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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 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.
Optinose (NASDAQ: OPTN) announced that it will report its second quarter 2020 financial results and corporate updates on August 4, 2020, before market open. The leadership team will host a conference call at 8:00 a.m. ET on the same day to discuss these results, including the launch of XHANCE®. Participants can join the call via U.S. or international numbers, with a replay available until August 11, 2020. The event will also be accessible through a webcast on Optinose's website.
Optinose (NASDAQ: OPTN) has appointed Catherine E. Owen to its Board of Directors. Catherine, currently Senior VP at Bristol-Myers Squibb, brings extensive global pharmaceutical experience, overseeing operations in 18 countries. Her background includes leadership roles at Johnson & Johnson, where she launched new products in immunology and infectious diseases. She began her career at AstraZeneca. Chairman Joe Scodari expressed confidence in her capabilities, emphasizing her strong marketing and strategic skills.
Optinose (NASDAQ: OPTN) has announced a co-promotion agreement with kaléo to promote XHANCE® (fluticasone propionate), an exhalation nasal spray for treating nasal polyps in adults in the U.S. The partnership aims to expand promotional reach to nearly 6,000 healthcare professionals, with kaléo leveraging its established relationships in the allergy sector. Promotional activities are expected to commence in Q4 2020. This collaboration aims to enhance awareness and usage of XHANCE in the target audience.
Optinose (NASDAQ: OPTN) has been recognized as one of the Philadelphia Business Journal’s “Best Places to Work” for 2020 in the medium-sized company category, marking the third consecutive year for this honor. The company, which employs over 200 people with a significant presence in Yardley, emphasizes a strong workplace culture and employee engagement, evidenced by an 84% participation rate in the related survey. Optinose focuses on improving the lives of patients served by ENT and allergy specialists and has made strides in launching its lead product, XHANCE.
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