Four biotech Nas­daq wannabes out­line IPO plans — and don't miss Chi-Med's HKEX pitch

If the string of biotech IPO fil­ings the Nas­daq saw on mar­ket close Fri­day says any­thing oth­er than that the win­dow for pub­lic fundrais­ing re­mains wide open, it’s about the di­ver­si­ty of ar­eas these as­pir­ing pub­lic drug­mak­ers op­er­ate in — from im­muno-on­col­o­gy and Alzheimer’s to di­a­bet­ic com­pli­ca­tions and car­dio in­di­ca­tions.

Keep scrolling to read about the lat­est mar­quee Chi­nese bio­phar­ma to file for a list­ing at the Hong Kong stock ex­change — fur­ther de­fus­ing ear­ly wor­ries that the city’s loos­ened rules for biotechs might not be enough to at­tract top play­ers.

Lieping Chen-found­ed Yale spin­off NextCure lines up $86M-plus pub­lic list­ing

Lieping Chen

Last month, Yale spin­out NextCure laid out the blue­print for its im­muno-on­col­o­gy re­search in Na­ture Med­i­cine, af­ter se­cur­ing $40 mil­lion up­front in an R&D col­lab­o­ra­tion with Lil­ly and bring­ing its cash haul to a cool $180 mil­lion. The com­pa­ny — found­ed in 2015 by Lieping Chen, a not­ed I/O re­searcher be­hind Am­plim­mune, a com­pa­ny bought out by As­traZeneca five years ago — is now plan­ning to go pub­lic in an $86.25 mil­lion IPO un­der the sym­bol $NXTC.

The Beltsville, Mary­land-based drug de­vel­op­er is fo­cus­ing on PD-L1-neg­a­tive tu­mors to help the scores of pa­tients for whom check­point in­hibitors don’t work. Its lead ex­per­i­men­tal drug — NC318 — tar­gets an im­munomod­u­la­to­ry re­cep­tor called Siglec-15 and is cur­rent­ly be­ing test­ed in a Phase I/II tri­al in pa­tients with ad­vanced or metasta­t­ic sol­id tu­mors.

Can a bac­te­r­i­al ap­proach to Alzheimer’s win an­oth­er $86M-plus from weary in­vestors?

Bio­gen’s re­cent Phase III dis­as­ter with ad­u­canum­ab dealt a huge blow to the Alzheimer’s field, but it’s al­so opened up an op­por­tu­ni­ty for small­er play­ers to tout how their ap­proach­es are dif­fer­ent. Cor­texyme is seem­ing­ly tak­ing ad­van­tage of that win­dow to push an IPO. The South San Fran­cis­co-based biotech needs the mon­ey to fund a Phase II/III study to ver­i­fy its the­o­ry — cour­tesy of UCSF psy­chi­a­trist Steve Dominy — that a bac­te­r­i­al pathogen called Por­phy­romonas gin­gi­valis plays a ma­jor role in the mem­o­ry wast­ing dis­ease. Cor­texyme’s lead drug, COR388, in­hibits gingi­pains, the tox­ic pro­tease se­cret­ed by P. gin­gi­valis. Backed by Pfiz­er (14.71%) and Take­da (12.32%), the com­pa­ny is now shoot­ing for $86 mil­lion in its pub­lic de­but. Its Nas­daq sym­bol of choice is $CRTX.

New York-based start­up etch­es path to­ward $86 mil­lion IPO

Found­ed in 2016, New York-based drug de­vel­op­er Ap­plied Ther­a­peu­tics has filed for a $86 mil­lion IPO, with plans to list un­der the sym­bol $APLT (no fi­nan­cial de­tails were dis­closed). The com­pa­ny, which has al­ready raised $38 mil­lion in gross pro­ceeds from eq­ui­ty and debt fi­nanc­ings, is work­ing on de­vel­op­ing treat­ments on the ba­sis of val­i­dat­ed path­ways for dis­eases that have so far yield­ed prod­ucts with poor ef­fi­ca­cy and tol­er­a­bil­i­ty. Its lead ex­per­i­men­tal drug — AT-001 — is be­ing eval­u­at­ed for use in di­a­bet­ic car­diomy­opa­thy, a fa­tal fi­bro­sis of the heart, as well as di­a­bet­ic pe­riph­er­al neu­ropa­thy.

Mile­stone aims $86M IPO to push nasal spray for rapid heart rate con­di­tion over fin­ish line

A biotech hail­ing from Cana­da is eye­ing $86 mil­lion in IPO cash to de­vel­op and com­mer­cial­ize its sole as­set: a nasal spray for­mu­la­tion of cal­ci­um chan­nel block­ers. Mile­stone Phar­ma­ceu­ti­cals has cho­sen parox­ys­mal supraven­tric­u­lar tachy­car­dia (PSVT) as etri­pamil’s first tar­get in­di­ca­tion. The rapid heart rate con­di­tion, which of­ten comes with pal­pi­ta­tions, chest pres­sure or pain, short­ness of breath and faint­ing, is usu­al­ly treat­ed with in­tra­venous in­fu­sions in the ER. But Mile­stone (which plans to list un­der $MIST) be­lieves that its rapid-on­set drug can help pa­tients re­solve these sud­den episodes quick­ly on their own. A suc­cess in the on­go­ing Phase III, the com­pa­ny says, will open up a mar­ket of around 2 mil­lion Amer­i­cans. And Phase II pro­grams for atri­al fib­ril­la­tion and angi­na are com­ing up in the next cou­ple of years.

