Medicis Pharmaceutical Corp.

– Developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions – – Lead clinical program, KAI-9531, an injectable GLP-1/GIP receptor dual agonist, demonstrated compelling results in Phase 2 trials in obesity and type 2 diabetes – – Ron Renaud, Chief Executive Officer, will lead seasoned executive team with deep industry expertise; Industry veteran John F. Milligan named Chair of the Board – – Financing co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital – BOSTON, Oct. 01, 2024 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (“Kailera” or “the Company”), today announced its launch as a clinical-stage biopharmaceutical company focused on advancing a broad pipeline of next-generation therapies for the treatment of obesity and related conditions. Kailera launches with a $400 million Series A financing co-led by Atlas Venture, Bain Capital Life Sciences, and RTW Investments, with participation from Lyra Capital. The Company is developing several clinical-stage injectable and oral therapies that have demonstrated potential as best-in-class treatments for chronic weight management. Kailera acquired exclusive rights for global development and commercialization of a portfolio of four metabolic disease assets outside of greater China from Jiangsu Hengrui Pharmaceuticals Co., Ltd (Hengrui), a leading global pharmaceutical company, in May 2024. Kailera’s most advanced program, KAI-9531 (in development as HRS9531 in China) is an injectable GLP-1/GIP (glucagon-like peptide-1, glucose-dependent insulinotropic polypeptide) receptor dual agonist that demonstrated compelling results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including KAI-7535, a clinical-stage oral small molecule GLP-1 receptor agonist, KAI-9531 formulated as a once-daily oral tablet, and KAI-4729, an injectable GLP-1/GIP/glucagon receptor tri-agonist. “In this period of rapid innovation in the metabolic space, I believe that Kailera is poised to make an impact beyond the current market leaders. We have an incredible opportunity to develop next-generation treatments for chronic weight management, helping people reclaim their health and live their lives to the fullest,” said Ron Renaud, Chief Executive Officer, Kailera Therapeutics. "With a clinically-advanced, differentiated pipeline, a talented and experienced team with a track record for building companies with lasting impact, and the support of a world-class investor syndicate, we are uniquely positioned to advance innovative therapies that have the potential to meaningfully impact both quality of life and overall health for many people.” Mr. Renaud brings more than 25 years of biotech leadership to Kailera, with deep expertise in executive leadership, finance, and operations. As CEO of Cerevel Therapeutics, he guided the company through significant milestones, culminating in its acquisition by AbbVie in 2024. Previously, Mr. Renaud spearheaded Translate Bio’s growth from an early-stage startup to a publicly traded company, establishing it as a leader in mRNA technology. As CEO of Idenix Pharmaceuticals, he streamlined operations and built a robust promising portfolio of potential treatments for hepatitis C. In conjunction with the launch, the Company also announced several key leadership appointments. Kailera’s seasoned management team brings deep industry experience and will be responsible for establishing operational infrastructure and driving critical milestones. The initial Kailera executive leadership team appointments include: Doug Bakan, Ph.D., Chief Technology Officer, formerly of Ventyx Biosciences, Arena Pharmaceuticals, and Medicis PharmaceuticalPaul Burgess, Chief Operating Officer and Chief Business Officer, formerly of Cerevel Therapeutics, Translate Bio, and CivitasPaula Cloghessy, Chief People Officer, formerly of Seres Therapeutics, Translate Bio, and Joule Unlimited TechnologiesScott Wasserman, M.D., Chief Medical Officer, formerly of Frazier Life Sciences, Latigo Biotherapeutics, and Amgen Additionally, John F. Milligan, Ph.D., has joined the Board of Directors as Chair. Dr. Milligan previously served as the President and Chief Executive Officer of Gilead Sciences, where he was instrumental in transforming the company from an early-stage private company into a global, multi-billion-dollar leader in biopharmaceuticals. Over the course of his three-decade tenure, he helped establish Gilead’s global presence and played a key role in the development and commercialization of over 25 innovative therapies, including the development of groundbreaking treatments for HIV and HCV. “I’m thrilled to join Kailera in their commitment to deliver next-generation therapies for obesity and related conditions,” said Dr. Milligan. “I look forward to working with the Kailera team to advance therapies with the potential to more comprehensively meet patients’ needs in short and long-term weight management and metabolic diseases, with a focus on improved efficacy and tolerability.” About Kailera TherapeuticsKailera Therapeutics (Kailera) is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions. Kailera’s most advanced program, KAI-9531 (being developed in China as HRS9531), is an injectable GLP-1/GIP receptor dual agonist that demonstrated positive results in Phase 2 trials in obesity and type 2 diabetes in China. The Company is also advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration. Kailera’s mission is to develop next-generation weight management therapies that give people the power to transform their lives and elevate their overall health. The Company is based in Waltham, MA and San Diego, CA. For more information, visit www.kailera.com and follow us on LinkedIn and X. Contact Information Maura GavaghanVice President, Corporate Communications and Investor Relationsmaura.gavaghan@kailera.com

