Tri­fec­ta of clin­i­cal stage biotechs un­veil IPO plans, brav­ing Wall Street's coro­n­avirus pan­ic

Coro­n­avirus fears pre­cip­i­tat­ed a rout on glob­al stock prices on Mon­day, but three clin­i­cal-stage biotechs are sol­dier­ing on with plans to make pub­lic de­buts. The biggest is Zen­tal­is Phar­ma­ceu­ti­cals — which is gun­ning for a $100 mil­lion IPO, three months af­ter an $85 mil­lion round of fi­nanc­ing.

Found­ed in late 2014, the on­col­o­gy com­pa­ny emerged out of stealth in late 2019 with the Se­ries C round. So far the com­pa­ny has raised about $162 mil­lion in gross pro­ceeds.

Zen­tal­is’ lead drug, ZN-c5, is a treat­ment for es­tro­gen re­cep­tor-pos­i­tive, hu­man epi­der­mal growth fac­tor re­cep­tor 2-neg­a­tive, or ER+/HER2-, ad­vanced or metasta­t­ic breast can­cer. In 2018, the com­pa­ny signed a deal to test the drug in com­bi­na­tion with Pfiz­er’s Ibrance — da­ta from this study, and the monother­a­py Phase 1/2 tri­al, are ex­pect­ed lat­er this year.

The New York-based com­pa­ny al­so has ZN-c3, cur­rent­ly in a Phase I/II tri­al un­der in­ves­ti­ga­tion for use in ad­vanced sol­id tu­mors — in ad­di­tion to ZN-d5, ini­tial­ly be­ing de­vel­oped for the treat­ment of hema­to­log­i­cal ma­lig­nan­cies; and ZN-e4, cur­rent­ly in a Phase I/II tri­al un­der eval­u­a­tion for use in ad­vanced non-small cell lung can­cer.

The com­pa­ny — which is run by long­time ven­ture cap­i­tal­ist An­tho­ny Sun — counts Alexan­dria Re­al Es­tate Eq­ui­ties, Even­tide As­set Man­age­ment, Far­al­lon Cap­i­tal, High­Light Cap­i­tal, Ma­trix Cap­i­tal Man­age­ment, Mayo Clin­ic, Per­cep­tive Ad­vi­sors, Phar­maron, Red­mile Group, Sur­vey­or Cap­i­tal (a Citadel com­pa­ny), Ty­bourne Cap­i­tal Man­age­ment and Viking Glob­al In­vestors as its share­hold­ers.

Lyra Ther­a­peu­tics

With the promise of an im­plant de­vel­oped by MIT’s Bob Langer and Har­vard’s George White­sides, ear, nose, and throat dis­ease-fo­cused Lyra Ther­a­peu­tics on Fri­day di­vulged its plans to leap on to the Nas­daq with a $57.5 mil­lion IPO, less than two years af­ter scor­ing $29.5 mil­lion in a Se­ries B round of fi­nanc­ing.

Led by Boston Sci­en­tif­ic vet­er­an Maria Pala­sis, Lyra’s drug de­liv­ery tech­nol­o­gy, which was orig­i­nal­ly meant to tar­get pe­riph­er­al artery dis­ease, of­fers the scope of de­liv­er­ing ex­ist­ing med­ica­tions to af­fect­ed tis­sue for sus­tained pe­ri­ods with a sin­gle ad­min­is­tra­tion.

Its lead ex­per­i­men­tal prod­ucts (LYR-210 and LYR-220) are de­signed to help pa­tients with chron­ic rhi­nos­i­nusi­tis (CRS), a con­di­tion in which the spaces in­side the nose and si­nus­es are swollen and in­flamed — re­sult­ing in a per­pet­u­al­ly stuffy nose and breath­ing dif­fi­cul­ties — for three months or longer, de­spite stan­dard treat­ment with a steroid spray. Some pa­tients even con­sid­er surgery so the spray can have bet­ter ac­cess to the af­fect­ed tis­sue.

