From L-R: Luigi Naldini, Genenta CEO Pierluigi Paracchi and Genenta CMO Carlo Russo

Genen­ta is at­tempt­ing a rare biotech leap from Mi­lan to Wall Street

Pier­lui­gi Parac­chi, CEO and one of the trio of lead­ers run­ning gene ther­a­py biotech Genen­ta, has fre­quent­ly lament­ed the ab­sence of Ital­ian biotechs on Nas­daq. And now, he’s tak­ing his Mi­lan-based com­pa­ny and jump­ing out in front of what he hopes some­day will be a pack of biotechs go­ing pub­lic in the US.

The Ital­ian biotech has been busy re­cent­ly with Phase I/II tri­als on their in­ves­ti­ga­tion­al glioblas­toma can­di­date Tem­fer­on — and it’s look­ing to ex­pand with an IPO. The six-year-old small biotech, found­ed out of the renowned San Raf­faele Hos­pi­tal in Mi­lan — led by a biotech ex­ec­u­tive, a not­ed aca­d­e­m­ic and a physi­cian — filed a Form F-1 with the SEC on Tues­day, pen­cil­ing in a planned raise of $35 mil­lion, though that’s been known to change in the lead­up to the flip on­to Wall Street.

Genen­ta has not raised a ton of mon­ey com­pared to oth­er biotechs — un­like some firms that will raise hun­dreds of mil­lions of dol­lars over mul­ti­ple rounds, Genen­ta raised just un­der $38.6 mil­lion in three rounds.

And ac­cord­ing to the F-1, they plan to keep that trend go­ing.

So what is the mon­ey go­ing to? The F-1 said $25.3 mil­lion to fin­ish up the cur­rent Tem­fer­on study, start up a Phase II study, pay for man­u­fac­tur­ing ac­tiv­i­ties, and more.

Any­thing else they raise will go to­wards the typ­i­cal: on­go­ing busi­ness de­vel­op­ment ac­tiv­i­ties, op­er­at­ing costs and “oth­er gen­er­al cor­po­rate pur­pos­es.”

To date, the com­pa­ny has been pri­vate­ly held — so who owns the com­pa­ny and who are its in­vestors?

The hos­pi­tal backer and two of the founders own a no­table chunk of the shares. CEO Parac­chi owns more than 2.2 mil­lion shares — a nice chunk at 15% of the com­pa­ny’s 15 mil­lion shares.

Sci­en­tif­ic co-founder Lui­gi Nal­di­ni — a sci­en­tist with an im­pres­sive back­ground in gene ther­a­py and the for­mer pres­i­dent of the Eu­ro­pean So­ci­ety of Gene and Cell Ther­a­py — has close to 1.4 mil­lion shares, and the Mi­lan hos­pi­tal has about 1.9 mil­lion shares — lever­ag­ing close to 36% con­trol of Genen­ta be­tween the three.

And Spafid S.p.A — an Ital­ian bank in Mi­lan — is the largest stock­hold­er with 3.4 mil­lion shares or 22%.

When Genen­ta was first found­ed in 2014, $11.4 mil­lion in shares were is­sued and pur­chased by “ac­cred­it­ed in­vestors,” ac­cord­ing to the F-1. These in­vestors in­clud­ed af­fil­i­ates of the Fer­rari fam­i­ly — and an un­named ear­ly in­vestor in Ad­vanced Ac­cel­er­a­tor Ap­pli­ca­tions, the biotech that was ac­quired by No­var­tis for just un­der $4 bil­lion in 2017.

On June 27, 2017, just over $8 mil­lion was ap­proved by share­hold­ers — and pur­chased by Ital­ian, British, and Swiss pri­vate in­vestors, fam­i­ly of­fices, and an­gel in­vestors, in­clud­ing the hold­ing com­pa­ny for the for­mer own­ers of Rot­tapharm, the Rovati fam­i­ly. Oth­er in­vestors in­clud­ed oth­er ear­ly in­vestors in AAAP and Giuseppe Vi­ta, for­mer chair­man of Scher­ing-Plough, which merged with Mer­ck back in ’09.

Af­ter this round of shares, then-head of No­var­tis in Eu­rope Gui­do Gui­di joined Genen­ta’s board as one of its di­rec­tors.

Fol­low­ing in 2019, an­oth­er close to $19 mil­lion was fur­ther ap­proved — with Chi­nese pri­vate eq­ui­ty firm Qianzhan In­vest­ment Man­age­ment tak­ing the lead. And fi­nal­ly, an­oth­er $1.7 mil­lion was is­sued last year.

In oth­er IPO news, Vaxxin­i­ty priced this morn­ing at on­ly $13 a share, un­der the ex­pect­ed $14-$16 a share. The Dal­las biotech is al­so re­leas­ing just 6 mil­lion shares for a to­tal of $78 mil­lion it’s hop­ing to raise — more than 10% un­der the ex­pect­ed 6.7 mil­lion shares.

