Elinzanetant Significantly Reduces Frequency of Moderate to Severe Vasomotor Symptoms Associated With Endocrine Therapy for Breast Cancer in Phase III Oasis-4 Study
'Menopausal symptoms are frequent side effects of endocrine therapy for breast cancer, often leading to discontinuation, which is why management of these symptoms can play an important role in breast cancer treatment,' said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon Portugal. 'With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options.'
In OASIS-4, elinzanetant showed statistically significant mean reductions in frequency of VMS compared to placebo from baseline to week 4 with −6.5 (95% confidence interval [CI], −7.2 to −5.8) with elinzanetant and −3.0 (95% CI, −3.9 to −2.2) with placebo, with statistical significance between elinzanetant and placebo (least squares [LS] mean difference [95% CI]: −3.5 [−4.4, −2.6]; p<0.001). At week 12, reductions in VMS frequency were −7.8 (95% CI, −8.5 to −7.1) with elinzanetant and −4.2 (95% CI, −5.2 to −3.2) with placebo, with statistical significance between elinzanetant and placebo (LS mean difference [95% CI]: −3.4 [−4.2, −2.5]; p<0.001). The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data 1,2,3 on elinzanetant in postmenopausal women with VMS, with fatigue, somnolence and diarrhea being the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group.
The mean change in the PROMIS SD SF 8b total T score from baseline to week 12 was −10.6 points (95% CI, −11.5 to −9.6) in the elinzanetant group and −4.1 points (95% CI, −5.3 to −2.9) in the placebo (LS mean difference between the trial groups, −6.1 points; 95% CI, −7.5 to −4.8; p<0.001). The mean change in the MENQOL total score from baseline to week 12 was −1.3 points (95% CI, −1.4 to −1.2) in the elinzanetant group and −0.5 points (95% CI, −0.7 to −0.3) in the placebo group (LS mean difference between the trial groups, −0.7 points; 95% CI, −0.9 to −0.5; p<0.001). Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 with elinzanetant versus placebo.
'The results from OASIS-4 represent a potential advancement in addressing a need for women undergoing breast cancer treatment. Vasomotor symptoms associated with endocrine therapy can impact patients' quality of life and may impact their ability to adhere to other treatments,' said Dr. Christian Rommel, member of the Executive Committee of Bayer AG's Pharmaceutical Division and Global Head of Research and Development. 'Advancing elinzanetant as an investigational, hormone-free treatment option for these patients reaffirms our commitment at Bayer to bring forward innovative treatments for the different health needs of women.'
Breast cancer is the most commonly diagnosed cancer in women globally with 2.3 million new cases in 2020, and nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer. Treatment with adjuvant endocrine therapy (such as tamoxifen) for up to 10 years substantially reduces the breast cancer mortality rate throughout the two decades after diagnosis. 4 Endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. Side effects of endocrine therapy, such as VMS (also referred to as hot flashes), may affect quality of life and treatment compliance, with potential impact on recurrence. 5 Currently, there are no approved treatment options available. There is an unmet medical need for an effective hormone-free treatment for VMS associated with endocrine therapy.
Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Data from OASIS-1 and -2 were published in the Journal of the American Medical Association (JAMA) 3 in August 2024. Detailed results of the Phase III study OASIS-3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world.
About the Elinzanetant Clinical Development Program
The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS-3 investigated the efficacy and safety of elinzanetant for the treatment of VMS due to menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries. OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of VMS associated with endocrine therapy for treatment or prevention of HR+ breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer. 474 patients at 90 centers in 16 countries (excluding the US) were randomized.
About Elinzanetant
Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.
About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.
VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman's life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life.
VMS may also be caused by endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.
About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women's lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s. It can also be the result of surgical or medical treatment, such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman's health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Addressing these symptoms is key to maintaining functional ability and quality of life in menopause, which is highly relevant from both a healthcare and socio-economic perspective.
About Women's Healthcare at Bayer
Women's Health is in Bayer's DNA. As a global leader in women's healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, 'Health for all, Hunger for none,' the company's products and services are designed to help people, and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information, go to www.bayer.com.
Find more information at https://pharma.bayer.com/
Follow us on Facebook:
Follow us on LinkedIn: Bayer | Pharmaceuticals
kw (2025-0077E)
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
References
Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246.
Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 27 (5): 498-505.
https://jamanetwork.com/journals/jama/fullarticle/2822766
Davies C, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. The Lancet. 2013 Mar 9;381(9869):805-16.
