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.

How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

Ben Zimmer, Priovant CEO

Roivant un­veils lat­est spin­out as Pfiz­er en­trusts JAK1/TYK2 to Pri­o­vant

In November, Pfizer disclosed it’s spun out the Phase II dual JAK1/TYK2 inhibitor to a startup formed in collaboration with an unnamed, experienced partner.

We now know who the partner is. And as Pfizer and Roivant officially take the wraps off Priovant Therapeutics, the companies reveal that they have started two registrational trials of the drug, brepocitinib, as part of a broader plan to develop a big, first-in-class franchise spanning multiple orphan and specialty autoimmune diseases.

State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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