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.  

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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