SEPTAGEN PHARMACEUTICALS

Community Round Memo

We are building the first drug and diagnostic to detect and treat the cardiovascular risk in women caused by loss of estrogen.

Hot flashes don’t kill women. Heart attacks do.

The menopause field treats the symptoms. Nobody treats the damage happening underneath them.

Heart disease kills more women than all cancers combined.

• About 25 million American women are in the menopausal transition right now.

• Stroke risk roughly doubles in the decade after menopause (AHA, 2020).

• 23% of women over 45 die within a year of a first heart attack (AHA).

The part nobody treats. Hormone therapy helps, and a patch helps more than a pill. Statins and blood thinners arrive decades later, once the risk is already high. Nothing on the market is aimed at the clotting and inflammation that estrogen loss sets in motion. That gap is where we are working, alongside hormone therapy rather than instead of it.

SEP-001 is an oral drug candidate. ThromboRisk is the blood test that finds the women it is meant for. Neither exists on the market today, and nothing else does this job.

WHAT WE ARE BUILDING

One test finds the women at risk. One drug treats them.

ThromboRisk. A blood test in development, designed to show which women carry the biology that drives this risk, before anything has happened to them. Detection has been the missing piece in this field. Nearly every recent failure in cardiovascular inflammation gave the right drug to the wrong patients.

SEP-001. An oral drug candidate designed to block PAR4, a switch on platelets that drives clotting and inflammation when blood vessels are injured. Existing blood thinners leave PAR4 alone. Blocking it is designed to calm the damage without touching the clotting you need when you cut yourself, which is what limits the drugs already on the market.

A drug, and a way to know who needs it. That pairing is the whole idea.

THE WINDOW

The damage happens during the transition. The heart attack comes twenty years later.

Perimenopause runs from a woman’s first irregular cycle until twelve months after her last period. In the year around that last period, her arteries stiffen about eight times faster than in the years before. Then it settles again. The average American woman has her first heart attack at 72.

It is not simply aging. Across 300 million lab tests in two national health systems, 52 of 90 common blood tests shift sharply at a woman’s final period. None of those shifts appear in men the same age, analyzed identically. (Reported in a preprint discussed in Nature Medicine2026;32:3097; not yet peer reviewed.)

The American Heart Association named perimenopause, not postmenopause, as the period of greatest cardiovascular risk acceleration (El Khoudary et al., Circulation 2020;142:e506).

HOW IT WORKS IN PRACTICE

Find her in the window. Treat her before the damage compounds.

• She enters the transition. Irregular cycles, often hot flashes. She is 45 to 55 and her doctor is treating symptoms, if anything.

• ThromboRisk measures her. A blood draw shows whether her platelets are running hot: the biology SEP-001 is designed to act on.

• SEP-001 treats the ones at risk. The women who test high get a drug aimed at the damage, in the years when it is actually happening.

• Her risk curve bends earlier. The goal is fewer heart attacks and strokes in her sixties and seventies, by acting in her forties and fifties. That is the objective, not a demonstrated result.

WHAT THIS ROUND FUNDS

Ten months. Three things.

• A human study. About 160 women across four stages of the transition, measuring what their platelets and endothelium are actually doing. This is the one that matters.

• Safety groundwork. Animal toxicology and the first formal meeting with the FDA.

• The test. Patent filing and laboratory validation for ThromboRisk.

If those three land, we’ll raise a larger round and move faster toward the clinic.

BE CLEAR-EYED ABOUT THIS

• SEP-001 has never been given to a human being.

• It is not approved by the FDA for anything.

• We do not yet own the patent. We hold an option from Vanderbilt University that we still have to exercise, and there are conditions on it we have not met.

• Most drug candidates at this stage fail.

• You should assume you could lose everything you put in.

The full risks are set out in our Form C. They are worth your time before you invest a dollar.

Every woman walks through this window. So will your daughters.

