On November 10, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported that it will host a key opinion leader (KOL) webinar on the role iNKT cells play in anticancer immune response and how iNKT targeting can be leveraged to expand the immunooncology landscape, Thursday, November 18, 2021, at 10a.m. Eastern Time (Press release, Portage Biotech, NOV 10, 2021, View Source [SID1234595061]).

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The webinar will feature presentations by Mitchell Kronenberg, Ph.D., from the La Jolla Institute for Immunology, and Anastasios Karadimitris MBBS, Ph.D. MRCP FRCPath, from Imperial College London. Dr. Kroenberg will provide an overview on invariant natural killer T cell (iNKT) cells and their mechanism of action to enable multiple parts of the immune system to attack and kill cancer.

Dr. Karadimitris will discuss the current iNKT clinical data landscape. Portage Biotech’s Chief Executive Officer and Director Ian B. Walters, M.D., MBA, will then discuss the company’s novel clinical development strategy and timing of data from its ongoing clinical trials. Portage is applying its iNKT agonists, PORT-2 and PORT-3 to convert PD-L1 negative tumors to PD-L1 positive, overcome PD-1 antibody resistance, and enable checkpoint inhibitors to be used in immunologically cold tumors. A live Q&A session will follow the formal presentations. To register for the event, please click here.

Mitchell Kronenberg received a B.A. from Columbia University, a Ph.D. in Biochemistry from the California Institute of Technology (Caltech) and served on the faculty of the UCLA School of Medicine from 1986-1997. He joined the La Jolla Institute for Immunology (LJI) in 1997 and was the President at LJI from 2003-2021. He currently serves as the LJI Chief Scientific Officer. Dr. Kronenberg and his team study T cells – white blood cells responsible for recognizing and responding to microbes and cancers. His laboratory focuses on a subset of T cells, that recognize glycolipids, or combinations of sugar and fat. Their research seeks to investigate how these T cells, called natural killer T cells (NKT), survive, grow, and regulate other immune cell types. He has co-authored more than 370 publications, and is a fellow of the American Association for the Advancement of Science (AAAS), a Distinguished Fellow of the American Association of Immunologists, a recipient of an NIH MERIT award, and an Institute for Scientific Information (ISI) Highly Cited Scientist. He is an advisor to a number of organizations including serving as a member of the Board of Scientific Counselors for Basic Science at the National Cancer Institute. Anastasios Karadimitris received his degree in from at Aristotelion University, Thessaloniki, Greece. He undertook his postgraduate clinical training in the UK, first in general medicine and subsequently in haematology including in bone marrow transplantation at Hammersmith Hospital, London. He undertook his research training with Professor Lucio Luzzatto at Memorial Sloan Kettering Cancer Centre New York, USA, Professor Irene Roberts at Hammermsith Hospital, London and the late Professor Vincenzo Cerundolo at the Weatherall Institute for Molecular Medicine, Oxford. Professor Karadimitris is currently the Langmuir Chair in Haematology and Director of the Hugh and Josseline Langmuir Centre for Myeloma Research, and the Co-Director of the Centre for Haematology, Faculty of Medicine Imperial College London. He is also an honorary consultant haematologist at the Department of Haematology, Hammersmith Hospital, Imperial College Healthcare NHS Trust.

About iNKT Agonists PORT-2 and PORT-3
PORT-2 and PORT-3 contain small molecule agonists (IMM60) of invariant natural killer T-cells (iNKT cells) developed by the University of Oxford, which play an important role in anti-tumor immune responses. iNKT cells are a distinct class of T lymphocytes and recognize lipid antigens on the surface of the tumor. Our synthetic iNKT agonists are designed to optimally engage the Tcell receptor on the iNKT and facilitate its binding to dendritic cells, resulting in the secretion of a large amount of pro-inflammatory cytokines. This leads to the activation and expansion of important immune system components and primes and boosts an adaptive immune attack against cancer. We see that monotherapy treatment with iNKT agonists shows a heightened immune response and better cancer control in animal models that are resistant to PD-1 antibody treatment. Combination therapy with PD-1 antibodies is synergistic with iNKT agonists and restores sensitivity to PD-1 blockade. While treatment with iNKT agonists alone shows promising preclinical activity against cancer, data suggests that when an iNKT agonist is co-packaged with tumor-specific antigens, potency is increased by up to 5x. PORT-2 is a liposomal formulation of our IMM60 iNKT agonist while PORT-3 is a co-formulation of our IMM60 iNKT agonist with an NY-ESO-1 peptide vaccine, co-packaged into a nanoparticle

On November 10, 2021 Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, reported financial and operating results for the third quarter 2021 (Press release, Lineage Cell Therapeutics, NOV 10, 2021, View Source [SID1234595093]). Lineage will host a conference call today at 4:30 p.m. Eastern Time to discuss its third quarter 2021 financial results and to provide a business update.

