Once a multi­bil­lion dol­lar com­pa­ny, Ova­Science ends a pen­ny­s­tock ve­hi­cle for Mil­len­do's re­verse merg­er

An am­bi­tious fer­til­i­ty com­pa­ny plagued by a se­ries of dis­ap­point­ments is play­ing out its fi­nal act — serv­ing as a ve­hi­cle for an­oth­er ven­ture’s suc­cess. Ova­Science, once val­ued at $1.8 bil­lion for its idea to help old­er women ex­tend their re­pro­duc­tive years, is merg­ing with Ann Ar­bor’s Mil­len­do Ther­a­peu­tics.

The re­verse merg­er is a way for Mil­len­do to back its way on­to the Nas­daq mar­ket, as Ova­Science is al­ready list­ed as $OVAS. Us­ing a near­ly-de­funct pub­lic com­pa­ny as a ve­hi­cle is a fair­ly com­mon way to gain ac­cess to the pub­lic mar­kets with­out go­ing on a lengthy road­show and putting to­geth­er your own IPO. Af­ter the merg­er is wrapped up, the com­bined com­pa­ny will be called Mil­len­do Ther­a­peu­tics, of course, and the new tick­er sym­bol will be $ML­ND.

Ju­lia Owens

A group of in­vestors has come to­geth­er to back Mil­len­do, com­mit­ting $30 mil­lion for af­ter the merg­er is com­plete. The mon­ey comes from New En­ter­prise As­so­ci­ates, Fra­zier Health­care Part­ners, and Roche Ven­ture Fund, among oth­ers. The new mon­ey will set up Mil­len­do to push for­ward two pro­grams: ATR-101, in Phase IIb tri­als for con­gen­i­tal adren­al hy­per­pla­sia, a rare en­docrine dis­ease; and a brand new drug to its pipeline called liv­o­le­tide. The lat­ter is a Phase II pro­gram ac­quired from French biotech Al­izé Phar­ma SAS last year. The med is meant to treat a rare ge­net­ic dis­ease called Prad­er-Willi Syn­drome (the most com­mon form of ge­net­ic obe­si­ty). That pro­gram is planned to en­ter Phase IIb/III tri­als in the first quar­ter of 2019.

“We are ex­cit­ed about the op­por­tu­ni­ties cre­at­ed by this merg­er, as it po­si­tions us to be­come a leader in rare en­docrine dis­eases with the fund­ing need­ed to pur­sue the po­ten­tial ap­proval and com­mer­cial­iza­tion of our first-in-class pro­grams,” said Ju­lia Owens, pres­i­dent and CEO of Mil­len­do, in a state­ment.

It’s good news for Mil­len­do, but a sad end for Ova­Science. Ova­Science was found­ed sev­en years ago around the dog­ma-chal­leng­ing claim by a sci­en­tist now at North­east­ern Uni­ver­si­ty that he had dis­cov­ered “egg pre­cur­sor” cells in hu­man ovaries that could gen­er­ate new, young eggs for old­er women, po­ten­tial­ly ex­tend­ing re­pro­duc­tive years. Ova­Science’s founders in­clud­ed Boston/Cam­bridge big shots like Rich Aldrich, Michelle Dipp, David Sin­clair and Christophe West­phal.

Ex­tend­ing fer­til­i­ty years was the long goal, but the com­pa­ny’s first lead prod­uct, called Aug­ment, was meant to boost a woman’s chance of preg­nan­cy dur­ing IVF treat­ment. The up­take for that ser­vice was painstak­ing­ly slow, and the com­pa­ny’s stock slow­ly de­clined over the years. One day a multi­bil­lion dol­lar com­pa­ny, the next it’s firm­ly a pen­ny­s­tock.

A new chap­ter in the de­cen­tral­ized clin­i­cal tri­al ap­proach

Despite the promised decentralized trial revolution, we haven’t yet moved the needle in a significant way, although we are seeing far bolder commitments to this as we continue to experience the pandemic restrictions for some time to come. The vision of grandeur is one thing, but operationalizing and execution are another and recognising that change, particularly mid-flight on studies, is worthy of thorough evaluation and consideration in order to achieve success. Here we will discuss one of the critical building blocks of a Decentralized and Remote Trial strategy: TeleConsent; more than paper under glass, it is a paradigm change and key digital enabler.

Su­per-se­cre­tive an­ti-ag­ing biotech Cal­i­co tees up the first vis­i­ble clin­i­cal tri­al of an ex­per­i­men­tal drug. And it’s for can­cer?

Over the past 7 years, Calico has been so much more than your average, run-of-the-mill secretive biotech players. It’s a riddle, wrapped in a mystery, inside an enigma, to repurpose an old Winston Churchill line dating from the time he confronted the Iron Curtain surrounding Stalin’s thoughts.

