Hadasit Medical Research Services & Development Ltd.

A novel approach to treating skin toxicities caused by EGFRi, based on a decade of research by leading Israeli cancer researchers JERUSALEM, June 8, 2023 /PRNewswire/ -- Hadasit, and Yissum, has spun off EMRIS Pharma in collaboration with NGT Healthcare2 VC. EMRIS Pharma is pioneering novel small molecule-based topical compounds that can improve both quality of life and treatment compliance for cancer patients. Based on over ten years of research collaboration by the founders, Dr. Sharon Merims, a senior dermatologist specializing in dermato-oncology at the Hadassah Medical Center, and Professor Ofra Benny from the Institute for Drug Research at the Hebrew University of Jerusalem, and with the support of NGT Healthcare2 VC, the company's first product aims to treat the skin toxicities caused by EGFRi (Epidermal Growth Factor Receptor inhibitors). Many of the molecularly targeted agents used in current cancer treatments, particularly those interfering with signal transduction EGFRi and small molecule tyrosine kinase inhibitors, are associated with papulopustular skin rash. This rash is observed in ~90% of patients receiving EGFR-targeted monoclonal antibodies, and often impacts the patient's quality of life, and the ability to continue the cancer treatment. Dr. Merims will serve as EMRIS Pharma's Chief Scientific Officer, and Professor Benny as the company's Chief Technology Officer. Emris ,founded by NGT Healthcare2 VC, licensed the technology from Hadasit, the Technology Transfer Company of Hadassah Medical Organization and Yissum, the Technology Transfer Company of the Hebrew University in Jerusalem, Israel. License terms include various payments such as license fees, milestones payments and royalties. "Current strategies for treating skin toxicities caused by EGFR inhibitors are of limited benefit and there is an urgent need for novel and potent treatment for these skin toxicities," said Dr. Sharon Merims. " Our novel proactive strategy for the management of EGFR therapy-mediated skin rash may help to maximize the benefit for oncology patients by minimizing the negative effects on quality of life, maintaining an optimal monoclonal antibody dose and thus leading to a better response to the anti-cancer treatment". "The lead compound developed by EMRIS Pharma has been initially successful in blocking EGFRi monoclonal antibodies from binding to EGFR both in vitro and ex vivo," said Professor Ofra Benny "The delivery system for this treatment is also unique in that it is a slow-release system that penetrates the deep layers of the epidermis where EGFR is most dense." "As a venture capital firm focused on healthcare innovation, we are excited to partner with EMRIS Pharma on their groundbreaking cancer treatment product. Their novel approach to managing skin toxicities caused by EGFR inhibitors has the potential to significantly improve the quality of life for cancer patients and increase treatment compliance. We believe that EMRIS Pharma's innovative research and development will lead to a brighter future for cancer patients, and we look forward to supporting their mission." - Zohar Gendler, Managing Partner &CEO, NGT Healthcare2 About The Hadassah Medical Center The Hadassah Medical Center was established in 1912 and is a world-class facility. For more than a century, Hadassah has set the standard of excellence for medical care and research in Israel. Every year, Hadassah provides nearly one million people with hospital services, and in keeping with worldwide trends, the Hadassah University Medical Center in Israel is moving toward day care and day hospitalization to reduce costs and risk of infection. Our doctors and scientists are on the frontlines, uniquely positioned to pinpoint ever-evolving medical needs. Their experience and ingenuity have yielded new ideas with huge potential in all areas of medicine, including therapeutics, diagnostic medical devices, and digital health. For more information about Hadassah, please visit - About the Hebrew University of Jerusalem The Hebrew University of Jerusalem is Israel's leading academic and research institution. Serving 24,000 students from 80 countries, it produces a third of Israel's civilian research and is ranked 12th worldwide in biotechnology patent filings and commercial development. Faculty and alumni of the Hebrew University have won eight Nobel Prizes and a Fields Medal. For more information about the Hebrew University, please visit . About Hadasit Medical Research Services and Development Hadasit is the technology transfer