Markus Warmuth, Monte Rosa CEO

Monte Rosa takes this week's IPO lead as a nine-fig­ure raise push­es in­dus­try to­tal past $9B

Ed­i­tor’s note: In­ter­est­ed in fol­low­ing bio­phar­ma’s fast-paced IPO mar­ket? You can book­mark our IPO Track­er here.

Ma­jor League Base­ball isn’t the on­ly in­dus­try that’s un­der­go­ing a reck­on­ing over “sticky stuff,” as Monte Rosa Ther­a­peu­tics takes its mol­e­c­u­lar glues pub­lic Thurs­day ready to shake up Nas­daq.

The Boston-based biotech priced its IPO late Wednes­day night and plans to start trad­ing Thurs­day at a launch price of $19 per share. Monte Rosa se­cured $222.3 mil­lion with the of­fer­ing as biotech con­tin­ues its record IPO pace: now with 54 com­pa­nies go­ing pub­lic in 2021, the in­dus­try is on track to see more than 100 de­buts in a cal­en­dar year for the first time ever, ac­cord­ing to the End­points News tal­ly.

And this year’s com­bined IPO raise? It’s over $9 bil­lion.

If they main­tain their pace, both to­tals would eclipse the marks set dur­ing last year’s pan­dem­ic-fu­eled craze, when biotech saw $16.5 bil­lion fun­neled to­ward 91 new­ly pub­lic com­pa­nies, per fig­ures from Nas­daq.

Monte Rosa has blazed a path to the pub­lic mar­ket ever since it closed a $96 mil­lion Se­ries B back in Sep­tem­ber 2020. CEO Markus War­muth suc­cess­ful­ly drummed up in­vestor ex­cite­ment over the biotech’s “mol­e­c­u­lar glue” tech­nol­o­gy that seeks to re­pro­gram how ubiq­ui­tin lig­as­es work, a func­tion crit­i­cal to the process of pro­tein degra­da­tion.

While oth­er com­pa­nies in this space had sought to de­vel­op in­hibitors, War­muth said at the time, that ap­proach re­quired tar­gets to have an ac­tive site. Monte Rosa’s ap­proach al­lows the biotech to go af­ter those with­out such sites, par­tic­u­lar­ly when the his­tor­i­cal­ly tricky tran­scrip­tion mech­a­nism is in­volved.

War­muth fol­lowed up that raise with an­oth­er $95 mil­lion round in March, short­ly af­ter which Monte Rosa filed to go pub­lic. Hav­ing raised enough cap­i­tal to get its lead pro­gram in­to the clin­ic, the biotech is ear­mark­ing some of the IPO funds for a planned Phase I/II tri­al.

The pro­gram, tar­get­ing GSPT1 for some ge­net­i­cal­ly-de­fined can­cers, had been ex­pect­ed to reach the IND phase by the end of 2020, War­muth told End­points last Sep­tem­ber. Now, though, launch­ing IND-en­abling stud­ies isn’t ex­pect­ed un­til the sec­ond half of this year.

Per Monte Rosa’s up­dat­ed S-1, the com­pa­ny plans to spend on­ly $47 mil­lion to $57 mil­lion on this study, sav­ing the ma­jor­i­ty of the funds for its oth­er can­di­dates. The biotech will save about $120 mil­lion to $130 mil­lion for this ef­fort, bankrolling a quar­tet of pre­clin­i­cal pro­grams that seek to tar­get CDK2, NEK7, VAV1 and BCL11A in a range of can­cers, in­flam­ma­to­ry dis­eases and au­toim­mune dis­eases.

At least three of these will hit the IND-en­abling phase with the cash, the S-1 says, though it’s un­clear which is the fur­thest ahead. Monte Rosa will set aside the re­main­ing $65 mil­lion to $75 mil­lion to con­tin­ue de­vel­op­ing its plat­form.

The biggest win­ner of the IPO is Ver­sant, which owns the largest stake in the com­pa­ny at 20.5% post-of­fer­ing. New En­ter­prise As­so­ci­ates takes home sec­ond with a 15.6% share af­ter the IPO fin­ish­es, while Cor­morant As­set Man­age­ment clocks in third at 6.1%. War­muth him­self will al­so take home some cash, giv­en that he owns more than 400,000 shares. Post-IPO, that will equate to a 1% stake in his com­pa­ny.

Monte Rosa plans to trade un­der the tick­er $GLUE. And next up on IPO watch, an­oth­er quar­tet of com­pa­nies are ex­pect­ed to price their IPOs in time for Fri­day trad­ing, in­clud­ing Graphite Bio, GH Re­search, El­e­va­tion On­col­o­gy and Al­pha Tekno­va.

Op­ti­miz­ing Cell and Gene Ther­a­py De­vel­op­ment and Pro­duc­tion: How Tech­nol­o­gy Providers Like Corn­ing Life Sci­ences are Spurring In­no­va­tion

Remarkable advances in cell and gene therapy over the last decade offer unprecedented therapeutic promise and bring new hope for many patients facing diseases once thought incurable. However, for cell and gene therapies to reach their full potential, researchers, manufacturers, life science companies, and academics will need to work together to solve the significant challenges facing the industry.