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"Lineage’s approach is to produce specific types of human cells and stably transplant those cells as a treatment for serious medical conditions. We believe our approach, in certain settings, can generate clinical outcomes beyond the reach of traditional methods, as evidenced by the restoration of retinal tissue in patients in our dry AMD trial and the restoration of a tissue matrix in patients in our spinal cord injury trial," stated Brian M. Culley, Lineage CEO. "During the third quarter, we reported positive interim outcomes in patients with dry AMD with geographic atrophy, initiated performance testing of our OPC1 delivery device for spinal cord injury, and we expanded our executive team with the appointment of a new General Counsel. Looking ahead, we are preparing for engagement with FDA for our OpRegen program to discuss aspects of product designation, manufacturing plans, and later-stage clinical development. In parallel, we look forward to the initiation of our OPC1 and novel delivery device clinical safety study early next year. We believe our technology platform has broad potential beyond even the indications we currently are pursuing and while we continue to advance our three clinical-stage programs, we also are evaluating new applications of our technology, either on our own or through strategic alliances."

Some of the milestones achieved in the third quarter include:

– Presented OpRegen clinical data at the 54th Annual Scientific Meeting of the American Retina Society from the ongoing Phase 1/2a study of OpRegen for the treatment of dry-AMD with GA; statistically significant evidence of a treatment effect with OpRegen was observed in Cohort 4 better vision patients.

– Reported continued positive interim clinical data with OpRegen: 8/12 (67%) of the Cohort 4 patients’ treated eyes were at or above baseline visual acuity at their last assessment, based on per protocol scheduled visits ranging from 9 months to over 3 years post-transplant, while visual acuity predictably declined in the majority of untreated eyes; notably, three patients with evidence of retinal restoration and confirmed history of GA growth continued to demonstrate areas of retinal restoration as of their last per protocol assessments, ranging from 9 months to 33 months following treatment.

– Announced the appointment of George A. Samuel III as General Counsel and Corporate Secretary. Mr. Samuel brings extensive corporate, transactional, intellectual property and commercial expertise which spans nearly 15 years across the life sciences and technology sectors as well as in private practice.

– Featured in the B. Riley Securities Fall 2021 "Growth Biotech Best Idea" Virtual Series as well as the 2021 Cantor Fitzgerald Virtual Global Healthcare Conference.

Some of the events and milestones anticipated by Lineage include:

– OpRegen Program

Additional interim data from the Phase 1/2a clinical study to be featured at the 2021 American Academy of Ophthalmology Annual Meeting in a presentation on November 13, 2021, as part of the Gene and Cell-Based Therapies Session, by Michael S. Ip, M.D., Professor, Department of Ophthalmology at the David Geffen School of Medicine at the University of California, Los Angeles.
Multiple interactions with the U.S. Food and Drug Administration (FDA) planned to discuss product designation, manufacturing plans, and later-stage clinical development, anticipated to begin in Q4 2021 and continue in Q1 2022.
– OPC1 Program

Complete evaluation of a novel Parenchymal Spinal Delivery (PSD) system in non-clinical testing; anticipated in Q4 2021.
Complete GMP production of OPC1 via an improved and larger-scale manufacturing process and a new thaw-and-inject formulation; anticipated in Q1 2022.
FDA interaction to discuss recent manufacturing improvements made to OPC1; anticipated in Q1 2022.
Initiation of clinical performance and safety testing of the novel PSD device for OPC1; anticipated Investigational New Drug (IND) amendment submission in Q1 2022.
– VAC Programs

Completion of enrollment by Cancer Research UK in the ongoing VAC2 Phase 1 non-small cell lung cancer study; anticipated in Q1 2022.
Continued development of a dendritic cell-based therapeutic for glioblastoma with our strategic partner; ongoing throughout 2022.
Evaluation of opportunities for new VAC product candidates based on internally identified or partnered tumor antigens; ongoing throughout 2022.
– Business Development

Evaluation of partnership opportunities and expansion of existing collaborations; ongoing throughout 2022.
Balance Sheet Highlights

Cash, cash equivalents, and marketable securities totaled $65.1 million as of September 30, 2021. Marketable securities of $4.3 million as of September 30, 2021 include the Company’s remaining ownership in OncoCyte Corporation ("OncoCyte") and Hadasit Bio-Holdings Ltd.

