On August 30, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported the schedule of four data presentations at the upcoming XIX International Workshop on Chronic Lymphocytic Leukemia (iwCLL), being held virtually September 17 – 20, 2021 (Press release, TG Therapeutics, AUG 30, 2021, View Source [SID1234587007]). Details of the data presentations are included below.

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"We are excited to share data from four combination clinical trials at the upcoming iwCLL conference, all of which evaluated either U2, the combination of UKONIQ plus ublituximab, alone or as a backbone in a triple combination regimen. We believe these data further highlight the potential of the U2 combination, which currently has a PDUFA date of March 25, 2022, to treat patients with CLL." Mr Weiss continued, "We are particularly excited to be able to share, earlier than expected, the updated Phase 1 results from the triple combination of U2 plus venetoclax in patients with relapsed/refractory CLL. The data shown thus far from this phase 1/2 study has been highly encouraging and led to the commencement of our ULTRA-V Phase 2/3 trial, which is also evaluating the U2 plus venetoclax triple combination."

IwCLL 2021 PRESENTATION INFORMATION

Oral Presentation Title: Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment-Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 UNITY-CLL Study

Abstract Number: 1083667
Presentation Date/Time: Saturday September 18, 2021 at 1:30 PM EDT/ 19:30 CEST
Session: Session 6: Front-Line Therapy of CLL
Lead Author: Wojciech Jurczak, MD, PhD, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland
Oral Presentation Title: A Phase 1/2 Study of Umbralisib, Ublituximab, and Venetoclax in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Abstract Number: 1083987
Presentation Date/Time: Sunday September 19, 2021 at 10:50 AM EDT/ 16:50 CEST
Session: Session 8: New Agents in CLL Clinical Trials
Lead Author: Paul M. Barr, MD, Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, NY
Oral Poster Presentation Title: TG-1701, a Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia

Abstract Number: 1083634
Presentation Date/Time: Sunday September 19, 2021 at 2:00 PM EDT/ 20:00 CEST
Session: Poster Session
Lead Author: Chan Y. Cheah MBBS, DMSc, Linear Clinical Research, and Department of Haematology, Sir Charles Gairdner Hospital, Nedlands Western Australia, and Medical School, University of Western Australia, Crawley, Western Australia
Poster Presentation Title: Phase I/II Study of Umbralisib (TGR-1202), Ublituximab (TG-1101), and Pembrolizumab in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Richter’s Transformation: 5-Year Follow-up

Abstract Number: 1083523
Presentation Date/Time: Available on demand
Session: Virtual Poster Gallery
Lead Author: Lindsey E. Roeker, MD, CLL Program, Leukemia Service, Division of Hematologic Oncology, Memorial Sloan-Kettering Cancer Center, New York, NY
Currently, the conference agenda, including abstract titles, is available via the iwCLL website at View Source Full text abstracts will be publicly available on September 13, 2021.

At the time of each presentation, the data presented will be available on the Publications page, located within the Pipeline section, of the Company’s website at www.tgtherapeutics.com/publications.cfm.

On August 30, 2021 SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that it has entered into a sponsored research collaboration with Dana-Farber Cancer Institute (Dana-Farber) (Press release, SpringWorks Therapeutics, AUG 30, 2021, View Source [SID1234587025]). The collaboration is designed to further investigate nirogacestat, SpringWorks’ investigational gamma secretase inhibitor (GSI), with anti-B-cell maturation antigen (BCMA) agents in a variety of preclinical multiple myeloma models. Constantine Mitsiades, M.D., Ph.D., Assistant Professor of Medicine at Dana-Farber and Harvard Medical School, will serve as the Principal Investigator for the research, which will utilize preclinical in vivo models from the Mitsiades Lab to simulate the multiple myeloma tumor microenvironment. In addition, the research will also deploy functional genomics approaches to explore determinants of response and mechanisms of resistance to GSI + BCMA combination therapy.

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Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of multiple myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, thereby enhancing the activity of BCMA-targeted therapies.1 To date, SpringWorks has entered into clinical collaborations with six industry partners to evaluate nirogacestat in combination with BCMA therapies across modalities.

