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%.

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End­points 20(+2) un­der 40, 2023; Bio­phar­ma's high­est-paid CEOs; N-of-1 CRISPR sto­ry goes on af­ter tragedy; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

We will be off Monday in observance of Memorial Day — and when we get back, it will be a straight march to ASCO, BIO and more. Enjoy the (long) weekend!

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Athena Countouriotis, Avenzo Therapeutics CEO (website via Nasdaq)

Ex-Turn­ing Point ex­ecs plan to have their next bet, Aven­zo, on the Nas­daq next sum­mer

The crew at Turning Point Therapeutics is back together for a new biotech that wants to acquire early-stage oncology small molecules, including antibody drug conjugates, and potentially form partnerships with China-based drug developers for ex-China rights as it eyes a speedy leap onto the Nasdaq around this time next year, CEO Athena Countouriotis told Endpoints News.

After selling Turning Point to Bristol Myers Squibb, announced at the onset of last year’s ASCO confab, she and colleague Mohammad Hirmand founded Avenzo Therapeutics. The CEO and CMO already have approximately $200 million in seed and Series A financing from five big-name investors to evaluate which drugs to bring into its pipeline. That includes SR One, OrbiMed, Foresite Capital, Citadel’s Surveyor Capital and Lilly Asia Ventures. Bidding wars for assets have led Avenzo to miss out on some deals in recent months, but the biotech has three active term sheets and hopes to bring in its first asset in the third quarter, Countouriotis said in a Friday morning interview.

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Rich Horgan (R) with his late brother, Terry

Rich Hor­gan spear­head­ed a gene ther­a­py for his broth­er. The tri­al end­ed in tragedy, but the work con­tin­ues for more pa­tients

Rich Horgan’s quest to create a custom gene therapy for his brother, Terry, ended in tragedy. But Horgan doesn’t believe it’s the end of the story.

Terry, a 27-year-old patient with Duchenne muscular dystrophy, died last October just eight days after receiving the therapy in a clinical trial in which he was the only participant. The case raised questions about the safety of certain gene therapies and what would happen to other drug programs under a nonprofit that Horgan created, called Cure Rare Disease.

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Bio­phar­ma's 20 high­est-paid CEOs of 2022, each bring­ing in $20M+ pay­days

Even in a down year for much of the biopharma market, 20 CEOs brought in pay packages valued at more than $20 million, an Endpoints News analysis found.

Endpoints collected data on more than 350 CEO compensation packages, covering a wide range of pharma, biotech, and life sciences companies. All told, the 20 largest earners made over $725 million in 2022 — an average package of $36.4 million. Three brought in paydays over $50 million, and one CEO broke the $100 million mark.

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Douglas Love, Annexon CEO

An­nex­on’s GA drug miss­es on pri­ma­ry goal but win on vi­su­al acu­ity will be fo­cus of planned late-stage tri­al

Annexon’s complement inhibitor didn’t prove better than sham at reducing lesion growth in a leading cause of blindness, but the biotech still plans to move forward on the back of secondary endpoints showing visual acuity preservation, which will “certainly” be the primary goal in a late-stage trial to be discussed shortly with the FDA, CEO Douglas Love told Endpoints News. 

The California biotech’s ANX007 was not statistically significant compared to pooled sham, the comparator, at 12 months in patients with geographic atrophy, per a Wednesday presentation. In every-month dosing, the GA lesion area changed about 6.2% from baseline (p=0.526) and 1.3% (p=0.896) in the every-other-month group. In a March note, Jefferies analyst Suji Jeong said a reduction of 20% to 30% would be “encouraging.”

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The 20(+2) un­der 40: Your guide to the next gen­er­a­tion of biotech lead­ers

This year’s list of 20 biotech leaders under the age of 40 includes a huge range of ambitions. Some of our honorees are planning to create the next big drug giant. Others are pushing the bounds of AI. One is working to revolutionize TB testing. All are compelling talents who are still young in age, but already far along in achievement.

And, as in years past, we went over. The 20 are actually 22 because of two double profiles that reflect how important teamwork is in the industry. As one of our honorees, Joe Illingworth of DJS Antibodies, told me in our interview, “It takes a village to raise a biotech.”

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FDA ap­proves Lex­i­con’s heart-fail­ure drug af­ter de­feat in di­a­betes

The FDA on Friday approved Lexicon’s heart failure drug sotagliflozin following a string of setbacks for the pharma company, including an FDA rejection in diabetes and the loss of a development deal with Sanofi.

The dual SGLT1 and SGLT2 inhibitor will be marketed as Inpefa and is a once-daily tablet. It’s been approved to reduce the risk of cardiovascular death and heart failure-related hospitalization or urgent visits in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors. The label spans the range of left ventricular ejection fraction, including preserved ejection fraction and reduced ejection fraction, as well as patients with or without diabetes, Lexicon said Friday.

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Eu­ro­pean Com­mis­sion to re­ceive few­er Pfiz­er-BioN­Tech vac­cine dos­es un­der amend­ed con­tract

The European Commission has made a few changes to its vaccine contract with Pfizer and BioNTech, reducing the dose volume while extending the delivery timeline to cope with “evolving public health needs.”

The Commission previously struck a contract in May 2021 for 900 million doses, with the option to purchase another 900 million. Of those, 450 million were expected to be delivered in 2023, though an amendment now calls for fewer doses. While neither the Commission nor Pfizer and BioNTech have revealed an exact amount, an unnamed source told Reuters that the amendment reduces the remaining expected doses by about a third.

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