8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

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): October 8, 2017

Intersect ENT, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-36545	20-0280837
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

Intersect ENT, Inc.

1555 Adams Drive

Menlo Park, California 94025

(Address of principal executive offices, including zip code)

(650) 641-2100

(Registrant’s telephone number, including area code)

Not Applicable

(Former name or former address, if changed since last report.)

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:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(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).

Emerging growth company  ☐

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 October 8, 2017, Intersect ENT, Inc. (the “Company”) issued a press release announcing the presentation of the results of RESOLVE II, a pivotal phase III study evaluating the safety and efficacy of SINUVA™, an investigational steroid releasing sinus implant, at the 4th Congress of European ORL-HNS in Barcelona, Spain, by Robert C. Kern, M.D., Chairman of Otolaryngology – Head and Neck Surgery at Northwestern University Feinberg School of Medicine.

A copy of the Company’s press release and the presentation are furnished and attached as Exhibits 99.1 and 99.2, respectively.

The information in this Item 7.01 and Exhibits 99.1 and 99.2 of this Current Report on Form 8-K are being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”). The information in this Item 7.01 and Exhibits 99.1 and 99.2 shall not be deemed incorporated by reference in any filing under the Securities Act, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.	Description
99.1	Press release entitled “Intersect ENT Announces Presentation of Results from RESOLVE II, a Pivotal Phase III Study Evaluating the Safety and Efficacy of SINUVA™, an Investigational Steroid Releasing Sinus Implant” dated October 8, 2017.
99.2	Presentation entitled “The Role of Corticosteroid-Eluting Stents For The Management of Recurrent Nasal Polyposis,” dated October 8, 2017.

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.

	Intersect ENT, Inc.
Dated: October 10, 2017	By:	/s/ David A. Lehman
		David A. Lehman
		General Counsel

EX-99.1

Exhibit 99.1

Intersect ENT Announces Presentation of Results from RESOLVE II, a Pivotal Phase III Study Evaluating the Safety and Efficacy of SINUVA™, an Investigational Steroid Releasing Sinus Implant

MENLO PARK, Calif. & BARCELONA, Spain — Oct. 8, 2017 — Intersect ENT, Inc. (NASDAQ: XENT), a company seeking to improve the quality of life for patients with ear, nose and throat conditions, today announced the first presentation of results from RESOLVE II, a randomized, double-blinded, controlled Phase III clinical trial, which assessed the safety and efficacy of SINUVA™, an investigational steroid releasing sinus implant.

The RESOLVE II pivotal study assessed the implant in 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery at study entry because of recurrent, medically refractory symptoms and bilateral nasal polyposis. Patients were randomized to either a treatment group, undergoing bilateral implant placement in the office setting, or a control group, undergoing a sham procedure. Both groups used mometasone furoate nasal spray once daily (200 mcg) through 90-day follow-up.

Robert C. Kern, M.D., chairman of Otolaryngology – Head and Neck Surgery at Northwestern University Feinberg School of Medicine and national co-principal investigator of the study, presented the results today at the 4^th Congress of European ORL-HNS in Barcelona, Spain. As previously reported, the study met the co-primary efficacy endpoints and four pre-specified secondary efficacy endpoints:

• Reduction in proportion of patients still indicated for repeat endoscopic sinus surgery at day 90: 39% of the treatment group vs. 63% of control (p=0.0004)

• Reduction in percent ethmoid sinus obstruction from baseline to day 90, as determined by the independent, blinded panel (p=0.0007)

• Reduction in nasal obstruction/congestion score from baseline to day 90 (p=0.0248)

• Improvement in decreased sense of smell score from baseline to day 90 (p=0.0470)

Safety was evaluated by endoscopic examination and evaluation of adverse events. One serious implant-related adverse event, an intranasal bleed requiring intervention, was observed. The overall incidence of adverse events was similar between groups.

The company previously announced, in October 2016, positive clinical results from the RESOLVE II study, and in September 2017, a meta-analysis from the RESOLVE and RESOLVE II studies. The company also announced in May 2017 that the U.S. Food and Drug Administration (FDA) had set a PDUFA target action date for January 7, 2018 for the SINUVA New Drug Application (NDA).

A copy of Dr. Kern’s presentation of the RESOLVE II study results can be found on the “Investor Relations” page of the company’s web site at www.IntersectENT.com until October 13, 2017 and will be included in the company’s Form 8-K, to be filed on or about October 10, 2017.

About SINUVA Steroid Releasing Sinus Implant

SINUVA is an investigational steroid releasing sinus implant designed to be placed during a routine physician office visit to provide a less invasive treatment option for chronic sinusitis patients with recurrent nasal polyps. The implant releases mometasone furoate to the ethmoid sinus lining to target polyposis directly. It was designed with greater radial strength than Intersect ENT’s PROPEL products in order to dilate obstructed sinuses. SINUVA has not been approved by the FDA and is available for investigational use only.

