CEO Jeremy Bender (Day One)

It’s a new $DAWN for Day One as start­up piv­ots to an IPO for more fund­ing to back its work in pe­di­atric can­cer

Pe­di­atric can­cer biotech Day One Phar­ma­ceu­ti­cals is head­ed for Nas­daq, in a move that comes less than three months af­ter their work on a brain can­cer treat­ment led to a nine-fig­ure crossover round backed by some blue-chip in­vestors.

The South San Fran­cis­co-based com­pa­ny is pen­cil­ing in $100 mil­lion as their ini­tial IPO tar­get, though the ul­ti­mate raise will like­ly be high­er. Tues­day’s fil­ing comes af­ter RA Cap­i­tal led a $130 mil­lion B round for the com­pa­ny in Feb­ru­ary, fol­low­ing what CEO Je­re­my Ben­der said at the time was “rapid” progress of their lead pro­gram.

When Day One prices in a few weeks, it will trade un­der the tick­er $DAWN.

As the phar­ma in­dus­try con­tin­ues de­vel­op­ing and push­ing for­ward can­cer treat­ments, Day One ex­ecs ar­gue that the main­stream play­ers left pe­di­atric can­cer be­hind. Adult pa­tients make up a sig­nif­i­cant­ly big­ger por­tion of the mar­ket, the com­pa­ny said, and there have been lags in un­der­stand­ing pe­di­atric bi­ol­o­gy prop­er­ly.

Day One’s mis­sion, then, is to try to fill that gap by de­vel­op­ing tar­get­ed ther­a­pies aimed specif­i­cal­ly at chil­dren. Their pro­posed treat­ments are en­tire­ly new ef­forts rather than re­for­mu­lat­ing adult treat­ments that come with heavy side ef­fects, like ra­di­a­tion ther­a­py and chemo.

Their lead pro­gram is a for­mer Take­da pro­gram called DAY101, an oral pan-RAF in­hibitor that can cross the blood-brain bar­ri­er and block mu­ta­tions in gliomas. As such, Day One is aim­ing for an in­di­ca­tion to treat pe­di­atric low-grade gliomas, the most com­mon form of brain tu­mors in chil­dren. The cur­rent stan­dard of care is plat­inum-based chemo, with no clear fa­vorite be­yond that, Ben­der told End­points News in Feb­ru­ary.

The biotech re­cent­ly launched a Phase II study for the ex­per­i­men­tal drug, with the goal of read­ing out top-line re­sults in the first half of 2022. Day One plans to ul­ti­mate­ly en­roll 60 pa­tients in the sin­gle-arm, open-la­bel study and hopes it can form the ba­sis of an ap­proval pack­age.

With­in its S-1, Day One plans to fun­nel its cash not on­ly to­ward this Phase II tri­al, but al­so launch a new Phase III study for the front­line treat­ment of pe­di­atric low grade gliomas next year. Its goals al­so in­clude a Phase II tri­al for RAF-al­tered sol­id tu­mors in pa­tients old­er than 12, as well as a Phase Ib/II study com­bin­ing DAY101 with Mer­ck Kg­GA’s MEK in­hibitor pi­masert­ib to treat adult MAPK-al­tered sol­id tu­mors.

The S-1 al­so pro­vid­ed some de­tails re­gard­ing that deal with Take­da and the com­pa­ny’s eq­ui­ty. Day One on­ly paid $1 mil­lion for the DAY101 can­di­date and at the time of the agree­ment, De­cem­ber 2019, of­fered a Take­da sub­sidiary about a 12% stake in the com­pa­ny. The sub­sidiary, Mil­len­ni­um Phar­ma­ceu­ti­cals, will con­tin­ue to own that stake when Day One goes pub­lic.

Ben­der for his part, owns a 3% stake, while CMO and founder Sam Black­man has a 4.6% stake. The biggest stake­hold­er is Canaan Part­ners at 21.9%, fol­lowed up by the At­las Ven­ture Fund at 16.9%.

Day One al­so not­ed that Derek DiRoc­co, the RA Cap­i­tal part­ner who joined the board with Feb­ru­ary’s raise, will be leav­ing the com­pa­ny af­ter a very short stint once the biotech be­gins trad­ing pub­licly.

Biotech IPOs con­tin­ue to boom as 2021 march­es for­ward, with more than 50 com­pa­nies hav­ing ei­ther filed or priced their IPOs so far this year. For the year, the com­bined biotech raise is ap­proach­ing $6.5 bil­lion, and is ex­pect­ed to reach near­ly $7 bil­lion lat­er this week when four more com­pa­nies make their Nas­daq de­buts.

In­side Track: Be­hind the Scenes of a Ma­jor Biotech SPAC

Dr. David Hung and Michelle Doig are no strangers to the SPAC phenomenon. As Founder and CEO of Nuvation Bio, a biotech company tackling some of the greatest unmet needs in oncology, Dr. Hung recently took the company public in one of this year’s biggest SPAC related deals. And as Partner at Omega Funds, Doig not only led and syndicated Nuvation Bio’s Series A, but is now also President of the newly formed, Omega-sponsored, Omega Alpha SPAC (Nasdaq: OMEG; oversubscribed $138m IPO priced January 6, 2021).

