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.

UP­DAT­ED: Mer­ck pulls Keytru­da in SCLC af­ter ac­cel­er­at­ed nod. Is the FDA get­ting tough on drug­mak­ers that don't hit their marks?

In what could be an early shot in the battle against drugmakers that whiff on confirmatory studies to support accelerated approvals, the FDA ordered Bristol Myers Squibb late last year to give up Opdivo’s approval in SCLC. Now, Merck is next on the firing line — are we seeing the FDA buckling down on post-marketing offenders?

Merck has withdrawn its marketing approval for PD-(L)1 inhibitor Keytruda in metastatic small cell lung cancer as part of what it describes as an “industry-wide evaluation” by the FDA of drugs that do not meet the post-marketing checkpoints on which their accelerated nods were based, the company said Monday.

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The 2021 top 100 bio­phar­ma in­vestors: As the pan­dem­ic hit and IPOs boomed, VCs swung in­to ac­tion like nev­er be­fore

The global pandemic may have roiled economies, killed hundreds of thousands and throttled entire industries, but the only effect it had on biopharma venture investing was to help turbocharge the field to giddy new heights.

Below you’ll find the new top 100 venture investors in the industry, ranked by the number of deals they were publicly involved in, as tracked by DealForma chief Chris Dokomajilar. The numbers master then calculated the estimated amount of money they put into each deal — divvying up the cash by the number of players — to indicate how they managed their syndicates.

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Antoine Papiernik, Sofinnova managing director (Business Wire)

Sofinno­va Part­ners stays fo­cused on late-stage deals with a new, $540M crossover fund

One of Europe’s most high-profile biopharma investors is getting $540 million to invest in new crossover deals for late-stage companies.

The Paris-based VC says the fresh Sofinnova Crossover Fund raise positions them as the “largest crossover investor in Europe dedicated to late-stage biopharma and medtech investments.”

They got a leg up in France after winning a special “Tibi” designation from the French government, giving them access to a pool of €6 billion that helped them gain an edge with institutional investors. Since they were founded close to 50 years ago, the venture group has backed more than 500 companies and currently has more than €2 billion under management.

Hal Barron, Endpoints UKBIO19

GSK, Vir's hopes for a Covid-19 an­ti­body fall flat in NIH 'mas­ter pro­to­col' with no ben­e­fit in hos­pi­tal­ized pa­tients

GlaxoSmithKline and Vir Biotechnology were hopeful that one of their partnered antibodies would carve out a win after getting the invite to a major NIH study in hospitalized Covid-19 patients. But just like Eli Lilly, the pair’s drug couldn’t hit the mark, and now they’ll be left to take a hard look at the game plan.

The NIH has shut down enrollment for GSK and Vir’s antibody VIR-7831 in its late-stage ACTIV-3 trial after the drug showed negligible effect in achieving sustained recovery in hospitalized Covid-19 patients, the partners said Wednesday.

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In­tro­duc­ing End­points FDA+, our new pre­mi­um week­ly reg­u­la­to­ry news re­port led by Zachary Bren­nan

CRLs. 483s. CBER, CDER and RWE. For biopharma professionals, these acronyms command attention because of the fundamental role FDA plays in drug development. Now Endpoints is doubling down on regulatory coverage, and launching a weekly report focusing on developments out of White Oak, with analysis and insight into what it all means.

Coverage will be led by our new senior editor, Zachary Brennan. He joins Endpoints from POLITICO, where he covered pharma. Prior to that he was the managing editor for Regulatory Focus, a news publication from the Regulatory Affairs Professionals Society.

As Brain­Storm con­tin­ues to tout ‘clear sig­nal’ on ALS drug, the FDA of­fers a rare pub­lic slap­down on the da­ta

A little more than a week after BrainStorm acknowledged that regulators at the FDA had informed them that the biotech needed more data before it could expect to gain an approval for its ALS treatment NurOwn — while still touting a “clear signal” of efficacy and not ruling out an application — the agency has decided to clarify the record in a most unusual statement.

The FDA statement amounts to a straight slap own, offering a different set of efficacy numbers from the company’s public presentation last November and ruling out any chance of statistical significance.

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Eli Lil­ly claims suc­cess in a new JAK in­di­ca­tion: hair loss

Over the last decade, drugmakers have proven JAK inhibitors can treat a smattering of immune-related diseases ranging from rheumatoid arthritis to Covid-19. Now Eli Lilly has pulled out a new one.

Lilly and its biotech partner Incyte announced Wednesday that their JAK inhibitor baricitinib effectively regrew patients’ hair in a Phase III trial for alopecia areata, an autoimmune condition that can cause sudden, severe and patchy hair loss. Lilly didn’t break down the results from the 546-patient trial, but the primary endpoint was improvement on a standard score for alopecia symptoms.

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CEO David Campbell (Janux)

Fresh off $1B+ Mer­ck deal, Janux locks down first pri­vate fundraise for its T cell en­gagers

Janux Therapeutics had kept a relatively low profile since being founded back in 2017 but burst onto the scene late last year when Merck plunked down more than $1 billion in promised milestones for its T cell engagers. Now, less than three months later, the small biotech has clinched its first round of private funding led by some prominent backers.

As it prepares its first programs for INDs, Janux completed a $56 million Series A on Wednesday morning, with Jay Lichter’s Avalon Ventures joining forces with new investors OrbiMed and RA Capital Management to fund the company. Janux will use the cash to primarily advance its T cell engagers targeting PSMA and TROP2, which are expected to hit the clinic in the first and second quarters of 2022, respectively.

Rachel Haurwitz, Caribou CEO (Kimberly White/Getty Images for TechCrunch)

A Jen­nifer Doud­na-launched up­start nabs $115M for off-the-shelf CAR-Ts

There is no shortage of biotechs pursuing off-the-shelf CAR-Ts, a so-called Holy Grail in oncology R&D. Now, less than a month after teaming up with AbbVie, a California player launched by CRISPR pioneer Jennifer Doudna has returned to the venture well, scooping up a big crossover round to help it along.

Caribou Biosciences took the wraps off a $115 million Series C on Wednesday morning, bringing their total raise to around $157 million, CEO Rachel Haurwitz said.

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