Noven Pharmaceuticals, Inc.

Following significant strides made in advancing its late-stage pipeline with dual positive readouts in 2023 and a few more anticipated this year, Oculis further expands its executive leadership team with the appointment of industry veteran as President of Research & Development Dr. Shah’s joins Oculis from Iveric Bio with extensive experience in drug development, regulatory affairs and ophthalmology, with over a dozen successful market approvals, which will be key as Oculis initiates preparations for global marketing applications including its first NDA submission to the U.S. FDA ZUG, Switzerland and BOSTON, April 10, 2024 (GLOBE NEWSWIRE) -- Oculis Holding AG (Nasdaq: OCS) (“Oculis”), a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announced the appointment of Dr. Snehal Shah, executive leader with over two decades of research & development (R&D) and regulatory experience, to the role of President of R&D. In this new role, Dr. Shah will be responsible for leading research and development strategies, and working towards achieving market authorizations by directing global regulatory activities required for future New Drug Application (NDA) submissions to the U.S. Food and Drug Administration (FDA), and the equivalent for regulators in other territories. Dr. Shah joins Oculis from Iveric Bio where he served as Chief Regulatory & Product Strategy Officer and led the successful approval of Izervay® for Geographic Atrophy in the U.S. He brings over 20 years of global experience in regulatory science, research & development, pharmacovigilance, and product strategy gained at leading large, medium and biotech pharmaceutical companies including Hoffmann La-Roche / Genentech, Noven Pharmaceuticals (Member of the Hisamitsu Group), Kyowa Kirin and Iveric Bio. He has a proven track record of spearheading innovative programs in various therapeutic areas including in ophthalmology for both small molecules and biologics through product development lifecycle phases from conception through commercialization. Riad Sherif, M.D., Chief Executive Officer of Oculis: “We are thrilled to welcome Snehal to Oculis as we continue to expand our U.S. footprint. Snehal’s leadership and development expertise, especially in ophthalmology, will be pivotal to advancing our innovative and differentiated pipeline. His extensive strategic experience in leading R&D and regulatory functions, and successful track record of bringing over a dozen market applications to approval will play a pivotal role in our efforts to deliver transformative new therapies to patients suffering from eye diseases.” Snehal Shah, Pharm.D., President of R&D of Oculis: “I am thrilled to join the exceptionally talented team at Oculis to lead R&D activities during a period of significant momentum and expansion which comes as we advance our leading candidate OCS-01 through Phase 3 trials towards our first anticipated NDA submission and expect the OCS-02 RELIEF Phase 2b trial results this quarter. Oculis’ highly diversified pipeline provides an opportunity to be part of an endeavour that aims to shift the treatment paradigm for ocular disorders, supporting patients throughout their disease continuum, which can lead to vision loss and ultimately blindness.” About Oculis Oculis (Nasdaq: OCS) is a global biopharmaceutical company purposefully driven to save sight and improve eye care. Oculis’s highly differentiated clinical-stage pipeline comprises multiple innovative product candidates in development for eye diseases of high unmet need. It includes OCS-01 eye drops, a topical candidate in Phase 3 development for diabetic macular edema (DME) and inflammation and pain following ocular surgery; OCS-02 eye drops, a topical biologic candidate in Phase 2 development for dry eye disease (DED) and uveitis; and OCS-05, a disease modifying candidate for acute optic neuritis (AON) and other neuro-ophthalmic disorders, such as glaucoma, diabetic retinopathy, geographic atrophy, and neurotrophic keratitis. The first in-patient, proof-of-concept trial with OCS-05 is currently ongoing in France. Headquartered in Switzerland and with operations in the US, Oculis’s goal is to deliver life-changing eye treatments to patients worldwide. The company is led by an experienced management team with a successful track record in the pharmaceutical industry, supported by leading international healthcare investors. For more information, please visit: Oculis Contacts Ms. Sylvia Cheung, CFO sylvia.cheung@oculis.com Investor & Media Relations LifeSci Advisors Corey Davis, Ph.D. cdavis@lifesciadvisors.com 1-212-915-2577 Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, the potential of Oculis to deliver transformative new therapies