About Intersect ENT^®

Intersect ENT is dedicated to transforming the landscape of care for patients with ear, nose and throat conditions. The company’s PROPEL family of dissolvable steroid releasing implants are clinically proven to improve outcomes for chronic sinusitis patients undergoing sinus surgery. In addition, Intersect ENT is continuing to expand its portfolio of products based on the company’s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost effective care.

For additional information on the company or the products including risks and benefits please visit www.IntersectENT.com.

Intersect ENT^® and PROPEL^® are registered trademarks and SINUVA is a trademark of Intersect ENT, Inc.

Forward-Looking Statements

The statements in this press release regarding Intersect ENT’s continued growth, product development and product adoption are “forward-looking” statements. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. These statements and risks include Intersect ENT’s ability to provide solutions to improve surgical outcomes, Intersect ENT’s ability to expand the use and adoption of its current products and advance its pipeline, Intersect ENT’s ability to obtain and maintain FDA or other regulatory approvals for our products, including SINUVA, and the ability to procure and maintain adequate coverage and reimbursement for our products and/or the procedures in which they are used. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties which are described in the company’s filings on Form 10-K, Form 10-Q and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.    

XENT-G	# # #
	Media Contact:	Nicole Osmer
		650.454.0504
		nosmer@intersectent.com
	Investor Contact:	Jeri Hilleman
		650.641.2105
		ir@intersectent.com

Intersect ENT | 1555 Adams Drive | Menlo Park, CA 94025 | 650.641.2100

EX-99.2

Exhibit 99.2

The role of corticosteroid-eluting stents for the management of recurrent nasal polyposis Robert C. Kern MD George A. Sisson Professor of Otolaryngology Chairman, Department of Otolaryngology-Head and Neck Surgery Northwestern University Feinberg School of Medicine Chicago, Illinois    

Disclosures Received research grants from NIH (Core PI) and Intersect ENT (Co-PI)    Received consulting fees from 480 Biomedical, Genentech, Sanofi, NUIG and GSK The steroid-releasing implant discussed in this presentation is not approved by the US FDA and has not received CE Mark. The implant is limited by the US law to investigational use only and is not for sale in any geography.    Intersect ENT provided funding, administrative support, and materials to complete this study. Sites were compensated for study-related labor and expenses in enrolling patients and acquiring data.

Chronic Rhinosinusitis with Nasal Polyps The multi-factorial pathophysiology of CRSwNP prevents long-term effectiveness of any single treatment option Medical management includes systemic and intranasal corticosteroids (INCS) Surgical treatment relieves blockage and improves ventilation o 40% recurrence rates of nasal polyps in 1.5 yr1 o Recurrent polyps positive predictor for revision surgery2 1DeConde et al Laryngoscope 2016;127:550-5 2Orlandi et al IFAR 2016;6S:S22-209

Investigational In-Office Therapy Designed for Nasal Polyps in CRS Patients An investigational corticosteroid-eluting, bioabsorbable sinus implant Designed to deliver 1350 mcg of mometasone furoate directly to the ethmoid sinus mucosa over approximately 90 days In-office placement under topical anesthesia The safety and efficacy evaluated in 4 studies                (2 RCTs, 1 Pilot, 1 PK), totaling 400 patients The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

The RESOLVE II Study Randomized, sham-controlled, double-blind, phase 3, pivotal trial To evaluate the safety and efficacy of the investigational sinus implant in adults with CRSwNP, who were indicated for repeat surgery to treat moderate-to-severe, medically-refractory symptoms of nasal obstruction/congestion and recurrent NPs in both ethmoid sinuses The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Patients CRSwNP Prior ESS, including bilateral total ethmoidectomy Indicated for revision ESS Persistent moderate-to-severe symptoms of nasal obstruction/congestion score ³ 2 (scale 0 to 3) on 5 out of 7 days despite ongoing INCS and recent course of high-dose steroids Post-nasal discharge, facial pain/pressure, or decreased sense of smell Bilateral ethmoid sinus polyps grade ³ 2 (scale 0 to 4 on each side) by an independent reviewer The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Methods N=300 34 clinical sites across the US Randomized 2:1 Treatment Implants + MFNS Baseline Screening Day 14 Day 30 Day 60 Day 90 Procedure Control Sham + MFNS eDiary Treatment group in-office bilateral implant placement in the ethmoid sinuses Control group in-office bilateral sham procedure All patients used mometasone furoate nasal spray (MFNS) once daily (200 mcg) through day 90 follow-up The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Methods Treatment Screening Implants + MFNS Baseline Day 60 Day 90 Reviewer Procedure Day 14 Day 30 Implant Panel grading Panel Control removal grading Sham + MFNS grading eDiary Screening NP grade confirmed by an independent reviewer Patients blinded to treatment assignment and masked/ear muffed during endoscopy Implants removed at day 60 to allow blinded video-endoscopy grading by an independent panel of 3 sinus surgeons Surgical or medical interventions allowed if medically necessary and imputed using most recent values prior to initiating or receiving intervention The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Assessment Patient-reported outcomes Endoscopic examination Adverse events The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Efficacy Endpoints Co-primary endpoints: Nasal obstruction/congestion score (scale 0-3), CFBL to day 30 Bilateral polyp grade (scale 0-8), CFBL to day 90 (an independent, blinded panel) 5 Prespecified secondary endpoints adjusted for multiplicity: Proportion of patients still indicated for repeat ESS at day 90 (investigators) Ethmoid sinus obstruction (100mm VAS), CFBL to day 90 (panel) Nasal obstruction/congestion score, CFBL to day 90 Decreased sense of smell score (scale 0-5), CFBL to day 90 Facial pain/pressure score (scale 0-5), CFBL to day 90 CFBL=change from baseline

