Amendment to the License Agreement with ADC Therapeutics

On November 10, 2021 Chiome Bioscience Inc. ("Chiome") reported that it has agreed with ADC Therapeutics SA ("ADCT") to make an amendment to the License Agreement of September 27, 2017 under which Chiome granted ADCT the worldwide, exclusive, sub-licensable right to anti-DLK-1 antibody including LIV-1205 for the development, manufacture and commercialization in Antibody-Drug Conjugates (ADC) fields (Press release, ADC Therapeutics, NOV 10, 2021, View Source [SID1234596043]).

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With this amendment, both parties agreed that ADCT’s exclusivity would be related to Pyrrolobenzodiazepine (PBD)-based ADC development only an area where ADCT has the exclusive proprietary rights to develop a PBD-based ADC targeting DLK-1, and in particular development of ADCT-701. This amendment allows Chiome to develop ADCs not incorporating a PBD-based ADC and gives Chiome greater flexibility in advancing strategic drug development of an anti-DLK-1 antibody, and to pursue the business potential of CBA-1205, including licensing opportunites, which is currently undergoing Phase 1 clinical trial. The amendment also restructured financial terms between the parties.

There is no impact on the financial performance in the fiscal period ending December 31, 2020.

<About ADC>
ADCs are a class of biopharmaceutical drugs designed as a targeted therapy for treating cancer. Unlike chemotherapy, ADCs are intended to target and kill tumor cells while sparing healthy cells. ADCs are complex molecules composed of an antibody linked to a biologically active cytotoxic payload or drug. ADCs combine the targeting capabilities of monoclonal antibodies with the cancer-killing ability of cytotoxic drugs. Pyrrolobenzodiazepines (PBD) are a class of compound that may have antibiotic or anti-tumor properties and used as the cytotoxic drug payloads in antibody-drug conjugates

Epigenomics AG publishes financial results for the first nine months 2021

On November 10, 2021 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first nine months of 2021 (Press release, Epigenomics, NOV 10, 2021, View Source [SID1234594995]).

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9M 2021 FINANCIAL RESULTS

Total revenue in the first nine months of 2021 increased to EUR 6,022 thousand (9M 2020: EUR 541 thousand), due to the sale of samples from the Company’s "biobank" in the amount of EUR 5,675 thousand. Product revenue decreased from EUR 453 thousand to EUR 330 thousand in the reporting period compared to the same period of the previous year due to the Covid-19 pandemic.
Research and development costs decreased from EUR 3,412 thousand to EUR 2,226 thousand in the nine-month period due to a reduction in clinical study costs related to Covid-19; however, patient enrollment for the Epi pro Colon post-approval study has recently begun to increase closer to pre Covid 19 levels.
Selling and administrative expenses increased slightly from EUR 5,442 thousand to EUR 5,809 thousand primarily due to the costs associated with the sale of the Biobank samples.
EBITDA (before share-based payment costs) improved significantly to EUR -209 thousand in the reporting period compared to EUR -8,090 thousand in the same period of the previous year. This is also primarily due to the biobank samples sale.
The net loss for the period also decreased significantly to EUR -691 thousand (9M 2020: EUR -9,109 thousand); accordingly, the loss per share decreased from EUR 1.59 to EUR 0.07 compared to the same period of the previous year.
Cash consumption decreased to EUR 3,598 thousand in the first nine months of 2021 (9M 2020: EUR 7,492 thousand).
As of 30 September 2021, the Company had cash and cash equivalents (including marketable securities) of EUR 23,555 thousand (31 December 2020: EUR 3,566 thousand).
OPERATIONAL DEVELOPMENTS

Epigenomics initiated clinical trial plans for Epi proColon "Next-Gen", an updated version of the assay that meets CMS reimbursement criteria based upon performance from prospectively collected banked clinical samples. The Company plans to begin enrollment in the summer of 2022.
In addition, Epigenomics executed a EUR 5.7 million sale of samples from the Company’s extensive biobank. The Company has retained the necessary samples to complete development activities for Epi proColon "Next-Gen".
In September the company successfully completed the placement of a subordinated non-interest-bearing mandatory convertible bond that raised EUR 16.5 million in gross proceeds.
OUTLOOK 2021

Revenue

As a result of the sale of the biobank to New Horizon Health Limited, the revenue and earnings guidance for the full year 2021 was adjusted on August 17, 2021: The Company expects revenues of EUR 6.0 million for the financial year 2021 (previously: EUR 0.4 million to EUR 1.0 million).
EBITDA / cash consumption

For EBITDA before share-based payment costs, Epigenomics forecasts a range of EUR -3.0 million to EUR -4.0 million (previously: EUR -7.0 million to EUR -9.0 million) for the full year 2021. Based on the Company’s 2021 business plan, cash consumption is expected to range between EUR 3.5 million to EUR 4.5 million (previously: EUR 7.0 million to EUR 9.0 million).
Further information

The financial report for the first nine months of 2021 is available on the Epigenomics’ website at: View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

The dial-in numbers for the conference call are (for registered participants):

Dial-in number Germany: +49 30 232531508
Dial-in number UK: +44 1635 598058
Dial-in number U.S.A.: +1 516-269-8975

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Company’s website following the call.

Perrigo Reports Third Quarter 2021 Financial Results From Continuing Operations

On November 10, 2021 Perrigo Company plc (NYSE: PRGO; TASE) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the third quarter of fiscal year 2021 ended October 2, 2021 (Press release, Perrigo Company, NOV 10, 2021, View Source [SID1234595046]). All comparisons are against the prior year fiscal third quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Major initiatives were completed in the third quarter that will secure Perrigo a bright future. The RX generic prescription business divestiture was completed, the acquisition of the highly successful HRA Pharma business was announced, and a major overhang on the business was removed through a favorable settlement of the Irish tax dispute paid for with proceeds from the successful arbitration in Belgium. Perrigo is now a solely focused consumer self-care company, poised for strong growth, unencumbered by the major overhangs of the past. Our team is intently focused on driving long-term profitable growth."

Kessler continued, "Our disappointing third quarter results reflect the continuing impacts of the challenging operating environment caused by the global COVID-19 pandemic that began in 2020, have continued in 2021 and are not indicative of our future growth potential. These challenges fall into three categories for Perrigo: a historically weak cough/cold season affecting first quarter sales and manufacturing efficiencies, higher input costs and the sudden supply chain disruption, primarily in the form of a shortage of truck drivers, which began in the third quarter. In combination, these factors are forecasted to negatively impact total year adjusted diluted EPS by $0.79, which could only be partially offset, leading us to lower our earnings guidance."

Kessler also noted, "Importantly, third quarter consumer off-take was very strong, as were factory orders on almost all of our businesses. This included a strong rebound in cough/cold sales. Unfortunately, we exited the quarter with record unshipped orders as there were not enough trucks or drivers to fulfill those orders in the U.S. Supply chain disruptions impacted CSCA net sales growth in the quarter by 5.7 percentage points."

Kessler concluded: "Our cough/cold business is rebounding, which will positively impact sales and manufacturing efficiencies. We have taken multiple steps to adjust our supply chain during this unusual period, which has already resulted in a significant improvement in October. And, we are taking action to mitigate higher input costs, including price increases on approximately 75% of the Company’s portfolio and delivering on project momentum cost savings. Through the combination of these actions, along with the anticipated closing and successful integration of HRA expected in the first half of next year, we still believe we will deliver on our original 2023 EPS transformation plan targets."

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Third Quarter 2021 Financial Highlights from Continuing Operations

Perrigo third quarter net sales were $1.04 billion, an increase of 4.0%. Organic(1) net sales growth was 2.6%, despite an increase in unfulfilled orders of 4.3 percentage points as a result of supply chain disruptions.

CSCA third quarter net sales of $694 million increased 4.6%, with organic growth of 4.2%; CSCI third quarter net sales of $349 million increased 2.8%, with organic net sales down by 0.6%.

Reported diluted loss per share was $0.40, compared to reported diluted earnings per share ("EPS") of $0.19 in the prior year quarter.

Adjusted diluted EPS, which excludes certain charges as outlined in Table I, decreased 25.0% to $0.45 per diluted share. Adjusted diluted EPS was negatively impacted by approximately $0.22 per diluted share from lower operating efficiencies, higher materials and freight costs, and two product recalls, as compared to the prior year quarter. The increase in unfulfilled orders depressed adjusted EPS by $0.08 per diluted share.
Year-to-Date 2021 Financial Highlights from Continuing Operations(2)

Perrigo year-to-date net sales were $3.03 billion, or flat, compared to the prior year period, including a negative impact of 3.4 percentage points from lower cough/cold-related net sales due to the historically weak 2020/2021 cough/cold season. Unfulfilled orders due to supply chain disruptions depressed growth by 1.4 percentage points.

CSCA year-to-date net sales of $1.96 billion were 1.8% lower compared to the prior year period; organic net sales were down 3.2%, including a negative 3.2 percentage points impact from lower cough/cold-related net sales. Unfulfilled orders due to supply chain disruptions depressed growth by 1.9 percentage points.

CSCI year-to-date net sales of $1.08 billion grew 3.3% compared to the prior year period; organic net sales were down 2.2%, including a negative 3.9 percentage points impact from lower cough/cold-related net sales. Unfulfilled orders due to supply chain disruptions depressed growth by 0.5 percentage points.

Reported diluted loss per share year-to-date was $1.22 per diluted share as compared to EPS of $0.70 in the prior year period.

Adjusted diluted EPS year-to-date decreased 22.5% to $1.45 per diluted share as compared to $1.87 per diluted share in the prior year period. Adjusted diluted EPS was negatively impacted by lower cough/cold-related net sales, lower operating efficiencies and higher materials and freight expenses.

See attached Appendix for details. Organic net sales growth excludes the effects of acquisitions and divestitures and the impact of currency.

In addition to other non-GAAP adjustments as described in the attached appendix, adjusted profit measures, including adjusted EPS and adjusted operating income, exclude from both periods certain costs, which are reported in GAAP continuing operations but were previously allocated to the RX business. On a go-forward basis, such costs are either covered by the transition services agreement or have been eliminated following closing. We do not believe such operational costs are representative of the future expenses of our continuing operations. See attached appendix for additional details.

Third Quarter 2021 Perrigo Results from Continuing Operations

Perrigo net sales for the third quarter were $1.04 billion, an increase of $40 million, or 4.0%. Favorable currency movements and acquisitions contributed 0.9 and 0.5 percentage points, respectively. Organic net sales growth was 2.6%, despite an increase in unfulfilled orders as a result of supply chain disruptions, including a lack of truck drivers in the U.S. and record backups at global shipping ports, which held back growth by 4.3 percentage points.

Net sales in the quarter were driven by 1) strong growth in e-commerce, primarily in CSCA, 2) contract manufacturing sales to the now-divested RX business, 3) increased pricing, 4) a rebound in cough/cold in the U.S., 5) the November 2020 acquisition of Eastern European dermatology brands in CSCI, and 6) $9 million in net favorable currency movements. These increases were partially offset by 1) discontinued products of $11 million, 2) lost distribution within the Healthy Lifestyle category in CSCA, 3) lower net sales in the CSCI contract manufacturing business, and 4) $4 million from a product recall.

Third quarter reported operating income was $438 million in 2021 compared to $79 million in 2020. Adjusted operating income was $112 million in 2021 and $141 million in 2020, a decrease of $29 million, or 20.6%. This decrease was driven by 1) $29 million from lower operating efficiencies resulting from the weak 2020/2021 cough/cold season, and higher materials and freight expenses, and 2) $9 million of costs from two product recalls. These results were partially offset by lower operating expenses, including project momentum cost savings.

Reported net loss was $54 million, or $0.40 per diluted share, compared to net income of $26 million, or $0.19 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, third quarter 2021 adjusted net income was $61 million, or $0.45 per diluted share, compared to $83 million, or $0.60 per diluted share, last year due to the factors described above.

Third Quarter 2021 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

CSCA third quarter net sales of $694 million grew 4.6%, including a 0.4 percentage point positive impact from favorable currency movements. Organic net sales increased 4.2%, despite an increase in unfulfilled orders slowing growth by 5.7 percentage points as a result of supply chain disruptions, including a lack of truck drivers in the U.S. and record backups at global shipping ports.

