On September 30, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that its tender offer to purchase any and all issued and outstanding shares of common stock of Pfenex Inc. (NYSE American: PFNX) at an offer price of $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, expired at midnight (New York City time), at the end of the day on Tuesday, September 29, 2020 (Press release, Ligand, SEP 30, 2020, View Source [SID1234567818]).

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The depositary for the tender offer has advised that, as of the expiration of the tender offer, a total of approximately 27,591,554 shares were validly tendered and not withdrawn in the tender offer (including shares delivered through notices of guaranteed delivery), representing approximately 80.3% of Pfenex’s outstanding shares. Ligand’s wholly-owned subsidiary will accept for payment all shares that were validly tendered and not withdrawn prior to expiration of the tender offer, and payment for such shares will be made promptly, in accordance with the terms of the tender offer.

Ligand expects the merger to close on October 1, 2020, with Pfenex becoming a wholly owned subsidiary of Ligand. As a consequence of the merger, each outstanding Pfenex share not tendered and purchased in the offer (other than those as to which holders properly exercise dissenters’ rights and those owned at the commencement of the tender offer by Ligand or its direct and indirect subsidiaries) will be converted into the right to receive the same $12.00 per share in cash, plus one non-transferable contractual contingent value right per share representing the right to receive a contingent payment of $2.00 in cash, if a certain specified milestone is achieved, without interest and less any required withholding taxes, that was offered in the tender offer. Following completion of the merger, Pfenex’s common stock will cease to be traded on the New York Stock Exchange American.

On September 30, 2020 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that management will participate in a fireside chat at the Jefferies Cell Therapy Virtual Summit on Tuesday, October 6, 2020 and 2:30 p.m. E.T (Press release, Fate Therapeutics, SEP 30, 2020, View Source [SID1234567817]).

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A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.fatetherapeutics.com.

On September 30, 2020 GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, reported its first half-year 2020 financial report, including the advances of its R&D portfolio and the new GENFIT corporate strategy (Press release, Genfit, SEP 30, 2020, https://ir.genfit.com/news-releases/news-release-details/genfit-first-half-year-2020-financial-report-and-new-corporate [SID1234567816]). The Half Year Business and Financial Report, including the new corporate strategy is available to the public and was filed with the French Autorité des marchés financiers (French Financial Markets Authority) today. The condensed consolidated financial statements are included in this press release and the complete financial statements are available on the "Investors" page of the GENFIT website.

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Conference Call in English on September 30, 2020 at 4:30pm EDT / 22:30 CEST, and in French on October 1, 2020 at 1:30am EDT / 7:30am CEST

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 877-407-9167 (toll-free U.S. and Canada), 201-493-6754 (international) or 0 800 912 848 (France) five minutes prior to the start time (no passcode needed). A replay will be available shortly after the call.

New corporate strategy and prospects

The company’s corporate strategy now focuses on two priority areas:

Phase 3 clinical trial ELATIVE evaluating elafibranor in PBC:
Patient enrolment now started, and results expected early 2023, given the current constraints due to the COVID-19 pandemic;
Following the positive Phase 2 data of elafibranor in PBC, the U.S. Food and Drug Administration (FDA) granted elafibranor Breakthrough Therapy designation. The ELATIVE study aims to confirm elafibranor’s previously successful results of efficacy, potential improvement in pruritus and safety in PBC patients;
Current market size for second line therapies in PBC is estimated at ~ $300MM in 2020 and is anticipated to experience double digit growth and estimates for 2025 are up to $1B. Elafibranor is a promising alternative therapy to the existing treatment in PBC, based on the significant unmet needs in this indication.

NIS4TM technology for (NASH) diagnosis:
NIS4TM technology data, recently published in The Lancet Gastroenterology & Hepatology, confirmed the technology’s diagnostic performance and garnered the support of leading NASH experts;
The recently announced exclusive licensing agreement with Labcorp for NIS4 TM technology will enable a large-scale commercial launch as of next year;
NIS4TM addresses patients’ and payers’ requirements as liver biopsy remains the only – although imperfect – approved diagnostic option in the clinical development field and cannot be replicated on a large scale due to its painful and invasive nature, and its cost for healthcare systems. It would be impossible to diagnose all patients with biopsies given the limited number of procedures that can be performed. The blood test commercialized by Lacorp will address these multiple challenges;
The NASH therapeutic market is potentially significant, however, the opportunity is dependent on quick, reliable and easy to execute diagnostic solutions to identify patients. NIS4TM technology represents the essential first step in managing patients with NASH and is the first step for patients to take control, even in the absence of treatments, of their disease.
GENFIT’s new strategy includes a plan, which aims to create two distinct operational subsidiaries by 2021 to enable more independent management and growth:

The first entity would be dedicated to the development of specialty indications, starting with the Phase 3 trial in PBC;

The second entity would house NASH solutions, including all programs related to the identification, evaluation and monitoring of patients with NASH. This independent structure would facilitate future partnerships for NIS4.
The two entities would remain a part of GENFIT as a listed company, who would ensure adequate decision making between both "business" entities, the goal being to best highlight each of the activities to benefit the Group’s valuation.

Concurrently, GENFIT is adopting a plan to reallocate and rationalize all capital with an objective to reduce the cash burn by more than 50% by 2022 compared to our cash burn prior to the RESOLVE-IT Phase 3 data. The program aims to reduce the current cash burn rate from €110M annually before our Phase 3 data, to approximately €45MM annually, beginning in 2022. Due to the residual expenses related to the termination of RESOLVE-IT, 2021 will be a transition year.

This plan incorporates the following key components:

The overall clinical development program for elafibranor in NASH and all activities associated with the commercial launch of elafibranor in NASH have been terminated given the low probability of success compared to required expenses. The termination includes the NASH combination therapy trials, the pediatric trials, and other trials such as the evaluation of the impact of elafibranor on liver fat composition;

A comprehensive cost-saving plan has been implemented, including the redirection of R&D activities and the termination of secondary programs (i.e. the RORgT program);

A workforce restructuring plan aims to reduce the overall workforce by 40%, encompassing both the U.S and France in order to align the company size to the new scope of activity.
Lastly, GENFIT plans to propose to the holders of its OCEANE bond (€180 million nominal amount with a maturity of October 16, 2022) and its shareholders, an adjustment of the terms of the OCEANE convertible bond. The Company’s objective is to begin this process towards the end of the year, in order to have a balance sheet which is structured in line with its new strategy.

Pascal Prigent, CEO of GENFIT, stated: "The decisions we have taken allow us to move GENFIT forward towards 2021 with a clear and precise roadmap. We are confident in the probability of success, and the potential of our two priority programs. The evolution of the company also ensures the structure adapts to our strategy, with an approach that is both organizationally and financially sound."

Key aspects of the half-year 2020 results

Key aspects of the half-year 2020 results are:

Cash and cash equivalents of €225.7 million at June 30, 2020 (€276.7 million at December 31, 2019);
Operating income of €5.9 million (€5.4 million at June 30, 2019), essentially from the Research Tax Credit, which amounted to €5.2 million for the first half 2020 (€5.3 million in the preceding half year);
Operating expenses of €55.0 million (€51.3 million at June 30, 2019) of which 67% represented R&D expenses.
The increase in operating expenses is due to increases in marketing and pre-commercialization expenses, which amounted to €9.5 million in the first half 2020 (€2.9 million in the first half 2019). Marketing and pre-commercialization expenses will significantly decrease as of the second half 2020 due to the discontinuation of the pre-commercialization work for elafibranor in NASH following the termination of this program in July 2020.

General and administrative expenses (€8,2 million in the first half 2020 compared to €9.5 million in the first half 2019) and research and development expenses (€36.9 million in the first half 2020 compared to €38.9 million in the first half 2019) have decreased slightly between 2019 and 2020. These expenses will progressively decrease as of the second half 2020 following the Company’s decision to begin the process of terminating the clinical trials for elafibranor in NASH, terminating secondary programs and to execute a comprehensive cost saving plan over 3 years. Significant expenses related to the termination of the RESOLVE-IT trial will be due in the second half 2020 and in 2021.

