An­oth­er busy week for IPOs be­gins with an off-the shelf cell ther­a­py play­er sniff­ing around uni­corn sta­tus

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A flur­ry of biotechs are ex­pect­ed to hit Nas­daq this week, with two com­pa­nies, Am­brx Bio­phar­ma and Cen­tu­ry Ther­a­peu­tics, set­ting the terms for their pub­lic de­buts, with ex­pect­ed rais­es at $126 mil­lion and $200 mil­lion, re­spec­tive­ly. Alza­mend Neu­ro is al­so join­ing in with a $12.5 mil­lion raise and two pre­clin­i­cal Alzheimer’s treat­ments in tow.

The newest rais­es bring the to­tal num­ber of biotech and bio­phar­ma com­pa­nies to file or price their IPOs this year to 69, ac­cord­ing to End­points News’ tal­ly. 

Af­ter ditch­ing its last ef­fort to go pub­lic, sec­ond time’s the charm for Am­brx

Am­brx Bio­phar­ma is fi­nal­ly gear­ing up to go pub­lic af­ter its last ef­fort flopped back in 2014.

The La Jol­la, CA-based biotech plans to of­fer 7 mil­lion shares at a range of $17 to $19, which would amount to a $126 mil­lion raise.

The last at­tempt to go pub­lic sent the com­pa­ny scram­bling, as the board OK’d a rad­i­cal­ly dif­fer­ent strat­e­gy to move for­ward, ap­prov­ing a plan to sell it­self to a syn­di­cate of Chi­nese in­vestors and phar­ma com­pa­nies. Last No­vem­ber, the com­pa­ny nabbed a $200 mil­lion crossover raise, mark­ing the cul­mi­na­tion of its piv­ot to Chi­na. Since 2015, it has inked dis­cov­ery deals with BeiGene, Suzhou-based Mab­Space, Shang­hai-based NovoCodex, and oth­ers.

Am­brx plans to dump $87.8 mil­lion in IPO pro­ceeds in­to its HER2-tar­get­ing an­ti­body-drug con­ju­gate ARX788, which is be­ing stud­ied in sol­id tu­mors, in­clud­ing breast and gas­tric can­cers. The most ad­vanced tri­al is a Phase II/III eval­u­at­ing the can­di­date in HER2-pos­i­tive metasta­t­ic breast can­cer in Chi­na, ac­cord­ing to the F-1/A.

An­oth­er $16.6 mil­lion is tagged for the Phase I de­vel­op­ment of a sec­ond can­di­date in the com­pa­ny’s ADC pipeline, ARX517, in prostate can­cer. A to­tal of $31.5 mil­lion is go­ing to­ward pre­clin­i­cal can­di­dates, in­clud­ing for IND-en­abling and Phase I stud­ies of its en­gi­neered pre­ci­sion bi­o­log­ics.

Am­brx plans to list un­der the tick­er $AMAM.

Cen­tu­ry Ther­a­peu­tics looks to jump on­to Nas­daq with al­lo­gene­ic cell ther­a­pies

There could soon be an­oth­er biotech uni­corn in town as Cen­tu­ry Ther­a­peu­tics has set the terms for a $200 mil­lion IPO. The com­pa­ny plans on of­fer­ing 10.6 mil­lion shares at a range of $18 to $20, the mid­point of which would bring its mar­ket val­ue to $1.1 bil­lion.

La­lo Flo­res

The com­pa­ny had pen­ciled in a $100 mil­lion raise on its S-1 back in May, but in the last year that num­ber has be­come a place­hold­er for com­pa­nies who go on to raise much more.

The news comes just a few months af­ter CEO La­lo Flo­res steered the com­pa­ny to a $160 mil­lion raise. Cen­tu­ry launched with a $250 mil­lion megaround back in 2019 to cre­ate a port­fo­lio of CAR-T and CAR-NKs us­ing in­duced pluripo­tent stem cells. It plans on fil­ing an IND for its lead can­di­date, CN­TY-101, in B-cell lym­phoma next year.

Flo­res will use $50 mil­lion of the IPO funds to prep CN­TY-101 for the clin­ic and ini­ti­ate a Phase I tri­al, ac­cord­ing to the com­pa­ny’s S-1/A. An­oth­er $110 mil­lion is set aside for its oth­er can­di­dates: CN­TY-103, for which Cen­tu­ry plans on fil­ing an IND in glioblas­toma in the first half of 2023; CN­TY-102, which will be IND-ready by the sec­ond half of 2023;  and CN­TY-104, which is be­ing de­vel­oped to treat AML and won’t be ready for an IND un­til mid-2024.

