Gary Glick (Scorpion Therapeutics)

UP­DAT­ED: Se­r­i­al en­tre­pre­neur Gary Glick sells an­oth­er one of his star­tups for $229M — this time to an un­like­ly buy­er

Gary Glick has proven him­self, time and again, a nifty start­up artist. Af­ter sell­ing Lyc­era to Cel­gene, he held a streak for IFM Ther­a­peu­tics — carv­ing a plate of in­flam­ma­tion pro­grams each time and turn­ing the re­sult­ing sub­sidiary over to Big Phar­ma, while keep­ing the core dis­cov­ery unit — and more re­cent­ly lined up $270 mil­lion for pre­ci­sion on­col­o­gy work at Scor­pi­on.

James Sapirstein

His lat­est deal, though, looks a bit dif­fer­ent.

Glick has sold First Wave Bio to Azur­Rx, a pen­ny stock biotech un­til a re­verse stock split on Fri­day pushed shares $AZRX back up. The stock has since slid down 11.76% to $4.81. The ma­jor­i­ty of the $229 mil­lion deal is in stock — with on­ly $18 mil­lion in cash — and as a re­sult, he will hand over the name, as­sets and con­trol to Azur­Rx CEO James Sapirstein.

Still, it ap­pears to be a good enough deal for Glick. The on­ly Form D First Wave has filed, dat­ed 2018, shows it set out to raise at most $5 mil­lion and had sold at least $2.6 mil­lion worth of eq­ui­ty pri­vate­ly.

First Wave was start­ed around the same time as IFM, Glick told End­points News, based on his old­er aca­d­e­m­ic work on im­mune me­tab­o­lism.

“So the com­pa­ny, un­like the oth­er com­pa­nies I start­ed, was not ven­ture-backed,” he said. “This is a com­pa­ny that was some­what self-fi­nanced with the group of in­di­vid­u­als who have helped start all of my com­pa­nies, and the goal was to run a very lean op­er­a­tion, very fo­cused op­er­a­tion, vir­tu­al­ly. There were nev­er any em­ploy­ees in the com­pa­ny, there were a few of us that con­sult­ed for the com­pa­ny and (got) eq­ui­ty as well.”

At the heart of the re­verse merg­er are the new for­mu­la­tions that First Wave has de­vised for niclosamide, an an­tipar­a­sitic drug ap­proved by the FDA to treat tape­worm in­fes­ta­tions. These small mol­e­cule for­mu­la­tions are gut-re­strict­ed, open­ing up a range of ap­pli­ca­tions in­clud­ing in­flam­ma­to­ry bow­el dis­ease — and they had some pos­i­tive clin­i­cal re­sults to back it up.

That caught the at­ten­tion of Azur­Rx, which spe­cial­izes in tar­get­ed, non-sys­temic ther­a­pies for gas­troin­testi­nal dis­eases.

“We have been talk­ing to First Wave for a very long time,” said Sapirstein, who not­ed he’s known Glick since their col­lege days.

Then came the Covid-19 pan­dem­ic, and sci­en­tif­ic find­ings out of Ko­rea that niclosamide — a wide­ly avail­able drug list­ed by the WHO as an es­sen­tial med­i­cine — may be a “game chang­er” as an an­tivi­ral. The serendip­i­tous de­vel­op­ment meant the val­ue of First Wave’s pro­grams bal­looned so much that Azur­Rx couldn’t quite af­ford the deal it was orig­i­nal­ly en­vi­sion­ing.

So this Jan­u­ary, the com­pa­nies set­tled for a li­cens­ing deal around two in­di­ca­tions: Covid-19 re­lat­ed GI in­fec­tions and im­mune check­point in­hibitor-as­so­ci­at­ed col­i­tis and di­ar­rhea in ad­vanced stage can­cer pa­tients.

James Pen­ning­ton

Four months in­to the Covid-19 study, Azur­Rx made the de­ci­sion to just snap it all up — and change its name to First Wave. Its pipeline will now ex­pand to in­clude three clin­i­cal IBD in­di­ca­tions in ul­cer­a­tive proc­ti­tis and ul­cer­a­tive proc­tosig­moidi­tis, ul­cer­a­tive col­i­tis and Crohn’s dis­ease.

“There is a wealth of clin­i­cal da­ta that sup­ports the an­tivi­ral and an­ti-in­flam­ma­to­ry ca­pa­bil­i­ties of niclosamide,” said James Pen­ning­ton, Azur­Rx CMO. “More re­cent­ly, da­ta gen­er­at­ed by First Wave Bio in ul­cer­a­tive proc­ti­tis sup­port­ed the broad­er po­ten­tial for niclosamide in mul­ti­ple in­flam­ma­to­ry bow­el dis­eases where we be­lieve our niclosamide for­mu­la­tions could of­fer sig­nif­i­cant ad­van­tages over oth­er cur­rent­ly avail­able treat­ments in­clud­ing steroids, 5-ASAs, and bi­o­log­ics – es­pe­cial­ly in the mild-to-mod­er­ate dis­ease stage.”

Sapirstein added that the new First Wave will al­so in­her­it the old First Wave’s man­u­fac­tur­ing process and set­up, al­low­ing for quick scale up.

