Leen Kawas, Athira

Seat­tle-based Athi­ra, aim­ing for tough Alzheimer's and Parkin­son's tar­gets, rais­es $204M for IPO

Fol­low­ing an $85 mil­lion Se­ries B round back in June, Athi­ra Phar­ma is set to be­come the third biotech in the last three days to go pub­lic Fri­day.

Athi­ra raised $204 mil­lion for its IPO af­ter pric­ing shares at $17 apiece, the high-point of its ex­pect­ed range. Ini­tial­ly peg­ging $100 mil­lion in fi­nanc­ing, Athi­ra said it of­fered 12 mil­lion to­tal shares and will trade un­der the tick­er $ATHA.

Now that Athi­ra plans to hit the Nas­daq, there have been more than 50 biotech IPOs this year, more than the to­tal from last year. Com­bined, the com­pa­nies have raised more than $11 bil­lion. Over half of those biotechs, in­clud­ing Athi­ra, raised at least $200 mil­lion each.

It’s al­so ap­proach­ing the 56 in­dus­try IPOs to oc­cur two years ago, per in­de­pen­dent an­a­lyst Brad Lon­car.

Athi­ra pro­vid­ed a de­tailed out­line with­in its S-1 of how it plans to use funds from the raise, il­lus­trat­ing that much of the mon­ey will be used to boost de­vel­op­ment for its lead ATH-1017 pro­gram, for­mer­ly dubbed NDX-1017. About $75 mil­lion will fund two tri­als in Alzheimer’s dis­ease, in­clud­ing a Phase II/III tri­al mea­sur­ing two dosage lev­els and a sep­a­rate Phase II tri­al, while an­oth­er $20 mil­lion will fund a Phase II study in Parkin­son’s de­men­tia.

An ad­di­tion­al $30 mil­lion is slat­ed to fund IND-en­abling stud­ies of two prod­ucts fur­ther down the pipeline — ATH-1019, for the treat­ment of neu­ropsy­chi­atric in­di­ca­tions, and ATH-1018, in neu­ropa­thy. It’s worth not­ing, how­ev­er, that these es­ti­mates were based on as­sump­tions of low­er IPO rais­es.

ATH-1017 fol­lows a fa­mil­iar strat­e­gy in Alzheimer’s re­search in tar­get­ing the dam­aged synap­tic net­work. But the com­pound fo­cus­es on a rel­a­tive­ly un­ex­plored path­way, the he­pa­to­cyte growth fac­tor (HGF), as well as its MET re­cep­tor. If suc­cess­ful, the pro­gram would re­gen­er­ate af­flict­ed tis­sue.

The com­pa­ny has got­ten this far thanks to a Per­cep­tive-led $85 mil­lion Se­ries B back in June, buoyed by da­ta in a Phase Ib that showed pa­tients tak­ing the ATH-1017 can­di­date were able to rec­og­nize a se­ries of re­peat­ed tones more quick­ly than the place­bo group. For those with de­men­tia, the nor­mal recog­ni­tion falls with­in a 400 to 450-mil­lisec­ond range, and the tri­al’s base­line was 390 mil­lisec­onds. The drug arm of the tri­al, which en­rolled just sev­en pa­tients, saw the av­er­age fall to 311 mil­lisec­onds, com­pared to no change in the four-pa­tient place­bo arm.

Joe Edel­man

Athi­ra will be go­ing up against some strong head­winds, as many Alzheimer’s pro­grams that have come be­fore have not proved promis­ing. Most promi­nent­ly, Bio­gen reg­is­tered fail­ures in sev­er­al high-pro­file stud­ies look­ing in­to the amy­loid be­ta the­o­ry. The com­pa­ny court­ed con­tro­ver­sy af­ter in­clud­ing APOe4 car­ri­ers, who are at a high­er risk of the dis­ease, in the low­er-dose arm of one of their tri­als with­out tak­ing them out of the place­bo group.

Per­cep­tive’s Joe Edel­man will own an 11.6% stake in the com­pa­ny, with CEO Leen Kawas get­ting 9.3% of shares.

Charles Baum, Mirati CEO

UP­DAT­ED: 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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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?

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.

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.

A top drug pro­gram at Bay­er clears a high bar for CKD — open­ing the door to an FDA pitch

Over the past 4 years, Bayer has been steering a major trial through a pivotal program to see if their drug finerenone could slow down the pace of chronic kidney disease in patients suffering from both CKD as well as Type 2 diabetes.

Today, their team jumped on a virtual meeting hosted by the American Society of Nephrology to offer a solid set of pivotal data to demonstrate that the drug can delay dialysis or a kidney replacement as well as cardio disease, while also adding some worrying signs of hyperkalemia among the patients taking the drug. And they’re hustling it straight to regulators in search of an approval for kidney disease and cardio patients — one of the toughest challenges in the book, as demonstrated by repeated past failures.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 92,400+ biopharma pros reading Endpoints daily — and it's free.