Lyra’s im­plants are placed deep in­to the sinonasal pas­sages, and slow­ly re­lease the steroid mometa­sone furoate over six months — us­ing this method, the drug gets clos­er to the af­fect­ed ar­eas, stays in place for a sus­tained pe­ri­od of time and elim­i­nates any com­pli­ance is­sues, the com­pa­ny con­tends.

LYR-210 is cur­rent­ly in a mid-stage study called LANTERN eval­u­at­ing the safe­ty and ef­fi­ca­cy of the prod­uct in up to 150 sur­gi­cal­ly-naïve CRS pa­tients who have failed pre­vi­ous med­ical man­age­ment. Da­ta from this study are ex­pect­ed in the first quar­ter of 2021. LYR-220 is be­ing de­vel­oped for use in CRS pa­tients who con­tin­ue to re­quire treat­ment to man­age symp­toms de­spite hav­ing had si­nus surgery — a proof-of-con­cept study is planned for next year.

En­ti­ties af­fil­i­at­ed with Per­cep­tive Ad­vi­sors own about a third (32.4%) of the com­pa­ny, while oth­er big share­hold­ers in­clude en­ti­ties af­fil­i­at­ed with North Bridge Ven­ture Part­ners (17.3%), en­ti­ties af­fil­i­at­ed with Po­laris Ven­ture Part­ners (16%), RA Cap­i­tal Health­care Fund (9.6%) and In­ter­south Part­ners VII (7.9%).

Ay­ala Phar­ma­ceu­ti­cals

An­oth­er mid-stage biotech — can­cer-fo­cused Ay­ala Phar­ma­ceu­ti­cals — dis­closed its plans for an IPO on Fri­day.

The Is­rael-based com­pa­ny, which is work­ing on treat­ments for rare and ag­gres­sive can­cers, pri­mar­i­ly in ge­net­i­cal­ly de­fined pa­tient pop­u­la­tions, is look­ing to make its de­but with a $50 mil­lion IPO. Ay­ala’s fo­cus is pri­mar­i­ly on tar­get­ing the aber­rant ac­ti­va­tion of the Notch path­way, which is im­pli­cat­ed in reg­u­lat­ing cell pro­lif­er­a­tion, cell fate, dif­fer­en­ti­a­tion, and cell death as well as drug re­sis­tance. Its pipeline of prod­ucts is de­signed to in­hib­it gam­ma-sec­re­tase — the en­zyme re­spon­si­ble for Notch ac­ti­va­tion.

The com­pa­ny’s lead ex­per­i­men­tal drug, AL101, was in-li­censed from Bris­tol My­ers Squibb (BMS) in 2017, al­though the gam­ma-sec­re­tase in­hibitor failed to in­duce a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in an ear­ly-stage study in pa­tients with var­i­ous types of can­cer. But Ay­ala’s faith in the com­pound is based on da­ta that showed clin­i­cal ac­tiv­i­ty in pa­tients with can­cers in which Notch was im­pli­cat­ed as a tu­mori­genic dri­ver.

AL101 is be­ing in­ves­ti­gat­ed as a monother­a­py in an open-la­bel Phase II tri­al as a treat­ment for re­cur­rent/metasta­t­ic ade­noid cys­tic car­ci­no­ma in pa­tients bear­ing Notch-ac­ti­vat­ing mu­ta­tions. The drug is al­so eval­u­at­ed as a ther­a­py for cer­tain pa­tients with triple-neg­a­tive breast can­cer and a rare form of T-cell spe­cif­ic leukemia.

The com­pa­ny’s sec­ond drug-in-de­vel­op­ment was al­so cre­at­ed at BMS. The ther­a­py is be­ing de­vel­oped to treat rare, dis­fig­ur­ing and of­ten de­bil­i­tat­ing types of soft tis­sue tu­mors called desmoid tu­mors, while No­var­tis has signed on as a part­ner to in­ves­ti­gate its use in mul­ti­ple myelo­ma.

Found­ed in 2017, the com­pa­ny has raised $46.3 mil­lion thus far. Its share­hold­ers in­clude BMS, No­var­tis as well as Is­rael Biotech Fund, aMoon Fund, Harel In­sur­ance and Fi­nance, and SBI In­vest­ments.

So­cial im­age: Maria Pala­sis, Lyra Ther­a­peu­tics

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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