Strategic focus shifting to advance core NPS™ technology in cardiac and oncology sectors, activate additional executive leadership and reduce dermatologic footprint. Former Chief Commercial Officer, Kevin Danahy, appointed Chief Executive Officer; Former Chief Executive Officer Darrin Uecker to serve as Chief Technology Officer; Robert W. Duggan appointed as Executive Chairman; Joe Talarico to assume VP Business Development position. Robert Duggan and the Company enter into a $65 Million Loan Agreement. HAYWARD, Calif.--(BUSINESS WIRE)-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX® System powered by Nano-Pulse Stimulation™ (NPS™) technology, today announced a shift in focus to advance its core technology. Pulse Biosciences is expanding strategic opportunities within healthcare, and anticipates a concentrated focus on cardiovascular applications, with potential expansion in oncology, gastroenterology, and other sectors where the Company has established key opinion leader relationships and emerging preclinical evidence. To support the realignment, Pulse Biosciences has made several executive team changes. Kevin Danahy, who served as Chief Commercial Officer since February, is succeeding Darrin Uecker as President and Chief Executive Officer. The Company is very pleased to announce that Mr. Uecker will devote his full time to the newly created role of Chief Technology Officer where he will be responsible for technology advancement and product development. Joe Talarico, who currently serves as Vice-President of North American Sales, will become Vice-President of Business Development where he will leverage his significant experience in the commercial introduction of new disruptive technologies. Board Chairman, Robert Duggan, will assume a newly created leadership role as the Company’s Executive Chairman. “During his time at Pulse, Kevin has demonstrated strong leadership and operational skills. The Board of Directors believes he is the right person to lead Pulse during this next pivotal phase. I am confident in NPS technology and its potential,” said Robert Duggan, Executive Chairman of Pulse Biosciences. “We have positioned the Company to now focus on high opportunity application areas.” Implementing the present time strategic opportunities does not require the significant sales, marketing and related administrative support team that has been in place. Accordingly, headcount now stands at 66 employees principally focused on engineering, business development and related new product support personnel. In June of 2022, Pulse Biosciences employed 121 employees. The vast majority of present time reduction in personnel mainly impacts dermatological sales, marketing and related support activities. Along with minimizing commercial activities, the Company plans to evaluate potential partners in the dermatology space. Additionally, the Company plans to hold an Investors Day in the next 60 days to show progress and highlight the promising opportunities in other health care verticals. In support of the change in strategy, Mr. Duggan, the majority shareholder and Executive Chairman, and the Company have entered into a loan agreement in which Mr. Duggan has agreed to loan the Company $65 million to fund its product development operations. “With the full backing of our board to make the shift in strategy at this time, I look forward to expanding into other areas of healthcare that can leverage our unique NPS technology,” said Kevin Danahy, Pulse Biosciences President and Chief Executive Officer. “Shifting our strategy aligns with our ability to demonstrate our proven mechanism of action and the safety and efficacy of our technology as it relates to other markets. I am excited to have the opportunity to collaborate with this top-quality executive team through our next phase of growth.” Mr. Danahy has more than 20 years of senior management experience at medical technology companies. Most recently, Mr. Danahy served as President of Solmetex, driving revenue growth for the company through the implementation of innovative and scalable solutions, while overseeing strategy, sales, marketing, operations, engineering, and service efforts. Previously, at Zimmer Biomet, Mr. Danahy held roles of increasing responsibility, most recently as Vice President of Global Emerging Technologies and Specialty Sales. Before his time at Zimmer, Mr. Danahy served as Sr. Director at Intuitive Surgical, where he successfully transformed the sales leadership training program. Early in his career, he served in commercial leadership roles at both Medtronic and Johnson & Johnson. Mr. Danahy received a Master of Science from Tufts University. “In conclusion, you can expect Team Pulse Biosciences to stiffen execution, measure what matters, economize wherever possible and do what it takes to achieve a dynamic, expanding and viable