Hans Schambye, Galecto CEO

Not two weeks af­ter clos­ing a Se­ries D round, Galec­to files for $100M IPO

Galec­to Biotech is piv­ot­ing to the pub­lic mar­ket less than two weeks af­ter com­plet­ing a $64 mil­lion Se­ries D round.

The Copen­hagen-based com­pa­ny filed its S-1 pa­per­work Wednes­day, seek­ing to raise $100 mil­lion in its IPO. If they hit that bench­mark, the com­pa­ny will have to­taled over $250 mil­lion in fi­nanc­ing in the last two years, ever since clos­ing a $90 mil­lion Se­ries C back in 2018.

Through late Au­gust, the biotech in­dus­try had raised a com­bined $11 bil­lion-plus across four dozen IPOs, per in­de­pen­dent an­a­lyst Brad Lon­car, which sur­passed the amount from all of 2019.

And af­ter four IPOs went pub­lic two Fri­days ago, Nas­daq’s head of health­care list­ings Jor­dan Saxe had the 2020 tal­ly at 56. Through Sept. 25, Saxe pegged the com­bined in­dus­try raise at $11.3 bil­lion.

Saxe’s tal­ly al­so matched Lon­car’s to­tal from 2018, mak­ing 2020 tied for the most biotech IPOs seen in any of the last four years. Sev­er­al fac­tors have con­tributed to the boom, Saxe said at the time, no­tably with the Covid-19 pan­dem­ic high­light­ing an al­ready-im­pres­sive amount of in­no­va­tion in the field.

There’s al­so been a steady in­crease of crossover in­vestors from the last few years, and with the pan­dem­ic econ­o­my, the fact that biotechs can pro­vide longer-term in­vest­ments than com­pa­nies re­liant on quar­ter-to-quar­ter sales num­bers makes the in­dus­try more ap­peal­ing.

Galec­to it­self fo­cus­es its re­search on a wide range of fi­brot­ic dis­eases, and its lead pro­gram GB0139 is cur­rent­ly in a Phase IIb tri­al for id­io­path­ic pul­monary fi­bro­sis. Much of the Se­ries D fund­ing is help­ing get that tri­al across the fin­ish line, with the com­pa­ny con­tin­u­ing its 450-pa­tient en­roll­ment de­spite the pan­dem­ic.

GB0139 is an in­haled galectin-3 in­hibitor with what CEO Hans Scham­bye said is a de­liv­ery sys­tem de­signed to max­i­mize drug ex­po­sure to the lung and min­i­mize sys­temic side ef­fects. The Galec­to can­di­date is hop­ing to com­pete with two oth­er drugs in the field, Boehringer’s Ofev and Roche’s Es­bri­et.

New fund­ing from the IPO will go to­ward ad­vanc­ing GB0139 in­to a Phase III IPF tri­al, ac­cord­ing to the S-1, though Galec­to did not spec­i­fy how much of its raise it’s ded­i­cat­ing to that cause. It’s al­so not en­tire­ly clear when the Phase III will start giv­en that da­ta are ex­pect­ed for the Phase IIb study by the mid­dle of 2022.

Galec­to is ad­di­tion­al­ly aim­ing to in­hib­it galectin-3 in fi­bro­sis re­lat­ed to NASH with its GB1211 pro­gram, an oral­ly de­liv­ered can­di­date. The can­di­date com­plet­ed a Phase I tri­al in 78 pa­tients, with a Phase IIa ex­pect­ed to be­gin in ear­ly 2021. Fur­ther down the pipeline is GB2064, a LOXL2 in­hibitor be­ing stud­ied in myelofi­bro­sis.

MedTech clinical trials require a unique regulatory and study design approach and so engaging a highly experienced CRO to ensure compliance and accurate data across all stages is critical to development milestones.

In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.

His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; 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.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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Seagen interim CEO Roger Dansey and Daiichi Sankyo CEO Sunao Manabe

Paving the way for Mer­ck­'s buy­out, Seagen los­es ar­bi­tra­tion dis­pute with Dai­ichi over ADC tech

As Seagen awaits a final buyout offer from Merck that could be in the territory of $40 billion, Seagen revealed Friday afternoon that it lost an arbitration dispute with Daiichi Sankyo relating to the companies’ 2008 collaboration around the use of antibody-drug conjugate (ADC) technology.

But that loss likely won’t matter much when it comes to Merck’s deal.

After breaking off its pact with Daiichi in mid-2015, the two companies battled over “linker” tech — a chemical bridge between an ADC’s antibody component and the cytotoxic payload — that Seagen claims Daiichi would improve upon and implement in its current generation of ADCs.

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Tony Coles, Cerevel CEO

Cerev­el takes the pub­lic of­fer­ing route, with a twist — rais­ing big mon­ey thanks to ri­val da­ta

As public biotechs seek to climb out of the bear market, a popular strategy to raise cash has been through public offerings on the heels of positive data. But one proposed raise Wednesday appeared to take advantage not of a company’s own data, but those from a competitor.

Cerevel Therapeutics plans to raise $250 million in a public offering and another $250 million in debt, the biotech announced Wednesday afternoon, even though it did not report any news on its pipeline. However, the move comes days after rival Karuna Therapeutics touted positive Phase III data in schizophrenia, a field where Cerevel is pursuing a similar program.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

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Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.