Janet Woodcock, acting FDA commissioner (Al Drago/Bloomberg via Getty Images)

New Alzheimer's drug ap­proval fall­out: Pub­lic Cit­i­zen seeks re­moval of FDA's Wood­cock, Cavaz­zoni and Dunn

As Capitol Hill begins to wake up to the financial and scientific mess behind the FDA’s approval of Biogen’s new controversial Alzheimer’s drug Aduhelm, nonprofit watchdog Public Citizen is now calling for the top three FDA officials who are responsible to be removed from their positions.

In a letter to HHS Secretary Xavier Becerra on Wednesday, the group highlighted the “litany of flaws” in the FDA’s approval of the new drug, including the “unprecedented, inappropriately close” collaboration between the FDA and Biogen in the analysis of key trial data, basing approval on an unvalidated surrogate endpoint, not following the advice of its expert advisory committee (3 members of which have since resigned), and the wide label that the agency granted.

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Barry Greene, Sage CEO

UP­DAT­ED: Sage's sec­ond chance at de­pres­sion hits the PhI­II pri­ma­ry, but ques­tions re­main over dura­bil­i­ty, side ef­fects

Looking to make a comeback after a big Phase III flop, Sage Therapeutics revealed data they believe could change the entire depression treatment landscape, given the vast array of failures in the field. But some results are spooking investors, sending Sage $SAGE shares down early Tuesday.

First, the primary: Sage and Biogen reported Phase III data for once-daily zuranolone Tuesday morning, saying the experimental drug hit its primary endpoint by spurring a statistically significant change from baseline in the 17-item Hamilton Rating Scale for Depression total score. After 15 days, patients in the drug arm saw an average change of -14.1 points, compared to -12.3 on placebo.

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CEO Harith Rajagopalan (Fractyl)

Af­ter a decade in the type 2 di­a­betes game, Fractyl Lab­o­ra­to­ries recharges with a fresh $100M and a new name

Harith Rajagopalan compared the way type 2 diabetes is managed to sticking your fingers in a dam that’s leaking from a number of places.

You can take drugs to lower your blood sugar, cholesterol, or blood pressure, but you’re not addressing what he says is the core issue — the metabolic abnormality that causes the disease.

“We’re so busy plugging the holes in the dam, we don’t have time to see that the whole infrastructure is at risk,” he said. “That infrastructure is a full-body systemic metabolic abnormality called metabolic syndrome, that we’re ignoring while we’re so busy trying to treat all of the individual symptoms of the condition.”

Michel Sade­lain puts his name and new cell en­gi­neer­ing tech be­hind 'ag­nos­tic' CAR-T start­up chas­ing epi­ge­net­ic anti­gens

It felt natural for Alain Maiore and Sebastian Amigorena to bring in Michel Sadelain as a co-founder of Mnemo Therapeutics. A CAR-T pioneer, Sadelain had been involved as an advisor since the early days — enthusiastic about Amigorena’s work in a genetic knockout that could enhance T cell memory and a new class of potential targets he’s discovered — and could introduce some well-known technologies to the toolbox. So they got the initial cash from Sofinnova Partners to plant roots in Paris and New York in early 2019; within a few months, they began to see more clearly just what the antigen discovery platform might unlock.

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Bio­gen sig­nals a big PhI­II fail­ure as the lead gene ther­a­py in their $800M Night­star buy­out goes down in flames

That $800 million buyout of Nightstar has turned into a bust for Biogen as the lead therapy in the deal failed a pivotal study, signaling a severe setback for the biotech’s ambitions in gene therapies.

The big biotech put out the word after the market closed on Monday that the gene therapy they picked up in the deal for a degenerative blindness called choroideremia failed the Phase III study, just a month after their #2 drug in the deal also flopped in a mid-stage study.

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As Covid-19 shifts the world's at­ten­tion to biotech, Noubar Afeyan's Flag­ship builds $3.4B fund to fu­el new in­ven­tions. Here's the plan

A little more than a year ago, Flagship Pioneering rolled out a monster fund with $1.1 billion in it to bankroll the platform companies they were creating inside their own labs. But it turns out, that was just the prelude to a much, much larger raise, as both current investors — who’ve been reaping the rewards of some booming biotech stocks — join in with new investors betting on more in the years to come.

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An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

A flurry of biotechs are expected to hit Nasdaq this week, with two companies, Ambrx Biopharma and Century Therapeutics, setting the terms for their public debuts, with expected raises at $126 million and $200 million, respectively. Alzamend Neuro is also joining in with a $12.5 million raise and two preclinical Alzheimer’s treatments in tow.

Alexander Vos, VectorY CEO

Start­ing fresh in man­u­fac­tur­ing, For­bion start­up re­fu­els to steer next-gen gene ther­a­py ap­proach for ALS, Alzheimer's in­to clin­ic

Forbion laid out its case for a next-generation gene therapy approach when it took the wraps off VectorY Therapeutics and its vectorized antibody tech in February. Now, the Dutch VC has tapped an experienced hand at cell and gene therapy manufacturing to steer the ship — and pulled a marquee syndicate for a €31 million ($37.6 million) seed round.

Alexander Vos, the new CEO, is a venture partner at BioGeneration Ventures and jumps immediately from VarmX, a BGV portfolio company developing an anticoagulant. But before that, he had led Dutch CDMO PharmaCell for eight years until it was bought out by Lonza.