Three biotechs hunt $336M-plus in a new round of IPOs — while Der­ma­vant pulls back

Raise mon­ey when you can, not when you must — the com­mon re­frain rang loud in two IPO fil­ings late Fri­day as ADC Ther­a­peu­tics and Fre­quen­cy Ther­a­peu­tics looked to top up their re­cent rais­es with mega IPOs.

But when you can’t, as Der­ma­vant found af­ter a sec­ond try, then quit­ting might be im­per­a­tive.

ADC and Fre­quen­cy were joined by lit­tle can­cer biotech Aprea Ther­a­peu­tics, seek­ing a col­lec­tive $336 mil­lion from Wall Street.

ADC Ther­a­peu­tics: $558M and count­ing

Chris Mar­tin ADC

Lau­sanne, Switzer­land-based ADC Ther­a­peu­tics is gun­ning for $150 mil­lion as it plots two piv­otal tri­als for its sig­na­ture and name­sake an­ti­body-drug con­ju­gates. AD­CT-402, which tar­gets CD19, is be­ing eval­u­at­ed in re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma; AD­CT-301 hits CD25 and is be­ing test­ed in stub­born cas­es of Hodgkin’s lym­phoma. As­sum­ing pos­i­tive re­sults, the com­pa­ny en­vi­sions BLA sub­mis­sions in late 2020 and the first half of 2022, re­spec­tive­ly.

The SEC fil­ing ar­rives two months af­ter CEO Chris Mar­tin brought the to­tal haul so far to $558.6 mil­lion by adding $103 mil­lion to a mam­moth $200 mil­lion Se­ries E.

ADC’s pitch cen­ters around a next-gen ap­proach to com­bin­ing an anti­gen-bind­ing an­ti­body with a cy­to­tox­ic pay­load, with the promise that its pyrroloben­zo­di­azepine (PBD) war­heads are “ap­prox­i­mate­ly 100 times more po­tent than war­heads used in cur­rent­ly mar­ket­ed AD­Cs.”

With a new in­fu­sion, the com­pa­ny plans to see two more ear­ly tri­als to fruition, in­clud­ing the CD22-tar­get­ing AD­CT-602 for acute lym­phoblas­tic leukemia and the AXL-tar­get­ing AD­CT-601 for sol­id tu­mors. Scal­ing up of com­mer­cial op­er­a­tions, along­side man­u­fac­tur­ing plans, will al­so be­gin in earnest.

Pe­ter Corr

Chair­man Pe­ter Corr and board mem­ber Stephen Evans-Freke stand to reap the biggest re­wards from the IPO, hav­ing se­cured a 42.7% stake through their pri­vate eq­ui­ty firm Au­ven Ther­a­peu­tics Man­age­ment. HP­WH, a stock cor­po­ra­tion tied to Swiss busi­ness Hans-Pe­ter Wild, con­trols 11.6% while As­traZeneca claims 7.1%.

Mar­tin, who was cred­it­ed for spin­ning off ADC from Spirogen af­ter he sold that ven­ture to As­traZeneca, holds 2.2% of the stock. CFO (and ex-CEO) Michael For­er has 1.7%.

Fre­quen­cy tunes in on $100M IPO

It has tak­en David Lucchi­no 2.5 years and $61.8 mil­lion to steer Fre­quen­cy out of stealth mode in­to a pub­lic de­but $FREQ, for which he’s set a $100 mil­lion goal.

David Lucchi­no

Lucchi­no, the CEO, and CSO Christo­pher Loose co-found­ed the biotech with Robert Langer back in 2014 based on the prog­en­i­tor cell ac­ti­va­tion tech in­vent­ed by the il­lus­tri­ous MIT re­searcher and Jeff Karp, a col­lab­o­ra­tor from Har­vard. The trio had pre­vi­ous­ly launched a medtech ven­ture to­geth­er that ul­ti­mate­ly sold for $30 mil­lion up­front.

The PCA plat­form is de­signed to gen­er­ate small mol­e­cules that spur re­gen­er­a­tion of tar­get cells. By tin­ker­ing with lo­cal prog­en­i­tor cells that are pre-pro­grammed to serve the pur­pose, the biotech be­lieves it can of­fer a safer and more ef­fi­ca­cious al­ter­na­tive to stem cell ther­a­pies.