Launched by industry legend Art Levinson of Genentech fame, with the infinitely deep pockets of Google for support, one of the few big headlines the anti-aging biotech has sparked focused on a major alliance with AbbVie — a giant outfit that conversely likes to show off its drug prospects whenever it can. Together, they’ve been focused on diseases that limit life span — quite an arc of ailments.

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RBC's Bri­an Abra­hams holds a mock ad­comm on Bio­gen's iffy ad­u­canum­ab da­ta — and most of these ex­perts don't see a path to an ap­proval

As catalysts go, few loom larger than the aducanumab adcomm slated for Nov. 6.

With its big franchise under assault, Biogen is betting the ranch that its mixed late-stage Alzheimer’s data can squeak past the experts and regulators and get onto the market. And the topic — after a decade of Alzheimer’s R&D disasters in what still represents the El Dorado of drug markets — remains in the center ring of discussions around late-stage pipeline prospects.

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Derek Chalmers, Cara Ther

Cara lines up a $440M deal for US rights to its late-stage drug for se­vere itch, with $150M cash on the ta­ble

With plans afoot to file an NDA for what could be its first approved drug, Cara Therapeutics is pivoting its focus to commercialization. And Swiss company Vifor Pharma is willing to surrender up to $440 million to market the candidate in the US.

Cara $CARA CEO Derek Chalmers said an NDA submission is coming this quarter for their intravenous drug Korsuva in chronic kidney disease-associated pruritus (CKD-aP), a severe itching condition. The Stamford, CT-based biotech read out positive topline data from a Phase III pivotal study back in April, and announced plans to approach EMA regulators shortly after filing with the FDA.

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James Sabry (Roche)

Roche's James Sabry inks his sec­ond AI deal in back-to-back pacts — this time part­ner­ing Genen­tech with Stan­ford spin­out Gen­e­sis Ther­a­peu­tics

Less than a week after Roche joined forces with Dyno Therapeutics to develop gene therapies using artificial intelligence, its giant subsidiary Genentech is hopping on the AI bandwagon with a different player.

Genentech has inked a deal with Stanford spinout Genesis Therapeutics to harness its AI power for drug development and discovery. Genesis is getting an upfront payment and milestones, but the companies are keeping the details under wraps for now. The Burlingame, CA-based biotech also stands to earn future royalties on any approved Genentech drugs that come from the deal.

En­do pays $658M in a fur­ther bet on col­la­gen-based med­i­cines, buy­ing out long­time bio­phar­ma part­ner

A little less than two years after Endo Pharmaceuticals’ deal to purchase Somerset Therapeutics fell through, the Irish drugmaker is returning to the well with a much bigger acquisition.

Endo has agreed to buy BioSpecifics Technologies for a whopping $658 million, the two companies announced Monday, in the culmination of a research agreement signed all the way back in 2004. Endo will purchase all of BioSpecifics’ outstanding stock for about $540 million, valuing the company at $88.50 per share — a 45% premium on the $61.02 share price at which the company closed on Friday.

Covid-19 roundup: Pars­ing Bourla, a top an­a­lyst sees im­proved chances for Pfiz­er vac­cine; Fau­ci: No sur­prise that Trump was hit by Covid-19

With a medley of adverse events hobbling the late-stage development of vaccines and drugs, Pfizer CEO Albert Bourla’s latest — extended — timeline for the mRNA approach they’re working on with BioNTech is giving some top analysts added confidence that the pharma giant can come up with the regulatory goods next month.

Parsing Bourla’s language in his comments last week, SVB Leerink’s Geoffrey Porges notes that Bourla’s decision to say they “may” be able to nail down the positive efficacy of their vaccine in a matter of days — a big change from his earlier certainty — may also indicate a delay on that to early November.

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IN8bio CEO William Ho (IN8bio)

Bring­ing their ge­net­i­cal­ly mod­i­fied gam­ma delta T cells to Nas­daq, IN8bio files for $86M IPO

The biotech IPO parade continues marching forward as 2020 turns toward the fourth quarter.

IN8bio, a New York-based company focused on genetically modified gamma delta T cell therapies, filed to go public Friday seeking an $86 million raise. The company has two clinical-stage candidates being studied in glioblastoma and leukemia, respectively.

By any stretch of the imagination, 2020 has already been a huge year for biotech, and nowhere does it appear more obvious than the vast amounts of companies hitting the public market.

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Gilead feels the heat as close al­ly Gala­pa­gos re­ports a big set­back on one of their top ex­per­i­men­tal drugs

The bad news keeps stacking up at Galapagos — which quite likely just lost control of a billion-dollar deal — and by extension their close partners at Gilead.

The biotech $GLPG reported after the bell Thursday that GLPG1972, one of their top development programs, flat failed a mid-stage study for osteoarthritis, flunking the primary and all secondary endpoints.

Testing 3 different doses of their drug, which relies on ADAMTS-5 inhibition, investigators concluded that none of them triggered a statistically significant response — as measured by cartilage thickness.

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