Aridis Phar­ma seeks $35M to fight in­fec­tions with im­munother­a­pies — lat­est in an IPO streak

Get­ting ready for its first Phase III tri­al, Aridis Phar­ma is now turn­ing to pub­lic in­vestors to sup­port its pathogen-spe­cif­ic im­munother­a­pies in a mod­est $35 mil­lion IPO.

Vu Truong

San Jose, CA-based Aridis joins an ever-grow­ing crowd of biotechs look­ing to cash in on the bull­ish sen­ti­ment on dis­play on Nas­daq. Their pitch: a port­fo­lio of ful­ly hu­man mon­o­clon­al an­ti­bod­ies treat life-threat­en­ing in­fec­tions such as hos­pi­tal-ac­quired pneu­mo­nia (HAP) and ven­ti­la­tor-as­so­ci­at­ed pneu­mo­nia (VAP), de­vel­oped from a pro­pri­etary dis­cov­ery plat­form.

All three of Aridis’ clin­i­cal pro­grams tar­get HAP and VAP, dif­fer­ing on­ly in the pathogen that they tar­get. With lead as­set AR-301, they are start­ing off with S. au­reus.

Er­ic Patzer

AR-301 and an­oth­er Phase II drug, AR-101 hit­ting P. aerug­i­nosa, are the core as­sets of a joint ven­ture Aridis set up a few months ago with Shen­zhen He­palink Phar­ma­ceu­ti­cal, in­vest­ing $1 mil­lion — He­palink chipped in the oth­er $15 mil­lion — in which the Chi­nese part­ner would de­vel­op and seek ap­proval for the drugs in the coun­try.

He­palink’s US sub­sidiary is a ma­jor stock­hold­er of Aridis, com­mand­ing 17.8% of the stock, fol­lowed by founder and CEO Vu Truong at 15.1% and chair­man Er­ic Patzer at 13.7%. Oth­er in­vestors in­clude Pineworld Cap­i­tal and Efung Rui­bo. No­tably, Robert Cough­lin, pres­i­dent and CEO of Mass­Bio, al­so holds less than 1% of the shares.

Oth­er than di­rect­ly fund­ing the clin­i­cal tri­als, the biotech — to be list­ed as $ARDS — is al­so al­lo­cat­ing part of the raise for the man­u­fac­tur­ing of clin­i­cal sup­plies for use in the tri­als, ac­cord­ing to the S-1.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Mer­ck makes a triple play on Covid-19: buy­ing out a vac­cine biotech, part­ner­ing on an­oth­er pro­gram and adding an an­tivi­ral to the mix

Merck is making a triple play in a sudden leap into the R&D campaign against Covid-19.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

The deal with IAVI covers recombinant vesicular stomatitis virus (rVSV) technology that is the basis for Merck’s successful Ebola Zaire virus vaccine. That’s going into the clinic later this year.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

As biotech IPOs siz­zle on vir­tu­al Wall Street, 3 new play­ers roll the dice on meg­a­money gam­bles top­ping $325M

Back in early January when I interviewed Generation Bio CEO Geoff McDonough on his $110 million mega-raise, he was thinking in terms of taking another 12 to 18 months to get into the clinic and then filing an IPO. They were, after all, still preclinical after 4 years in the lab.

But with investors still clearly focused on biotech during the pandemic, a lot of things are going faster now. Including IPOing, which is sizzling for the right companies.

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Al­ny­lam nabs speedy re­view, set­ting up 3rd pos­si­ble ap­proval in 3 years

After nearly two decades in the haze of preclinical and clinical development, things seems to be coming into focus for Alnylam Pharmaceuticals.

Two years ago the company landed the first approved drug for RNA interference (RNAi), a Nobel Prize-winning technique discovered in plants and pioneered around the turn of the century. Then last year, they landed another approval. Now, fresh off a massive investment from Blackstone, they’ve received an FDA priority review designation for a third therapy, setting them up to potentially nab three different approvals in three consecutive years.

Ax­o­vant spin­out Arvelle ups Se­ries A haul, de­ploy­ing $200M-plus to com­mer­cial­ize epilep­sy drug in Eu­rope

One of the characteristic features of the sprawling biotech group Vivek Ramaswamy has built at Roivant is its ability to whip up big-money financing deals for its subsidiaries. Axovant was a prime example, raising $315 million in an IPO — a monster by 2015 and even today’s standards — with an Alzheimer’s pitch before a spectacular flop forced the company to replot its course directly and pivot to gene therapy.

Covid-19 roundup: Janet Wood­cock steps aside — for now — as FDA drug czar; WHO hits the brakes on hy­droxy study af­ter lat­est safe­ty alarm

The biopharma industry will soon get a look at what the FDA will look like once CDER’s powerful chief Janet Woodcock retires from her post.

Long considered one of the most influential regulators in the agency, if not its single most powerful official when it counts, Woodcock is being detached to devote herself full-time to the White House’s special project to fast-forward new drugs and vaccines for the pandemic. The move comes a week after some quick reshuffling as Woodcock and CBER chief Peter Marks joined Operation Warp Speed. Initially they opted to recuse themselves from any FDA decisions on pandemic treatments and vaccines, after consumer advocates criticized the move as a clear conflict of interest in how the agency exercises oversight on new approvals.

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Andrew Hopkins, Exscientia founder and CEO (Exscientia)

Af­ter years of part­ner­ships, AI biotech Ex­sci­en­tia lands first ma­jor fi­nanc­ing round at $60M

After years racking up partnerships with biotechs and Big Pharma, the AI drug developer Exscientia has landed its first large financing round.

The UK-based company raised $60 million in a Series C round led by Novo Holdings — more than double the $26 million it garnered in a Series B 18 months ago. The round will help further the company’s expansion into the US and further what it calls, borrowing a term from the software world, its “full-stack capabilities,” i.e. its ability to develop drugs from the earliest stage to the market.

Af­ter de­cou­pling from Re­gen­eron, Sanofi says it’s time to sell the $13B stake picked up in the mar­riage

With Regeneron shares going for a peak price — after doubling from last fall — Sanofi is putting a $13 billion stake in their longtime partner on the auction block. And Regeneron is taking $5 billion of that action for themselves.

Sanofi — which has been decoupling from Regeneron for more than a year now — bought in big in early 2013, back when Regeneron’s stock was going for around $165 a share. Small investors flocked to the deal, buzzing about an imminent takeover. The buyout chatter wound down long ago.

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Piv­otal myas­the­nia gravis da­ta from ar­genx au­gur well for FcRn in­hibitors in de­vel­op­ment

Leading the pack of biotechs vying for a piece of the generalized myasthenia gravis (gMG) market with an FcRn inhibitor, argenx on Tuesday unveiled keenly anticipated positive late-stage data on its lead asset, bringing it one step closer to regulatory approval.

Despite steroids, immunosuppressants, acetylcholinesterase inhibitors, and Alexion’s Soliris, patients with the rare, chronic neuromuscular disorder (more than 100,000 in the United States and Europe) don’t necessarily benefit from these existing options, leaving room for the crop of FcRn inhibitors in development.