Smith, K.L., Verma, N., Blackford, A.L. et al. Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation. npj Breast Cancer 8, 53 (2022). https://doi.org/10.1038/s41523-022-00414-0
Expand
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Business Wire
2 hours ago
- Business Wire
New England Journal of Medicine (NEJM) to Publish Results From Savara's Pivotal Phase 3 IMPALA-2 Clinical Trial in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
LANGHORNE, Pa.--(BUSINESS WIRE)-- Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced that the results from the Phase 3 IMPALA-2 clinical trial will be published online in NEJM. The manuscript, titled 'A Phase 3 Trial of Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis' Following the online publication in NEJM, the manuscript will be available on the Congresses & Publications page of the Company's corporate website. 'IMPALA-2, the largest and longest Phase 3 clinical trial conducted in patients with autoimmune PAP, demonstrated that 48 weeks of once daily administration of inhaled molgramostim addresses the underlying pathophysiology of this chronic rare lung disease,' said Bruce Trapnell, M.D., Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine and Lead Clinical Investigator of the IMPALA-2 trial. 'Treatment with molgramostim improved the cardinal manifestations of autoimmune PAP, namely it reduced pulmonary surfactant burden and improved pulmonary gas transfer, respiratory health-related quality of life, and patient functionality. Additionally, molgramostim was well tolerated with no notable safety concerns.' IMPALA-2 achieved statistical significance on its primary endpoint, change from baseline in the hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%) at Week 24. Molgramostim significantly improved pulmonary gas transfer as measured by DLco% at Week 24 compared with placebo (9.8% vs. 3.8%; estimated treatment difference, 6.0%; P<0.001 by comparison of least-squares means [LSMs]). The beneficial effect of molgramostim on pulmonary gas transfer was maintained to Week 48 as shown by the difference in LSM change from baseline in DLco% at Week 48 between molgramostim and placebo groups (11.6% vs. 4.7%; estimated treatment difference, 6.9%; P<0.001). The mean improvements in DLco% from baseline for molgramostim (9.8% at Week 24 and 11.6% at Week 48) are similar to the minimal clinically meaningful difference (MCID) in DLco% of 10% reported for pulmonary fibrosis. 1 Molgramostim improved respiratory health-related quality of life as measured by the St. George's Respiratory Questionnaire (SGRQ) Total and Activity scores. The magnitude of LSM reduction from baseline in SGRQ Total score was significantly greater in the molgramostim group than placebo at Week 24 (-11.5 points vs. -4.9 points, estimated difference, -6.6 points; P=0.007) and remained numerically greater at Week 48 (-10.7 points vs. -5.9 points, estimated difference, -4.9 points [95% confidence interval, -10.8, 1.0]). The LSM change from baseline in SGRQ Activity score was greater for molgramostim compared with placebo at Week 24 (-13.0 points vs. -5.2 points, estimated difference, -7.8 points [95% confidence interval, -14.1, -1.5]) and at Week 48 (-13.4 vs. -7.4 points, estimated difference, -6.0 points [95% confidence interval, -13.6, 1.6]). Molgramostim improved patient function as measured by exercise capacity (expressed as peak metabolic equivalents [METs]). A MET is a unit of resting oxygen uptake which measures energy expenditure. The LSM change from baseline in peak-METs was greater at Week 48 for molgramostim than placebo (1.1 vs. 0.6; estimated treatment difference, 0.6; [95% confidence interval, 0.1, 1.0]). Peak-METs is a clinically useful unit of measure reflecting exercise capacity, prognosis, and mortality in cardiovascular disease for which a 0.5-MET increase comprises a clinically useful measure of rehabilitation. 2 Using the treadmill test in IMPALA-2, the LSM change in peak-METs from baseline to Week 48 was 1.1 in molgramostim-treated patients and the between-group difference observed at Week 48 was 0.6 peak-METs. Molgramostim reduced surfactant burden as measured by ground glass opacity (GGO) score, an exploratory endpoint in IMPALA-2; GGO scores were determined by two blinded radiologists from a chest CT scan, with scores ranging from 0 to 15 (higher scores are worse). The mean reduction from baseline in GGO score was greater in the molgramostim group than the placebo group at Week 24 (-2.1 vs -1.1). Further, the number of patients who received ≥1 whole lung lavage as rescue therapy during the double-blind intervention period was lower with molgramostim than placebo (6 [7%] vs. 11 [13%]). In IMPALA-2, molgramostim was well tolerated. Most treatment-emergent adverse events (AEs) were mild or moderate, and few led to discontinuation, with 98% of patients in the molgramostim group and 96% of patients in the placebo group