As a result of changes in revenues and expenses, the net loss amounted to €53.0 million at June 30, 2020 (€51.1 million at June 30, 2019). The net loss for 2019 was €65.1 million.

On September 30, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a company whose mission is to deliver innovative therapies that improve the lives of people with cancer, reported that effective January 1, 2021, Mark Velleca, M.D. Ph.D., will transition to the role of senior advisor and continue to serve as a member of the G1 Board of Directors. John ("Jack") Bailey, a member of the company’s board, has been named as G1’s next Chief Executive Officer (Press release, G1 Therapeutics, SEP 30, 2020, View Source [SID1234567815]).

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Mr. Bailey has nearly thirty years of commercial pharmaceutical experience and an in-depth understanding of healthcare market dynamics and the evolution of value-based healthcare systems in the U.S. He has extensive experience successfully guiding the launch and growth of multiple pharmaceutical products. Most recently, Mr. Bailey served as President of GlaxoSmithKline’s pharmaceuticals and vaccines business in the U.S., with responsibility for commercialization efforts across the company’s oncology, immunology/rare disease, respiratory and vaccines portfolios. Earlier in his career, he held various senior leadership positions at Eli Lilly and Company. Mr. Bailey was appointed to the G1 Board of Directors in March 2020. He also serves on the board of Emergo Therapeutics and is a past member of the Board of Directors of PhRMA, the pharmaceutical industry trade association, and the North Carolina Biotechnology Center.

Dr. Velleca has served as G1’s chief executive officer since 2014, joining after its Series A round of venture financing. During this time, he has overseen the successful growth and evolution of G1 from a discovery organization to a fully integrated biopharmaceutical company anticipating the commercialization of its lead investigational therapy, trilaciclib, in early 2021.

"Since moving trilaciclib from the lab into clinical trials in 2014, up through FDA’s granting of Breakthrough Therapy Designation in 2019 and Priority Review of our NDA in 2020, G1 has demonstrated the ability to successfully advance innovative products that benefit patients with cancer. The board and I believe this moment is the right time to institute a leadership transition. Having worked closely with Jack on the board, I am confident he is the right person to lead this remarkable organization into and through its next chapter," said Dr. Velleca. "It has been incredibly rewarding to work alongside this highly talented group of committed professionals for the past six years, and I look forward to continuing my engagement with the company as a board member and senior advisor. I am certain that Jack, together with the leadership team and entire company, will deliver on our vision of improving cancer care and building a successful commercial enterprise."

Garry Nicholson, chairman of the G1 Board of Directors, said, "Jack has a deep understanding of the business through his tenure on the G1 board, and his appointment as CEO is the result of a thorough succession planning process. He brings extensive global leadership experience, a proven track record and tremendous knowledge of our industry. I am confident that under Jack’s stewardship, the company will continue to thrive and become a profitable commercial entity. On behalf of the entire board, I want to thank Mark for his extraordinary leadership and his unwavering commitment to patients. G1 will continue to benefit from Mark’s scientific and clinical expertise as an advisor and director."

"G1 is well positioned to make meaningful contributions to advancing the standard of care in oncology, and I am honored to succeed Mark as CEO," said Mr. Bailey. "Mark and the G1 team have built a patient-focused culture that emphasizes collaboration, respect and integrity. Together with the leadership team and all G1 employees, I look forward to building on this strong foundation to bring trilaciclib to patients battling a range of cancers. Most importantly, I share my new colleagues’ passion for delivering better treatment options to these patients."

On September 30, 2020 Thrive Earlier Detection Corp., a company dedicated to incorporating earlier cancer detection into routine medical care, reported it has strengthened its leadership team with key appointments (Press release, Thrive Earlier Detection, SEP 30, 2020, View Source [SID1234567814]). Sam Asgarian, M.D., has been appointed to chief medical officer and Frank Diehl, Ph.D., as executive vice president of product solutions . Dina Ciarimboli, former general counsel at Third Rock Ventures, has joined Thrive full time as chief legal officer following her interim role as general counsel since the company’s launch.