Ven­ture in­vestors col­lec­tive­ly claim more than 80% of the com­pa­ny, with New York-based RTW In­vest­ments, No­vo Hold­ings, Québec’s de­vel­op­ment fund and BDC Cap­i­tal tak­ing the top spots. Ven­rock, Do­main As­so­ci­ates, Pap­pas Cap­i­tal and For­bion split the rest.

A biotech pi­o­neer in Chi­na mo­tions to join the heavy­weight group on HKEX

Mean­while, Chi-Med is kick­ing up some fresh ac­tiv­i­ty on the oth­er side of the At­lantic, fil­ing for what will be its third IPO at the Hong Kong stock ex­change.

Of­fi­cial­ly Hutchi­son Chi­na MediTech, the Hong Kong-based com­pa­ny cel­e­brat­ed a land­mark ap­proval in Chi­na last Sep­tem­ber for a ma­jor can­cer drug that was dis­cov­ered and de­vel­oped in the coun­try. Elu­nate — per­haps bet­ter known as fruquin­tinib, part­nered with Eli Lil­ly — is mar­ket­ed as a col­orec­tal can­cer treat­ment.

But loom­ing larg­er in its glob­al game plan is savoli­tinib, a MET in­hibitor that Chi-Med is pair­ing with part­ner As­traZeneca’s Tagris­so in a Phase II study. Re­cent da­ta from AACR bol­stered their claim that the savoli­tinib add-on can tam­per re­sis­tance among EGFR lung can­cer pa­tients. Throw in the neu­roen­docrine tu­mor drug su­r­u­fa­tinib, and you have the trio of drugs at the top of Chi-Med’s spend­ing list, primed for reg­is­tra­tional tri­als and quick NDAs.

Chris­t­ian Hogg

“We are tar­get­ing two fur­ther new drug ap­provals over the next two years, on savoli­tinib and su­r­u­fa­tinib, sub­ject to pos­i­tive clin­i­cal out­comes,” said CEO Chris­t­ian Hogg, who counts him­self as the pre­cur­sor to the now 420-mem­ber sci­en­tif­ic team.

Pre­vi­ous list­ings on the Nas­daq $HCM and the Lon­don Stock Ex­change (AIM: $HCM) left Hong Kong bil­lion­aire Li Ka-Shing’s CK Hutchi­son un­touched as the ma­jor­i­ty share­hold­er, own­ing 60.2% of the stock. But with the new list­ing in Hong Kong, it plans to cut back its shares to less than 50% such that Chi-Med will of­fi­cial­ly no longer be a sub­sidiary of CK Hutchi­son.


By Na­tal­ie Grover and Am­ber Tong

Im­age: Shut­ter­stock

Paul Hudson, Getty Images

Sanofi CEO Hud­son lays out new R&D fo­cus — chop­ping di­a­betes, car­dio and slash­ing $2B-plus costs in sur­gi­cal dis­sec­tion

Earlier on Monday, new Sanofi CEO Paul Hudson baited the hook on his upcoming strategy presentation Tuesday with a tell-tale deal to buy Synthorx for $2.5 billion. That fits squarely with hints that he’s pointing the company to a bigger future in oncology, which also squares with a major industry tilt.

In a big reveal later in the day, though, Hudson offered a slate of stunners on his plans to surgically dissect and reassemble the portfoloio, saying that the company is dropping cardio and diabetes research — which covers two of its biggest franchise arenas. Sanofi missed the boat on developing new diabetes drugs, and now it’s pulling out entirely. As part of the pullback, it’s dropping efpeglenatide, their once-weekly GLP-1 injection for diabetes.

“To be out of cardiovascular and diabetes is not easy for a company like ours with an incredibly proud history,” Hudson said on a call with reporters, according to the Wall Street Journal. “As tough a choice as that is, we’re making that choice.”

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Amarin CEO John Thero discussing the company's plans for Vascepa, August 2019 — via Bloomberg

Amarin wins a block­buster ap­proval from the FDA. Now every­one can shift fo­cus to the patent

For all those people who could never quite believe that Amarin $AMRN would get an expanded label with blockbuster implications, the stress and anxiety on display right up to the last minute on Twitter can now end. But new, pressing questions will immediately surface now that the OK has come through.

On Friday afternoon, the FDA stamped its landmark approval on the industrial strength fish oil for reducing cardio risks for a large and well defined population of patients. The approval doesn’t give Amarin everything it wants in expanding its use, losing out on the primary prevention group, but it goes a long way to doing what the company needed to make a major splash. The approval was cited for patients with “elevated triglyceride levels (a type of fat in the blood) of 150 milligrams per deciliter or higher. Patients must also have either established cardiovascular disease or diabetes and two or more additional risk factors for cardiovascular disease.”