completing the 48-week double-blind period on treatment. About IMPALA-2 IMPALA-2 was a global, pivotal, Phase 3, 48-week, randomized, double-blind, placebo-controlled clinical trial designed to compare the efficacy and safety of molgramostim 300 mcg self-administered once daily by inhalation with matching placebo in patients with autoimmune PAP. The trial was conducted at 43 clinical trial sites across 16 countries, including the U.S., Canada, Japan, South Korea, Australia, and countries in Europe, including Turkey. The primary efficacy assessment was hemoglobin-adjusted percent predicted diffusing capacity of the lungs for carbon monoxide (DLco%), a gas transfer measure, and the primary endpoint was change from baseline to Week 24 in percent predicted DLco%, with a secondary endpoint of change from baseline to Week 48 in percent predicted DLco%. Three additional secondary efficacy variables evaluated clinical measures of patient benefit: St. George's Respiratory Questionnaire (SGRQ) Total score, SGRQ Activity score, and exercise capacity using a treadmill test, with each endpoint measured at Weeks 24 and 48. The primary time point for efficacy assessments was at Week 24; however, efficacy was assessed through Week 48 to evaluate durability of effect. Safety was assessed through Week 48. All patients who completed the 48-week double-blind treatment period continued into a 96-week open-label period during which molgramostim 300 mcg is administered once daily. Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutralized by antibodies against GM-CSF, rendering macrophages unable to adequately clear surfactant. As a result, an excess of surfactant accumulates in the alveoli, causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue. Patients may also experience episodes of fever, chest pain, or coughing up blood, especially if secondary infection develops. In the long term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant. About Savara Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases. Our lead program, molgramostim inhalation solution (molgramostim), is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP). Molgramostim is delivered via an investigational eFlow® Nebulizer System (PARI Pharma GmbH) specifically developed for inhalation of a large molecule. Our management team has significant experience in rare respiratory diseases and pulmonary medicine, identifying unmet needs, and effectively advancing product candidates to approval and commercialization. More information can be found at and LinkedIn. 1 Raghu G, et al. Am J Respir Crit Care Med 2022;205:e18-e47. 2 Ross R, et al. Circulation 2016;134:e653-e99; Grace SL, et al. Can J Cardiol 2014;30:945-8; Kehler DS, et al. J Cardiopulm Rehabil Prev 2017;37:250-6.
Business Wire
3 hours ago
- Business Wire
Life Sciences BC's 10th Annual Invest in BC Conference Connects Industry Leaders
VANCOUVER, British Columbia--(BUSINESS WIRE)--Life Sciences British Columbia (LSBC) is proud to present the 10th Annual Invest in BC, powered by Lumira Ventures, taking place October 28–29, 2025 at the Vancouver Convention Centre West. Celebrating a decade of impact, Invest in BC has become a cornerstone event for the province's thriving life sciences sector. It brings together investors, entrepreneurs, researchers, and industry leaders for two days of high-impact networking, strategic partnering, and investment exploration. Whether attending to pitch, partner, or learn, participants will find unparalleled opportunities to connect and collaborate. 'Invest in BC is where innovation meets opportunity,' said Wendy Hurlburt, President and CEO of Life Sciences BC. 'This event brings together the full spectrum of our ecosystem—from early-stage ventures to global industry leaders—to spark conversations, build relationships, and accelerate the future of health.' Event Highlights: 30+ companies pitching across Biotech, MedTech, and Digital Health Dedicated partnering sessions for one-on-one meetings Exhibitor booths showcasing cutting-edge industry solutions Panels featuring ecosystem thought leaders Networking to spark meaningful connections Companies Selected to Pitch Include: Arbutus Medical, ARC Medical, AVEE HEALTH, Bold Therapeutics, Careteam Technologies, eSense Health, Evolved Therapeutics, Eyam Health, EyecareX, GuideStar Medical Devices, HTuO Biosciences, Ikomed, ImageCyte Technologies, Integrated Nanotherapeutics, Kapoose Creek Bio, Molecular You, NZ Technologies, Optigo Biotherapeutics, Pramana Pharmaceuticals, Redwood AI, Reverb Therapeutics, Seragene Therapeutics, Sonic Incytes, Sonus Microsystems, Sustained Therapeutics, Total Flow Medical, Variational AI, Vesalius Cardiovascular, ViewsML Technologies, VoxCell BioInnovation, and Zymeworks. "British Columbia's world-leading life sciences and biomanufacturing ecosystem continues to thrive, with B.C. companies making lives better globally," said Ravi Kahlon, Minister of Jobs and Economic Growth. "As uncertainty and anti-science sentiment grow south of our borders, B.C. remains a stable, science-driven jurisdiction committed to life sciences research and commercialization. We're making it easier than ever for companies to do business in the province. I invite investors and entrepreneurs to join the momentum and grow their businesses in B.C." Thank You to Our Confirmed Supporters Invest in BC is made possible by the generous support of these organizations: Event Details: Dates Location: Vancouver Convention Centre West Secure Your Spot: Early registration available until September 26. For more information or to register, visit:
