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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

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What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

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Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

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