to patients suffering from eye diseases; expected future milestones and catalysts; anticipated clinical readouts, including the expected OCS-02 RELIEF Phase 2b trial results; the potential benefits of Oculis’ executive leadership team additions; the initiation, timing, progress and results of Oculis’ clinical and preclinical studies; Oculis’ research and development programs, regulatory and business strategy, future development plans, and management; Oculis’ ability to advance product candidates into, and successfully complete, clinical trials; the timing or likelihood of regulatory filings and approvals; and the timing or likelihood of Oculis’ NDA submissions to the U.S. FDA and the equivalent for regulators in other territories, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (the “SEC”). Copies of these documents are available on the SEC’s website, Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

→ You know how we told you last week that we’d keep our eyes peeled for where ex- Roche Pharmaceuticals CEO Bill Anderson turns up next? Well, he gave us an answer in a big way. Anderson will be the CEO at Bayer starting April 1, the German pharma said Wednesday. Unlike Roche , Merck , J&J and the CEO transition that follows, Bayer chose not to go in-house for Werner Baumann ’s replacement. Investors have been grumbling about the company’s stock performance, so much so that activist investor Jeff Ubben rallied the troops to find someone outside the company to take control. In the end, the investors won. Shares $BAYRY jumped 6% when news circulated about Anderson’s hiring. Baumann’s retirement after 35 years at Bayer, seven of those as CEO, marks another major change in its leadership. Marianne De Backer , Bayer’s wheeler-dealer who engineered the acquisitions of AskBio and Vividion , will replace George Scangos as CEO of Vir Biotechnology on April 3. → Astellas will do some shifting of its own, starting at the top with the April 1 departure of Kenji Yasukawa , the president and CEO since 2018. Chief strategy officer Naoki Okamura will take the helm while EVP of corporate strategy Adam Pearson will be elevated to Okamura’s old post. It doesn’t stop there: Chief commercial officer Yukio Matsui will also retire at the same time as Yasukawa, and Claus Zieler — Astellas’ president, established markets commercial — is set to take Matsui’s place. The extensive C-suite shakeup comes as Astellas says a patent cliff and declining revenue are behind it, and the company is ready to go for “aggressive” growth. It also follows the retirement of CMO Bernhardt Zeiher , who spoke with Amber Tong in August 2022 about the gene therapy AT132 for X-linked myotubular myopathy that Astellas picked up from Audentes — and is linked to multiple patient deaths that shook the entire gene therapy landscape. Since Tadaaki Taniguchi succeeded Zeiher on Oct. 1, Astellas scooped up two gene therapy programs from struggling Taysha and saw a clinical hold get lifted for its Pompe disease gene therapy candidate AT845 . → Previously known as miRagen , Viridian Therapeutics drew in some serious coin once it trotted out Phase I/II data for its thyroid eye disease drug VRDN-001 in August 2022. But after that $270 million offering, Viridian will have a different conductor leading the way, with Jonathan Violin handing the orchestra to new president and CEO Scott Myers . You may remember Myers from his days as CEO of AMAG Pharmaceuticals , the Makena maker that was sold to Covis Pharma back in 2020. He’s also been chief executive at Rainier Therapeutics and Cascadian Therapeutics . → Everything’s coming up Alnylam at super-stealthy Feng Zhang upstart Aera Therapeutics , which has tapped Akin Akinc as CEO and John Maraganore as chairman, Business Insider reports . Akinc takes the helm at the gene editing biotech after ending his 19 years at the RNAi titan in September 2022 as head of oncology. Maraganore has populated Peer Review with an endless array of board appointments and advisory roles ever since he stepped down from the top spot at Alnylam. → A spokesperson for Merck tells Endpoints News that Iya Khalil will join the pharma giant on Feb. 13 as VP and head of data, AI & genome sciences. In a LinkedIn post, Khalil bid farewell to Novartis , where she was global head of the AI innovation laboratory since May 2020. “I want to thank Novartis and all of my colleagues for the unique opportunity to launch the AI lab and NIBR ’s commitment to the continued efforts of the AI team under the exceptional leadership of Fiona Marshall ,” she wrote. Turnabout is fair play here: Novartis plucked Marshall from Merck to replace Jay Bradner as president of NIBR last fall. Merck has been diving deeper into AI through