34:36 — Fundraising across an ocean — European capital & U.S. ambitions 35:52 — Network, trust & why relationships drive fundraising 39:57 — BIO San Diego — partnering conversations & nurturing relationships 41:38 — Where Auxilius goes from here — Phase 3, licensing & the vision 43:28 — Where to find Auxilius — www.auxiliuspharma.com 44:59 — Closing thoughts: what they don't teach you about startups 45:21 — Thank you & sign off