company and innovation engine of Hadassah Medical Organization in Jerusalem. Hadasit transforms the cutting-edge research coming out of Hadassah into marketable medical technologies, that can change the world and better humanity. With more than 260 active patent families, which have yielded numerous medical and commercial breakthroughs, Hadasit established companies, licenses technologies, and collaborates with leading international companies and research facilities around the world. To date, Hadasit had spun off over 65 companies, including the publicly traded Hadasit Bio-Holdings (TASE: HDST) in which Hadasit is a major shareholder. Yissum is the technology transfer company of The Hebrew University of Jerusalem. Founded in 1964, it serves as a bridge between cutting-edge academic research and a global community of entrepreneurs, investors, and industry. Yissum's mission is to benefit society by converting extraordinary innovations and transformational technologies into commercial solutions that address our most urgent global challenges. Yissum has registered over 11,000 patents globally; licensed over 1,140 technologies and has spun out more than 200 companies. Yissum's business partners span the globe and include companies such as Boston Scientific, ICL, Intel, Johnson & Johnson, Merck, Novartis and many more. Additional information about EMRIS Pharma: [email protected]. Logo - SOURCE Hadasit

GAITHERSBURG, Md.--(BUSINESS WIRE)--Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company pioneering the development of phage-based therapies to combat bacterial infections, is pleased to announce a collaboration and license agreement with the Israeli Phage Therapy Center (IPTC) of the Hebrew University of Jerusalem and Hadassah Medical Center. Researchers at the IPTC have discovered several phages that have exceptionally broad coverage against antibiotic resistant bacteria. Under the agreement, Hadasit and Yissum, the technology transfer companies of Hadassah and the Hebrew University, grants APT exclusive rights to make, use, and sell licensed phages for human therapy, with the right to sublicense through multiple tiers. APT also has the first right to evaluate additional phages discovered by IPTC researchers for inclusion in APT’s phage bank. As consideration for the license and first right of refusal, APT made an upfront payment and will pay royalties from net sales on any therapeutic composition comprising a licensed phage. This press release features multimedia. View the full release here: (Photo: Business Wire) Notably, the licensed phages have already been used in emergency compassionate-use treatments for numerous patients for whom antibiotic options had been exhausted. In April 2023 the IPTC reported that 78% of compassionate-use bacteriophage treatments for antibiotic-resistant infections given since 2018 to patients at the Hadassah Medical Center and other hospitals in Israel have resulted in favorable outcomes. The center has received 159 requests for compassionate use of phage therapy for previously failed infections from Israel, the US, Finland and Germany. The most common indications for phage requests were bone and respiratory infections, with the most common bacteria being Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcus aureus. Of the 18 patients who received intravenous phage therapy, 14 (78%) achieved clinical remission, and four (22%) were classified as treatment failure. No major side effects were reported. “Over the past several years, we have built a mutually beneficial relationship with the scientists and clinicians at the Israeli Phage Therapy Center,” said Greg Merril, CEO of APT. “We are thrilled to enter into this collaboration and license agreement and to continue our work with Dr. Nir-Paz, Dr. Hazan, and the impressive group of phage scientists at Hebrew University and Hadassah Medical Center. We believe that phage-based therapies have the potential to revolutionize the treatment of bacterial infections, particularly in patients who have exhausted all other options, and this collaboration will enhance APT’s phage bank and enable us to bring these therapies to more patients in need.” "We are excited to announce our collaboration and licensing agreement with the foremost phage therapy biotech firm, Adaptive Phage Therapeutics,” said Ronan Hazan, PhD, Head of the Israeli Phage Therapy Center and the Israeli Phage Bank and Head of the Institute of Biomedical and Oral Research (IBOR) of the Dental Medicine Faculty of the Hebrew University. “This partnership is a significant milestone in our