$50 Million from Recent Financing Extends Expected Cash Runway Beyond the Expected PDUFA Action Date for XHANCE as a Treatment for Chronic Sinusitis
Revised Note Purchase Agreement Extends Start of Amortization to September 2025
YARDLEY, Pa., Nov. 30, 2022 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today provided corporate updates and announced that CEO Peter Miller will participate in a fireside chat at the 34th Annual Piper Sandler Healthcare Conference on December 1, 2022.
“The addition of cash from the recent financing and the amendment of our note purchase agreement with Pharmakon enable our organization to focus on XHANCE growth and the submission of a supplemental NDA in early 2023,” stated CEO Peter Miller. "We believe chronic sinusitis is an enormous opportunity relative to our current business with up to 10 times the number of diagnosed patients versus our current nasal polyps indication – many of whom are treated by the same physicians we call on today. We believe a first-ever approval in chronic sinusitis would be a significant advancement in care for patients and represents a valuable opportunity for our specialty business and a potential partner in primary care."
On November 23, 2022, the Company’s previously announced common stock and warrant financing closed resulting in approximately $50.0 million of gross proceeds to the Company, prior to deducting underwriting discounts and commissions and expenses payable by the Company. The Company expects that its current cash and cash equivalents (inclusive of the proceeds from the financing) will be sufficient to fund its operations and debt service obligations through the expected PDUFA action date for XHANCE as a treatment for chronic sinusitis in the fourth quarter of 2023.
Concurrent with the financing, the Company amended and restated its note purchase agreement with Pharmakon. The amended and restated agreement extends the interest only period from September 30, 2023 to September 30, 2025, extends the maturity date from September 30, 2024 to June 30, 2027, modifies the financial covenant requiring the Company to achieve minimum trailing twelve-month consolidated XHANCE net product sales and royalties (including eliminating such covenant until the twelve-month period ending March 31, 2024), and modifies certain other terms.
For additional details regarding the amended and restated Note Purchase Agreement, please review the Company’s recent SEC filings on Form 8-K. These filings are available on the Investors page of the Optinose website as well as at the SEC’s website sec.gov.
34th Annual Piper Sandler Healthcare Conference
Chief Executive Officer Peter Miller will present a company overview and business update at the 34th Annual Piper Sandler Healthcare Conference on December 1, 2022, at 12:30 p.m. ET. To listen to a webcast of the presentation live, please visit the Investors page of the Optinose website. A replay of the webcast will be available for 60 days following the conclusion of the event.
About the ReOpen Program
The ReOpen program comprises two global, randomized, double-blind, placebo-controlled Phase 3 trials that evaluated the efficacy and safety of one or two sprays of XHANCE (OPN-375) in each nostril twice daily, over 24 weeks, in patients suffering from chronic sinusitis (CS). In ReOpen1, the first of the two trials, 332 patients were treated who had CS with or without concurrent nasal polyps. In ReOpen2, the second of the two trials, 222 patients were treated who had CS, none of whom also had nasal polyps. The co-primary endpoints were change from baseline in symptoms, as measured by a composite score of patient-reported symptoms (including nasal congestion, facial pain or pressure, and nasal discharge) through week 4, and change in inflammation inside the sinus cavities, as measured by the change in the average of percentages of volume occupied by disease across the ethmoid and maxillary sinuses as measured by CT scan.
About Chronic Sinusitis
Chronic sinusitis (CS), cited as the second most common chronic disease of adults in the US1, is a serious chronic inflammatory disease affecting as many as 30 million adults in the United States and costing the U.S. economy over $30 billion in direct and indirect costs every year.2 CS is characterized by chronic inflammation affecting the paranasal sinuses and the nasal cavity, where the openings from the sinuses normally ventilate and drain. Chronic sinusitis is associated with symptoms that persist for at least 12 weeks, with most patients suffering for many years. In addition, the condition is often associated with multiple acute exacerbations that result in substantial use of antibiotics. In some patients, chronic sino-nasal inflammation is accompanied by development of polyps in the nasal cavities, referred to as nasal polyposis. Today, there are no FDA-approved drug treatments for the majority of chronic sinusitis patients who do not have nasal polyps, though there are medications, including XHANCE, approved by FDA for treatment of nasal polyps. The term “chronic rhinosinusitis” is also often used as an umbrella term in medical literature to refer to patients with chronic inflammatory disease in the nose and sinuses, with or without nasal polyps.
