Robert Hariri, Celularity CEO (Vivien Killilea/Getty Images for Brain Mapping Foundation)

Celu­lar­i­ty warns of loom­ing lay­offs, spot­lights ear­ly pro­grams as mon­ey runs dry

Celu­lar­i­ty has warned “a sub­stan­tial por­tion” of its em­ploy­ees that lay­offs could be loom­ing in the face of a repri­or­i­ti­za­tion ef­fort. In the same breath, it tout­ed some of its very ear­ly next-gen can­di­dates in de­gen­er­a­tive dis­eases and on­col­o­gy.

“While Celu­lar­i­ty is hope­ful that there will be no need to sub­stan­tial­ly re­duce its head­count, the no­ti­fi­ca­tions were pro­vid­ed in ac­cor­dance with ap­plic­a­ble law and to main­tain full trans­paren­cy with its em­ploy­ees,” the news re­lease reads, in part.

Ac­cord­ing to SEC fil­ings sub­mit­ted in No­vem­ber, the re­or­ga­ni­za­tion comes as the com­pa­ny is strug­gling with lit­tle cash and as­sets. As of Sept. 30, 2022, it count­ed $42.6 mil­lion of cash and cash equiv­a­lents — which was on­ly enough to get it through the first quar­ter of 2023. In the same fil­ing, the com­pa­ny raised “sub­stan­tial doubt about its abil­i­ty to con­tin­ue as a go­ing con­cern” and pre­dict­ed a need to find new fi­nanc­ing.

Al­though Celu­lar­i­ty boasts of a wide pipeline of pla­cen­tal-based ther­a­pies, the on­ly com­mer­cial ones are bio­ma­te­ri­als for wound heal­ing and to re­place dam­aged tis­sue af­ter surgery. One ex­am­ple is In­terfyl, which is de­rived from a pla­cen­ta and used in the US to re­place or add to dam­aged tis­sue in wounds or from trau­ma or surgery. Celu­lar­i­ty has part­nered with CH Trad­ing Group in an ex­clu­sive ter­ri­to­ry agree­ment to dis­trib­ute these prod­ucts in more than 100 coun­tries.

The rest of Celu­lar­i­ty’s po­ten­tial is locked up in ear­ly tri­als or even pre­clin­i­cal stage. The com­pa­ny al­so hopes to ap­ply for an IND this year for an­oth­er pla­cen­tal-based can­di­date that helps in the for­ma­tion of new car­ti­lage.

In de­gen­er­a­tive dis­eases, Celu­lar­i­ty says it will reeval­u­ate pre­vi­ous tri­als for a pla­cen­tal-based cell ther­a­py for Crohn’s dis­ease and will look in­to its next-gen­er­a­tion cell ther­a­pies for fa­cioscapu­lo­humer­al mus­cu­lar dy­s­tro­phy.

CY­CART-19, an al­lo­gene­ic pla­cen­tal-de­rived T cell ther­a­py for can­cer, could start a Phase I tri­al this year as the com­pa­ny works on an­swer­ing FDA’s con­cerns on its IND. In 2021, it part­nered with Imu­gene to use CF33-CD19, an on­colyt­ic virus, and com­bine it with Celu­lar­i­ty’s CAR-T cell ther­a­py.

In 2021, Celu­lar­i­ty merged with a SPAC named GX Ac­qui­si­tion Corp, which gave the com­pa­ny $138 mil­lion to work with. The biotech al­so drew at­ten­tion ear­ly in the pan­dem­ic af­ter it tried to test an NK cell in­fu­sion for Covid-19.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

Clay Siegall, Morphimmune CEO

Up­dat­ed: Ex-Seagen chief Clay Sie­gall emerges as CEO of pri­vate biotech

Clay Siegall will be back in the CEO seat, taking the helm of a private startup working on targeted cancer therapies.

It’s been almost a year since Siegall resigned from Seagen, the biotech he co-founded and led for more than 20 years, in the wake of domestic violence allegations by his then-wife. His eventual successor, David Epstein, sold the company to Pfizer in a $43 billion deal unveiled last week.

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Stuart Peltz, former PTC Therapeutics CEO

Stu­art Peltz re­signs as PTC Ther­a­peu­tics CEO af­ter 25 years

Stuart Peltz, the longtime CEO of PTC Therapeutics who’s led the rare disease drug developer since its founding 25 years ago, is stepping down.

Succeeding him in the top job is Matthew Klein, who joined PTC in 2019 and was promoted to chief operating officer in 2022. In a call with analysts, he said the CEO transition has been planned for “quite some time” — in fact, as part of it, he gave the company’s presentation at the JP Morgan healthcare conference earlier this year.

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Bet­ter Ther­a­peu­tics cuts 35% of staff while await­ing dig­i­tal ther­a­peu­tic ap­proval

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

Mark Womack, BioCina CEO

Q&A: BioCi­na’s new CEO Mark Wom­ack on the CD­MO he says is 'worth trav­el­ing over'

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

No­vo Nordisk oral semaglu­tide tri­al shows re­duc­tion in blood sug­ar, plus weight loss

Novo Nordisk is testing higher levels of its oral version of its GLP-1, semaglutide, and its type 2 diabetes trial results released today show reductions in blood sugar as well as weight loss.

In the Phase IIIb trial, Novo compared its oral semaglutide in 25 mg and 50 mg doses with the 14 mg version that’s currently the maximum approved dose. The trial looked at how the doses compared when added to a stable dose of one to three oral antidiabetic medicines in people with type 2 diabetes who were in need of an intensified treatment.

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Ly­me vac­cine test com­ple­tion is pushed back by a year as Pfiz­er, Val­ne­va say they'll ad­just tri­al

Valneva and Pfizer have adjusted the end date for the Phase III study of their investigational Lyme disease vaccine, pushing it back by a year after issues at a contract researcher led to thousands of US patients being dropped from the test.

In a March 20 update to, Valneva and Pfizer moved the primary completion date on the trial, called VALOR, from the end of 2024 to the end of 2025.

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FDA spells out how can­cer drug de­vel­op­ers can use one tri­al for both ac­cel­er­at­ed and full ap­provals

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.

Genen­tech to halt com­mer­cial man­u­fac­tur­ing in Cal­i­for­nia HQ, with lay­offs at­tached

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

The move is the result of a decision Genentech made in 2007 to relocate its commercial manufacturing operations from its South San Francisco headquarters said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech will produce medicines at its new clinical supply center, which opened in South San Francisco last year while many of its commercial products will be made at other production sites or by contract manufacturers.

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