Benito Vega
I coated 89bio (NASDAQ:ETNB) in early 2021, and the stock is down 75% since then, which supplies me a cause to take one other have a look at this firm.
ETNB is a NASH drug developer. FGF21 analogue BIO89-100 or Pegozafermin is the lead and solely molecule. The firm is a “a 2018 spinoff of a few NASH assets, notably BIO89-100, originally held by Teva, with a $60mn financing led by Orbimed, the leading biopharma fund.” Last time, once I coated it, that they had good early stage part 1 proof of idea knowledge from the molecule in NASH. In a set of round 91 sufferers, the molecule confirmed robust liver fats discount and was typically well-tolerated. Additional knowledge revealed in March confirmed that “BIO89-100 at 13 weeks has led to reductions in the liver volume of up to 15% and liver fat volume of up to 65% in patients compared to baseline.”
Just this yr, in June, the corporate reported {that a} part 2 trial in extreme hypertriglyceridemia met its main endpoint. Severe hypertriglyceridemia or SHTG is the corporate’s second indication, and in contrast to NASH, it’s considerably ignored. Key knowledge:
- Trial met main endpoint demonstrating statistically important and clinically significant reductions throughout all doses (63% on the 27mg QW dose; p<0.001) in triglycerides (TG) from baseline; outcomes have been constant in sufferers on or not on background remedy –
– Observed important and potent reductions in atherogenic lipids (non-HDL-C and apo B), liver fats, and enhancements in liver enzymes and glycemic management markers –
– ENTRIGUE outcomes help 89bio’s transition to a late-stage improvement firm; Phase 3 anticipated to provoke in first half of 2023 –
According to Deepak L. Bhatt, MD, MPH, Executive Director of Interventional Cardiovascular Programs, Brigham and Women’s Hospital Heart & Vascular Center, Professor of Medicine, Harvard Medical School:
There is a essential want for SHTG therapy choices that not solely cut back triglycerides but additionally tackle broader cardiometabolic dangers together with hepatic steatosis and enhance insulin sensitivity. Treatment with pegozafermin demonstrated spectacular triglyceride discount coupled with significant reductions in non-HDL-C and enhancements in cardiometabolic parameters. Taken collectively, pegozafermin’s profile in ENTRIGUE exhibits nice potential to uniquely tackle the important thing wants for sufferers with SHTG.
On this information, the corporate tried to lift $75mn ($94mn) in a secondary providing, and the stock dropped on that information. There was some minor security concern with the trial, particularly with the 27mg/week dose. There have been two discontinuations within the trial, and each got here from this cohort. One affected person discontinued as a result of belly cramps, and the opposite as a result of nausea and vomiting. Overall, 22% and 17% of sufferers on this dose group skilled nausea and diarrhea respectively.
The firm’s most essential catalyst forward is topline knowledge from the ENLIVEN trial in NASH. Just final week, the corporate introduced completion of enrollment of the 219-patient trial. ENLIVEN is a placebo-controlled Phase 2b trial in biopsy-confirmed NASH sufferers with fibrosis stage 2 or 3. The trial will topline in early 2023. With constructive earlier stage knowledge in the identical indication, plenty of analysts count on a constructive end result from this trial.
However, NASH is the graveyard of plenty of biotech corporations and failed applications. Indeed, FGF21, the pathway that ETNB targets, has seen plenty of failures, essentially the most notable being Bristol-Myers Squibb’s (BMY) pegbelfermin. Besides ETNB, Akero Therapeutics (AKRO) is one other NASH participant with a competing FGF21 molecule. While Akero is barely forward in improvement, it’s also twice the market cap.
Financials
ETNB has a market cap of $194mn and a money reserve of $139mn. R&D bills have been $19.7 million for the three months ended June 30, 2022, whereas G&A bills have been $5.1 million. That offers them about 6-7 quarters of money.
Bottomline
ETNB is at a really thrilling stage of their improvement, nonetheless the market appears to not discover. They simply posted robust knowledge in SHTG, a market which some analysts estimate is close to $500mn for Pegozafermin. They had good POC knowledge in NASH, and additional knowledge will seem subsequent yr. However, traders are cautious of the NASH subject, the place many corporations have gone to die; and with out NASH, simply the SHTG indication is not ok. That could also be the principle cause the stock stays depressed. I look ahead to 2023, when the NASH trial knowledge might change all that.
About the TPT service
Thanks for studying. At the Total Pharma Tracker, we provide the next:-
Our Android app and web site characteristic a set of instruments for DIY traders, together with a work-in-progress software program the place you may enter any ticker and get in depth curated analysis materials.
For traders requiring hands-on help, our in-house consultants undergo our instruments and discover the most effective investible shares, full with purchase/promote methods and alerts.
Sign up now for our free trial, request entry to our instruments, and discover out, without charge to you, what we are able to do for you.
