Ritonavir

Conference Call and Webcast Today at 4:30 p.m. ET Development Program Highlights and Anticipated Milestones Ovaprene® hormone-free monthly intravaginal contraceptive candidate – pivotal Phase 3 contraceptive efficacy study recruiting across the United States; foundation grant announced yesterday will provide funding to allow Daré to expand the number of clinical sites to accelerate the development timeline Sildenafil Cream, 3.6% topical formulation of sildenafil being developed to treat female sexual arousal disorder - continued operational progress toward a planned Phase 3 study, including constructive discussions with FDA; Phase 3 design, development, and collaboration strategy updates DARE-HPV proprietary, fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert for the treatment of human papillomavirus (HPV)-related cervical diseases – conducting activities necessary to enable submission of an IND application to the FDA for a Phase 2, randomized, placebo-controlled, double-blind clinical study of DARE-HPV for clearance of high-risk HPV infection in women, which will be supported with funding Daré receives as an ARPA-H Sprint for Women’s Health $10 million awardee DARE-VVA1 proprietary formulation of tamoxifen for intravaginal administration being developed as a hormone-free alternative to estrogen-based therapies for the treatment of moderate-to-severe dyspareunia, or pain during sexual intercourse – conducting activities in preparation for a Phase 2 clinical study of DARE-VVA1 based on Daré's FDA-cleared IND DARE-PTB1 intravaginal ring designed to deliver bio-identical progesterone continuously for up to 14 days for the prevention of preterm birth – conducting activities necessary to enable submission of an IND application to the FDA for a Phase 1 clinical study, which will be supported by a $2 million grant from NICHD Foundation grant of up to approximately $10.7 million to fund activities related to the identification and development of a novel non-hormonal intravaginal contraceptive product candidate and to add additional clinical sites to accelerate the ongoing Ovaprene® pivotal study. SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today reported financial results for the quarter ended September 30, 2024 and provided a company update. “We continue to be excited about the increased attention on the health and wellbeing of women, including by the Advanced Research Projects Agency for Health (ARPA-H) as evidenced by their recent announcement related to the awardees of the ARPA-H Sprint for Women’s Health and our announcement of the $10 million award we were selected to receive for DARE-HPV, an innovative investigational treatment for HPV-related cervical diseases. Essentially all cervical cancer cases worldwide are caused by HPV infection. We are also very pleased by the foundation’s continued commitment to invest in the development of non-hormonal contraceptive methods as evidenced by the grant we announced yesterday of up to approximately $10.7 million to fund activities related to our identification and development of a novel non-hormonal intravaginal contraceptive product candidate and to add additional clinical sites to accelerate the ongoing Ovaprene® pivotal study.” “We continue to execute on our mission to accelerate development of and bring to market innovative treatments that women want and need by advancing our late-stage candidates – all of which represent a first-in-category opportunity – as we seek to deliver value for all Daré stakeholders. In addition to the continued commercialization by our collaborator Organon of XACIATO™ (clindamycin phosphate) vaginal gel 2%, the first FDA-approved product to emerge from our portfolio and a treatment for bacterial vaginosis in females aged 12 and older* that is available by prescription nationwide, we continue to advance our first-in-category Phase 3 development candidates with ongoing enrollment in our Phase 3 study of Ovaprene at sites across the U.S., and continued constructive interactions with the FDA focused on aligning on the Phase 3 program for Sildenafil Cream 3.6% in female sexual arousal disorder. Despite its high prevalence, there are currently no FDA-approved treatments for female sexual arousal disorder and we look forward to advancing this program into Phase 3. Additionally, we are conducting activities in preparation for a Phase 2 clinical study of DARE-VVA1 and a Phase 1 study of DARE-PTB1, which is supported by a $2 million grant from NICHD,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “The progress across our portfolio, along with the $10.7 million grant agreement announced yesterday, the $10 million award from ARPA-H announced in October, the $15 million equity line arrangement we established with Lincoln Park Capital Fund, LLC in October, and the $22 million we secured in the non-dilutive strategic royalty financing in the second quarter, put Daré on track for meaningful milestones in 2025.” *Please see below for important safety and other information. Ovaprene® Phase 3 StudyOvaprene is a novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare. Working with study collaborators at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) and commercial collaborator Bayer, Daré commenced patient enrollment in the Ovaprene® pivotal Phase 3 clinical study in December 2023. Non-hormonal contraception represents a significant commercial market opportunity, and there are currently no monthly, hormone-free contraceptives approved by the U.S. Food and Drug Administration (FDA). Ovaprene® has potential to be a disruptive product in the contraceptive category and an important option for women who cannot use hormone-based birth control products or prefer not to do so. Recruitment is currently