Norbert Bischofberger, Kronos CEO

Three more biotechs look to jump on­to Nas­daq amid IPO boom, in­clud­ing Nor­bert Bischof­berg­er's Kro­nos

Three drug de­vel­op­ers an­nounced plans to go pub­lic on Fri­day, a sign that the IPO win­dow for bio­phar­ma is wide open.

First up is Daly City, CA-based Spruce Bio­sciences. They filed for an $86 mil­lion IPO to de­vel­op their pipeline for clas­sic con­gen­i­tal adren­al hy­per­pla­sia (CAH). Cur­rent­ly, on­ly steroids are avail­able to treat the con­di­tion, which af­fects the adren­al glands above the kid­neys. Spruce’s tildac­er­font, a non-steroidal op­tion, is in a Phase IIb tri­al in adults with clas­sic CAH and poor dis­ease con­trol. The com­pa­ny ex­pects a topline read­out here in the next 12 to 15 months. The small mol­e­cule is al­so in a Phase IIb study in adults with clas­sic CAH and good dis­ease con­trol. Spruce ex­pects topline da­ta here in the first half of 2022.

The com­pa­ny says IPO mon­ey will help fund op­er­a­tions for at “least the next 12 months.” And they plan fur­ther R&D work to po­ten­tial­ly treat chil­dren with clas­sic CAH and oth­er rare en­docrine dis­or­ders.

Spruce raked in an $88 mil­lion Se­ries B round in Feb­ru­ary, led by Omega Funds and Abing­worth. So far, the com­pa­ny has blown through $42.9 mil­lion, ac­cord­ing to its S-1 fil­ing. Oth­er in­di­ca­tions could al­so be in tildac­er­font’s fu­ture. “In ad­di­tion to ad­dress­ing these un­met needs in CAH, tildac­er­font’s mech­a­nism of ac­tion could al­so be rel­e­vant in pa­tients suf­fer­ing oth­er ab­nor­mal­i­ties of the hy­po­thal­a­m­ic-pi­tu­itary adren­al ax­is, in­clud­ing non-clas­sic CAH, Cush­ing’s Dis­ease, and poly­cys­tic ovary syn­drome,” Wiebke Arlt, di­rec­tor of the In­sti­tute of Me­tab­o­lism and Sys­tems Re­search at the Uni­ver­si­ty of Birm­ing­ham, said in Feb­ru­ary.

Next up we have Shat­tuck and Kro­nos, who both filed for $100 mil­lion IPOs to fo­cus on can­cer treat­ments.

Austin, TX-based Shat­tuck says it’s de­vel­op­ing a new class of ag­o­nist redi­rect­ed check­points, or ARCs. Its lead can­di­date, SL-172154, is de­signed to in­hib­it CD47 and stim­u­late CD40, and is cur­rent­ly in a Phase I tri­al for ovar­i­an can­cer. Ini­tial da­ta are ex­pect­ed in the sec­ond half of next year.

The com­pa­ny al­so plans to be­gin a sec­ond Phase I tri­al in pa­tients with cu­ta­neous squa­mous cell car­ci­no­ma or head and neck squa­mous cell car­ci­no­ma, from which dose-es­ca­la­tion da­ta would be avail­able in the sec­ond half of 2022. Their Take­da-part­nered can­di­date, SL-279252, is in a Phase I tri­al for ad­vanced sol­id tu­mors and lym­phoma. Dose-es­ca­la­tion da­ta is com­ing in the sec­ond half of next year, Shat­tuck an­nounced.

Back in June, Shat­tuck reeled in a $118 mil­lion Se­ries B from Red­mile Group and over 10 oth­er in­vestors. It in­tends to use the IPO funds to push SL-172154 from Phase I to Phase II, and de­vel­op ad­di­tion­al can­di­dates. So far, the com­pa­ny has burned through $48.3 mil­lion.

“Longer-term, we are pur­su­ing ad­di­tion­al dis­ease ar­eas, in­clud­ing au­toim­mune dis­eases, where our dual-sided fu­sion pro­tein plat­forms may pro­vide ad­van­tages over cur­rent treat­ment modal­i­ties,” the biotech said in its S-1.

Then there’s Nor­bert Bischof­berg­er’s Kro­nos. The 30-year Gilead vet joined Kro­nos in 2018, pitch­ing in to an $18 mil­lion seed round to launch the biotech. Af­ter an­nounc­ing $155 mil­lion in pri­vate fi­nanc­ing in Au­gust, Kro­nos hit the $278 mil­lion mark.

In Ju­ly, Kro­nos picked up en­tosple­tinib — a drug that was shelved when Bischof­berg­er was head of R&D at Gilead. Kro­nos forked over a “few mil­lion” in cash and a slice of eq­ui­ty to get it and an­oth­er SYK in­hibitor, lan­raplenib, the CEO told End­points News fol­low­ing the deal. And now, the biotech plans on us­ing IPO pro­ceeds to fund a reg­is­tra­tional Phase II/III study of en­tosple­tinib in com­bi­na­tion with in­duc­tion chemother­a­py (IC) in acute myeloid leukemia (AML) pa­tients with NPM1 mu­ta­tions. That would in­clude a $29 mil­lion mile­stone pay­ment to Gilead.

