MEDICAL

Emmaus Life Sciences Announces Launch of Full-Service Telehealth Solution

Emmaus Life Sciences, Inc. | April 12, 2022

Emmaus_Life_Sciences
Emmaus Life Sciences, Inc. (OTQXC: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease, today announced the launch of an innovative full-service telehealth solution with its strategic partners, including Asembia LLC, US Bioservices Corporation and UpScriptHealth. The telehealth program capitalizes on the expansion of telemedicine in the U.S. to afford patients and providers on-line access to Endari®, the company's prescription-grade L-glutamine oral powder, for the treatment of sickle cell disease.

The launch of our full-service telehealth solution reflects our stated commitment to make Endari accessible to sickle cell patients in need and we are excited to be launching the program, Our solution will allow patients to see a doctor without leaving home, thereby eliminating unnecessary travel time and expense and the risk of infection that can occur with hospital visits. Eligible patients will be able to receive a same-day physician authorization and prescription for Endari and to have the prescription delivered to their homes within just a few days. As the telehealth solution grows, we are optimistic that it will help us to reach new patients and add meaningful revenue for Emmaus."

Yutaka Niihara, M.D., M.P.H., Emmaus' Chairman and Chief Executive Officer.

According to a December 3, 2021 report from the U.S. Department of Health & Human Services (HHS), available at the HHS website at https://www.hhs.gov, the share of Medicare visits conducted through telehealth in 2020 increased 63-fold, from approximately 840,000 in 2019 to 52.7 million. The report noted that telehealth was particularly helpful in offsetting potential foregone behavioral health care and that states with the highest use of telehealth in 2020 included Massachusetts, Vermont, Rhode Island, New Hampshire, and Connecticut. Other industry sources suggest that the trend toward telehealth accelerated in 2021 and is likely to be sustained.

We believe that affording patients and telehealth prescribers access to Endari in a quick and convenient way will improve their experience and potentially increase adherence rates, We look forward to working with our strategic partners on this important project."

George Sekulich, Senior Vice President of Global Commercialization of Emmaus.

About Emmaus Life Sciences
Emmaus Life Sciences, Inc. is a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell disease. The company currently markets U.S. Food and Drug Administration approved Endari® (L-glutamine oral powder) indicated to reduce the acute complications of sickle cell disease in adults and children 5 years and older. The company is also engaged in the discovery and development of innovative treatments and therapies for certain rare and orphan diseases as well as those affecting larger populations, such as diverticulosis.

About Sickle Cell Disease
There are approximately 100,000 people living with sickle cell disease (SCD) in the United States and millions more globally. The sickle gene is found in every ethnic group, not just among those of African descent; and in the United States an estimated 1-in-365 African Americans and 1-in-16,300 Hispanic Americans are born with SCD.1 The genetic mutation responsible for SCD causes an individual's red blood cells to distort into a "C" or a sickle shape, reducing their ability to transport oxygen throughout the body. These sickled red blood cells break down rapidly, become very sticky, and develop a propensity to clump together, which causes them to become stuck and cause damage within blood vessels. The result is reduced blood flow to distal organs, which leads to physical symptoms of incapacitating pain, tissue and organ damage, and early death


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The incorporation of mortality data into healthcare data sets allows fraud prevention, accurate billing, and benefits distribution, and true outcome analysis (especially in fatal disease areas like oncology, where survival is a key endpoint). The net effect of adding mortality data is strengthening identity protection, reducing healthcare costs, and improving health treatments and care delivery.


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INDUSTRY OUTLOOK

Curocell, Breaks Ground on 'CAR-T Manufacturing GMP Facility'

Curocell, Inc. | December 24, 2021

Curocell, currently on PhaseⅠCAR-T Therapy clinical trial with CRC01 has recently broken ground for the new CAR-T Center in Dungok Residential & Industrial Area in Daejeon International Science & Business Belt. The GMP Facility for commercial manufacturing CAR-T Cell therapy and R&D Center for further pipeline development are constituting the 17,325 square-meter site of CAR-T Center. By the first half of 2023, construction is expected to be completed and in 2024, when the CAR-T Center is fully operational, supply of advanced cure should be possible for patients in pain. Also, Curocell is expecting to expand their business to global market by in-housing all processes of CAR-T therapy development and production. About CRC01 (anbalcabtagene autoleucel) CRC01, recognized CD19 and is based on OVIS™, a first-in-class CAR-T platform. OVIS™ technology downregulates PD1 and TIGIT expression on CAR-T cells. Through overcoming the immune suppression by PD-1 and TIGIT ligands, OVIS™ CAR-T has superior cytotoxicity to tumor cells in the tumor microenvironment. Phase II clinical trial of CRC01 will start in South Korea in the first half of 2022. About Curocell Curocell, based in Daejeon, South Korea, is clinical-stage biotech innovating CAR-T therapies. Curocell is developing OVIS™ technology with the goal of improving clinical efficacy of CAR-T therapies.