proceeding at 10 sites across the United States, supported by a central advertising campaign for the study that launched in March 2024. Based on the current average enrollment rate, Daré anticipates that approximately half of its target number of participants to complete the study, or 125 women, will complete approximately 6 months of product use by the end of the second quarter of 2025. The foundation grant announced yesterday will provide funding to allow Daré to expand the number of clinical sites recruiting in the study, which is intended to accelerate the overall development timeline. Sildenafil Cream, 3.6% Progress toward Phase 3 StudySildenafil Cream is a proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra®, for topical on-demand administration to treat female sexual arousal disorder (FSAD). Daré completed all study analyses of data from the exploratory Phase 2b RESPOND clinical study and held an end-of-Phase 2 meeting with the FDA in December 2023. In prior quantitative studies, Sildenafil Cream increased genital tissue blood flow, and the Phase 2b at-home study was specifically designed to identify the patient population that experienced the most meaningful improvement from Sildenafil Cream and the questions to ask them that best reflect that improvement. The patient population and the endpoints proposed to the FDA for Phase 3 clinical development were those where Daré's exploratory post-hoc analyses of the Phase 2b study data showed that Sildenafil Cream demonstrated statistically significant and meaningful patient improvement. Ongoing discussions with the FDA are focused on aligning on primary and secondary patient reported outcome endpoints for the Phase 3 studies as well as other data that might be required for a new drug application (NDA) submission. Based on FDA feedback Daré has received, two successful Phase 3 clinical studies of Sildenafil Cream will be required to support an NDA for Sildenafil Cream for the treatment of FSAD, and Daré anticipates that each Phase 3 study will be approximately $15.0 million in direct costs. Daré will take into account its capital resources before initiating a Phase 3 study. Daré’s planned initial Phase 3 study of Sildenafil Cream, 3.6% would be the first ever Phase 3 pivotal study of a therapeutic candidate for the treatment of arousal disorder in women. Daré intends to provide updates on the Phase 3 program, as well as relevant updates on the initial Phase 3 study timing and Daré’s collaboration strategy as they become available. Financial Highlights for the Quarter ended September 30, 2024 Cash and cash equivalents: $11.2 million at September 30, 2024. General and administrative expenses: $2.0 million in 3Q-2024 as compared to $2.7 million in 3Q-2023, with the current quarter’s decrease primarily attributable to reduced professional services expense and reduced commercial readiness expenses. Research and development expenses: $2.7 million in 3Q-2024 as compared to $6.7 million in 3Q-2023, a 60% decrease compared to Q3-2023, with the current quarter’s decrease primarily attributable to a decrease in costs related to development activities for Sildenafil Cream as a result of the Phase 2b RESPOND clinical study completion in June 2023, partially offset by increases in costs related to Ovaprene’s development, including the ongoing pivotal Phase 3 clinical trial. Conference Call Daré will host a conference call and live webcast today, November 14, 2024, at 4:30 p.m. Eastern Time to review financial results for the quarter ended September 30, 2024 and to provide a company update. To access the conference call via phone, dial (646) 307-1963 (U.S.) or (800) 715-9871 (toll free). The conference ID number for the call is 6400145. The live webcast can be accessed under “Presentations, Events & Webcasts” in the Investors section of the company's website at http://ir.darebioscience.com. Please log in approximately 5-10 minutes prior to the call to register and to download and install any necessary software. The webcast will be archived under “Presentations, Events & Webcasts” in the Investors section of the company's website at http://ir.darebioscience.com and available for replay until November 28, 2024. About XACIATO™ (clindamycin phosphate) vaginal gel 2% XACIATO is indicated for the treatment of bacterial vaginosis in females 12 years and older. A single-dose user-filled disposable applicator delivers 5g of vaginal gel containing 100mg of clindamycin. Selected Safety Information XACIATO is contraindicated in individuals with a history of hypersensitivity to clindamycin or lincomycin. Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Polyurethane condoms are not recommended during treatment with XACIATO or for 7 days following treatment. During this time period, polyurethane condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases. Latex or polyisoprene condoms should be used. XACIATO may result in the overgrowth of Candida spp. in the vagina resulting in vulvovaginal candidiasis, which may require antifungal treatment. The most common adverse reactions reported in >2% of patients and at a higher rate in the XACIATO group than in the placebo group were vulvovaginal candidiasis and vulvovaginal discomfort. XACIATO has not been studied in pregnant women. However, based on the low systemic absorption of XACIATO following the intravaginal route of administration in nonpregnant women, maternal use is not likely to result in significant fetal exposure to the drug. There are no data on the effect of clindamycin on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for clindamycin and any potential adverse effects on the breastfed child from clindamycin or from the underlying maternal condition. Please see the Prescribing Information, Patient Information, and Instructions for Use. About Daré Bioscience Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, sexual health, pelvic pain, fertility, infectious diseases, and menopause. The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older, which is under a global license agreement with Organon. Visit www.xaciato.com for information about XACIATO. Daré’s portfolio also includes potential first-in-category candidates in clinical development: Ovaprene®, a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra®, to treat female sexual arousal disorder (FSAD); and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more about Daré’s full portfolio of women’s health product candidates and mission to deliver differentiated therapies for women, please visit www.darebioscience.com. Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards. Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website. Forward-Looking Statements Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “project,” “target,” “objective,” “on track,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to plans and expectations with respect to Daré’s product candidates, including clinical development plans, trial design, timelines, costs, milestones, targeted indications, anticipated regulatory approval pathways, and potential alignment with the FDA on requirements for a successful NDA submission, the potential for FDA approval of Ovaprene based on a single pivotal clinical study, the expectation that a product candidate, if approved, could be a first-in-category product, the potential market size and opportunity for a product candidate, if approved, the amount and timing of Daré’s receipt of funds under the recently announced foundation grant agreement, Daré’s anticipated use of funds it receives and Daré’s expectations with respect to the impact of such grant funding on its Ovaprene development program, the expectation that Daré will receive $10 million in funding under ARPA-H’s Sprint for Women’s Health, Daré’s ability to access $15 million in additional capital under its equity line arrangement with Lincoln Park Capital Fund at times and in amounts it desires to help advance development of its investigational products, and the potential for Daré’s product candidates to demonstrate they are safe and effective for their respective target indications. As used in this press release, the description of a product candidate as “first-in-category” is a forward-looking statement relating to the potential of the candidate to represent a new category of product if it were to receive marketing approval for the indication for which Daré is developing it. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Daré’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, without limitation, risks and uncertainties related to: Daré’s ability to raise additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern; Daré’s ability to achieve the product development and other milestones required for it to receive payments under its ARPA-H funding award and grant agreements with the foundation; the limits on Daré’s ability to sell stock to Lincoln Park Capital Fund under the purchase agreement at times it may desire to raise additional capital; Daré’s ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate; Daré’s ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of its product candidates; Daré’s ability to add new clinical study sites to the Ovaprene pivotal study and the ability of such additional sites to enroll subjects in a manner that accelerates the study timeline; Daré’s dependence on third parties to conduct clinical trials and manufacture and supply clinical trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that the FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Daré’s interpretation of or conclusions regarding data from clinical studies of its product candidates; the risk that development of a product candidate requires more clinical or nonclinical studies than Daré anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions, geopolitical events, public health emergencies, and major disruptions in government operations on Daré’s operations, financial results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers; Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’s ability to satisfy the monetary obligations and other requirements in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its product and product candidates; Daré’s ability to adequately protect or enforce its, or its licensor’s, intellectual property rights; the lack of patent protection for the active ingredients in certain of Daré’s product candidates which could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental investigations or actions relating to Daré’s product or product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. Contacts: Daré Bioscience Investor Relationsinnovations@darebioscience.com Source: Daré Bioscience, Inc. Daré Bioscience, Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) Three months ended September 30, 2024 2023 Revenue License fee revenue$- $1,000,000 Royalty revenue 41,691 - Total revenue 41,691 1,000,000 Operating expenses General and administrative 2,041,268 2,696,779 Research and development 2,656,772 6,674,636 License fee expense 25,000 25,000 Total operating expenses 4,723,040 9,396,415 Loss from operations (4,681,349) (8,396,415) Other income (expense) (21,152) 97,319 Net loss$(4,702,501) $(8,299,096) Foreign currency translation adjustments$22,935 $(15,030) Comprehensive loss$(4,679,566) $(8,314,126) Loss per common share: Basic$(0.55) $(1.09) Diluted$(0.55) $(1.09) Weighted average number of shares outstanding: Basic 8,534,433 7,587,637 Diluted 8,534,433 7,587,637 Daré Bioscience, Inc. and Subsidiaries Condensed Consolidated Balance Sheets Data September 30,2024 December 31,2023 (unaudited) Cash and cash equivalents$11,232,609 $10,476,056 Working capital (deficit)$1,790,546 $(2,936,897) Total assets$18,058,801 $21,282,215 Total stockholders' deficit$(1,484,483) $(5,047,640)

