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.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

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Raymond Stevens, Structure Therapeutics CEO

Be­hind Fri­day's $161M IPO: A star sci­en­tist, GPCR drug dis­cov­ery and a plan to chal­lenge phar­ma in di­a­betes

What does it take to pull off a $161 million biotech IPO these days?

In Structure Therapeutics’ case, it means having a star scientist co-founder paired with the computational drug discovery company Schrödinger, $198 million in private funding from blue-chip investors, almost six years of research work on G protein-coupled receptors and a slate of oral, small-molecule drugs, with an eye on the huge and growing diabetes and weight-loss market.

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Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

Af­ter 13 years, Ramy Mah­moud steps in­to CEO seat at Opti­nose; Ru­pert Vessey set to ex­it Bris­tol My­ers in Ju­ly

After 13 years as president and COO at Optinose, Ramy Mahmoud has stepped into a new role as its CEO. He is taking the place of Peter Miller, who stepped down earlier this week, though Miller is still staying with the company as a consultant.

In 2010, the two business partners joined Optinose to take it in a new direction, transforming it from a delivery platform to product company. They previously worked together at Johnson & Johnson, when Miller was president at Janssen and Mahmoud headed medical affairs. Miller said after he learned about Optinose, “I did what I always do, which is find people smarter than me to talk with about the idea. And the first person I called was Ramy … and I said, ‘Hey, Ramy, what do you think of this technology?’”

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Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

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Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.