Business Wire

Novaremed Secures US $50 Million Capital Commitment from Global Emerging Markets

Share

Novaremed AG (Novaremed), a clinical-stage Swiss biopharmaceutical company, announced today that it has signed an agreement with GEM Global Yield LLC SCS (GEM), a Luxembourg-based private, alternative investment group for a US $50 million capital commitment.

Under the agreement, GEM commits to provide Novaremed with a share subscription facility of up to US $50 million for a 36-month term following the public listing of the company’s shares. Novaremed will control the timing and maximum amount of drawdown under this facility and has no minimum drawdown obligation. Concurrent with a public listing of Novaremed shares, the company will issue warrants to GEM to purchase shares of Novaremed.

Subject to the funding becoming available, the proceeds from this financing will be used to progress the clinical development of Novaremed’s lead product, NRD135S.E1, an investigational non-opioid small molecule drug for the treatment of painful diabetic peripheral neuropathy (PDPN).

“We are very pleased about this financial arrangement with GEM,” said Isaac Kobrin, M.D., Executive Chairman of the Board of Novaremed. “This funding agreement with GEM will help us, upon the company’s public listing, to advance our highly innovative lead product that we are developing for the non-opioid treatment of patients affected by diabetes-related chronic neuropathic pain. The ongoing opioid crisis has increased the high unmet medical need for novel treatments, which can control chronic pain without inducing addiction, dependence and abuse.”

About Painful Diabetic Peripheral Neuropathy (PDPN)

Peripheral nerve injury from various etiologies (e.g., diabetic peripheral neuropathy, postherpetic neuralgia, neuropathy due to cancer or trauma) may result in chronic and severe intractable neuropathic pain. PDPN is one of the most frequent complications of diabetes. Up to 20% of patients with PDPN experience chronic, debilitating neuropathic pain that substantially impairs quality of life. Many of the currently available drugs for the treatment of PDPN have limited efficacy and are often not well tolerated due to multiple side effects, including those to central nervous system.

The rapidly increasing prevalence of diabetes and of PDPN as well as the limitations of the available therapies makes the treatment of PDPN a condition of high unmet medical need.

About NRD135S.E1

NRD135S.E1 (or NRD.E1) is a new chemical entity, that is orally available and being developed for the treatment of PDPN. The mechanism of action of NRD.E1 is different to that of approved pain therapies as the investigational drug does not bind to or interact with receptors associated with pain nor does it bind to opioid receptors.

Completed clinical studies with NRD.E1 include three Phase I studies (single and multiple ascending dose studies and food-effect study). The Phase IIa Proof of Concept study (ClinicalTrials.gov Identifier: NCT02345291) was a 3-week, dose finding, placebo-controlled, randomized, multi-center study. The study was conducted in 88 patients with moderate to severe PDPN and compared three doses (10mg, 40mg and 150 mg/day) of NRD.E1 to placebo. Results showed a clinically relevant, dose-related pain reduction; NRD.E1 was well tolerated at all tested doses.

Novaremed has an open IND for NRD.E1 to conduct a 12-week Phase II study in 120 patients with moderate to severe PDPN in the US. The study compares efficacy, safety and tolerability of one dose of NRD.E1 to placebo. The primary objective of the study is to demonstrate that NRD.E1 is superior to placebo in relieving neuropathic pain associated with PDPN. The primary endpoint is the change from the baseline to Week 12 in the weekly mean of daily pain, as measured by an 11-point Numeric Rating Scale (NRS). The main secondary objectives of the study are to evaluate (i) the safety and tolerability of NRD.E1, (ii) the presence of withdrawal symptoms after abrupt drug interruption, and (iii) the effect of NRD.E1 on insomnia and quality-of-life indicators.

In December 2020, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to NRD.E1 for the treatment of PDPN.

About Novaremed

Novaremed Ltd, a wholly owned subsidiary of Novaremed AG was founded in 2008 in Israel and Novaremed AG was founded in 2017 in Switzerland. Novaremed aims to become a leader in the discovery and development of innovative treatment options for chronic pain and currently is developing NRD.E1, an orally active non-opioid small molecule with a novel mechanism of action for the treatment of PDPN.

About the GEM Group

Global Emerging Markets (“GEM”) is a $3.4 billion, alternative investment group with operations in Paris, New York, and Los Angeles. GEM manages a diverse set of investment vehicles focused on emerging markets and has completed over 400 transactions in 70 countries. Each investment vehicle has a different degree of operational control, risk-adjusted return, and liquidity profile. The family of funds and investment vehicles provide GEM and its partners with exposure to: Small-Mid Cap Management Buyouts, Private Investments in Public Equities and select venture investments. For more information: www.gemny.com

Contact information

For further information about Novaremed, please contact:
Isaac Kobrin, M.D.
Executive Chairman of the Board
isaac.kobrin@novaremed.com
www.novaremed.com

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

SHINE, Phoenix merger focused on advancing fusion technology20.4.2021 20:00:00 CEST | Press release

SHINE Medical Technologies LLC and Phoenix LLC today announced that the companies have completed a merger under which Phoenix has become a wholly owned subsidiary of SHINE. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210420006038/en/ Greg Piefer, CEO of SHINE (left), talks with Evan Sengbusch, general manager of SHINE's Phoenix division, and Ross Radel, chief technology officer and chief operating officer of the Phoenix division, at the Phoenix headquarters and manufacturing center in Fitchburg, Wis., on April 16, 2021. (Photo: SHINE Medical Technologies) SHINE is a next-generation nuclear technology company focused on unlocking the power of fusion technologies to benefit the planet and humankind. The company’s goal is to deliver on the long-term promise of clean fusion energy by advancing fusion technology starting with the commercialization of medical isotopes. Phoenix designs and manufactures the world’s strongest stea