organization that delivers patients, physicians and caregivers products and services that significantly improve quality of life,” said Robert Duggan, Executive Chairman of Pulse Biosciences. About Pulse Biosciences® Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients. The Company’s proprietary Nano-Pulse Stimulation technology delivers nano-second pulses of electrical energy to non-thermally clear cells while sparing adjacent non-cellular tissue. The CellFX® System is the first commercial product to harness the distinctive advantages of NPS technology to treat a variety of applications for which an optimal solution remains unfulfilled. The initial commercial use of the CellFX System is to address a range of dermatologic conditions that share high demand among patients and practitioners for improved dermatologic outcomes. Designed as a multi-application platform, the CellFX System offers customer value with a utilization-based revenue model. Visit pulsebiosciences.com to learn more. To stay informed about the CellFX System, please visit CellFX.com and sign up for updates. Pulse Biosciences, CellFX, Nano-Pulse Stimulation, NPS and the stylized logos are among the trademarks and/or registered trademarks of Pulse Biosciences, Inc. in the United States and other countries. Forward-Looking Statements All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to Pulse Biosciences’ expectations regarding the Company’s Controlled Launch program and the Company’s other activities to develop and commercialize NPS technology to drive growth, such as statements concerning the timing and prospects for converting participants in the Controlled Launch into commercial customers, statements concerning customer adoption and future use of the CellFX System, and statements concerning the use of best practices to drive utilization across clinics, statements about market opportunities in dermatology and in other medical specialties, statements about potential future regulatory clearances and about expanding the CellFX System’s indications for use, statements relating to the effectiveness of the Company’s NPS technology and the CellFX System to improve patient outcomes, statements about the Company’s rights offering or any other of its future financing activities, and other future events. These forward-looking statements are not historical facts but rather are based on Pulse Biosciences’ current expectations, estimates, and projections regarding Pulse Biosciences’ business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expects,” “intends,” “plans,” “projects,” “believes,” “estimates,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Pulse Biosciences’ control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Pulse Biosciences’ filings with the Securities and Exchange Commission. Pulse Biosciences undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

CRESSKILL, N.J. and JERUSALEM, March 24, 2021 (GLOBE NEWSWIRE) -- Brainsway Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today reported fourth quarter and full year 2020 financial results and provided an operational update. Recent Financial and Operational Highlights For the three months ended December 31, 2020, revenues were $7.1 million, a 17% increase sequentially from the third quarter of 2020, and a 12% increase from the fourth quarter of 2019. Cash, cash equivalents and short-term deposits as of December 31, 2020 amounted to $17.2 million, compared with $16.0 million at the end of the previous quarter, reflecting positive cash flow from operations. As of December 31, 2020, BrainsWay’s Deep TMS installed base was 629 total systems, a 19% increase compared to prior year results. As of December 31, 2020, the Company had shipped 216 OCD coils as add-on helmets to certain of BrainsWay’s new and existing systems. Published real-world OCD data in Journal of Psychiatric Research showing that 73% of patients achieved response at an early stage of Deep TMS treatment, and demonstrating durability of therapeutic effect. Successfully closed a follow-on equity offering in March 2021 raising $45.2 million of gross proceeds. Enhanced commercial leadership team with the addition of Fran Hackett as Vice President of North American Sales; bringing more than 30 years of domestic and international sales, business development, and executive leadership to BrainsWay. “Our return to strong growth with record quarterly revenues in the fourth quarter, the success of our over-subscribed follow-on raise generating approximately $45 million in gross proceeds, and the reinforcement of our sales leadership team have placed us on strong footing to deliver on our commercialization and growth strategy,” stated Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Looking ahead, we remain focused on our efforts to secure reimbursement in OCD, further develop and leverage compelling clinical data in multiple existing and planned indications, progress with our recently initiated controlled market release in smoking addiction, and expand the number of U.S. sales territories we cover from 13 to 18. We believe that these initiatives and achievements position us well to advance in our mission to improve health and transform lives.” Fourth Quarter 2020 Financial Results Total revenues for the fourth quarter of 2020 were $7.1 million, compared with $6.0 million in the third quarter