Business Wire
3 hours ago
- Business Wire
Sonendo Strengthens Leadership Team With Promotion of John McGaugh to Chief Operating Officer
LAGUNA HILLS, Calif.--(BUSINESS WIRE)--Sonendo, Inc. ('Sonendo' or the 'Company') (OTC Pink: SONX), a leading dental technology company and developer of the GentleWave® System, today announced the promotion of John McGaugh to Chief Operating Officer. Mr. McGaugh previously held the position of Senior Vice President of Operations. 'Since Sonendo embarked on its strategic reset in early-2024, the Company has stabilized revenue, generated significant leverage in gross margin, and meaningfully lowered total operating expenses, adjusted EBITDA loss and cash burn,' stated Bjarne Bergheim, President and Chief Executive Officer of Sonendo. 'John has been a significant contributor to all those improvements, and we expect he will continue to drive additional operating leverage as the Company continues to execute its plans to achieve profitability. John is a valuable member of the team, and I am excited to see him take on the role of Chief Operating Officer.' In addition to his previous responsibilities overseeing quality, manufacturing, supply chain, and technical services operations, Mr. McGaugh now has oversight of Sonendo's capital and consumables sales teams and commercial operations. Mr. McGaugh has over 20 years overseeing global manufacturing operations. He joined Sonendo in May 2023 and has been instrumental in leading significant operational efficiencies with console assembly and procedure instrument margin contributions. Prior to his time at Sonendo, Mr. McGaugh served as a multi-site operational leader for Abbott Vascular. In addition to his experience at Abbott, Mr. McGaugh has held leadership roles at Boston Scientific and American Medical Systems. About Sonendo Sonendo is a commercial-stage medical technology Company focused on saving teeth from tooth decay, the most prevalent chronic disease globally. Sonendo develops and manufactures the GentleWave® System, an innovative technology platform designed to treat tooth decay by cleaning and disinfecting the microscopic spaces within teeth without the need to remove tooth structure. The system utilizes a proprietary mechanism of action, which combines procedure fluid optimization, broad-spectrum acoustic energy and advanced fluid dynamics, to debride and disinfect deep regions of the complex root canal system in a less invasive procedure that preserves tooth structure. The clinical benefits of the GentleWave System when compared to conventional methods of root canal therapy include improved clinical outcomes, such as superior cleaning that is independent of root canal complexity and tooth anatomy, high and rapid rates of healing and minimal to no post-operative pain. In addition, the GentleWave System can improve the workflow and economics of dental practices. For more information about Sonendo and the GentleWave System, please visit To find a GentleWave doctor in your area, please visit Forward Looking Statements This news release includes forward-looking statements (statements which are not historical facts) within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the Company's ability to continue to drive additional operating leverage and/or execute its plans to achieve profitability, whether as a result of Mr. McGaugh or otherwise. You are cautioned that such statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions; speak only as of the date they are made; and, as a result, are subject to risks and uncertainties that may change at any time. Factors that could cause the Company's actual results to differ materially from these forward-looking statements are described in detail in the 'Risk Factors' section of the Company's Annual Report on Form 10-K that was filed with the Securities and Exchange Commission on March 26, 2025. Such filings are available at The Company undertakes no obligation to publicly update or revise forward-looking statements to reflect subsequent developments, events, or circumstances, except as may be required under applicable securities laws. Readers are cautioned not to put undue reliance on forward-looking statements, and the Company assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.
