From pro­tein degra­da­tion to 'toad ven­om': An­oth­er five biotechs will make the Nas­daq shuf­fle af­ter fil­ing SEC pa­per­work

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Fri­day proved to be an­oth­er busy day for biotech IPOs, with five more com­pa­nies fil­ing their S-1s and F-1s with the SEC ahead of ex­pect­ed jumps to Nas­daq.

Four biotechs pen­ciled in ini­tial es­ti­mates of $100 mil­lion rais­es: pro­tein-degra­da­tion play­er Monte Rosa, gene edit­ing biotech Graphite Bio, “toad ven­om”-fo­cused GH Re­search and mon­o­clon­al an­ti­body de­vel­op­er El­e­va­tion On­col­o­gy. The fifth com­pa­ny, reagents provider Al­pha Tekno­va, es­ti­mates at least $75 mil­lion with their raise.

The to­tal num­ber of biotechs to file or price their IPOs this year has now reached 65, ac­cord­ing to the End­points News tal­ly.

Al­so ear­ly on Mon­day, Janux Ther­a­peu­tics set its IPO terms for an es­ti­mat­ed $152 mil­lion raise by of­fer­ing 9.5 mil­lion shares in the $15 to $17 range. It’s ex­pect­ed to price by the end of this week, ac­cord­ing to Re­nais­sance Cap­i­tal.

Here’s a look at the lat­est biotechs do­ing the Nas­daq shuf­fle.

Al­most at the clin­ic, Monte Rosa preps its IPO

Since last Sep­tem­ber, Monte Rosa has pulled in two fundrais­ing rounds of $96 mil­lion and $95 mil­lion apiece. That mo­men­tum is lead­ing them to­ward the next step of be­com­ing a pub­lic com­pa­ny.

Their plat­form re­volves around de­vel­op­ing “mol­e­c­u­lar glues” that can re­pro­gram the ubiq­ui­tin lig­as­es cen­tral to pro­tein degra­da­tion, a field that’s been pro­duc­ing tons of buzz among in­vestors over the last cou­ple years. The re­sult­ing can­di­dates are dif­fer­ent from oth­er small mol­e­cule de­graders, such as PRO­TAC, that work more like in­hibitors.

Monte Rosa doesn’t have any clin­i­cal pro­grams just yet, but they’ve been plan­ning IND stud­ies for their lead can­di­date by the end of this month. The ex­per­i­men­tal drug will tar­get GSPT1, a reg­u­la­to­ry pro­tein im­pli­cat­ed in the syn­thet­ic lethal­i­ty of sol­id tu­mor cells.

With­in its S-1, Monte Rosa stayed silent over ex­act­ly how far it ex­pects to bring this pro­gram, on­ly di­vulging that some of the cash will be di­rect­ed to­ward it. The rest of the mon­ey will help fund fur­ther de­vel­op­ment of the plat­form and oth­er pre­clin­i­cal pro­grams.

Once it goes pub­lic, Monte Rosa plans to list un­der the tick­er $GLUE.

Ver­sant-backed Graphite pen­cils in a $100 mil­lion raise

Graphite came out of a part­ner­ship from Ver­sant and Stan­ford gene ther­a­py ex­perts, first get­ting things start­ed back in Sep­tem­ber 2020 with a $45 mil­lion round.

Matthew Por­teus

Now they’re ready to make the pub­lic leap less than a year lat­er, ex­pect­ing to launch their first clin­i­cal tri­al by the end of 2021 in sick­le cell dis­ease. The plat­form comes from Matthew Por­teus, an aca­d­e­m­ic founder of CRISPR Ther­a­peu­tics, who is work­ing along­side gene ther­a­py ex­pert Maria Grazia Ron­car­o­lo.

Draw­ing from re­search work led by Dan­ny De­v­er while a post­doc at Por­teus’ lab, Graphite’s big promise is to in­crease in­te­gra­tion ef­fi­cien­cy from less than 1% to greater than 50% “across di­verse ge­net­ic le­sions in a wide range of cell types.” The trio each serve as the co-aca­d­e­m­ic founders at Graphite.