This pric­ing re­flects how the mar­ket is get­ting more dif­fi­cult — and un­for­giv­ing — for biotechs now look­ing to make the leap from pri­vate­ly-held to pub­lic.

ZS Per­spec­tive: 3 Pre­dic­tions on the Fu­ture of Cell & Gene Ther­a­pies

The field of cell and gene therapies (C&GTs) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C&GTs that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.

Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.

Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.

Graphic: Kathy Wong for Endpoints News

What kind of biotech start­up wins a $3B syn­di­cate, woos a gallery of mar­quee sci­en­tists and re­cruits GSK's Hal Bar­ron as CEO in a stun­ner? Let Rick Klaus­ner ex­plain

It started with a question about a lifetime’s dream on a walk with tech investor Yuri Milner.

At the beginning of the great pandemic, former NCI chief and inveterate biotech entrepreneur Rick Klausner and the Facebook billionaire would traipse Los Altos Hills in Silicon Valley Saturday mornings and talk about ideas.

Milner’s question on one of those mornings on foot: “What do you want to do?”

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FDA+ roundup: FDA's neu­ro­science deputy de­parts amid on­go­ing Aduhelm in­ves­ti­ga­tions; Califf on the ropes?

Amid increased scrutiny into the close ties between FDA and Biogen prior to the controversial accelerated approval of Aduhelm, the deputy director of the FDA’s office of neuroscience has called it quits after more than two decades at the agency.

Eric Bastings will now take over as VP of development strategy at Ionis Pharmaceuticals, the company said Wednesday, where he will provide senior clinical and regulatory leadership in support of Ionis’ pipeline.

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Chamath Palihapitiya and Pablo Legorreta

Bil­lion­aires Chamath Pal­i­hapi­tiya and Pablo Legor­re­ta hatch an $825M SPAC for cell ther­a­py biotech

Three years after Royalty Pharma chief Pablo Legorreta led a group of investors to buy up a pair of biotechs and create a new startup called ProKidney, the biotech is jumping straight into an $825 million public shell created by SPAC king and tech billionaire Chamath Palihapitiya.

ProKidney was founded 6 years ago but really got going at the beginning of 2019 with the $62 million acquisition of inRegen, which was working on an autologous — from the patient — cell therapy for kidney disease. After extracting kidney cells from patients, researchers expand the cells in the lab and then inject them back into patients, aiming to restore the kidneys of patients suffering from CKD.

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Sec­ondary patents prove to be key in biosim­i­lar block­ing strate­gies, re­searchers find

While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.

Hal Barron (GSK via YouTube)

GSK R&D chief Hal Bar­ron jumps ship to run a $3B biotech start­up, Tony Wood tapped to re­place him

In a stunning switch, GlaxoSmithKline put out word early Wednesday that R&D chief Hal Barron is exiting the company after 4 years — a relatively brief run for the man chosen by CEO Emma Walmsley in late 2017 to turn around the slow-footed pharma giant.

Barron is being replaced by Tony Wood, a close associate of Barron’s who’s taking one of the top jobs in Big Pharma R&D. He’ll be closer to home, though, for GSK. Barron has been running a UK and Philadelphia-based research organization from his perch in San Francisco.

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CBO: Medicare ne­go­ti­a­tions will ham­per drug de­vel­op­ment more than pre­vi­ous­ly thought

As President Biden’s Build Back Better Act — and, with it, potentially the Democrats’ last shot at major drug pricing reforms in the foreseeable future — remains on life support, the Congressional Budget Office isn’t helping their case.

The CBO last week released a new slide deck, outlining an update to its model on how Medicare negotiations might take a bite out of new drugs making it to market. The new model estimates a 10% long-term reduction in the number of new drugs, whereas a previous CBO report from August estimated that 8% fewer new drugs will enter the market over 30 years.

Joshua Brumm, Dyne Therapeutics CEO

FDA or­ders DMD tri­al halt, rais­ing ques­tions about a whole class of promis­ing drugs

Dyne Therapeutics’ stock took a nasty hit this morning after the biotech put out word that the FDA had slapped a clinical hold on their top program for Duchenne muscular dystrophy. And now speculation is bouncing around Biotwitter that there could be a class effect at work here that would implicate other drug developers in the freeze.

Dyne execs didn’t have a whole lot to say about why the FDA sidelined their IND for DYNE-251 in DMD while “requesting additional clinical and non-clinical information for” the drug.

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CEO Lex Rovner (64x Bio)

A George Church spin­out fight­ing the vi­ral vec­tor bot­tle­neck in cell and gene ther­a­py lands $55M

A synthetic biology company spun out of George Church’s lab is set to tackle the gene therapy manufacturing bottleneck, and it just landed $55 million in a Series A financing round to do so.

64x Bio comes out of the Harvard Department of Genetics. CEO Lex Rovner and her team — which right now, sits around 10 people — are looking to tackle a key hurdle for major companies: manufacturing cell and gene therapies.