Youer Pharmaceutical Technology (Shanghai) Co., Ltd.

- Progressing ATI-2138 into Atopic Dermatitis -- Management to Host Conference Call at 5:00 PM ET Today - WAYNE, Pa., May 07, 2024 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced its financial results for the first quarter of 2024 and provided a corporate update. “We are pleased to announce that following a review of the potential development pathways for ATI-2138, our investigational ITK/JAK3 compound with best-in-class potential, we have decided to progress ATI-2138 into a proof-of-concept Phase 2a trial in patients with moderate to severe atopic dermatitis,” stated Dr. Neal Walker, co-founder and Interim Chief Executive Officer & President of Aclaris. “Across all of our programs, we remain focused on executing a capital efficient strategy to advance novel immuno-inflammatory therapies.” Research and Development Highlights: ITK Inhibitor Programs ATI-2138, an investigational oral covalent ITK/JAK3 inhibitor Aclaris plans to progress ATI-2138 into a Phase 2a trial in subjects with moderate to severe atopic dermatitis.In September 2023, Aclaris reported positive results from its Phase 1 multiple ascending dose (MAD) trial of ATI-2138. ITK Selective Compound Aclaris is progressing to development candidate selection a second generation ITK selective inhibitor for autoimmune indications. Lepzacitinib (ATI-1777), an investigational topical “soft” JAK 1/3 inhibitor In January 2024, Aclaris reported positive top-line results from its Phase 2b trial in atopic dermatitis (AD).Aclaris is currently seeking a global development and commercialization partner for this program (excluding Greater China). As previously announced, in 2022 Aclaris granted Pediatrix Therapeutics exclusive rights to develop and commercialize lepzacitinib in Greater China. Zunsemetinib (ATI-450), an investigational oral small molecule MK2 inhibitor Aclaris plans to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib as a potential treatment for pancreatic cancer and metastatic breast cancer. Aclaris expects these trials to be primarily funded by grants awarded to Washington University. Financial Highlights: Liquidity and Capital Resources As of March 31, 2024, Aclaris had aggregate cash, cash equivalents and marketable securities of $161.4 million compared to $181.9 million as of December 31, 2023. A majority of cash expenditures in the first quarter of 2024 were related to payments associated with exit activities, including the wind down of discontinued R&D programs and the previously announced reduction in force. Aclaris anticipates payments associated with these activities to be substantially completed by the second quarter of 2024. As a result, Aclaris expects significantly lower quarterly cash expenditures in future quarters, without giving effect to any potential business development activities resulting from its ongoing strategic review of its business. Financial Results First Quarter 2024 Net loss was $16.9 million for the first quarter of 2024 compared to $28.2 million for the first quarter of 2023.Total revenue was $2.4 million for the first quarter of 2024 compared to $2.5 million for the first quarter of 2023. The decrease was primarily driven by lower contract research revenue during the three months ended March 31, 2024.Research and development (R&D) expenses were $9.8 million for the quarter ended March 31, 2024 compared to $22.6 million for the prior year period. The $12.8 million decrease was primarily the result of lower: Zunsemetinib development expenses associated with clinical activities for a Phase 2a trial for hidradenitis suppurativa, a Phase 2b trial for rheumatoid arthritis, and drug candidate manufacturing costs.Costs associated with lepzacitinib preclinical development activities and a Phase 2b clinical trial for AD.ATI-2138 development expenses, including costs associated with a Phase 1 MAD trial and other preclinical activities.Compensation-related expenses due to a decrease in headcount and higher forfeiture credits. General and administrative (G&A) expenses were $6.8 million for the quarter ended March 31, 2024 compared to $8.8 million for the prior year period. The decrease was primarily due to a reduction in compensation-related expenses due to lower headcount and higher forfeiture credits.Licensing expenses were $1.0 million for the quarter ended March 31, 2024 compared to $1.1 million for the prior year period. The decrease was due to the achievement of a commercial milestone during the three months ended March 31, 2023, offset by an increase in royalties earned under the Lilly license agreement.Revaluation of contingent consideration resulted in a $2.8 million loss for the quarter ended March 31, 2024 compared to a gain of $0.8 million for the prior year period. Conference Call and Webcast As previously disclosed on April 30, 2024, management will host a conference call and webcast, with an accompanying slide presentation, at 5:00 PM ET today to provide a corporate update. To access the live webcast of the call and the accompanying slide presentation, please visit the “Events” page of the “Investors” section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website. About Aclaris Therapeutics, Inc. Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of drug candidates powered by a robust R&D engine exploring protein kinase regulation. For additional information, please visit www.aclaristx.com. Cautionary Note Regarding Forward-Looking Statements Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include expectations regarding its plans for its development programs, including its plans to seek a development and commercialization partner for lepzacitinib, the clinical development of ATI-2138, and its plan to support Washington University in St. Louis in its investigator-initiated Phase 1b/2 trials of zunsemetinib, as well as Aclaris’ expectations regarding the wind down of discontinued R&D programs and costs associated with its recent reduction in force and the associated impact on anticipated cash burn, and its strategic review of its business. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Aclaris’ reliance on third parties over which it may not always have full control, Aclaris’ ability to enter into strategic partnerships on commercially reasonable terms, the uncertainty regarding the macroeconomic environment and other risks and uncertainties that are described in the Risk Factors section of Aclaris’ Annual Report on Form 10-K for the year ended December 31, 2023, and other filings Aclaris makes with the U.S. Securities and Exchange Commission from time to time. These documents are available under the “SEC Filings” page of the “Investors” section of Aclaris’ website at www.aclaristx.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to Aclaris as of the date of this release, and Aclaris assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise. Aclaris Therapeutics, Inc.Condensed Consolidated Statements of Operations(unaudited, in thousands, except share and per share data) Three Months Ended March 31, 2024 2023 Revenues: Contract research $657 $889 Licensing 1,741 1,639 Total revenue 2,398 2,528 Costs and expenses: Cost of revenue (1) 809 808 Research and development (1) 9,845 22,587 General and administrative (1) 6,844 8,790 Licensing 1,031 1,061 Revaluation of contingent consideration 2,800 (800)Total costs and expenses 21,329 32,446 Loss from operations (18,931) (29,918)Other income, net 1,990 1,758 Net loss $(16,941) $(28,160)Net loss per share, basic and diluted $(0.24) $(0.42)Weighted average common shares outstanding, basic and diluted 71,074,858 66,872,778 (1) Amounts include stock-based compensation expense as follows: Cost of revenue $252 $299 Research and development (29) 2,602 General and administrative 1,866 3,905 Total stock-based compensation expense $2,089 $6,806 Aclaris Therapeutics, Inc.Selected Consolidated Balance Sheet Data(unaudited, in thousands, except share data) March 31, 2024 December 31, 2023 Cash, cash equivalents and marketable securities $161,365 $181,877 Total assets $174,065 $197,405 Total current liabilities $20,080 $30,952 Total liabilities $32,051 $40,226 Total stockholders' equity $142,014 $157,179 Common stock outstanding 71,248,017 70,894,889 Aclaris Therapeutics, Inc.Selected Consolidated Cash Flow Data(unaudited, in thousands) March 31, 2024 March 31, 2023 Net loss $(16,941) $(28,160)Depreciation and amortization 243 198 Stock-based compensation expense 2,089 6,806 Revaluation of contingent consideration 2,800 (800)Changes in operating assets and liabilities (9,006) (4,397)Net cash used in operating activities $(20,815) $(26,353) Aclaris Therapeutics Contact: investors@aclaristx.com

November is Prematurity Awareness Month, Announcement Comes in Celebration of World Prematurity Day on Friday, Nov. 17 LONG BEACH, Calif., Nov. 16, 2023 /PRNewswire/ -- MemorialCare Miller Children's & Women's Hospital Long Beach, along with Pediatrix Medical Group, who has been a long-standing neonatology partner with MemorialCare, have come together to create the Miller Children's & Women's Neonatal Network. This new relationship enables coordinated delivery of provider services to the neonatal intensive care unit (NICU) network establishing a forum for improved communication, financial transparency, and shared program and provider planning. The Neonatal Network will have shared governance between Miller Children's & Women's and Pediatrix, with the neonatologists remaining employees of Pediatrix. Continue Reading Dr. Antoine Soliman, Regional Medical Director of the Miller Children’s & Women’s Network and Yair Katz, chief executive, Miller Children’s & Women’s Miller Children's & Women's features a level IV NICU, the highest designation in California, signifying it can care for the sickest and smallest babies. In addition, it has an extremely low birth weight program – caring for babies less than 2 pounds at birth – and has a transport program that allows Miller Children's & Women's the ability to support area community hospitals with smaller and lower acuity maternity and neonatal care. "Expanding Miller Children's & Women's Hospital Long Beach as a regional destination for neonatal and pediatric care is an important part of our mission in caring for the most premature and sickest babies, as well as their families," says Yair Katz, chief executive, Miller Children's & Women's. "With all that we are seeing going on in the world today in children's health, we were deeply committed to seeing this through so we can do our part to ensure all babies and their families have access to the highest level of care possible regardless of socioeconomic status." To successfully execute this strategic initiative, Miller Children's & Women's has appointed Dr. Antoine Soliman as the Regional Medical Director of the Miller Children's & Women's Network. In this administrative capacity, Dr. Soliman will oversee the performance and quality of the network, lead the onboarding of new sites and serve on the joint operating committee. Dr. Soliman will remain a practicing neonatologist in a limited capacity in Miller Children's NICU, to maintain his direct patient care provider experience. In addition, Dr. Soliman will continue to serve as medical director of the Miller Children's NICU and oversee the recruitment of his replacement for this role. "I'm deeply honored and humbled to accept the regional directorship of the Miller Children's & Women's Neonatal Network," says Dr. Soliman. "Miller Children's & Women's has made great advances in neonatal care the last few years, graduating healthier babies born quite ill and extremely premature. Our team is remarkable and expanding our capabilities further into the community is paramount to us. I can't think of a better time to announce and launch this partnership, as we celebrate Prematurity Awareness Month and World Prematurity Day later this week." Miller Children's & Women's, one of eight free standing children's hospitals in California, is unique in that it has a full-service maternity and high-risk program licensed under the children's hospital. This expanded neonatal network will also support regional care by laying the groundwork for recruitment of top talent and bringing access to high-risk maternal and neonatal care into bordering communities' backyards – delivering the highest level of care possible. About MemorialCare Miller Children's & Women's Hospital Long Beach: MemorialCare Miller Children's & Women's Hospital Long Beach is a member of MemorialCare, a not-for-profit, integrated health care system. Miller Children's & Women's is one of only eight free-standing children's hospitals in California, is recognized by U.S. News & World Report as a 'Best Children's Hospital' for pediatric pulmonology and lung surgery — treating more than 14,000 children each year — and has become a regional pediatric destination for more than 65,000 children, who need specialized care in outpatient specialty and satellite centers. With maternal-fetal medicine specialists and neonatologists available 24/7, Miller Children's & Women's cares for women with high-risk pregnancies and premature infants under one roof. About Pediatrix Medical Group Pediatrix® Medical Group, Inc. (NYSE:MD) is the nation's leading provider of physician services. Pediatrix-affiliated clinicians are committed to providing coordinated, compassionate and clinically excellent services to women, babies and children across the continuum of care, both in hospital settings and office-based practices. Specialties include obstetrics, maternal-fetal medicine and neonatology complemented by more than 20 pediatric subspecialties, as well as pediatric primary and urgent care clinics. The group's high-quality, evidence-based care is bolstered by significant investments in research, education, quality-improvement and safety initiatives. The physician-led company was founded in 1979 as a single neonatology practice and today provides its highly specialized and often critical care services through more than 5,000 affiliated physicians and other clinicians in 37 states. To learn more about Pediatrix, visit or follow us on Facebook, Instagram, LinkedIn, Twitter and the Pediatrix blog. Investment information can be found at . SOURCE MemorialCare Miller Children’s & Women’s Hospital Long Beach