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INDUSTRIAL IMPACT

Cellarity Expands Leadership Team to Continue Evolution of a Breakthrough Platform to Encode Biology and Purposefully Create New Medicines

Cellarity | February 11, 2022

Cellarity, a life sciences company founded by Flagship Pioneering to encode and simulate human biology to reimagine the way we create medicines, announced today the expansion of its executive leadership team with three key appointments. As Chief Scientific Officer, Laurens Kruidenier, Ph.D., will lead the continued evolution of Cellarity’s platform and pipeline and oversee cross functional integration across all aspects of computation, drug creation, and optimization. As Chief People Officer, Anna O’Driscoll will lead the development of human resources and talent development strategies to enable the fast growth of Cellarity and make the company a top place to work for talent. As Senior Vice President and Head of Data and Software Engineering, Parul Doshi will spearhead the development of a leading and scalable data infrastructure to support the entire drug creation and development process. “We are building a transformative company and bringing together a strong team of people with a track record of making things happen. Laurens is not only an exceptional translational scientist, with experience and success advancing primary research into clinical-stage programs, he is also a team and company builder, helping integrate and mature drug discovery platforms.” Fabrice Chouraqui, Ph.D., CEO of Cellarity and a CEO-Partner at Flagship Pioneering Dr. Chouraqui continued, “Anna brings deep experience in talent and leadership development in the biotech industry, and she is known for her passion to positively impact the employee experience. Parul not only brings broad expertise in data infrastructure across the entire pharma value chain, from preclinical and clinical to tech operations and commercialization but also hands-on expertise in software engineering. I am excited that these top leaders have joined us at this pivotal time as Cellarity grows our team, advances key programs, and scales a pipeline of important new therapeutics.” Cellarity has developed unique capabilities to encode biology and model computationally the changes that occur between health and disease to design breakthrough medicines. Cellarity's transformative approach to drug creation looks beyond an individual molecular target to understand the complex biological network of cellular changes that underlie the start and progression of a disease. Built at the confluence of systems biology, single cell data, and machine learning, the Cellarity platform leverages a more complete view of cell biology to purposefully create drugs. Since all diseases stem from a disorder at the cellular level, Cellarity’s approach can be applied to virtually every disease and uncovers new biology and treatments that are unlikely to be found through target-based discovery. “Despite the tremendous progress the industry has made in advancing medical treatments, most diseases do not have curative therapies, and there are thousands of conditions that lack treatments,” said Dr. Kruidenier. “I’m impressed with Cellarity’s drug creation engine, which looks beyond the single target and embraces the full complexity of human disease. I look forward to working with the team to realize the truly transformative nature of the Cellarity platform and advance into the clinic novel medicines in diverse therapeutic areas to meet a wide range of patient needs.” Laurens Kruidenier, Ph.D., Chief Scientific Officer Dr. Kruidenier has more than 25 years of experience in discovery research, both in academic settings as well as in the life sciences industry and a track-record of success in drug discovery and development, driving research programs into clinical study and integrating teams and technologies for growth and scale. Prior to joining Cellarity, Dr. Kruidenier was Chief Scientific Officer (CSO) at Prometheus Biosciences, a precision medicine company in the immune-mediated disease space. At Prometheus, he helped mature the company from an early, seed-stage Cedars-Sinai-spinout into a Nasdaq-listed, platform-driven portfolio company with three active Phase 2 clinical trials. Previously, he held the roles of Vice President of Discovery at Second Genome, where he was responsible for a portfolio of microbiome programs