Right now, medicine does nothing in it.

wefunder.com/septagenWe are building the first drug and diagnostic to detect and treat the cardiovascular risk in women caused by loss of estrogen during the menopause transition.

SEP-001 is an oral drug candidate. ThromboRisk is the blood test that finds the women it is meant for. Neither exists on the market today, and nothing else does this job.

WHAT WE ARE BUILDING

One test finds the women at risk. One drug treats them.

ThromboRisk. A blood test in development, designed to show which women carry the biology that drives this risk — before anything has happened to them. Detection has been the missing piece in this field. Nearly every recent failure in cardiovascular inflammation gave the right drug to the wrong patients.

SEP-001. An oral drug candidate designed to block PAR4, a switch on platelets that drives clotting and inflammation when blood vessels are injured. Existing blood thinners leave PAR4 alone. Blocking it is designed to calm the damage without touching the clotting you need when you cut yourself — which is what limits the drugs already on the market.

A drug, and a way to know who needs it. That pairing is the whole idea.

WHY THIS MATTERS

Hot flashes don’t kill women. Heart attacks do.

The menopause field treats the symptoms. Nobody treats the damage happening underneath them.

Heart disease kills more women than all cancers combined.

• About 25 million American women are in the menopausal transition right now.

• Stroke risk roughly doubles in the decade after menopause (AHA, 2020).

• 23% of women over 45 die within a year of a first heart attack (AHA).

The part nobody treats. Hormone therapy helps, and a patch helps more than a pill. Statins and blood thinners arrive decades later, once the risk is already high. Nothing on the market is aimed at the clotting and inflammation that estrogen loss sets in motion. That gap is where we are working, alongside hormone therapy rather than instead of it.

THE WINDOW

The damage happens during the transition. The heart attack comes twenty years later.

Perimenopause runs from a woman’s first irregular cycle until twelve months after her last period. In the year around that last period, her arteries stiffen about eight times faster than in the years before. Then it settles again. The average American woman has her first heart attack at 72.

It is not simply ageing. Across 300 million lab tests in two national health systems, 52 of 90 common blood tests shift sharply at a woman’s final period. None of those shifts appear in men the same age, analysed identically. (Reported in a preprint discussed in Nature Medicine 2026;32:3097 — not yet peer reviewed.)

The American Heart Association named perimenopause — not postmenopause — as the period of greatest cardiovascular risk acceleration (El Khoudary et al., Circulation 2020;142:e506).

HOW IT WORKS IN PRACTICE

Find her in the window. Treat her before the damage compounds.

• She enters the transition. Irregular cycles, often hot flashes. She is 45 to 55 and her doctor is treating symptoms, if anything.

• ThromboRisk measures her. A blood draw shows whether her platelets are running hot — the biology SEP-001 is designed to act on.

• SEP-001 treats the ones at risk. The women who test high get a drug aimed at the damage, in the years when it is actually happening.

• Her risk curve bends earlier. The goal is fewer heart attacks and strokes in her sixties and seventies, by acting in her forties and fifties. That is the objective, not a demonstrated result.

WHAT THIS ROUND FUNDS

Ten months. Three things.

• A human study. About 160 women across four stages of the transition, measuring what their platelets are actually doing. This is the one that matters.

• Safety groundwork. Animal toxicology and the first formal meeting with the FDA.

• The test. Patent filing and laboratory validation for ThromboRisk.

If those three land, we raise a larger round and move toward the clinic.

BE CLEAR-EYED ABOUT THIS

• SEP-001 has never been given to a human being.

• It is not approved by the FDA for anything.

• We do not yet own the patent. We hold an option from Vanderbilt University that we still have to exercise, and there are conditions on it we have not met.

• Most drug candidates at this stage fail.

• You should assume you could lose everything you put in.

The full risks are set out in our Form C. They are worth your time before you invest a dollar.

Every woman walks through this window. So will your daughters.

Right now, medicine does nothing in it.

wefunder.com/septagen

Septagen Pharmaceuticals · September 2026