IPO mar­ket warms with Spero, Al­lena head­ing to Wall Street

Two Boston biotechs are div­ing in to a frothy IPO mar­ket this morn­ing as they head­ed to the Nas­daq to raise a com­bined $152 mil­lion.

An­tibi­otics com­pa­ny Spero Ther­a­peu­tics brought in $77 mil­lion by sell­ing 5.5 mil­lion shares at $14 each. The com­pa­ny orig­i­nal­ly hoped to raise $92 mil­lion in the of­fer­ing, ac­cord­ing to a state­ment filed with the SEC in late Oc­to­ber. Spero’s IPO was helped along with sup­port from in­sid­ers, with Spero back­ers com­mit­ting to buy 39% of its IPO ($30 mil­lion) be­fore it went live.

Spero is one of the many com­pa­nies tack­ling drug-re­sis­tant an­tibi­otics. Its ex­per­i­men­tal drug SPR741 is meant to punch up the ef­fec­tive­ness of an­tibi­otics by pen­e­trat­ing the out­er cell mem­branes of Gram-neg­a­tive bac­te­ria. The com­pa­ny al­so has a broad-spec­trum prod­uct, SPR994, in Phase I clin­i­cal tri­als. The clear ma­jor­i­ty of the cap­i­tal raised in its IPO is in­tend­ed to car­ry SPR994 through clin­i­cal tri­als, ac­cord­ing to the SEC state­ment.

The oth­er new­com­er to the mar­ket, Al­lena Ther­a­peu­tics, raised $75 mil­lion in its IPO, sell­ing 5.3 mil­lion shares at $14 apiece. That’s al­so be­low ear­li­er pre­dic­tions. Last month in an SEC fil­ing, Al­lena said it ex­pect­ed to raise $98 mil­lion at $16 per share. Al­lena share­hold­ers bagged $25 mil­lion, or about 31%, of the com­pa­ny’s to­tal of­fer­ing.

Al­lena ar­rives on Wall Street with a bit of bag­gage: two Phase II flops. Al­lena’s lead drug is ALLN-177 for hy­per­ox­aluria, which oc­curs when too much ox­alate is present in urine. The con­di­tion can dam­age the kid­neys. ALLN-177’s re­cent Phase IIb tri­al failed to demon­strate a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in uri­nary ox­alate ex­cre­tion. But the biotech claimed a suc­cess for some post-hoc analy­sis and a sec­ondary end­point: time-weight­ed av­er­age 24-hour uri­nary ox­alate ex­cre­tion. That’s what they want the FDA to sign off on as their pri­ma­ry end­point for a piv­otal study, which will fo­cus on more se­vere cas­es of en­teric hy­per­ox­aluria. They’re head­ed for the Phase III tri­al next year, with da­ta ex­pect­ed in 2019. Pro­ceeds from this IPO will be used to fund the piv­otal tri­al.

Al­though both com­pa­nies raised cap­i­tal on the low end of their ranges, the ac­tiv­i­ty is still in­dica­tive of a warm­ing IPO mar­ket for biotechs. IPO re­search firm Re­nais­sance Cap­i­tal re­port­ed in Sep­tem­ber that biotechs helped dri­ve up the av­er­age re­turns of the 29 of­fer­ings in Q3.

We start­ed out the year with sev­er­al an­a­lysts pre­dict­ing an okay­ish year for biotech IPOs — not 2014 hot, but equal to or slight­ly bet­ter than the 28 IPOs we saw last year. So far, we’re look­ing at a slight­ly hot­ter year than last. With Spero and Al­lena added to the mix, we’re at 33 IPOs in 2017.

Cell and Gene Con­tract Man­u­fac­tur­ers Must Em­brace Dig­i­ti­za­tion

The Cell and Gene Industry is growing at a staggering 30% CAGR and is estimated to reach $14B by 20251. A number of cell, gene and stem cell therapy sponsors currently have novel drug substances and products and many rely on Contract Development Manufacturing Organizations (CDMO) to produce them with adherence to stringent regulatory cGMP conditions. Cell and gene manufacturing for both autologous (one to one) and allogenic (one to many) treatments face difficult issues such as: a complex supply chain, variability on patient and cellular level, cell expansion count and a tight scheduling of lot disposition process. This complexity affects quality, compliance and accountability in the entire vein-to-vein process for critically ill patients.

A lab technician works during research on coronavirus at Johnson & Johnson subsidiary Janssen Pharmaceutical in Beerse, Belgium, Wednesday, June 17, 2020. (Virginia Mayo/AP Images)

UP­DAT­ED: End­points News ranks all 28 play­ers in the Covid-19 vac­cine race. Here's how it stacks up to­day

(This piece was last updated on August 13. Endpoints News will continue to track the latest developments through the FDA’s marketing decisions.)

The 28 players now in or close to the clinical race to get a Covid-19 vaccine over the finish line are angling for a piece of a multibillion-dollar market. And being first — or among the leaders — will play a big role in determining just how big a piece.

