Phase­Bio de­tails dol­lars in As­traZeneca deal as it rolls out a plan for $86M-plus IPO

It turns out the $34 mil­lion Se­ries D Phase­Bio an­nounced just days ago was a pre­lude to a big­ger sto­ry: With its new­ly honed or­phan dis­ease-fo­cused strat­e­gy, the biotech is an­gling for an IPO worth at least $86 mil­lion.

Jonathan Mow

The main draw re­mains PB2452, a re­ver­sal agent for the blood thin­ner Bril­in­ta (tica­grelor) for use in acute sit­u­a­tions where pa­tients are ex­pe­ri­enc­ing ac­tive bleed­ing or re­quire ur­gent surgery. Phase­Bio li­censed the drug — al­so known as an an­ti-an­ti-co­ag­u­lant — late last year from Med­Im­mune with­out dis­clos­ing the terms; we now know the deal is heav­i­ly back-end­ed with an up­front fee of on­ly $100,000 and $68 mil­lion in to­tal po­ten­tial mile­stones.

Med­Im­mune, the bi­o­log­ics arm of As­traZeneca (which mar­kets Bril­in­ta), al­so owns 5% of the stock, sec­ond on­ly to New En­ter­prise As­so­ci­ates. Oth­er ma­jor share­hold­ers in­clude Hat­teras Ven­ture Part­ners, John­son & John­son In­no­va­tion – JJDC, Fletch­er Spaght Ven­tures, and board chair­man Clay Thorp.

Though the drug has on­ly just gone through Phase I, Phase­Bio in­tends to hus­tle through a dose-find­ing Phase IIa and be­gin a larg­er Phase II tri­al in the sec­ond half of 2019 with mon­ey from the pub­lic raise.

“PB2452 can be de­vel­oped in a much short­er time pe­ri­od, and it will pay for us to de­vel­op PB1046,” their in-house as­set for pul­monary ar­te­r­i­al hy­per­ten­sion, CEO Jonathan Mow told me in a re­cent in­ter­view. “So even though it’s on­ly in Phase I, we will get to the lat­er stages of de­vel­op­ment much more quick­ly than we will with PB1046.”

Com­pared to PB2452, PB1046 strikes clos­er to Phase­Bio’s roots — it’s been in the pipeline for some time, and is based on the “elastin-like polypep­tides” plat­form tech that the com­pa­ny was found­ed on. The ther­a­peu­tic fu­sion pro­teins cre­at­ed on this plat­form un­der­go a ful­ly re­versible phase tran­si­tion — there­by sig­nif­i­cant­ly ex­tend­ing their half lives. That al­lows for PB1046 to be dosed once-week­ly, an ex­tra ad­van­tage com­bined with its nov­el mech­a­nism of ac­tion that Mow be­lieves would give it a shot in the com­pet­i­tive PAH mar­ket.

Pro­ceeds from the IPO would al­so pay for Phase­Bio to ex­plore ad­di­tion­al in­di­ca­tions for PB1046, which is cur­rent­ly in Phase II, as well as “de­vel­op­ment of our ELP tech­nol­o­gy and pre­clin­i­cal pro­grams.”

It would be a siz­able in­fu­sion of cash for the com­pa­ny, which un­til three months ago had on­ly $8.7 mil­lion in the bank.

The Malvern, PA-based biotech plans to list un­der the sym­bol $PHAS.

Regeneron CEO Leonard Schleifer speaks at a meeting with President Donald Trump, members of the Coronavirus Task Force, and pharmaceutical executives in the Cabinet Room of the White House (AP Photo/Andrew Harnik)

OWS shifts spot­light to drugs to fight Covid-19, hand­ing Re­gen­eron $450M to be­gin large scale man­u­fac­tur­ing in the US

The US government is on a spending spree. And after committing billions to vaccines defense operations are now doling out more of the big bucks through Operation Warp Speed to back a rapid flip of a drug into the market to stop Covid-19 from ravaging patients — possibly inside of 2 months.

The beneficiary this morning is Regeneron, the big biotech engaged in a frenzied race to develop an antibody cocktail called REGN-COV2 that just started a late-stage program to prove its worth in fighting the virus. BARDA and the Department of Defense are awarding Regeneron a $450 million contract to cover bulk delivery of the cocktail starting as early as late summer, with money added for fill/finish and storage activities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Andrew Kruegel, Kures president and co-founder (Columbia Tech Ventures via Vimeo)

Af­ter psilo­cy­bin and ke­t­a­mine, a new biotech comes along de­vel­op­ing a drug Scott Got­tlieb fought

Andrew Kruegel was six years into his chemistry work at Columbia University, when, one day in August 2016, he learned he might have only 30 days before the government made him destroy his research.

