On September 19, 2022 Viracta Therapeutics, Inc. (Nasdaq: VIRX), a precision oncology company targeting virus-associated malignancies, reported the succession of its President and Chief Executive Officer, Ivor Royston, M.D. to Mark Rothera, who was appointed as President and CEO and member of the Board of Directors, effective today (Press release, Viracta Therapeutics, SEP 19, 2022, View Source [SID1234619644]). Dr. Royston will support the leadership transition and continue to serve as a member of the Board of Directors.

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"We are pleased to welcome Mark as Viracta’s new President and Chief Executive Officer, given his demonstrated strategic execution, deep commercialization experience and proven global leadership skills, as the Company advances Nana-val towards later-stage clinical development, marketing approval and important global strategic positioning," said Roger J. Pomerantz, M.D., F.A.C.P, Chairman of the Board of Directors at Viracta. "On behalf of the Viracta Board of Directors, we would like to thank Ivor for his visionary leadership in advancing a new and potentially disruptive modality in the treatment of Epstein-Barr virus-associated cancers, and look forward to his continued service on the Board."

"I am thrilled to be joining Viracta at this exciting time, as the company progresses Nana-val across multiple indications with the ambition of representing a tumor-agnostic approach to Epstein-Barr virus-associated cancers," said Mr. Rothera. "I appreciate the solid foundation Ivor has established at Viracta, the strong team that he has assembled and the opportunity to expand on the promising clinical data in EBV-positive lymphoma. I view this transition as a passing of the baton and look forward to leveraging my strategic and global commercial experience to optimally position Nana-val to help patients suffering from some of the most aggressive forms of cancer, whilst maintaining a clear focus on driving shareholder value."

Mr. Rothera brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of commercial and global leadership, including driving the successful build of multiple biotech companies, predominantly in the field of rare or specialty diseases. Prior to joining Viracta, Mr. Rothera served as President and CEO of Silence Therapeutics, a clinical-stage organization focused on developing RNA therapies for hematology, cardiovascular and rare diseases. He previously served as CEO of Orchard Therapeutics, where he oversaw its transformation from a small U.K.-based, privately held company with two clinical-stage programs into a leading gene therapy company with seven clinical-stage programs and fully integrated capabilities. During his tenure, Orchard Therapeutics secured more than $600 million in financing and grew from a market capitalization of $250 million to more than $1.7 billion at its peak. Prior to Orchard, Mr. Rothera served as Chief Commercial Officer of PTC Therapeutics, where he helped it evolve into a commercial company with a global footprint, including the successful launch of two rare disease therapies. Previously, he served as Global President of Aegerion Pharmaceuticals Inc. and Vice President and General Manager of commercial operations at Shire Human Genetic Therapies for Europe, Middle East and Africa. Mr. Rothera received an M.A. in Natural Sciences from Cambridge University and an M.B.A. from the European Institute for Business Administration (INSEAD).

"As the Company progresses in its transition from development stage towards commercialization, Viracta will benefit from Mark’s over 30 years of global leadership experience in the biopharmaceutical industry, having driven the strategic advancement of multiple biotechnology companies from development stage to commercialization," stated Dr. Royston. "I am fortunate to have been involved in building a superb management team that will continue our vision of creating new therapies for virus-associated cancers. With this transition, I look forward to supporting the advancement of the Company as a Viracta board member and I am confident and excited about Viracta’s future under Mark’s leadership."

About Nana-val (Nanatinostat and Valganciclovir)

Nanatinostat is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in Epstein-Barr virus (EBV)-associated malignancies. Nanatinostat is currently being investigated in combination with the antiviral agent valganciclovir as an all-oral combination therapy, Nana-val, in various subtypes of EBV-associated malignancies. Ongoing trials include a pivotal, global, multicenter, open-label Phase 2 basket trial in multiple subtypes of relapsed/refractory EBV+ lymphoma (NAVAL-1) as well as a multinational Phase 1b/2 trial in patients with EBV+ recurrent or metastatic nasopharyngeal carcinoma and other EBV+ solid tumors.

About EBV-Associated Cancers

Approximately 90% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic or associated with mononucleosis. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Cells containing latent virus are increasingly susceptible to malignant transformation. Patients who are immunocompromised are at an increased risk of developing EBV+ lymphomas. EBV is estimated to be associated with approximately 2% of the global cancer burden including lymphoma, nasopharyngeal carcinoma and gastric cancer.

On September 19, 2022 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that company management will participate in an upcoming investor conference (Press release, Instil Bio, SEP 19, 2022, View Source [SID1234619643]):

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Jefferies Cell and Genetic Medicine Summit
Company presentation and Q&A: Thursday, September 29, 2022 at 10:30 a.m. ET

A live webcast, if recorded, of the presentation can be accessed under "News & Events" in the Investors section of the Company’s website at www.instilbio.com. The archived webcast will be available on the Company’s website shortly after the event.

