Covis Pharma Holdings BV

Transaction supported by 100% of First Lien and 100% of Second Lien Lenders Results in material strengthening of the Company’s balance sheet and liquidity pro > Existing Equity Sponsors remain the majority shareholder in Covis Covis operationally and financially in a position to scale its business organically and inorganically ZUG, Switzerland, June 01, 2023 (GLOBE NEWSWIRE) -- Covis Finco Sarl (together with its subsidiaries “Covis” or the “Company”), today announced the closing of its financial recapitalization transaction per the previously announced Support Agreement entered into with its Equity Sponsors, 100% of its First Lien Lenders (including Revolving Facility Lenders) and 100% of its Second Lien Lenders (the “Recapitalization”). The Recapitalization and resulting ~$450 million debt reduction right-sizes Covis’ balance sheet and materially improves its go-forward liquidity and cash flow profile. Funds managed by an affiliate of Apollo Global Management (the “Equity Sponsors”) remain majority owners of the Company, while the First Lien Lenders will receive a significant minority stake. The Company is now positioned to scale its business through execution of organic growth initiatives while also pursuing inorganic growth opportunities, which have historically been a key value lever for the Company. “We are pleased to have received unanimous support from all of our key financial stakeholders to complete this transaction and are excited to capitalize on the resulting operational and financial flexibility to profitably and sustainably scale the business with a primary focus on patient outcomes and improving the health of people with serious medical conditions,” said Michael Porter, CEO of Covis. Covis’ advisors included Paul, Weiss, Rifkind, Wharton & Garrison LLP and Slaughter and May as legal counsel and PJT Partners as financial advisor. The First Lien Term Lenders were advised by Weil, Gotshal & Manges LLP as legal counsel and Houlihan Lokey Capital, Inc. as financial advisor and the Administrative Agent for the Revolving Facility Lenders and Second Lien Lenders were advised by Freshfields Bruckhaus Deringer LLP as legal counsel and Berkeley Research Group, LLC as financial advisor. About Covis Covis Pharma, founded in 2011 and headquartered in Luxembourg, is a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses. Additional information is available at Media Contact press@covispharma.com

Vancouver, British Columbia--(News - April 10, 2023) - NervGen Pharma Corp. (TSXV: NGEN) (OTCQX: NGENF) ("NervGen" or the "Company"), a clinical stage biotech company dedicated to developing innovative solutions for the treatment of nervous system damage, today announced the appointment of Mr. Michael Kelly to the position of President & CEO effective April 10, 2023. Mr. Kelly has also been appointed as a member of NervGen's Board of Directors. "We are very excited to welcome Mike to NervGen and are confident he will play a major role in shaping the future of the Company. Mike is a highly experienced pharmaceutical executive with a strong track record of leadership and success," stated Bill Radvak, Executive Chairman. "Mike brings three decades of pharmaceutical experience, playing instrumental roles in the creation, development and strengthening of several companies. We are delighted to have him lead the team as we prepare to initiate our Phase 1b/2a clinical trial of our lead drug candidate, NVG-291, in spinal cord injury this year. Most recently, Mike played a key leadership role as President of US operations at Adapt Pharma, Inc. and its highly successful launch of NARCAN® (naloxone HCl) Nasal Spray in the US and Canada and eventual sale to Emergent BioSolutions for US$735 million." "I'm excited to take on this leadership role at NervGen," said Mike Kelly. "The Company is built on strong foundational science with significant preclinical data. The team is both passionate and focused on advancing NVG-291, which could help millions of individuals suffering from spinal cord injury, Alzheimer's disease, multiple sclerosis, and other forms of nervous system damage. I look forward to leading the team and transitioning NervGen to the next level of growth." Mr. Kelly currently serves on the Board of Directors of ARS Pharmaceuticals, which he joined in May 2019. Prior to Adapt, he was CEO and Board member for Covis Pharma Inc, who, along with its European affiliate, grew and sold the company assets for $1.2 billion to Concordia Healthcare in 2015. Previously, Mr. Kelly was also a member of the founding management team of Azur Pharma Limited, a specialty pharmaceutical company, and later, following a successful strategic merger, served as the Senior Vice President of Sales and Marketing for Jazz Pharmaceuticals plc. Prior to his tenure at Azur Pharma, he served as Vice President of Commercial Operations and Medical Affairs at Guilford Pharmaceuticals Inc., Vice President of Sales and Marketing at ViroPharma Incorporated, and held various commercial and medical roles at TAP Pharmaceuticals Inc. Mr. Kelly holds a Bachelor of Science in Business Administration from The College of New Jersey and a Master of Business Administration from Rider University. Mr. Radvak added, "I want to take this opportunity to thank Dr. Adam Rogers who assumed the role of Interim President and Mr. Glenn Ives who assumed the role of Lead Director and