"SpringWorks has demonstrated its commitment to understanding the science and advancing the clinical exploration of GSI + BCMA combination therapies," said Dr. Mitsiades. "I am pleased to collaborate with them towards the goal of improving clinical outcomes for patients with multiple myeloma while simultaneously enabling the advancement of the underlying science."

"We are delighted to be collaborating with the Mitsiades Lab at Dana-Farber to expand our understanding of nirogacestat’s mechanism of action when combined with BCMA therapies," said Badreddin Edris, Ph.D., Chief Operating Officer of SpringWorks. "Dr. Mitsiades and his colleagues have been at the forefront of developing cutting-edge translational models of multiple myeloma and we believe that this collaboration has the potential to yield novel insights that can help us to further refine our approach to improving outcomes for these patients."

Under the terms of the sponsored research agreement, SpringWorks will be responsible for funding the work and will retain an option to exclusively license any new intellectual property emerging from the research collaboration.

About Nirogacestat

Nirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy receptors for BCMA-directed therapies. Nirogacestat’s ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma. SpringWorks is evaluating nirogacestat as a BCMA potentiator and has six collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, two CAR T cell therapies, two bispecific antibodies and a monoclonal antibody. SpringWorks has also formed research collaborations with Fred Hutchinson Cancer Research Center and Dana-Farber Cancer Institute to further characterize the ability of nirogacestat to modulate BCMA and potentiate BCMA therapies using a variety of preclinical multiple myeloma models.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors and from the European Commission for the treatment of soft tissue sarcoma. The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

On August 30, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company") a clinical-stage immuno-oncology company focused on the development of therapies and treatments targeting cancer treatment resistance, reported financial results for the quarter ended June 30, 2021 (Press release, Portage Biotech, AUG 30, 2021, View Source [SID1234586992]).

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"With the transformation of Portage now complete, our focus for the coming year is to significantly accelerate our clinical pipeline of novel immuno-oncology therapeutics designed to overcome cancer treatment resistance," said Dr. Ian Walters, chief executive officer of Portage Biotech. "Our recent financings provide us with the resources to complete Phase 1 and Phase 2 clinical trials for our lead invariant natural killer T cell (iNKT) agonists, PORT-2 and PORT-3, which we believe have the potential to synergize with PD-1 agents and overcome PD-1 resistance. These attributes represent a substantial opportunity to expand the already significant PD-1 cancer treatment market. Recent increased interest and transactional activity from big pharma in the iNKT space has served as further validation of the role of iNKT cells in cancer. With sufficient resources now in place, we plan to also advance our broader pipeline and to other value-driving catalysts in the coming fiscal year."

First Quarter FY 2022 Financial & Business Highlights

Increased financial resources with over $29 million raised since fiscal year-end:
Successful public offering of 1,150,000 shares with gross proceeds of $26.5 million, securing a cash runway sufficient to advance programs and enable achievement of numerous milestones.
Generation of an additional $2.6 million proceeds through the sale of approximately 91,000 shares via the Company’s At-the-Market offering.
Improved stock liquidity:
Inclusion in the Russell 2000 Index, bringing added visibility to the Company’s robust immuno-oncology pipeline.
Broad-based investor outreach planned for Fall 2021 through participation and/or presentation at the following conferences:
H.C. Wainwright 23rd Annual Global Investment Conference (Sept. 13-15, 2021)
Oppenheimer & Co. Fall Healthcare Life Sciences and MedTech Summit (Sept. 20-23, 2021)
Cantor Fitzgerald Virtual Global Healthcare Conference (Sept. 27-30, 2021)
First Quarter FY 2022 Clinical Highlights