The com­pa­ny is al­so look­ing to con­duct a Phase I/II tri­al of its can­di­date KB-0742 for the treat­ment of ad­vanced sol­id tu­mors, and to fur­ther de­vel­op its SYK and CDK9 pro­grams. Its ac­cu­mu­lat­ed deficit is $39 mil­lion.

“Sub­ject to clear­ance of an In­ves­ti­ga­tion­al New Drug ap­pli­ca­tion (IND) for KB-0742, which we plan to sub­mit in the fourth quar­ter of 2020, we plan to ini­ti­ate a Phase I/II clin­i­cal tri­al in pa­tients with ad­vanced sol­id tu­mors in 2021,” the S-1 states.

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).

Aduhelm OK 'bit­ter­sweet' for ALS ad­vo­cates; Con­trast­ing Covid-19 vac­cine read­outs; GSK joins TIG­IT bat­tle; 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 the busiest days of June now behind us, we’re starting to think seriously about the second half of the year. In August, we have scheduled a special report where Endpoints will compile a list of the 20 most influential R&D executives in biopharma. Know a luminary who should definitely be included? Nominate them now.

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Who are the lu­mi­nar­ies dri­ving the biggest ad­vances in bio­phar­ma R&D? End­points News is ask­ing for your nom­i­na­tions for a spe­cial re­port

In biopharma, driving a drug to market is the ultimate goal — but none of that happens without a strong research and development program. At the most successful companies, those R&D efforts are spearheaded by true innovators in the field who are always looking for that next novel mechanism of action or breakthrough safety profile.

Now, Endpoints News is asking you to tell us who those guiding lights are.

Leen Kawas, Athira CEO

Biotech founder placed on leave as $400M Alzheimer's start­up idea comes un­der scruti­ny

Athira Pharma, the Alzheimer’s biotech that emerged out of obscurity last year and raised nearly $400 million for a dark-horse approach to treating neurodegeneration, has found itself in sudden turmoil.

On Tuesday evening, the company released a terse statement announcing that CEO and founder Leen Kawas had been placed on administrative leave while an independent review board investigated “actions stemming” from her doctoral research at Washington State University. Mark Litton, who joined the company as COO two years ago, will take over day-to-day operations, they said.

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Bris­tol My­ers breaks the bank on Ei­sai's fo­late re­cep­tor ADC drug, lay­ing out more than $3B+ for rights

For years, innovation in oncology has been a crapshoot with Big Pharma — the whales at the table — dropping the big bucks for the key to the next generation of tumor fighters. Bristol Myers Squibb hasn’t exactly made a name for being an innovator in the space, but that doesn’t mean it won’t splash in when it sees a potential winner.

Now, with a massive check in hand, the drugmaker is willing to put its intuition to the test.

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Michael Chambers (L) and John Ballantyne

Dana­her strikes deal to buy boom­ing next-gen man­u­fac­tur­er Alde­vron for $9.6B

Life sciences conglomerate Danaher Corp. $DHR has struck a deal to buy the fast-growing Aldevron, one of the world’s top manufacturers of hotly sought-after plasmid DNA, mRNA and recombinant proteins for the burgeoning world of vaccine and drugmakers pushing some game-changing technologies.

Buyout talks set the stage for Danaher to settle on a $9.6 billion cash pact to acquire the private Fargo, ND-based company — a key supplier for a disruptive new Covid vaccine as well as a host of gene and cell therapy and CRISPR gene editing players — founded by Michael Chambers and CSO John Ballantyne as a crew of 2 back in 1998.

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Christian Hogg, Hutchmed CEO

Hutchmed files for $600M+ IPO in Hong Kong as lead on­col­o­gy drug su­r­u­fa­tinib awaits FDA's good graces

In oncology, a flush of Chinese-developed drugs has the biopharma industry rethinking the poles of power in R&D as the blossoming nation continues to make a name for itself and pick up bundles of cash in the process. Now, as its lead drug faces a pivotal FDA review, the company formerly known as Chi-Med is planting its flag on home soil with a massive public offering.

Hutchmed — recently renamed from Chi-Med, or Hutchison China MediTech — will look to raise $603 million as part of a Hong Kong IPO that serves as a homecoming of sorts for the Chinese-based oncology player, which has listed on Nasdaq since 2016.

FDA's con­tro­ver­sial Aduhelm de­ci­sion leaves ALS pa­tients feel­ing spurned

The FDA’s controversial approval of Biogen’s Aduhelm drug for Alzheimer’s disease has been met with fierce resistance from all corners of the biopharma industry, but few seem to be as upset with the decision as ALS patients and advocacy groups.

For all that’s already been written and discussed about the agency’s announcement, from the drug’s exorbitantly high price of $56,000 per year to criticism over lowered standards, ALS patients see something more. ALS patients and associations say they largely regarded Aduhelm’s approval as a bittersweet double standard: happy that those with Alzheimer’s have a new drug available, but questioning how the FDA evaluated Biogen’s drug compared to the experimental programs being studied for their own disease.

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Spring reg­u­la­to­ry agen­da: What’s com­ing soon-ish from the FDA

The FDA’s lack of a permanent commissioner does not seem to be halting its progress to propose and finalize dozens of new regulations, with the latest batch covering everything from adverse event reporting to supplemental application submissions to annual reports for INDs.

Overall, FDA expects to release more than 40 new proposed regulations and finalize another 24 in the coming months and years.

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