and Head of GI Immunology Research at Takeda Pharmaceuticals, where he was responsible for developing the global discovery research and business development strategy into inflammatory diseases of the bowel. Earlier in his career, Dr. Kruidenier held various positions at different discovery units at GlaxoSmithKline, where he led preclinical teams and projects in immuno-inflammation, epigenetic, and protein degradation drug discovery. He completed his post-doctoral training at the University of London and holds an M.Sc. in medical biology from Utrecht University and a Ph.D. in mucosal immunology from Leiden University. His research has resulted in multiple publications in top tier scientific journals, including Nature. Anna O’Driscoll, Chief People Officer Ms. O’Driscoll has more than a decade of experience in human resources and was most recently Vice President of Human Resources at Alnylam Pharmaceuticals, where she worked in roles spanning R&D, Commercial, Corporate Functions, Learning and Development, and Employee Relations as Alnylam evolved from a research organization to a leading biotech company. Prior to Alnylam, she was Head of Talent Strategy and Process at Shire and in the Human Resources Leadership Development Program at Johnson & Johnson. Ms. O’Driscoll graduated with an MBA from the Institute of Chartered Financial Analysts and a bachelor’s degree in marketing and languages from Dublin City University. Parul Doshi, Senior Vice President, Head of Data and Software Engineering Ms. Doshi has more than twenty years of experience in information technology (IT) and software engineering and was most recently Head of IT & Digital for Takeda’s Vaccine division. She spent the past 16 years at Takeda, in roles of increasing seniority across several divisions of the company. She notably led the IT programs to launch oncology products NINLARO® and ALUNBRIG® as well as the consolidation of the Vaccines Business Unit to Cambridge, Massachusetts and integration of ARIAD Pharmaceuticals post acquisition. Prior to Takeda, Ms. Doshi worked as a developer at Patni Computer Systems, servicing major companies such as Fidelity Investments and LEGO®. Ms. Doshi graduated with an MBA in information technology and finance from Savitribai Phule Pune University, and a bachelor’s in economics and applied statistics from the University of Rajasthan. About Cellarity Cellarity's mission is to fundamentally transform the way medicines are created through the development of the first full stack digital cell. Founded by Flagship Pioneering in 2017, Cellarity has developed unique capabilities combining high-resolution data, single cell technologies, and machine learning to encode biology, model interventions, and purposefully design breakthrough medicines. By focusing on the cellular changes that underlie disease instead of a single target, Cellarity’s approach uncovers new biology and treatments and is applicable to a vast array of disease areas. The company currently has programs underway in metabolic disease, hematology, immuno-oncology, and respiratory disease. The company has raised $123 million as part of a Series B funding round with contributions from funds and accounts managed by Blackrock, The Baupost Group, Banque Pictet on behalf of their clients, and eight other investors alongside Flagship Pioneering. About Flagship Pioneering Flagship Pioneering conceives, creates, resources, and develops first-in-category bioplatform companies to transform human health and sustainability. Since its launch in 2000, the firm has, through its Flagship Labs unit, applied its unique hypothesis-driven innovation process to originate and foster more than 100 scientific ventures, resulting in more than $140 billion in aggregate value. To date, Flagship has deployed over $2.6 billion in capital toward the founding and growth of its pioneering companies alongside more than $19 billion of follow-on investments from other institutions. The current Flagship ecosystem comprises 42 transformative companies, including Axcella Health (Nasdaq: AXLA), Codiak BioSciences (Nasdaq: CDAK) Denali Therapeutics (Nasdaq: DNLI), Evelo Biosciences (Nasdaq: EVLO), Foghorn Therapeutics Indigo Ag, Kaleido Biosciences (Nasdaq: KLDO), Moderna (Nasdaq: MRNA), Omega Therapeutics (Nasdaq: OMGA), Rubius Therapeutics (Nasdaq: RUBY), Sana Biotechnology (Nasdaq: SANA), Seres Therapeutics (Nasdaq: MCRB), and Sigilon Therapeutics.

