BREAKING — Auxilius Pharma closes $4M Series A for AUX-001 FDA greenlights 505(b)(2) pathway — Phase II skipped AUX-001 half-life >9 hours — once daily Target market: 11M Americans with chronic stable angina First new US oral angina therapy since 2006? Global angina market est. $7.8B by 2028 BREAKING — Auxilius Pharma closes $4M Series A for AUX-001 FDA greenlights 505(b)(2) pathway — Phase II skipped AUX-001 half-life >9 hours — once daily Target market: 11M Americans with chronic stable angina First new US oral angina therapy since 2006? Global angina market est. $7.8B by 2028
Cardiovascular Dispatch · Clinical Stage

Auxilius Pharma
fixes a pill nobody else would.

A seven-person company is reviving a heart drug Roche abandoned - and betting that the next breakthrough in angina isn't new chemistry, just better dosing.

Boston · Warsaw Founded 2019 AUX-001 Series A
Auxilius Pharma logo
The logo of a company whose entire thesis fits on a single tablet: take it once, feel it all day.
By the YesPress Desk Cardiology · Drug Development Filed: Auxilius Pharma S.A.

In a Boston office that doubles as a Warsaw registration document, a chemist is studying a graph of a drug's concentration in human blood. The line climbs, then refuses to fall the way the textbooks say it should. That stubborn, slow decline - a half-life past nine hours - is the entire company. It means a patient with a tired, oxygen-starved heart can take one tablet in the morning and stop thinking about it. For the roughly 11 million Americans living with chronic stable angina, "stop thinking about it" is a luxury they rarely get.

This is Auxilius Pharma right now: a clinical-stage cardiovascular company with seven people, two continents, one drug, and a freshly closed $4 million Series A. It is not trying to invent a molecule. It is trying to perfect one that already exists - and that, oddly, is the harder sell.

"We are focused on transforming cardiovascular care through innovation and science."

Jed Litwiniuk — Co-Founder & CEO
Above: the company's stated mission. Below: roughly 200 words explaining why a sentence that modest is actually a contrarian bet.

01 / THE PROBLEMThe patients medicine quietly gave up on

Angina is chest pain from a heart not getting enough blood. The standard playbook - beta-blockers, calcium channel blockers, nitrates - was largely written decades ago. The last genuinely new oral angina therapy approved in the United States arrived in 2006. Since then, the field has been quiet. Too quiet for a condition that, by GlobalData's estimate, anchors a global market worth around $7.8 billion across seven major markets by 2028.

Here is the uncomfortable part. Many patients take their pills exactly as told and still hurt. The drugs work, but the dosing fights them: multiple tablets a day, tolerance that blunts nitrates over time, side effects that erode the will to keep going. Adherence collapses. Symptoms return. The system shrugs and calls it "optimal treatment."

The central tension

The problem was never a shortage of molecules. It was that the good ones were packaged badly.

02 / THE FOUNDERS' BETTwo classmates and a discontinued asset

Jed Litwiniuk and Uwe Tigör met in a master's program at Columbia University's Mailman School of Public Health. In 2019 they founded Auxilius around a deceptively boring idea: take a medicine that already works somewhere in the world and make it work better, more conveniently, and through a faster regulatory door.

Their asset of choice was nicorandil - a potassium-channel opener and nitrate originally developed by Chugai Pharmaceutical, later acquired by Roche, and then orphaned when Roche walked away from its cardiovascular portfolio. A useful drug, shelved for reasons that had nothing to do with whether it helped hearts. Auxilius picked it back up and went to work on the one thing that mattered: how often you have to swallow it.

"Once daily dosing brings about many advantages in terms of convenience for patients and better adherence."

Jed Litwiniuk — on the case for reformulation
The least glamorous sentence a biotech CEO can say in public. Also, quite possibly, the most honest one in cardiology this decade.

