UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
____________________________________________________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 27, 2018
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OPTINOSE, INC.
(Exact Name of Registrant as Specified in its Charter)
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DELAWARE | 001-38241 | 42-1771610 |
(State or Other Jurisdiction of Incorporation or Organization) | (Commission File No.) | (I.R.S. Employer Identification No.) |
1020 Stony Hill Road, Suite 300
Yardley, Pennsylvania 19067
(Address of principal executive offices and zip code)
(267) 364-3500
(Registrant’s telephone number, including area code)
(Former name or former address, if changed from last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
q | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
q | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
q | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
q | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). | |
ý | Emerging growth company |
ý | If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. |
Item 7.01 Regulation FD Disclosure
On February 27, 2018, OptiNose, Inc. (the Company) announced that it will present clinical and health economic outcomes data at the 2018 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in Orlando, Florida, March 2 - 5, 2018. Abstracts are available on the AAAAI/WAO Joint Congress website.
In addition, the Company today announced it expects to make XHANCE (fluticasone propionate) nasal spray 93mcg available through retail pharmacies in early April 2018.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. | Description | |
99.1 | ||
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.
OptiNose, Inc. | ||
By: /s/ Keith A. Goldan | ||
Keith A. Goldan | ||
Chief Financial Officer | ||
Date: February 27, 2018
Exhibit 99.1
Optinose to Highlight Data at the 2018 AAAAI/WAO Joint Congress
Optinose expects to make XHANCE (fluticasone propionate) nasal spray 93mcg available through retail pharmacies in early April 2018
YARDLEY, Pa., Feb. 27, 2018- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today announced the Company will present clinical and health economic outcomes data at the 2018 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in Orlando, Florida, March 2 - 5, 2018. Abstracts are available on the AAAAI/WAO Joint Congress website.
In addition, the Company today announced it expects to make XHANCE available through retail pharmacies in early April 2018.
Optinose data is expected to be highlighted in six scientific posters accepted for presentation during this Joint Congress:
Poster Session #3209 - Chronic Rhinosinusitis: Quality of Life and Newer Therapies is scheduled on Sunday, March 4 from 9:45 a.m. to 10:45 a.m. in the Convention Center, South Concourse, Level 1, South Hall A2.
• | Poster 519: EDS-FLU Improves Quality of Life and Health Status: Pooled Analysis of Phase 3 Trials Navigate I and II |
• | Poster 523: Disease Burden of Chronic Rhinosinusitis (CRS) is as Severe as Other Serious Chronic Diseases |
• | Poster 524: Economic Impact Associated with a Reduction in Surgical Eligibility among Adult Patients with Chronic Rhinosinusitis - A Population Cost Offset Model |
• | Poster 527: Exhalation Delivery System with Fluticasone (EDS-FLU) Improves Health-Related Quality of Life (HRQoL) in Patients with Chronic Rhinosinusitis with Nasal Polyps: Results from NAVIGATE II |
Poster Session #3211 - Chronic Rhinosinusitis: With and Without Nasal Polyps is scheduled on Sunday, March 4 from 9:45 a.m. to 10:45 a.m. in the Convention Center, South Concourse, Level 1, South Hall A2.
• | Poster 534: Exhalation Delivery System with Fluticasone (EDS-FLU) Improves Outcomes in Chronic Rhinosinusitis without Nasal Polyps (CRSsNP) in Patients With or Without Recent Intranasal Steroid Use |
Poster Session #4212 - Allergic Rhinitis: Diagnosis and Treatment is scheduled on Monday, March 5 from 9:45 a.m. to 10:45 a.m. in the Convention Center, South Concourse, Level 1, South Hall A2.
Exhibit 99.1
• | Poster 867: Exhalation Delivery Systems (EDS) Greatly Increase Topical Delivery to Target Sites for Chronic Rhinosinusitis (CRS) Compared to Nasal Sprays or Pressurized MDIs (pMDI) |
The poster presentations are intended for scientific discussion only.
About Optinose
Optinose is a global specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. Optinose has offices in the U.S., the U.K. and Norway. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
Cautionary Note on Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements that are not historical facts are hereby identified as forward-looking statements for this purpose and include, among others, statements relating to: the planned retail availability of XHANCE in early April 2018 and other future events. Forward-looking statements are based upon management’s current expectations and assumptions and are subject to a number of risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: our ability to establish supply chain and commercial infrastructure and capabilities to launch XHANCE; physician and patient acceptance of XHANCE; our ability to obtain adequate third-party reimbursement for XHANCE; varying interpretation of clinical data; and the risks, uncertainties and other factors discussed in the “Risk Factors” section and elsewhere in our filings with the Securities and Exchange Commission - which are available at www.sec.gov. As a result, you are cautioned not to place undue reliance on any forward-looking statements. Any forward-looking statements made in this press release speak only as of the date of this press release, and we undertake no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Media Contact
Kate Traynor, Sloane & Company
Ktraynor@sloanepr.com
212.446.1871
Optinose Investor Contact
Jonathan Neely
Jonathan.neely@optinose.com
267.521.0531
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