Hilton Releases 2020 ESG Report, Reinforcing Commitment to Positive Global Impact20.4.2021 17:49:00 CEST | Press release

Hilton (NYSE: HLT) has released its 2020 Environmental, Social and Governance (ESG) Report, which highlights the company’s continued commitment to redefining sustainable travel and driving positive impact on people and the planet. Through Hilton’s Travel with Purpose program, the company continues to take important steps to integrate positive social impact and environmental stewardship throughout its operations, communities and supply chain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210420005911/en/ Hilton releases 2020 ESG report, reinforcing commitment to positive global impact. (Photo: Business Wire) “As we weathered this unpredictable year, Hilton has remained focused on our Team Members and the communities we serve around the world,” said Kristin Campbell, general counsel and chief ESG officer, Hilton. “We took a nimble approach during this difficult period to deliver meaningful support, while remaining focused on

Xsolla Unifies Skill-Based Gaming and Esports Platform, Monetization and Subscription Programs20.4.2021 16:30:00 CEST | Press release

Xsolla, the video game commerce company powered by its Transaction Engine and Business Engine to help developers and publishers market, sell, connect and optimize their games globally, has launched their new esports solution, enabling video game developers, publishers, and esports event producers to create engaging fan experiences with safe and secure payment processing, globally. The new program provides a straightforward, streamlined solution for the fastest growing entertainment segment worldwide. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210420005530/en/ Xsolla Unifies Skill-Based Gaming and Esports Platform, Monetization and Subscription Programs (Graphic: Business Wire) With Xsolla’s full suite of products, companies can work with esports properties or build their own esports platform with streamlined payments and subscriptions plans. With programs that scale from small local skill-based matchups to massive global

The Federation of Royal Colleges of Physicians Approves UpToDate Clinical Decision Support for CPD20.4.2021 15:30:00 CEST | Press release

UpToDate, the clinical decision support tool from Wolters Kluwer, Health has been approved by the Federation of the Royal Colleges of Physicians of the United Kingdom as a continuing professional development (CPD) activity. The organization is a collaboration between the Royal College of Physicians of London, Royal College of Physicians of Edinburgh, and Royal College of Physicians and Surgeons of Glasgow. The colleges have more than 50,000 members among them worldwide. The approval of UpToDate comes following new guidelines introduced by the Federation that recognize the use of online resources with current medical content (e-libraries) as CPD. Earning CPD while caring for patients Members will now be able to earn and track credits eligible for continuing professional development while using UpToDate to research clinical questions at the point of care. CPD credits are earned from UpToDate by consulting information relevant to a specific clinical question, thus broadening clinical know

MSCI Calls on Capital to Lead the Net-Zero Revolution20.4.2021 15:21:00 CEST | Press release

Addressing climate change will require the largest reconstruction of the global economy since the Industrial Revolution, according to a report published today by MSCI Inc. (NYSE: MSCI), a leading provider of critical decision support tools and services for the global investment community. ‘The Role of Capital in the Net-Zero Revolution’highlights how capital markets participants must be a powerful and positive force to urgently drive the systemic transformation needed to avert climate catastrophe. This call to action identifies specific steps that companies as well as owners and managers of capital must take to drive the achievement of a net-zero economy by 2050. Analysis by MSCI of its All Country World Investable Markets Index (MSCI ACWI IMI) - a measure of approximately 9,000 publicly listed companies across 50 developed and emerging markets with a market value of over USD 70 trillion1 – revealed those companies annually emit an estimated 11.2 gigatons of carbon dioxide equivalent (

PPG Reports Increased Sales of Sustainably Advantaged Products, Continued Progress on Sustainability Goals20.4.2021 15:04:00 CEST | Press release

PPG (NYSE:PPG) today launched its 2020 Sustainability Report, highlighting the company’s strong, continued progress against key environmental, social and governance (ESG) areas. The report is available at sustainability.ppg.com. “Our unwavering commitment to ‘protect and beautify the world’ guides our more than 46,000 employees to further advance our sustainability progress each day,” said Michael H. McGarry, PPG chairman and chief executive officer. “We continue to innovate, invest and develop sustainably advantaged products and processes that our customers and other stakeholders count on to create a more sustainable future. As highlighted in our latest Sustainability Report, we have made significant progress within our many ESG-related initiatives, and we continue to drive our ambitious targets forward.” Throughout last year, PPG improved the sustainability of its products, processes and operations, decreasing its overall global environmental footprint. Achievements included: 35% of

Tradeweb Joins Climate Bonds Initiative Partners Program20.4.2021 15:00:00 CEST | Press release

Tradeweb Markets Inc. (Nasdaq: TW), a leading, global operator of electronic marketplaces for rates, credit, equities and money markets, today announced it has joined the Climate Bonds Initiative’s Partners Program, a global movement seeking to mobilise bond markets for climate change solutions. Climate Bonds Initiative is an international, investor-focused not-for-profit organisation, promoting investment in projects and assets necessary for a rapid transition to a low carbon and climate resilient economy. The Climate Bonds Standard and Certification Scheme is a labelling scheme for bonds, loans and other debt instruments. The rigorous scientific criteria ensure consistency with the goals of the Paris Climate Agreement. The Scheme is used globally by bond issuers, governments, investors and the financial markets to prioritize investments, which genuinely contribute to addressing climate change. The Climate Bonds Initiative has been tracking the green labelled market since 2009. By par

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom