Mark Smith, Finch Therapeutics CEO

Bear mar­ket shows no signs of abat­ing, claim­ing Finch Ther­a­peu­tics as the lat­est lay­off vic­tim

Much ink has been spilled over the con­tin­u­ing wave of lay­offs hit­ting the biotech in­dus­try, and that doesn’t look to be stop­ping any­time soon.

Finch Ther­a­peu­tics re­port­ed Tues­day morn­ing that it would be lay­ing off 37 staffers, or ap­prox­i­mate­ly 20% of its work­force, per an SEC fil­ing. The de­ci­sion to cut costs comes about a month af­ter Finch said the FDA had placed a treat­ment for C. dif­fi­cile in­fec­tions on par­tial clin­i­cal hold, and rough­ly three weeks af­ter paus­ing its he­pati­tis B pro­gram.

“This was a dif­fi­cult de­ci­sion; how­ev­er, we be­lieve this de­ci­sion will put us in a stronger fi­nan­cial po­si­tion to ex­e­cute up­on our strate­gic pri­or­i­ties and con­tin­ue to de­liv­er on our mis­sion to har­ness the mi­cro­bio­me to serve pa­tients and their fam­i­lies,” CEO Mark Smith said in a pre­pared state­ment.

Finch shares $FNCH, al­ready down 64% since the start of the year, showed no change as the mar­ket opened Tues­day.

Tues­day’s lay­offs may have been in the works fol­low­ing a rough March, which saw the FDA hold and the he­pati­tis B pause. Reg­u­la­tors had re­quest­ed Finch pro­vide more in­for­ma­tion on its screen­ing pro­to­cols for C. dif­fi­cile in­fec­tions, the biotech said, re­port­ed­ly point­ing to is­sues at a man­u­fac­tur­er Finch had ac­quired while a Phase II study was un­der­way.

The man­u­fac­tur­er, Open­Bio­me, was placed on hold in late 2019, but Finch was al­lowed to con­tin­ue us­ing donor sam­ples from be­fore then in its study. The hold was re­leased in Jan­u­ary 2021, and Finch bought the com­pa­ny’s man­u­fac­tur­ing tech two months lat­er. Finch be­gan dos­ing Phase III pa­tients last No­vem­ber, but the FDA re­turned with ques­tions this past Jan­u­ary.

At the time it re­port­ed the hold, Finch al­so not­ed that some pa­tients were dosed in this study while the hold was in ef­fect. The com­pa­ny says it’s re­view­ing the mat­ter.

The biotech fol­lowed up at the end of March say­ing it had re­spond­ed to the hold no­tice and ob­tained ad­di­tion­al feed­back from the agency. Per Finch, ex­ecs not­ed reg­u­la­tors want­ed changes to the Phase III test­ing al­go­rithm used to di­ag­nose sus­pect­ed re­in­fec­tions, as well as more in­fo on the tri­al’s sta­tis­ti­cal analy­sis plan. The com­pa­ny is ex­pect­ing “at least” a one quar­ter de­lay.

Finch’s March 31 up­date al­so re­vealed the biotech would be paus­ing he­pati­tis B ac­tiv­i­ties “fol­low­ing a strate­gic re­view” of its pipeline. The move will al­low Finch to fo­cus on its C. dif­fi­cile and autism spec­trum dis­or­der pro­grams.

The biotech, much like its in­dus­try com­pa­tri­ots, falls on hard times as 2022 is yet to let up on the sec­tor. Finch’s lay­offs come as part of a broad­er reshift­ing with­in the biotech space fol­low­ing record ac­tiv­i­ty dur­ing the pre­vi­ous two years.

Much of the down­turn has been cap­tured in the XBI, an in­dex mea­sur­ing the in­dus­try’s per­for­mance as a whole. It’s down about 30% on the year and down al­most 50% from its peak in Feb­ru­ary 2021. And some­times, the move­ments ap­pear to be hap­pen­ing ran­dom­ly: on Mon­day, for ex­am­ple, the XBI fell 5% de­spite the lack of ma­jor news.

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.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Benjamine Liu, TrialSpark CEO

Paul Hud­son and Tri­alSpark's mu­tu­al de­sire to speed up de­vel­op­ment con­verges in three-year, six-drug goal

A unicorn startup that originally set out to hasten clinical studies for biopharma partners dug further into its revised path of internal drug development by linking arms with Sanofi in a pact that the biotech’s CEO said originated from the top.

TrialSpark and the Big Pharma on Tuesday committed to in-licensing and/or acquiring six Phase II/Phase III drugs within the next three years.

“I’ve known Paul Hudson for a while and we were discussing the opportunity to really re-imagine a lot of different parts of pharma,” TrialSpark CEO Benjamine Liu told Endpoints News, “and one of the things that we discussed was this opportunity to accelerate the development of new medicines in mutual areas of interest.”

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New Chroma Medicine board member Jeff Marrazzo

Jeff Mar­raz­zo has found a buzzy new biotech cause to cham­pi­on. And once again, he's all in

Jeff Marrazzo is one of those biotech execs who has always been focused on the next big goal. He has a track record for meeting objectives, relentlessly staying on message, and breaking new ground.

The fact that he stayed around for a couple of years after Roche’s $4.3 billion Spark buyout, making sure the organization he founded weathered Covid-19, is one example. And that came after he carefully guided the company to the first-ever US approval of a gene therapy — no easy task.

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Take­da to pull key hy­poparathy­roidism drug from the mar­ket en­tire­ly by end of 2024 af­ter years of man­u­fac­tur­ing woes

Takeda on Tuesday morning made an announcement that almost 3,000 people with the rare disease known as hypoparathyroidism were fearing.

Due to unresolved supply issues and manufacturing woes, Takeda said it will cut its losses and discontinue its hypoparathyroidism drug, known as Natpara (parathyroid hormone), halting all manufacturing of the drug by the end of 2024.

The decision to not re-commercialize Natpara will be a blow to not only the 2,400 people who were awaiting supplies of their reliable injection since 2019, but also the additional nearly 400 people who were accessing the drugs via the company’s Special Use Program as Takeda sought to resolve these manufacturing issues over the past five years.

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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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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Astel­las, Pan­th­er­na add or­gan to mR­NA tie-up; Rock­et launch­es sale of six fig­ures worth of stock

Astellas and Pantherna have expanded their November 2021 pact surrounding the latter’s mRNA platform to include a new target organ, the duo announced Tuesday morning, though they did not specify what that target is.

German biotech Pantherna is home to two platform technologies — one that designs mRNAs for non-vaccine therapies and another that designs LNPs. Astellas and Pantherna’s deal appears to mainly revolve around the first platform, which Astellas said it is using to research direct reprogramming, or turning cells from one kind into another without an intermediate stem cell phase.

Andrew Crockett, KalVista CEO

KalVista ends a PhII study ear­ly af­ter pa­tients suf­fer se­vere and life-threat­en­ing side ef­fects

KalVista took a beating Tuesday after announcing it would scrap a Phase II trial for one of its experimental drugs.

The biotech said in an early morning press release that it is terminating the study for KVD824 after multiple patients in every treatment group saw unsafe, elevated levels of certain liver enzymes. By ending the trial now, KalVista hopes to save some money and funnel it toward another study for its lead program, CEO Andrew Crockett said in a statement.