mission to combat antimicrobial resistance using phage therapy. It is our conviction that phage therapy holds enormous potential to transform the way infectious diseases are treated, and this collaboration will help us bring these innovative treatments to patients in need. We look forward to working together to advance the field of phage therapy and develop new solutions to the growing threat of antimicrobial resistance." "As an infectious disease doctor, I recognize the urgent need for new solutions in the fight against antimicrobial resistance. I am thrilled to see the Israeli Phage Therapy Center entering into a collaboration and licensing agreement with Adaptive Phage Therapeutics, the leading phage therapy biotech firm,” said Ran Nir-Paz, MD, Professor of Clinical Microbiology and Medicine at the department of Clinical Microbiology and Infectious Diseases at the Hadassah Hebrew University Medical Center and co-founder of the Israeli Phage Therapy Center. “Phage therapy holds great promise in addressing this global crisis, and this partnership is a crucial step forward in bringing these innovative treatments to patients in need." The emergency clinical use of the phages licensed under this agreement have led to several published case studies and other manuscripts currently being prepared for publication, including: Nir-Paz R, Gelman D, Khouri A, Sisson BM, Fackler J, Alkalay-Oren S, Khalifa L, Rimon A, Yerushalmy O, Bader R, Amit S, Coppenhagen-Glazer S, Henry M, Quinones J, Malagon F, Biswas B, Moses AE, Merril G, Schooley RT, Brownstein MJ, Weil YA, Hazan R. 2019. Successful treatment of antibiotic-resistant, poly-microbial bone infection with bacteriophages and antibiotics combination. Clin Infect Dis 69:2015–2018. 10.1093/cid/ciz222. PubMed. Ameneh Khatami, Ruby C Y Lin, Aleksandra Petrovic-Fabijan, Sivan Alkalay-Oren, Sulaiman Almuzam, Philip N Britton, Michael J Brownstein, Quang Dao, Joe Fackler, Ronen Hazan, Bri’Anna Horne, Ran Nir-Paz, Jonathan R Iredell. Bacterial lysis, autophagy and innate immune responses during adjunctive phage therapy in a child. EMBO Mol Med (2021)13:e13936. 9 August 2021 About The Israeli Phage Therapy Center (IPTC) The IPTC was operating since 2018, by the Hadassah Medical Center and the Hebrew University of Jerusalem. The center has received 159 requests for compassionate use of phage therapy for previously failed infections from Israel, the US, Finland and Germany. The most common indications for phage requests were bone and respiratory infections, with the most common bacteria being Pseudomonas aeruginosa, Acinetobacter baumannii and Staphylococcus aureus. Of the 18 patients who received intravenous phage therapy, 14 (78%) achieved clinical remission, and four (22%) were classified as treatment failure. No major side effects were reported. About The Hadassah Medical Center The Hadassah Medical Center was established in 1912 and is a world-class facility. For more than a century, Hadassah has set the standard of excellence for medical care and research in Israel. Every year, Hadassah provides nearly one million people with hospital services, and in keeping with worldwide trends, the Hadassah University Medical Center in Israel is moving toward day care and day hospitalization to reduce costs and risk of infection. Our doctors and scientists are on the frontlines, uniquely positioned to pinpoint ever-evolving medical needs. Their experience and ingenuity have yielded new ideas with huge potential in all areas of medicine, including therapeutics, diagnostic medical devices, and digital health. For more information about the Hadassah Medical Center, please visit About the Hebrew University of Jerusalem The Hebrew University of Jerusalem is Israel's leading academic and research institution. Serving 24,000 students from 80 countries, it produces a third of Israel's civilian research and is ranked 12th worldwide in biotechnology patent filings and commercial development. Faculty and alumni of the Hebrew University have won eight Nobel Prizes and a Fields Medal. For more information about the Hebrew University, please visit . About Adaptive Phage Therapeutics, Inc. (APT) Adaptive Phage Therapeutics (APT) is a clinical-stage company advancing therapies to treat multidrug-resistant infections based on a phage bank concept originally initiated at the National Institutes of Health (NIH) by APT co-founder Carl R. Merril, M.D., Capt. USPHS (ret). APT phage bank is being steadily expanded with new phage discoveries and collections from a variety of sources, including the biodefense labs of US Department