Tony Coles, Yumanity chairman and co-founder

Tony Coles takes sec­ond neu­ro­science start­up pub­lic as Yu­man­i­ty re­verse merges

Maybe Tony Coles just doesn’t like IPOs.

A month af­ter tak­ing one of his two neu­ro­science biotechs — Cerev­el — pub­lic as part of a $445 mil­lion SPAC trans­ac­tion, the long­time ex­ec­u­tive and drug de­vel­op­er is tak­ing the oth­er one pub­lic as part of a re­verse merg­er. Yu­man­i­ty Ther­a­peu­tics will re­verse merge with strug­gling cys­tic fi­bro­sis biotech Pro­teosta­sis Ther­a­peu­tics.

In an in­ter­view af­ter Cerev­el went pub­lic, Coles not­ed the sta­bil­i­ty a SPAC could give over an IPO dur­ing a tur­bu­lent mar­ket. On Mon­day, he talked up the shared sci­en­tif­ic back­ground be­tween Yu­man­i­ty and Pro­teosta­sis.

“To­day’s an­nounce­ment brings to­geth­er two or­ga­ni­za­tions that share a com­mon sci­en­tif­ic her­itage in the sci­ence of pro­tein mis­fold­ing and brings that sci­ence one step clos­er to nov­el so­lu­tions for pa­tients suf­fer­ing from the de­bil­i­ta­tion of neu­rode­gen­er­a­tive dis­eases,” Coles said in a state­ment.

In an in­ter­view, Yu­man­i­ty CEO Richard Pe­ters echoes those com­ments, sin­gling out  the pre­clin­i­cal pipeline Pro­teosta­sis has built around pro­tein mis­fold­ing. He al­so not­ed the fi­nan­cial ben­e­fits, say­ing it was an “ef­fi­cient” way of ac­cess­ing pub­lic mar­kets and point­ing to con­cur­rent in­vest­ments from Alexan­dria Ven­ture In­vest­ments, Bio­gen, Fi­deli­ty, Mer­ck, Pfiz­er, Red­mile Group, and Sanofi Ven­tures. The to­tal raised re­mains undis­closed.

He al­so framed their merg­er in the con­text of the Cerev­el raise and re­cent neu­ro­science in­ter­est from Big Phar­ma, in­clud­ing a Mer­ck col­lab­o­ra­tion with Yu­man­i­ty and a No­var­tis col­lab­o­ra­tion with Sang­amo.

”“That’s just in the span of 3 months,” he told End­points News. “The mo­men­tum is just phe­nom­e­nal.”

Still, Pro­teosta­sis won’t play a ma­jor role post-merg­er. The com­pa­ny cut its own staff by 79%, leav­ing just five em­ploy­ees to sup­port the merg­er and ef­forts to spin off their CF pro­gram to an­oth­er com­pa­ny.

Yu­man­i­ty, built around an MIT-de­signed plat­form to find new treat­ments for Alzheimer’s, ALS and oth­er neu­rode­gen­er­a­tive dis­or­ders, pulled Coles out of brief de­par­ture from biotech in 2014. The com­pa­ny has on­ly grown in ca­chet since, even as Coles took the CEO spot at Cerev­el and switched over to the chair­man­ship at Yu­man­i­ty. They say they’ve raised over $100 mil­lion from pri­vate in­vestors.

In June, the com­pa­ny an­nounced a col­lab­o­ra­tion with Mer­ck that had an undis­closed up­front in­vest­ment — part of a larg­er Se­ries C — and $500 mil­lion in mile­stones to de­vel­op treat­ments for ALS and a groups of de­gen­er­a­tive dis­or­ders called fron­totem­po­ral lo­bar de­men­tia. That work re­mains from the clin­ic, but it marked the first ma­jor val­i­da­tion for the start­up. Since aban­don­ing an Alzheimer tri­al built around the BACE hy­poth­e­sis in 2017, Mer­ck had descaled its neu­ro­science ef­forts, fo­cus­ing large­ly on ear­ly-stage work.

