Dave Mehalick, Coeptis CEO

'Tim­ing could­n't be bet­ter': An ex-gener­ics mak­er goes SPAC route with blank check in­tend­ed for sports mar­ket

Dave Mehal­ick orig­i­nal­ly planned for his com­pa­ny to be a gener­ics mak­er with five drugs in the hop­per. But quick­ly af­ter found­ing Co­ep­tis Ther­a­peu­tics in 2017, he re­al­ized that area of the phar­ma­ceu­ti­cal mar­ket was “re­al­ly be­com­ing a race to the bot­tom.”

So, he piv­ot­ed. The lit­tle-known Pitts­burgh-area biotech raised a cou­ple mil­lion dol­lars over the years from pri­vate in­vestors, went pub­lic on the OTC Pink mar­ket and linked arms with Vy­Gen-Bio, the Karolin­s­ka In­sti­tutet and Stat­era Bio­phar­ma to be­come an on­col­o­gy cell ther­a­py de­vel­op­er.

And, as oth­er biotechs and medtechs re­nege on their blank-check merg­ers and some SPACs them­selves re­treat from their IPO plans, Co­ep­tis has de­cid­ed to move for­ward with the blank check route and merge with Bull Horn Hold­ings Corp., the com­pa­ny dis­closed Tues­day. The SPAC raised $75 mil­lion near­ly 18 months ago to fo­cus on ac­quir­ing a “lead­ing sports, en­ter­tain­ment and brand” com­pa­ny.

“I think it’s great tim­ing be­cause we’re com­ing in at a low end in the biotech mar­ket,” CEO Mehal­ick told End­points News.”I think the pric­ing of where Co­ep­tis stands right now is a great pric­ing for in­vestors for the SPAC. I think we’re very well-po­si­tioned, which what I feel will be the next leg in the biotech mar­ket in the com­ing months to years. I think the tim­ing couldn’t be bet­ter.”

He de­scribed the process as hap­pen­ing in “pret­ty rapid fash­ion.”

“We were al­ready con­tem­plat­ing up­list­ing to a ma­jor ex­change. We were in the process, in the throes of work­ing with bankers to move to­wards that, and then one of our bankers ap­proached us with an op­por­tu­ni­ty,” the CEO said. “I met with the se­nior man­age­ment of Bull Horn, and we seemed to hit it off pret­ty much right out of the gate as they got an op­por­tu­ni­ty to see what we were do­ing.”

The merg­er agree­ment comes just six days af­ter Co­ep­tis an­nounced it plans to ac­quire Stat­era’s TLR5 ag­o­nist plat­form, in­clud­ing en­tolimod, for $6 mil­lion up­front and undis­closed biobucks to fol­low. In De­cem­ber, the FDA lift­ed its clin­i­cal hold on en­tolimod for the treat­ment of acute ra­di­a­tion syn­drome. The po­ten­tial lethal ra­di­a­tion stock­pile drug will like­ly en­ter a Phase II by the end of 2022, Mehal­ick said, not­ing sci­en­tif­ic meet­ings to dis­cuss the clin­i­cal plans be­gin to­day.

Co­ep­tis al­so in­tends to help Stat­era de­vel­op and com­mer­cial­ize STAT-201 for adult and pe­di­atric pa­tients with Crohn’s dis­ease, ac­cord­ing to an SEC fil­ing.

Co­ep­tis is work­ing on de­vel­op­ing a cell ther­a­py tar­get­ing CD38-re­lat­ed can­cers and a pre-clin­i­cal in vit­ro di­ag­nos­tic for such can­cers with part­ner Vy­Gen-Bio. The ther­a­peu­tic is in­tend­ed to en­able com­bo ther­a­py with an­ti-CD38 mon­o­clon­al an­ti­bod­ies. Vy­Gen is led by Karolin­s­ka In­sti­tutet pro­fes­sors and lead­er­ship. The three ex­ec­u­tives — Evren Ali­ci, Arni­ka Wag­n­er and Hans-Gustaf Ljung­gren — are al­so on Co­ep­tis’ sci­en­tif­ic ad­vi­so­ry board, and the in­sti­tu­tion is where most of Co­ep­tis’ sci­en­tif­ic work cur­rent­ly takes place.

Mehal­ick said the com­pa­ny will beef up its head­count, cur­rent­ly un­der 10, to in­clude a lab at Karolin­s­ka — near Stock­holm — and hire more in the biotech’s na­tive Wex­ford, PA.

The CEO found­ed Co­ep­tis in 2017 with for­mer em­ploy­ees from Three Rivers Phar­ma­ceu­ti­cals, which was bought by Kad­mon in 2010. Sanofi ac­quired Kad­mon for about $1.9 bil­lion last Sep­tem­ber. Af­ter orig­i­nal­ly go­ing the gener­ics route, Co­ep­tis switched paths and sold its as­sets to ANI Phar­ma­ceu­ti­cals for about $2.3 mil­lion, ac­cord­ing to an SEC fil­ing.

Co­ep­tis al­so had a co-de­vel­op­ment agree­ment with Vi­ci Health Sci­ences, inked in 2019, for CPT60621, an oral liq­uid ver­sion of an ap­proved Parkin­son’s drug. Be­cause of its fo­cus on the Vy­Gen part­ner­ship, Co­ep­tis said it has “re­cent­ly stopped al­lo­cat­ing pri­or­i­ty re­sources” to the as­set and Vi­ci “in­tends to buy-out most or all of Co­ep­tis’ re­main­ing own­er­ship rights,” ac­cord­ing to a March SEC fil­ing.

The biotech’s name “comes from the idea that God fa­vors our un­der­tak­ings,” Mehal­ick said.