recent partnerships with Absci , BigHat Biosciences and Saama . → STAT writer (and friend of Peer Review) Jason Mast revealed Kathy High ’s departure from AAV gene therapy developer AskBio this week. High co-founded Spark Therapeutics and cemented her legacy in the field with her work on the retinal disease drug Luxturna , the first gene therapy to receive FDA approval. Roche ponied up $4.3 billion for Spark, and High then bolted for AskBio in January 2021, becoming the Bayer sub’s president of therapeutics. STAT indicates that High is on sabbatical at Rockefeller University. → What little remains of Flagship ’s Rubius is still scrambling to determine next steps, and while its strategic review rolls on, CEO Dannielle Appelhans ’ tenure has been extended from Jan. 31 to “no later than March 3,” an SEC filing states . Meanwhile, it’s Laurence Turka ’s turn to leave Rubius after three years as CSO and head of research and translational medicine. Finally, ex-Novartis head of oncology Susanne Schaffert , Francis Cuss and Michael Rosenblatt have all resigned from the board of directors. → TCR biotech T-knife Therapeutics made some noise in 2021 with $110 million in Series B financing and several key hires, including COO Megan Baierlein and CSO Peggy Sotiropoulou . This week T-knife is back with Behzad Kharabi as CMO. Kharabi left J&J for Gilead ’s Kite in 2018 and rose to global program clinical lead for Tecartus , the CAR-T therapy that was first approved in the summer of 2020 for relapsed or refractory mantle cell lymphoma. Tecartus then scored another FDA nod a year later for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. → An SEC filing shows that 2seventy bio COO Nicola Heffron will pack her bags on March 10. No specific reason was given other than the standard line that it wasn’t “due to any disagreement with the Company on any matter.” A Celgene and Shire vet, Heffron jumped over to bluebird bio ’s cancer spinout when Nick Leschly split bluebird into the two separate companies in 2021. She started at bluebird in January 2020 as SVP, Europe. → With apologies to Boz Scaggs , the inability of Adagio Therapeutics ’ Covid-19 antibody to put up a defense against the Omicron variant signaled a breakdown dead ahead for the Tillman Gerngross biotech. Gerngross gave up his spot as CEO, the company rebranded as Invivyd , layoffs ensued , and multiple execs walked out the door. The latest is CSO Laura Walker , who co-founded Adagio and has also worked at Adimab (another Gerngross joint). Interim head of discovery and preclinical Lukas Dillinger will handle CSO duties until Invivyd finds her replacement. → Only a year into his tenure as head of R&D and medical affairs and CMO at Sobi , Anders Ullman has decided to retire on April 1. Tony Hoos , who will take over for the 67-year-old Ullman, has led the global rare disease business unit at GSK and is the former head of medical in Europe for Amgen . Additionally, Hoos spent a year as medical chief of Flagship’s Valo Health . Ullman was a board member at Sobi before he replaced Ravi Rao , the current CMO with Oxford Biomedica and Sitryx . → On April 1, Laetitia Rouxel will become the CFO of German-based Evotec , which boasts a slew of discovery partnerships from a who’s who in the pharma world — Eli Lilly , Boehringer Ingelheim , Novo Nordisk and Bristol Myers Squibb among them. An 11-year Pfizer vet, Rouxel has been divisional finance chief for beauty and fragrance company Coty and global CFO of Dutch plastic pipe provider Wavin . Enno Spillner , Evotec’s CFO since 2016, is leaving at the end of next month when his contract runs out. → Scholar Rock ’s first-year CEO and ex- Acceleron R&D chief Jay Backstrom has lined up a familiar face to take on the role of chief commercial officer. Tracey Sacco joined Acceleron in 2012 as senior director, corporate development and would later work on the product launch of the Bristol Myers-partnered drug Reblozyl . She was SVP, global strategic marketing when Merck bought the biotech for $11.5 billion in the fall of 2021. Scholar Rock hasn’t evaded the onslaught of layoffs in the industry, trimming 25% of its staff in May 2022. → Friedreich’s ataxia specialist Larimar Therapeutics has appointed Gopi Shankar as chief development officer. Shankar just had a 12-year run at J&J and had been Janssen ’s VP and global head, biologics development sciences since 2018. Larimar waited out a clinical hold for its Friedreich’s ataxia candidate CTI-1601 that lasted more than a year until it was lifted in September 2022 . However, a partial hold on the drug is still in place. → Another hire has bubbled up at T cell engager biotech Lava Therapeutics , with Charles Morris taking the CMO reins from Benjamin