Indication for Repeat ESS Criteria     SCREENING & DAY 90 Is the patient indicated for repeat ESS? Nasal polyp grade (on each side) Nasal Obstruction/Congestion score 0 1 2 ³3 1 (mild) NoNo No No 2 (moderate) NoNo Yes Yes 3 (severe) NoNo Yes Yes 11

Baseline Demographics & Clinical Characteristics Variable    Treatment Control Total no. of patients 20199 Age (y)50.5±12.947.9±12.4 Male subjects63.2%56.6% Number of prior ESS 141.3%41.4% ³258.7%58.6% Allergic rhinitis77.1%79.8% Asthma73.6%*61.6% AERD14.9%17.2% Nasal obstruction/congestion score (scale 0-3)2.4±0.52.4±0.5 Decreased sense of smell score (scale 0-5)4.1±1.44.1±1.4 Facial pain/pressure score (scale 0-5)1.9±1.42.2±1.4 Bilateral polyp grade (scale 0-8)6.0±0.95.9±1.0 * p <0.05

Co-Primary Efficacy Results Nasal Obstruction/Congestion Bilateral Polyp Grade (eDiary) (Independent Panel) 0 0 30 90 Day Day    to to baseline -0.5 Baseline -0.5 from    Change from p=0.0073 Change -1 -1 p=0.0074 Treatment Control Met both co-primary efficacy objectives The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not 13 currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Met 4 out of 5 Prespecified Secondary Endpoints Reduction in proportion of patients still indicated for repeat ESS at day 90 (p=0.0004) Reduction in percent ethmoid obstruction, CFBL to day 90 (panel) (p=0.0007) Reduction in nasal obstruction/congestion, CFBL to day 90 (p=0.0248) Improvement in sense of smell score, CFBL to day 90 (p=0.0470) Reduction in facial pain/pressure score, CFBL to day 90 (p=0.9130) The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Reduction in Proportion of Patients Still Indicated for Repeat ESS at Day 90 100% 90% .0004 80% p=0 -37% 70% 60% -61% 63% 50% 40% 30% 39% 20% 10% 0% Treatment Control The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Reduction in Bilateral Polyp Grade by Investigators Study Day 0 14 30 45 60 75 90 SEM) 0 ± -0.5 (mean Control -1 baseline -1.5 * from * -2 * Treatment* Change -2.5 * p-value < 0.05 * p<0.0001 The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Reduction in Nasal Obstruction/Congestion Score Study Day 0 14 30 45 60 75 90 SEM) 0 ± (mean -0.5 Control baseline     -1 * * from * Treatment Change -1.5 * p-value < 0.05 * p<0.05 The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Proportion of Patients Experiencing Improvement Variable Treatment Control P-value OR (95% CI) Nasal obstruction/congestion score 44.2% 25.8% 0.0022 1.72 (1.18, 2.49) ³1.0-point reduction to day 30 Bilateral polyp grade (panel) 36.4% 22.7% 0.0179 1.61 (1.06, 2.42) ³1.0-point reduction BL to day 90 Bilateral polyp grade (investigators) 72.0% 36.7% <0.0001 1.96 (1.49, 2.58) ³1.0-point reduction BL to day 90 The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Investigational Sinus Implant for In-Office Treatment of Nasal Polyps The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Safety 4 Serious adverse events in 3 patients (2 treatment and 1 control), but only 1 (0.5%) implant-related (epistaxis) Similar incidence of adverse events between treatment and control groups (45.3% vs. 37.4%) The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.

Conclusion The RESOLVE II study following in-office placement of the corticosteroid-releasing implants in patients with recurrent nasal polyps met both co-primary objectives: o Reduction in nasal obstruction/congestion and o Reduction in bilateral polyp grade The study also showed a reduction in the need for revision surgery. The steroid-eluting sinus implant discussed here is not approved by the US FDA and has not received CE Mark. The product is an investigational drug not currently available for sale in any geography. The steroid releasing implants are limited by federal (or US) law to investigational use only.