FORT LAUDERDALE, Fla.--( BUSINESS WIRE )--Pediatrix Medical Group, Inc. (NYSE: MD), the nation’s leading provider of highly specialized health care for women, children and babies, today announced that its board of directors has appointed Sylvia Young, a recognized leader in healthcare and long-term healthcare executive, as an independent director, effective May 12, 2023. Ms. Young, a veteran of hospital administration since 1985, most recently served as President and CEO of the HCA Continental Division, a multi-state regional healthcare system that is part of Hospital Corporation of America (HCA). Prior to her appointment to the Denver-based Division headquarters, Ms. Young served as President of HCA’s Sunrise Health System, including Sunrise Hospital and Medical Center, Sunrise Children’s Hospital, MountainView Hospital and Southern Hills Hospital, as well as four ambulatory surgery centers in Las Vegas, NV. Ms. Young retired from HCA in March 2023. “Sylvia’s comprehensive knowledge of the healthcare landscape and her commitment to women and children’s services will allow her to provide valuable counsel to both our board of directors and the entire Pediatrix organization,” said Dr. Jim Swift, Chief Executive Officer. “Sylvia will be a great addition to our board. Her background, skills and deep knowledge of our company and what we do will be very beneficial to Pediatrix,” said Mark S. Ordan, Executive Chair, and Guy Sansone, Lead Independent Director, of the Pediatrix Board of Directors. “We are excited to welcome a true leader in our sector as we continue to focus on delivering long-term value for our stakeholders and taking great care of our patients.” "I've had the pleasure, while in my former role at HCA, of seeing first-hand the exceptional care that Pediatrix provides and how they bring the company’s mission to life every day," said Sylvia Young. "I am humbled and honored to join the Pediatrix board." In 2022, Ms. Young was named one of “2022 Top Women to Watch in Healthcare” by Modern Healthcare Magazine. She currently serves as an independent director on the board of Lincoln Educational Services Corporation. ABOUT PEDIATRIX MEDICAL GROUP Pediatrix® Medical Group, Inc. (NYSE:MD) is the nation’s leading provider of physician services. Pediatrix-affiliated clinicians are committed to providing coordinated, compassionate and clinically excellent services to women, babies and children across the continuum of care, both in hospital settings and office-based practices. Specialties include obstetrics, maternal-fetal medicine and neonatology complemented by more than 20 pediatric subspecialties, as well as pediatric primary and urgent care clinics. The group’s high-quality, evidence-based care is bolstered by significant investments in research, education, quality-improvement and safety initiatives. The physician-led company was founded in 1979 as a single neonatology practice and today provides its highly specialized and often critical care services through more than 5,000 affiliated physicians and other clinicians in 37 states. To learn more about Pediatrix, visit www.pediatrix.com or follow us on Facebook , Instagram , LinkedIn , Twitter and the Pediatrix blog . Investment information can be found at www.pediatrix.com/investors . Certain statements and information in this press release may be deemed to contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may include, but are not limited to, statements relating to the Company’s objectives, plans and strategies, and all statements, other than statements of historical facts, that address activities, events or developments that we intend, expect, project, believe or anticipate will or may occur in the future. These statements are often characterized by terminology such as “believe,” “hope,” “may,” “anticipate,” “should,” “intend,” “plan,” “will,” “expect,” “estimate,” “project,” “positioned,” “strategy” and similar expressions, and are based on assumptions and assessments made by the Company’s management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate. Any forward-looking statements in this press release are made as of the date hereof, and the Company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties. Important factors that could cause actual results, developments, and business decisions to differ materially from forward-looking statements are described in the Company’s most recent Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q, including the sections entitled “Risk Factors”, as well the Company’s current reports on Form 8-K, filed with the Securities and Exchange Commission, and include the impact of the Company’s transition to a third-party revenue cycle management provider; the impact of surprise billing legislation; the effects of economic conditions on the Company’s business; the effects of the Affordable Care Act and potential healthcare reform; the Company’s relationships with government-sponsored or funded healthcare programs, including Medicare and Medicaid, and with managed care organizations and commercial health insurance payors; the Company’s ability to comply with the terms of its debt financing arrangements; the impact of the COVID-19 pandemic on the Company and its financial condition and results of operations; the impact of the divestiture of the Company’s anesthesiology and radiology medical groups; the impact of management transitions; the timing and contribution of future acquisitions or organic growth initiatives; the effects of share repurchases; and the effects of the Company’s transformation initiatives, including its reorientation on, and growth strategy for, its pediatrics and obstetrics business.