of Defense, internal phage discovery initiatives at APT, and academic phage research labs collaborators around the world. APT is the sponsor of ongoing clinical trials in Prosthetic Joint Infection (PJI) and Diabetic Foot Osteomyelitis (DFO), addressing notable unmet patient needs in those bacterial infection indications. APT’s phage bank has also been used in over 70 compassionate cases under FDA emergency Investigational New Drug allowance in which standard-of-care antibiotics had failed. APT phage bank is paired with a phage susceptibility test (PST) that matches each patient bacterial isolate to specific lytic phage within APT’s collection – analogous to an antibiotic susceptibility test for matching antibiotics. The APT PST will be commercialized worldwide in collaboration with Mayo Clinic Laboratories. APT’s clinical development program has attracted substantial financial support from The Defense Health Agency (DHA), NIAID/NIH, The Mayo Clinic, the AMR Action Fund, Deerfield Management, and other VC funds and healthcare systems. For more information, visit .

Phase 2a Clinical Study of RG6501 (OpRegen®) in Patients with GA Secondary to AMD Initiated by Genentech, a Member of the Roche Group Submitted RMAT and Pre-IND Materials to Support OPC1 and VAC2 Programs in Spinal Cord Injury and Oncology, Respectively Launched Two New Cell Therapy Programs for the Treatment of Hearing and Vision Loss Established New R&D Facility and Expanded Existing cGMP Manufacturing Facility CARLSBAD, Calif.--(BUSINESS WIRE)-- Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing allogeneic cell therapies for unmet medical needs, today reported financial and operating results for the fourth quarter and full year ended December 31, 2022 and will host a conference call today at 4:30 p.m. Eastern Time to discuss these results. “2022 marked a year of clinical and regulatory execution for the Lineage team, as we worked alongside our partners and internally to advance our clinical and preclinical programs,” stated Brian M. Culley, Lineage CEO. “A significant area of focus last year was our alliance with Roche and Genentech, including supporting the initiation of a Phase 2a clinical study of OpRegen in patients with GA secondary to AMD. We believe we have selected the most capable partner to advance OpRegen and we anticipate that the findings from the Phase 2a study will be highly informative to the OpRegen development program in any future larger, comparative trials. We also made considerable progress expanding and diversifying our pipeline, primarily through the addition of two new cell transplant programs. We believe the learnings from our dry AMD program may prove valuable to our newer product opportunities, which are similarly based on our differentiated cell transplant technology. “We also completed key regulatory activities for our OPC1 and VAC2 programs, which help provide insights into their continued development,” Mr. Culley added. “Our corporate objectives for 2023 will be to emphasize the further progression of our allogeneic cell therapy programs, making responsible investments in the expansion of our novel approach to cell transplant medicine in disease settings where we believe we can make a meaningful impact, and the continued support of both our newly established and existing collaborations, all in support of our overarching vision of building Lineage into a leading cell therapy company.” Other significant milestones achieved in 2022 include: RG6501 (OpRegen) Continued execution under our collaboration with Roche and Genentech across multiple functional areas, including support for ongoing Phase 2a clinical study in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Long-term follow-up of patients from the Phase 1/2a clinical study of OpRegen: Positive clinical data presented at 2022 Association for Research in Vision and Ophthalmology Annual Meeting. OPC1 Completed verification and validation and preclinical testing activities for a novel parenchymal spinal delivery (PSD) system to support planned regulatory submissions. Key data from OPC1, a Phase 1 clinical study in acute thoracic spinal cord injury and a Phase 1/2a clinical study in subacute cervical spinal cord injury, were published in the Journal of Neurosurgery: Spine. Preclinical testing of a new thaw and inject formulation of OPC1, manufactured via an improved and larger-scale process, demonstrated functional recovery, improvement in gait coordination and motor performance with a reduction of the area of cavitation. Engagement with the California Institute of Regenerative