Acceleration of development programs from the Company’s first-in-class immuno-oncology asset portfolio, including milestones related to lead iNKT agonists PORT-2 and PORT-3 and intratumoral amphiphilic therapy PORT-1. Key milestones included:
PORT-2: The first patient was dosed in the IMP-MEL randomized Phase 1/2 study of PORT-2, a liposomal formulation of Portage’s IMM60 iNKT agonist. In the trial, PORT-2 will be tested both as a monotherapy and in combination with standard of care (Keytruda) in melanoma and NSCLC. The PORT-2 study has 6 arms and is expected to enroll up to 100 patients.
PORT-3:
The first patient dosed in the PRECIOUS Phase 1 study of PORT-3, a nanoparticle coformulation of Portage’s iNKT agonist (IMM60) and NY-ESO-1 in patients with NY-ESO-1 expressing tumors. The Phase 1 portion of the trial is expected to enroll 15 patients while the randomized Phase 2 portion is expected to enroll an additional 42 patients.
This platform is designed to demonstrate proof of concept with NY-ESO-1 as an enrichment factor for patient accrual. Portage’s patent position extends to other known tumor antigens, and the Company is prepared to rapidly launch other assets into the clinic if we see strong activity of this formulation.
Notably, Portage received additional grant support from the Horizon 2020 program to explore next-generation targeted nanoparticles.
PORT-1: Presentation of interim data at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference from the IT-01 Phase 2 trial conducted by Intensity Therapeutics demonstrated strong safety and survival data for INT230-6 (PORT-1) both as a monotherapy and in combination with pembrolizumab or ipilimumab in solid tumors.
First Quarter FY 2022 Financial Results

The Company generated a net loss and comprehensive loss of approximately $3.2 million in the three months ended June 30, 2021 ("Fiscal 2022 Quarter"), compared to a net loss of approximately $0.7 million and a comprehensive loss of approximately $0.6 million in the three months ended June 30, 2020 ("Fiscal 2021 Quarter"), an increase in loss of $2.5 million and $2.6 million, respectively, year over year. Operating expenses, which include research and development and general and administrative expenses, were $3.6 million in the Fiscal 2022 Quarter, compared to $1.0 million in the Fiscal 2021 Quarter, an increase of $2.6 million, which is discussed more fully below. Operating expenses included $2.2 million of non-cash stock-based compensation expense in the Fiscal 2022 Quarter, compared to $0.3 million in the Fiscal 2021 Quarter.

The Company’s other items of income and expense were substantially non-cash in nature and were approximately $0.3 million net other income in each of the Fiscal 2022 Quarter and the Fiscal 2021 Quarter. Non-cash items included in other income and expenses in the Fiscal 2022 Quarter were:

A gain of $0.4 million representing the change in the fair value of the warrants issued with respect to the SalvaRx settlement; and
A small loss of $0.04 million generated by Stimunity, which operates our STING platform, accounted for under the equity method in the Fiscal 2022 Quarter, compared to a $0.4 million gain in the Fiscal 2021 Quarter.
Additionally, the Company reflected a net income tax benefit of approximately $0.1 million in the Fiscal 2022 Quarter, attributable to recoverable research and development tax credits generated in the U.K., partially offset by the foreign currency exchange rate effect on deferred tax liability.

Research & Development ("R&D") costs increased by approximately $1.0 million, from approximately $0.5 million during the three months ended June 30, 2020, to approximately $1.5 million during the three months ended June 30, 2021. The increase was primarily attributable to non-cash stock-based compensation expense associated with grants made under the 2021 Equity Incentive Plan in connection with our R&D efforts of $1.0 million.

General and administrative ("G&A") expenses increased by approximately $1.5 million, from approximately $0.5 million during the three months ended June 30, 2020, to approximately $2.0 million during the three months ended June 30, 2021. The principal reason for the increase in the Fiscal 2022 Quarter was the $1.1 million of non-cash stock-based compensation expense associated with the Company’s 2021 Equity Incentive Plan. No stock-based compensation expense under the 2021 Equity Incentive Plan was incurred during the three months ended June 30, 2020. Additionally, the Company incurred an increase of $0.3 million in professional fees relating to initiatives associated with a corporate restructuring and public relations/business development. Finally, D&O insurance premiums increased by $0.4 million in the current year period due to market rate increases in the cost of coverage.

As of June 30, 2021, the Company had cash and cash equivalents of approximately $28.6 million and total current liabilities of approximately $2.5 million (inclusive of approximately $0.7 million warrant liability settleable on a non-cash basis). For the three months ended June 30, 2021, the Company is reporting a net loss of approximately ($3.2) million and cash used in operating activities of approximately $1.6 million. As of July 31, 2021, the Company had approximately $28.0 million of cash on hand.

