Ilan Ganot, Solid Bio CEO

Lay­offs hit an­oth­er biotech as Duchenne play­er Sol­id Bio cuts staff by 35%

An­oth­er biotech has joined the ranks of the re­or­ga­nized, as Duchenne play­er Sol­id Bio­sciences re­port­ed a new way of do­ing things Wednes­day and an­nounced lay­offs and a C-suite de­par­ture.

Sol­id Bio is re­duc­ing its work­force by 35%, ac­cord­ing to an SEC fil­ing for its first-quar­ter re­sults Wednes­day, in ad­di­tion to a new em­pha­sis on its two gene ther­a­pies. The pipeline shift in­cludes an out­sourced man­u­fac­tur­ing process rather than what was used pre­vi­ous­ly, al­low­ing for a more stream­lined de­vel­op­ment process, the com­pa­ny said.

“We be­lieve that a new, out­sourced process may pro­vide im­prove­ments to man­u­fac­tura­bil­i­ty as well as ad­di­tion­al or­ga­ni­za­tion­al ef­fi­cien­cies,” Sol­id Bio said in its 10-Q. “We an­tic­i­pate that the use of trans­fec­tion-based man­u­fac­tur­ing process­es for both SGT-001 and SGT-003, will al­low us to fo­cus our op­er­at­ing struc­ture and bet­ter lever­age ex­ter­nal man­u­fac­tur­ing ex­per­tise.”

Joel Schnei­der

On top of all this, COO Joel Schnei­der will leave the com­pa­ny at the end of May to be­come CEO of a pri­vate gene ther­a­py biotech. Shares of Sol­id Bio $SLDB, al­ready a pen­ny stock, did not re­act much to the news, drop­ping about 1% in ear­ly Wednes­day trad­ing.

Wednes­day doesn’t mark the first time Sol­id Bio has run in­to some set­backs. Its lead gene ther­a­py, dubbed SGT-001 and de­signed to treat Duchenne mus­cu­lar dy­s­tro­phy, has run in­to sev­er­al road­blocks at the FDA in­clud­ing mul­ti­ple clin­i­cal holds over the last few years.

The holds have since been lift­ed, but an ini­tial da­ta cut re­leased in March 2021 did not ap­pear to in­vig­o­rate in­vestors as much as the biotech hoped. Though the tri­al was de­signed to eval­u­ate mi­crody­s­trophin pro­tein ex­pres­sion and dis­tri­b­u­tion, Sol­id Bio em­pha­sized func­tion­al and pa­tient-re­port­ed out­comes at the 12-month mark in­stead.

At the time, an­a­lyst Joseph Schwartz said the re­sults rep­re­sent­ed a “glimpse” of hope in the drug’s ef­fec­tive­ness. But in an in­vestor call Wednes­day, Schwartz still ap­peared un­sat­is­fied with the biotech’s abil­i­ty to mit­i­gate the risk for pa­tients. He asked ex­ecs about how Sol­id Bio is set­ting up its pro­to­col to en­sure pa­tients can tol­er­ate the drug, giv­en the new man­u­fac­tur­ing process.

Rox­ana Don­isa Dreghi­ci

Rox­ana Don­isa Dreghi­ci, Sol­id Bio’s head of clin­i­cal de­vel­op­ment, ac­knowl­edged that though the com­pa­ny is con­fi­dent in its pro­to­col, there still may be some changes.

“We’ve def­i­nite­ly op­ti­mized our fol­low up of the pa­tients of pre­vi­ous two in­fu­sions and in­fu­sions af­ter the first cou­ple of weeks of mon­i­tor­ing,” she said, al­lud­ing to pa­tients who took the drug be­fore the man­u­fac­tur­ing shift. “We’re mak­ing sure every­thing is still ap­plic­a­ble for the new ma­te­r­i­al.”

CEO Ilan Gan­ot added that Sol­id Bio has al­ready start­ed en­gag­ing with reg­u­la­tors about the changes, and in­tends to be ready to dose in ear­ly 2023. Sol­id Bio had pre­vi­ous­ly part­nered with Forge Bi­o­log­ics on man­u­fac­tur­ing, but is “build­ing a new re­la­tion­ship” with an­oth­er un­named ven­dor to pro­duce SGT-001, he said.

Wednes­day’s news comes amidst a tsuna­mi wave of lay­offs across the biotech sec­tor, with seem­ing­ly a new com­pa­ny an­nounc­ing a “re­struc­tur­ing” every day. It’s a much dif­fer­ent en­vi­ron­ment than the in­dus­try saw dur­ing the peak months of Covid-19 quar­an­tine, sig­ni­fied by a stark fig­ure — as of Tues­day, the XBI fell to the same lev­el it was in April 2020, when the pan­dem­ic was in its ear­ly months.

Image courtesy of The Janssen Pharmaceutical Companies of Johnson & Johnson.

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Andrey Zarur, GreenLight Biosciences CEO

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Roger Perlmutter, Eikon Therapeutics CEO

Roger Perl­mut­ter builds Eikon's pipeline with deal-mak­ing flur­ry, rais­ing $106M more

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