Oth­er than niclosamide, First Wave will keep Azur­Rx’s lead Phase IIb pro­gram, MS1819, a po­ten­tial treat­ment for se­vere ex­ocrine pan­cre­at­ic in­suf­fi­cien­cy in pa­tients with cys­tic fi­bro­sis.

For Glick, the sale al­lows him to fo­cus on oth­er ven­tures — and the next big thing he’s work­ing on.

Ed­i­tor’s Note: This sto­ry has been up­dat­ed to add com­ments by Gary Glick.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Dipal Doshi, Entrada Therapeutics CEO

Ver­tex just found the next big ‘trans­for­ma­tive’ thing for the pipeline — at a biotech just down the street

Back in the summer of 2019, when I was covering Vertex’s executive chairman Jeff Leiden’s plans for the pipeline, I picked up on a distinct focus on myotonic dystrophy Type I, or DM1 — one of what Leiden called “two diseases (with DMD) we’re interested in and we continue to look for those assets.”

Today, Leiden’s successor at the helm of Vertex, CEO Reshma Kewalramani, is plunking down $250 million in cash to go the extra mile on DM1. The lion’s share of that is for the upfront, with a small reserve for equity in a deal that lines Vertex up with a neighbor in Seaport that has been rather quietly going at both of Vertex’s early disease targets with preclinical assets.

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Rami Elghandour, Arcellx CEO

Up­dat­ed: Gilead, Ar­cel­lx team up on an­ti-BC­MA CAR-T as biotech touts a 100% re­sponse rate at #ASH22

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Concurrent with the deal, Arcellx revealed its latest cut of data for the program known as CART-ddBCMA, ahead of a full presentation at this weekend’s ASH conference — a 100% response rate among patients getting the therapy. Investors jumped at the dual announcements, sending Arcellx shares $ACLX up more than 25% in Friday’s morning session.

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WIB22: Am­ber Salz­man had few op­tions when her son was di­ag­nosed with a rare ge­net­ic dis­ease. So she cre­at­ed a bet­ter one

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Amber Salzman’s life changed on a cold, damp day in Paris over tiny plastic cups of lukewarm tea.

She was meeting with Patrick Aubourg, a French neurologist studying adrenoleukodystrophy, or ALD, a rare genetic condition that causes rapid neurological decline in young boys. It’s a sinister disease that often leads to disability or death within just a few years. Salzman’s nephew was diagnosed at just 6 or 7 years old, and died at the age of 12.

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Ahead of ad­comm, FDA rais­es un­cer­tain­ties on ben­e­fit-risk pro­file of Cy­to­ki­net­ic­s' po­ten­tial heart drug

The FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet next Tuesday to discuss whether Cytokinetics’ potential heart drug can safely reduce the risk of cardiovascular death and heart failure in patients with symptomatic chronic heart failure with reduced ejection fraction.

The drug, known as omecamtiv mecarbil and in development for more than 15 years, has seen mixed results, with a first Phase III readout from November 2020 hitting the primary endpoint of reducing the odds of hospitalization or other urgent care for heart failure by 8%. But it also missed a key secondary endpoint analysts had pegged as key to breaking into the market.

Ab­b­Vie slapped with age dis­crim­i­na­tion law­suit, fol­low­ing oth­er phar­mas

Add AbbVie to the list of pharma companies currently facing age discrimination allegations.

Pennsylvania resident Thomas Hesch filed suit against AbbVie on Wednesday, accusing the company of passing him over for promotions in favor of younger candidates.

Despite 30 years of pharma experience, “Hesch has consistently seen younger, less qualified employees promoted over him,” the complaint states.

WIB22: Lead­ing NK cell re­searcher re­flects on roots in Iran, the UK and Texas

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

In a small but widely-cited 11-person study published in NEJM in 2020, seven patients saw signs of their cancer completely go away after getting a new therapy made from natural killer cells. The study was one of the earliest to provide clinical proof that the experimental treatment method had promise.

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Jonathan Lim, Erasca CEO (ARCH Venture Partners)

Eras­ca delves fur­ther in­to RAS/MAPK with No­var­tis drug, prices $100M of­fer­ing

After receiving feedback on pivotal studies from European regulators, but not yet the FDA, Novartis is out-licensing a pan-RAF inhibitor going after tumors excited by the RAS/MAPK pathway.

To get the exclusive worldwide license to the asset, Erasca is paying the Swiss Big Pharma $20 million upfront in cash and $80 million worth of shares. Erasca CEO Jonathan Lim told analysts Friday morning that the process was “competitive,” implying his biotech was far from the only one attempting to snag the drug from Novartis, which is going through a reorganization and a fine-tuning to its pipeline.

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WIB22: Chas­ing af­ter ever-evolv­ing sci­ence takes a drug hunter across the pond

This profile is part of Endpoints News’ 2022 special report about Women in Biopharma R&D. You can read the full report here.

Like many scientists, Fiona Marshall would tell you that she loved the natural world growing up — going to look at crabs running around the beach near her childhood home, pondering about the tides. But one thing about biology, in particular, stood out: It was constantly changing, and changing very quickly.

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