Medicine (CIRM), as well as various patient advocacy organizations and patient advocates continued. VAC2 Pre-Investigational New Drug (IND) application briefing package submitted to the FDA to support U.S. clinical development for immuno-oncology. Reported completion of enrollment in VAC2 Phase 1 non-small cell lung cancer (NSCLC) Study by Cancer Research UK. Following technology transfer of the program from Cancer Research UK to Lineage and improvement of manufacturing processes, production scale increased and accordingly the cost of goods was reduced significantly, along with marked improvements in the purity and functionality of the manufactured material. Launched two new cell therapy programs for the treatment of hearing and vision loss. Process development and related activities were ongoing in support of planned preclinical testing. Established new U.S. R&D facility and expanded current GMP manufacturing facility in Israel. Strengthened intellectual property portfolio with Notice of Allowance for various patent applications including but not limited to covering oligodendrocyte progenitor cells. Announced appointment of Jill Howe as Chief Financial Officer. Some of the events and milestones anticipated by Lineage in 2023 include: Results from imaging analyses of structural changes in addition to visual data from a Phase 1/2a clinical study of RG6501 (OpRegen), to be presented at the 2023 Association for Research in Vision and Ophthalmology Annual Meeting. Type B Meeting with FDA to discuss our proposed amendment to the Investigational New Drug Application (IND) for OPC1 to enable clinical testing of a novel spinal cord delivery system, anticipated in the second quarter. Clinical data update from the ongoing VAC2 Phase 1 NSCLC study, pending release from Cancer Research UK, anticipated in the second quarter. Amendment of an IND for OPC1 to enable clinical testing of a novel spinal cord delivery system. Initiation of DOSED (Delivery of Oligodendrocyte Progenitor Cells for Spinal Cord Injury: Evaluation of a Novel Device) clinical study of OPC1. Submission of an additional OPC1 manuscript describing magnetic resonance imaging (MRI) findings from the subacute studies in both thoracic and cervical spinal cord injury. Submission of a grant application to CIRM for the continued support of the clinical development of OPC1. Development update on hypo immune induced pluripotent stem cell (iPSC) lines for neurology indications, under collaboration with Eterna Therapeutics. Updates from ongoing ANP1 preclinical testing at the University of Michigan Kresge Hearing Research Institute under a collaboration with the University of Michigan. Evaluation of new partnership opportunities and/or expansion of existing collaborations. Continued participation in investor and partnering meetings and medical and industry conferences to broaden awareness of our mission, programs, and accomplishments. Balance Sheet Highlights Cash, cash equivalents, and marketable securities totaled $57.9 million as of December 31, 2022, which is expected to support planned operations into Q3 2024. Fourth Quarter Operating Results Revenues: Lineage’s revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues for the three months ended December 31, 2022 were approximately $1.9 million, a net increase of $0.7 million as compared to $1.2 million for the same period in 2021. The increase was related to the recognition of deferred collaboration revenues in connection with a Collaboration and License Agreement (the “Roche Agreement”) we entered into with F. Hoffmann-La Roche Ltd. and Genentech, Inc., a member of the Roche Group (collectively or individually, “Roche” or “Genentech”), in 2021, partially offset by lower royalty and 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 December 31, 2022 were $8.5 million, a decrease of $20.7 million as compared to $29.2 million for the same period in 2021. The overall decrease was almost entirely driven by a decrease in R&D expenses under the Roche Agreement. R&D Expenses: R&D expenses for the three months ended December 31, 2022 were $4.1 million, a decrease of $20.7 million as compared to $24.8 million for the same period in 2021. The decrease was substantially driven by the prior year $21.0 million accrual for financial obligations payable to the Israel Innovation Authority (“IIA”) and Hadasit Medical Research Services and Development Ltd (“Hadasit”), in connection with the $50.0 million upfront payment received under the Roche Agreement. This decrease was partially offset by $0.1 million and $0.2 million in higher expenses to support the development of the new photoreceptor and auditory neuron cell therapy program, respectively. G&A Expenses: G&A expenses for the three months ended December 31, 2022 were $4.3 million, a decrease of $0.1 million as compared to $4.4 million for the same period in 2021. The decrease was primarily attributable to a decrease of $0.4 million in legal and litigation expenses, partially offset by approximately $0.1 million in higher salaries and related benefit fees, and $0.1 million in higher share-based compensation expense. Loss from Operations: Loss from operations for the three months ended December 31, 2022 was $6.6 million, a decrease of $21.6 million as compared to $28.2 million for the same period in 2021, principally owing to collaboration-related expense accruals of $21.0 million under the Roche Agreement. Other Income, Net: Other income, net for the three months ended December 31, 2022 was $0.3 million, compared to other income, net of $0.2 million for the same period in 2021. The net variance was primarily related to offsetting variances between the changes in the value of marketable equity securities, as well as exchange rate fluctuations related to Lineage’s international subsidiaries for the applicable periods. Net Loss Attributable to Lineage: The net loss attributable to Lineage for the three months ended December 31, 2022 was $6.4 million, or $0.03 per share (basic and diluted), compared to a net loss attributable to Lineage of $29.0 million, or $0.17 per share (basic and diluted), for the same period in 2021. Full Year Operating Results Revenues: Lineage’s revenue is generated primarily from licensing fees, collaboration revenues, royalties, and research grants. Total revenues for the year ended December 31, 2022 were $14.7 million, an increase of $10.4 million as compared to $4.3 million for the same period in 2021. The increase was primarily related to a $12.2 million increase in collaboration revenues recognized from deferred revenues stemming from the $50.0 million upfront payment under the Roche Agreement, partially offset by lower royalty and grant revenues. Operating Expenses: Operating expenses are comprised of R&D expenses and G&A expenses. Total operating expenses for the year ended December 31, 2022 were $36.5 million, a decrease of $15.6 million as compared to $52.1 million for the same period in 2021. R&D Expenses: R&D expenses for the year ended December 31, 2022 were $14.0 million, a decrease of $19.9 million as compared to $33.9 million for the same period in 2021. The decrease was substantially driven by the prior year $21.0 million accrual for financial obligations payable to the IIA and Hadasit. This decrease was partially offset by $0.7 million and $0.5 million in R&D spending on the new auditory neuron and photoreceptor cell therapy programs, respectively. G&A Expenses: G&A expenses for the year ended December 31, 2022 were $22.5 million, an increase of approximately $4.3 million as compared to $18.2 million for the same period in 2021. The increase was primarily attributable to increases of $2.1 million in litigation and legal expenses, $1.3 million in salaries and related benefit fees, $0.9 million in share-based compensation expenses, and $0.4 million in audit and tax services, partially offset by $0.5 million in lower investor relations expense. Loss from Operations: Loss from operations for the year ended December 31, 2022 was $22.5 million, a decrease of $26.7 million as compared to $49.2 million for the same period in 2021. Other Income/(Expenses), Net: Other income (expenses), net for the year ended December 31, 2022 reflected other expense, net of ($3.3) million, compared to other income, net of $5.9 million for the same period in 2021. The net variance was primarily related to a prior year gain on sale of marketable equity securities, as well exchange rate fluctuations related to Lineage’s international subsidiaries for the applicable periods. Net Loss Attributable to Lineage: The net loss attributable to Lineage for the year ended December 31, 2022 was $26.3 million, or $0.15 per share (basic and diluted), compared to a net loss attributable to Lineage of $43.0 million, or $0.26 per share (basic and diluted), for 2021. Conference Call and Webcast Interested parties may access today’s conference call by dialing (800) 715-9871 from 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 March 16, 2023, by dialing (800) 770-2030 from the U.S. and Canada and entering conference ID number 5707771. About Lineage Cell Therapeutics, Inc. Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical and preclinical programs are in markets with billion dollar opportunities and include five allogeneic (“off-the-shelf”) product candidates: (i) OpRegen, a retinal pigment epithelial cell therapy in Phase 2a development for the treatment of geographic atrophy secondary to age-related macular degeneration, is being developed under a worldwide collaboration with Roche and Genentech, a member of the Roche Group; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; (iii) VAC2, a dendritic cell therapy produced from Lineage’s VAC technology platform for immuno-oncology and infectious disease, currently in Phase 1 clinical development for the treatment of non-small cell lung cancer; (iv) ANP1, an auditory neuronal progenitor cell therapy for the potential treatment of auditory neuropathy; and (v) PNC1, a photoreceptor neural cell therapy for the potential treatment of vision loss due to photoreceptor dysfunction or damage. For more information, please visit or follow the company on Twitter @LineageCell. Forward-Looking Statements Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “aim,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “can,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to: the significance of the Phase 2a clinical study of OpRegen, including the potential that it will be informative and increase the probability of success in future larger, comparative trials; that our cash, cash equivalents and marketable securities is sufficient to support our planned operations into the third quarter of 2024; the timing and nature of events and milestones anticipated to occur in 2023, including plans and expectations regarding publications and presentations related to our programs, the timing of anticipated regulatory submissions to the FDA related to our programs, the potential future achievements of our clinical, preclinical and development programs, the timing of the anticipated submission of a grant application to CIRM, the initiation of clinical trials and the availability of clinical data updates related to our programs, plans and expectations regarding potential new partnership opportunities and existing collaborations, and our ability to broaden awareness of our mission, programs and accomplishments; the potential of our cell therapy platform and our ability to become a leading cell therapy company. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including, but not limited to, the following risks: that we may need to allocate our cash to unexpected events and expenses causing us to use our cash, cash equivalents and marketable securities more quickly than expected; that positive findings in early clinical and/or nonclinical studies of a product candidate may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; that competing alternative therapies may adversely impact the commercial potential of OpRegen; that Roche and Genentech may not successfully advance OpRegen or be successful in completing further clinical trials for OpRegen and/or obtaining regulatory approval for OpRegen in any particular jurisdiction; that Lineage may not be able to manufacture sufficient clinical quantities of its product candidates in accordance with current good manufacturing practice; and those risks and uncertainties inherent in Lineage’s business and other risks discussed in Lineage’s filings with the Securities and Exchange Commission (SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s most recent Annual Report on Form 10-K filed with the SEC and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS (IN THOUSANDS) December 31, 2022 December 31, 2021 ASSETS CURRENT ASSETS Cash and cash equivalents $ 11,355 $ 55,742 Marketable securities 46,520 2,616 Accounts and grants receivable, net 297 50,840 Prepaid expenses and other current assets 1,828 2,351 Total current assets 60,000 111,549 NONCURRENT ASSETS Property and equipment, net 5,673 4,872 Deposits and other long-term assets 627 630 Goodwill 10,672 10,672 Intangible assets, net 46,692 46,822 TOTAL ASSETS $ 123,664 $ 174,545 LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES Accounts payable and accrued liabilities $ 8,608 $ 27,969 Lease liabilities, current portion 916 801 Financing lease, current portion 36 30 Deferred revenues 9,421 18,119 Liability classified warrants, current portion - 197 Total current liabilities 18,981 47,116 LONG-TERM LIABILITIES Deferred tax liability 2,076 2,076 Deferred revenues, net of current portion 27,725 32,454 Lease liability, net of current portion 2,860 1,941 Financing lease, net of current portion 84 30 Other long-term