Winograd . Morris recently held the same title at Celyad Oncology , a biotech hanging on by its fingernails after cutting the cord on development of its allogeneic BCMA CAR-T, CYAD-211 . He also spent two years as medical chief of Radius Health , the now-private company acquired by Gurnet Point Capital and Jim Momtazee ’s Patient Square Capital last summer. → Jeremy Levin’s Ovid is bringing in a new duo with the hiring of Manoj Malhotra as CMO and Toshiya Nishi as epilepsy research head. Malhotra, who’s known Levin for some time, joins the team from Eisai’s neurology business group and has prior stints at Mallinckrodt , Novartis and Takeda under his belt. Meanwhile, Nishi comes to the company from Takeda, where he co-invented soticlestat . In his new role, Nishi will be focused on preclinical development, specifically KCC2. → Going after STAT3 with its lead asset TTI-101 , Houston’s Tvardi Therapeutics has recruited John Kauh as CMO. As VP of clinical development at Hutchmed , Kauh worked on surufatinib , a drug that got dinged with a CRL last year as part of the FDA’s broader clampdown on China-only trial data. Tvardi, co-founded by the University of Texas MD Anderson Cancer Center’s Ron DePinho , last raised cash in June 2021 with a $74 million Series B . → New York cancer biotech Treadwell Therapeutics has welcomed Roger Sidhu as CMO. Sidhu previously showed up in Peer Review when he left Roivant in September 2021 to become medical chief at Brooklyn ImmunoTherapeutics , now named Eterna Therapeutics . Sidhu was VP of clinical development at Kite before landing the CMO and head of R&D posts at Roivant in 2020. → David Gaiero has been promoted to CFO of Cyteir Therapeutics , which laid off 70% of its staff last month and is down to 15 employees who will redouble the Lexington, MA biotech’s efforts in ovarian cancer with a combo therapy of CYT-0851 and capecitabine . Gaiero was named VP of finance at Cyteir in December 2020 after three years as VP, corporate controller and interim CFO at Wave Life Sciences . → Back in September, Palisade Bio downsized its team of 13 by 20% to keep pushing forward with development of its lead candidate. Now, the Carlsbad, CA-based company is promoting Robert McRae to the position of COO. McRae has been with the company since December 2021, having joined as SVP, operations and strategic development. Prior to Palisade, McRae was with Viracta Therapeutics as VP, operations & strategic alliances. In addition to McRae’s promotion, interim CEO JD Finley is grabbing a seat on the company’s board of directors. → JP Gabriel has been named chief technical operations officer at RNAi player Silence Therapeutics after the retirement of SVP, technical operations and Ferring vet Jørgen Wittendorff . Gabriel has held positions in manufacturing and quality at Roche/ Genentech , Ultragenyx and most recently, Ocugen , where he was SVP, technical operations. Almost a year ago, Craig Tooman succeeded Mark Rothera as Silence’s CEO in a shakeup that involved the promotion of Rhonda Hellums to Tooman’s old CFO job. Rothera now runs the show at Viracta Therapeutics. → Shanghai MicuRx Pharmaceutical has pulled in Regis Vilchez as CMO of its American subsidiary, MicuRx Pharmaceuticals . Vilchez is bringing with him experience from Boehringer Ingelheim, Merck, Roche, Abbott / AbbVie and Mallinckrodt . During his career, Vilchez has contributed to the global development of a number of therapies, including Victrelis , Ocaliva and StrataGraft . → Didier Vingadassalom gets his own cadenza in this portion of Peer Review as senior director, business development at Concerto Biosciences . Vingadassalom is a Sanofi alum who comes from SQZ Biotechnologies , where he was senior director, business development and head of alliance management. Co-founded by CEO Cheri Ackerman and CSO Jared Kehe — both trained pianists — microbe-focused Concerto hit the stage three months ago with $23 million in Series A funding . → Blue Water Vaccines , which back in August ditched SPAC merger plans , has reeled in Frank Jaeger as SVP of marketing and business development. Jaeger hails from Clarus Therapeutics , where he was SVP and CCO. Before that, Jaeger was with the team at AbbVie, helping launch AndroGel from its men’s health business unit. → Biren Amin has joined the board of directors at ImmPACT Bio , a CAR-T outfit chaired by ex- Gossamer Bio CEO Sheila Gujrathi . Since leaving Jefferies in 2021, Amin has been finance chief at Immuneering and now tackles the roles of CFO and chief strategy officer for Pyramid Biosciences . → Ex- Blueprint Medicines chief Jeff Albers has been named chairman of the board at MOMA Therapeutics , a Third Rock biotech that raised $150 million in a Series