De­spite bruis­ing mar­ket, two biotechs price their IPOs while an­oth­er launch­es its Nas­daq bid

The cur­rent mar­ket sit­u­a­tion for biotechs is cer­tain­ly not ide­al, but that is not de­ter­ring a few com­pa­nies from div­ing in­to the wa­ters of Wall Street.

Two com­pa­nies, Boston-based Hill­e­Vax and San Diego-based Be­lite Bio, will make their Nas­daq de­buts Fri­day, while an­oth­er biotech that has some fa­mil­iar names at­tached filed for an IPO.

Af­ter fil­ing ear­li­er this month Hill­e­Vax grabs more than $150M

Hill­e­Vax, a norovirus vac­cine de­vel­op­er spun out from Take­da by late biotech leg­end Tachi Ya­ma­da, went pub­lic on the back of a $150 mil­lion-plus de­but and priced its IPO at $17 per share.

Hill­e­Vax is a lit­tle over 10 months from be­ing spun out of Take­da and has back­ing from Fra­zier Health­care Part­ners. The start­up launched with a norovirus vac­cine can­di­date that had al­ready com­plet­ed sev­er­al Phase I and Phase II tri­als.

The biotech al­so es­ti­mates that the net pro­ceeds from the of­fer­ing will be ap­prox­i­mate­ly $200 mil­lion on the base deal.

Ac­cord­ing to the S-1/A, there are sev­er­al pur­pos­es for the IPO. Hill­e­Vax says it in­tends to use ap­prox­i­mate­ly $125 mil­lion of the pro­ceeds to fund the clin­i­cal de­vel­op­ment of the HIL-214 norovirus vac­cine can­di­date, but ac­knowl­edged the net pro­ceeds will not be enough to com­plete de­vel­op­ment and will even­tu­al­ly re­quire more cap­i­tal.

How­ev­er, Hill­e­Vax says it may al­so use a por­tion of the re­main­ing net pro­ceeds to in-li­cense, ac­quire or in­vest in com­ple­men­tary as­sets, but there are no cur­rent agree­ments to do so. With Hill­e­Vax’s cur­rent op­er­at­ing plan, it be­lieves its ex­ist­ing cash, to­geth­er with the es­ti­mat­ed net pro­ceeds from the of­fer­ing, will be suf­fi­cient to meet its an­tic­i­pat­ed cash re­quire­ments through at least the next 24 months.

Af­ter the stock de­buts, Fra­zier Life Sci­ences will hold 22.4% of shares, with Take­da Vac­cines, Inc. hold­ing 18.6% and Ya­ma­da’s es­tate net­ting 2.6%.

Be­lite Bio nets $30 mil­lion-plus as it con­tin­ues rapid mo­tion

Be­lite Bio is of­fer­ing shares at $6 apiece as it makes an eight-fig­ure de­but Fri­day.

The com­pa­ny is de­vel­op­ing an eye dis­ease pro­gram, dubbed LBS-008, with a Phase III tri­al that launched in the first quar­ter. The com­pa­ny is test­ing it in both dry AMD and Star­gardt dis­ease, with the piv­otal study ex­am­in­ing ado­les­cents who suf­fer from the lat­ter con­di­tion. Its can­di­date is an oral once-a-day treat­ment de­signed to re­duce and main­tain the de­liv­ery of vi­t­a­min A to the eye.

Ac­cord­ing to the F-1, Be­lite Bio es­ti­mates that it will re­ceive net pro­ceeds of $32.2 mil­lion, or ap­prox­i­mate­ly $37.2 mil­lion if the un­der­writ­ers ex­er­cise their op­tions. Lin Bio­science In­ter­na­tion­al, the biotech’s prin­ci­pal share­hold­er, agreed to pur­chase $15 mil­lion worth of shares in the of­fer­ing, Be­lite Bio said.