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Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarepta has a friend in the FDA after all. Four months after the agency determined that it would be wrong to give Sarepta an accelerated approval for their Duchenne MD drug golodirsen, regulators have executed a stunning about face and offered the biotech a quick green light in any case.

It was the agency that first put out the news late Thursday, announcing that Duchenne MD patients with a mutation amenable to exon 53 skipping will now have their first targeted treatment: Vyondys 53, or golodirsen. Having secured the OK via a dispute resolution mechanism, the biotech said the new drug has been priced on par with their only other marketed drug, Exondys 51 — which for an average patient costs about $300,000 per year, but since pricing is based on weight, that sticker price can even cross $1 million.

Sarepta shares $SRPT surged 23% after-market to $124.

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Paul Biondi (File photo)

Paul Biondi's track record at Bris­tol-My­ers cov­ered bil­lions in deals of every shape and size. Here's the com­plete break­down

Paul Biondi was never afraid to bet big during his stint as business development chief at Bristol-Myers Squibb. And while the gambles didn’t all pay out, by any means, his roster of pacts illustrates the broad ambitions the pharma giant has had over the last 5 years — capped by the $74 billion Celgene buyout.

On Thursday, we learned that Biondi had exited the company. And Chris Dokomajilar at DealForma came up with the complete breakdown on every buyout, licensing pact and product purchase Bristol-Myers forged during his tenure in charge of the BD team at one of the busiest companies in biopharma.

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Paul Biondi (File photo)

Bris­tol-My­er­s' strat­e­gy, BD chief Paul Bion­di ex­it­ed the com­pa­ny — just ahead of the $74B Cel­gene deal close

Paul Biondi, who orchestrated billions of dollars in deals for Bristol-Myers Squibb over the 5 years he’s run their business development team, has exited the company. Biondi left last month, according to a company spokesperson, in pursuit of another — unspecified — external opportunity.

After 17 years with Bristol-Myers Squibb, Paul Biondi, Head of Strategy and Business Development, decided to leave the company to pursue an external opportunity. The company wishes him well in his new endeavors. Bristol-Myers Squibb  is actively searching for Paul’s successor, and will make an announcement, as appropriate.

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Arie Belldegrun at UKBIO 2019. Shai Dolev for Endpoints News

Kite Phar­ma's ex-CEO con­tra­dicts founder as CAR-T patent tri­al heats up, with con­flict­ing val­u­a­tions

Two days after Kite Pharma founder Arie Belldegrun told a federal courtroom that a meeting he had with a Memorial Sloan Kettering executive wasn’t about licensing their immunotherapy patent, Kite’s ex-CEO Aya Jakobovits said it was.

The admission came Tuesday during cross-examination in a patent infringement case that features two of the biggest cancer biotechs and some of the most well-known names in American medicine.

Jakobovits initially said she was not in attendance, didn’t know it was going to happen and didn’t know what took place, according to Law360. But then the plaintiff’s lawyer handed her a document – whose contents were not publicly revealed – and asked again if she learned after-the-fact that the meeting involved a potential patent license.

“Yes,” Jakobovits eventually said.

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On the heels of promis­ing MCL da­ta, Kite hus­tles its 2nd CAR-T to the FDA as the next big race in the field draws to the fin­ish line

Three days after Gilead’s Kite subsidiary showed off stellar data on their number 2 CAR-T KTE-X19 at ASH, the executive team has pivoted straight to the FDA with a BLA filing and a shot at a near-term approval.

In a small, 74-patient Phase II trial reported out at the beginning of the week, investigators tracked a 93% response rate with two out of three mantle cell lymphoma patients experiencing a complete response.

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What does $6.9B buy these days in on­col­o­gy R&D? As­traZeneca has a land­mark an­swer

Given the way the FDA has been whisking through new drug approvals months ahead of their PDUFA date, AstraZeneca and their partners Daiichi Sankyo may not have to wait until Q2 of next year to get a green light on trastuzumab deruxtecan (DS-8201).

The pharma giant this morning played their ace in the hole, showing off why they were willing to commit to a $6.9 billion deal — with $1.35 billion in a cash upfront — to partner on the drug.

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Arie Belldegrun (Photo: Jeff Rumans for Endpoints News)

Ju­ry finds Gilead li­able for $585M and big roy­al­ties in Kite CAR-T patent case

A Kite deal that’s already become a burden on Gilead’s back just got heavier as a California jury has ruled Gilead must pay Bristol-Myers Squibb and Sloan Kettering $585 million plus a 27.6% royalty for patent infringement committed by its subsidiary. The ruling is almost certain to be appealed.

Kite Pharma — founded by Arie Belldegrun, now focused on a next-gen CAR-T company — has been facing a lawsuit since the day its first CAR–T therapy won approval in October, 2017. Juno Therapeutics and Sloan Kettering filed a complaint saying Kite had copied its technology. Gilead acquired Kite in June of that year for $11.9 billion.  Juno was acquired the following year by Celgene for $9 billion, before Celgene was acquired by Bristol-Myers Squibb in 2019.

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