4DMT shoots for a $75M IPO, its sec­ond at­tempt to go pub­lic with its gene ther­a­py vec­tor pro­grams

Just a few months af­ter with­draw­ing its IPO fil­ing, 4D Mol­e­c­u­lar Ther­a­peu­tics is seek­ing to go pub­lic once again.

The Emeryville, CA-based com­pa­ny sub­mit­ted a new S-1 on Tues­day, de­tail­ing plans for a $75 mil­lion raise as it aims for the sec­ond time to hit the Nas­daq. 4DMT had pre­vi­ous­ly sought a $100 mil­lion IPO back in Sep­tem­ber 2019, but with­drew the fil­ing in Ju­ly of this year af­ter com­plet­ing a $75 mil­lion Se­ries C in June.

Should 4DMT com­plete the tran­si­tion to a pub­lic com­pa­ny this time around, they’ll join a crowd­ed IPO par­ty that’s last­ed near­ly the en­tire year.

Nas­daq head of health­care list­ings Jor­dan Saxe pro­vid­ed the most re­cent tal­ly for biotech IPOs in late Oc­to­ber, count­ing 72 com­pa­nies go­ing pub­lic at the time. Com­bined, those out­lets have raised rough­ly $13.2 bil­lion. The de­buts have slowed since the sum­mer, but Saxe pegged a “fair es­ti­mate” of 75 IPOs and just un­der $14 bil­lion in pro­ceeds to round out 2020.

Sev­er­al fac­tors have con­tributed to this year’s wave, Saxe pre­vi­ous­ly told End­points News, as the Covid-19 pan­dem­ic has high­light­ed in­no­va­tion and crossover in­vestors have steadi­ly in­creased biotech in­vest­ments in the sec­ond half of the 2010s. The pan­dem­ic econ­o­my has al­so made biotech com­pa­nies more ap­peal­ing giv­en that they’re less re­liant on quar­ter-to-quar­ter sales num­bers.

In the last four years, on­ly 2018 comes close in terms of the sheer amount of biotechs shoot­ing for Wall Street. That year’s tab to­taled 56 IPOs, ac­cord­ing to in­de­pen­dent an­a­lyst Brad Lon­car.

With­in the new S-1, 4DMT didn’t pro­vide too much de­tail about how much mon­ey they’d spend on each of their pro­grams. The com­pa­ny did list, how­ev­er, that on­go­ing clin­i­cal tri­als for their lead­ing pro­grams 4D-310 and 4D-125 would be their top pri­or­i­ty. Both of those can­di­dates are cur­rent­ly in Phase I/II with da­ta like­ly com­ing next year.

David Kirn

The main re­search dri­ving the com­pa­ny has been build­ing out a base of more than a bil­lion vec­tor cap­sid se­quences, which CEO David Kirn said in June need­ed years to take place. 4DMT need­ed that time to run the se­quences through non-hu­man pri­mates to see which shells were the least tox­ic and most like­ly to pre­vent an­ti­body re­sis­tance.

By do­ing so, the biotech hopes this screen­ing mod­el can help find the cap­sids most suit­able for the vec­tor de­liv­ery of gene ther­a­pies.

4DMT’s lead can­di­date, 4D-310, is in­tend­ed to treat Fab­ry dis­ease, with the goal of ini­tial­ly treat­ing ear­ly on­set ver­sions be­fore ex­pand­ing in­to se­vere, late-on­set pa­tients. 4D-125, mean­while, has the goal of treat­ing an in­her­it­ed vi­sion loss dis­or­der called XL­RP. Roche has part­nered with 4DMT to in-li­cense the pro­gram be­fore it be­gins a piv­otal tri­al.

The biotech is al­so con­duct­ing a Phase I study in 4D-110, which is tar­get­ed at pa­tients with choroi­deremia re­lat­ed to mu­ta­tions in the CHM gene.

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.

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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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

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 manufacturing operations from its South San Francisco headquarters location to other facilities or move the work to CDMOs, said Andi Goddard, Genentech’s SVP of quality and compliance for pharmaceutical technical operations, in an interview with Endpoints News. Genentech has made changes in capabilities and invested more in technology, so it doesn’t need as many large-scale manufacturing facilities as it did in the past, she said.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

What do you get when you combine ChatGPT generative AI technology with specific pharma and clinical datasets? A time-saving tool that can answer questions about medical conference abstracts and clinical findings in seconds in one new application from ZoomRx called FermaGPT.

ZoomRx is debuting a public version of its generative AI product specifically for medical conferences beginning this week for the upcoming American Association for Cancer Research (AACR) annual meeting that runs April 14-19.

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Quince Ther­a­peu­tics faces takeover bid from share­hold­er Echo Lake Cap­i­tal

A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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Flare Therapeutics biochemists Yong Li (L) and Valerie Vivat

A $123M Flare will get Third Rock on­col­o­gy biotech in­to the clin­ic this year

Flare Therapeutics will start its first human trial this year with an investigational urothelial cancer drug after pulling together a $123 million Series B from Big Pharmas, VCs and its incubator, Third Rock Ventures.

Launched in 2021 on the idea that a biotech could finally succeed at drugging the much-sought-after but stubborn transcription factor, Flare Therapeutics said Wednesday it is now primed for the clinic after closing its large financing haul earlier this year. The raise is a relatively stark figure in a tough startup financing environment but further buoys the upbeat signals coming out of other Third Rock biotechs in recent weeks, including the $200 million CARGO Therapeutics and $100 million Rapport Therapeutics rounds.

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In­cyte wins ac­cel­er­at­ed ap­proval for PD-1 in rare skin can­cer

Incyte touted an accelerated approval for its PD-1 retifanlimab in a rare skin cancer on Wednesday, roughly a year and a half after the drug suffered a rejection in squamous cell carcinoma of the anal canal (SCAC).

Retifanlimab, marketed as Zynyz, was approved for metastatic or recurrent locally advanced Merkel cell carcinoma (MCC), a fast-growing skin cancer typically characterized by a single, painless nodule. It’s roughly 40 times rarer than melanoma, according to the nonprofit Skin Cancer Foundation — but incidence is growing, particularly among older adults, Incyte said in its announcement.

A new study finds that many patient influencers are sharing prescription drug experiences along with health information.

So­cial me­dia pa­tient in­flu­encers ‘danc­ing in the gray’ of phar­ma mar­ket­ing, more clar­i­ty need­ed, re­searcher says

It’s no surprise that patient influencers are talking about their health conditions on social media. However, what’s less clear is what role pharma companies are playing, how big the patient influencer industry is, and just how is information about prescription drugs from influencers relayed — and received — on social media.

While University of Colorado associate professor Erin Willis can’t answer all those questions, she’s been researching the issue for several years and recently published new research digging into the communication styles, strategies and thinking of patient influencers, many of whom partner with pharma companies.

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