On September 19, 2022 The Executive Board of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") reported its earnings guidance for the current fiscal year 2022 due to currency gains and efficiencies in study initiation costs. The currency translation gains are due to good currency management in connection with the positive development of the U.S. dollar. The initial set-up costs for the prospective FDA pivotal study for Epi proColon "Next-Gen", for which the first subject was recently enrolled, were lower than anticipated.

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For the full year 2022, the Executive Board now expects adjusted EBITDA (before share-based payment expenses) to be within the range of EUR -10.5 million to EUR -11.5 million and cash consumption in the range of EUR -14.5 million to EUR -15.5 million. Previously, the Company expected EBITDA (before share-based payment expenses) and cash consumption to range from EUR -15.0 million to EUR -17.0 million. The revenue forecast remains unchanged between EUR 0.3 million to EUR 0.8 million.

On September 19, 2022 Epigenomics Inc, a wholly-owned subsidiary of Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company"), reported it has enrolled its first subject in a new pivotal clinical trial supporting the Company’s "Next-Generation" blood-based diagnostic screening test for the detection of colorectal cancer (CRC) (Press release, Epigenomics, SEP 19, 2022, View Source [SID1234619641]).

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The prospective, multi-center study titled CRC-DRAW (CRC–Detection Reliable Assessment With Blood) will enroll screening eligible participants 45 years of age and older who are at average risk for colorectal cancer. Over the course of the trial, it is expected to enroll over 15,000 subjects to achieve the proposed statistical endpoints needed for the study. Clinical outcomes generated from CRC-DRAW will be used to support the planned Pre-Market Approval (PMA) submission of the Company’s "Next-Generation" CRC screening test with the U.S. Food and Drug Administration (FDA).

"CRC is still the number two cause of cancer deaths in the U.S. because numerous patients remain unscreened due to barriers with access" said Greg Hamilton, CEO of Epigenomics. "More than ever physicians need options that patients will embrace and we believe that a reliable blood-based test that is effective and affordable provides a meaningfully differentiated solution to this problem. We have initiated our CRC-DRAW trial because we are confident the improved performance of our "Next-Gen" test will give patients, physicians and providers an easy-to-use non-invasive option that will dramatically increase screening rates and ultimately save lives."

"Epigenomics has been a long-standing pioneer in the liquid biopsy space with the first ever FDA approved cancer test from blood," said Dr. Andrew A. Lukowiak, President and Chief Scientific Officer. "We have utilized this know-how and experience to augment our previous test with additional biomarkers to significantly improve the performance. We look forward to presenting preliminary test performance data within the next couple of months."

On September 19, 2022 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, reported it has entered into an exclusivity agreement with a view to acquire all the share capital and voting rights of Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases (Press release, Genfit, SEP 19, 2022, https://ir.genfit.com/news-releases/news-release-details/genfit-acquire-clinical-stage-biopharmaceutical-company [SID1234619640]).

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The acquisition of Versantis fits perfectly within GENFIT’s strategic vision of becoming a global leader in ACLF (acute-on-chronic liver failure) and is another critical milestone in the execution of GENFIT’s strategic plan. With this acquisition, GENFIT consolidates its position in ACLF via the integration of a clinically advanced asset presenting a solid scientific rationale supported by encouraging Phase 1b and preclinical data. GENFIT will also further expand its pipeline in other liver diseases characterized by high unmet medical needs with additional product candidates developed by Versantis. In addition, GENFIT’s know-how in ACLF will broaden, with the integration of Versantis’ team of experts, joining forces to accelerate both research and development.

ACLF is an underserved medical condition associated with short-term mortality (23% to 74% mortality at 28 days, depending on severity grade) and a significant cost of care. No drugs have been approved in this indication so far and incidence is growing at epidemic rates due to an aging population and a higher prevalence of diabetes, obesity, NASH, as well as alcohol and drug-induced liver injury. From a patient perspective, the ACLF syndrome is characterized by an abrupt life-threatening worsening of a pre-existing advanced chronic liver disease resulting in liver and extrahepatic organ failure (brain, kidneys, cardiovascular and respiratory). The cascade of multiple organ failures, including the development of a neuropsychiatric condition called hepatic encephalopathy (HE), together, lead to major complications in patients with ACLF, who can rapidly progress into coma and death. Every year, an estimated 137’000 patients are hospitalized in the US with ACLF, with very few therapeutic options. This represents an important unmet medical need.