Chris Loose

Fre­quen­cy is start­ing out with hair cells in the in­ner ear. Its lead drug can­di­date, FX-322, is in a Phase IIa tri­al with top-line da­ta ex­pect­ed in H2 2020. Astel­las has bought in­to ex-US de­vel­op­ment and com­mer­cial­iza­tion rights in a $625 mil­lion deal — $80 mil­lion up­front — an­nounced in Ju­ly. Soon af­ter­wards, the Woburn, MA-based biotech raised $62 mil­lion in Se­ries C cash.

An IND for the next pro­gram, one for mul­ti­ple scle­ro­sis, is planned for the sec­ond half of 2021, ac­cord­ing to the S-1.

In 2018 Lucchi­no took home a com­pen­sa­tion pack­age worth $743,700, while Loose got $578,134. Carl LeBel, the chief de­vel­op­ment of­fi­cer, re­ceived $477,721.

Per­cep­tive owns the largest chunk of shares at 7.8%, while Tai­wa­nia Cap­i­tal Man­age­ment Cor­po­ra­tion and Alexan­dria’s Joel Mar­cus each hold about 5%.

Aprea: All eggs in the p53 bas­ket

In the midst of re­cruit­ing for its first piv­otal tri­al, Aprea Ther­a­peu­tics has pen­ciled in $86 mil­lion for that and oth­er pro­grams around its lead drug, APR-246.

Chris­t­ian Schade

The Swedish com­pa­ny has all its eggs in the p53 bas­ket as the pro­tein is ex­pressed from TP53, a gene prone to mu­ta­tions in can­cer. APR-246, which is de­signed to re­ac­ti­vate mu­tant p53, is first di­rect­ed to myelodys­plas­tic syn­dromes in a com­bo with chemo. Both the FDA and the EMA have grant­ed or­phan sta­tus, with Eu­ro­pean reg­u­la­tors ex­tend­ing that des­ig­na­tion to acute myeloid leukemia and ovar­i­an can­cer.

David Sall­man of Mof­fitt Can­cer Cen­ter is a key col­lab­o­ra­tor in the US, sched­uled to give the fi­nal word on com­plete re­sponse rates from a Phase I/II study. Pierre Fe­naux is lead­ing an­oth­er study in France, which is al­so cit­ed to sup­port the up­com­ing Phase III (read­out slat­ed for 2020).

Al­so ex­pect­ed in 2020: an IND for APR-458, an oral p53 re­ac­ti­va­tor.

That ap­proach has at­tract­ed some high-pro­file in­vestors, all of whom are fea­tur­ing promi­nent­ly as prin­ci­pal stock­hold­ers: Karolin­s­ka De­vel­op­ment (17.21%), Ver­sant (17.73%), 5AM Ven­tures (17.73%), Health­Cap (14.77%), Red­mile Group (13.15%) and Sec­toral As­set Man­age­ment (10.35%). CEO Chris­t­ian Schade keeps 3.65%.

Aprea counts around $60 mil­lion in cash and cash equiv­a­lents.

Der­ma­vant fi­nal­ly gives up on IPO

Vivek Ra­maswamy’s der­ma­tol­ogy-fo­cused biotech off­shoot first filed for an IPO in March but post­poned a list­ing in June. Three months lat­er, Der­ma­vant has qui­et­ly con­ced­ed that $100 mil­lion raise is not hap­pen­ing any time soon by of­fi­cial­ly with­draw­ing.

Der­ma­vant was not iden­ti­fied among the five Vants that Sum­it­o­mo Dainip­pon gained con­trol of just a few days ago, but the $3 bil­lion cash deal does give the Japan­ese phar­ma an op­tion to buy up to six oth­er star­tups un­der the Roivant um­brel­la. Two pub­lic com­pa­nies — My­ovant and Urovant — were in­clud­ed in the pact.

Fol­low­ing Ra­maswamy’s strat­e­gy for spin­ning off themed com­pa­nies, Der­ma­vant ac­quired tap­inarof, a PhI­II-ready pso­ri­a­sis drug, from GSK. Todd Za­vod­nick was re­cruit­ed as CEO af­ter Jack­ie Fouse left for Agios.

The last cap­i­tal in­fu­sion for Der­ma­vant hap­pened last Au­gust when No­vaQue­st Cap­i­tal Man­age­ment pro­vid­ed $100 mil­lion “in ex­change for con­di­tion­al mile­stone pay­ments achieved by tap­inarof.”

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 83,000+ biopharma pros reading Endpoints daily — and it's free.