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OptiNose, Inc. (NASDAQ: OPTN), founded in 2010 and headquartered in Yardley, Pennsylvania, is a global specialty pharmaceutical company focused on improving the lives of patients treated by ear, nose, and throat (ENT) and allergy specialists. The company is known for its innovative approach to pharmaceutical development and commercialization, aiming to offer value to both the healthcare system and its stakeholders.
OptiNose's flagship product is XHANCE (fluticasone propionate) nasal spray, a unique therapeutic that utilizes the proprietary Exhalation Delivery System (EDS). This system delivers a topical corticosteroid deep into the nasal passages to treat chronic rhinosinusitis with nasal polyps. Unlike traditional nasal sprays, XHANCE targets inflammation high and deep within the nasal passages, reaching areas previously inaccessible by standard treatments.
Recently, XHANCE was approved by the FDA for the treatment of chronic rhinosinusitis without nasal polyps, expanding its potential patient base significantly. This approval was backed by robust clinical data from the ReOpen program, consisting of two global, randomized, double-blind, placebo-controlled Phase 3 trials. These trials demonstrated significant improvement in both symptoms and inflammation for patients with chronic sinusitis, with or without nasal polyps. Some common adverse reactions included epistaxis, headache, and nasopharyngitis, consistent with its labeled safety profile.
OptiNose continues to innovate, working on faster and cost-effective product developments and exploring new commercial models. The company collaborates with ENT and allergy specialists to bring breakthrough treatments to patients, focusing on efficiency and effectiveness in all its operations. OptiNose's commitment to values and ethical practices ensures their dedication to patient care and improved health outcomes.
For the latest updates and detailed information on OptiNose's financial performance, current projects, and strategic developments, visit their website or follow them on social media platforms like X and LinkedIn.
Optinose (NASDAQ:OPTN) will report its fourth quarter 2020 financial results and provide corporate updates on March 3, 2021, before market opening. A conference call with the leadership team is scheduled for 8:00 a.m. Eastern Time on the same day. CEO Peter Miller will present a company overview at the Cowen 41st Annual Health Care Conference on March 4, 2021, at 1:30 p.m. Eastern Time. Investors can access the conference call and webcast through the company's website, with replays available for a limited time.
Optinose (NASDAQ:OPTN) announced the granting of a non-qualified stock option for 15,000 shares to a new employee as an inducement for employment. The stock options were approved by the company’s Compensation Committee and granted outside of the 2010 Stock Incentive Plan, following Nasdaq Rule 5635(c)(4). The options have an exercise price of $4.12, based on the closing price on January 19, 2021, and will vest over four years, contingent on continued employment.
Optinose (NASDAQ: OPTN) announced the granting of non-qualified stock option awards for 35,000 shares of common stock to two new employees. These awards were approved by the Compensation Committee and adhere to Nasdaq Listing Rule 5635(c)(4). The exercise prices for the options are $4.56 and $4.34, reflecting the respective closing prices on the grant dates of December 7 and December 14, 2020. The options have a 10-year term and vest over four years, contingent upon continued service with the company.
Optinose (NASDAQ:OPTN) announced the appointment of Tomas J. Heyman as a new director, bringing extensive pharmaceutical industry experience, particularly in business development. He previously led Johnson & Johnson's venture capital group, managing around $1.5 billion in investments. William F. Doyle, a longstanding board member since 2010, will resign after the December 11, 2020 board meeting. Doyle played a crucial role in the strategic direction leading to FDA-approved products using Optinose's Exhalation Delivery System.
Optinose reported Q3 2020 net revenues of $15.4 million, a significant increase from $8.7 million in Q3 2019, driven by a 61% rise in total prescriptions for XHANCE. New prescriptions surged 23% from Q2 2020. The company exceeded its debt facility revenue threshold, allowing for an additional $20 million drawdown to bolster its cash position. However, net losses for the quarter were $21.2 million, or $0.43 per share. Optinose also anticipates $127-$132 million in total operating expenses for 2020, down from previous guidance.
Optinose (NASDAQ:OPTN) reported preliminary net revenues of $15.4 million for XHANCE® for Q3 2020, marking a 78% increase year-over-year and a 50% increase quarter-over-quarter. This growth allows the company to consider drawing an additional $20 million under its debt facility, potentially extending its cash runway. A full financial report is expected on November 5, 2020.
Optinose announced the publication of a peer-reviewed study demonstrating the efficacy of XHANCE (EDS-FLU) in patients with nasal polyps who remain symptomatic after standard nasal steroid treatments. The study, published in the International Forum of Allergy & Rhinology, shows that patients switching to XHANCE experienced significant improvement compared to those continuing conventional treatments. As XHANCE is FDA-approved for nasal polyps in adults, this data supports its role as an important treatment option before moving to surgery or biologics. The study analyzed pooled data from NAVIGATE I and II trials.
Optinose (NASDAQ: OPTN), a pharmaceutical company specializing in ear, nose, and throat (ENT) and allergy treatments, has announced that CEO Peter Miller will present a company overview and business update at the Cantor Virtual Global Healthcare Conference on September 16, 2020, at 2:00 p.m. ET. The presentation can be accessed via live webcast on the Optinose investors page, with a replay available for 30 days post-event. For further information, visit www.optinose.com.
Optinose (NASDAQ: OPTN) announced a public offering of 6,000,000 shares at $5.85 per share, with an additional 900,000 shares available to the underwriter. The offering is set to close on August 18, 2020, pending customary conditions. Proceeds will support working capital, the commercialization of XHANCE, and clinical development for both XHANCE in chronic sinusitis and OPN-019 for COVID-19. Credit Suisse is the sole bookrunner for the offering.
Optinose (NASDAQ: OPTN) has announced a proposed underwritten public offering of its common stock, in which all shares will be offered by the company. The underwriter will have a 30-day option to purchase an additional 15% of shares. Funds from the offering will be used for working capital, the commercialization of XHANCE, and clinical development of XHANCE for chronic sinusitis and OPN-019 for COVID-19. Credit Suisse Securities (USA) LLC is acting as the sole bookrunner. The offering is registered with the SEC under Form S-3.
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