ADC Ther­a­peu­tics is­n't go­ing pub­lic in the US af­ter all, while three oth­er biotech IPOs bring in $319M

ADC Ther­a­peu­tics is tak­ing a last-minute U-turn at the NYSE af­ter bump­ing their IPO goal up from $150 mil­lion to a po­ten­tial $200 mil­lion — while three oth­er biotechs went ahead by pric­ing at the mid­point or low end of their re­spec­tive ranges.

De­spite ear­li­er in­di­ca­tions that in­sid­ers would pur­chase $115 mil­lion worth of shares, the Lau­sanne, Switzer­land-based com­pa­ny cit­ed “ad­verse mar­ket con­di­tions” for its de­ci­sion to with­draw.

Chris Mar­tin ADC

“We are for­tu­nate to have a strong bal­ance sheet, high­ly sup­port­ive in­vestors, al­ter­na­tive fi­nanc­ing op­tions and a steady flow of forth­com­ing mile­stones, all of which fac­tored in­to our de­ci­sion to not pro­ceed with an ini­tial pub­lic of­fer­ing in the cur­rent mar­ket con­di­tions,” CEO Chris Mar­tin said in a state­ment.

The biotech is flush with cash to run piv­otal tri­als for two of its name­sake an­ti­body-drug con­ju­gates. Just two months ago ADC stacked an­oth­er $103 mil­lion on a $200 mil­lion Se­ries E.

But fund­ing oth­er, ear­li­er stud­ies may call for more cap­i­tal, as will the scale-up of com­mer­cial and man­u­fac­tur­ing op­er­a­tions to sup­port mar­ket­ing around the world. If all goes ac­cord­ing to plan, ADC plans to launch its first prod­uct, the CD-19 tar­get­ing AD­CT-402 for re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma, in 2021. They would be set­ting up a mar­ket­ing team in New Jer­sey and eye­ing a “sub­stan­tial in­crease in staff, par­tic­u­lar­ly in the North Amer­i­can part of the or­ga­ni­za­tion,” Mar­tin told Fierce­Biotech in June.

Biotech has en­joyed a hot streak of high-val­u­a­tion IPOs in 2019, with sev­er­al more gun­ning for $100 mil­lion this week. But as the elec­tion year looms, how long that win­dow will stay open has be­come a peren­ni­al ques­tion.

Viela Bio had lit­tle is­sue bag­ging $150 mil­lion on its Nas­daq de­but $VIE, thought the price of $19 rep­re­sent­ed the low end of the range. The As­traZeneca spin­out had to sell more shares — 7.9 mil­lion to­tal — to main­tain the deal size.

Bing Yao

CEO Bing Yao has laid out swift clin­i­cal time­lines for the au­toim­mune dis­ease pipeline he’s carved out of the Med­Im­mune bi­o­log­ics unit, which be­came a rel­ic fol­low­ing an over­haul at As­traZeneca. The an­ti-CD19 drug inebi­lizum­ab is now un­der re­view and, if ap­proved, will di­rect­ly chal­lenge Alex­ion’s Soliris in neu­romyelitis op­ti­ca spec­trum dis­or­der — a block­buster in­di­ca­tion that Roche is al­so an­gling for.

Mean­while, Fre­quen­cy Ther­a­peu­tics {FREQ} couldn’t quite reach the orig­i­nal $100 mil­lion CEO David Lucchi­no had pen­ciled in. Not on­ly did it price at the low end of the range at $14 to bag $84 mil­lion, the com­pa­ny al­so sold on­ly 6 mil­lion shares in­stead of 6.7 mil­lion.

The new cash will help fund a Phase IIa tri­al for its lead drug can­di­date — a small mol­e­cule drug that promis­es to stim­u­late re­gen­er­a­tion of hair cells in the in­ner ear, there­by restor­ing hear­ing. FX-322 was de­signed on the PCA, or prog­en­i­tor cell ac­ti­va­tion, plat­form out of a col­lab­o­ra­tion be­tween il­lus­tri­ous MIT re­searcher Robert Langer and Har­vard’s Jeff Karp.

Aprea was the safe and small play­er in the group, and the IPO price of $15 as well as the $85 mil­lion it reaped was more or less with­in ex­pec­ta­tions. For the biotech, which has roots in Swe­den’s Karolin­s­ka De­vel­op­ment, all eggs are in the p53 bas­ket. In the up­com­ing piv­otal tri­al they will test their the­o­ry that re­ac­ti­vat­ing mu­tant p53 can make a dif­fer­ence in myelodys­plas­tic syn­dromes when com­bined with chemother­a­py.

Tri­als for that lead pro­gram, APR-246, and man­u­fac­tur­ing as well as IND work for its oral p53 re­ac­ti­va­tor, APR-458, fea­tured promi­nent­ly in the IPO $APRE.

UP­DAT­ED: In a stun­ning turn­around, Bio­gen says that ad­u­canum­ab does work for Alzheimer's — but da­ta min­ing in­cites con­tro­ver­sy and ques­tions

Biogen has confounded the biotech world one more time.

In a stunning about-face, the company and its partners at Eisai say that a new analysis of a larger dataset on aducanumab has restored its faith in the drug as a game-changer for Alzheimer’s and, after talking it over with the FDA, they’ll now be filing for an approval of a drug that had been given up for dead.