On August 30, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a dermatologic diagnostics company providing personalized genomic information to inform treatment decisions, reported that it has been included in The Healthcare Technology Report’s Top 100 Healthcare Technology Companies of 2021 list (Press release, Castle Biosciences, AUG 30, 2021, View Source [SID1234587008]).

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The companies selected for this year’s list include a variety of organizations, from well-known names to newer, rapidly growing companies, in the fields of healthcare software, biotechnology, medical devices and consumer health technology. Awardees were nominated and selected based on a thorough evaluation process. Among the key criteria considered were product or service quality, customer adoption, management team caliber, organizational effectiveness and company growth, among other factors.

"Congratulations to Castle Biosciences for being recognized as one of the Top Healthcare Technology companies in our 2021 list," said the editorial team of The Healthcare Technology Report. "Organizations such as Castle are making great strides to both modernize and advance healthcare. We look forward to continued advancements from Castle in the field of skin cancer testing."

"We are honored to be recognized as a Top 100 Healthcare Technology Company," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "We are committed to transforming the management of skin cancer and other dermatologic conditions through our innovative genomic tests. Since our formation in 2008, we have been focused on improving patient care and outcomes through the application of emerging artificial intelligence techniques in molecular diagnostics. As we continue to grow our suite of tests for diseases with unmet clinical need, accolades like these reinforce our focus and reflect our position as a leader in dermatologic testing."

The full list can be viewed at https://thehealthcaretechnologyreport.com/.

About The Top 100 Healthcare Technology Companies of 2021

This year’s awardees comprise a broad range of companies from well-known names to relatively newer but rapidly growing enterprises. The diverse range of sophisticated products and services offered through these companies — from digital pharmacies to holistic patient care and AI-powered robotics to digital healthcare payments — have not only led to the modernization of the healthcare sector but also to a brighter future where healthcare is democratized for all. Advancements in healthcare, whether through data and communications, research and clinical trials, or consumer offerings, have also helped to create an environment where more promising care alternatives are possible. The pioneering companies selected for this year’s list have one thing in common: they are revolutionizing the way we live, and the way we navigate one of the most important factors for all of us: our health.

About The Healthcare Technology Report

The Healthcare Technology Report provides market research and insights, business news, investment activity updates and important corporate developments related to the healthcare technology sector. Based in New York City, the firm is run by a seasoned team of editors, writers and media professionals highly knowledgeable on healthcare technology and the various companies, executives and investors that make up the sector.

On August 30, 2021 Ziopharm Oncology, Inc. ("Ziopharm" or the "Company") (Nasdaq: ZIOP), reported the appointment of Kevin S. Boyle, Sr. as its new Chief Executive Officer, effective today (Press release, Ziopharm, AUG 30, 2021, View Source [SID1234586993]). As previously planned, Heidi Hagen, Interim CEO, is returning to her position as a member of the Board of Directors (the "Board"). Mr. Boyle has also been named to the Board. In addition, today the Company has announced promotions within its senior leadership.

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Mr. Boyle has over 20 years of experience in leading businesses in competitive and transformative situations and has a strong track record of delivering shareholder value. He is also an accomplished capital markets professional with strong banking relationships cultivated by raising over $2.0 billion in equity and debt capital over his career. Most recently, Mr. Boyle was CEO of Kuur Therapeutics (formerly known as Cell Medica Ltd.), leading the company through a successful transformation, culminating in a $185 million acquisition in May 2021 by Athenex, a global biopharma company focusing on the development and commercialization of cancer therapies.

The appointment of Mr. Boyle and the elevation of roles and responsibilities for select executives continue the Board’s actions to solidify the senior leadership team, move the Company forward and execute on its distinctive cell therapy platform and potentially groundbreaking cancer therapies.

"On behalf of the entire Board of Directors, we welcome Kevin to the Company," said James Huang, Executive Chairman. "During the robust search process, the Board was pleased to interview a number of very strong candidates. The Board was deliberative, and considered candidates from big pharma to small biotechs, and Kevin rose to the top of the list during the process. Kevin brings tremendous business experience with his operational expertise, strong financial acumen, and an ability to drive disciplined capital allocation. He has a strong track record of successfully guiding companies, both in and out of the biotech sector, through critical periods in their growth trajectories. In particular, his work at Kuur demonstrated his operational expertise in effectively managing a business with capital constraints and demanding timelines. We have the right science and scientific team to deliver, and we are confident that we now have the right person to successfully lead the Company forward towards clinical and business success."

