AlloVir rides IPO boom on first mar­ket day, soars af­ter bag­ging $276 mil­lion

Mass­a­chu­setts-based AlloVir hit Wall Street Thurs­day, join­ing the ranks of drug mak­ers to strike big in the 2020 IPO boom.

The biotech’s 16.3 mil­lion shares priced at $17 each — the mid­point of a $16 to $18 range — earn­ing $276 mil­lion. AlloVir, which sur­vived on most­ly grant mon­ey and was known as Vira­Cyte un­til last year, ini­tial­ly reg­is­tered for a $100 mil­lion IPO on Ju­ly 6. But in the foot­steps of oth­er phar­mas go­ing pub­lic for the first time this year, it up­sized by 1.5 mil­lion shares.

Shares $ALVR kept ris­ing through­out the day, clos­ing up 49.35% at $25.39.

Many have ben­e­fit­ed from the “his­toric” boom, in­clud­ing a col­lec­tive $772 mil­lion-plus haul last week by iTeos, Nurix, An­nex­on and In­ozyme, all of which priced at the high end or above their ex­pect­ed ranges.

The first signs of a boom ap­peared in Jan­u­ary, then gave way to a slow­er pe­ri­od as a re­sult of the Covid-19 pan­dem­ic. But a resur­gence is un­der­way — by June, all 23 new­ly pub­lic com­pa­nies priced above their mid­point or up­sized their of­fer­ing. SPACs (spe­cial pur­pose ac­qui­si­tion com­pa­nies) al­so played a part; they now rep­re­sent near­ly 35% of list­ings, as op­posed to 3% in 2014, the Nas­daq’s Jay Heller told End­points ear­li­er this month.

AlloVir launched from the Bay­lor Col­lege of Med­i­cine’s Cen­ter for Cell and Gene Ther­a­py in 2013, and was tapped by David Hal­lal last year to be El­e­vate­Bio’s first port­fo­lio com­pa­ny. The deal meant a $120 mil­lion round of fund­ing for AlloVir’s late-stage drug de­vel­op­ment.

Hal­lal owned 28.39%  of shares af­ter the of­fer­ing, ac­cord­ing to AlloVir’s S-1/A fil­ing. Vikas Sin­ha, Ans­bert Gadicke and Morana Jo­van-Em­biri­cos, all on El­e­vate­Bio’s board of di­rec­tors, owned 23.26%, 21.99%  and 25.36% re­spec­tive­ly.

The com­pa­ny will use its IPO funds to ad­vance its al­lo­gene­ic T cell ther­a­pies for treat­ing vi­ral dis­eases. Its cur­rent pro­grams span 12 dif­fer­ent virus­es, but the lead can­di­date, Vi­ra­lym-M, tar­gets BK virus, cy­tomegalovirus, ade­n­ovirus, Ep­stein-Barr virus, and hu­man her­pesvirus-6. The com­pa­ny has three Phase III piv­otal tri­als and three Phase II proof-of-con­cept tri­als for use of Vi­ra­lym-M in pe­di­atric and adult pa­tients planned for 2020 and 2021.

In a Phase II proof-of-con­cept tri­al of Vi­ra­lym-M in­clud­ing 58 par­tic­i­pants, 93% of stem cell trans­plant pa­tients who were in­fect­ed with tar­get virus­es showed a “clin­i­cal re­sponse,” ac­cord­ing to the S-1. The drug earned pri­or­i­ty med­i­cines (PRIME) des­ig­na­tion by the EMA to treat in­fec­tions caused by tar­get­ed virus­es in HSCT pa­tients, and re­gen­er­a­tive med­i­cine ad­vanced ther­a­py (RMAT) des­ig­na­tion by the FDA to treat he­m­or­rhag­ic cys­ti­tis caused by BKV in adults and chil­dren.

“While these des­ig­na­tions may not lead to a faster de­vel­op­ment process and do not in­crease the like­li­hood that a prod­uct can­di­date will re­ceive ap­proval from the FDA or EMA, we ex­pect that PRIME and RMAT des­ig­na­tions will re­sult in in­creased EMA and FDA in­ter­ac­tions to sup­port our de­vel­op­ment ef­forts and may en­able an ex­pe­dit­ed reg­u­la­to­ry re­view process,” AlloVir’s S-1 fil­ing states.

Oth­er drugs in the pipeline in­clude ALVR106 to treat res­pi­ra­to­ry syn­cy­tial virus, in­fluen­za, parain­fluen­za virus and hu­man metap­neu­movirus; ALVR107 to treat he­pati­tis B; ALVR108 to treat hu­man her­pesvirus-8; and ALVR109 to treat SARS-CoV-2. AlloVir’s mech­a­nisms in­clude what CSO Ann Leen has called “an im­mune sys­tem in a dish”: virus-spe­cif­ic T cells from blood donors that are used to re­store im­mu­ni­ty in those with T cell de­fi­cien­cies.

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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