Three more biotechs tum­ble on­to Wall Street to­day, rais­ing $475M as the IPO par­ty rocks on

It’s just an­oth­er day in the 2020 biotech IPO boom. Three went pub­lic this morn­ing and a fourth gained 75 per­cent on its Nas­daq trad­ing de­but.

Lead­ing the pack is the bi­o­log­i­cal an­a­lyt­ics-fo­cused com­pa­ny Berke­ley Lights, which priced at $22 per share and raised $178.2 mil­lion. Next up is ALX On­col­o­gy, which at $19 per share raised $161.5 mil­lion. Then comes T-cell biotech Pan­dion, re­vis­ing pre­vi­ous num­bers to $18 per share and of­fer­ing an up­sized 2 mil­lion more shares, rais­ing $135 mil­lion.

Ad­di­tion­al­ly, Soft­bank Group-backed Re­lay Ther­a­peu­tics opened on Thurs­day and leapt from its ini­tial $20 IPO price to more than $35 at mar­ket close.

Pan­dion hit the high end of their range, while ALX and Berke­ley Lights both priced above the range.

2020 has al­ready been a ‘his­toric’ year for biotech IPOs, with 13 com­pa­nies hav­ing raised over $200 mil­lion be­fore Au­gust. On­ly two reached that mark in 2019, and sev­en passed the thresh­old in 2018.

So far this year, 38 biotechs have filed for an IPO com­pared with 26 at this point last year, ac­cord­ing to Brad Lon­car.

There had been hints of an ex­cit­ing year brew­ing all the way back in Jan­u­ary. Things slowed down fol­low­ing the ex­treme mar­ket volatil­i­ty caused by the Covid-19 pan­dem­ic in March. But the rel­a­tive­ly small biotech Zen­tal­is raised $165 mil­lion at the be­gin­ning of April, ig­nit­ing a new surge of IPO fundrais­ing in the sec­tor.

SPACs, or spe­cial pur­pose ac­qui­si­tion com­pa­nies, are al­so get­ting in on the ac­tion. As Nas­daq head of cap­i­tal mar­kets Jay Heller told End­points News ear­li­er this week, SPACs now make up al­most 35 per­cent of all new list­ings af­ter com­pris­ing just three per­cent of the IPO mar­ket in 2014.

Though Berke­ley Lights doesn’t pro­duce any drugs, they have de­vel­oped a “dig­i­tal cell bi­ol­o­gy” plat­form that can an­a­lyze liv­ing cells in a mul­ti­tude of ways and use this in­for­ma­tion to de­liv­er live bi­ol­o­gy to their cus­tomers. In the­o­ry, this can help ac­cel­er­ate drug de­vel­op­ment and pro­duc­tion and they part­nered with Sanofi and Pfiz­er on an­ti­body dis­cov­ery.

ALX On­col­o­gy has al­ready had a suc­cess­ful fundrais­ing year, haul­ing in $105 mil­lion in Feb­ru­ary to fund a range of mid-stage stud­ies on its on­ly pipeline can­di­date — an an­ti­body tar­get­ing CD47. Some in the in­dus­try have seen promise in this area, as Gilead bought the biotech Forty Sev­en for near­ly $5 bil­lion in Jan­u­ary. ALX’s can­di­date hopes to re­duce tox­i­c­i­ty by not at­tract­ing macrophages.

Pan­dion signed a part­ner­ship with Astel­las last year for up to $800 mil­lion to de­vel­op an­ti­body treat­ments for au­toim­mune dis­or­ders. The com­pa­ny al­so earned $85 mil­lion from a Se­ries B round back in April. Its lead can­di­date PT101, which aims to boost im­mune re­spons­es by ex­pand­ing T cell pop­u­la­tions, is cur­rent­ly in a Phase Ia clin­i­cal tri­al.

The sharp in­crease in Re­lay Ther­a­peu­tics’ ear­ly trad­ing could al­low Soft­back’s Vi­sion Fund to sell their stake at a huge prof­it. In 2018 the group in­vest­ed $300 mil­lion in the biotech for 32 per­cent of the com­pa­ny, a sum that is now val­ued at about $1 bil­lion. The Vi­sion Fund al­so in­vest­ed ear­ly in Uber and Slack, but Re­lay is on­ly the ninth of its 88 in­vest­ments to go pub­lic. In the 12 month pe­ri­od end­ing last March, the Vi­sion fund post­ed an in­vest­ment loss of $17 bil­lion.

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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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 clinicaltrials.gov, 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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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.

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.

Zhi Hong, Brii Biosciences CEO

Brii Bio­sciences stops man­u­fac­tur­ing Covid-19 an­ti­body com­bo, plans to with­draw EUA re­quest

Brii Biosciences said it will stop manufacturing its Covid-19 antibody combination, sold in China, and is working to withdraw its emergency use authorization request in the US, which it started in October 2021.

The Beijing and North Carolina biotech commercially launched the treatment in China last July but is now axing the work and reverting resources to other “high-priority programs,” per a Friday update. The focus now is namely hepatitis B viral infection, postpartum depression and major depressive disorders.

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FDA ad­vi­sors unan­i­mous­ly rec­om­mend ac­cel­er­at­ed ap­proval for Bio­gen's ALS drug

A panel of outside advisors to the FDA unanimously recommended that the agency grant accelerated approval to Biogen’s ALS drug tofersen despite the drug failing the primary goal of its Phase III study, an endorsement that could pave a path forward for the treatment.

By a 9-0 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee said there was sufficient evidence that tofersen’s effect on a certain protein associated with ALS is reasonably likely to predict a benefit for patients. But panelists stopped short of advocating for a full approval, voting 3-5 against (with one abstention) and largely citing the failed pivotal study.

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