Kleo Pharmaceuticals, Inc.

- Dr. Neal Walker to transition to Chair of the Board of Directors - Current Board Chair Christopher Molineaux to become Lead Independent Director - Douglas Manion, M.D. appointed to succeed Dr. Walker as Chief Executive Officer and appointed to the Board of Directors - Kevin Balthaser appointed Chief Financial Officer to succeed retiring Frank Ruffo - Matthew Rothman appointed General Counsel WAYNE, Pa., Nov. 22, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced several key leadership changes. Effective January 1, 2023, co-founder and current chief executive officer, Dr. Neal Walker, will transition to the role of chair of the board of directors where he will continue to help guide the long-term strategic direction of Aclaris. Current chair, Christopher Molineaux, will remain on the board and transition to lead independent director. Dr. Doug Manion will transition from chief operating officer to the role of chief executive officer, while continuing to serve as president. Dr. Manion will also serve as a member of the Aclaris board of directors effective January 1, 2023. In addition, Aclaris is announcing the retirement of co-founder and chief financial officer Frank Ruffo effective December 31, 2022. Mr. Ruffo has served as Aclaris’ chief financial officer since its inception in 2012. Kevin Balthaser has been appointed chief financial officer, effective January 1, 2023. Mr. Balthaser joined Aclaris in 2017 and has served in a number of roles of increasing responsibility, most recently as vice president, finance. Prior to joining Aclaris, Mr. Balthaser held various positions of increasing responsibility within the accounting and finance department at Lannett Company, Inc., a publicly traded generic pharmaceutical company, where he was also a member of the team responsible for executing capital market transactions and acquisitions. Mr. Balthaser began his career with the international accounting firm PricewaterhouseCoopers LLP. Mr. Balthaser received an M.B.A. from Villanova University and a B.S. in finance from Pennsylvania State University. Aclaris is also announcing the appointment of Matthew Rothman, J.D. to the role of general counsel and corporate secretary, effective immediately. Mr. Rothman joined Aclaris in 2018 and has served in a number of roles of increasing responsibility within the legal department, most recently as vice president, legal and compliance. Mr. Rothman began his career as an associate in the corporate and securities group at Dechert LLP. Mr. Rothman received a J.D. from the University of Pennsylvania Law School and a B.S. from the University of Pittsburgh. “We are very excited to be announcing these updates to the leadership team for Aclaris,” said Dr. Walker. “As Aclaris has evolved, we have built our leadership team with experienced high quality industry leaders with track records of proven success. Frank and I have led Aclaris since its founding and I want to thank Frank for his leadership, dedication and service to the company and wish him well in his retirement. I look forward to working with Doug and the team closely as they transition into their new roles and as I continue my commitment to Aclaris as chair of the board.” Dr. Manion joined Aclaris as president and chief operating officer in August 2022. Dr. Manion brings over 25 years of pharmaceutical industry experience in both large and small companies. Prior to joining Aclaris, Dr. Manion served as executive vice president of research and development at Arena Pharmaceuticals until its acquisition by Pfizer Inc. Before joining Arena Pharmaceuticals, Dr. Manion served as chief executive officer of Kleo Pharmaceuticals until its acquisition by BioHaven Pharmaceutical Holding Company Ltd. Between 2005 and 2016, Dr. Manion served in roles of increasing responsibility at Bristol-Myers Squibb, or BMS, most recently as senior vice president, head of specialty development and head of R&D China and Japan. During his tenure at BMS, he held leadership roles overseeing global clinical research, clinical development, pharmacovigilance and biostatistics across various therapeutic areas, including virology, immunology, neurology, cardiology, metabolic diseases, genetically-defined diseases and fibrosis. Dr. Manion’s previous biopharmaceutical experience included leadership roles at GlaxoSmithKline, DuPont Pharmaceuticals and DuPont Merck Pharmaceuticals. “I am deeply honored for the opportunity to lead Aclaris,” stated Dr. Manion. “During the past year, Aclaris has retained industry leadership talent and experience to guide our company as we enter a period robust with planned key milestones across our lead clinical development