As a pioneer in ACLF, Versantis has acquired a unique expertise, developing clinical-stage technology and assets aiming to improve ACLF patients’ outcomes.

Its main asset, VS-01, is a first-in-class innovative liposomal-based therapeutic product candidate currently in clinical development as a potential first-line therapy for the timely recovery of ACLF and UCD. If approved, it would be the first drug to use the intraperitoneal route to simultaneously support the liver, kidney and brain, the organs that most often fail in cirrhotic patients. VS-01 operates to clear toxic metabolites from the body following paracentesis, by extracting them from the blood into the peritoneal (abdominal) cavity, where they are captured by proprietary scavenging liposomes which are then drained from the body. A planned 60-patient, randomized and controlled Phase 2 Proof-of-concept trial of VS-01 in ACLF is expected to launch in the fourth quarter 2022. Efficacy and safety interim data are expected as early as the first half of 2024. The US Food and Drug Administration (FDA) granted VS-01 with the Orphan Drug Designation (ODD) in ACLF and in UCD and with the Rare Pediatric Diseases Designation (RPDD) for the acute treatment of UCD. The European Medicines Agency (EMA) also granted VS-01 with ODD in acute liver failure. Given the unmet medical need and the current standard of care, GENFIT intends to seek approval of these candidates via expedited regulatory pathways.

VS-02 is a pre-clinical oral, small molecule drug candidate being developed for the chronic management of HE, considered an endemic disease worldwide. HE is a nervous system disorder brought on by advanced chronic liver disease. VS-02 will be developed as a unique colon-active formulation designed to minimize systemic absorption of ammonia and act where ammonia is primarily produced, while reducing glutamine levels in the brain.

GENFIT will also be able to develop TS-01, a unique point-of-care diagnostic device in prototype development for the at-home measurement of ammonia in the blood, the primary cause of HE.

The deal should be completed during the fourth quarter 2022, following completion of the consultation of GENFIT’s employees representative bodies.

In parallel, GENFIT continues the development of its other program evaluating NTZ in ACLF, with a pre-IND meeting scheduled with the FDA in the coming weeks, following encouraging Phase 1 data.

Pascal Prigent, Chief Executive Officer of GENFIT, commented: "Versantis has an exciting portfolio that is complementary to GENFIT’s. We are also thrilled to welcome a talented team that has developed a strong scientific expertise in ACLF. We believe that significant synergies exist and that this acquisition will accelerate the development of several promising drug candidates in areas of high unmet needs." Jean-François Mouney, Co-founder and Chairman of the Board of GENFIT, added: "This agreement is a new chapter in the implementation of GENFIT’s strategy, which expands and diversifies our portfolio with assets presenting a significant market potential." Vincent Forster, PhD, Chief Scientific Officer and Meriam Kabbaj, PhD, Chief Operations Officer, both Board Members and Co-founders of Versantis, concluded: "We are enthusiastic to be part of GENFIT, considering their experience in exploring severe and underserved conditions. We think that GENFIT’s knowledge and experience in the development of programs targeting complex liver diseases will be invaluable to accelerate and maximize the probability of success of our programs. We also are excited by the new opportunities offered by GENFIT’s research capabilities."

Financials
The deal includes an initial consideration of CHF40 million due at closing, with contingent consideration of up to CHF65 million upon positive Phase 2 results for VS-01 and VS-02 and regulatory approval of VS-01. In addition, Versantis is eligible to receive 1/3 of the net proceeds resulting from the potential sale of the Pediatric Review Voucher of VS-01’s pediatric application by GENFIT to a third party, or 1/3 of the fair market value of this Voucher if GENFIT opts to apply it to one of its own programs. GENFIT will finance the base acquisition consideration from its current cash and cash equivalents. Based on our development plan for our current programs and for Versantis’ programs, the revenue expected from our partnership agreements, and accounting for transaction costs, we anticipate that funding of the Group’s corporate development is secured for approximately 2 years.

GENFIT will host a conference call on September 19, 2022 at 08:00am ET / 1.00pm GMT / 2.00pm CET in English and in French

Both the English and French conference calls will be accessible on the investor page of our website, under the events section at https://ir.genfit.com/ or by calling 888-394-8218 (toll-free US and Canada), 0800 358 6377 (toll-free UK) or 0805 101 219 (France toll-free) five minutes prior to the start time (confirmation code: 3338254). A replay will be available shortly after the call.

Upcoming calls and events

Live conference call today, September 19, at 8:00am ET / 1:00pm GMT / 2:00pm CET in English and in French
Half-year financial results (press release) on September 28, 2022
Pipeline days on October 5 (French session in Paris, France) and October 19 (English session in NYC, United States)