B round last May. Albers, who’s still chairman at Blueprint, started a gig at Atlas Venture last month as a venture partner. → In its first Peer Review appearance since buying Antares Pharma for just shy of $1 billion last April, Halozyme has elected Barbara Duncan to the board of directors. Duncan was CFO of Intercept from 2009-16 and chairs the board at Fusion Pharmaceuticals . → Touting a Phase II win with the ex-Amgen drug obicetrapib last month, NewAmsterdam Pharma has elected John Smither to the board of directors. Smither is an Amgen vet whose past CFO appointments include Sienna Biopharmaceuticals (two separate stints), Kite (interim) and Arcutis . → Sam Truex’ s Upstream Bio flowed onto our radar with a $200 million debut last June, and this week the inflammatory disease biotech has reserved space for Tectonic Therapeutic CMO Marcella Ruddy on the board of directors. To conclude her five years at Regeneron , Ruddy was VP, clinical development for inflammation and immunology from 2018-21. → Waypoint Holdings chairman and CEO Thomas Dietz is headed to the board of directors at RNA player Nutcracker Therapeutics . Dietz, the chairman of Eiger BioPharmaceuticals , owns board seats at Paratek Pharmaceuticals and Leap Therapeutics . → Carisma Therapeutics , the company that took the spotlight with its CAR-M therapy , is bringing in some firepower from one of its allies to its team. Moderna ’s Lin Guey , who oversees the partnership between the two companies, will be joining Carisma’s scientific advisory board. During her career, Guey has worked at Tessera , Xilio , Shire and Pfizer. → Repligen has named ex- Millipore CEO Martin Madaus to its board of directors. Madaus is a senior operating executive at The Carlyle Group and the former North America president and CEO of Roche Diagnostics . → The chief marketing officer of Evolus , Crystal Muilenburg , is hopping onto the board of directors at Elevai Labs . While at Evolus, Muilenburg has helped lead the re-launch of Jeuveau . Prior to Evolus, Muilenburg was with Sienna Biopharmaceuticals and had a decade-long stint at Allergan . → Acticor Biotech , which recently revised its pipeline to postpone a Phase II study, has pulled out a seat on its board of directors for Patricia Zilliox — who will be replacing Corinne Le Goff . Zilliox serves as president and CEO of Eyevensys and has held roles at Alcon Laboratories and the Clinical Research Institute. → Boston-based Anodyne Nanotech , dealing with microneedle tech, has brought on Jeff Mihm to its board of directors. Mihm formerly served as CEO of Noven Pharmaceuticals .

BOSTON--(BUSINESS WIRE)-- Anodyne Nanotech, Inc., a venture-backed biotechnology company based in Boston and specializing in the transdermal delivery of biologics, announced today the appointment of Jeff Mihm as a member of its Board of Directors. Mr. Mihm previously served as the CEO of Noven Pharmaceuticals, a leading transdermal company. During his tenure as CEO, Noven gained FDA approval of a novel transdermal prescription patch product, transformed its manufacturing and quality systems and implemented a new strategic direction for the company. Mr. Mihm has significant experience with strategic partnerships and licensing transactions, including through Noven’s long-running joint venture with Novartis. Mr. Mihm played an integral role in the $428 million sale of Noven to Hisamitsu Pharmaceuticals. He currently serves as the Executive-in-Residence at the College of Pharmacy and the McCombs School of Business at the University of Texas at Austin. "We are thrilled to welcome Jeff Mihm to our Board of Directors," said Anodyne CEO Jake Lombardo. "He brings a wealth of experience and expertise in the pharmaceutical industry. We are confident he will be a valuable addition to Anodyne as we advance our Hero Patch platform and develop innovative new products for the delivery of biologics, with a specific focus on peptide therapeutics and monoclonal antibodies.” “I am excited to join Anodyne’s Board of Directors and start working with the management team,” said Mr. Mihm. “I believe Anodyne’s microneedle platform technology has the potential to completely transform the transdermal industry and provide tremendous benefits to future patients.” About Anodyne Nanotech Anodyne Nanotech is a Boston-based biotechnology company dedicated to improving human health by developing innovative and efficient methods of delivering biologic drugs. The company is advancing its patented, solid state porous microneedle technology—the Hero Patch—to deliver clinically-meaningful doses of macro-molecules without the need for injections via traditional hypodermic needles. For more information about Anodyne Nanotech, Inc., please visit