DEC 2025: Auxilius Pharma closes $4M Series A AUX-001: first new US oral angina therapy since 2006? FDA: 505(b)(2) pathway accepted - Phase II skipped STRATEGY: twice-daily becomes once-daily SCALE: 7 people, 11M American patients DEC 2025: Auxilius Pharma closes $4M Series A AUX-001: first new US oral angina therapy since 2006? FDA: 505(b)(2) pathway accepted - Phase II skipped STRATEGY: twice-daily becomes once-daily SCALE: 7 people, 11M American patients
Founder · CEO · Cardiovascular

Jedrzej Litwiniuk

He went looking for a heart drug. He found one that had already been invented, tested, and then shelved.

Auxilius Pharma Boston · New York Columbia MHA
Jedrzej Litwiniuk, CEO of Auxilius Pharma
Jed Litwiniuk - the finance hand who decided chemistry was the better arbitrage.
The Story 01

A once-daily pill that picks up where Roche walked away

Nicorandil works. Cardiologists outside the US have leaned on it for years to ease the chest pain of chronic stable angina. It was developed by Chugai Pharmaceutical, acquired by Roche, and then its cardiovascular program was quietly discontinued. The molecule didn't fail. It just got orphaned.

Jedrzej Litwiniuk - Jed to most people - looked at that abandoned program and saw something other people missed: not a dead end, but a starting line. His company, Auxilius Pharma, took the old twice-daily drug and rebuilt it into AUX-001, an extended-release formulation designed to be taken once a day, with a half-life that runs past nine hours. The science isn't a leap into the unknown. It's a sharper question asked about something already known.

That is the whole thesis. Auxilius calls them "value-added medicines" - drugs with established clinical histories, reformulated to do more for patients while carrying a fraction of the development risk of a brand-new molecule. The company's tagline says it plainly: Your Heart, Our Mission.

We are focused on transforming cardiovascular care through innovation and science. Jed Litwiniuk, CEO · Auxilius Pharma
By The Numbers 02
$4M
Series A, Dec 2025
9h+
AUX-001 half-life
11M
US angina patients
2006
Last new US oral therapy

Figures from company disclosures and trade press, Dec 2025. Total funding to date is roughly $7.8M across seed and Series A.

The Pivot 03

From the deal table to the lab bench

Most biotech founders come up through chemistry or the clinic. Litwiniuk came up through money. He interned at JPMorgan Chase. He ran investment as a Director at PZU, one of Poland's largest insurers. He managed mergers, acquisitions and development at LUX MED, a major healthcare group. Then he served as Advisory Board Member and Chief Financial Officer at Picket Pharmaceuticals.

In 2019 two things happened. He earned an Executive Master of Health Administration from Columbia University's Mailman School of Public Health, and he co-founded Auxilius Pharma with Uwe Tigör, MD, the company's Chief Medical Officer. The pairing is the point: a physician who knows what the heart needs, and an operator who knows how capital and regulation actually move.

A career built on spotting mispriced value

There's a thread running through the resume. Investment desks, M&A, corporate finance - all jobs about finding value that the market has not yet recognized. AUX-001 is the same instinct applied to medicine. A drug the industry had written off becomes, with the right reformulation and the right regulatory path, a potential first-line therapy. The skill didn't change. The asset class did.

Early career
Intern, JPMorgan Chase
Earlier
Director, Investment - PZU
Earlier
Manager, M&A & Development - LUX MED
Earlier
Advisory Board Member & CFO - Picket Pharmaceuticals
2019
Executive MHA, Columbia Mailman · Co-founds Auxilius Pharma
2023
Auxilius raises $1M seed, begins clinical program
2024
FDA accepts 505(b)(2) pathway for AUX-001
2025
Closes $4M Series A to fund Phase Ib
The Science, Plainly 04

Why one pill instead of two changes the math

It sounds small. Take a drug people swallow twice a day and make it once a day. But adherence is where many good medicines quietly fail - people forget the second dose, and the benefit erodes. Litwiniuk's argument is that convenience is not a luxury feature here. It is the mechanism.

Once daily dosing brings about many advantages in terms of convenience for patients and better adherence. Jed Litwiniuk, to Clinical Trials Arena

AUX-001 is positioned to do two things at once: control angina symptoms and reduce hospitalizations. That second part matters to the people who pay the bills. Auxilius says payors have signaled willingness to reimburse precisely because fewer hospital visits is a number an insurer understands. And because the FDA accepted a 505(b)(2) regulatory pathway, the program can lean on existing safety data and skip Phase II - going from a Phase Ib bioequivalence study straight toward a Phase III efficacy trial.

The development risk, visualized

New molecule
High
Value-added
Lower
Patient need
High

Illustrative - the value-added thesis: keep the unmet need high, push the risk down. Based on Auxilius's stated strategy.

The candidate

AUX-001

An oral, extended-release reformulation of nicorandil. Designed for once-daily dosing without tachyphylaxis risk, addressing both macrovascular and microvascular angina.

The opening

A category frozen since 2006

If approved, AUX-001 would be the first new innovative oral therapy for chronic stable angina in the US in nearly two decades.

The next breakthrough may already exist. It just needs a better question.

The Auxilius Pharma thesis
The Person 05

Cross-Atlantic by design

Auxilius is a company with a Boston address, New York roots, and a lab footprint in Poland - a structure that mirrors its founder's own geography. Litwiniuk's career spans both sides of the ocean: Polish institutions like PZU and LUX MED on one side, Columbia and a US-incorporated biotech on the other. That dual fluency is not decorative. Drug development is a global game of capital, regulation and clinical evidence, and Auxilius plays it across borders on purpose.

What stands out about the operation is its discipline. Seven employees. A single lead candidate. A regulatory path chosen to conserve both time and money. There is no sprawl here, no portfolio of moonshots. It is a focused bet, run by someone whose instinct from a decade on investment desks is to concentrate resources where the risk-adjusted return is clearest. For a finance mind, the appeal of value-added medicines is almost aesthetic: the unmet need stays high while the path to market stays comparatively short.

The partnership with Uwe Tigör gives the company its other half. A CEO who understands how money and approvals move, paired with a physician who understands what patients actually need - the two halves of getting a medicine from idea to pharmacy shelf. Litwiniuk has been candid that the work is about outcomes patients and payors can both feel: fewer symptoms, fewer hospital stays, one pill a day.

What's Next 06

The clinic, then the verdict

With the December 2025 Series A in hand, the near-term plan is concrete: complete pharmaceutical optimization and run a Phase Ib bioequivalence study - roughly 35 healthy volunteers, measuring whether once-daily AUX-001 matches the original twice-daily formulation over a month. If the numbers hold, a Phase III efficacy trial is the next milestone, a placebo-controlled study in patients with chronic stable angina.

The stakes are simple to state and hard to reach. Get it right, and millions of people who still have chest pain despite optimal treatment get a new first-line option, and an insurer gets fewer hospitalizations to pay for. Get it wrong, and it joins the long list of promising reformulations that never crossed the line. Litwiniuk has spent his career pricing exactly this kind of bet. Now he is the one holding it.

Find & Follow 07

The links

Profile compiled from public sources: company site, trade press and professional listings. Last updated June 2026.