As­cle­tis reaps record $400M from Hong Kong in­vestors in the ex­change's first-ever pre-rev­enue biotech list­ing

The first pre-rev­enue biotech to list on Hong Kong’s stock ex­change has land­ed. And its suc­cess will like­ly spur plen­ty of more such of­fer­ings in search of a big pay­off.

As­cle­tis has raised $400 mil­lion by sell­ing 224 mil­lion new shares at around $1.78 (HK$14) — right in the mid­dle of its an­tic­i­pat­ed HK$12 to HK$16 range, Reuters re­port­ed. It’s sched­uled to be­gin trad­ing on Au­gust 1, less than three months af­ter it first filed for the IPO.

GIC, Sin­ga­pore’s sov­er­eign wealth fund, signed on to be the cor­ner­stone in­vestor and com­mit­ted $75 mil­lion for around 19% of the IPO shares. The rest — which in turn ac­counts for about 20% of As­cle­tis’ en­larged share cap­i­tal — was all snapped up in an over­sub­scribed fren­zy.

Jinzi Wu

Found­ed by ex-GSK ex­ec Jinzi Wu in 2011, As­cle­tis has a rep­u­ta­tion in Chi­na for be­ing the first do­mes­tic com­pa­ny to de­vel­op a hep C cure. The drug, Gano­vo, is ex­pect­ed to be ap­proved in Q3 of 2018. The team plans to fol­low that up with an­oth­er HCV treat­ment, ravi­dasvir (in-li­censed from Roche), along with HIV drug ASC09, and liv­er can­cer ther­a­py HASC06.

Be­ing the first biotech to test the new list­ing rules wasn’t easy. Wu pre­vi­ous­ly said that As­cle­tis faced “some chal­lenges” in nail­ing down the com­pa­ny’s val­u­a­tion.

The smooth tra­jec­to­ry of As­cle­tis’ IPO like­ly paves the way for the six oth­er biotechs and one CRO — from Hua Med­i­cine to Stealth Bio­Ther­a­peu­tics — that’s of­fered their own IPO pitch.

It’s al­so a mile­stone for HKEX, which has been an­gling to be­come an IPO des­ti­na­tion for biotech up­starts, es­pe­cial­ly the kind that’s been pop­ping up in main­land Chi­na the past decade.

Just a few days ago, word came out that the list­ing com­mit­tee is dis­cussing a sec­ondary list­ing with BeiGene $BGNE — the Bei­jing-based, Cel­gene-part­nered biotech whose Nas­daq list­ing (and im­mense suc­cess) had been seen as an im­pe­tus for Hong Kong to change its rules.

In its fil­ing, BeiGene wrote that it be­lieves it’s “well po­si­tioned to cap­ture the sig­nif­i­cant mar­ket op­por­tu­ni­ties in Chi­na” with its core as­sets zanubru­ti­nib, tislelizum­ab and pami­parib, all of which would ben­e­fit from the raise, from clin­i­cal tri­als to reg­is­tra­tion and com­mer­cial­iza­tion in both Chi­na and the US.

But the star to­day is As­cle­tis. The past year has brought a rush of biotech de­buts in the US, with Ru­bius claim­ing the largest biotech IPO so far on Nas­daq — rais­ing $241 mil­lion — while De­nali scored $250 mil­lion in late 2017. Now As­cle­tis, a com­pa­ny not well known out­side of Chi­na, has left those top per­form­ers in the dust, in­clud­ing Ax­o­vant, which held the record for the biggest biotech IPO.

With the fresh in­fu­sion of cash, Wu and his team can now car­ry on with the planned R&D and com­mer­cial­iza­tion of core prod­ucts, as well as in-li­cens­ing more drugs.

Two pre­vi­ous rounds of fi­nanc­ing had brought a col­lec­tive $155 mil­lion in­to As­cle­tis’ ac­counts. Among their back­ers: C-Bridge Cap­i­tal, Qian­Hai Eq­ui­ty In­vest­ment FOF, Gold­man Sachs, and Tasly Phar­ma­ceu­ti­cal. Wu and his wife Ju­ly He are still the largest share­hold­ers of the com­pa­ny at the mo­ment, own­ing over 60% of the shares.

It’s fi­nal­ly over: Bio­gen, Ei­sai scrap big Alzheimer’s PhI­I­Is af­ter a pre­dictable BACE cat­a­stro­phe rais­es safe­ty fears

Months after analysts and investors called on Biogen and Eisai to scrap their BACE drug for Alzheimer’s and move on in the wake of a string of late-stage failures and rising safety fears, the partners have called it quits. And they said they were dropping the drug — elenbecestat — after the independent monitoring board raised concerns about…safety.

We don’t know exactly what researchers found in this latest catastrophe, but the companies noted in their release that investigators had determined that the drug was flunking the risk/benefit analysis.

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It's not per­fect, but it's a good start: FDA pan­elists large­ly en­dorse Aim­mune's peanut al­ler­gy ther­a­py

Two days after a fairly benign review from FDA staff, an independent panel of experts largely endorsed the efficacy and safety of Aimmune’s peanut allergy therapy, laying the groundwork for approval with a risk evaluation and mitigation strategy (REMS).

