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

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.