Mean­while, Yu­man­i­ty is just be­gin­ning to en­ter the clin­ic on its in­ter­nal pipeline. The com­pa­ny’s plat­form is built on work from Su­san Lindquist, who en­gi­neered yeast as a mod­el for the mis­fold­ed pro­teins that play a role in nu­mer­ous neu­rode­gen­er­a­tive dis­eases. They kicked off a healthy vol­un­teer study for their first drug in Parkin­son’s last year, and bio­mark­er re­sults in Parkin­son’s pa­tients are ex­pect­ed ear­ly next year. They al­so plan to start a study in Lewy body de­men­tia in 2021.

Aside from the Se­ries C — the long­time ex­ec­u­tive and drug de­vel­op­er is tak­ing the one pub­lic as part of a re­verse merg­er­whose full sum was undis­closed — Yu­man­i­ty was al­so one of a hand­ful of pri­vate biotechs that se­cured loans from the pay­check pro­tec­tion pro­gram, the fa­cil­i­ty set up by Con­gress to help small busi­ness­es pay em­ploy­ees de­spite lost rev­enue from Covid-19. They re­ceived $1 mil­lion to $2 mil­lion, ac­cord­ing to fed­er­al dis­clo­sures.

Asked at the time if the com­pa­ny, which like many biotechs is pre-rev­enue, was in dan­ger of lay­ing off em­ploy­ees, CBO Paulash Mohsen de­clined to com­ment, but said “we are grate­ful for the PPP loan and the sta­bil­i­ty it pro­vid­ed for us dur­ing an un­cer­tain macro en­vi­ron­ment.”

”It al­lowed us to sta­bi­lize things and nav­i­gate through a chal­leng­ing time,” Pe­ters added, not­ing they didn’t lay any­one off.

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

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David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

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Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.

Hedge fund jumps in with Avoro ac­tivists in an at­tempt to de­rail Mer­ck­'s $11B Ac­celeron buy­out

Avoro Capital, which made its bones blowing up the Seagen-Immunomedics deal and then selling the smaller biotech for $21 billion, is getting an assist in its quest to derail Merck’s $11 billion buyout of Acceleron $XLRN.

Wednesday morning one of Acceleron’s biggest investors joined the opposition. Darwin Global Management, a hedge fund which owns about 4% of Acceleron, blasted the Merck deal, saying the Big Pharma is getting the company for billions less than what it’s worth. Earlier, Holocene Advisers, reportedly a top-20 investor in Acceleron, said it would not tender its stock after criticizing the $180-per-share deal.

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Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

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Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Suresh Katta, Saama CEO (via YouTube)

As AI con­tin­ues to en­tice Big Phar­ma, a Car­lyle-led drug­mak­er syn­di­cate shells out $430M for cloud com­put­ing play­er

The AI revolution permeating Big Pharma took a big financial step forward Wednesday, with VCs and major drugmakers coming together to acquire a cloud-focused company.

Led by the Carlyle Group, the investors will put up $430 million for a majority stake in Saama, a company that collects patient data to help speed along the drug development process. The investment arms of Pfizer, Merck, Amgen and McKesson all participated in the financing, in addition to other prominent life sciences VCs like Northpond.

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Boost­er bo­nan­za: FDA en­dors­es 'mix-and-match' scheme, and Mod­er­na and J&J too

The FDA late Wednesday signed off on authorizing the use of heterologous — or what FDA calls a “mix and match” of a primary vaccine series and different booster doses — for all currently available Covid-19 vaccines, in addition to separately authorizing Moderna and J&J boosters.

On the mix-and-match approach, which FDA officials insisted isn’t too confusing in a press conference, the agency offered the example of an 18-year-old who received the J&J shot at least two months ago and may now receive a single booster of the J&J, a half dose of the Moderna, or the Pfizer-BioNTech booster.