Company reports Q3 2024 XHANCE net revenue of $20.4 million, an increase of 3% compared to Q3 2023 Company reports positive inflection in new prescriptions of XHANCE starting in September Company decreases full year 2024 XHANCE net revenue guidance to be between $75.0 to $79.0 million and increases expected average net revenue per prescription guidance to be approximately $270 Company decreases full year 2024 operating expenses guidance to be between $90.0 to $93.0 million Conference call and webcast to be held today at 8:00 a.m. Eastern Time YARDLEY, Pa., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Optinose (NASDAQ:OPTN), a pharmaceutical company focused on patients treated by ear, nose and throat (ENT) and allergy specialists, today reported financial results for the quarter ended September 30, 2024, and provided recent operational highlights. “While our revenue in third quarter was not in line with our expectations, we believe that we are now observing a clear inflection in new prescription demand," stated CEO Ramy Mahmoud, MD, MPH. "We believe the recent accelerating trend in new prescription demand reinforces the magnitude of the longer-term opportunity. In addition, we believe that our experience in the initial phases of the launch has improved our understanding of the key drivers of adoption and that this experience will help support achievement of our peak year objective." Third Quarter 2024 and Recent Highlights New Prescriptions (NRx)The four-week moving average of weekly NRx ranged between approximately 1,760 to 1,960 for the weeks ended June 28, 2024 through September 6, 2024. With the inflection first observed in September, the moving average increased to approximately 2,300 to 2,500 NRx per week in October (through the week ended October 25) an increase of approximately 20% to 40% percent compared to the prior range. In addition, NRx for the most recent six weeks ending the week of October 25th include the top five ranked weeks for NRx in 2024. Third Quarter 2024 Financial Results Total revenuesThe Company reported $20.4 million in net revenue from sales of XHANCE during the three-month period ended September 30, 2024, an increase of 3% compared to $19.8 million during the three-month period ended September 30, 2023. For the nine-month period ended September 30, 2024, the Company reported $55.8 million in net revenue from sales of XHANCE, an increase of 9% compared to the nine-month period ended September 30, 2023. Costs and expenses and net lossFor the three-month and nine-month periods ended September 30, 2024, research and development expenses were $0.9 million and $3.1 million, respectively. Selling, general and administrative expenses were $19.5 million and $64.1 million, respectively, for the three-month and nine-month periods ended September 30, 2024. The net income for the three-month period ended September 30, 2024 was $0.5 million, or $0.00 per share (diluted). The net loss for the nine-month period ended September 30, 2024 was $21.2 million, or $0.20 per share (diluted). Balance SheetThe Company had cash and cash equivalents of $82.5 million as of September 30, 2024. Financial Guidance XHANCE Net Revenue The Company expects XHANCE net revenues for the full year of 2024 to be between $75.0 to $79.0 million. Previously the Company expected XHANCE net revenues for the full year of 2024 to be between $85.0 to $90.0 million. XHANCE Average Net Revenue per PrescriptionThe Company expects full year 2024 XHANCE average net revenue per prescription to be approximately $270. Previously the Company expected full year 2024 XHANCE average net revenue per prescription to exceed $250. Operating ExpensesThe Company expects total GAAP operating expenses (selling, general & administrative expenses and research & development expenses) for 2024 to be between $90.0 to $93.0 million, of which the Company expects stock-based compensation to be approximately $6.0 million. Previously the Company expected total GAAP operating expenses for 2024 to be between $95.0 to $101.0 million, of which the Company expected stock-based compensation to be approximately $6.0 million. Company to Host Conference CallMembers of the Company’s leadership team will host a conference call and presentation to discuss financial results and corporate updates beginning at 8:00 a.m. Eastern Time today. Participants may access the conference call live via webcast by visiting the Investors section of Optinose’s website at http://ir.optinose.com/presentations. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number and a personal PIN that can be used to access the call. In addition, a replay of the webcast will be available on the Company website for 60 days following the event. OptiNose, Inc.Condensed Consolidated Statement of Operations(in thousands, except share and per share data)(Unaudited) Three Months Ended Nine Months Ended September 30, September 30, 2024 2023 2024 2023 Revenues: Net product revenues $20,437 $19,823 $55,807 $51,122 Total revenues 20,437 19,823 55,807 51,122 Costs and expenses: Cost of product sales $2,065 $2,225 $5,277 $6,502 Research and development 949 1,281 3,083 4,017 Selling, general and administrative 19,475 18,011 64,121 60,839 Total costs and expenses 22,489 21,517 72,481 71,358 Loss from operations (2,052) (1,694) (16,674) (20,236)Other (income) expense (2,519) 7,600 4,507 5,280 Net income (loss) $467 $(9,294) $(21,181) $(25,516) Less: undistributed earnings to participating shareholders (74) — — — Net income (loss) - basic $393 $(9,294) $(21,181) $(25,516)Net income (loss) per share of common stock - basic $— $(0.08) $(0.15) $(0.23)Weighted average common shares outstanding - basic 174,328,570 112,230,155 144,900,726 111,996,456 Net income (loss) - basic $393 $(9,294) $(21,181) $(25,516)Add: Unrealized gain on the fair value of warrants — — (8,700) — Net income (loss) - diluted $393 $(9,294) $(29,881) $(25,516)Net income (loss) per share of common stock - diluted $— $(0.08) $(0.20) $(0.23)Weighted average common shares outstanding - diluted 174,369,875 112,230,155 149,634,133 111,996,456 OptiNose, Inc.Condensed Consolidated Balance Sheet Data(in thousands) September 30, December 31, 2024 2023 (unaudited) Cash and cash equivalents $82,497 $73,684 Other assets 48,523 34,045 Total assets $131,020 $107,729 Total current liabilities (1) $162,430 $176,524 Other liabilities 9,687 17,811 Total stockholders' equity (41,097) (86,606)Total liabilities and stockholders' equity $131,020 $107,729 (1) – All outstanding principal and fees payable upon maturity have been classified as a current liability in accordance with Generally Accepted Accounting Principles ("GAAP") because, as of the date hereof, the Company believes that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months. As a result, the Company's unaudited financial statements for the three and nine months ended September 30, 2024 (“3Q2024 Financial Statements”) will state that there is substantial doubt about the Company's ability to continue as a going concern (i.e., a "going concern" paragraph). Please refer to the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2024 (including the 3Q2024 Financial Statements) which will be filed after the issuance of this press release for additional information. About OptinoseOptinose 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, visit www.optinose.com or follow us on X and LinkedIn. About XHANCEXHANCE is a drug-device combination product that uses the Exhalation Delivery System™ (also referred to as the EDS®) designed to deliver a topical steroid 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 both the treatment of chronic rhinosinusitis without nasal polyps (also called chronic sinusitis) and chronic rhinosinusitis with nasal polyps (also called nasal polyps) in patients 18 years of age or older. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS: Hypersensitivity to any ingredient in XHANCE. WARNINGS AND PRECAUTIONS: Local nasal adverse reactions, including epistaxis, erosion, ulceration, septal perforation, Candida albicans infection, and impaired wound healing, can occur. 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 until healing has occurred.Glaucoma and cataracts may occur with long-term use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use XHANCE long-term.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 and infections can occur, including 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.Assess for decrease in bone mineral density initially and periodically thereafter. ADVERSE REACTIONS: Chronic rhinosinusitis without nasal polyps: The most common adverse reactions (incidence ≥3%) are epistaxis, headache, and nasopharyngitis.Chronic rhinosinusitis with nasal polyps: 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, including Instructions for Use. 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 as the first FDA-approved drug treatment for chronic rhinosinusitis without nasal polyps (also referred to as chronic sinusitis) and expanded market opportunities relating thereto; the potential benefits of the Exhalation Delivery System; the Company’s expectations for XHANCE net revenue and average net revenue per prescription for full year 2024; the Company’s expectations for GAAP operating expenses (selling, general and administrative expenses and research & development expenses) and stock-based compensation for 2024; key drivers that generate promotional response for XHANCE; the Company's believe that the inflection in new prescription demand which started in September reinforces the magnitude of the longer-term opportunity for XHANCE; the Company's belief that its experience in the initial phases of the launch has improved its understanding of the key drivers of adoption and that this experience will help support achievement of its peak year objective for XHANCE; the Company's belief that it is probable that it will not maintain compliance with certain financial covenants contained in its Amended and Restated Note Purchase Agreement for at least the next 12-months and the consequences thereof; and other statements regarding the Company's future operations, financial performance, financial position, prospects, objectives, strategies 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: physician and patient acceptance of XHANCE for its new indication; the Company’s ability to maintain adequate third-party reimbursement for XHANCE (including its new indication); the prevalence of chronic sinusitis and market opportunities for XHANCE may be smaller than expected; the Company’s ability to efficiently generate XHANCE prescriptions and net revenues; unanticipated costs and expenses; the Company's ability to achieve its financial guidance; the risk that the positive inflection in new XHANCE prescriptions starting in September does not continue and grow; the Company’s ability to comply with the covenants and other terms of its Amended and Restated Note Purchase Agreement; the Company’s ability to continue as a going concern; risks and uncertainties relating to intellectual property and competitive products; 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 Contact Jonathan Neely jonathan.neely@optinose.com 267.521.0531