joined me in leading the NervGen team through this transition period. We are stepping down from these interim roles with every confidence that Mike Kelly's expertise and experience make him the ideal candidate to lead NervGen forward." Mr. Kelly's compensation package was strategically structured to be closely aligned with shareholders' interests in progressively building equity in NervGen's clinical programs and intellectual property. Grant of Retention Securities & Options In connection with the appointment of Mr. Kelly as President and Chief Executive Officer, the Company has granted 590,000 retention securities (the "Retention Securities") to Mr. Kelly, each exercisable into one common share at a price of $1.78 per share for a period of 10 years and that vest equally every month over a three-year period. The Retention Securities were granted outside of the Company's stock option plan, as an inducement grant to Mr. Kelly becoming the President and Chief Executive Officer of the Company pursuant to Section 6.4 of TSX Venture Exchange Policy 4.4 - Security Based Compensation ("Policy 4.4"). The Company has also granted 2,892,000 incentive stock options to Mr. Kelly exercisable at a price of $1.78 per share for a period of 10 years and that vest equally every month over a three-year period. The options have been granted in accordance with the policies of the TSX Venture Exchange and the conditions of the Company's stock option plan. The Board of Directors also approved certain clarifying amendments to the Company's existing stock option plan to more closely align with the requirements under Policy 4.4. About NVG-291 NervGen holds exclusive worldwide rights to NVG-291, a first-in-class therapeutic targeting pathogenic mechanisms that interfere with nervous system repair. NVG-291 is a therapeutic peptide derived from the intracellular domain of the receptor protein tyrosine phosphatase sigma (PTPσ). NVG-291-R, a rodent analog of NVG-291, has been shown to promote nervous system repair and functional recovery in animal models of spinal cord injury, peripheral nerve injury, multiple sclerosis and stroke, through enhanced plasticity, axonal regeneration, and remyelination. About NervGen NervGen (TSXV: NGEN) (OTCQX: NGENF) is a clinical stage biotech company dedicated to developing innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. NervGen's lead drug candidate, NVG-291, is currently planned for a Phase 1b/2a clinical trial. The Company's initial target indications include spinal cord injury, Alzheimer's disease and multiple sclerosis. For more information, go to . For further information, please contact: Huitt Tracey, Corporate Communications htracey@nervgen.com 604.537.2094 Nancy Thompson, Vorticom Public Relations nancyt@vorticom.com 212.532.2208 Follow NervGen on Twitter, LinkedIn, and Facebook for the latest news on the Company. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. Cautionary Note Regarding Forward-Looking Statements This news release may contain "forward-looking information" and "forward-looking statements" within the meaning of applicable Canadian and United States securities legislation. Such forward-looking statements and information herein include, but are not limited to, the Company's current and future plans, expectations and intentions, results, levels of activity, performance, goals or achievements, or any other future events or developments constitute forward-looking statements, and the words "may", "will", "would", "should", "could", "expect", "plan", "intend", "trend", "indication", "anticipate", "believe", "estimate", "predict", "likely" or "potential", or the negative or other variations of these words or other comparable words or phrases, are intended to identify forward-looking statements. Forward-looking statements include, without limitation, statements relating to: the timing of the clinical development of NVG-291; the anticipated contributions of our new President & CEO and the structure of his compensation to build value in our clinical programs and intellectual property; the objectives and timing of our planned Phase 1b/2a clinical trial in individuals with spinal cord injury; our initial target indications of spinal cord injury, Alzheimer's disease and multiple sclerosis; the belief that modulating the activity of PTPσ is a promising target for reducing the clinical effects of nervous system damage through multiple mechanisms; and the creation of innovative treatments that enable the nervous system to repair itself following damage, whether due to injury or disease. Forward-looking statements are based on estimates and assumptions made by the Company in light of management's experience and perception of historical trends, current conditions and expected future developments, as well as other factors that we believe are appropriate and reasonable in the circumstances. In making forward-looking statements, the Company has relied on various assumptions, including, but not limited to: the Company's ability to manage the effects of the COVID-19 pandemic; the accuracy of the Company's financial projections; the Company obtaining positive results in its clinical and other trials; the Company obtaining necessary regulatory approvals; and general business, market and economic conditions. Many factors could cause our actual results, level of activity, performance or achievements or future events or