OTC net sales were driven by 1) strong growth in e-commerce, 2) contract manufacturing sales to the now divested RX business, 3) higher incidences of cough/cold illness as society returns to in-person activities, benefiting the Cough/Cold and Pain categories, 4) a double-digit percentage increase in the branded OTC business, and 5) increased pricing stemming from management actions taken earlier in the year. These gains were partially offset by 1) lost distribution within the Healthy Lifestyle category, 2) $10 million in discontinued products, primarily from the discontinuation of diabetes care products in the Healthy Lifestyle category, and 3) lower net sales in the Allergy category due primarily to the recall of third-party manufactured product.

Net sales in the Oral Self-Care category declined mid-single digits due primarily to delayed receipt of ex-U.S. manufactured product, leading to record unfulfilled customer orders.

Net sales in the Nutrition category grew mid-single digits driven by new product launches within infant formula as well as strong growth in the oral electrolytes business.

Reported operating income was $90 million in 2021 compared to $122 million in 2020. Adjusted operating income decreased $28 million to $106 million driven by 1) lower operating efficiencies due primarily to the weak 2020/2021 cough/cold season and higher materials and freight expenses, and 2) a product recall during the quarter. These factors were partially offset by lower operating expenses, including project momentum cost savings.

Consumer Self-Care International Segment

CSCI net sales of $349 million increased $10 million, or 2.8%, including a 1.9 percentage point positive impact from favorable currency movements and a 1.5 percentage point positive impact from acquisitions. Organic net sales decreased 0.6%. Unfulfilled orders increased 1.5 percentage points as a result of supply chain disruptions, due primarily to record backups at global shipping ports.

Net sales in the quarter were driven by 1) the November 2020 acquisition of three Eastern European OTC Dermatology Brands, 2) higher net sales in the U.K. store brand business, 3) greater demand for NiQuitin smoking cessation products in the Healthy Lifestyle category, 4) increased pricing, and 5) $6 million in favorable currency movements. These drivers were more than offset by 1) lower than normal buy-in for cough/cold products by pharmacies, 2) a decline in net sales in the contract manufacturing category, 3) lower demand for weight loss products across Europe, which led to lower net sales for XLS Medical within the Healthy Lifestyle category, and 4) a product recall that negatively impacted the Vitamins, Minerals & Supplements (VMS) category.

Reported operating income was $4 million in 2021 compared to $10 million in 2020. Adjusted operating income decreased $6 million to $46 million due to a $6 million negative impact related to the VMS product recall and less favorable product mix, which were partially offset by lower operating expenses.

Settlement of the Irish Revenue Notice of Amended Assessment ("NoA")

The Company announced on September 29, 2021 that it had reached a settlement with the Irish Office of the Revenue Commissioners for the Notice of Amended Assessment ("NoA") dated November 29, 2018. As part of the settlement terms, Perrigo made a total cash payment to Irish Revenue of €266.1 million in the fourth quarter of 2021. This payment has resolved the entire €1.6 billion NoA against the Company.

Receipt in Cash of €355 million from the Belgian Arbitration Decision

Perrigo announced on September 29, 2021 that it received the entire €355 million in cash on behalf of Alychlo NV and Holdco I BE NV ("Sellers") in payment of the previously announced arbitration award issued in favor of Perrigo Ireland 2 ("Perrigo Ireland"). The award was issued August 27, 2021, by a tribunal sitting under the rules of the Belgian Centre for Arbitration and Mediation and related to claims arising under the Stock Purchase Agreement between Sellers and Perrigo Ireland dated November 6, 2014. Under Belgian law, Sellers have the right to challenge the tribunal’s award for up to three months following the date of the award. However, Perrigo does not believe that Sellers have any legal grounds for any such challenge.

Fiscal 2021 Outlook from Continuing Operations

The Company is updating its fiscal 2021 outlook to reflect third quarter results and management expectations for the remainder of the year. The Company now expects calendar year 2021 adjusted diluted EPS of between $2.00 to $2.10.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2021 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time.

Portage Biotech Hosting Key Opinion Leader Webinar on How iNKT Agonists Could Improve Immuno-Oncology Treatment

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

Lineage Reports Third Quarter 2021 Financial Results and Highlights Progress From Clinical Cell Therapy Programs

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.