Set to be the first pre-rev­enue biotech to list in Hong Kong, As­cle­tis lays out pri­or­i­ties in IPO ap­pli­ca­tion

As­cle­tis is get­ting the ball rolling on the first pre-rev­enue biotech IPO in Hong Kong.

Hangzhou-based As­cle­tis, whose in-house he­pati­tis C drug is on the brink of ap­proval, has ap­plied to list on the stock ex­change of Hong Kong. If it goes through, the bulk of the cash will go to­ward four core prod­ucts, which are in NDA, Phase III, Phase II, and Phase I stages re­spec­tive­ly.

Wu Jinzi

Found­ed by ex-GSK ex­ec Wu Jinzi 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.

In a heav­i­ly redact­ed ap­pli­ca­tion proof (not to be con­fused with a prospec­tus), the biotech broke down how it plans to use the undis­closed amount of fund­ing:

  • 30% for R&D of core prod­uct pipeline
  • 25% for com­mer­cial­iza­tion of Gano­vo and ravi­dasvir
  • 15% to in-li­cense new drug can­di­dates, to be iden­ti­fied lat­er
  • 10% for R&D of ASC21, an HCV drug from Medi­vir
  • 10% to two in-house ear­ly-stage pro­grams in HBV and NASH
  • 10% for gen­er­al pur­pos­es

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 are the largest share­hold­ers of the com­pa­ny at the mo­ment, own­ing over 60% of the shares.

While the com­pa­ny is still run­ning in the red, it be­gan to ag­gres­sive­ly build up its com­mer­cial­iza­tion team as ear­ly as 2016, which now boasts of 145 mem­bers ready to reach out to hun­dreds of hos­pi­tals once Gano­vo gets the green light. As a whole, As­cle­tis, which start­ed out in 2011 with eight staffers, now has 256 em­ploy­ees.

Now that the ap­pli­ca­tion is in, reg­u­la­tors will be­gin vet­ting the list­ing in a process that could take up to 12 weeks. Just a few days ago, HKEX an­nounced that they will be helped in this process by a pan­el of 13 biotech pro­fes­sion­als, fea­tur­ing names like Zai Lab founder Saman­tha Du and promi­nent VC Jonathan Wang of Or­biMed Asia.

Mor­gan Stan­ley, Gold­man Sachs, and CMS are act­ing as joint spon­sors.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

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The home run count: The $100M+ mega-round boom in biotech in­spired a $6.7B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

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For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

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Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

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Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

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Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

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Bio­phar­ma com­pa­nies pledge $1B to fund an­tibi­otics R&D as field shriv­els; Four biotechs hunt $797M+

→ As promised, a group of some 20 biopharma companies have pooled close to $1 billion to fund new research in antibiotics — a field that has been dying of late. Small margins and tiny markets have killed off a slate of players in the field and drove out most of the big organizations. Now Eli Lilly, Pfizer and others hope to foot the bill for a group of 2 to 4 new antibiotics in the next 10 years. Pfizer alone pledged $100 million for the industry effort. “With the AMR Action Fund, the pharmaceutical industry is investing nearly $1 billion to sustain an antibiotic pipeline that is on the verge of collapse, a potentially devastating situation that could affect millions of people around the world,” said David Ricks, Eli Lilly CEO and president of IFPMA.