of 2020, and $6.3 million in the fourth quarter of 2019, increases of 17% and 12%, respectively. Quarterly recurring lease revenues were $3.4 million, remaining consistent with the fourth quarter of 2019, and comprising 48% of total revenues. Gross margin for the fourth quarter of 2020 was 78%, an increase of 1% as compared to the gross margin for the fourth quarter 2019. Operating expenses for the fourth quarter totaled $5.9 million, compared with $6.8 million for the fourth quarter of 2019. Operating loss for the fourth quarter was $0.4 million, compared with an operating loss of $2.0 million for the same period in 2019. Financial Results for the Full-Year Ended December 31, 2020 Total revenue for the year ended December 31, 2020, was $22.1 million, a decrease of 5% from $23.1 million generated in 2019. Total lease revenue for the year was $13.6 million, an increase of 3% from $13.2 million in 2019. For the full year 2020, lease revenues were 61.5% of total revenues, compared to 57.2% in 2019. Net loss for the year was $5.4 million, compared to a loss of $10.3 million in 2019. As of December 31, 2020, the Company had cash and cash equivalents and short-term deposits of approximately $17.2 million, compared with $21.9 million at December 31, 2019, reflecting cash use of $4.7 million for full-year 2020. This cash balance does not include the approximately $41.9 million in net proceeds after deducting underwriting commissions and discounts and estimated offering expenses from the follow-on equity offering closed in March 2021. Conference Call and Webcast BrainsWay’s management will host a conference call on Thursday, March 25, 2021, at 8:30 a.m. Eastern Time to discuss these results and answer questions. Thursday, March25, at 8:30 AM Eastern Time: United States: 877-407-3982 Israel: 1 809 406 247 International: 201-493-6780 Conference ID: 13717245 Webcast: To listen to a live webcast, please visit the Investors section of the BrainsWay website at Please access the Company’s website at least 10 minutes ahead of the conference call to register. The webcast replay will be available on the website for two weeks following the completion of the call. About BrainsWay BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal studies demonstrating clinically proven efficacy. Current indications include major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Cresskill, NJ and Jerusalem, Israel, BrainsWay is committed to increasing global awareness and broad access to Deep TMS. For the latest news and information about BrainsWay, please visit . Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words, and include, but are not limited to, statements about the expected proceeds, use of proceeds and closing of the underwritten offering. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, and the effect of the global COVID-19 health pandemic on our business and continued uncertainty and market impact relating thereto. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission, including the Company's Annual Report on Form 20-F. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at v. Contacts: BrainsWay: Hadar Levy SVP and General Manager HadarL@brainsway.com Investors: Bob Yedid LifeSci Advisors 646-597-6989 Bob@LifeSciAdvisors.com BRAINSWAY LTD. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION U.S. dollars in thousands (except share and per share data) December 31, 2020 2019 (unaudited) (unaudited) ASSETS CURRENT ASSETS: Cash and cash equivalents $ 16,961 $ 21,674 Short-term deposits 221 221 Trade receivables, net 5,582 5,507 Other accounts receivable 1,534 1,427 24,298 28,829 NON-CURRENT ASSETS: Long-term deposit 163 168 Leased systems 5,198 5,491 System components and other property and equipment $ 4,352 $ 4,248 9,713 9,907 $ 34,011 $ 38,736 LIABILITIES AND EQUITY CURRENT LIABILITIES: Trade payables $ 781 $ 1,320 Other accounts payable 3,769 3,379 Deferred revenues 1,543 1,305 Liability in respect of research and development grants 707 714 6,800 6,718 NON-CURRENT LIABILITIES: Deferred revenues and other liabilities 2,015 2,353 Liability in respect of research and development grants 5,524 5,367 Warrants 38 78 7,577 7,798 EQUITY: Share capital 233 233 Share premium 95,135 93,649 Share-based payment 3,748 4,435 Adjustments arising from translating financial statements from functional currency to presentation currency (2,188 ) (2,188 ) Accumulated deficit (77,294 ) (71,909 ) 19,634 24,220 $ 34,011 $ 38,736 BRAINSWAY LTD. CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS U.S. dollars in thousands (except share and per share data) Year ended December 31, Three months ended December 31, 2020 (unaudited) 2019 (unaudited) 2020 (unaudited) 2019 (unaudited) Revenues $22,057 $23,101 $7,066 $6,292 Cost of revenues 5,058 5,129 1,566 1,442 Gross profit 16,999 17,972 5,500 4,850 Research and development expenses, net 5,823 7,876 1,576 1,809 Selling and marketing expenses 11,283 13,269 2,999 3,604 General and administrative expenses 4,722 5,303 1,332 1,428 Total operating expenses 21,828 26,448 5,907 6,841 Operating loss 4,829 8,476 407 1,991 Finance expense, net 319 1,430 239 178 Loss before income taxes 5,148 9,906 646 2,169 Income taxes 237 422 (240) 147 Net loss and total comprehensive loss $5,385 $10,328 $406 $2,316 Basic and diluted net loss per share $(0.24) $(0.50) $(0.02) $(0.10)