Eye­ing $86M, Galera leads a pack of three mod­est biotech IPOs push­ing past high pro­file stum­bles

Ex­act­ly one year af­ter kick­ing off a piv­otal Phase III study for its lead drug — a com­pan­ion for can­cer pa­tients re­ceiv­ing ra­dio­ther­a­py — Galera is look­ing to the Nas­daq for some new cash to com­plete the clin­i­cal work and fu­el its com­mer­cial dri­ve.

CEO Mel Sorensen has pen­ciled in an $86 mil­lion ask, which was filed on the same day as liv­er dis­ease com­pa­ny 89bio and rare dis­ease di­ag­nos­tics shop Cen­to­gene. The trio marks the first batch of IPO fil­ings in the wake of two high­ly an­tic­i­pat­ed but ul­ti­mate­ly dis­ap­point­ing pub­lic de­buts by BioN­Tech and Vir, sig­nal­ing dwin­dling biotech fer­vor on Wall Street. 89bio and Cen­to­gene are seek­ing $70 mil­lion and $69 mil­lion, re­spec­tive­ly.

Galera’s pitch is cen­tered square­ly around GC4419, a mimet­ic drug of the nat­u­ral­ly oc­cur­ring en­zyme su­per­ox­ide dis­mu­tase. By spurring the con­ver­sion of ex­cess su­per­ox­ide— which ac­cu­mu­lates quick­ly un­der ra­di­a­tion — in­to hy­dro­gen per­ox­ide, the biotech be­lieves it can al­le­vi­ate se­vere oral mu­cosi­tis, an un­pleas­ant side ef­fect char­ac­ter­ized by in­flam­ma­tion and ul­cer­a­tion of the mu­cous mem­brane lin­ing the di­ges­tive tract. Not on­ly that, but the hy­dro­gen per­ox­ide will help kill can­cer cells.

The first in­di­ca­tion they are aim­ing at is lo­cal­ly ad­vanced head and neck can­cer, and a 365-pa­tient Phase III tri­al is un­der­way. A sec­ond pro­gram for esophagi­tis, pri­mar­i­ly tar­get­ing pa­tients with tho­racic tu­mors or lung can­cer, will al­so ben­e­fit from the IPO, as will an­oth­er sim­i­lar drug primed for in­creas­ing the po­ten­cy of stereo­tac­tic body ra­di­a­tion ther­a­py.

That first Phase III was launched with the help of a whop­ping $150 mil­lion fundraise last Sep­tem­ber, in­clud­ing $70 mil­lion in Se­ries C cash and an $80 mil­lion roy­al­ty agree­ment with what is now known as Black­stone Life Sci­ences. It end­ed up with 7.4% of the stock $GRTX, the least among the group of well-heeled ma­jor in­vestors in­clud­ing NEA (20.4%), No­var­tis (17.0%), No­vo (15%) and Sofinno­va (12.2%).

Un­der the deal with Black­stone, it had agreed to build and train a sales force of around 40 reps in the US, Galera wrote in the S-1.

Sorensen, who took over as CEO from founder Robert Beard­s­ley in 2012, took home a com­pen­sa­tion worth $521,624 last year. COO Beard­s­ley’s pack­age came close at $423,405, while CBO Arthur Fratam­i­co and CMO Jon Holm­lund were both en­ti­tled to slight­ly more than $400,000.

89Bio, mean­while, has leapt di­rect­ly from Se­ries A to the pub­lic mar­kets just one year af­ter emerg­ing out of Or­biMed’s cra­dle. The lead prod­uct can­di­date is an FGF21 ana­log carved out of Te­va’s pipeline, now with hu­man da­ta from healthy vol­un­teers to boast.

De­ploy­ing FGF21 to tack­le NASH — a red hot field of its own — isn’t a new con­cept, but 89Bio be­lieves its gly­coP­E­Gy­la­tion meth­ods can stand out due to bet­ter tol­er­a­bil­i­ty and dura­bil­i­ty.

With the new cash in­fu­sion, the com­pa­ny $ETNB aims to wrap up an on­go­ing Phase Ib/IIa tri­al whose topline da­ta are ex­pect­ed in the sec­ond half of 2020, while al­so fund­ing a Phase II in se­vere hy­per­triglyc­eridemia.

