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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 announced significant results from the Phase 3 ReOpen2 trial for XHANCE, a nasal therapy for chronic sinusitis without nasal polyps. The trial, involving 222 patients, showed marked improvement in both symptoms and inflammation, fulfilling co-primary endpoints. This is the first evidence supporting effective treatment for a large population lacking FDA-approved medications. With potential for a new indication, Optinose aims to expedite analyses of both ReOpen trials and pursue expanded access to XHANCE, promising new hope for millions affected by chronic sinus disease.
Optinose (NASDAQ:OPTN) announced key leadership changes as Keith A. Goldan, CFO, departs for another opportunity, effective June 10, 2022. Michele Janis, VP of Finance, is appointed Acting CFO, while Anthony Krick becomes Vice President and Chief Accounting Officer. CEO Peter Miller praised Goldan’s contributions during the company's transition to a public entity. Janis and Krick are expected to maintain strong financial oversight and investor communication.
Optinose (NASDAQ:OPTN) reported a 35% increase in net revenue for XHANCE, reaching $14.8 million in Q1 2022 compared to Q1 2021. The company anticipates full-year net revenue of at least $90 million for XHANCE. Notably, XHANCE prescriptions grew by 11%, with new prescriptions up 9%. The ReOpen1 clinical trial achieved both co-primary endpoints, showing significant improvement in chronic sinusitis patients. However, the company posted a net loss of $25.3 million for Q1 2022 and expects operating expenses between $135-$140 million for the year.
Optinose (NASDAQ:OPTN) will report its first-quarter 2022 financial results and corporate updates on May 12, 2022, before market open. A conference call hosted by the leadership team is scheduled for the same day at 8:00 a.m. Eastern Time. Participants can join the call by dialing the provided numbers or accessing a simultaneous webcast on the company’s website. A replay of the call will be available until May 19, 2022. Optinose specializes in pharmaceuticals for ear, nose, and throat (ENT) and allergy care, focusing on patient needs.
Optinose (NASDAQ:OPTN) announced the appointment of R. John Fletcher as a Class III director to its Board of Directors. He brings over 30 years of strategy and finance experience in the healthcare and pharmaceutical sectors. Fletcher’s previous roles include founding Fletcher Spaght Inc. and serving as a Senior Manager at The Boston Consulting Group. His expertise will contribute to enhancing shareholder value. The company also signed a Cooperation Agreement with Kingdon Capital and Velan Capital regarding this appointment.
Optinose (NASDAQ:OPTN), a specialty pharmaceutical company, will present a company overview and business update at the Needham Virtual Healthcare Conference on April 12, 2022, at 11:45 a.m. ET. Interested parties can listen to the live webcast on Optinose's Investors page, with a replay available for 60 days post-event. The company focuses on patients treated by ENT and allergy specialists. For more information, visit www.optinose.com.
Optinose reported a 52% increase in XHANCE net revenue to $73.7 million in 2021, with a 28% rise in total prescriptions. The company's net loss stood at $82.3 million, or $1.45 per share. For 2022, XHANCE revenue is projected to exceed $90 million, despite anticipated declines in early-year revenue and prescriptions. Top-line results from the ReOpen2 clinical trial are expected in Q2 2022. As of December 31, 2021, Optinose had cash reserves of $110.5 million following a $42.8 million public offering.
Optinose (NASDAQ:OPTN) announced that its XHANCE treatment met both co-primary endpoints in the ReOpen1 clinical trial for chronic sinusitis. The trial involved 332 patients and demonstrated statistically significant improvements in both symptom scores and CT scan results compared to a placebo. Given the absence of FDA-approved drug treatments for the estimated 30 million adults suffering from chronic sinusitis, this outcome is a potential breakthrough. Top-line results from the second trial, ReOpen2, are expected in Q2 2022.
Optinose (NASDAQ:OPTN) will report its Q4 2021 financial results and corporate updates on March 8, 2022, before market open. A conference call will follow at 8:00 a.m. ET for discussions on the results. The company’s CEO, Peter Miller, is set to present at the Cowen 42nd Annual Health Care Conference on March 9, 2022, at 2:10 p.m. ET. Interested parties can join the call via telephone or access a live webcast on the company’s website. A replay of both the conference call and the webcast will be available for 60 days.
Optinose (NASDAQ:OPTN) announced the appointment of Drs. Eric Bednarski and Kyle Dempsey to its Board of Directors. Both new directors bring extensive healthcare investment experience from MVM Partners, a growth equity firm. Eric, a seasoned investor, previously held positions at Advent Healthcare Ventures and Silicon Valley Bank. Kyle has a background in consulting at Bain & Company, emphasizing healthcare commercialization. Chairman Joe Scodari expressed confidence in their contributions, highlighting their expertise in global healthcare investments.
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