Bull Horn is led by CEO Robert Stri­ar and CFO Christo­pher Calise. Stri­ar is pres­i­dent of M Style, a mar­ket­ing firm fo­cused on sports, en­ter­tain­ment and con­sumer prod­ucts. Calise leads strate­gic work at pri­vate place­ment in­sur­ance hold­ing com­pa­ny Crown Glob­al.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Alex­ion puts €65M for­ward to strength­en its po­si­tion on the Emer­ald Isle

Ireland has been on a roll in 2022, with several large pharma companies announcing multimillion-euro projects. Now AstraZeneca’s rare disease outfit Alexion is looking to get in on the action.

Alexion on Friday announced a €65 million ($68.8 million) investment in new and enhanced capabilities across two sites in the country, including at College Park in the Dublin suburb of Blanchardstown and the Monksland Industrial Park in the central Irish town of Athlone, according to the Industrial Development Agency of Ireland.

A Mer­ck part­ner is sucked in­to the fi­nan­cial quag­mire as key lender calls in a note

Another biotech standing on shaky financial legs has fallen victim to the bears.

Merck partner 4D Pharma has reported that a key lender, Oxford Finance, shoved the UK company into administration after calling in a $14 million loan they couldn’t immediately make good on. Trading in their stock was halted with a market cap that had fallen to a mere £30 million.

“Despite the very difficult prevailing market conditions,” 4D reported on Friday, the biotech had been making progress on finding some new financing and turned to Oxford with an alternative late on Thursday and then again Friday morning.

Members of the G7 from left to right: Prime Minister of Italy Mario Draghi, European Commission President Ursula von der Leyen, President Joe Biden, German Chancellor Olaf Scholz, British Prime Minister Boris Johnson, Canadian Prime Minister Justin Trudeau, Prime Minister of Japan Fumio Kishida, French President Emmanuel Macron and European Council President Charles Michel (AP Photo/Susan Walsh)

Biden and G7 na­tions of­fer funds for vac­cine and med­ical prod­uct man­u­fac­tur­ing project in Sene­gal

Amidst recently broader vaccine manufacturing initiatives from the EU and European companies, the G7 summit in the mountains of Bavaria has brought about some positive news for closing vaccine and medical product manufacturing gaps around the globe.

According to a statement from the White House, the G7 leaders have formally launched the partnership for global infrastructure, PGII. The effort will aim to mobilize hundreds of billions of dollars to deliver infrastructure projects in several sectors including the medical and pharmaceutical manufacturing space.

No stranger to gene ther­a­py woes, Astel­las runs in­to an­oth­er safe­ty-re­lat­ed clin­i­cal hold

Astellas Pharma, which has been at the forefront of uncovering the risks associated with gene therapies delivered by adeno-associated viruses, must take another safety alarm head-on.

The FDA has slapped a clinical hold on Astellas’ Phase I/II trial of a gene therapy candidate for late-onset Pompe disease, after investigators flagged a serious case of peripheral sensory neuropathy.

It marks the latest in a streak of setbacks Astellas has encountered since making a splashy entry into the gene therapy space with its $3 billion buyout of Audentes. But the lead program, AT132 for the treatment of X-linked myotubular myopathy (XLMTM), had to be halted more than once after a total of four patients died in the trial — and the scientific community still doesn’t have all the answers of what caused the deaths.

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David Loew (Ipsen)

Ipsen snags an ap­proved can­cer drug in $247M M&A deal as an­oth­er bat­tered biotech sells cheap

You can add Paris-based Ipsen to the list of discount buyers patrolling the penny stock pack for a cheap M&A deal.

The French biotech, which has had plenty of its own problems to grapple with, has swooped in to buy Epizyme $EPZM for $247 million in cash and a CVR with milestones attached to it. Epizyme shareholders, who had to suffer through a painfully soft launch of their EZH2a inhibitor cancer drug Tazverik, will get $1.45 per share along with a $1 CVR tied to achieving $250 million in sales from the drug over four consecutive quarters as well as an OK for second-line follicular lymphoma by Jan. 1, 2028.

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State bat­tles over mifepri­s­tone ac­cess could tie the FDA to any post-Roe cross­roads

As more than a dozen states are now readying so-called “trigger” laws to kick into effect immediate abortion bans following the overturning of Roe v. Wade on Friday, these laws, in the works for more than a decade in some states, will likely kick off even more legal battles as states seek to restrict the use of prescription drug-based abortions.

Since Friday’s SCOTUS opinion to overturn Americans’ constitutional right to an abortion after almost 50 years, reproductive rights lawyers at Planned Parenthood and other organizations have already challenged these trigger laws in Utah and Louisiana. According to the Guttmacher Institute, other states with trigger laws that could take effect include Arkansas, Idaho, Kentucky, Mississippi, Missouri, North Dakota, Oklahoma, South Dakota, Tennessee, Texas, and Wyoming.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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Fed­er­al judge de­nies Bris­tol My­er­s' at­tempt to avoid Cel­gene share­hold­er law­suit

Some Celgene shareholders aren’t happy with how Bristol Myers Squibb’s takeover went down.

On Friday, a New York federal judge ruled that they have a case against the pharma giant, denying a request to dismiss allegations that it purposely slow-rolled Breyanzi’s approval to avoid paying out $6.4 billion in contingent value rights (CVR).

When Bristol Myers put down $74 billion to scoop up Celgene back in 2019, liso-cel — the CAR-T lymphoma treatment now marketed as Breyanzi — was supposedly one of the centerpieces of the deal. After going back and forth on negotiations for about six months, BMS put $6.4 billion into a CVR agreement that required an FDA approval for Zeposia, Breyanzi and Abecma, each by an established date.