David Baker working with a student on their protein design (Jason Mast)

Sci­en­tists are fi­nal­ly learn­ing how to de­sign pro­teins from scratch. Drug de­vel­op­ment may nev­er be the same

SEATTLE — It’s a cloudy Thursday afternoon in mid-July and David Baker is reclining into the futon in his corner office at the University of Washington, arms splayed out like a daytime talk show host as he coaches another one of his postdocs through the slings and arrows of scientific celebrity.

“Be jealous of your time,” he says, before plotting ways of sneaking her out of Zooms. “It’s this horrible cost to science that you’re tied up in some stupid meeting.”

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Pre­sent­ing a live End­points News event: Man­ag­ing a biotech in tur­bu­lent times

Biotech is one of the smartest, best educated industries on the planet. PhDs abound. We’ve had a long enough track record to see a new generation of savvy, experienced execs coming together to run startups.

And in these times, they are being tested as never before.

Biotech is going through quite a rough patch right now. For 2 years, practically anyone with a decent resume and some half-baked ideas on biotech could start a company and get it funded. The pandemic made it easy in many ways to pull off an IPO, with traditional road shows shut down in exchange for a series of quick Zoom meetings. Generalist investors flocked as the numbers raised soared into the stratosphere.

Patty Murray, D-WA (Graeme Sloan/Sipa USA)(Sipa via AP Images)

Sen­ate user fee reau­tho­riza­tion bill omits ac­cel­er­at­ed ap­proval re­forms, shows wide gaps with House ver­sion

The Senate health committee on Tuesday released its first version of the bill to reauthorize all the different FDA user fees. But unlike the House version, there are only a few controversial items in the Senate’s version, which does not address either accelerated approval reforms or clinical trial diversity (as the House did).

While it’s still relatively early in the process of finalizing this legislation (the ultimate statutory deadline is the end of September), the House and Senate, at least initially, appear to be starting off in different corners on what should be included.

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Warren Buffett, Berkshire Hathaway CEO

Berk­shire Hath­away pulls out of Ab­b­Vie, Bris­tol My­ers Squibb in­vest­ments

It looks like Warren Buffett is sticking to ice cream and railroads for the moment.

The billionaire CEO of Berkshire Hathaway backed out of two major holdings in the pharma industry, Forexlive first reported, including a $410 million investment in AbbVie and a $324.4 million stake in Bristol Myers Squibb.

The move comes after Berkshire abandoned its Teva shares just last quarter, Bloomberg reported.

Long-ex­pect­ed UK lay­offs im­mi­nent for No­var­tis fol­low­ing sale

Nearly a year ago, more than 200 workers at Novartis’ Grimsby, UK, facility were able to hang on to their jobs after the pharma closed a Switzerland site as a part of its workforce restructuring plan. Now, it looks like those employees’ time is up, as the site has been sold, Grimsby Telegraph reported today.

The manufacturing site has been sold to Humber Industrials, a subsidiary of International Process Plants. None of the current staff members will be working with the new owners, however.

FDA lob­bies Con­gress over rare dis­ease court rul­ing with wide im­pli­ca­tions

Usually reserved for making decisions on drug applications or enforcing what Congress stipulates, the FDA is now dipping its toe into the wild world of congressional politics as it attempts to fix a major court decision that could have a chilling effect on rare disease R&D.

The case in question from last October saw a US appeals court overturn a prior FDA court win, saying that the agency never should’ve approved a rare disease drug because a previously approved but more expensive drug with the same active ingredient has orphan drug exclusivity barring such an approval.

Peter Marks (Greg Nash/Pool via AP)

Even FDA's Pe­ter Marks is wor­ried about the com­mer­cial vi­a­bil­i­ty of gene and cell ther­a­pies

When bluebird bio’s gene therapy to treat beta thalassemia won European approval in 2019, the nearly $2 million per patient price tag for the potential cure seemed like a surmountable hurdle.

Fast forward two years later, and bluebird has withdrawn Zynteglo, the beta thal drug, along with the rest of its gene therapy portfolio from Europe, which the company said is generally unwilling to pay a fair price for the treatment.

Pri­cy in­halers re­main ex­pen­sive due to de­vice tweaks that keep com­peti­tors at bay, re­searchers find

New research published in Health Affairs today highlights the way in which the FDA’s inhaler regulations have rewarded incremental adjustments to older products, thereby enabling companies to skirt around cheaper competition.

A DC appeals court clerk and researchers from Harvard and the University of Calgary dug through all the patents and regulatory exclusivities granted to inhalers approved by the FDA between 1986 and 2020, finding that of the 62 inhalers approved, 53 (or 85%) were brand-name products, with a median of 16 years of protection from generic competition.