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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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Giovanni Caforio, Bristol Myers Squibb CEO (Nicolas Messyasz/Sipa via AP Images)

Bris­tol My­ers turns at­ten­tion to new prod­ucts in wake of Revlim­id patent loss

Bristol Myers Squibb CEO Giovanni Caforio is shifting his focus to newer products as generic sales continue to gnaw at the company’s blockbuster myeloma drug Revlimid.

Both Revlimid and Abraxane sales took a dive last year thanks to generic rivals, BMS reported in its Q4 and full-year results on Thursday. As a result, Q4 sales dipped 5% and full-year sales remained flat. However, Caforio sees a silver lining — or rather, two of them.

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Lina Khan, FTC chair (Graeme Jennings/Pool via AP)

FTC makes an ex­am­ple of GoodRx, bans dis­counter from shar­ing pri­vate health da­ta with ad­ver­tis­ers

Prescription drug discount provider GoodRx will no longer be allowed to share its users’ sensitive health data with advertisers after the Federal Trade Commission charged the online coupon provider with failing to notify consumers of such disclosures to Facebook, Google, and other companies.

GoodRx agreed to pay a $1.5 million civil penalty for violating the FTC’s Health Breach Notification Rule after the FTC said it repeatedly violated a 2017 promise to not share sensitive personal health information. The FTC alleged that the company shared users’ prescription medications and personal health conditions with third party advertisers and platforms like Facebook, Google, Criteo, Branch and Twilio.

Rob Davis, Merck CEO

Mer­ck’s Keytru­da nears $21B in sales, dou­bles down on com­bo tri­als

Merck’s cancer immunotherapy Keytruda notched sales of $20.9 billion in 2022, cementing its status as one of the world’s top-selling drugs. However, it’s far from resting on that accomplishment.

Merck executives touted nine ongoing trials in its annual earnings call on Thursday, including five studies in Phase III, for Keytruda (pembrolizumab) in combination with other immuno-oncology drugs. The trials include combinations with Merck’s own developments as well as other pharma companies’ candidates, including its melanoma collaboration with Moderna and its mRNA technology plus Keytruda, aimed at creating a personalized vaccine treatment to reduce the risk of cancer recurrence or death.

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