Or­biMed con­tin­ues to con­trol the largest chunk of eq­ui­ty at 41.2%, while Lon­gi­tude Ven­ture Part­ners claims 24.9%, RA Cap­i­tal gets 21.6% and Pon­tif­ax has 11.5%.

For the busy year, CEO Ro­han Palekar nabbed a com­pen­sa­tion pack­age worth $708,161 while Ram Wais­bourd got $318,002 for dou­bling as CBO and COO.

Cen­to­gene $CNTG, a Ger­man out­fit, is ded­i­cat­ing its pro­ceeds to de­vel­op­ing new bio­mark­ers and dou­bling down out­reach to po­ten­tial phar­ma part­ners, in ad­di­tion to ex­pand­ing its tech plat­form.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

No­var­tis is ax­ing 150 ear­ly dis­cov­ery jobs as CNI­BR shifts fo­cus to the de­vel­op­ment side of R&D

Novartis is axing some 150 early discover jobs in Shanghai as it swells its staff on the drug development side of the equation in China. And the company is concurrently beefing up its investment in China’s fast-growing biotech sector with a plan to add to its investments in local VCs.

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Democratic presidential candidate, U.S. Sen. Elizabeth Warren (D-MA) speaks during the Nevada Democrats' "First in the West" event at Bellagio Resort & Casino on November 17, 2019 in Las Vegas, Nevada (Getty Images)

Eliz­a­beth War­ren pro­pos­es us­ing com­pul­so­ry li­cens­ing, an­titrust ac­tions to break bio­phar­ma’s con­trol of drug pric­ing — and here are the block­busters she’s tar­get­ing first

Nancy Pelosi’s drug pricing bill may have sparked some industrial strength headaches on the money side of biopharma, but Elizabeth Warren seems determined to become biopharma’s Nightmare on Pennsylvania Avenue.
Warren, one of the top-ranked candidates for the Democratic presidential nomination backing Medicare for all, is circulating a new plan that promises to break the industry’s grip on drug prices — and she has some very specific examples of how she would do it.
The Warren plan would rely on the federal government’s compulsory licensing powers to seize the IP of blockbuster drugs like Truvada and Harvoni to provide them at a fraction of what Gilead sells them for in the US. And she would throw some antitrust actions in as needed to rein in the price of Humira, AbbVie’s cash cow that continues to dominate the list of the most profitable therapeutics on the market.
Notably, she plans to rely on the powers already vested in the federal government, rather than suggest remedies that would require the assent of a deeply divided Congress.
In addition to the blockbusters on the list, Warren sends a clear signal that the same tactics would be used to beef up the supply of cheap antibiotics, as needed. And the same action could befall any other therapy patients can’t afford.

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Mer­ck’s $1B cash gam­ble pays off with a sur­pris­ing PhI­II car­dio suc­cess for Bay­er’s heart drug veri­ciguat

More than 3 years after Merck stepped up and paid $1 billion in cold, hard cash to gain the US commercial rights to Bayer’s high-risk heart drug vericiguat in a broad-ranging cardio alliance, the partners say their Phase III study has come through with promising data and a date with regulators.
We don’t have the data, and won’t until they put it out at an upcoming scientific session, but Merck touted the results, saying that their big Phase III VICTORIA study hit the primary endpoint  — with vericiguat combined with available therapies reducing “the risk of the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF) compared to placebo when given in combination with available heart failure therapies.”
Depending on the hard data, and how it breaks out with the combinations used, this drug could pose a threat to Novartis’ blockbuster drug Entresto, currently at $1.6 billion while analysts expect peak sales to hit $4 billion.
The drug is a soluble guanylate cyclase (sGC) stimulator, which Bayer and Merck have had high hopes for. Evidently, so did cardiologists. Cowen’s last analysis set potential sales at $400 million in 2024, but that number could go up significantly now.
Cowen’s Steve Scala noted this morning:
Vericiguat could be a lucrative product for Merck, and one with potentially under-appreciated value. At Cowen’s Therapeutics Conference in September 2019, 80% of specialists anticipated a positive result from VICTORIA whereas only 51% of investors shared this optimism.
Investigators recruited more than 5,000 patients at more than 600 centers in 42 countries for this study — one of the most expensive propositions in R&D. Millions of people in the US suffer from heart failure with reduced ejection fraction when the failing heart fails to contract properly to eject blood into the system. Bayer holds ex-US rights to the drug and also stands to earn cash from the $1.1 billion in milestones Merck agreed on for their collaboration.
Remarkably, the drug was pushed into Phase III despite failing the mid-stage trial — though investigators flagged a success at the high dose of 10 mg. In VICTORIA, researchers started patients at 2.5 mg and then titrated up to 5 and then 10 mg.