The com­pa­ny plans to use 2.5% of the net pro­ceeds for the Phase III clin­i­cal tri­al of LBS-008 for STGD1, and 68.2% for fur­ther clin­i­cal de­vel­op­ment of LBS-008 for dry AMD. The re­main­der will be for work­ing cap­i­tal and oth­er gen­er­al us­es.

Be­lite Bio hopes the of­fer­ing will en­able it to com­plete its on­go­ing Phase II and Phase III clin­i­cal tri­als in both dry AMD and Star­gardt dis­ease, the F-1 states.

Chair­man and CEO Yu-Hsin Lin will have 11.5% of the stock, with CFO Hao-Yuan Chuang hold­ing 2.21%. Lin Bio­science will hold 68.1%.

A com­pa­ny files its IPO and plans to res­ur­rect a med­i­cine with a check­ered past

He­mo­glo­bin Oxy­gen Ther­a­peu­tics LLC is plan­ning to raise $30 mil­lion, ac­cord­ing to its S-1. The com­pa­ny is based in Soud­er­ton, PA and plans to pro­duce he­mo­glo­bin-based oxy­gen car­ri­ers (HBOCs), or hu­man blood sub­sti­tutes, for hu­man and vet­eri­nary use.

Their prod­ucts, called He­mo­p­ure for hu­mans and Oxy­glo­bin for an­i­mals, were ac­quired from OPK Biotech in 2014, which in turn had pre­vi­ous­ly pur­chased them from Biop­ure in 2009. He­mo­glo­bin Oxy­gen Ther­a­peu­tics’ im­me­di­ate fo­cus is to re­launch He­mo­p­ure and Oxy­glo­bin un­der ap­proved in­di­ca­tions in ju­ris­dic­tions where they al­ready have mar­ket­ing au­tho­riza­tions.

Ac­cord­ing to STAT News, Biop­ure was sued by the SEC af­ter reg­u­la­tors ac­cused the com­pa­ny of mis­lead­ing in­vestors about its He­mo­p­ure prod­uct. A for­mer ex­ec­u­tive at Biop­ure was sen­tenced for ly­ing to a fed­er­al judge and stag­ing a fake can­cer di­ag­no­sis to avoid be­ing ques­tioned.

The fil­ing states that they in­tend to use $20 mil­lion to­ward the re­assem­bly of the com­pa­ny’s fa­cil­i­ty in Soud­er­ton with the re­main­ing pro­ceeds for gen­er­al cor­po­rate ex­pens­es. The com­pa­ny says the funds won’t be enough to ful­ly com­plete the re­launch of the prod­ucts, and will re­quire ap­prox­i­mate­ly $15 mil­lion more to com­plete this process.

“We will need to seek such ad­di­tion­al funds through pub­lic or pri­vate eq­ui­ty or debt fi­nanc­ings or oth­er sources, such as strate­gic col­lab­o­ra­tions or li­cense and de­vel­op­ment agree­ments. If we do not suc­cess­ful­ly raise such monies, the fa­cil­i­ty can­not be com­plet­ed, and we will be un­able to pro­duce and com­mer­cial­ly dis­trib­ute any prod­uct,” the F-1 fil­ing said.

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.

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.

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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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.

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.

Chris Anzalone, Arrowhead CEO

Take­da, Ar­row­head spot­light da­ta from small tri­al show­ing RNAi works in a rare liv­er con­di­tion

Almost two years after Takeda wagered $300 million cash to partner with Arrowhead on an RNAi therapy for a rare disease, the companies are spelling out Phase II data that they believe put them one step closer to their big dreams.

In a small, open label study involving only 16 patients who had liver disease associated with alpha-1 antitrypsin deficiency (AATD), Arrowhead’s candidate — fazirsiran, previously ARO-AAT — spurred substantial reductions in accumulated mutant AAT protein in the liver, a hallmark of the condition. Investigators also tracked improvements in symptoms, with seven out of 12 who received the high, 200 mg dose seeing regression of liver fibrosis.

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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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