03 / THE PRODUCTAUX-001, or the art of the slow exit

AUX-001 is an oral, extended-release, once-daily formulation of nicorandil for chronic stable angina pectoris. In a first-in-human Phase I pharmacokinetic study, it delivered a once-daily profile with a half-life exceeding nine hours and an improved safety and tolerability picture versus traditional immediate-release nicorandil - with, the company says, no risk of the drug tolerance that haunts long-acting nitrates. Auxilius positions it to address both macrovascular and microvascular angina while reducing hospitalizations.

Daily dose
>9h
Half-life
11M
US patients
$7.8B
2028 market
Four numbers that, stacked together, explain why a small team is unbothered by the words "we didn't invent the molecule."

The regulatory move is the clever part. Auxilius is advancing AUX-001 through the FDA's 505(b)(2) pathway, which lets a sponsor lean on existing data for a known compound. The FDA's acceptance meant the company could skip Phase II entirely. For a startup, skipping a phase is the difference between a marathon and a manageable jog.

The paper trail

How Auxilius got here

2019
Litwiniuk and Tigör found Auxilius Pharma, built on value-added cardiovascular medicines.
June 2023
Closes a $1M seed round (led by CofounderZone) and commences its clinical program.
March 2024
Announces a positive Phase Ia safety profile for AUX-001.
2024–2025
FDA accepts the 505(b)(2) NDA approach; Phase Ib bioequivalence study (~35 volunteers) planned; Phase III (~250 patients, 12 weeks) targeted.
Dec 2025
Raises a $4M Series A to fund pharmaceutical optimization and the Phase Ib trial.

04 / THE PROOFData, a discontinued drug, and a wall of advisors

Proof in pharma is slow and conditional, and Auxilius is honest about where it stands: clinical-stage, not commercial. But the markers are real. A positive Phase Ia. An FDA-blessed pathway. A pharmacokinetic curve that does what the founders said it would. And a scientific advisory board that reads like a cardiology guest list - including names such as Juan Kaski, John McMurray, Colin Berry, John Beltrame and Michael Weber.

Figure 1 · Funding to date

A lean raise for a lean team

Seed · 2023
$1.0M
Series A · 2025
$4.0M
Total raised
~$7.8M*

*Total funding reported across rounds. Bars scaled for comparison, not to absolute dollars. Sources: company filings and public funding databases.

Note how little money is on this chart. In a field where Phase III trials routinely cost nine figures, frugality isn't a virtue here - it's the whole strategy.

Jed Litwiniuk, MHA

Co-Founder · CEO

Columbia-trained health administrator steering strategy, financing and the company's once-daily thesis.

Uwe Tigör, MD

Co-Founder · CMO

Physician driving clinical and medical strategy for AUX-001 and the cardiovascular pipeline.

A health administrator and a doctor who met in grad school. The org chart is small enough to fit on a napkin, which is roughly where good biotech ideas tend to start.

05 / THE MISSION"Your Heart, Our Mission"

The tagline sounds like every other pharma tagline until you notice it is also the business plan. Auxilius enhances established medications with optimized dosage forms that benefit patients, providers and payors - a category the industry calls "value-added medicines." It is unglamorous by design. There is no moonshot here, no platform deck promising to cure ten diseases. There is one drug, one indication to start, and a plan to add more if AUX-001 lands - coronary microvascular disease and heart failure among them.

Why it works

Pick a proven molecule. Fix its worst habit. Take the faster regulatory road. Repeat.

06 / TOMORROWWhy a slow-falling line matters

If AUX-001 clears its trials, the payoff isn't abstract. It would be the first innovative new oral angina therapy in the US since 2006, aimed squarely at the patients who do everything right and still hurt. Beyond angina, Auxilius has signaled ambitions to chase additional indications where the same molecule could help, including microvascular disease and heart failure. The risk is equally plain: clinical trials fail, regulators change their minds, and small companies run out of road. None of that is hidden here.

Return to that graph - the concentration of a drug in human blood, declining slower than the textbook predicted. The chemist isn't looking at chemistry. She's looking at a morning where a patient takes one pill instead of four, walks to the mailbox without stopping, and forgets, for an entire day, that anything is wrong with their heart. Roche shelved that morning. Auxilius Pharma is trying to put it back on the calendar - one slow-falling line at a time.