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.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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Who are the women blaz­ing trails in bio­phar­ma R&D? Nom­i­nate them for End­points' 2022 spe­cial re­port

Over the past three years, Endpoints News has spotlighted 60 women who have blazed trails and supercharged R&D across the biopharma world. And judging from the response we’ve received, to both our special reports and live events, telling their stories — including any obstacles they may have had to overcome — has inspired our readers in many different ways.

But change takes time, and the fact remains that women are still underrepresented at the upper ranks of the drug-making world.

Up­dat­ed: Amid mas­sive re­struc­tur­ing, Bio­gen looks to re­duce phys­i­cal pres­ence in Boston

Biogen is putting a sizable chunk of office and research space in Kendall Square and Weston, MA up for sublease, marking another big change as the biotech grapples with the aftershock of a disastrous and controversial rollout for its Alzheimer’s drug.

The subbleases are “part of Biogen’s overall implementation of the ‘Future of Work,’ which is allowing us to optimize our footprint and reduce the amount of space we occupy, taking into consideration new elements such as the hybrid work model,” Biogen spokesperson Ashleigh Koss wrote in a statement to Endpoints News, adding that the company has had subleases across several buildings for years.

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Bernat Olle, Vedanta Biosciences CEO

Cit­ing 'chal­leng­ing eco­nom­ic en­vi­ron­ment,' PhI­II-ready mi­cro­bio­me biotech lays off 20% of staffers

The market downturn isn’t just sweeping up public biotechs.

Vedanta Biosciences, a developer of oral drugs derived from the human microbiome, is laying off about 20% of its staff — an unfortunately common occurrence these days. But CEO Bernat Olle took the unusual step of sharing the decision on LinkedIn and offering to connect the employees being let go with any company that’s hiring in their areas.

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Hervé Affagard, MaaT Pharma CEO

One year in­to clin­i­cal hold, FDA has more ques­tions about 'pooled' mi­cro­bio­me ther­a­py

The FDA is still wary about a trial testing a microbiome therapy in patients with steroid-resistant acute graft-versus-host disease (aGVHD).

A year after MaaT Pharma’s IND application in the US was first met with a clinical hold, the French biotech said the agency is maintaining the hold. The crux of the matter, MaaT suggested, has to do with the way it puts together its drug candidate, which is administered as an enema (i.e. an injection of fluid into the bowel).

Pfiz­er launch­es re­bate pro­gram for rare dis­ease pa­tients who have to stop tak­ing Panzy­ga

Pfizer is launching its second-ever rebate program, this time for Panzyga, its treatment for a rare neurological disease of the peripheral nerves.

The program began last month, according to STAT which first reported the news, and offers a refund of out-of-pocket costs for patients who must discontinue their course before the fifth treatment for “clinical reasons.”

Panzyga was approved back in 2018 to treat primary immunodeficiency (PI) in patients two years and older and chronic immune thrombocytopenia (cITP) in adults. It has since picked up an indication in chronic inflammatory demyelinating polyneuropathy (CIDP), a condition that’s characterized by weakness of the arms or legs, tingling or numbness, and a loss of deep tendon reflexes, according to the NIH.

Horizon's back-to-school campaign for children with cystinosis includes an all about me poster as part of a care package box.

Hori­zon read­ies kids and fam­i­lies for back to school with week­long ac­tiv­i­ties around rare dis­ease cysti­nosis

Going back to school is usually a bumpy readjustment from summer freedom for all kids, but especially for kids with chronic health conditions. Horizon Therapeutics is hoping to help smooth the way for some who have the rare disease cystinosis. Cystinosis is a genetic disease that causes the amino acid cystine to build up in different tissues and organs.

The “Gear Up” for school campaign is running all week with different online and at-home events and activities for families and children with cystinosis. Each family who signed up receives a care package mailed to their home including an activity coloring book “Michael’s Show-and-Tell.” The book tells Michael’s story about living with cystinosis while offering kids matching, coloring and finding object games along with information.

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Alessandro Maselli, Catalent CEO

Catal­ent ac­quires North Car­oli­na CD­MO for $475M, boost­ing oral solids work

As Catalent has been expanding its reach in the US this year, as well as recently completing a C-suite shuffle, the company announced last night that it has acquired the CDMO Metrics Contract Services for $475 million from Mayne Pharma Group.

The acquisition will increase Catalent’s capabilities in oral solid formulation development, manufacturing and packaging as well as expand its capacity to handle more highly potent compounds.

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