Recent Developments in the Stem Cell Market

NEW YORK, May 22, 2018 /PRNewswire/ --

According to Grand View Research, Inc., the global stem cell market is projected to reach a value of USD 15.63 billion by 2025, while growing at a CAGR of 9.2%. The increasing number of research studies that aim at broadening the scope of stem cells associated products is on the strongest drivers of this market. The report also indicates that scientists are engaged in discovering novel methods to create human stem cells. This is to address the increasing demand for stem cell production for potential investigation in disease management. Experts in the field recognize this new field as the possible next major advancement in healthcare, one that can transform the industry. Some of the possible treatments of stem cell products could be of Parkinson's disease, type 1 diabetes, spinal cord injury, Alzheimer's disease, and others. International Stem Cell Corp. (OTC: ISCO), Intellia Therapeutics, Inc. (NASDAQ: NTLA), Omeros Corporation (NASDAQ: OMER), BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), Gilead Sciences, Inc. (NASDAQ: GILD)

Recent results of an international trial of a stem cell transplant treatment shows that it could be a "game changer" for many patients with multiple sclerosis. According to Fortune, "Interim results from an international trial of a stem cell transplant treatment showed a much higher success rate than the control group, which received a drug treatment. MS is a disease that affects the brain, spinal cord, and immune system, leading to a number of disabilities. The stem cell treatment uses chemotherapy to wipe out a patient's immune system and then "re-boots" it using stem cells from the patient's blood and bone marrow that are unaffected by the disease."

International Stem Cell Corp. (OTCQB: ISCO) a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, today provided a business update announcing operating results for the three months ended March 31, 2018.

"This was a successful quarter for us both operationally and financially. We were able to decrease net loss by more than 70% compared to the prior year quarter, as well as successfully move forward with our research and development activities. As a result, we have significantly decreased our cash burn while moving forward with our clinical trial. These outcomes give us confidence in the Company's future," said Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO.

Q1 2018 Financial Highlights

• Consolidated revenue for the first quarter of 2018 was $2.6 million, an increase of 30% compared to the consolidated revenue of $2.0 million for the first quarter of 2017.
• Combined operating income for the quarter ended March 31, 2018 from our two wholly owned revenue generating subsidiaries was $631,000, an increase of 10% compared to $572,000 in the first quarter of 2017.
• Average net cash used in operating activities, excluding capital expenditures and patent costs, was approximately $16,000 per month during the three months ended March 31, 2018, a decrease of 92%, compared to $190,000 per month for the same period in 2017.
• Net loss for ISCO was $830,000 for the first quarter of 2018 compared to a net loss of $3.1 million for the first quarter in 2017, a decrease of 73%.

Recent Clinical Trial Highlights

• The 2nd cohort of patients in the clinical trial for Parkinson's disease was successfully transplanted with 50,000,000 ISC-hpNSC® cells.
• Data Safety Monitoring Board (DSMB), a group of experts monitoring the clinical trial of ISC-hpNSC®, has reviewed the safety data from the 2nd cohort in the clinical trial. The DSMB has authorized the clinical trial to move forward with accelerated enrollment and dose escalation to the 3rd cohort. Recruitment for the 3rd cohort will begin immediately, with patients receiving a higher dose of 70,000,000 ISC-hpNSC®.
• United States Patent and Trademark Office (USPTO) has granted the Company a key patent on the method used to manufacture ISC-hpNSC, which are administered in ISCO's ongoing Parkinson's disease clinical trial, and which can potentially be utilized in therapies to treat traumatic brain injury and stroke.
• Presented Interim Clinical Results at the American Academy of Neurology in Los Angeles, CA.

About International Stem Cell Corporation - International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (http://www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (http://www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com."

Intellia Therapeutics, Inc. (NASDAQ: NTLA) is a leading genome editing company focused on developing proprietary, curative therapeutics using the CRISPR/Cas9 system. Intellia believes the CRISPR/Cas9 technology has the potential to transform medicine by permanently editing disease-associated genes in the human body with a single treatment course, and through optimized cell therapies that can treat cancer and immunological diseases by replacing patients' diseased cells. Recently, the company new scientific advisors in immuno-oncology and autoimmunity. The advisors hail from prestigious international institutions and collectively have both scientific and clinical expertise in cell therapies in these areas.

Omeros Corporation (NASDAQ: OMER) is a Seattle-based commercial-stage biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system. On April 26, 2018, the company announced that the U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to OMS721 for the treatment of patients with high-risk hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA), specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy drug designation for OMS721, which last year received the designation from FDA for the treatment of Immunoglobulin A (IgA) nephropathy. OMS721 is Omeros' lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI) is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. On March 28, 2018, the company announced that it has amended the protocol of its Phase 3 clinical trial of NurOwn® for the treatment of amyotrophic lateral sclerosis (ALS). Per the protocol amendment, Canada-based ALS patients may now enroll in the ongoing Phase 3 NurOwn clinical trial. NurOwn utilizes a patient's own cells which have been engineered outside the body, to produce and secrete factors known to promote neuronal survival. NurOwn has the potential to be the first ALS treatment to improve patient functioning as a regenerative medicine.

Gilead Sciences, Inc. (NASDAQ: GILD) is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. Recently, Kite, a Gilead Company, announced it has leased a new facility in the Netherlands to engineer cell therapies in Europe. The 117,000 square-foot site in Hoofddorp (SEGRO Park Amsterdam Airport) will enable Kite to efficiently manufacture and deliver its cell therapies to people living with cancer in Europe and will provide more than 300 new jobs when fully operational in 2020. The facility will engineer and produce innovative cell therapies, including axicabtagene ciloleucel, a Chimeric Antigen Receptor T cell (CAR T) therapy that is currently under review by the European Medicines Agency and which is approved in the United Statesas Yescarta®. In addition to the Netherlands facility, Kite has recently purchased a new building in Santa Monica from Astellas Pharma Inc. that will be used for cell therapy research, development and the expansion of clinical manufacturing capabilities, and has leased a 26,000 square-foot facility in Gaithersburg, Maryland. The Maryland site will support the work of a new Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to develop adoptive cell therapies targeting patient-specific tumor neoantigens.

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