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Inside FDA HQ (File photo)

The FDA just ap­proved the third Duchenne MD drug. And reg­u­la­tors still don’t know if any of them work

Last year Sarepta hit center stage with the FDA’s controversial reversal of its CRL for the company’s second Duchenne muscular dystrophy drug — after the biotech was ambushed by agency insiders ready to reject a second pitch based on the same disease biomarker used for the first approval for eteplirsen, without actual data on the efficacy of the drug.

On Wednesday the FDA approved the third Duchenne MD drug, based on the same biomarker. And regulators were ready to act yet again despite the lack of efficacy data.

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Stéphane Bancel speaks to President Donald Trump at the White House meeting on March 2 (AP Images)

UP­DAT­ED: Mod­er­na of­fers steep dis­count in US sup­ply deal — but still takes the crown with close to $2.5B in vac­cine con­tracts

The US pre-order for Moderna’s Covid-19 vaccine is in.

Operation Warp Speed is reserving $1.525 billion for 100 million doses of Moderna’s Phase III mRNA candidate, rounding out to about $15 per dose — including $300 million in incentive payments for timely delivery. Given that Moderna has a two-dose regimen, it’s good for vaccinating 50 million people. The US government also has the option to purchase another 400 million doses for a total of $6.6 billion, or $16.5 per dose.

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Xuefeng Yu in Hong Kong, 2019 (Imaginechina via AP Images)

CanSi­no reaps $748M wind­fall from Shang­hai IPO — as it warns Covid-19 vac­cine won't be a huge mon­ey mak­er

CanSino began the year with a clear goal to secure a secondary listing on Shanghai’s STAR market. Then something more urgent came along: As a rising vaccine developer on a mission to bring global standard immunizations to China, it heeded the call to make a vaccine to protect against a virus that would paralyze the whole world.

Xuefeng Yu and his team managed to keep doing both.

More than a month after CanSino’s Covid-19 vaccine candidate is authorized for military use in China, the Hong Kong-listed company has made a roaring debut in Shanghai. It fetched $748 million (RMB$5.2 billion) by floating 24.8 million shares, and soared 88% on its first trading day.

Cal­lid­i­tas bets up to $102M on a biotech buy­out, snag­ging a once-failed PBC drug

After spending years developing its oral formulation of the corticosteroid budesonide, Sweden’s Calliditas now has its sights set on the primary biliary cholangitis field.

The company will buy out France-based Genkyotex, and it’s willing to bet up to €87 million ($102 million) that Genkyotex’s failed Phase II drug, GKT831, will do better in late-stage trials.

Under the current agreement, Calliditas $CALT will initially pay €20.3 million in cash for 62.7% of Genkyotex (or €2.80 a piece for 7,236,515 shares) in early October, then circle back for the rest of Genkyotex’s shares under the same terms. If nothing changes, the whole buyout will cost Calliditas €32.3 million, plus up to  €55 million in contingent rights.

Qi­a­gen in­vestors spurn Ther­mo Fish­er’s takeover of­fer, de­rail­ing a $12B+ deal

Thermo Fisher Scientific had announced an $11.5 billion takeover of Dutch diagnostics company Qiagen back in March, but the deal apparently did not sit well with Qiagen investors.

After getting hammered by critics who contended that Qiagen $QGEN was worth a lot more than what Thermo Fisher wanted to spend, investors turned thumbs down on the offer — derailing the buyout even after Thermo Fisher increased its offer to $12.6 billion in July. Qiagen’s share price has been boosted considerably by Covid-19 as demand for its testing kits surged.

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James Wilson, WuXi Global Forum at JPM20

FDA puts up a red light for Pas­sage Bio’s first gene ther­a­py pro­gram, de­lay­ing a pro­gram from James Wilson's group at Penn

Gene therapy pioneer James Wilson spearheaded animal studies demonstrating the potential of new treatments injected directly into the brain, looking to jumpstart a once-and-done fix for an extraordinarily rare disease called GM1 gangliosidosis in infants. His team at the University of Pennsylvania published their work on monkeys and handed it over to Passage Bio, a Wilson-inspired startup building a pipeline of gene therapies — with an IND for PBGM01 to lead the way.

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Bayer's Marianne De Backer with Endpoints founder John Carroll, Endpoints@JPM20 (Jeff Rumans for Endpoints News)

UP­DAT­ED: Hunt­ing a block­buster, Bay­er forges an $875M-plus M&A deal to ac­quire women’s health biotech

Bayer has dropped $425 million in cash on its latest women’s health bet, bringing a UK biotech and its non-hormonal menopause treatment into the fold.

KaNDy Therapeutics had its roots in GlaxoSmithKline, which spun out several neuroscience drugs into NeRRe Therapeutics back in 2012. Five years later the team created a new biotech to focus solely on NT-814 — which they considered “one of the few true innovations in women’s health in more than two decades.”

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