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.

Charles Baum, Mirati CEO

Mi­rati plots a march to the FDA for its KRAS G12C drug, breath­ing down Am­gen’s neck with bet­ter da­ta

Mirati Therapeutics $MRTX took another closely-watched step toward a now clearly defined goal to file for an approval for its KRAS G12C cancer drug adagrasib (MRTX849), scoring a higher response rate than the last readout from the class-leading rival at Amgen but still leaving open a raft of important questions about its future.

Following a snapshot of the first handful of responses, where the drug scored a tumor response in 3 of 5 patients with non-small cell lung cancer, the response rate has now slid to 45% among a pooled group of 51 early-stage and Phase II patients, 43% — 6 of 14 — when looking solely at the Phase I/Ib. Those 14 patients had a median treatment duration of 8.2 months, with half still on therapy and 5 of 6 responders still in response.

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In his­toric Covid-19 ad­comm, vac­cine ex­perts de­bate a sea of ques­tions — but of­fer no clear an­swers

The most widely anticipated and perhaps most widely watched meeting in the FDA’s 113-year history ended late Thursday night with a score of questions and very few answers.

For nearly 9 hours, 18 different outside experts listened to public health agencies and foundations present how the United States’ Covid-19 vaccine program developed through October, and they debated where it should go from there: Were companies testing the right metrics in their massive trials? How long should they track patients before declaring a vaccine safe or effective? Should a vaccine, once authorized, be given to the volunteers in the placebo arm of a trial?

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Michel Vounatsos, Biogen CEO (via YouTube)

Bio­gen spot­lights a pair of painful pipeline set­backs as ad­u­canum­ab show­down looms at the FDA

Biogen has flagged a pair of setbacks in the pipeline, spotlighting the final failure for a one-time top MS prospect while scrapping a gene therapy for SMA after the IND was put on hold due to toxicity.

Both failures will raise the stakes even higher on aducanumab, the Alzheimer’s drug that Biogen is betting the ranch on, determined to pursue an FDA OK despite significant skepticism they can make it with mixed results and a reliance on post hoc data mining. And the failures are being reported as Biogen was forced to cut its profit forecast for 2020 as a generic rival started to erode their big franchise drug.

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Adam Koppel and Jeffrey Schwartz, Bain

Bain ex­ecs Adam Kop­pel and Jef­frey Schwartz line up $125M for their first blank check deal as Wall Street con­tin­ues to em­brace biotech

Adam Koppel and Jeffrey Schwartz have jumped into the blank check game, raising $125 million for a stock listing in search of a company.

Their SPAC, BCLS Acquisition Corp, raised $125 million this week, with a line on $25 million more as it scouts for a biotech in search of money and a place on Wall Street.

The two principals at Bain Life Sciences have been on a romp since they set up the Bain operation 4 years ago. Their S-1 spells out a track record of 22 deals totaling $650 million for the life sciences group, which led to 9 IPOs.

Stephen Hahn, FDA commissioner (AP Images)

As FDA sets the stage for the first Covid-19 vac­cine EUAs, some big play­ers are ask­ing for a tweak of the guide­lines

Setting the stage for an extraordinary one-day meeting of the Vaccines and Related Biological Products Advisory Committee this Thursday, the FDA has cleared 2 experts of financial conflicts to help beef up the committee. And regulators went on to specify the safety, efficacy and CMC input they’re looking for on EUAs, before they move on to the full BLA approval process.

All of this has already been spelled out to the developers. But the devil is in the details, and it’s clear from the first round of posted responses that some of the top players — including J&J and Pfizer — would like some adjustments and added feedback. And on Thursday, the experts can offer their own thoughts on shaping the first OKs.

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Biond­Vax stock im­plodes af­ter a big PhI­II gam­ble for its uni­ver­sal flu vac­cine fails

After flying high on Wall Street for the last few months of a pandemic, BiondVax’s stock and dreams of getting approval for its universal flu vaccine hit the windshield.

The Jerusalem-based biotech announced on Friday that its only clinical candidate, M-001, failed both primary and secondary endpoints in a Phase III study. There was no statistically significant difference in reduction of flu illness and severity between the vaccine and placebo groups, according to the company. The vaccine did prove safe, if ineffective, BiondVax said.

Pascal Soriot, AstraZeneca CEO (Zach Gibson/Bloomberg via Getty Images)

UP­DAT­ED: FDA gives As­traZeneca the thumbs-up to restart PhI­II Covid-19 vac­cine tri­als, and J&J is prepar­ing to re­sume its study

Several countries had restarted their portions of AstraZeneca’s global Phase III Covid-19 vaccine trial after the study was paused worldwide in early September, but the US notably stayed on the sidelines — until now. Friday afternoon the pharma giant announced the all clear from US regulators. And on top of that, J&J announced Friday evening that it’s preparing to resume its own Phase III vaccine trial.

Adrian Gottschalk, Foghorn CEO (Foghorn)

Foghorn hits Nas­daq in $120M de­but as the biotech IPO boom shows no sign of slow­ing

It’s been a record year for biotech IPOs, and the execs at Nasdaq would like nothing better than to see that momentum continue into the first half of next year.

Since January, 72 biotech and biopharma companies have hit Wall Street, according to Nasdaq head of healthcare listings Jordan Saxe, together raising $13.2 billion.

The latest is Flagship’s Foghorn Therapeutics, which priced its shares last night at $16 apiece, the midpoint of a $15 to $17 range. The Cambridge, MA-based biotech — which initially filed for a $100 million raise on Oct. 2 — is netting $120 million from a 7.5 million-share offering. The proceeds will go right into its gene traffic control platform, including two lead preclinical oncology candidates.

Ul­tragenyx in­jects $40M to grab Solid's mi­crody­s­trophin trans­gene — while side­step­ping the AAV9 vec­tor that stirred up safe­ty fears

Since before Ilan Ganot started Solid Bio to develop a gene therapy for kids like his son, who has Duchenne muscular dystrophy, Ultragenyx CEO Emil Kakkis has been watching and advising the former investment banker as he navigated the deep waters of drug development.

Just as Solid is getting back up on its feet after a yearlong clinical hold, Kakkis has decided to jump in for a formal alliance.

With a $40 million upfront, Ultragenyx is grabbing 14.45% of Solid’s shares $SLDB and the rights to its microdystrophin construct for use in combination with AAV8 vectors. Solid’s lead program, which utilizes AAV9, remains unaffected. The company also retains rights to other applications of its transgene.