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.

Dan Skovronsky, Eli Lilly CSO

UP­DAT­ED: An­a­lysts are quick to pan Eli Lil­ly's puz­zling first cut of pos­i­tive clin­i­cal da­ta for its Covid-19 an­ti­body

Eli Lilly spotlighted a success for one of 3 doses of their closely-watched Covid-19 antibody drug Wednesday morning. But analysts quickly highlighted some obvious anomalies that could come back to haunt the pharma giant as it looks for an emergency use authorization to launch marketing efforts.

The pharma giant reported that LY-CoV555, developed in collaboration with AbCellera, significantly reduced the rate of hospitalization among patients who were treated with the antibody. The drug arm of the study had a 1.7% hospitalization rate, compared to 6% in the control group, marking a 72% drop in risk.

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UP­DAT­ED #ES­MO20: Trodelvy da­ta show that Gilead­'s $21B buy­out may have been worth the big pre­mi­um

Gilead CEO Dan O’Day has been on a shopping spree. And while some analysts gawked at the biotech’s recent $21 billion Immunomedics buyout, new data released at virtual ESMO 2020 suggest the acquisition may have been worth the hefty price.

The deal, announced last weekend, will give California-based Gilead $GILD Trodelvy, which was recently approved for metastatic triple-negative breast cancer (mTNBC).

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#ES­MO20: As­traZeneca bur­nish­es Tagris­so's ad­ju­vant NSCLC pro­file with 'un­prece­dent­ed' re­duc­tion in brain mets. Can they win over skep­tics?

When AstraZeneca trumpeted “momentous” and “transformative” results for Tagrisso earlier this year at ASCO, some practitioners threw cold water on the ADAURA fervor. Sure, the disease-free survival data look good, but overall survival is the endpoint that matters when it comes to choosing adjuvant therapy for non-small cell lung cancer patients, the experts said.

The OS data still aren’t here, but AstraZeneca is back at ESMO to bolster their case with a look at brain metastasis data.

Exelixis CEO Michael Morrissey (file photo)

#ES­MO20: Look out Mer­ck. Bris­tol My­ers and Ex­elix­is stake out their com­bo’s claim to best-in-class sta­tus for front­line kid­ney can­cer

Now that the PD-(L)1 checkpoints are deeply entrenched in the oncology market, it’s time to welcome a wave of combination therapies — beyond chemo — looking to extend their benefit to larger numbers of patients. Bristol Myers Squibb ($BMY} and Exelixis {EXEL} are close to the front of that line.

Today at ESMO the collaborators pulled the curtain back on some stellar data for their combination of Opdivo (the PD-1) and Cabometyx (the TKI), marking a significant advance for the blockbuster Bristol Myers franchise while offering a big leg up for the team at Exelixis.

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Donald Trump and White House chief of staff Mark Meadows, before boarding Marine One (Getty Images)

Pric­ing deal col­laps­es over Big Phar­ma's re­fusal to is­sue $100 'cash card­s' be­fore the elec­tion — re­port

Late in August, as negotiations on a pricing deal with President Trump reached a boiling point, PhRMA president Stephen Ubl sent an email update to the 34 biopharma chiefs that sit on his board. He wrote that if the industry did not agree to pay for a $100 “cash card” sent to seniors before November, White House chief of staff Mark Meadows was going to tell the news media Big Pharma was refusing to “share the savings” with the elderly — and that all of the blame for failed drug pricing negotiations would lie squarely on the industry.

Leen Kawas, Athira

Seat­tle-based Athi­ra, aim­ing for tough Alzheimer's and Parkin­son's tar­gets, rais­es $204M for IPO

Following an $85 million Series B round back in June, Athira Pharma is set to become the third biotech in the last three days to go public Friday.

Athira raised $204 million for its IPO after pricing shares at $17 apiece, the high-point of its expected range. Initially pegging $100 million in financing, Athira said it offered 12 million total shares and will trade under the ticker $ATHA.

Now that Athira plans to hit the Nasdaq, there have been more than 50 biotech IPOs this year, more than the total from last year. Combined, the companies have raised more than $11 billion. Over half of those biotechs, including Athira, raised at least $200 million each.

#ES­MO20: Alk­er­mes of­fers their first snap­shot of a ben­e­fit for their next-gen IL-2 drug. But why did 1 pa­tient starve to death?

Everyone in the cancer R&D arena is looking to build new franchises around better drugs and combos. And one busy pocket of that space is centered entirely on creating an IL-2 drug that can be as effective as the original without the toxicity that damned it to the sidelines.

Alkermes $ALKS formally tossed its hat into the ring of contenders at virtual ESMO today, highlighting the first glimpse of efficacy for their candidate, ALKS 4230, as both a monotherapy as well as in combination with Merck’s Keytruda.

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Albert Bourla (Photo by Steven Ferdman/Getty Images)

Pfiz­er match­es Mod­er­na with their full Covid-19 tri­al blue­print — As­traZeneca says it will un­veil its pro­to­col 'short­ly'

Yesterday, after sustained public pressure as Moderna released its Phase III Covid-19 trial blueprint, Pfizer released its own full trial design for their vaccine trials. The move was designed to boost transparency and shore up public trust in the vaccines, but it also revealed differences in how the two companies are approaching the much-watched studies while failing to satisfy the demands of the fiercest advocates for transparency.

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Stronger to­geth­er? Boehringer and Mi­rati team to put first KRAS-KRAS com­bo in the clin­ic

Researchers are still waiting to see how much any of the vaunted KRAS drugs now in the clinic can, after decades of preclinical research and some early human studies, help patients. But while they do, two of the leading developers will look to see whether a KRAS-KRAS combo might pose a better shot than any KRAS alone.

Boehringer Ingelheim and Mirati have signed a collaboration to combine Mirati’s closely-watched lead KRAS inhibitor, MRTX849, in a clinical trial with the pan-KRAS blocker that Boehringer has quietly developed with high expectations behind their flashier contenders.

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