Third Quarter Operating Results

Revenues: Lineage’s revenue is generated primarily from research grants, royalties, and licensing fees. Total revenues for the three months ended September 30, 2021 were approximately $2.3 million, an increase of $1.7 million as compared to $0.6 million for the same period in 2020. The increase was primarily related to a $1.6 million increase in royalty revenues, and a $0.3 million increase in licensing revenues in connection with a collaboration agreement, partially offset by a $0.2 million decrease in grant revenues.

Operating Expenses: Operating expenses are comprised of research and development (R&D) expenses and general and administrative (G&A) expenses. Total operating expenses for the three months ended September 30, 2021 were $8.1 million, an increase of $0.9 million as compared to $7.2 million for the same period in 2020.

R&D Expenses: R&D expenses for the three months ended September 30, 2021 were $2.8 million, a decrease of approximately $0.8 million as compared to $3.6 million for the same period in 2020. The decrease was primarily driven by lower VAC program expenses, related to a non-recurring prior year accrual of a $1.6 million signature fee to Cancer Research UK, partially offset by an increase in OPC1 expenses resulting from a return of unspent project funds of approximately $0.8 million in the prior year period from a former Asterias BioTherapeutics, Inc. ("Asterias") service provider.

G&A Expenses: G&A expenses for the three months ended September 30, 2021 were $5.3 million, an increase of approximately $1.7 million as compared to $3.6 million for the same period in 2020. The increase was primarily attributable to increases of $0.8 million in litigation and other expenses related to Lineage’s merger with Asterias, and $0.5 million in share-based compensation.

Loss from Operations: Loss from operations for the three months ended September 30, 2021 was approximately $6.8 million, an increase of $0.1 million as compared to $6.7 million for the same period in 2020.

Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended September 30, 2021 reflected other expense, net of ($2.0) million, compared to other expense, net of ($1.2) million for the same period in 2020. The variance was primarily related to a decrease in the value of Lineage’s OncoCyte shares, a decrease in interest income following settlement of the Juvenescence Limited note receivable in the prior year, and no sales of marketable equity securities as compared to the prior year’s quarter.

Net loss attributable to Lineage: The net loss attributable to Lineage for the three months ended September 30, 2021 was $7.8 million, or $0.05 per share (basic and diluted), compared to a net loss attributable to Lineage of $7.8 million, or $0.05 per share (basic and diluted), for the same period in 2020.

Conference Call and Webcast

Lineage will host a conference call and webcast today, at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its third quarter 2021 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from elsewhere outside the U.S. and Canada and should request the "Lineage Cell Therapeutics Call". A live webcast of the conference call will be available online in the Investors section of Lineage’s website. A replay of the webcast will be available on Lineage’s website for 30 days and a telephone replay will be available through November 18, 2021, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from elsewhere outside the U.S. and Canada and entering conference ID number 9352189.

On November 10, 2021 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the third quarter ended September 30, 2021 (Press release, In8bio, NOV 10, 2021, View Source [SID1234595109]). In addition, the Company provided an overview of recent corporate developments.

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"Our IPO has provided the capital to enable us to advance our clinical programs for INB-100 in leukemia and INB-200 in newly diagnosed glioblastoma (GBM) and other solid tumors as well as progress our preclinical-stage assets," said William Ho, Chief Executive Officer and co-founder of IN8bio. "Both of our clinical programs continue to progress and we took the opportunity during the required safety observation period for the allogeneic INB-100 trial to improve our manufacturing processes and overall gamma-delta T cell yield. We look forward to the continued advancement of our clinical and preclinical programs and to providing updates on them in the future."

Third Quarter Business Highlights & Corporate Updates

In July 2021, IN8bio appointed Emily Fairbairn and Luba Greenwood as two independent members of the Company’s Board of Directors. Ms. Fairbairn is currently a principal of Transcend Partners and was co-founder and CEO of Ascend Capital. Ms. Greenwood serves as Managing Partner of Binney Street Capital LLC, a venture capital fund established by the Dana Farber Cancer Institute, and as CEO of LUCA Biologics.

In August 2021, IN8bio closed its initial public offering, in which it issued and sold 4,000,000 shares of common stock at a public offering price of $10.00 per share. The net proceeds to the Company were approximately $32.3 million, after deducting underwriting discounts, commissions and offering expenses.

In August 2021, IN8bio completed dosing of the first cohort of INB-100, a Phase 1 clinical trial of donor-derived allogeneic gamma-delta T cells in leukemia patients undergoing haploidentical hematopoietic stem cell transplant (HSCT). No severe adverse infusion reactions, cytokine release syndrome, neurotoxicity (or ICANS) or dose-limiting toxicities were observed. Episodes of mild-to-moderate acute skin graft-versus-host-disease (GvHD) responsive to standard therapy have been observed. Additional patients will be enrolled at the first dose-level to further assess these events and any potential relationship to the ongoing positive clinical responses observed in the INB-100 treated patients. Skin biopsies were consistent with the expected pathology in post-HSCT GvHD and the vast majority of immune cell infiltration were alpha-beta T cells. All three patients treated with INB-100 continue in remission with the first two patients beyond 18- and 16-months post-transplant, respectively. The Company continues to expect to report initial results from the first cohort in this Phase 1 trial in 2022, with topline results for all cohorts in 2023.

