GSK-backed Liq­uidia takes a seat at the IPO ta­ble, look­ing for a $57.5M stake to take on Unit­ed Ther­a­peu­tics

Liq­uidia Tech­nolo­gies be­lieves the time is ripe to go pub­lic, ask­ing in­vestors to sign on for a $57.5 mil­lion IPO de­signed to get them through a late-stage study of a “new and im­proved” way to de­liv­er an in­haled drug to treat pul­monary ar­te­r­i­al hy­per­ten­sion — and take down Unit­ed Ther­a­peu­tics’ stan­dard of care Ty­va­so in the process.

The biotech — which has a tech­nol­o­gy col­lab­o­ra­tion in place with Glax­o­SmithK­line — has been work­ing on per­fect­ing its drug par­ti­cle tech in de­vel­op­ing LIQ861, an in­haled form of tre­pros­tinil. Their boast is that they know how to con­sis­tent­ly make the well known drug in a way that can be de­liv­ered in a dis­pos­able in­haler. And that, they say, would put Ty­va­so and its neb­u­liz­er — which earned $404 mil­lion last year — to shame.

The biotech plans to list as $LQ­DA.

Neal Fowler

Liq­uidia re­searchers have vault­ed from an ear­ly-stage study straight in­to a fair­ly small Phase III study which they plan to take to the FDA for an ap­proval. And they al­so plan to use IPO cash to ad­vance a post-op­er­a­tive pain pro­gram for LIQ865 through a Phase II-en­abling tox­i­c­i­ty study.

The biotech land­ed a $15 mil­lion up­front from GSK in 2015 to help fund the work, and al­so al­lied with the Bill and Melin­da Gates Foun­da­tion along the way on vac­cine tech. They’re based in Mor­risville, NC and the com­pa­ny is helmed by Neal Fowler.

The Gates Foun­da­tion owns 7.5% of the eq­ui­ty, and some high-pro­file ven­ture groups al­so claim sig­nif­i­cant chunks of the stock. New En­ter­prise As­so­ci­at­ed owns 18.7% of the stock, while Canaan has 17.7%.

This new, mod­est-sized IPO comes on the heels of a record spree of biotech IPOs over the last cou­ple of weeks. Now we’re see­ing the new S-1s come in that will tell us how far the IPO mar­ket can go this year.  

Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Stephen Hoge, Moderna president (Moderna)

On morn­ing of FDA Covid-19 ad­comm, Mod­er­na com­pletes PhI­II en­roll­ment, putting them neck-and-neck with Pfiz­er

Weeks away from a potential EUA application, Moderna announced they have completed enrollment in their 30,000-person Phase III Covid-19 vaccine trial, with over a third of volunteers non-white and a quarter over the age of 65.

The announcement caps what has been the most closely-watched recruitment race in the history of drug development, as Pfizer and Moderna rushed to get enough volunteers to prove whether or not experimental vaccines could actually protect people from contracting Covid-19. Pfizer reached that mark on Sept. 15. Moderna said around the same time that they would slow down enrollment to ensure they enrolled enough participants from minority and at-risk groups.

Pfiz­er scoops up an an­tibi­ot­ic in rare M&A deal, bag­ging a vir­tu­al start­up op­er­at­ing on a shoe­string bud­get

Pfizer is stepping up with a rare antibiotics buyout deal today, grabbing Palo Alto, CA-based Arixa Pharmaceuticals in a bid to add a new oral version of avibactam, a beta lactamase inhibitor — or BLI — approved back in 2015 as part of the IV treatment Avycaz.

The Arixa acquisition follows some encouraging Phase I responses demonstrating that 60% to 80% of the oral drug is absorbed into the bloodstream. Only 7% of the IV version is absorbed orally, far below the 30% threshold Arixa has pointed to as a therapeutic threshold. The buyout gives Pfizer’s hospital group a line on a new oral combo with antibiotics like ceftibuten to go after drug-resistant cases of urinary tract infections and other ailments.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.

John Maraganore, Alnylam CEO (Scott Eisen/Bloomberg via Getty Images)

With lumasir­an on the FDA's doorstep, Al­ny­lam reads out new PhI­II da­ta in PH1

Just over a month away from its December PDUFA date, Alnylam flaunted new data from two Phase III studies to back lumasiran in primary hyperoxaluria type 1 (PH1), a rare liver condition.

The Cambridge, MA-based biotech snagged a priority review for the candidate back in June, and got positive feedback from the EMA’s Committee for Medicinal Products for Human Use just last week. Lumasiran uses RNA interference (RNAi) to silence the gene for glycolate oxidase, an enzyme used in the production of oxalate.

News brief­ing: UK biotech 4D phar­ma heads for Nas­daq via SPAC; Dr. Red­dy's shuts down man­u­fac­tur­ing af­ter cy­ber­at­tack

Another pharma company is intending to use a SPAC to join the Nasdaq.

4D pharma, a UK-based biotech, is reverse-merging with a blank check company in a deal worth up to $37.6 million. The move will give 4D pharma a new Nasdaq ticker, which will be $LBPS, using the American Depositary Share program.

As a result of the move, 4D pharma will gain $14.6 million in cash held by the blank check company, dubbed Longevity. The merger is expected to be completed in early 2021, after which shares will be immediately tradeable.

Can B cells break the bound­aries of cell ther­a­py? Long­wood start­up has $52M to prove a new en­gi­neer­ing tech

Back in December 2017, as the cell therapy world was still basking in the virtually back-to-back approvals of two pioneering CAR-Ts, researchers at Seattle Children’s Research Institute reported a scientific first in a different corner of the field: engineer B cells to treat disease.

The team, led by David Rawlings and Richard James, eventually worked with Longwood Fund to start a biotech around those findings. And now Atlas Venture and RA Capital Management are coming on board to lead a $52 million launch round, joined by Alta Partners, for Be Biopharma.

Bo Cumbo, AavantiBio CEO (file photo)

Bo Cum­bo jumps from the top com­mer­cial post at Sarep­ta to the helm of a gene ther­a­py start­up with some in­flu­en­tial back­ers, big plans and $107M

After a 7-year stretch building the commercial team at Sarepta, longtime drug salesman Bo Cumbo is jumping to the entrepreneurial side of the business, taking the helm of a startup that’s got several deep-pocket investors. And he’s not just bringing his experience in selling drugs.

He tells me that when he told Sarepta CEO Doug Ingram about it, his boss got excited about the venture and opted to jump in with a $15 million investment from Sarepta to add to the launch money, alongside 3 of the busiest investors in biotech.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.

HHS secretary Alex Azar (at the podium) and FDA commissioner Stephen Hahn (Pete Marovich/Getty Images)

Covid-19 roundup: Azar open­ly plan­ning Hahn ouster — re­port; Vul­ner­a­ble pop­u­la­tions like­ly to get vac­cines by Jan­u­ary

The relationship between HHS secretary Alex Azar and FDA commissioner Stephen Hahn has deteriorated to the point where Azar has suggested replacing Hahn, according to a Politico report.

Azar was angered by the FDA’s pushback of the Trump administration’s proposals for authorizing Covid-19 vaccines, so much so that he began openly floating potential replacements for Hahn. The report cited six unnamed sources that said Azar discussed bringing up Hahn’s removal to the White House.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,200+ biopharma pros reading Endpoints daily — and it's free.