Leap of faith? Buzzy an­ti-ag­ing biotech Uni­ty pitch­es an $85M IPO based on mouse da­ta

Can an old mouse that looks and acts youth­ful and vir­ile in­spire in­vestors to back an $85 mil­lion IPO?

Uni­ty Biotech­nol­o­gy is about to find out.

Bob Nelsen

One of the buzzi­est of the new breed of biotech, backed by Bob Nelsen at Arch, Uni­ty raised $217 mil­lion in ven­ture fund­ing for its pre­clin­i­cal work on rid­ding bod­ies of senes­cent cells. These old­ster cells tend to clut­ter sys­tems in peo­ple as they age, and Uni­ty’s the­o­ry — on­ly stud­ied in mice — sup­ports the idea that sweep­ing away the cel­lu­lar dust could help sus­tain a longer, health­i­er life.

Just weeks ago the com­pa­ny said they were ready to start their first hu­man study on os­teoarthri­tis, and their S-1 spells out a pipeline full of plans to try out their ideas in the clin­ic.

Arch is still the largest in­vestor, with 27.5% of the eq­ui­ty. WuXi Phar­maT­e­ch comes in sec­ond with 8.9%. And Ven­rock, the Mayo Clin­ic, Bail­lie Gif­ford and Fi­deli­ty al­so have a piece. The com­pa­ny plans to trade as $UBX.

The of­fer­ing in­cludes a grand mis­sion state­ment:

We be­lieve that by cre­at­ing med­i­cines that tar­get fun­da­men­tal ag­ing mech­a­nisms, we can re­duce the eco­nom­ic, per­son­al, and so­ci­etal bur­den of ag­ing and en­hance qual­i­ty of life.

Kei­th Leonard, Uni­ty CEO

The S-1 al­so un­der­scores, per­haps un­in­ten­tion­al­ly, the ex­tra­or­di­nary risks ahead. It out­lines some of the drugs that have been tout­ed for their an­ti-ag­ing po­ten­tial, not­ing the prob­lems on each. There’s been much dis­cus­sion but lit­tle hard ev­i­dence that drugs like ra­pamycin, a pow­er­ful im­muno­sup­pres­sant, or resver­a­trol, a com­po­nent of red wine that in­spired a $720 mil­lion buy­out by GSK that led nowhere, could ad­dress ag­ing. And the mech­a­nisms of ac­tion for much-dis­cussed drugs like met­formin are poor­ly un­der­stood. 

The biotech has burned through more than $87 mil­lion of pri­vate funds to gath­er to­geth­er its pre­clin­i­cal case. Now Uni­ty will test just how much mon­ey the pub­lic mar­kets is will­ing to of­fer pre­clin­i­cal com­pa­nies that have set out on biotech mis­sions to achieve life-al­ter­ing goals.

It’s a leap of faith over a broad chasm of risk. 

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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Chris Kim, Liminatus Pharma CEO

A fledg­ling biotech goes SPAC route to bankroll can­cer vac­cine, CAR-T and CD47

A relatively unknown clinical-stage biotech — backed by a Korean lighting company and focused on a cancer vaccine out of a Thomas Jefferson University lab — is headed to Nasdaq via the blank check route.

Liminatus Pharma will get about $316 million in proceeds from the SPAC combination to fund its ongoing Phase IIa study of a cancer vaccine, bring a CAR-T therapy into the clinic and prep a CD47 immune checkpoint inhibitor for human trials, the company said this week.

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Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

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Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

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Bay­er starts work on $43M+ ex­pan­sion of OTC man­u­fac­tur­ing site in Penn­syl­va­nia

German pharma giant Bayer will be looking to make a significant investment into one of its US plants that produces over-the-counter drugs.

Bayer announced that it will spend $43.6 million to expand its facility in Myerstown, PA, a small town east of Harrisburg. Bayer plans to increase the site by 70,000 square feet and will have room for the installation of eight packaging lines and an area to install rooftop solar panels. The project is expected to be completed by 2025 and will add around 50 to 75 jobs.

US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

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