Andrew Allen, Gritstone bio CEO (Gritstone via website)

Up­dat­ed: Grit­stone goes the cred­it fa­cil­i­ty route, se­cur­ing $80M to keep clin­i­cal ef­forts run­ning

A Cal­i­for­nia de­vel­op­er is fol­low­ing up on one of the hottest trends in biotech, tak­ing out a loan to ex­tend its op­er­at­ing run­way while the biotech sec­tor takes a beat­ing on Nas­daq.

Vac­cine out­fit Grit­stone bio put out word Thurs­day that it en­tered in­to an $80 mil­lion cred­it fa­cil­i­ty with Her­cules Cap­i­tal and Sil­i­con Val­ley Bank. The fa­cil­i­ty, a type of loan, breaks down in the fol­low­ing: $20 mil­lion drawn by Grit­stone at clos­ing, with an­oth­er $10 mil­lion avail­able to with­draw by March 15, 2023. The re­main­ing $50 mil­lion will be­come avail­able in tranch­es through June 15, 2024 as Grit­stone achieves cer­tain, un­spec­i­fied mile­stones.

Celia Econo­mides

Grit­stone CFO Celia Econo­mides tells End­points News that part of the rea­son the com­pa­ny went down the cred­it fa­cil­i­ty route was for flex­i­bil­i­ty’s sake. “It does en­able us a lot of flex­i­bil­i­ty to just con­tin­ue ex­e­cut­ing — not have to wor­ry about the stock price, not have to wor­ry about how the mar­ket might re­act on po­ten­tial cat­a­lysts that we have com­ing up,” Econo­mides said.

She added that the com­pa­ny is look­ing at the “ap­pro­pri­ate cap­i­tal con­ser­va­tion mea­sures,” iden­ti­fy­ing costs and spend­ing or­ga­ni­za­tion-wide and fig­ur­ing out what needs to be pri­or­i­tized.

As for run­way, the com­pa­ny is hold­ing back some of the de­tails un­til af­ter the com­pa­ny’s Q2 earn­ings call in a cou­ple of weeks. But Econo­mides said that it is enough cap­i­tal to get the biotech through com­pa­ny mile­stones over the next 18 months.

Found­ed in 2015, the biotech once known as Grit­stone On­col­o­gy launched with a $102 mil­lion megaround co-led by Ver­sant and was orig­i­nal­ly fo­cused on a neoanti­gen ap­proach. The com­pa­ny then went pub­lic in 2018, rais­ing $100 mil­lion. At the out­set of the Covid-19 pan­dem­ic, the biotech tout­ed some in­ves­ti­ga­to­ry work in Covid-19 vac­cines, which bal­looned the com­pa­ny’s share price to over $27 a share by Jan­u­ary 2021.

To­day, the Nas­daq opened with $GRTS at $2.87 a share — a drop of 78% year-to-date.

Grit­stone’s co-founder and CEO, An­drew Allen, said in a re­lease that the biotech ex­pects sev­er­al da­ta read­outs over the next 18 months, with the soon­est read­out com­ing on the com­pa­ny’s SLATE-KRAS prod­uct can­di­date, slat­ed for lat­er in Q3.

“Es­tab­lish­ing this fa­cil­i­ty re­duces our de­pen­dence on the cap­i­tal mar­kets and en­ables us to fo­cus on ex­e­cut­ing against our clin­i­cal, op­er­a­tional, and strate­gic goals,” Allen added.

Oth­er can­di­dates in Grit­stone’s pipeline in­clude a can­di­date for HIV, part­nered pro­grams for Covid-19 and oth­er on­col­o­gy in­di­ca­tions such as col­orec­tal can­cer.

The biotech added in its an­nounce­ment Thurs­day that it will di­vulge more in­for­ma­tion about the cred­it fa­cil­i­ty in an up­com­ing SEC fil­ing. The biotech’s most re­cent quar­ter­ly fil­ing for Q1 this year point­ed out that it has $192.5 mil­lion in cur­rent as­sets, in­clud­ing cash and se­cu­ri­ties.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP)

Can a smart­phone app de­tect Covid? Pfiz­er throws down $116M to find out

What can a cough say about a patient’s illness? Quite a bit, according to ResApp Health — and Pfizer’s listening.

The pharma giant is shelling out about $116 million ($179 million AUD) to scoop up the University of Queensland spinout and its smartphone technology that promises to diagnose Covid and other respiratory illnesses based on cough and breathing sounds, the university announced last week.

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Big Phar­ma heavy­weights seek tweaks to FDA's clin­i­cal out­come as­sess­ment guid­ance

Pfizer, GSK, Janssen, Regeneron, Boehringer Ingelheim and at least a half dozen other companies are calling on the FDA to provide significantly more clarity in its draft guidance from this summer on clinical outcome assessments, which are a type of patient experience.

The draft is the third in a series of four patient-focused drug development guidance documents that the FDA had to create as part of the 21st Century Cures Act, and they describe how stakeholders (patients, caregivers, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information for medical product development and regulatory decision-making.

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Rob Etherington, Clene CEO

Star­tup's gold nanocrys­tal ALS drug flops a PhII tri­al, a re­minder of the dis­ease's ob­sta­cles de­spite Amy­lyx OK

Despite the FDA approving an ALS drug for the first time in five years last week, the disease continues to fluster researchers, and another biotech is feeling the pain of a mid-stage failure.

Clene Nanomedicine reported early Monday that its ALS program, which uses gold nanocrystals to try to catalyze intracellular reactions, did not achieve its Phase II primary or secondary endpoints. And in a press release, the company noted for the first time that it’s speaking with “potential strategic partners” about the program — language that typically indicates a biotech is preparing to sell off an asset.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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An­oth­er warn­ing let­ter for Lupin as FDA iden­ti­fies de­fi­cien­cies at In­dia-based site

With few new details of what needs fixing, Lupin disclosed last week that the FDA recently sent a warning letter to its Tarapur, India-based site.

After an inspection from March 22 to April 4, Lupin disclosed in an April stock filing that it received a Form 483 with four observations, but it didn’t offer any details on the observations.

Similar to comments made in April, the company said last week it does not believe the FDA slap will disrupt its drug supplies or the existing revenues from operations of this facility.

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