Shoot­ing for PhI­II, Spero tees up a new lead an­tibi­ot­ic in-li­censed cheap as it lines up $86M IPO

Ankit Ma­hade­via

Late last week Spero Ther­a­peu­tics threw its S-1 in­to the IPO ring as the biotech queue for jump­ing in­to the pub­lic are­na was grow­ing longer by the day.

Spero got start­ed with some seed fund­ing from At­las Ven­ture and a high-pro­file part­ner­ship with Roche, but that pact end­ed last year with­out near­ly as much fan­fare as it was orig­i­nal­ly an­nounced.

The biotech’s lead an­tibi­ot­ic is SPR994, an oral for­mu­la­tion of the car­bapenum-class an­tibi­ot­ic tebipen­em, which Spero in-li­censed from Mei­ji Sei­ka with a very mod­est up­front of $600,000, with up to $3 mil­lion in mile­stones. The Japan­ese com­pa­ny won an ap­proval for this an­tibi­ot­ic in 2009 and hand­ed over da­ta on 1200 pa­tients. The ther­a­py is sold as Orapen­em.

That fits in­to a new strat­e­gy for flip­ping biotechs in­to the pub­lic mar­kets. By in-li­cens­ing the prod­uct on a re­gion­al ba­sis — the an­nounce­ment came out yes­ter­day — Spero can style it­self as a near-term late-stage biotech com­pa­ny, which is like­ly to be much more ap­pe­tiz­ing the in­vestors.

Two more drugs — SPR741 and SPR206 — are com­ing off Spero’s plat­form tech, which is de­signed to punch up an­tibi­otics so they can pen­e­trate the out­er cell mem­branes of Gram-neg­a­tive bac­te­ria.

The plan now is to tee up a Phase I study of SPR994 and then move straight in­to a piv­otal Phase III for com­mu­ni­ty-ac­quired uri­nary tract in­fec­tions, pro­vid­ed they get the FDA’s bless­ing.

Spero was launched by found­ing CEO Ankit Ma­hade­via, who earned a pay pack­age worth a to­tal of $814,985 last year. Ma­hade­via al­so owns 2.8% of the stock. The biotech gath­ered a $51.7 mil­lion crossover round last spring.

Two of At­las’ funds own around 23% of the eq­ui­ty now, with SR One com­ing in at 17% and the old Google Ven­tures ring­ing up at 13.2%. Oth­er in­vestors in­clude Lund­beck­fond, RA and Os­age Uni­ver­si­ty Part­ners

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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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.

Charlie Silver (Mission Bio)

'We want to be every­where.' Mis­sion Bio rais­es $70M be­hind re­sis­tance-hunt­ing se­quenc­ing plat­form

Charlie Silver wants to look really, really closely at a lot of your cells. And he just got a lot of money to do so.

Silver’s startup, Mission Bio, raised $70 million in a Series C round Thursday led by Novo Holdings. The money, which brings Mission Bio to $120 million raised since its 2012 founding, will be used to advance the single-cell sequencing platform they built to detect early response or resistance to new cancer therapies.

Franz-Werner Haas, CureVac CEO

UP­DAT­ED: On the heels of a snap $1B raise, Cure­Vac out­lines plans to seek emer­gency OK for their Covid-19 vac­cine in a mat­ter of months

CureVac jumped onto Nasdaq Thursday night, landing with an extra $213 million after pricing a batch of shares at $16 a pop. Add in an extra $118 million share purchase by founder Dietmar Hopp — who owns a controlling interest — and another $640 million from deals and the German biotech has raised a cool billion dollars in the space of just 3 weeks.

The company’s stock $CVAC will now start trading this morning, with analysts eager to find out whether the go-go atmosphere on Wall Street will swell the biotech’s share price.

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As the world Terns: Liv­er dis­ease biotech makes ex­ec­u­tive changes; Sanofi vet Kather­ine Bowdish named CEO of PIC Ther­a­peu­tics

→ The C-suite has shuffled considerably at liver disease-focused Terns Pharmaceuticals out of Foster City, CA. Senthil Sundaram now assumes the CEO post, replacing Weidong Zhong, who was at the helm since Terns was founded and is now moving into two new roles: CSO and chairman of the board. Sundaram makes his way to Terns after 2 years as CFO of Nightstar Therapeutics, which would later be acquired by Biogen. He was also VP and head of business development at NASH player Intercept after 13 years in investment banking.

Martin Shkreli (Shutterstock)

Mar­tin Shkre­li con­tin­ued to or­ches­trate an­ti-com­pet­i­tive schemes for Dara­prim be­hind bars — FTC

Martin Shkreli didn’t just blog, read up on drug development news and run his biotech business with a contraband cell phone in prison. According to the FTC, he was also coordinating the anticompetitive scheme to shield Daraprim — the drug at the center of a price-gouging controversy that earned him the “Pharma Bro” nickname — from generic rivals.

Back in January the FTC, together with New York’s attorney general, launched a federal lawsuit against Shkreli, who’s now serving a 7-year sentence for defrauding investors in his hedge fund, alleging that he effectively created a drug monopoly. While Shkreli’s notorious move to raise the per tablet price of Daraprim from $17.50 to $750 was perfectly legal, the tactics he allegedly deployed to box out competitors weren’t.

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.

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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NIH director Francis Collins at a Senate Appropriations subcommittee hearing for Operation Warp Speed (Graeme Jennings/Pool via AP Images)

Covid-19 roundup: 'No­vem­ber or De­cem­ber' Collins' best bet on a vac­cine OK; First plas­ma tri­al sug­gests mor­tal­i­ty re­duc­tion

Count NIH director Francis Collins out for any wager that the FDA would authorize a Covid-19 vaccine in October.

The discussion came up during a call with reporters because some states and local governments have been told by the CDC to have vaccination plans ready to go by Oct. 1. Pharma execs, most notably from Pfizer and BioNTech, have raised hopes about a licensure during that month; President Donald Trump last week sounded an optimistic note about having a vaccine on the market “right around” Election Day on Nov. 3 — or possibly before.

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