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Vas Narasimhan. Getty Images

UP­DAT­ED: Failed PhI­II fe­vip­iprant tri­als pour more cold wa­ter on No­var­tis' block­buster R&D en­gine — and briefly spread the chill to a high-pro­file biotech

Back in July, during an investor call where Novartis execs ran through an upbeat assessment of their Q2 performance, CEO Vas Narasimhan and development chief John Tsai were pressed to predict which of the two looming Phase III readouts — involving cardio drug Entresto and asthma therapy fevipiprant, respectively — had a higher likelihood of success. Tsai gave the PARAGON-HF study with Entresto minimally better odds, but Narasimhan emphasized that their strategy of giving fevipiprant to more severe patients gave them confidence.

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UP­DAT­ED: The FDA sets a reg­u­la­to­ry speed record, pro­vid­ing a snap OK for Ver­tex's break­through triplet for cys­tic fi­bro­sis

The FDA has approved Vertex’s new triplet for cystic fibrosis at a record-setting speed.

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IM­brave150: Roche’s reg­u­la­to­ry crew plans a glob­al roll­out of Tecen­triq com­bo for liv­er can­cer as PhI­II scores a hit

Just weeks after Bristol-Myers Squibb defended its failed pivotal study pitting Opdivo against Nexavar in liver cancer, Roche says it’s beat the frontline challenge with a combination of their PD-L1 Tecentriq with Avastin. And now they’re rolling their regulatory teams in the US, Europe and China in search of a new approval — badly needed to boost a trailing franchise effort.
Given their breakthrough and Big Pharma status as well as the use of two approved drugs, FDA approval may well prove to be something of a formality. And the Chinese have been clear that they want new drugs for liver cancer, where lethal disease rates are particularly high.
Researchers at their big biotech sub, Genentech, say that the combo beat Bayer’s Nexavar on both progression-free survival as well as overall survival — the first advance in this field in more than a decade. We won’t get the breakdown in months of life gained, but it’s a big win for Roche, which has lagged far, far behind Keytruda and Opdivo, the dominant PD-1s that have captured the bulk of the checkpoint market so far.
Researchers recruited hepatocellular carcinoma — the most common form of liver cancer — patients for the IMbrave150 study who weren’t eligible for surgery ahead of any systemic treatment of the disease.
Roche has a fairly low bar to beat, with modest survival benefit for Nexavar, approved for this indication 12 years ago. But they also plan to offer a combo therapy that could have significantly less toxicity, offering patients a much easier treatment regimen.
Cowen’s Steven Scala recently sized up the importance of IMbrave150, noting:

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UP­DAT­ED: Clay Sie­gall’s $614M wa­ger on tu­ca­tinib pays off with solid­ly pos­i­tive piv­otal da­ta and a date with the FDA

Back at the beginning of 2018, Clay Siegall snagged a cancer drug called tucatinib with a $614 million cash deal to buy Cascadian. It paid off today with a solid set of mid-stage data for HER2 positive breast cancer that will in turn serve as the pivotal win Siegall needs to seek an accelerated approval in the push for a new triplet therapy.

And if all the cards keep falling in its favor, they’ll move from 1 drug on the market to 3 in 2020, which is shaping up as a landmark year as Seattle Genetics prepares for its 23rd anniversary on July 15.

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David Liu, Liu Group

David Liu un­veils newest ad­vance­ment in CRISPR tech: Prime edit­ing

The researcher behind base-editing is out with what some scientists are hailing as the biggest advancement in CRISPR technology since that 2016 breakthrough: “prime editing.” The new molecular gadget is capable of erasing any base pair and stenciling in another and cutting or adding long segments of DNA without breaking both strands of the helix.

David Liu, base editing pioneer and founder of Beam Therapeutics, published the findings in Nature alongside Andrew Anzalone. They estimated that the breakthrough “in principle” puts 89% of human diseases in purview — although experts cautioned that human therapies were a long way off.

Bhaskar Chaudhuri. Frazier Healthcare Partners

Fra­zier Health­care Part­ner­s' der­ma­tol­ogy up­start at­tracts a mar­quee syn­di­cate, $94M+ for 'in-be­tween' top­i­cal drug

For the past three years Frazier Healthcare Partners’ Bhaskar Chaudhuri has been carefully and quietly grooming Arcutis Therapeutics, a new dermatology play he co-founded to deliver topical formulations of well-known drugs. Now that the biotech is poised to enter Phase III, he’s being joined by a marquee syndicate for its $94.5 million Series C.

HBM Healthcare Investments, Vivo Capital, BlackRock, Omega Funds, Pivotal BioVentures, and Goldman Sachs jumped on board, joining Bain Capital Life Sciences, OrbiMed and RA Capital Management in backing Arcutis’ lead topical cream for plaque psoriasis.

A new com­pa­ny en­ters the Tec­fidera fight, of­fer­ing to kill two birds

The remedy for the most common side effect for one of the most common multiple sclerosis drugs is simple: aspirin.

Taking aspirin with Biogen’s Tecfidera will reduce the flush, a sometimes painful form of red skin irritation, many patients experiences. The problem is that the aspirin has to be taken at least 30 minutes before Tecfidera, turning a simple twice-a-day, one-dose oral drug into a staggered two-drug regimen.

UP­DAT­ED: Bris­tol-My­ers makes Op­di­vo pitch for front­line lung can­cer with open la­bel PhI­II study

Despite a head start, when Bristol-Myers Squibb and its pioneering checkpoint inhibitor Opdivo suffered a key lung cancer setback in 2016, they found themselves relegated to the backseat as Merck’s Keytruda seized the wheel on the road to immunotherapy stardom. Bristol-Myers has since suffered blow after blow in its quest to take a big slice of the lucrative market, peppered with some small successes. On Tuesday, the New Jersey drugmaker touted positive data from a Phase III open-label study in a bid to carve itself a piece of the frontline lung cancer market.