Led by BioN­Tech, six biotechs line up for Oc­to­ber IPOs

Oc­to­ber: The sea­son of swirling red leaves, Jack-o-lanterns, post­sea­son base­ball and this year, a fresh har­vest of six biotech IPOs ripe with clin­i­cal-stage drugs, try­ing to raise a com­bined $817 mil­lion next week.

All of the com­pa­nies have ear­marked a sub­stan­tial por­tion of the ex­pect­ed pro­ceeds to clin­i­cal work, push­ing such ther­a­pies as mR­NA for melanoma, inebi­lizum­ab for NMOSD, and an­ti­bod­ies for blood can­cer and sol­id tu­mors clos­er to tri­als.

The biotechs, in or­der of mar­ket cap: BioN­Tech (BN­TX), ADC Ther­a­peu­tics (AD­CT), Viela Bio (VIE), Fre­quen­cy Ther­a­peu­tics (FREQ), Aprea Ther­a­peu­tics (APRE), and Monopar Ther­a­peu­tics (MN­PR).


BioN­Tech is hop­ing to raise $251 mil­lion at $18-$20 per share. For them, the IPO will func­tion at least part­ly a way to gath­er the lost cash that would have come in through a $100 mil­lion in­vest­ment from Hong Kong. BioN­Tech re­vealed in their first fil­ing for the IPO in Sep­tem­ber that the in­vest­ment was held up, pos­si­bly due to the protests in Hong Kong and the US-Chi­na trade stand­off, but up­dat­ed IPO fil­ings re­veal the can­cer com­pa­ny is no longer ex­pect­ing that in­vest­ment and have re­tak­en those shares.

BioN­Tech’s mR­NA plat­form has at­tract­ed some no­table buzz and in­vestor in­ter­est. It will use the bulk of the IPO to push through its tri­als on ad­vanced melanoma, HPV+ head and neck can­cer, and triple-neg­a­tive breast can­cer, along with the tri­als of four drugs be­ing de­vel­oped in part­ner­ship with Genen­tech, Sanofi and Gen­mab. Its tar­get mar­ket cap is $4.5 bil­lion.

ADC Ther­a­peu­tics

ADC Ther­a­peu­tics is aim­ing at $200 mil­lion at $23-$26 per share. The IPO is part of their surge to­ward a pos­si­ble 2020 ap­proval ap­pli­ca­tion on their lead drug — the CD19-tar­get­ed AD­CT-402 (lon­cas­tux­imab tesirine) for re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma. The IPO comes on the heels of a whop­ping $303 mil­lion E round and, in ad­di­tion to see­ing the AD­CT-402 Phase II tri­al to com­ple­tion, will fund ear­li­er and sim­i­lar stage tri­als on oth­er drugs and AD­CT-402 com­bi­na­tion treat­ments. The S1 lays out a plan to push to­ward AD­CT-402 ap­proval fol­low­ing the Phase II study and then con­duct post-mar­ket con­fir­ma­to­ry tri­als. They aim for a $1.8 bil­lion mar­ket cap.

Viela Bio

Viela Bio, an As­traZeneca spin­off, is ask­ing for $150 mil­lion at $19-$21 per share, an IPO that would bring them clos­er to­wards uni­corn sta­tus. They will use the bulk of pro­ceeds to sup­port the BLA ap­proval process and the com­mer­cial­iza­tion of inebi­lizum­ab, a CD-19 an­ti­body used to treat neu­romyelitis op­ti­ca spec­trum dis­or­der, a rare and of­ten de­bil­i­tat­ing au­toim­mune dis­ease char­ac­ter­ized by op­tic nerve and spinal cord in­flam­ma­tion.  In ad­vance of the BLA, they signed a li­cens­ing deal with Chi­nese phar­ma Han­soh worth up to $220 mil­lion.

Fre­quen­cy Ther­a­peu­tics

Fre­quen­cy Ther­a­peu­tics hopes to bring in $101 mil­lion at $14-$16 per share. The de­gen­er­a­tive dis­ease biotech, which re­cent­ly brought in $147 mil­lion in Se­ries C fund­ing, will ad­vance clin­i­cal de­vel­op­ment for its lead drug, FX-322. FX-322 tar­gets sen­sorineur­al hear­ing loss and, like the rest of Fre­quen­cy’s plat­form is a small mol­e­cule drug.  They have their eyes on a $526 mil­lion mar­ket cap.

Aprea Ther­a­peu­tics

Aprea Ther­a­peu­tics seeks $75 mil­lion at $14-16 per share. Aprea is un­der­tak­ing a Phase III tri­al for APR-246 for TP53 mu­tant myelodys­plas­tic syn­dromes, a group of dis­or­ders in­volv­ing dis­rup­tions to blood cell pro­duc­tions. That in­di­ca­tion has re­ceived fast track and or­phan drug sta­tus. The largest share of pro­ceeds, how­ev­er, will go to con­duct­ing Phase Ib/II tri­als on APR-246 for hema­to­log­i­cal and sol­id tu­mors. The small Stock­holm-based biotech aims for a  $325 mil­lion mar­ket cap.

Monopar Ther­a­peu­tics

Last­ly, tiny Monopar Ther­a­peu­tics, based in the qui­et Chica­go sub­urb of Wil­mette, Illi­nois is seek­ing $40 mil­lion at $8-$10 per share. A small start­up with a star founder — Bio­Marin co-founder Christo­pher Starr — the biotech has a Phase III clin­i­cal pro­gram va­lidive for se­vere oral mu­cosi­tis caused by chemora­dio­ther­a­py in head and neck can­cer pa­tients and a Phase II tri­al on cam­siru­bicin for soft tis­sue sar­co­ma. The funds will go in large part to­wards build­ing out a team that can sup­port the tri­als. They aim for a mar­ket cap of $130 mil­lion.


Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

Phase III read­outs spell dis­as­ter for Genen­tech’s lead IBD drug

Roche had big plans for etrolizumab. Eyeing a hyper-competitive IBD and Crohn’s market where they have not historically been a player, the company rolled out 8 different Phase III trials, testing the antibody for two different uses across a range of different patient groups.

On Monday, Roche released results for 4 of those studies, and they mark a decided setback for both the Swiss pharma and their biotech sub Genentech, potentially spelling an end to a drug they put over half-a-decade and millions of dollars behind.

Eric Shaff (Seres)

UP­DAT­ED: Af­ter a 4-year so­journ, strug­gling mi­cro­bio­me pi­o­neer Seres claims a break­out PhI­II come­back. And shares re­spond in fren­zied spike

Almost exactly 4 years ago, Seres Therapeutics $MCRB experienced one of those soul-crunching failures that can raise big questions about a biotech’s future. Out front in their pursuit of a gut punch to C. difficile infection (CDI), the Phase II test was a flat failure, and investors wiped out a billion dollars of equity value that never returned in the years that followed.

Seres, though, pressed ahead, changing out CEOs a year ago — bidding Merck vet Roger Pomerantz farewell from the C suite — and pushing through a Phase III, hoping that amping up the dosage would make the key difference. And this morning, they unveiled a claim that they had aced the Phase III and positioned themselves for a run at a landmark FDA OK.

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Michel Vounatsos, Biogen CEO (via YouTube)

UP­DAT­ED: Bio­gen scores a pri­or­i­ty re­view for its Alzheimer's drug ad­u­canum­ab, mov­ing one gi­ant leap for­ward in its con­tro­ver­sial quest

Biogen scored a big win at the FDA today as regulators accepted their application for the controversial Alzheimer’s drug aducanumab and gave it a priority review.

The PDUFA date is March 7, 2021.

Significantly, Biogen says it did not use its priority review voucher to win special treatment at the FDA. The agency handed that out gratis.

That’s the ideal scenario Biogen was looking for as disappointed analysts wondered aloud about the delayed application earlier in the year.

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In­novent and Eli Lil­ly chal­lenge Mer­ck­'s mega-block­buster Keytru­da in non-small cell lung can­cer field

China-based Innovent Biologics and its multinational ally Eli Lilly shared Phase III evidence that their PD-1 inhibitor combo can delay the progression of nonsquamous non-small cell lung cancer.

But the drugmakers will face stiff competition in China from Merck’s Keytruda, the ruling PD-1 which is already approved to treat both squamous and nonsquamous NSCLC and boasts positive overall survival rates.

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Anap­tys­Bio's etokimab pro­vides more dis­ap­point­ing re­sults, rais­ing ques­tions about com­pound's fu­ture

The lead program for AnaptysBio’s in-house pipeline has hit another setback.

Etokimab, an IL-33 inhibitor, did not achieve statistically significant improvement in a Phase II trial for patients suffering from chronic rhinosinusitis with nasal polyps. Researchers measured the individuals’ bilateral nasal polyps score and sino-nasal outcome test, finding that neither improved upon a placebo after both four- and eight-week time markers, though they did demonstrate improvement over baseline levels of the examinations.

Brian Stuglik, Verastem CEO

The du­velis­ib hot pota­to is tossed to a new own­er as Ve­rastem looks to re­or­ga­nize around the pipeline

When Infinity put up duvelisib for a no-money-down instant deal, the biotech was looking for a quick exit from a clinical disaster. AbbVie had walked away from their alliance after looking at how the data stacked up in a crowded field.

And while it was approvable, it wasn’t looking pretty to anyone who thought in commercial terms.

One Big Pharma’s trash, though, was seen as a biotech treasure as a deeply troubled Verastem stepped up to grab the PI3K-delta/gamma — promising to run it across the goal lines at the FDA. And they did just that, only with little to show for it.

DFC CEO Adam Boehler and Kodak CEO Jim Continenza (Kodak)

Covid-19 roundup: Cure­Vac beefs up its uni­corn IPO dreams as bil­lion­aire own­er takes this Covid-19 mR­NA play­er on a forced march to Nas­daq; Ko­dak's $765M deal is put on hold

When CureVac initially jotted down $100 million for its IPO raise a couple of weeks ago, it seemed small. The German mRNA player, after all, had jumped into a Covid-19 race that swelled the sails of Moderna and BioNTech by tens of billions. And after raising $640 million in a slate of deals, $100 million in a hot market like this seemed like a pittance in the bigger scheme of things.

Today, we got a look at a figure that probably comes closer to the game-changing number the top execs probably have in mind. Selling 15.3 million shares at the high end of their $14 to $16 range would net a $243 million bounty. Majority owner Dietmar Hopp is putting in another €100 million, bringing the total to around $350 million. And what are the chances they want to do even better than that?

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Warren Huff, Reata CEO

Rea­ta sug­gests Friedre­ich's atax­ia pro­gram could be de­layed, send­ing stock plung­ing

Reata Pharmaceuticals $RETA made waves last October when its drug omaveloxolone produced positive trial results in treating a rare neurological disorder, but the candidate’s path forward became much murkier Monday.

In a report of quarterly earnings, the biotech divulged that the FDA is considering delaying omaveloxolone’s NDA pending completion of a second trial. That could push back approval by at least a year given that the target population, individuals with Friedreich’s ataxia, is limited and progression of the hard-to-treat illness is notoriously slow. The Covid-19 pandemic would also hinder Reata’s ability to complete an additional trial.