Andrew Hirsch, C4 Therapeutics CEO

C4's An­drew Hirsch blows up IPO to $182M, while on­colyt­ic virus up­start nabs $87M of­fer­ing

On Fri­day, Mass­a­chu­setts-based biotechs C4 Ther­a­peu­tics and On­corus be­came the lat­est to jump on­to Nas­daq.

Less than a month af­ter be­ing tapped as C4 Ther­a­peu­tics’ new CEO, Bind and Agios vet An­drew Hirsch is march­ing the biotech to Wall Street with an up­sized IPO.

C4, which ini­tial­ly filed for $100 mil­lion, priced 9.6 mil­lion shares at $19 mil­lion apiece, net­ting $182.4 mil­lion. The pro­ceeds will be used to push the com­pa­ny’s first pro­tein degra­da­tion can­di­dates in­to the clin­ic, ac­cord­ing to an S-1/A fil­ing.

C4 is work­ing on small mol­e­cule pro­tein de­graders that se­lec­tive­ly de­stroy dis­ease-caus­ing pro­teins, in­clud­ing some that it calls “un­drug­gable.” The Wa­ter­town, MA-based pre­clin­i­cal com­pa­ny has burned through $140 mil­lion. It’s eye­ing a clin­i­cal de­but for its can­di­date CFT7455 — which tar­gets IKZF1/3 in mul­ti­ple myelo­ma (MM), pe­riph­er­al T-cell lym­phoma and man­tle cell lym­phoma pa­tients — in the first half of 2021.

“We ex­pect to sub­mit an in­ves­ti­ga­tion­al new drug ap­pli­ca­tion, or IND, for this prod­uct can­di­date to the U.S. Food and Drug Ad­min­is­tra­tion, or the FDA, in the fourth quar­ter of 2020 and be­gin a first-in-hu­man Phase 1/2 clin­i­cal tri­al for this prod­uct in the first half of 2021,” the S-1/A states.

The com­pa­ny said it be­lieves the can­di­date “could even­tu­al­ly re­place ther­a­pies based in the class of mol­e­cules known as IMiDs as the as the stan­dard of care in mul­ti­ple in­di­ca­tions, in­clud­ing MM.”

C4’s sec­ond pre­clin­i­cal can­di­date, CFT8634 for syn­ovial sar­co­ma and SMAR­CB1-delet­ed sol­id tu­mors, is ex­pect­ed to en­ter a Phase I/II tri­al by the end of next year. Its BRAF V600E and RET pro­grams, which are still in dis­cov­ery, could be “in the clin­ic by the end of 2022,” ac­cord­ing to the fil­ing.

Hirsch has an op­tion on 3.5% of the com­pa­ny’s stock with “an ex­er­cise price per share equal to the pub­lic of­fer­ing price in the IPO.” That’s on top of a $560,000 base salary and bonus plan. He hails from Agios, where he served as CFO for 4 years. And be­fore that, he wrapped the Bind bank­rupt­cy.

Back in June, C4 raised $170 mil­lion, in the form of a $150 mil­lion B round and $20 mil­lion in ven­ture debt from Per­cep­tive. Co­bro, which co-led the B round, holds 6.1% of stock af­ter the of­fer­ing. Per­cep­tive has 6.3%.

C4 hit Nas­daq on Fri­day un­der the tick­er $CC­CC.

On­corus priced 5.8 mil­lion shares at $15 apiece, the mid­point of a $14 to $16 range, pulling in $87 mil­lion. The biotech had ini­tial­ly filed for an $86 mil­lion IPO in Sep­tem­ber.

The biotech’s lead can­di­date, ON­CR-177, is cur­rent­ly in Phase I de­vel­op­ment for mul­ti­ple sol­id tu­mor can­cers, in­clud­ing squa­mous cell car­ci­no­ma of the head and neck, breast can­cer and melanoma. About $32 mil­lion of IPO pro­ceeds will be used to push the can­di­date, an on­colyt­ic Her­pes Sim­plex Virus (oHSV) vi­ral im­munother­a­py, through Phase I, ac­cord­ing to the com­pa­ny’s S-1/A fil­ing.

“We ex­pect to re­port pre­lim­i­nary da­ta from this tri­al in mul­ti­ple da­ta read­outs be­gin­ning in the sec­ond half of 2021 through the sec­ond half of 2022,” the fil­ing states.