Mr. Huang continued, "We also sincerely thank Heidi for her commitment to the Company and the outstanding job she has done over the past six months. We look forward to her continued contributions as a dedicated and valued Board member."

Mr. Boyle said, "I am excited to join the Ziopharm team and am impressed by the extraordinary opportunity that lies ahead. Heidi, the management team and the Board have laid the foundation for Ziopharm to succeed based on its best-in-class science. I understand the challenges ahead and I look forward to working diligently with our dedicated and talented team to unlock our incredible potential as an innovative, world-class oncology company. My priorities will be to deliver shareholder value and to ensure the success of the organization by driving the TCR-T program forward, while seeking and executing validating partnerships across our entire portfolio of scientific assets."

The Board’s selection of Mr. Boyle was unanimous. The CEO search committee was comprised of Robert Postma, Heidi Hagen and Mary Thistle, with support and guidance from the entire Board.

About Kevin S. Boyle, Sr.

During Mr. Boyle’s tenure as CEO of Kuur Therapeutics, he successfully led the company through a $185 million acquisition of Kuur by Athenex. After the acquisition, he supported the integration of Kuur’s CAR-NKT cell platform into Athenex’s Cell Therapy Division. Mr. Boyle joined Kuur Therapeutics in 2018 as CFO, playing a lead role in corporate strategy and financial planning as the company progressed with a pipeline of cell therapy products in both the US and Europe. He successfully led fundraising efforts while executing a restructuring of the company and he was promoted to CEO by the Kuur Board as an endorsement of his leadership abilities during this time.

Kevin previously served as CFO of multiple companies including FloWorks International, Sigma3, RecoverCare, and SPT. He was also previously an officer at two public companies, American Commercial Lines and Seabulk International. He started his career in investment banking.

Mr. Boyle received a law degree from the University of Pennsylvania and a Bachelor of Science degree in Industrial Management & Economics from Carnegie Mellon University. Houston is home to Mr. Boyle and his family. He was recently honored by the Houston Business Journal with the 2021 Most Admired CEO Award.

Executive Team Promotions

The Company also announced today that it has promoted Dr. Raffaele Baffa MD, Ph.D., to Head of Research and Development, adding to his role as Chief Medical Officer. Dr. Baffa joined the Company in November 2020 and has been instrumental in refocusing the Company’s development pipeline. In his expanded role, in addition to directing the development and implementation of Ziopharm’s clinical strategy and plans, Dr. Baffa will oversee and direct research and preclinical development activities in alignment with Ziopharm’s strategy for the development of innovative cell therapies. As the Head of Research and Development, he will also be responsible for ensuring the quality of science and expansion of its therapeutic application.

Ziopharm also announced the promotion of Dr. Adam Levy Ph.D., MBA to Executive Vice President, Corporate Development and Investor Relations. Dr. Levy joined Ziopharm in November 2020 as Executive Vice President of Investor Relations and Corporate Communications. Previously, Dr. Levy held the position of Executive Director and Head, Corporate Strategy and Investor Relations for Gilead Sciences. Prior to Gilead, Dr. Levy served in corporate strategy roles at Alexion and Bristol Myers Squibb. In his newly expanded role, Dr. Levy will lead the Company’s corporate development strategy, including executing licensing and business development deals across the Company’s portfolio, which is an increasingly critical priority for the Company. Dr. Levy will continue to direct investor-related activities and communications.

Mr. Huang added, "It is with great pleasure we announce the promotions of Raffaele and Adam. They each bring tremendous experience and we have benefitted from their contributions since they joined the company in 2020. We look forward to their continued efforts in their expanded roles."

Conference Call and Webcast

Ziopharm will host a conference call and webcast for the investment community today, August 30, 2021, at 4:30 p.m. EDT. The conference call can be accessed by dialing 877-451-6152 (U.S. and Canada) or 201-389-0879 (International). The passcode for the conference call is 13722687. A live webcast may be accessed using the link here, or by visiting the "Investors" section of the Ziopharm website at www.ziopharm.com. The call will be recorded and available for replay on the Company’s website for approximately 90 days after the call.