Kruegel had been studying kratom, a leaf long used in Southeast Asia as a stimulant or for pain. It had opioid-like properties, he found, but seemed to offer pain relief without the addictive potential or respiratory side effects of traditional opioids — a riddle that might help illuminate how human opioid receptors work.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Bio­gen shares spike as ex­ecs com­plete a de­layed pitch for their con­tro­ver­sial Alzheimer's drug — the next move be­longs to the FDA

Biogen is stepping out onto the high wire today, reporting that the team working on the controversial Alzheimer’s drug aducanumab has now completed their submission to the FDA. And they want the agency to bless it with a priority review that would cut the agency’s decision-making time to a mere 6 months.

The news drove a 10% spike in Biogen’s stock $BIIB ahead of the bell.

Part of that spike can be attributed to a relief rally. Biogen execs rattled backers and a host of analysts earlier in the year when they unexpectedly delayed their filing to the third quarter. That delay provoked all manner of speculation after CEO Michel Vounatsos and R&D chief Al Sandrock failed to persuade influential observers that the pandemic and other factors had slowed the timeline for filing. Actually making the pitch at least satisfies skeptics that the FDA was not likely pushing back as Biogen was pushing in. From the start, Biogen execs claimed that they were doing everything in cooperation with the FDA, saying that regulators had signaled their interest in reviewing the submission.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

The home run count: The $100M+ mega-round boom in biotech in­spired a $7.3B feed­ing fren­zy — so far this year

Over the last 6 months there’s been a blizzard of money piling up drifts of the green stuff through the biotech landscape. And the forecast calls for more cash windfalls ahead.

Even as a global pandemic has killed more than half a million people, blighted economies and divided nations over the proper response, it’s also helped ignite an unprecedented burst of big-time investing. And not just in Covid-19 deals, as we’ve looked at before.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Nello Mainolfi (Kymera via YouTube)

Out to re­vive R&D, a resur­gent Sanofi pays $150M cash to part­ner up with a pi­o­neer­ing pro­tein degra­da­tion play­er

Frank Nestle was appointed Sanofi’s global head of immunology and inflammation research therapeutic area just days before dupilumab, the blockbuster-to-be IL-4 antibody, would be accepted for priority review. After four years of consolidating immunology expertise from multiple corners of the Sanofi family and recruiting new talents to build the discovery engine, he’s set eyes on a Phase I-ready program that he believes can grow into a Dupixent-sized franchise.

Atul Deshpande, Harbour BioMed chief strategy officer & head, US operations (Harbour BioMed)

An­oth­er biotech IPO set-up? Multi­na­tion­al biotech leaps from round to round, scoop­ing up cash at a blis­ter­ing pace

A short four months after announcing a $75 million haul in Series B+ fundraising, the multinational biotech Harbour BioMed pulled in another round of investments and eclipsed the nine-digit mark in the process.

Harbour completed its Series C financing, the company announced Thursday morning, raising $102.8 million and bringing its total investment sum to over $300 million since its founding in late 2016. The biotech plans to use the money to transition early-stage candidates from the discovery phase, fund candidates already in the clinic, and prep late-stage candidates for commercialization.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

Covid-19 roundup: CDC de­bat­ing who should get first avail­able vac­cines; EU in Gilead talks af­ter US gob­bled first remde­sivir dos­es

The federal government has now spent billions of dollars accelerating the development of a Covid-19 vaccine, and yet they’ve remained hush-hush on who, precisely, would actually get inoculated once the first doses are approved and available. Internally, though, they have been debating it.

The CDC and an advisory committee of outside health experts have been working since April to devise a ranking system that would determine who receives a vaccine and when, The New York Times reported. The question of who is first in line for inoculation is important because no matter how many doses developers can make or how quickly they can make them, doses will still come out in batches; 300 million inoculations will not appear overnight.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.

For­bion spot­lights late-stage plays, carves out new €250M growth fund

Having staked its rep on picking out a mix of biotech investment opportunities across the “build,” “enable,” “growth” continuum, Forbion is launching its first fund dedicated to late-stage opportunities.

Forbion Growth Opportunities Fund’s first close brought in €185 million ($208 million). Existing investors Pantheon, KfW Capital and the European Investment Fund came on board, joined by new backers Eli Lilly, Horizon Therapeutics, Belgian Growth Fund and New Waves Investments.

Mer­ck ex­pands scope of Zymeworks an­ti­body al­liance, adding close to $900M in mile­stones

Nearly a decade after first partnering with Merck, Vancouver-based biotech Zymeworks has expanded its collaboration with the pharma giant once again.

Zymeworks re-upped with Merck in a new licensing agreement, granting the New Jersey pharma giant the right to develop up to 3 additional multispecific antibody candidates. In exchange, the biotech will receive an undisclosed upfront payment — Merck is always loath to discuss cash terms — and nearly $900 million in combined regulatory ($411 million) and commercial ($480 million) milestones.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 84,800+ biopharma pros reading Endpoints daily — and it's free.