On­corus land­ed a $79.5 mil­lion Se­ries B led by Cowen and Per­cep­tive Ad­vi­sors last year for its work in the on­colyt­ic virus space. So far, the biotech has spent $96.3 mil­lion.

“Not all on­colyt­ic virus­es are the same and I think the in­vestors that came in­to this round clear­ly saw that we were much dif­fer­ent than oth­ers that are out there,” CEO Ted Ash­burn told End­points.

Cowen holds 5.5% of the biotech’s shares af­ter the of­fer­ing, ac­cord­ing to the S-1/A. “En­ti­ties af­fil­i­at­ed with MPM Cap­i­tal” have 12.4%.

On­corus will be list­ed un­der the tick­er $ON­CR.

Last week, Nas­daq count­ed $11.3 bil­lion in biotech IPOs this year. A num­ber of fac­tors, in­clud­ing the Covid-19 pan­dem­ic, con­tributed to a “per­fect storm” for an IPO boom, Nas­daq head of health­care list­ings Jor­dan Saxe told End­points News. He es­ti­mat­ed there will be 65-70 biotech IPOs by the end of the year, on the low end.

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

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Covid-19 roundup: WSJ of­fers in­side look at Ox­ford-As­traZeneca deal, in­clud­ing fi­nan­cial terms; Lil­ly plant un­der scruti­ny again

Oxford scientists developing a Covid-19 vaccine are working with British drugmaker AstraZeneca, and together the pair have become one of the frontrunners in the race to end the pandemic. But a new Wall Street Journal report out Wednesday offered a behind-the-scenes look at how that deal came together in the wake of a scholar-led revolt over a potential collaboration with Merck, and included previously unreported financial terms of the AstraZeneca deal.

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Jean-Pierre Sommadossi, Atea president and CEO (file photo)

Roche wades deep­er in­to Covid-19 fight, ink­ing an­tivi­ral pact with $350M cash fol­low­ing Re­gen­eron deal

Roche is making its first bet on an antiviral against Covid-19 in style, shelling out $350 million in cash to grab ex-US rights.

The drug comes from Atea Pharmaceuticals, the 7-year-old biotech created by Pharmasset co-founder Jean-Pierre Sommadossi, which essentially rebranded itself as a Covid-19 fighter in May when it closed a whopping $215 million venture round. Over a dozen investors bought in, including marquee names like Bain Capital and RA Capital.

CEO Marc Gleeson (Azura)

Azu­ra Oph­thalmics gets a $20M boost for its R&D work on eye dis­eases

Three years after closing a $16 million Series B, the same group of investors are back to give Azura Ophthalmics a $20 million boost.

That brings the Tel Aviv-Yafo, Israel-based biotech’s total fundraise to $38 million, and should pave the way for a registration study of its lead candidate in Meibomian gland dysfunction (MGD) and related eye diseases, CEO Marc Gleeson told Endpoints News.

The topical candidate, dubbed AZR-MD-001, is designed to address abnormal hyperkeratinization, or the build-up and shedding of proteins at the opening of or within the Meibomian gland. When Meibomian glands become dysfunctional, rapid evaporation of the tear film can occur, leading to dry eye disease.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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David Hung (file photo)

Mas­ter deal­mak­er David Hung re­tools a SPAC sedan in­to a fi­nanc­ing mus­cle ve­hi­cle that leaves his can­cer start­up with $850M and a place on Wall Street

It’s only right that one of the industry’s top dealmakers just completed one of the biggest SPAC-related deals in the pipeline.

David Hung, of Medivation fame, has completed a back flip into the market, merging with EcoR1 Capital’s SPAC Panacea and landing neatly on Wall Street with an $NUVB stock ticker after filling out the blank check in his name. In addition to the $144 million held in the SPAC — provided none of the investors opt out — Hung is getting ahold of $500 million more being chipped in by a slate of institutional investors who feel that Hung could have the keys to another Medivation-style success.

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Peter Kolchinsky and Raj Shah (file photo)

Pe­ter Kolchin­sky and Raj Shah's RA Cap­i­tal has $461M more to play with, af­ter 'rapid' in­vest­ment in the last 15 months

Just over 15 months after launching its first venture fund, RA Capital Management is ready for more. And this time the firm is bringing an even bigger load of cash to the table.

Announcing the close of its Nexus II fund on Wednesday, RA said it raised $461 million for investments in private companies across the biotech industry. The first venture fund, which raised $300 million, has churned through roughly 80% of its capital already, a pace that managing partner Raj Shah called unusually quick.