programs that have emerged from the KINect® drug discovery platform. With the additions of Kevin and Matt into key roles, I am confident that the leadership team in place is optimized to execute across our strategic initiatives.” “Our board and leadership team have always been thoughtful and deliberate about how the company should evolve over time,” said Mr. Molineaux. “We believe Doug, an experienced executive working in both large and small life sciences companies, is the right CEO to deliver on our strategy and continue to build the company. On behalf of the board of directors, I also thank Neal for his leadership and dedication, having successfully shifted the company’s focus to immuno-inflammatory diseases, strengthened our balance sheet, and built a strong leadership team. We are grateful he will continue to provide Aclaris valuable advice and guidance in his new role as chair of the board of directors.” 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 “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include statements about Aclaris’ strategic direction, timing of its clinical development programs and the expected benefits of Aclaris’ leadership transition plan. 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 COVID-19 pandemic 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, 2021 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 Contact: Robert A. Doody Jr.Vice President, Investor Relations484-639-7235rdoody@aclaristx.com

As Bernhardt Zeiher retires from Astellas ’ chief medical officer position, the selection of his successor says a lot about the changes he’s seen at the company over his 12-year tenure. Tadaaki Taniguchi , the new CMO, is a surgeon in oncology by training who’s led development for Merck , Bristol Myers Squibb and AstraZeneca in Japan before moving to the US, where he will be based. His most recent role at AstraZeneca was SVP, head of oncology business unit Asia strategy. Looking back on his time, Zeiher told Endpoints News that he believes the successes his group — spanning almost 2,700 people — has had with the current pipeline sets the company up for the next wave of cancer therapies, be it bifunctional antibodies, cell therapies or oncolytic viruses. On top of notching label expansions for the Pfizer -partnered prostate Xtandi , in recent years Astellas also saw the European approval of Xospata in acute myeloid leukemia (although it was rejected by the FDA) and Seagen ’s Padcev in urothelial cancer. “Probably the biggest thing we’ve done as an organization is really grow our oncology portfolio, capabilities and really established a strong presence there,” he said. When he first joined Astellas from Pfizer — leaving as the inflammatory disease area lead — Zeiher recalled the company being a “very regional company” with headquarters in Japan and offices in Europe and the US. His tenure, he would say, was also characterized by a “great deal of globalization,” which meant forming more global structures, harmonizing procedures and improving efficiencies. The company is also moving into earlier-stage projects and cutting-edge technologies such as gene therapy. Ever since Astellas acquired Audentes for $3 billion, it’s been uncovering safety concerns with AAV gene therapies, with patient deaths rocking the entire community . Under Zeiher, researchers are still working to find out the exact issues and how to resolve them — something Taniguchi will also have to pick up once he starts in October. “It’s been very much a roller coaster,” Zeiher said, but added, “we remain incredibly committed to gene therapy.” — Amber Tong → Ex- Kleo Pharmaceuticals chief Doug Manion has turned up as president and COO of Aclaris , just a month after the Wayne, PA immuno-inflammatory disease biotech appointed Intercept and Pfizer alum Gail Cawkwell as CMO. Manion was a Bristol Myers exec for 11 years before taking the Kleo job, and he led R&D at Arena Pharmaceuticals until Pfizer ’s big $6.7 billion purchase in December 2021. With Manion’s arrival, Neal Walker has relinquished the title of president but will retain his CEO duties. → Striking a €300 million oncology deal on Thursday with Innovent to expand its reach in China, Sanofi has made several hires, starting with the appointment of Olivier Bogillot as head of US general medicines. Bogillot came to the French pharma from Bristol Myers in 2015 and will finish out his time as president of Sanofi France before starting his new gig on Sept. 1. Next, Deborah Glasser became head of vaccines, North America at the multinational on June 20, breaking away from Biogen after almost three years as US SVP of the Alzheimer’s franchise and 13 years overall. Besides