Additional Relevant Details Ranevetmab (NV-01) pivotal efficacy and field safety study

• A statistically significant improvement on the assessed level of pain as measured using CSOM improvement success/fail criteria between enrollment and day 28 (p=0.0414), day 56 (p=0.0268) and day 84 (p=0.0448). The successful day 28 endpoint was this study’s primary endpoint, as agreed under protocol concurrence with the United States Food and Drug Administration’s Center for Veterinary Medicine.
• Statistically significant reductions in the assessed level of pain between ranevetmab-treated dogs and placebo as measured using changes in median total CSOM score between enrollment and day 28 (p=0.0025) and day 56 (p=0.0074).
• A statistically significant difference between ranevetmab-treated dogs and placebo for the CSOM Global Assessment on the only day it was measured: day 28 (p=0.0291). The Global Assessment measures overall owner experience with the treatment course.
• A statistically significant improvement on the assessed level of pain as measured using CBPI treatment success/fail criteria between enrollment and day 14 (p=0.0237), day 28 (p=0.0227) and day 56 (p=0.0046).
• The CBPI component measurements Pain Severity Score and Pain Interference Score both yielded statistically significant improvements on the assessed level of pain on days 14, 28 and 56.
• Veterinarian’s assessments of dog lameness, local joint effects and weight bearing ability were numerically superior to placebo for each composite variable at most evaluation points and included a statistically significant overall treatment effect for lameness.

Frunevetmab (NV-02) pilot field studyIntravenous and subcutaneous administration of frunevetmab were examined: both routes of administration were highly effective and the groups were combined for analysis. The combined frunevetmab treatment groups yielded:

• A statistically significant improvement on the assessed level of pain as measured using CSOM improvement success/fail criteria between enrollment and both day 42 (p=0.0479) and day 56 (p=0.0033).
• Statistically significant reductions in the assessed level of pain as measured using changes in median total CSOM score between enrollment and day 42 (p=0.0077) and day 56 (p<0.0001). The day 28 score was extremely close to statistical significance (p=0.0539).
• A statistically significant difference between frunevetmab-treated cats and placebo for the CSOM Global Assessment on both days it was measured: day 28 (p=0.0134) and day 56 (p=0.0030).
• A statistically significant improvement on the assessed level of pain as measured using FMPI improvement success/fail criteria (success was defined as a reduction of ≧ 10 in total score) between enrollment and both day 42 (p=0.0076) and day 56 (p=0.0242).
• A statistically significant improvement over placebo on the assessed level of pain measured using reductions in median FMPI total score at day 42 (p=0.0002) and day 56 (p=0.0160).