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Thrive is leading a new era in earlier detection of multiple types of cancer to empower longer, healthier lives. In April, the company published the results from its DETECT-A study, the first and only prospective, interventional study of a blood test used to detect multiple cancers in an asymptomatic population. DETECT-A advances the entire field of blood-based multi-cancer screening, as it doubled the number of cancers found by screening methods in a real world setting, the majority of which were earlier stage disease. Most recently, Thrive announced a $257 million Series B financing which, among other strategic initiatives, will enable the company to develop additional real-world evidence and seek approval of its blood test, CancerSEEK, through a registrational trial. The appointments of these key executives strengthen Thrive’s leadership team, bringing product development, medical and legal expertise to advance the company’s bold mission.

"Since our founding in 2019, Thrive has made significant progress on our mission to save lives by making earlier detection of cancer a routine part of medical care. We published the first-ever prospective study of a multi-cancer blood test in the journal Science, completed our second financing, and now we have further strengthened our leadership team to advance our mission," said David J. Daly, chief executive officer of Thrive. "As our first chief medical officer, Sam brings deep experience from Aetna and CVS Health, where he introduced new innovations into the healthcare system. Frank is a foundational pioneer in blood-based cancer detection and a proven R&D business leader. Dina has been integral since the launch of Thrive, and her strategic counsel will continue to be instrumental to our success."

Each of these executive leaders bring significant experience to Thrive:

Dr. Sam Asgarian, chief medical officer, will lead medical strategy, including the integration of CancerSEEK into routine medical care. Prior to Thrive, Dr. Asgarian was vice president of CVS Health’s Transformation Health Product organization, where he was responsible for the modernization of clinical products and implementation of new solutions to improve consumer convenience and personalize health and wellness. Dr. Asgarian joined CVS as part of the Aetna acquisition, where he served as the chief medical officer of the clinical services organization, overseeing medical management and clinical policy operations across Aetna’s commercial and Medicare businesses. Dr. Asgarian holds a B.A. in molecular and cell biology from the University of California at Berkeley, an M.A. in medical sciences from Loyola University Chicago, an M.D. from Tulane University and an MBA from Cornell University.
Dr. Frank Diehl, executive vice president of product solutions, is a globally recognized leader in cancer biology and detection who has pioneered the use of circulating tumor DNA (ctDNA) to detect and track the progression of cancer. He will lead product development and innovation at Thrive. In 2008, he co-founded one of the world’s first liquid biopsy companies, Inostics, where he served as chief scientific officer through its acquisition by Sysmex and ultimately became CEO of Sysmex Inostics. Dr. Diehl completed a postdoctoral fellowship at the Ludwig Center for Cancer Genetics and Therapeutics at Johns Hopkins University and worked in the laboratory of Thrive co-founders Drs. Bert Vogelstein and Kenneth Kinzler, where he developed the first quantitative DNA blood test for colorectal cancer screening. Dr. Diehl holds a Ph.D. in molecular pathology from Ruprecht-Karls University in Heidelberg, Germany.
Ms. Dina Ciarimboli, chief legal officer, will continue to advise on corporate and legal initiatives, company strategy and implementation. Prior to joining Thrive full time, Ms. Ciarimboli was general counsel at Third Rock Ventures, where she was responsible for advising the firm on all legal matters related to fund and firm management and provided legal support to its company creation platform. Prior to joining Third Rock, Ms. Ciarimboli served as general counsel to several venture capital firms focused on early stage investing in various industries including biotech, diagnostics, medical devices and healthcare services. Earlier, she served as an associate at Testa, Hurwitz & Thibeault, LLP and as a senior associate at PricewaterhouseCoopers. Ms. Ciarimboli holds a B.A. in accounting and philosophy from Boston College and completed a J.D. at Boston College School of Law.