her work with the infamous aducanumab , Glasser was global VP and asset lead for Biogen’s SMA ( Spinraza ) portfolio. Finally, Kellogg and Keurig Dr. Pepper vet Andrew Loucks — the ex-CEO of Sensory Cloud — will be Sanofi’s head of North America consumer healthcare effective Aug. 8. → Lars Staal Wegner is out as CEO of Copenhagen-based Evaxion Biotech , and the immunotherapy player has welcomed Per Norlén as his successor. Norlén left AstraZeneca in 2010 to become CMO of Alligator Bioscience and was elevated to CEO at the Swedish biotech seven years later. He recently juggled the roles of CMO at Xintela and CEO of its subsidiary Targinta . Wegner’s resignation doesn’t mean he’s left the company for good: He’ll still be an advisor at Evaxion, part of the IPO class of 2021 whose shares $EVAX have tanked along with everyone else in the industry this year. → Dutch CNS biotech Vico Therapeutics has poached Micah Mackison from Locanabio , naming him CEO after his two-and-a-half-year tenure as CBO and EVP of strategy and corporate development. From 2015-20, he was SVP, corporate development and strategy at Assembly Biosciences and he’s also led corporate strategy at Lundbeck . Early in his career, Mackison held financial posts at Pfizer and Eli Lilly . Vico is targeting spinocerebellar ataxia types 3 and 1 and Huntington’s with its lead asset, an antisense oligonucleotide named VO659 . → When Nektar ’s drug bempeg crumbled in multiple late-stage trials in combination with Bristol Myers’ Opdivo , it opened the floodgates for layoffs , as nearly 70% of the workforce lost their jobs. Chief commercial officer John Northcott exited the company in June and has now resurfaced at Arvinas in the same capacity. Northcott, a Roche / Genentech vet assigned to Avastin , has also been commercial chief with Lexicon Pharmaceuticals and Pharmacyclics before making his way to Nektar in December 2019. In July 20221, John Houston -led Arvinas inked another protein degradation deal with Pfizer worth $1 billion in cash and up to $1.4 billion in milestones. → Launching last November with $50 million in financing from Flagship , tRNA biotech Alltrna has selected Joanne Protano as CFO. This marks another appointment within Noubar Afeyan ’s family of companies for Protano, who was Flagship’s SVP of finance, new ventures from 2015-17. Since then, she’s been VP of finance and SVP of finance and operations for Rubius Therapeutics . Lovisa Afzelius handed the keys to Michelle Werner at Alltrna in April, part of a wave of CEO-partner appointments at Flagship that included Margo Georgiadis and Michael Severino . → Gracell Biotechnologies has made its second Peer Review appearance in three weeks with Wendy Li as CMO. Li worked in oncology development at Genentech, Sanofi and Pfizer, then held CMO posts at Sihuan Pharmaceutical and Exuma Biotech . Samuel Zhang , a Big Pharma vet in his own right, joined as CBO in July at the Chinese CAR-T player, which opened 2021 by raising a hefty $209 million in the good old days of IPOs. → With its lead drug taletrectinib in Phase II studies for ROS1 fusion-positive NSCLC, US-China biotech AnHeart Therapeutics has named Shuanglian Li as CMO (US). Prior to leading clinical development at Ansun Biopharma and Skyline Therapeutics , Li was global clinical lead for the EGFR inhibitor mobocertinib at Takeda and had been a medical director at Ariad Pharmaceuticals until the Japanese pharma snapped it up five years ago in a $5.2 billion deal. → Led by ex- Novartis Gene Therapies business chief Lisa Deschamps and notching an $80 million Series A last December, gene therapy outfit AviadoBio has tapped David Cooper as CMO. Cooper, a 14-year Novo Nordisk vet in medical affairs, had filled the role of VP, clinical development, CNS since 2019 at uniQure and worked on such drugs as Huntington’s candidate AMT 130 , which revealed early data in late June that “pleasantly surprised” CEO Matt Kapusta . → Massachusetts-based PharmaEssentia has brought aboard Lih-Ling Lin as CSO. Lin joins the company from Sanofi, where she served as head of checkpoint immunology cluster in the immunology and inflammation research area. Prior to that, Lin was with Pfizer for more than 21 years, rounding out her tenure with the drug giant as senior director, inflammation and immunology. → Over at Feng Zhang ’s Arbor Biotechnologies , Lee Ann Marchionna has signed on as chief people officer. During her time as a principal at Vitality HR , Marchionna was either an interim chief people officer or a fractional chief human resources officer for an extensive list of companies, including Albireo , Spero Therapeutics , Entrada Therapeutics , Ikena Oncology and Genocea Biosciences . Earlier, she was VP of human resources at Thermo Fisher . Now she focuses her attention on a CRISPR biotech that gathered up a $215 million Series B round in November 2021. → San Francisco protein degradation shop Nurix Therapeutics has locked in Eric Schlezinger as chief people officer. After leading human resources at Vir Biotechnology from 2017-19, Schlezinger held the same role at Adamas Pharmaceuticals , a Parkinson’s biotech that Supernus bought for $400 million in October 2021. Nurix cashed in with a $120 million round in March 2020, then bolstered its alliance with Sanofi as the French pharma dished out $22 million nearly 10 months later on top of the $77 million from the original deal in 2019. → Swinging and missing again with its stem cell therapy for stroke in June, Athersys has named Kasey Rosado as interim CFO shortly after shareholders at the cash-strapped company signed off on a reverse stock split. Rosado is a PricewaterhouseCoopers vet who was senior managing director at Ankura before joining Athersys, which severed ties with Aspire Capital Fund a month ago, ripping up a $100 million agreement. → Sunnyvale, CA-based anti-aging company Rubedo Life Sciences has plugged in Ali Siam as CBO and Ofir Moreno as SVP of drug discovery. A J&J strategic marketing vet who also had a three-year stay at AbbVie , Siam comes to Rubedo after his stint as business chief of Celmatix . Moreno has ended a nearly 12-year association with MEI Pharma , where he was promoted to SVP of pharmaceutical sciences in July 2019. → Singular Genomics Systems is bringing in two new faces , both from 10x Genomics , to its exec team with the appointments of Sam Ropp as CCO and Jeff Bullard as head of sales for North America. During his tenure at 10x, Ropp was SVP of global sales. Ropp also has experience from Becton Dickinson and Bio-Rad Laboratories under his belt. Meanwhile, Bullard was senior director of sales — America. Prior to his decade-long stint with 10x, Bullard was with Thermo Fisher, Life Technologies , Ion Torrent and Applied Biosystems / Ambion. → Two Illumina vets have joined Seattle proteomics company Nautilus Biotechnology : Eric Spence (VP of instrument engineering) spent four years with Illumina, then hopped over to Agilent Technologies before taking on a string of roles at Genapsys , leaving the genomic sequencing player as senior director, instrument development. Ken Kuhn (VP of reagent and platform development) was senior director of product development during a 16-year career at Illumina, and he’s recently been VP of systems integration, product development and operations at Encodia . → After losing its CEO in February, biotech research group ReNeuron has locked in its CFO Catherine Isted to the chief exec role. Isted joined the UK-based company in October 2021 after a stint at Oxford Biomedica . Isted will officially take the mantle on Sept. 1. → Rolando Brawer has taken on the role of EVP, strategy & corporate development for digital cell biology specialist Berkeley Lights . Brawer — a former Genomic Health / Exact Sciences exec — recently served as VP, science & technology, alliances & ventures at Danaher Corporation , and from 2014-16, he was head of licensing at Thermo Fisher. → Right before Amgen agreed to buy Chemocentryx for $3.7 billion, the Big Pharma gave Michael Drake a seat on the board of directors. Since August 2020, Drake has been president of the University of California and was president of Ohio State from 2014-20. → Gary Nabel and Joseph Papa lead a group of new board members at Paul Peter Tak ’s Candel Therapeutics that will replace Alan Smith , Shaan Ghandi and Udi Meirav on Aug. 8. Nabel, the chief innovation officer at OPKO and ex-Sanofi CSO, along with Papa — the outgoing Bausch Health CEO — will be joined by Eko Devices CFO Renee Gaeta on the board. → Chaired by Mike Grey , mitochondria-focused Reneo Pharmaceuticals has elected Roshawn Blunt to the board of directors. Blunt, who joined the board at Kronos Bio in November 2021, is an Amgen and J&J vet who is the managing director of 1798 Consultants . → After VBL Therapeutics ’ ovarian cancer drug ofranergene obadenovec whiffed in Phase III a couple weeks ago, the biotech chopped its staff by 35%, while Ron Cohen , Bennett Shapiro and Alison Finger have all resigned this week from the board of directors. VBL says it has enough cash available to keep going with a smaller crew for the next year. → Andrew Hirsch -led protein degradation biotech C4 Therapeutics has added Laura Bessen and Donna Grogan to the board of directors. At the tail end of her 15 years with Bristol Myers (2001-2016), Bessen was VP, head of US medical. Grogan was CMO of Clementia