Suck­ing up tal­ent out of No­var­tis, a boom­ing Ru­bius adds an­oth­er $100 mil­lion mega-round to the kit­ty

Just 8 months af­ter putting the fin­ish­ing touch­es to a $120 mil­lion round, Flag­ship start­up Ru­bius Ther­a­peu­tics is back at the mon­ey well, draw­ing up an­oth­er big mega-round of $100 mil­lion.

Tor­ben Straight Nis­sen

This time, with more than $220 mil­lion to the good since jump­ing off the start­ing line, Ru­bius de­scribes the raise as a “crossover round.” So does that mean that there’s an S-1 un­der con­struc­tion?

Not ex­act­ly.

“We’re con­sid­er­ing all op­tions,” says CEO Tor­ben Straight Nis­sen. As for an IPO, that’s one of sev­er­al routes that could be open to the com­pa­ny — when the time is right.

Un­usu­al­ly, the biotech is not spelling out where the cash is com­ing from. All that the CEO is will­ing to say is that the syn­di­cate in­cludes “some of the largest mu­tu­al funds…as well as oth­er ma­jor in­vestors.”

A few years ago it would have been a vir­tu­al mis­sion im­pos­si­ble to gath­er more than $200 mil­lion for a biotech that has yet to file its first IND. But Flag­ship chief Noubar Afeyan has been one of the lead­ing pro­po­nents of a move to find new plat­form com­pa­nies with big po­ten­tial for some game-chang­ing tech­nol­o­gy and then com­ing up with the big mon­ey need­ed to build a full pipeline of ther­a­pies, rather than one or two pi­lot projects to demon­strate their po­ten­tial.

Noubar Afeyan

It’s a high risk, high re­ward strat­e­gy that has been pur­sued ag­gres­sive­ly by Mod­er­na, an­oth­er Flag­ship com­pa­ny which just added $500 mil­lion on a $7 bil­lion val­u­a­tion — well ahead of piv­otal da­ta.

What­ev­er lim­it there may be to in­vestor ap­petite for biotech risk, we aren’t see­ing it yet. In the past 72 hours we’ve tracked more than $650 mil­lion in new in­vest­ments in the field, with the mon­ey scat­tered in Cam­bridge/Boston, the Bay Area, Mary­land and New York. The $250 mil­lion raised for a new As­traZeneca spin­out came from three new Chi­nese in­vestors, who are burst­ing on the scene with more cash for qual­i­fied syn­di­cates. And this is the sec­ond $100 mil­lion raise this week.

The R&D plan at Ru­bius is to push ahead with some lead en­zyme re­place­ment ther­a­pies be­ing spawned on a plat­form that seeks to de­vel­op a brand new class of cell ther­a­pies.

The big idea at Ru­bius is that re­searchers can take red blood cells — de­signed by na­ture to trans­port oxy­gen — hi­jack them through ge­net­ic en­gi­neer­ing tech and get them to car­ry pro­teins need­ed to fight var­i­ous dis­eases. It’s an off-the-shelf ap­proach, rather than one per­son­al­ized for each pa­tient.

De­vel­op­ing a new class of med­i­cine, though, calls ear­ly on for some pricey man­u­fac­tur­ing ca­pac­i­ty. And af­ter es­tab­lish­ing a sup­ply line with CMOs, Ru­bius is do­ing some cal­cu­la­tions on how it should con­struct its own in-house process.

“Clear­ly,” says the CEO, “one of the ex­plo­rations is build or buy.” And they don’t have to stay too close to home in Cam­bridge, MA. Oth­er lo­ca­tions in or around Boston and the rest of Mass­a­chu­setts could serve.

The staff, mean­while, has al­ready grown to 67, which in­cludes adding a man­u­fac­tur­ing chief. Spencer Fisk jumped to Ru­bius just a few days ago, join­ing what seems to be a steady mi­gra­tion out of No­var­tis’ cell and gene ther­a­py op­er­a­tion. He was the glob­al head of Cell and Gene Tech­ni­cal De­vel­op­ment and Man­u­fac­tur­ing. Fisk took the place of Karen Walk­er, who left for Seat­tle Ge­net­ics last spring. Walk­er had, in turn, be­come one of three key man­agers in the cell unit at No­var­tis, which was thor­ough­ly re­or­ga­nized about two years ago, when Us­man “Oz” Azam left the helm to run a cell ther­a­py start­up.

It’s a small world in the cell ther­a­py field. Now Fisk is work­ing at a biotech where for­mer No­var­tis can­cer chief David Ep­stein is ex­ec­u­tive chair­man.

Burst­ing at the seams, Ru­bius is al­so now mov­ing in­to 45,000 square feet in new digs at 399 Bin­ney. By this sum­mer, he adds, the staff should be up to around 100 — no small af­fair.

Im­age: 399 Bin­ney Street (Alexan­dria Re­al Es­tate Eq­ui­ties)

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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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

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