Biotech Values

[Mufaso]

VKTX cc on VK2735 was very well received by the analyst community. Most seemed amazed by the tolerability/safety results. Here are some initial thoughts:

• Outstanding tolerability. "Almost no side-effects”. No clinically significant difference between study participants and placebo
  
• 2 subjects had diarrhea in placebo compared to 1 in the 2nd highest dose of 20 mg.
  
• placebo effect was high at 2.1% weight loss. Possible reason was the small numbers (n=10 for placebo) and 2 subjects had diarrhea.
  
• 2 total discontinuations- one for family reasons- other was for abdominal reasons.
  
• Noted that effect was durable 6 days after study dosing stopped while placebo group gained 0.5% weight. Had this been included the placebo adjusted weight loss would have been 3.8%. Also noted that other drugs in testing had rebounds immediately after dosage stopped.
  
• PK was such that they saw slow accumulation- seems like VK2735 is almost "self-titrating". Brian Lian when asked if there was a need to titrate said "doesn't look like it but we will continue to do titrate"
  
• Found it interesting that one analyst (Justin Zelin at BTIG) asked if oral was safer than Subq version.
  
• Viking did not disclose what the "special formulation" was for an oral peptide that made it work.
  
• Adding another cohort at higher dose- likely to see increased weight loss. Overall study numbers may change slightly. Adding a few more placebo at the same time.
  
• Question about manufacturing a peptide and whether there was a point at where it didn't make sense to dose scale- answer was "we aren't stopping and we are spending a lot of time on manufacturing- currently have plenty of material for registrational studies". Brian Lian did not seem deterred at all by this question.
  
• Regarding food, participants were asked to dose in the am after waking and not to consume food for 30 mins.
  
• Just got data so no Metabolic data available yet (e.g. for lipids, glucose etc.). Will likely release metabolic data towards end of the summer.

I think this was a home run. Placebo adjusted Weight loss close to 4% at 28 days, clear indication of dose response, incredibly good safety profile.