Traditionally, peanut allergies are managed by avoidance, but the threat of accidental exposure cannot be nullified. Some allergists have devised a way to dose patients off-label with peanut protein derived from supermarket products to wean them off their allergies. But the idea behind Aimmune’s product was to standardize the peanut protein, and track the process of desensitization — so when accidental exposure in the real world invariably occurs, patients are less likely to experience a life-threatening allergic reaction.

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Lisa M. DeAngelis, MSKCC

MSK picks brain can­cer ex­pert Lisa DeAn­ge­lis as its next CMO — fol­low­ing José Basel­ga’s con­tro­ver­sial ex­it

It’s official. Memorial Sloan Kettering has picked a brain cancer expert as its new physician-in-chief and CMO, replacing José Baselga, who left under a cloud after being singled out by The New York Times and ProPublica for failing to properly air his lucrative industry ties.

His replacement, who now will be in charge of MSK’s cutting-edge research work as well as the cancer care delivered by hundreds of practitioners, is Lisa M. DeAngelis. DeAngelis had been chair of the neurology department and co-founder of MSK’s brain tumor center and was moved in to the acting CMO role in the wake of Baselga’s departure.

Penn team adapts CAR-T tech, reengi­neer­ing mouse cells to treat car­diac fi­bro­sis

After establishing itself as one of the pioneer research centers in the world for CAR-T cancer therapies, creating new attack vehicles to eradicate cancer cells, a team at Penn Medicine has begun the tricky transition of using the basic technology for heart repair work.

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Tal Zaks. Moderna

The mR­NA uni­corn Mod­er­na has more ear­ly-stage hu­man da­ta it wants to show off — reach­ing new peaks in prov­ing the po­ten­tial

The whole messenger RNA field has attracted billions of dollars in public and private investor cash gambled on the prospect of getting in on the ground floor. And this morning Boston-based Moderna, one of the leaders in the field, wants to show off a few more of the cards it has to play to prove to you that they’re really in the game.

The whole hand, of course, has yet to be dealt. And there’s no telling who gets to walk with a share of the pot. But any cards on display at this point — especially after being accused of keeping its deck under lock and key — will attract plenty of attention from some very wary, and wired, observers.

“In terms of the complexity and unmet need,” says Tal Zaks, the chief medical officer, “this is peak for what we’ve accomplished.”

Moderna has two Phase I studies it wants to talk about now.

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Sanofi takes a $260M hit to ex­tri­cate it­self from a dis­as­trous al­liance with Lex­i­con

Sanofi spent $300 million in cash to get into a $1.7 billion alliance with Lexicon on their SGLT1/2 diabetes drug sotagliflozin. And now that the drug has been spurned by the FDA after burning through a program that provided mixed late-stage data and a late shot at a last-place finish, the French pharma giant is forking over another $260 million to get out of the deal.

Sanofi’s unhappiness was already apparent when the company — now under new CEO Paul Hudson — posted a statement back in July that they were dropping the deal. But it wasn’t that simple. 

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Rit­ter bombs fi­nal PhI­II for sole lac­tose in­tol­er­ance drug — shares plum­met

More than two years ago Ritter Pharmaceuticals managed to find enough silver lining in its Phase IIb/III study — after missing the top-line mark — to propel its lactose intolerance toward a confirmatory trial. But as it turned out, the enthusiasm only set the biotech and its investors up to be sorely disappointed.

This time around there’s little left to salvage. Not only did RP-G28 fail to beat placebo in reducing lactose intolerance symptoms, patients in the treatment group actually averaged a smaller improvement. On a composite score measuring symptoms like abdominal pain, cramping, bloating and gas, patients given the drug had a mean reduction of 3.159 while the placebo cohort saw a 3.420 drop on average (one-sided p-value = 0.0106).

Ear­ly snap­shot of Ad­verum's eye gene ther­a­py sparks con­cern about vi­sion loss

An early-stage update on Adverum Biotechnologies’ intravitreal gene therapy has triggered investor concern, after patients with wet age-related macular degeneration (AMD) saw their vision deteriorate, despite signs that the treatment is improving retinal anatomy.

Adverum, on Wednesday, unveiled 24-week data from the OPTIC trial of its experimental therapy, ADVM-022, in six patients who have been administered with one dose of the therapy. On average, patients in the trial had severe disease with an average of 6.2 anti-VEGF injections in the eight months prior to screening and an average annualized injection frequency of 9.3 injections.

Alex Ar­faei trades his an­a­lyst's post for a new role as biotech VC; Sanofi vet heads to Vi­for

Too often, Alex Arfaei arrived too late. 

An analyst at BMO Capital Markets, he’d meet with biotech or pharmaceutical heads for their IPO or secondary funding and his brain, trained on a biology degree and six years at Merck and Endo, would spring with questions: Why this biomarker? Why this design? Why not this endpoint? Not that he could do anything about it. These execs were coming for clinical money; their decisions had been made and finalized long ago.