liabilities 2 30 TOTAL LIABILITIES 51,728 83,647 SHAREHOLDERS’ EQUITY Preferred shares, no par value, authorized 2,000 shares; none issued and outstanding as of December 31, 2022 and 2021, respectively - - Common shares, no par value, authorized 250,000 shares; 170,093 and 169,477 shares issued and outstanding as of December 31, 2022 and 2021, respectively 440,280 434,529 Accumulated other comprehensive loss (3,571 ) (5,211 ) Accumulated deficit (363,370 ) (337,097 ) Lineage Cell Therapeutics, Inc. shareholders’ equity 73,339 92,221 Noncontrolling deficit (1,403 ) (1,323 ) Total shareholders’ equity 71,936 90,898 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 123,664 $ 174,545 LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS (IN THOUSANDS, EXCEPT PER SHARE DATA) Year Ended December 31, 2022 2021 REVENUES: Collaboration revenues $ 13,367 $ 1,120 Royalties 1,336 2,776 Grant revenues - 445 Total revenues 14,703 4,341 Cost of sales 728 1,426 Gross profit 13,975 2,915 OPERATING EXPENSES: Research and development 13,987 33,914 General and administrative 22,508 18,212 Total operating expenses 36,495 52,126 Loss from operations (22,520 ) (49,211 ) OTHER INCOME (EXPENSES): Interest income, net 829 2 Gain on sale of marketable securities - 6,024 Unrealized loss on marketable equity securities (2,194 ) (2,299 ) Gain on extinguishment of debt - 523 Gain on revaluation of warrant liability 225 205 Other income (expense), net (2,152 ) 1,486 Total other income/(expense) (3,292 ) 5,941 LOSS BEFORE INCOME TAXES (25,812 ) (43,270 ) Income tax expense (541 ) - NET LOSS (26,353 ) (43,270 ) Net loss attributable to noncontrolling interest 80 251 NET LOSS ATTRIBUTABLE TO LINEAGE $ (26,273 ) $ (43,019 ) NET LOSS PER COMMON SHARE: BASIC AND DILUTED $ (0.15 ) $ (0.26 ) WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING: BASIC AND DILUTED 169,792 164,502 LINEAGE CELL THERAPEUTICS, INC. AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF CASH FLOWS (IN THOUSANDS) Year Ended December 31, 2022 2021 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss attributable to Lineage $ (26,273 ) $ (43,019 ) Net loss attributable to noncontrolling interest (80 ) (251 ) Adjustments to reconcile net loss attributable to Lineage to net cash used in operating activities: Gain on sale of marketable equity securities - (6,024 ) Unrealized loss on marketable equity securities 2,194 2,299 Accretion of income on marketable debt securities (501 ) - Depreciation expense, including amortization of leasehold improvements 582 663 Change in right-of-use assets and liabilities (35 ) 14 Amortization of intangible assets 145 210 Stock-based compensation 4,287 3,519 Common stock issued for services - 202 Gain on revaluation of warrant liability (225 ) (205 ) Foreign currency remeasurement and other loss/(gain) 2,272 (1,566 ) Loss/(gain) on sale of assets (11 ) 24 Gain on extinguishment of debt - (523 ) Changes in operating assets and liabilities: Accounts and grants receivable (Note 3) 50,314 (857 ) Prepaid expenses and other current assets 446 (72 ) Accounts payable and accrued liabilities (18,702 ) 21,645 Deferred revenue and other liabilities (13,354 ) 380 Net cash provided by (used in) operating activities 1,059 (23,561 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchases of marketable debt securities (53,412 ) - Maturities of marketable debt securities 7,666 - Purchases of property and equipment, net (413 ) (340 ) Proceeds from sale of OncoCyte common shares - 10,064 Proceeds from the sale of HBL common shares - 21 Net cash (used in) provided by investing activities (46,159 ) 9,745 CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from employee options exercised 648 7,240 Common shares received and retired for employee taxes paid (17 ) (54 ) Proceeds from sale of common shares 148 30,865 Proceeds from exercise of subsidiary warrants, net 991 - Repayments of financing lease liabilities (32 ) (20 ) Payments for offering costs (106 ) (1,101 ) Net cash provided by financing activities 1,632 36,930 Effect of exchange rate changes on cash, cash equivalents and restricted cash (873 ) (20 ) NET INCREASE (DECREASE) IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH (44,341 ) 23,094 At beginning of year 56,277 33,183 At end of year $ 11,936 $ 56,277 SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION: Cash paid during year for interest $ 13 $ 13 SUPPLEMENTAL SCHEDULE OF NON-CASH FINANCING AND INVESTING ACTIVITIES: Receivable from sale of common shares in at the market offering $ - $ 147 Receivable from exercise of stock options $ 32 $ 189