until the company was sold to Ipsen , which has had a devil of a time with the centerpiece of the deal, the rare bone disease drug palovarotene . → Radhika Tripuraneni is headed to the board of directors at Eli Lilly’s NASH collaborator Terns Pharmaceuticals . Tripuraneni, the chief development officer with Prothena , is the ex-VP of medical affairs for MyoKardia and Alexion . → Foresite Labs incubator Alumis has brought on Sapna Srivastava , the former chief financial and strategy officer of Intellia Therapeutics , to its board of directors. Along with her stint at Intellia, Srivastava is the ex-chief financial and strategy officer for Abide Therapeutics (acquired by Lundbeck). → New Jersey-based Amneal Pharmaceuticals has pulled up a chair for former FDA deputy commissioner Deb Autor on the board of directors. Autor spent half of her six years at Mylan as head of global quality and the other half as head of strategic global quality and regulatory policy. She was also AstraZeneca’s global head of regulatory excellence from 2019-21. → Puma Biotechnology — which experienced a drop in its stock in 2019 after sales of its drug Nerlynx fell short of Wall Street estimates — has recruited Alessandra Cesano to its board of directors. Cesano serves as CMO of ESSA Pharmaceuticals and is the former CMO of NanoString . Cesano has also previous stints at Cleave Biosciences , Nodality , Amgen, Biogen and SmithKline Beecham . → Canadian biopharma Find Therapeutics — backed by investors CTI Life Sciences and adMare BioInnovations , among others — has named Paul Truex as chairman of the board, taking over for Laurence Rulleau , who will remain on the board. Truex currently serves as chairman and CEO of Thryv Therapeutics . Truex also has experience from stints at Milestone , Trius , Anthera , Peninsula and Versicor . → Rallybio , run by a crew of Alexion alums who picked up an old Kymab anemia drug from Sanofi in May, has plucked up Wendy Chung for its board of directors. Chung is a professor of pediatrics and medicine at Columbia University Irving Medical Center and also serves on the board of Prime Medicine . Additionally, Chung sits on the scientific advisory boards of Sage Bionetworks , Taysha , Helix and Regeneron Genetics Center .

Appoints Douglas Manion, M.D., FRCP (C), as President and COO WAYNE, Pa., Aug. 01, 2022 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, today announced the appointment of Douglas Manion, M.D., FRCP (C), as President and Chief Operating Officer. Dr. Manion will be responsible for overseeing day-to-day operations, continuing to develop Aclaris’ infrastructure and helping Aclaris develop its vision and overall strategic direction alongside Neal Walker, Aclaris’ CEO, and Aclaris’ board of directors. “We are excited to strengthen our leadership team by welcoming Dr. Manion to Aclaris,” said Dr. Neal Walker, CEO of Aclaris. “Doug’s significant experience across the business, strong background in drug development, and track record of leading organizations, building teams and creating value for both large and small organizations will be extremely valuable as we continue to advance our drug development pipeline.” Dr. Manion brings over 25 years of pharmaceutical industry experience in both large and small companies. Most recently, he served as Executive Vice President of Research and Development at Arena Pharmaceuticals, Inc., where he oversaw all research and development activities until its acquisition by Pfizer Inc. Prior to that, Dr. Manion was the Chief Executive Officer of Kleo Pharmaceuticals, Inc., an immuno-oncology company, until its acquisition by Biohaven Pharmaceutical Holding Company Ltd. Dr. Manion’s previous biopharmaceutical experience included leadership roles at Bristol-Myers Squibb, GlaxoSmithKline, DuPont Pharmaceuticals and DuPont Merck Pharmaceuticals. “Aclaris is at an exciting stage in its life, and I am thrilled to join the organization,” said Dr. Manion. “I look forward to leveraging my strengths in helping Aclaris grow and execute on its strategy.” Dr. Manion’s appointment is effective August 1, 2022. In connection with his appointment, Dr. Walker will no longer serve as the President, but will continue to serve as Aclaris’ Chief Executive Officer. 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 “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Aclaris’ current beliefs and expectations. These forward-looking statements include the future contributions of Dr. Manion. 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 COVID-19 pandemic 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, 2021 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 Contact investors@aclaristx.com