Aptinyx looks to bring its NM­DA pipeline to Nas­daq, fil­ing for an $80 mil­lion IPO

A day af­ter Aptinyx closed an op­tion deal with Al­ler­gan for a small mol­e­cule de­pres­sion drug, the biotech hand­ed in its S-1, pen­cil­ing in an $80 mil­lion raise as it looks to join the IPO queue. If they make it, they will trade un­der the $AP­TX han­dle.

Nor­bert Riedel

Run by CEO Nor­bert Riedel, Evanston, IL-based Aptinyx was spun out of the $1.7 bil­lion buy­out of Nau­rex — with $560 mil­lion in cash — which Al­ler­gan CEO Brent Saun­ders want­ed for its lead NM­DA drug aimed at ma­jor de­pres­sion. That drug is now dubbed ra­pastinel, which won a break­through drug des­ig­na­tion at the FDA.

We learned from the S-1 that Al­ler­gen was able to pick up its op­tion this week on a fol­low-up oral drug for de­pres­sion for on­ly $1 mil­lion, with an­oth­er pair of drugs still on the ta­ble for an­oth­er $1 mil­lion op­tion fee each. And Al­ler­gan has stayed al­lied with the NM­DA team, fund­ing half of the R&D costs at a rate of about $4 mil­lion a year in 2016 and 2017.

Aptinyx had $82.4 mil­lion in cash and equiv­a­lents at the end of March af­ter rais­ing a grand to­tal of $135 mil­lion, and even with the IPO would need to raise more for a Phase III ef­fort. Be­ing on Nas­daq would like­ly make that eas­i­er, pro­vid­ed the da­ta looks good.

Still fo­cused on NM­DA, Aptinyx’s most ad­vanced drug now is in Phase II stud­ies for chron­ic pain, with a read­out ex­pect­ed in the first half of next year that could set the biotech on a course for some risky piv­otal work. An ear­ly-stage drug, NYX-783, is be­ing de­vel­oped for post-trau­mat­ic stress dis­or­der. And an IND is com­ing up on a can­di­date for Parkin­son’s de­men­tia.

The NM­DA path­way has in­spired a mul­ti­tude of re­search pro­grams over the years, with plen­ty of set­backs in the field along the way. Aptinyx, though, be­lieves it found the right ap­proach on mod­u­la­tion that can make it work, and if Al­ler­gan comes out on top with their de­pres­sion drug, the small­er biotech will ben­e­fit enor­mous­ly.

But it’s slam dunk.

Adams Street Part­ners is the lead play­er in the syn­di­cate that backed Aptinyx, with close to 15% of the eq­ui­ty. New Leaf, Lon­gi­tude and Fra­zier Life Sci­ences each hold 11.63%, with Bain com­ing at 7%.

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.

The IPO queue adds 5 more biotechs hop­ing to ring in 2021 by blitz­ing Nas­daq

Following a record year for IPOs — in terms of both proceeds and count — there’s already a long lineup of biotechs ready to jump onto Nasdaq in the new year. The companies are likely looking for much higher raises than they initially projected on their S-1s. Now it’s time to see if investors are still hungry for another round of biotech stocks.

Sana helped set the pace early on, as its founders look to divvy up a fortune from their IPO. And late last week 5 more biotechs crowded in, looking to pick up the pace where 2020 left off. Here they are:

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Dan Skovronsky, Eli Lilly CSO (Lilly via Facebook)

Eli Lil­ly tees up dis­cov­ery pact worth more than $1.6B with Merus for T cell-fo­cused bis­pe­cif­ic an­ti­bod­ies

Under science chief Dan Skovronsky, Eli Lilly has taken some big swings at next-gen therapies, including trying to find the next big thing in oncology. Now, after one early failure in the field, Lilly is going back to the bispecific antibody well with a new deal with a Dutch biotech.

Lilly will pay $40 million upfront with an additional $20 million equity stake in Merus NV to identify and develop three bispecific antibodies looking to engage the CD3 antigen on T cells and redirect immune cells, the Indianapolis pharma giant said Tuesday.

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Sekar Kathiresan (Verve)

'Bluest of blue-chip in­vestors' pump $94M in­to Sekar Kathire­san's quest to bring CRISPR to the heart

Going into his first JP Morgan conference, Sekar Kathiresan had some major news to share. His ambitious cardiovascular-focused startup, Verve Therapeutics, had designated the PCSK9 base editor as its lead program, homed in on severe heterozygous familial hypercholesterolemia as the first indication, and released animal data suggesting the in vivo edits to the monkey livers last up to six months. For a company that had just been in the public for less than a year, “it was wonderful.”

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CEO Marshall Fordyce (Vera)

UP­DAT­ED: An am­bi­tious GV-backed gene edit­ing up­start re-emerges as a one-drug kid­ney com­pa­ny

In September 2019, Trucode Gene Repair launched, after two-plus years of early development, with $34 million from GV and Kleiner Perkins and ambitious plans to take on the raft of CRISPR companies with a new form of gene editing.

Those plans, though, would only last a few months. By February, company leadership was already pivoting, filing a trademark and domain name for a new company, called Vera Therapeutics. On Monday, they completed the switch, “launching” with an $80 million Series C round led by Abingworth and plans to focus their efforts on atacicept, a 20-year-old molecule now in development for kidney disease.

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A car­dio­vas­cu­lar cell ther­a­py play­er grabs $54M for a new be­gin­ning — where next-gen CAR-T ap­proach fea­tures promi­nent­ly

Before the advent of CAR-T, the term cell therapy conjured up very different images. Sure, there were cancer immunotherapies like Dendreon’s Provenge, but more common were the various flavors of stem cell therapies and cell transplantation.

None of that has gone away, even if they’ve been nudged out of the spotlight — and a little biotech has garnered $54 million (£40 million) to show that both the old and new ideas of cell (and gene) therapy can mesh together to form a special breed of platform company.

Andrew Allen (Gritstone)

As coro­n­avirus vari­ants trig­ger new alarms, the NIH is putting an un­der-the-radar ‘next-gen’ vac­cine in­to PhI

Over the past year, the world has been transfixed by the development of new vaccines to fight SARS-CoV-2. In a frenzy of activity, the new mRNA approach has delivered pioneering emergency approvals in record time. And with some setbacks, the more traditional big players are coming along with added jabs as the most affluent nations in the world begin to vaccinate large portions of their populations.

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