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INDUSTRIAL IMPACT

MindMed Announces Transitions to Management Team

Mind Medicine (MindMed) Inc. | December 30, 2021

Mind Medicine Inc. a leading biotech company developing psychedelic-inspired therapies, announced that its Chief Technology Officer, Bradford Cross, has transitioned from his role. "On behalf of the Board of Directors and Executive team, I would like to thank Bradford for his contributions to the Company and wish him all the best in his future endeavors. We remain dedicated to advancing our pipeline and ongoing digital therapeutics platform forward under the leadership of MindMed Chief Medical Officer, Dr. Daniel Karlin. We enter 2022 well positioned both financially and strategically to continue on our mission to transform mental health treatment." Robert Barrow, Chief Executive Officer and Director of MindMed Additionally, Don Gehlert, PhD will be transitioning from his role as CSO and will continue as a Senior Scientific Advisor. Mr. Barrow added "Don has been and will continue to be an integral part of our organization. While this represents a change in his title, our entire team will continue to work closely with Don and benefit from his incredible breadth of experience in developing innovative CNS therapeutics." About MindMed MindMed is a clinical-stage biotech company that seeks to discover, develop and deploy psychedelic-inspired medicines and therapies to address addiction and mental illness. The Company is assembling a compelling drug development pipeline of innovative treatments based on psychedelic substances including psilocybin, LSD, MDMA, DMT and an ibogaine derivative, 18-MC. The MindMed executive team brings extensive biopharmaceutical experience to MindMed's approach to developing the next generation of psychedelic-inspired medicines and therapies. MindMed trades on the NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED. MindMed is also traded in Germany under the symbol MMQ.

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INDUSTRIAL IMPACT

Calyxt Announces Pricing of Offering Of Common Stock and Warrants and Updates Business and Risk Factor Disclosure

Cellectis Inc. | February 19, 2022

Cellectis, a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, and Calyxt, Inc. , a majority-owned subsidiary of Cellectis S.A., announced the placement to an institutional investor in an underwritten offering of (i) 3,880,000 shares of Calyxt common stock, (ii) pre-funded warrants to purchase up to 3,880,000 shares of its common stock, and (iii) common warrants to purchase up to 7,760,000 shares of its common stock. The shares of common stock and the pre-funded warrants were each sold in combination with corresponding common warrants, with one common warrant to purchase one share of common stock for each share of common stock or each pre-funded warrant sold. The pre-funded warrants will have an exercise price of $0.0001 per share of Calyxt common stock and the common warrants will have an exercise price of $1.41 per share of Calyxt common stock. The pre-funded warrants will be immediately exercisable and remain exercisable until exercised, while the common warrants will be exercisable six months after the date of issuance and will have a term of five years from the date of exercisability. The aggregate public offering price for each share of common stock or each pre-funded warrant and, in each case, an accompanying common warrant was $1.41. All securities sold in the Offering were sold by Calyxt. In connection with the Offering, Calyxt disclosed certain preliminary estimated financial information as of December 31, 2021: Calyxt’s cash and cash equivalents was $13.7 million, restricted cash was $0.6 million, total current liabilities were $4.1 million, and financing lease obligations, including current portion, were $17.9 million. This preliminary financial information, which has not been audited, is based on information currently available to Calyxt and is subject to the completion of Calyxt’s year-end financial closing procedures. It is possible that Calyxt’s independent registered public accounting firm may identify items that require Calyxt to make adjustments to the preliminary estimates set forth above and those changes could be material. In connection with the Offering, Calyxt also provided an updated description of certain aspects of its business and updated the risk factor disclosure from Calyxt’s prior filings with the U.S. Securities and Exchange Commission. About Cellectis  Cellectis is a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies. Cellectis utilizes an allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR-T cells to treat cancer patients, and a platform to make therapeutic gene editing in hemopoietic stem cells for various diseases. As a clinical-stage biopharmaceutical company with over 21 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN®, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to���treat diseases with unmet medical needs. As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM). .HEAL is a new platform focusing on hemopoietic stem cells to treat blood disorders, immunodeficiencies and lysosomal storage diseases.   Cellectis headquarters are in Paris, France, with locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market and on Euronext Growth.   About Calyxt Calyxt is a plant-based synthetic biology company. The Company leverages its proprietary PlantSpring™ technology platform to engineer plant metabolism to produce innovative and high value plant-based chemistries for use in customers' materials and products. As plant-based solutions, the Company's synthetic biology products can be used in helping customers meet their sustainability targets and financial goals. Calyxt's diversified offerings are primarily delivered through its proprietary BioFactory™ production system.

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Spotlight

The incorporation of mortality data into healthcare data sets allows fraud prevention, accurate billing, and benefits distribution, and true outcome analysis (especially in fatal disease areas like oncology, where survival is a key endpoint). The net effect of adding mortality data is strengthening identity protection, reducing healthcare costs, and improving health treatments and care delivery.

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