Optinose is a specialty pharmaceutical company focused on serving the needs of patients cared for by ear, nose and throat (ENT) and allergy specialists. To learn more, please visit www.optinose.com or follow us on Twitter and LinkedIn.
XHANCE is a drug-device combination product that uses the Exhalation Delivery System (also referred to as the EDS) designed to deliver a topical anti-inflammatory to the high and deep regions of the nasal cavity where sinuses ventilate and drain. XHANCE is approved by the U.S. Food and Drug Administration for the treatment of nasal polyps in patients 18 years of age or older and has been studied for treatment of chronic sinusitis in two phase 3 trials, ReOpen1 and ReOpen2. Top-line results from these trials are the first ever that we are aware of that show improvement in both symptoms and inflammation inside the sinuses, and reduction in acute exacerbations of disease, with a nasal therapy for chronic sinusitis patients, including patients with or without nasal polyps. If approved, XHANCE may be the first drug ever FDA-approved for treatment of chronic sinusitis either with or without nasal polyps.
Important Safety Information
CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE.
WARNINGS AND PRECAUTIONS:
- Local Nasal Effects: epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing. Monitor patients periodically for signs of possible changes on the nasal mucosa. Avoid use in patients with recent nasal ulcerations, nasal surgery, or nasal trauma.
- Close monitoring for glaucoma and cataracts is warranted.
- Hypersensitivity reactions (e.g., anaphylaxis, angioedema, urticaria, contact dermatitis, rash, hypotension, and bronchospasm) have been reported after administration of fluticasone propionate. Discontinue XHANCE if such reactions occur.
- Immunosuppression: potential increased susceptibility to or worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
- Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue XHANCE slowly.
- Patients with major risk factors for decreased bone mineral content should be monitored and treated with established standards of care.
ADVERSE REACTIONS: The most common adverse reactions (incidence ≥ 3%) are epistaxis, nasal septal ulceration, nasopharyngitis, nasal mucosal erythema, nasal mucosal ulcerations, nasal congestion, acute sinusitis, nasal septal erythema, headache, and pharyngitis.
DRUG INTERACTIONS: Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir, ketoconazole): Use not recommended. May increase risk of systemic corticosteroid effects.
USE IN SPECIFIC POPULATIONS: Hepatic impairment. Monitor patients for signs of increased drug exposure.
Please see full Prescribing Information.
- Hamilos DL. Chronic rhinosinusitis: epidemiology and medical management. J Allergy Clin Immunol. 2011 Oct;128(4):693-707; quiz 708-9. doi: 10.1016/j.jaci.2011.08.004. Epub 2011 Sep 3. PMID: 21890184.
- Palmer JN, Messina JC, Biletch R, Grosel K, Mahmoud RA. A cross-sectional, population-based survey of U.S. adults with symptoms of chronic rhinosinusitis. Allergy Asthma Proc. 2019 Jan 14;40(1):48-56. doi: 10.2500/aap.2019.40.4182. PMID: 30582496.
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 potential benefits of XHANCE for treating chronic sinusitis and reducing disease exacerbations; the Company's plans to seek approval for a follow-on indication for XHANCE for the treatment of chronic sinusitis and the potential benefits of such indication; the potential for XHANCE to be the first FDA-approved drug product for the treatment of chronic sinusitis; the Company plans to submit an sNDA for XHANCE as a treatment for chronic sinusitis in early 2023 and the expected PDUFA action date; the potential benefits of the modifications to the Company’s Note Purchase Agreement with Pharmakon; the Company’s expectation that its cash and cash equivalents will be sufficient to fund operations and its debt service obligations through the expected PDUFA action date for XHANCE as a treatment for chronic sinusitis in the fourth quarter of 2023; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives 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: potential for varying interpretation of the results from the ReOpen Trial program; uncertainties related to the clinical development program and regulatory approval of XHANCE for the treatment of chronic sinusitis; the prevalence of chronic sinusitis; market opportunities for XHANCE may be smaller than expected; the Company’s ability to grow XHANCE; unanticipated costs and expenses; the Company’s ability to comply with the covenants and other terms of the amended and restated Note Purchase Agreement with Pharmakon; risks and uncertainties relating to intellectual property; and the risks, uncertainties and other factors discussed under the caption "Item 1A. Risk Factors" and elsewhere in the Company’s most recent Form 10-K and Form 10-Q 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 the Company undertakes no obligation to update such forward-looking statements, whether as a result of new information, future developments or otherwise.
Optinose Investor/Media Contact