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.

2023 Spot­light on the Fu­ture of Drug De­vel­op­ment for Small and Mid-Sized Biotechs

In the context of today’s global economic environment, there is an increasing need to work smarter, faster and leaner across all facets of the life sciences industry.  This is particularly true for small and mid-sized biotech companies, many of which are facing declining valuations and competing for increasingly limited funding to propel their science forward.  It is important to recognize that within this framework, many of these smaller companies already find themselves resource-challenged to design and manage clinical studies themselves because they don’t have large teams or in-house experts in navigating the various aspects of the drug development journey. This can be particularly challenging for the most complex and difficult to treat diseases where no previous pathway exists and patients are urgently awaiting breakthroughs.

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Rick Modi, Affinia Therapeutics CEO

Ver­tex-part­nered gene ther­a­py biotech Affinia scraps IPO plans

Affinia Therapeutics has ditched its plans to go public in a relatively closed-door market that has not favored Nasdaq debuts for the drug development industry most of this year. A pandemic surge in 2020 and 2021 opened the doors for many preclinical startups, which caught Affinia’s attention and gave the gene therapy biotech confidence in the beginning days of 2022 to send in its S-1.

But on Friday, Affinia threw in the S-1 towel and concluded now is not the time to step onto Wall Street. The biotech has put out few public announcements since the spring of this year. Endpoints News picked the startup as one of its 11 biotechs to watch last year.

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Albert Bourla, Pfizer CEO (Efren Landaos/Sipa USA/Sipa via AP Images)

Pfiz­er makes an­oth­er bil­lion-dol­lar in­vest­ment in Eu­rope and ex­pands again in Michi­gan

Pfizer is continuing its run of manufacturing site expansions with two new large investments in the US and Europe.

The New York-based pharma giant’s site in Kalamazoo, MI, has seen a lot of attention over the past year. As a major piece of the manufacturing network for Covid-19 vaccines and antivirals, Pfizer is gearing up to place more money into the site. Pfizer announced it will place $750 million into the facility, mainly to establish “modular aseptic processing” (MAP) production and create around 300 jobs at the site.

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Vas Narasimhan, Novartis CEO (Thibault Camus/AP Images, Pool)

No­var­tis bol­sters Plu­vic­to's case in prostate can­cer with PhI­II re­sults

The prognosis is poor for metastatic castration-resistant prostate cancer (mCRPC) patients. Novartis wants to change that by making its recently approved Pluvicto available to patients earlier in their course of treatment.

The Swiss pharma giant unveiled Phase III results Monday suggesting that Pluvicto was able to halt disease progression in certain prostate cancer patients when administered after androgen-receptor pathway inhibitor (ARPI) therapy, but without prior taxane-based chemotherapy. The drug is currently approved for patients after they’ve received both ARPI and chemo.

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Pfiz­er-backed Me­di­ar Ther­a­peu­tics ropes in an­oth­er Big Phar­ma in­vestor

A biotech centered on treating fibrosis — born out of Mass General and Brigham and Women’s Hospital — has received a financial boost.

According to an SEC filing, the company has raised $31,761,186 in its latest funding round, which includes 17 investors. The filing lists six names attached to the company, including Meredith Fisher, a partner at Mass General Brigham Ventures and Mediar’s acting CEO.

Ken Greenberg, SonoThera CEO

Gene ther­a­py goes acoustic as ARCH-backed biotech launch­es with ul­tra­sound gene de­liv­ery plat­form

After co-founding two biotechs off virus-based therapies, one for pain and one for cancer, Ken Greenberg decided to go in a different direction for his newest biotech, SonoThera.

Based out of San Francisco, SonoThera announced Monday morning that it raised $60.75 million to develop new gene therapies — but delivered by ultrasound, which Greenberg says can address the major challenges facing more conventional viral gene therapies.

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Af­ter M&A fell through, Ther­a­peu­tic­sMD sells hor­mone ther­a­py, con­tra­cep­tive ring for $140M cash plus roy­al­ties

TherapeuticsMD, a women’s health company whose one-time billion-dollar valuation seems a distant memory as its blockbuster aspirations petered out, is finally cashing out.

Australia’s Mayne Pharma is paying $140 million upfront to license essentially TherapeuticsMD’s whole portfolio, including two prescription drugs that treat conditions relating to menopause, a contraceptive vaginal ring as well as its prescription prenatal vitamin brands.

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Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

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