When Cen­tu­ry goes pub­lic, it plans to trade un­der the tick­er $IP­SC.

Alza­mend Neu­ro at­tracts in­vestors with its own be­ta-amy­loid Alzheimer’s ap­proach

The week af­ter Bio­gen’s con­tro­ver­sial ap­proval for its Alzheimer’s drug Aduhelm, Alza­mend Neu­ro priced a $12.5 mil­lion IPO to take its own slate of neu­rode­gen­er­a­tive drugs in­to the clin­ic.

The Tam­pa-based biotech is putting up 2.5 mil­lion shares at $5 apiece — rais­ing a bit more than the $11.5 mil­lion it pen­ciled in on its S-1 back in May.

The lead can­di­date, AL001, is an ion­ic cocrys­tal of lithi­um cre­at­ed at the Uni­ver­si­ty of South Flori­da. While con­ven­tion­al lithi­um salts have long been used as a pro­phy­lac­tic for de­pres­sion — and are cur­rent­ly used as a mood sta­bi­liz­er for pa­tients with bipo­lar dis­or­der — they re­quire mul­ti­ple dos­es through­out the day to reach ther­a­peu­tic con­cen­tra­tions in the blood. Cur­rent lithi­um drugs like lithi­um chlo­ride and lithi­um car­bon­ate suf­fer tox­i­c­i­ties and poor phys­io­chem­i­cal prop­er­ties. But Alza­mend thinks it doesn’t have to be that way.

Sci­en­tists at USF set out to make a new lithi­um cocrys­tal com­po­si­tion that would al­low for low­er dos­ing, with im­proved phys­io­chem­i­cal prop­er­ties. Alza­mend plans on sub­mit­ting an IND for AL001 by the end of the month, and tagged $5.3 mil­lion in IPO funds for topline read­outs on Phase I tri­als in mild to mod­er­ate Alzheimer’s.

The com­pa­ny’s sec­ond pre­clin­i­cal can­di­date, AL002, is a cell ther­a­py that aims to re­store the abil­i­ty of a pa­tient’s im­mune sys­tem to fight off Alzheimer’s and is set to re­ceive $3.6 mil­lion in IPO mon­ey.

Like Aduhelm, Alza­mend says its AL002 is de­signed to clear be­ta-amy­loids, sticky plaques that ac­cu­mu­late in pa­tients’ brains. One the­o­ry is that as peo­ple age, their im­mune sys­tems be­come un­able to pro­duce nat­ur­al be­ta-amy­loid an­ti­bod­ies, which lead to the plaque build-up caus­ing Alzheimer’s symp­toms. How­ev­er, nu­mer­ous failed tri­als from oth­er com­pa­nies’ amy­loid-clear­ing drugs have led some sci­en­tists to be­lieve that amy­loid is mere­ly a symp­tom of the dis­ease, rather than the root cause.

Alza­mend says both can­di­dates have shown a pos­i­tive ef­fect on be­ta-amy­loids in pre­clin­i­cal tri­als. An­oth­er $305,000 in IPO pro­ceeds is set aside to pay li­cense fees and mile­stones to USF, ac­cord­ing to an S-1/A.

Alza­mend will list un­der $ALZN.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Lisa Deschamps, AviadoBio CEO

Ex-No­var­tis busi­ness head hops over to a gene ther­a­py start­up — and she's reeled in $80M for a dash to the clin­ic

Neurologist and King’s College London professor Christopher Shaw has been researching neurodegenerative diseases like ALS and collaborating with drugmakers for the last 25 years in the hopes of pushing new therapies forward. But unfortunately, none of those efforts have come anywhere close to fruition.

“So, you know, after 20 years in the game, I said, ‘Let’s try and do it ourselves,’” he told Endpoints News. 

Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Radek Spisek, Sotio CEO (Cellestia)

A qui­et Czech biotech bags $315M to dri­ve its blos­som­ing can­cer pipeline through the clin­ic

In the rather insular world of biotech, most innovation inevitably comes from a cluster of R&D hubs — Cambridge, San Francisco, etc. But sometimes success stories sprout from rocky soil, which is most certainly the case with Prague-based Sotio Biotech and its suddenly jam-packed pipeline of cancer drugs.

After years in quiet development, Sotio now has $315 million in new funds to play with from parent company PPF Group, an investment group founded in the Czech Republic, as the biotech looks to advance its growing pipeline through early- and mid-stage trials.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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