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Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading symbol(s)
Name of each exchange on which registered
Common stock, par value $0.001 per share
OPTN
Nasdaq Global Select Market
Item 8.01 Other Events
On July 13, 2022 OptiNose, Inc. (the “Company”) issued a press release announcing that an analysis of pooled data from the ReOpen1 and ReOpen2 trials found that the 372-mcg treatment group achieved a type 1 error controlled statistically significant reduction of 66% in the incidence of exacerbations compared to placebo comparator. Reductions in the number of exacerbations, ranging from 53 to 80%, were found for subgroups of chronic sinusitis patients with or without nasal polyps receiving one or two sprays per nostril of XHANCE twice daily (186 mcg or 372 mcg BID) in additional pre-planned exploratory analyses that were not type 1 error controlled. Exacerbations were defined as a worsening of at least one of the four cardinal symptoms of chronic sinusitis (nasal congestion/obstruction, rhinorrhea, facial pain/pressure, and loss of sense of smell) lasting at least 3 days accompanied by an escalation in medical care, such as doctor visits or antibiotic or steroid prescription. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Additional detail regarding these findings is set forth below.
Treatment Group
n
Events
LS Mean
Incidence Rate Ratio (Active/PBO)
P-value (1)
Frequency of Exacerbations over 24 Weeks (Full Analysis Set/All Patients)
XHANCE 186 or 372 mcg
362
35
0.081
0.389
0.001
XHANCE 372 mcg
180
15
0.072
0.343
0.002(2)
XHANCE 186 mcg
182
20
0.092
0.441
0.012
Placebo EDS
185
41
0.208
-
-
Frequency of Exacerbations over 24 Weeks (Patients with Nasal Polyps)
XHANCE 186 or 372 mcg
137
12
0.052
0.276
0.005
XHANCE 372 mcg
68
4
0.038
0.203
0.010
XHANCE 186 mcg
69
8
0.070
0.376
0.055
Placebo EDS
69
17
0.187
-
-
Frequency of Exacerbations over 24 Weeks (Patients without Nasal Polyps)
XHANCE 186 or 372 mcg
225
23
0.113
0.472
0.032
XHANCE 372 mcg
112
11
0.113
0.470
0.077
XHANCE 186 mcg
113
12
0.113
0.474
0.076
Placebo EDS
116
24
0.239
-
-
a.The p-value, or probability value, is a measure of statistical significance reflecting the likelihood that an observed result occurred by chance and compares the indicated group to the relevant placebo EDS group. Unless otherwise noted, all p-values shown in this table represent nominal p-values (meaning they are exploratory, not type 1 error controlled) and therefore have an increased possibility of being a chance finding
b.This p-value for all patients receiving XHANCE 372 mcg in the ReOpen Program is a type 1 error controlled statistically significant result. All other p-values shown in this table are nominal p-values.
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized.
