Anirvan Ghosh, Unity CEO (via Facebook)

Uni­ty finds it­self with a fi­nite amount of cash as new da­ta pro­vide a ray of hope for in­vestors

It has not been an easy road for the an­ti-ag­ing start­up Uni­ty Biotech­nol­o­gy. From staff cuts to a lead pro­gram loss, the com­pa­ny has run in­to sev­er­al ob­sta­cles on its jour­ney, but their lat­est news points to both the per­ils and po­ten­tial ahead.

In the biotech’s Q2 re­sults on Fri­day, the com­pa­ny re­vealed it has on­ly enough cash to fund its op­er­a­tions through the first quar­ter of next year, with post­ed re­sults show­ing that Uni­ty had $64.5 mil­lion in cash and mar­ket se­cu­ri­ties at the end of the quar­ter. This is com­pared to the $79.2 mil­lion the biotech had at the end of March. The com­pa­ny al­so had an op­er­at­ing loss of $12.3 mil­lion for the quar­ter as well.

End­points News reached out to Uni­ty about the sit­u­a­tion but has not re­ceived a re­sponse by press time and will up­date ac­cord­ing­ly.

The com­pa­ny price $UBX dropped in­to the pen­ny stock range ear­li­er this year and has been gy­rat­ing in and out since. How­ev­er, da­ta re­leased this morn­ing are bring­ing bet­ter news for in­vestors, push­ing the stock price up by more than 100% Fri­day morn­ing.

And that may help pave the way to bring­ing in more cash, if they can fol­low the road to a fol­low-on.

The com­pa­ny post­ed 12- and 18-week da­ta from its Phase II BE­HOLD study of UBX1325, a senolyt­ic Bcl-xL in­hibitor, in pa­tients with di­a­bet­ic mac­u­lar ede­ma (DME). UBX1325 was one of the ma­jor fo­cus­es of the com­pa­ny af­ter its lead can­di­date flopped in 2020.

At 18 weeks, af­ter a sin­gle in­jec­tion of UBX1325, the change in pa­tients’ best cor­rect­ed vi­su­al acu­ity (BC­VA) was an in­crease of 6.1 ET­DRS let­ters, rep­re­sent­ing an im­prove­ment of +5.0 ET­DRS let­ters com­pared to sham-treat­ed sub­jects and a val­ue of P= 0.0368. The da­ta al­so showed that pa­tients treat­ed with UBX1325 main­tained a cen­tral sub­field thick­ness (CST) com­pared to sham-treat­ed pa­tients who demon­strat­ed pro­gres­sive wors­en­ing of CST.

Pa­tients treat­ed with a sin­gle in­jec­tion of UBX1325 for 12 weeks had a mean im­prove­ment in BC­VA of +4.7 ET­DRS let­ters from base­line com­pared to +1.3 ET­DRS let­ters in sham-treat­ed pa­tients, lead­ing to a val­ue of p=0.1148.

“The vi­sion gains ob­served are greater than what has been pre­vi­ous­ly re­port­ed with the stan­dard of care in sim­i­lar pa­tient pop­u­la­tions, and the dura­bil­i­ty of ef­fect sug­gests that UBX1325 could ad­dress the large un­met need for longer-last­ing, dis­ease-mod­i­fy­ing treat­ments for pa­tients with DME. These da­ta rep­re­sent an im­por­tant and ex­cit­ing step in val­i­dat­ing the senolyt­ic ther­a­peu­tic con­cept that is core to UNI­TY’s plat­form,” said Uni­ty CEO Anir­van Ghosh.

The com­pa­ny is bull­ish on the find­ings and is forg­ing ahead with more stud­ies for UBX1325 for now.

This pos­i­tive news is a wel­come re­prieve af­ter sev­er­al re­cent set­backs for Uni­ty.

In 2020, af­ter the com­pa­ny saw mas­sive in­vest­ments from names such as Jeff Be­zos, Pe­ter Thiel and Bob Nelsen, its Phase II study test­ing whether their lead drug UBX0101 could al­le­vi­ate pain in peo­ple with os­teoarthri­tis of the knee showed vir­tu­al­ly no dif­fer­ence in pa­tients on the place­bo arm. This re­sult­ed in a 30% cut in the biotech’s staff and Nelsen’s even­tu­al de­par­ture, and the com­pa­ny piv­ot­ed to oph­thal­mol­o­gy and neu­rol­o­gy.

At the start of this year, the com­pa­ny sliced away an­oth­er 50% of its work­force, pri­mar­i­ly in its dis­cov­ery re­search unit, to stretch its cash in­to 2023.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Will Lewis, Insmed CEO

In­smed plots up­com­ing med launch­es built on its first drug lessons and con­sumer play­book mar­ket­ing strate­gies

With its first drug launch in the books, Insmed is now focusing on building out a road map for upcoming products – with an eye on consumer marketing strategies.

For CEO Will Lewis, that means tapping consumer insights as early as possible and developing products and packaging that are intuitive and easy to use. It also means translating those patient experiences into creative and atypical biopharma marketing, and in both cases, taking a page from consumer marketers’ playbooks.

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Severin Schwan, outgoing Roche CEO (via Getty Images)

Roche hires new di­ag­nos­tics chief from with­in, ahead of C-suite shake-up

More than two months after Severin Schwan announced he’s leaving Roche and handing the reins to diagnostics chief Thomas Schinecker, the pharma giant has revealed who’s taking Schinecker’s place.

Matt Sause, who currently leads Roche’s North American diagnostics business, is popping the cork on the big global promotion to take effect on March 15. The 20-year Roche veteran has served a handful of roles across the company’s diagnostics and pharma units, including a stint at Genentech where he was lifecycle leader for blockbuster Tecentriq’s head and neck cancer programs.

FTC chair Lina Khan with National Community Pharmacists Association CEO Douglas Hoey (NCPA via Twitter)

FTC chair Lina Khan pledges to use all tools to in­ves­ti­gate PBMs

KANSAS CITY, Mo. — Pharmacy benefit managers have become a thorn in the side of the pharma and insurance industries in recent years, and just a couple of months after the Federal Trade Commission signaled it would investigate unlawful PBM practices, FTC chair Lina Khan is looking to turn up the heat even more.

Khan sat down with National Community Pharmacists Association CEO Douglas Hoey on Monday morning at the NCPA’s annual convention, with a fireside chat in the heart of the Midwest.

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