In September 2021, IN8bio announced the peer-reviewed publication of preclinical results that it believes provides foundational support for the use of its DeltEx Drug Resistant Immunotherapy (DRI) in newly diagnosed GBM. This work, published in Scientific Reports, a Nature Portfolio journal, focused on the use of gamma-delta T cells genetically engineered to be chemotherapy resistant through the addition of an O6-Methylguanine-DNA Methyltransferase (MGMT). Concurrent dosing of DRI cells with temozolomide (TMZ) resulted in a significant improvement in survival outcomes in mice over either monotherapy alone in both classical and mesenchymal primary high-grade gliomas.

In October and November 2021, the Company presented updates on its programs at the 2021 Advanced Therapies Congress and at the 13th Annual Protein and Antibody Engineering Summit (PEGS) Europe.
Upcoming Scientific Presentations

36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper), November 10 – 14, 2021.

26th Annual Meeting of the Society of Neuro-Oncology (SNO), November 18 – 21, 2021.
Third Quarter 2021 Financial Highlights

Cash position: As of September 30, 2021, the Company had cash of $40.7 million, compared to $18.0 million as of December 31, 2020. The increase in cash was primarily due to the IPO proceeds, net of cash used by the Company in operations to advance its programs and research and development.

Research & Development (R&D) expense: R&D expense was $1.4 million for the three months ended September 30, 2021, compared to $1.1 million for the comparable prior year period. The increase in R&D expense was primarily due to increased third-party clinical trial related activities and contract manufacturing costs for the ongoing clinical trials and increased personnel-related costs, including salaries, benefits and stock-based compensation.

General and administrative expense: General and administrative expense was $2.0 million for the three months ended September 30, 2021, compared to $0.6 million for the comparable prior year period. The increase was primarily due to increased personnel costs, including salaries, benefits and stock-based compensation and increased legal expenses in anticipation of operating as a public company.

Net loss: The Company reported a net loss of $3.4 million, or $0.25 per basic and diluted common share, for the three months ended September 30, 2021, compared to a net loss of $1.7 million and a net loss attributable to common stockholders of $2.2 million, or $0.60 per basic and diluted common share, for the comparable prior year period.

On November 10, 2021 Oxford Finance LLC ("Oxford"), a leading specialty finance firm that provides senior debt to life sciences and healthcare services companies worldwide, reported the closing of a $50 million senior secured term loan with Kezar Life Sciences, Inc. (NASDAQ: KZR) ("Kezar" or "the Company"), a clinical-stage biotechnology company discovering and developing breakthrough treatments for immune-mediated and oncologic disorders (Press release, Kezar Life Sciences, NOV 10, 2021, View Source [SID1234595142]).

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Proceeds from the transaction will be used for general growth capital and for further advancement of the Company’s clinical candidates, KZR-616 and KZR-261.

Founded in 2015, Kezar uses cutting-edge science to develop breakthrough treatments for immune-mediated and oncologic disorders – with the hope of helping people overcome their disease and live a better life. The Company is pioneering first-in-class, small molecule therapies that harness master regulators of cellular function to inhibit multiple drivers of disease via single, powerful targets.

"Kezar is led by a highly skilled management team with extensive, scientific expertise in immunology and oncology. The Company is positioned to tackle the toughest diseases through innovative small molecule therapies that unlock the potential for profound therapeutic benefits," said Christopher A. Herr, senior managing director at Oxford. "Oxford is proud to support a company dedicated to providing a new, hopeful approach to those affected by autoimmune disease and cancer."

"This non-dilutive strategic financing, together with our current cash, strengthens our balance sheet as we advance our clinical programs and overall platform for patients affected by a range of immune-mediated and oncologic diseases," said Marc Belsky, chief financial officer of Kezar Life Sciences. "Importantly, this facility provides us with greater financial and operational flexibility as we approach top-line data readouts for KZR-616 in the second quarter of 2022."

On November 10, 2021 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, reported that management will participate in a fireside chat at the Jefferies London Healthcare Conference on Wednesday, November 17, 2021 at 1:40 p.m. GMT/ 8:40 a.m. EST (Press release, IGM Biosciences, NOV 10, 2021, View Source [SID1234595229]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.