Bob Langer-found­ed Lyra Ther­a­peu­tics rais­es $56M in lat­est high-end biotech IPO

An­oth­er pan­dem­ic biotech IPO has sold at the high range.

Lyra Ther­a­peu­tics said to­day their pub­lic of­fer­ing, first filed in ear­ly March, raised $56 mil­lion, with 3.5 mil­lion shares sell­ing at $16. Al­though that was a price-per-share at the top of their $14 to $16 range, the of­fer­ing re­mains just a hair short of the ini­tial goal of a $57.5 mil­lion.

Found­ed around an im­plant de­vel­oped by MIT’s Bob Langer and Har­vard’s George White­sides, Lyra is test­ing their lead can­di­date, LY-210, in a Phase II tri­al for chron­ic rhi­nos­i­nusi­tis — a con­di­tion in which spaces in­side the nose and si­nus­es are con­tin­u­al­ly in­flamed, caus­ing breath­ing dif­fi­cul­ty and a per­pet­u­al­ly stuffy nose amid a long list of oth­er symp­toms. Orig­i­nal­ly de­vel­oped for pe­riph­er­al artery dis­ease, the com­pa­ny’s im­plant is used to de­liv­er the gener­ic an­ti-in­flam­ma­to­ry mometa­sone furoate di­rect­ly to the af­fect­ed mus­cles.

Lyra’s raise comes on the heels of a string of sev­er­al large biotech IPOs, as com­pa­nies such as Zen­tal­is Phar­ma­ceu­ti­cals and ORIC Ther­a­peu­tics were able to raise large amounts of cap­i­tal in a mar­ket ea­ger to find as­sets large­ly in­su­lat­ed from the pan­dem­ic. Ear­li­er this week, ADC Ther­a­peu­tics, af­ter with­draw­ing a $200 mil­lion fil­ing in Oc­to­ber, re­turned with a $100 mil­lion of­fer­ing.

The com­pa­ny has a sec­ond as­set — es­sen­tial­ly the same im­plant but larg­er to ac­com­mo­date pa­tients whose si­nus­es have been en­larged from surgery — now en­ter­ing a proof-of-con­cept tri­al, but the vast ma­jor­i­ty of the pro­ceeds will go to a Phase III tri­al and com­mer­cial­iza­tion costs for LY-210. A da­ta read­out on the Phase II is ex­pect­ed in the first quar­ter of 2021.

The IPO comes just 3 months af­ter a $30 mil­lion Se­ries C led by Per­cep­tive Ad­vi­sors. En­ter­ing the pub­lic of­fer­ing, Per­cep­tive owned about a third of the com­pa­ny (32.4%). Oth­er large share­hold­ers in­clud­ed 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%).

Covid-19 roundup: Eu­rope pur­chas­es 80M dos­es of Mod­er­na's vac­cine; CO­V­AXX se­cures $2.8B in emerg­ing mar­ket pre-or­ders

With the announcement of its vaccine efficacy data last week, Moderna is starting to line up customers for its Covid-19 mRNA jabs.

The Massachusetts-based biotech announced Wednesday it has agreed to sell an initial round of 80 million doses to the European Commission, with the option to double the amount to 160 million. Once the member states rubber stamp the approval, the deal will be finalized.

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Pascal Soriot (AP Images)

UP­DAT­ED: As­traZeneca, Ox­ford on the de­fen­sive as skep­tics dis­miss 70% av­er­age ef­fi­ca­cy for Covid-19 vac­cine

On the third straight Monday that the world wakes up to positive vaccine news, AstraZeneca and Oxford are declaring a new Phase III milestone in the fight against the pandemic. Not everyone is convinced they will play a big part, though.

With an average efficacy of 70%, the headline number struck analysts as less impressive than the 95% and 94.5% protection that Pfizer/BioNTech and Moderna have boasted in the past two weeks, respectively. But the British partners say they have several other bright spots going for their candidate. One of the two dosing regimens tested in Phase III showed a better profile, bringing efficacy up to 90%; the adenovirus vector-based vaccine requires minimal refrigeration, which may mean easier distribution; and AstraZeneca has pledged to sell it at a fraction of the price that the other two vaccine developers are charging.

