An ear­ly ar­rival among '17 biotech IPOs, Anap­tys­Bio keeps to its range in suc­cess­ful $75M play

Hamza Suria, Anap­tys­Bio

Anap­tys­Bio has upped its shares but still man­aged to hit the mid-point of its IPO range, rais­ing $75 mil­lion.

The suc­cess­ful out­ing marks an en­cour­ag­ing start to the year for biotech IPOs, which have been in rough ter­rain af­ter a year of ups and downs on Wall Street. Right now, a mid-range IPO looks pret­ty good. And it per­haps bodes well for the ini­tial line­up of biotech com­pa­nies look­ing to start the year with an IPO raise.

San Diego-based Anap­tys­Bio priced 5 mil­lion shares — up by a mil­lion — at $15 a share. The un­der­writ­ers have a 30-day op­tion to pur­chase up to an ad­di­tion­al 750,000 shares of com­mon stock, which will trade un­der the ANAB sym­bol.

In an­oth­er sign of en­cour­age­ment, Ob­sE­va, the Gene­va-based de­vel­op­er of new ther­a­pies for re­pro­duc­tive health, raised $97 mil­lion by pric­ing shares at $15 apiece — al­so with­in the range. The biotech will trade as OB­SV.

It’s been a long time com­ing for Anap­tys­Bio.

The biotech set out to raise $86 mil­lion in an IPO ini­tial­ly filed in the fall of 2015, as the mar­ket be­gan to sour for new of­fer­ings and gen­er­al­ists be­gan to flee for safer fields. Helmed by Hamza Suria, the com­pa­ny built its rep­u­ta­tion around next-gen an­ti­bod­ies that can bind to mul­ti­ple tar­gets. Anap­tys­Bio de­vel­oped com­bined an­ti­bod­ies as­sem­bled on an IgG scaf­fold in which the tips of the Y-shaped pro­tein could be de­signed to bind to mul­ti­ple tar­gets.

That rep at­tract­ed the likes of Mer­ck $MRK, No­var­tis $NVS and Roche $RHH­BY as well as Cel­gene $CELG and Tesaro $TSRO on col­lab­o­ra­tions that helped fund the com­pa­ny’s work.

Last year on­ly 28 biotechs man­aged to com­plete their IPOs. That wasn’t aw­ful, but it was a far cry from the go-go days of 2013-2015. In 2014, there were 66 IPOs. The gen­er­al con­sen­sus is we’ll see a few more biotech IPOs this year, but not a lot more.

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Biohaven CEO Vlad Coric (Photo Credit: Andrew Venditti)

Pssst: That big Bio­haven Alzheimer's study? It was a bust. Even the sub­group analy­sis ex­ecs tout­ed was a flop

You know it’s bad when a biopharma player plucks out a subgroup analysis for a positive take — even though it was way off the statistical mark for success, like everything else.

So it was for Biohaven $BHVN on MLK Monday, as the biotech reported on the holiday that their Phase II/III Alzheimer’s study for troriluzole flunked both co-primary endpoints as well as a key biomarker analysis.

The drug — a revised version of the ALS drug riluzole designed to regulate glutamate — did not “statistically differentiate” from placebo on the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 11 (ADAS-cog) and the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB).  The “hippocampal volume” assessment by MRI also failed to distinguish itself from placebo for all patients fitting the mild-to-moderate disease profile they had established for the study.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

CEO Stephen Yoder (Pieris)

Pieris fi­nal­ly vaults FDA hold on next-gen sol­id tu­mor hunter, clear­ing the path for mid-stage tri­al

Finally freed from the restraints of a partial FDA clinical hold on its lead HER2-positive solid tumor candidate, Pieris Pharmaceuticals is now racing toward Phase II.

The FDA slapped a partial hold on Pieris’ PRS-343 back in July, restricting the biotech from enrolling new patients in a Phase I trial. While Pieris was allowed to continue dosing patients who were already enrolled, the agency requested they conduct an additional “in-use and compatibility study” before recruiting any more.

News brief­ing: Ve­rastem CMO ex­its two weeks af­ter join­ing com­pa­ny; Ther­mo Fish­er inks $550M M&A deal

Two weeks after joining Verastem Oncology as chief medical officer, Frank Neumann is leaving the company for another job.

Neumann had joined Verastem after leaving bluebird bio, which surprisingly split into two companies last week, one in oncology and one in rare diseases. It’s not yet clear to where Neumann is headed next, but he noted in a statement that Verastem’s data and strategy were “truly exciting.”

FDA hits the brakes on His­to­gen's knee car­ti­lage ther­a­py, ask­ing for more in­fo on man­u­fac­tur­ing process

A month after filing the IND application for its human extracellular matrix designed to regenerate knee cartilage, Histogen has hit a roadblock.

The FDA on Tuesday verbally notified the San Diego-based biotech that it was placing a clinical hold on the planned Phase I/II clinical trial of HST-003 due to pending CMC information and additional questions needed to complete their review.

Histogen had planned to test the safety and efficacy of implanting hECM within microfracture interstices and related cartilage defects to regenerate that cartilage in conjunction with a microfracture procedure. The company said in a press release that it expects to receive written notice of the clinical hold from the FDA by Feb 12.

Andrew Allen, Gritstone CEO (Gritstone via website)

Grit­stone con­tin­ues Covid-19 push with deal to de­vel­op 'self-am­pli­fy­ing RNA' vac­cines, as shares con­tin­ue bal­loon­ing

Gritstone Oncology has had a big week, and it’s only Wednesday.

On Tuesday, the biotech revealed plans to start clinical testing of an experimental Covid-19 vaccine — in tandem with NIAID — that can also target other coronaviruses, with the goal of preventing future pandemics should SARS-CoV-2 prove difficult to cure with current vaccines. Then, on Wednesday morning, Gritstone licensed lipid nanoparticle technology from Genevant Sciences to develop what it’s calling “self-amplifying RNA vaccines” against Covid-19.

Hal Barron, GSK R&D chief (GSK via YouTube)

Glax­o­SmithK­line's $4B bis­pe­cif­ic can­cer drug al­liance with Mer­ck KGaA hit by big set­back with a PhI­II fail­ure on NSCLC

Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein.

But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda.

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The IPO flood keeps ris­ing with 4 more biotechs and a SPAC on their way to Nas­daq

After a record year for biotech IPOs in 2020, forecasts were bullish on another strong year showing for public offerings — and 2021 hasn’t disappointed so far. Now, a clutch of four biotechs chasing rare disease and cancer and a New York SPAC are ready to join the party.

Three more companies filed to head to Nasdaq on Tuesday, as well as a SPAC, with an additional Dutch biotech filing Friday. All in all, early days indicate another big year, at least to start, with 12 companies either pricing or filing their IPOs in the first 20 days of January.