Alk­er­mes forges $950M biotech buy­out deal in a bold bet on an ear­ly-stage CNS drug plat­form

Alkermes $ALKS is investing $100 million cash and committing up to $850 million more in milestones in a big wager on a very early-stage CNS discovery platform. And the biotech is adding $20 million more to fund next year’s new research work on the platform it’s acquiring in today’s buyout with an eye to expanding the research work in oncology.

The biotech, helmed by Richard Pops, is buying Rodin Therapeutics, which had focused early on Alzheimer’s disease. Pops’ buyout, though, isn’t focused solely on the most troublesome sector in pharma R&D.

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(Image: Associated Press)

Amarin emerges from an ex­pert pan­el re­view with a clear en­dorse­ment for Vas­cepa and high odds of suc­cess when the FDA weighs in for­mal­ly

Several FDA experts who gathered Thursday to consider the landmark approval of Vascepa to reduce cardio events in an at-risk population voiced their unease about various aspects of the efficacy and safety data, or ultimately the population it should be used to treat. But the overwhelming belief that the data pointed to the drug’s benefit and clearly outweighed risks carried the day for Amarin.

The panel voted unanimously (16 to 0) to support the company’s positive data presentation — backing an OK for expanding the label to include reducing cardio risk. The vote points Amarin $AMRN down a short path to a formal decision by the FDA, with the odds heavily in its favor. Chances are the rest of the questions about the future of this drug will be hashed out in the label’s small print.

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Left to right: Arthur Pappas, Robert Nelsen, Peter Kolchinsky Doug Cole and David Beier

In rare po­lit­i­cal for­ay, top biotech in­vestors urge Con­gress to re­ject drug pric­ing bill

Thirteen of the top biotech venture capitalists in the country wrote a letter last week warning lawmakers that if Congress passes a drug pricing bill House Speaker Nancy Pelosi has put before lawmakers, they won’t be able to invest in biomedical research at their current rate, and patients will suffer.

“If policies such as those included within H.R. 3, the Lower Drug Costs Now Act, are passed, our ability to continue to invest in future biomedical innovation will be severely constrained, thus crushing the hopes of millions of patient waiting for the next breakthroughs to treat or cure their cancers, rare genetic diseases, Alzheimer’s, or other serious and life-threatening conditions,” they wrote in a letter addressed to the highest-ranking Democrats and Republicans in the House and Senate and acquired by Endpoints News. 

Dicer­na scores broad, 'rest of liv­er' deal with No­vo Nordisk, bag­ging $225M in cash to hit some 30 tar­gets with RNAi plat­form

Turns out Dicerna wasn’t done with deals yet after locking in $200 million upfront from Roche for a hepatitis B cocktail two weeks ago.

Novo Nordisk has signed on as the latest partner to its GalXC RNAi platform, handing over $175 million in cash to claim any and all targets of interest in liver-related cardio-metabolic diseases that are not already reserved in previous pacts. The Danish drugmaker — which has signaled its interest to expand considerably beyond its core diabetes franchise into areas like NASH — is also purchasing $50 million worth of Dicerna’s equity at a 25% premium of $21.93 per share. More research payments and milestones extending to the billions are on the line.

Gene ther­a­py wins the in­side track at EMA; PPD files for IPO

→ Gene therapy maker Orchard Therapeutics has been granted an accelerated assessment for OTL-200 by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The gene therapy — in development in partnership with the San Raffaele-Telethon Institute for Gene Therapy (SR-Tiget) in Milan, Italy — being used towards the treatment of metachromatic leukodystrophy.

→ Pharmaceutical Product Development has announced that its parent company, PPD, Inc has submitted a draft to the SEC relating to the proposal of an IPO of the parent company’s common stock. Number of shares and price range have not yet been determined.