developments to differ materially from those expressed or implied by the forward-looking statements, including without limitation, a lack of revenue, insufficient funding, the impact of the COVID-19 pandemic, reliance upon key personnel, the uncertainty of the clinical development process, competition, and other factors set forth in the "Risk Factors" section of the Company's Annual Information Form, Short Form Base Shelf Prospectus, financial statements and Management Discussion and Analysis which can be found on SEDAR.com. All clinical development plans are subject to additional funding. Readers should not place undue reliance on forward-looking statements made in this news release. Furthermore, unless otherwise stated, the forward-looking statements contained in this news release are made as of the date of this news release, and we have no intention and undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. The forward-looking statements contained in this news release are expressly qualified by this cautionary statement. To view the source version of this press release, please visit

Pictured: FDA sign in front of building/Courtesy Sarah Silbiger/Getty Images After 12 years on the market, the FDA announced Thursday it has withdrawn its previous approval for the only drug on the market to prevent preterm birth, Covis Pharma’s Makena. The withdrawal renders the use and distribution of Makena and its generic versions unlawful, effective immediately. The decision was jointly issued by Robert Califf, FDA Commissioner, and Namandjé Bumpus, the agency’s chief scientist. According to a March 7 press release, Covis requested a wind down of Makena (hydroxyprogesterone caproate) that would allow current patients to complete their 21-week course of treatment and exhaust the remaining inventory. This proposal had been set forth before, but, according to Covis’ press release, the FDA’s Center for Drug Evaluation and Research (CDER) did not agree with it. CDER “requested that the proceedings continue until concluded with a decision from the FDA Commissioner and Chief Scientist,” the company said. In a Friday press release issued in response to the FDA’s decision to withdraw the approval, Covis stated, “CDER recognizes that a limited supply of Makena and generics has already been distributed and acknowledges that some healthcare providers might continue to prescribe or administer that limited remaining supply to their patients. The company recommends that healthcare providers consider FDA’s conclusion on the withdrawal of Makena.” Covis’ request for a wind down came in response to a three-day hearing in October 2022 that concluded with the FDA’s Obstetrics Reproductive and Urologic Drugs Advisory Committee voting to withdraw Makena’s approval in a 14-1 decision. A post-approval confirmatory study had found that the drug failed to show the clinical benefits of decreasing preterm births and improving infant outcomes. The decision to withdraw the approval solidifies the advisory committee’s conclusion that the drug was not working as intended. Covis agreed with its conclusion also, stating that it was seeking to voluntarily withdraw the NDA granted to Makena in light of the committee’s recommendations. The company had already outlined its plan for voluntary withdrawal shortly after the 2022 hearing. In October 2020, the FDA proposed withdrawing the NDA approval of Makena after reviewing data that Covis collected over a nine-year period. The briefing documents that the FDA issued ahead of the 2022 hearing further emphasized the agency’s stance on the issue. Califf and Bumpus outlined the rationale for the withdrawal in the decision. They said it is based on their review of CDER’s and Covis’ submissions, the 100-plus public comments submitted to the docket on the matter since 2020, the 2022 hearing transcript and the Presiding Officer’s report. In the document detailing the decision, Califf said that “the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved.” How It Started The FDA approved Makena via the accelerated approval pathway in 2011, back when the drug was developed by Hologic. AMAG Pharmaceuticals bought the rights to Makena a few years later. In October 2020, Luxembourg-based Covis Group entered a $647 million deal to acquire AMAG, along with the global rights for Makena, approved to reduce the risk of preterm birth in women who had one baby and a history of spontaneous preterm birth. The end of the saga underscores the concerns that have been raised in recent years with the accelerated approval pathway. Other drugs that have been approved through this pathway include Aduhelm, which prompted an OIG investigation into the pathway in 2022 The FDA said that there is “a crucial need” for treatments to reduce the risks associated with preterm birth. “It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes—particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” Califf said. The opportunity that exists for other pharma companies in the market to address this patient population is two-pronged, with preterm birth complications being the leading cause of death among children younger than five-years-old and considering the long-term health problems associated with preterm births. “Nothing in this opinion today is intended to minimize these concerns—to the contrary, our hope is that this decision will help galvanize further research,” Bumpus said.