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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

Endpoints Premium

Premium subscription required

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

In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Iain McGill, Quell CEO

Eu­ro­pean in­vestors pour $156M to beat Blue­stone, Third Rock and RA Cap­i­tal in multi­bil­lion-dol­lar race to the clin­ic

Amid burgeoning efforts to create a new type of cell therapy out of regulatory T cells — whether by channeling or blocking their immunosuppressive power — Quell Therapeutics wants to shoot for a first.

If everything goes well, the Syncona-backed biotech will be in the clinic early next year, marking what it calls the historic feat of dosing a patient with a CAR-Treg with multiple edited genes.

Like the flu vac­cine every year, the FDA could move quick­ly on a vari­ant-tar­get­ed Covid vac­cine

In the same way that the FDA signs off on flu vaccines every year without requiring large clinical trials to measure their efficacy, the FDA may employ a similar strategy in authorizing variant-focused versions of the mRNA vaccines.

As the world braces for more data on the latest variant Omicron, which may reduce vaccine efficacy, top vaccine developers like Moderna and Pfizer-BioNTech have promised they can pull together a new vaccine targeted against a specific Covid variant in about 100 days. Since Omicron emerged last week, Pfizer-BioNTech, Moderna and J&J have all said they’ve begun work on Omicron-specific vaccines, if needed.

Jonathan Montagu (L) and Gerry Harriman, HotSpot co-founders

HotSpot gets hot­ter with $100M raise to push to­ward clin­ic

HotSpot Therapeutics, the allostery-focused biotech that works on what it calls “natural hotspots” — hence the name — is getting a bit hotter in its valuation from investors. And to that end they’ve raised $100 million.

The four-year-old AI computational biotech started by two former Nimbus execs announced this morning that it closed its Series C round right at the line of a 9-figure investment, courtesy of some big investors.

Thanks­giv­ing edi­tion: Top 15 End­points sto­ries of 2021; Can you name that vac­cine?; Mer­ck­'s Covid an­tivi­ral dis­ap­points; FDA nom­i­nee's in­dus­try ties; 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.

Happy Thanksgiving to all those who are celebrating it — although, if we are being honest, this week’s abbreviated edition is really for those who are not. Wherever you’re tuning in from, we appreciate your support, hope you find this recap helpful and we wish you a wonderful weekend.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,100+ biopharma pros reading Endpoints daily — and it's free.

What were End­points read­ers tun­ing in­to this year? Here’s a look at our 15 most pop­u­lar re­ports of the year (so far)

At the beginning of this year, I laid out a basic objective for Endpoints News as we headed to our 5th anniversary. We’ve long been doing a fine job covering the breaking news in R&D — if I do say so myself — but we needed to expand our horizons on industry coverage, increase the staff and go much, much deeper when the stories demanded it.

In a phrase: broader and deeper.

It’s safe to say, based on our daily web traffic, that you all seemed to like this idea. We’ve doubled the staff — thanks to a growing group of paid subscribers — ramped up the daily report and now publish a regular slate of in-depth articles. And traffic — those clicks you always read about — have gone up in volume too. Monthly sessions are up 43%, to close to 1.5 million. Unique readers are up 63%, to 874,480 in October, after setting a record of close to a million the month before. Page views are running at 3 million-plus a month. And the overall number of subscribers has surged to 124,000.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,100+ biopharma pros reading Endpoints daily — and it's free.

Ursula von der Leyen, President of the European Commission

Omi­cron: Re­searchers scram­ble as new coro­n­avirus mu­ta­tion takes flight around the globe — Pfiz­er/BioN­Tech, Mod­er­na vow swift re­sponse

As Americans were waking up for their Black Friday rituals, they were greeted with the news that a new mutation of the Covid-19 virus has appeared and been sequenced — after it caught an international flight to Hong Kong. And two of the leading Covid-19 vaccine developers promised delivery of a new vaccine “within 100 days” if necessary while a third spelled out its 3-prong strategy hours later.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 124,100+ biopharma pros reading Endpoints daily — and it's free.