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Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

Af­ter Ko­dak de­ba­cle, US lends $1.1B to a syn­thet­ic bi­ol­o­gy com­pa­ny and their big Covid-19, mR­NA plans

In mid-August, as Kodak’s $765 million government-backed push into drug manufacturing slowly fell apart in national headlines, Ginkgo Bioworks CEO Jason Kelly got a message from his company’s government liaison: HHS wanted to know if they, too, might want a loan.

The government’s decision to lend Kodak three quarters of a billion dollars raised eyebrows because Kodak had never made drugs before. But Ginkgo, while not a manufacturing company, had spent the last decade refining new ways to produce materials inside cells and building automated facilities across Boston.

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Chi­na opens the door for biotech in­vestors in Hong Kong to buy Shang­hai stocks, and vice ver­sa

When Shanghai’s STAR board began opening its doors to biotech, it was considered not just a rival to Nasdaq but also the stock exchange in Hong Kong. Those perceptions may take an amicable turn as China expands a mutual access program with the city.

The changes mean investors in mainland China will be able to own Hong Kong biotech chapter stocks, while those in Hong Kong — a much more internationally connected group — would have access to those listed on STAR. In effect, it turns the Shanghai market into a globally accessible exchange overnight while also broadening a key source of revenue for HKEX.

Carl Hansen, AbCellera CEO (University of British Columbia)

From a pair of Air Jor­dans to a $200M-plus IPO, Carl Hansen is craft­ing an overnight R&D for­tune fu­eled by Covid-19

Back in the summer of 2019, Carl Hansen left his post as a professor at the University of British Columbia to go full time as the CEO at a low-profile antibody shop he had founded called AbCellera.

As biotech CEOs go, even after a fundraise Hansen wasn’t paid a whole heck of a lot. He ended up earning right at $250,000 for the year. His compensation package included a loan — which he later paid back — and a pair of Air Jordan tennis shoes. His newly-hired CFO, Andrew Booth, got a sweeter pay packet than that — which included his own pair of Air Jordans.

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FDA hands Liq­uidia and Re­vance a CRL and de­fer­ral, re­spec­tive­ly, as Covid-19 cre­ates in­spec­tion chal­lenge

Two biotechs said they got turned away by the FDA on Wednesday, in part due to pandemic-related travel restrictions.

North Carolina-based Liquidia Technologies was handed a CRL for its lead pulmonary arterial hypertension drug, citing the need for more CMC data and on-site pre-approval inspections, which the FDA hasn’t been able to conduct due to travel restrictions. The agency also deferred its decision on Revance Therapeutics’ BLA for its frown line treatment, because it needs to inspect the company’s northern California manufacturing facility. The action, Revance emphasized, was not a CRL.

News brief­ing: FDA re­quests new tri­al for Reata's Friedre­ich's atax­ia pro­gram; J&J's Trem­fya picks up ex­pand­ed la­bel in Eu­rope

Three months after Reata Pharmaceuticals suggested its Friedreich’s ataxia program omaveloxolone could be delayed, the company revealed that is indeed going to be the case.

Reata $RETA shares took a nosedive Wednesday after the biotech revealed that the FDA said supplemental data for its pivotal trial did not strengthen the case for approval. As a result, the drug is likely to need another study before the FDA takes up the case.

Jef­frey Hat­field takes over from Diego Mi­ralles as CEO of Vi­vid­ion; Drag­on­fly scores a new ex­ec with COO Alex Lu­gov­skoy

→ San Diego protein degradation startup Vividion Therapeutics has made a change at the top with Jeffrey Hatfield taking the helm as CEO, replacing Diego Miralles six months after Roche forked over $135 million to collaborate with Vividion on their small molecule degraders. Hatfield is chairman of the board at miRagen Therapeutics and previously held the CEO job at Zafgen and Vitae Pharmaceuticals. He also had a series of leadership roles at Bristol Myers Squibb from 1996-2004, including SVP, immunology and virology divisions.

Bax­ter con­tin­ues on-shoring push with $50M In­di­ana ex­pan­sion

It’s been a banner year for the once humdrum business of manufacturing drugs, particularly vaccines. Billions have been spent ramping up facilities for Covid-19 jabs, while individual CDMOs have expanded their facilities, apparently anticipating demand or responding to a government-led push to onshore drug manufacturing.

Now Baxter Biopharma Solutions, the CDMO wing of the many-armed healthcare giant Baxter, is getting in on the game. On Tuesday, they announced plans to spend $50 million to expand their flagship, 600,000 square-foot facility in Bloomington, IN.