Maria Grazia Ron­car­o­lo

The biotech has since built up its pipeline in­to three pro­grams, with can­di­dates for X-linked se­vere com­bined im­mune de­fi­cien­cy and Gauch­er dis­ease on top of the sick­le cell lead. All three are ex­pect­ed to be fun­neled cash with the IPO, and the two fol­low-up pro­grams are still in IND-en­abling stud­ies.

Graphite plans to list un­der the tick­er $GRPH af­ter its de­but.

Toad-al­ly rad­i­cal: RA’s psy­che­del­ic wa­ger keeps on truck­ing

The psy­che­delics space con­tin­ues to see heavy in­vestor in­ter­est, and RA Cap­i­tal backed GH Re­search just two months ago with a nine-fig­ure round. GH is tak­ing its pro­grams pub­lic now, with a lead in­halant cen­tered around the sub­stance col­lo­qui­al­ly known as “toad ven­om.”

Though the drug’s sci­en­tif­ic name is a mouth­ful — 5-Methoxy-N, N-di­methyl­trypt­a­mine is the of­fi­cial name — it picked up the toad ven­om nick­name due to its pres­ence in a cer­tain toad species na­tive to the south­west­ern US and north­west­ern Mex­i­co. The psy­che­del­ic saw a rapid rise in recre­ation­al use in the mid-2010s, per a VICE News re­port, as in­di­vid­u­als at­tempt­ed to achieve the ‘ego death’ phe­nom­e­non.

GH is start­ing with treat­ment-re­sis­tant de­pres­sion and has two oth­er undis­closed in­di­ca­tions on tap. The DMT in­halant, dubbed GH001, is cur­rent­ly be­ing stud­ied in the Phase II por­tion of a Phase I/II clin­i­cal tri­al.

The Dublin-based biotech is al­so work­ing on an in­jectable for­mu­la­tion of the drug. GH’s IPO raise is ex­pect­ed to help de­vel­op both of these can­di­dates, with a Phase IIb study planned for GH001 and a Phase IIa tri­al to like­ly be set up for the oth­er can­di­date.

GH Re­search will list un­der the tick­er $GHRS once it goes pub­lic.

A for­mer Mer­ri­mack pro­gram gets a Nas­daq chance

El­e­va­tion On­col­o­gy has spent its time try­ing to re­vamp Mer­ri­mack’s high-pro­file serib­an­tum­ab pro­gram in­to some­thing that can treat sol­id tu­mors with the rare NRG1 ge­nom­ic fu­sion.

Af­ter flop­ping in NSCLC, serib­an­tum­ab was ac­quired by El­e­va­tion back in 2019 for up to $58 mil­lion. The drug can­di­date is a mon­o­clon­al an­ti­body that binds to HER3 and was one in a long string of clin­i­cal busts for Mer­ri­mack, ul­ti­mate­ly re­sult­ing in the biotech sell­ing sev­er­al as­sets and lay­ing off all its staff and ex­ec­u­tives.

El­e­va­tion launched in Ju­ly 2020 and quick­ly added a $65 mil­lion Se­ries B round to com­plete en­roll­ment in a Phase II study. Their S-1 was scant on de­tails over how far El­e­va­tion wants to take the pro­gram with its raise.

When it goes pub­lic, El­e­va­tion plans to list un­der the tick­er $ELEV.

Reagents provider Al­pha Tekno­va will make its pub­lic jump 

Al­pha Tekno­va has been around since 2000, but now it’s go­ing pub­lic on the backs of its reagents. The Hol­lis­ter, CA-based com­pa­ny says it has about 3,000 cus­tomers span­ning the en­tire life sci­ences mar­ket, in­clud­ing biotechs, larg­er phar­ma com­pa­nies and CROs.

Al­pha Tekno­va of­fers three prod­ucts: pre-poured me­dia plates for cell growth and cloning, liq­uid cell cul­ture me­dia and sup­ple­ments for cel­lu­lar ex­pan­sion, and mol­e­c­u­lar bi­ol­o­gy reagents for sam­ple ma­nip­u­la­tion, re­sus­pen­sion and pu­rifi­ca­tion.

Funds from the IPO will large­ly go to­ward up­ping man­u­fac­tur­ing and im­prov­ing ef­fi­cien­cy, though Al­pha Tekno­va said it couldn’t quan­ti­fy ex­act­ly how much. Once it goes pub­lic, the com­pa­ny plans to list un­der the tick­er $TKNO.

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.

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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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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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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