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Regenerative Medicine Market to Reach Valuation US$ 23.7 Bn by 2027 – GlobeNewswire

January 08, 2021 10:00 ET | Source: Precedence Research

OTTAWA, Jan. 08, 2021 (GLOBE NEWSWIRE) -- The global regenerative medicine market is representing impressive CAGR of 16.1% during the forecast period 2020 to 2027.

Regenerative medicine is the division of medicine that promotes methods to repair, regrow or replace injured or diseased tissues, organs or cells. Regenerative medicine comprises of the formation and use of remedial stem cells, manufacturing of artificial organs, and tissue engineering. The combinations of tissue engineering, cell and gene therapies can strengthen the natural healing procedure in the places it is desired most, or occupy the role of a permanently injured organ. Regenerative medicine is a rather new field that connects experts in chemistry, biology, engineering, computer science, robotics, medicine, genetics and other domains to find explanations to some of the most interesting medical problems confronted by humankind.

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Growth Factors:

Factors such as increasing prevalence of chronic disorders and genetic disorders, increasing popularity of stem cells, increasing number of trauma emergencies is driving the growth of regenerative medicine market. An illness or disorder that usually persists for 3 months or longer and might get worse over a period is termed as chronic disorder. Chronic diseases mostly occur in the elderly people and can typically be controlled but not repaired. The most prevalent types of chronic ailments are heart disease, arthritis, cancer, diabetes, and stroke. Cardiovascular disorders are the biggest cause of deaths worldwide. As per the WHO data, deaths due to cardiovascular disorders represent almost 31% of the deaths globally. Almost 85% of these demises are due to stroke and heart attack. Diabetes is another most prevalent chronic ailment that affects millions of people globally. According to International Diabetes Federation (IDF), around 463 million adults (age group: 20-79 years) are battling with diabetes and by the year 2045 the number will rise to a staggering 700 million. Furthermore, approximately 75% of all health care expenses are owed to chronic ailments. Four out of the five most costly health conditions are chronic disorders such as cancer, heart disease, pulmonary conditions, and mental disorders. Regenerative medicine approaches such as stem cell therapy can cure the chronic ailments such as diabetes and arthritis, which otherwise require lifetime of medications.

The role of regenerative medicine in post trauma recovery is constantly evolving as more and more research is showing positive results. The use of regenerative medicine can be a landmark moment in the history of healthcare that will transform the treatment of chronic ailments and trauma related conditions. Thus, the high incidence of chronic ailments is driving the growth of regenerative medicine market.

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Regional Analysis:

The report covers data for North America, Europe, Asia Pacific, Latin America, and Middle East and Africa. In 2019, North America dominated the global market with a market share of more than 45%. U.S. represented the highest share in the North American region primarily due to constant activity in the field of drug discovery and tissue engineering. Moreover, early adoption of latest healthcare technologies also contributed to the high market share of the United States.

Europe was the second important market chiefly due to favorable reimbursement scenario and presence of latest healthcare infrastructure. The presence of skilled researchers in the European region is also expected to boost the demand for regenerative medicine market in the near future. Asia Pacific is anticipated to grow at the maximum CAGR of around18% in the forecast period due to high incidence of trauma cases and chronic disorders. Latin America and the African and Middle Eastern region will display noticeable growth.

Report Highlights:

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Key Market Players and Strategies:

The major companies operating in the worldwide regenerative medicine are Integra Life Sciences Corporation, Aspect Biosystems, Amgen, Inc., Medtronic plc, AstraZeneca, Novartis AG, Smith & Nephew plc, MiMedx Group, Shenzhen SibionoGeneTech Co., Ltd., and Baxteramong others.

High investment in the research and development along with acquisition, mergers, and collaborations are the key strategies undertaken by companies operating in the global regenerative medicine market. Recently Fuse Medical, Inc., an evolving manufacturer and supplier of innovative medical devices for the spine and orthopedic marketplace, declared the launch of FuseChoice Plus and FuseChoice Umbilical and Amniotic Membranes, and FuseChoice Plus Amniotic Joint Cushioning Fluid, the newest additions to a wide-ranging line of biologics product offerings.

Market Segmentation

By Product

By Application

By Geography

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Regenerative Medicine Market to Reach Valuation US$ 23.7 Bn by 2027 - GlobeNewswire

Unlocking The Unlimited Potential Of Stem Cells – CodeBlue

As we enter 2021, it goes without saying that Covid-19 has changed how we live our lives. On top of pushing multiple industries to adopt digital processes like never before, the pandemic has accelerated the advancements in the field of biotechnology, with one of the most recent successes being the development of Covid-19 vaccines with a 95 per cent success rate.

Prior to that, however, the world has already seen several leaps forward in the world of biotechnology over the past decades, especially in the field of medicine. Before Covid-19, diseases like H1N1 and SARS ravaged the world. Through a significant amount of research in the field of biotechnology, we have made sure that those diseases no longer pose a great threat.

Beyond creating more robust defences against diseases, one of the most well-known biotechnological breakthroughs is the in-vitro fertilization (IVF) method. This breakthrough gave birth to Dolly the sheep in 1996, which opened a floodgate for future exploration and development in the field of biotechnology.

In recent years, some of the most exciting news in biotechnology came from stem cell research. For instance, CRISPR, a powerful gene-editing technology is now being used to treat sickle-cell anemia and can potentially cure cancer and HIV in the future.

As stem cell research continues to progress, it is important for patients to be aware of the kinds of stem cells which can be collected and stored, along with their unlimited potential for curing a variety of diseases.

Biotechnological Breakthroughs Over The Years In A Continuous Bid for Medical Advancement

In the 1980s, stem cells could only be collected right before the transplant, which posed a few problems. They included not having enough stem cells if the patient develops a complication and the risk that the quality and validity of stem cells might be compromised.

Since then, many discoveries have been made and developed in the biotechnology industry. These include isolation, cryopreservation, and long-term storage technology which paved the way for stem cell storage and cord blood banking.

Through this technology, we are able to collect and store stem cells for future use. This allows for more stem cells to be well-preserved ahead of time, giving patients the assurance and peace of mind needed.

With stem cells being increasingly used in a variety of medical cases, cord blood banking a simple and harmless procedure in which cord blood, also known as umbilical cord blood (UCB), is collected and cryopreserved for future use.

In recent years, UCB has gained more prominence among medical experts. This is because cord blood is loaded with stem cells that can be used to treat diseases such as anemia and immune system disorders.

One thing to note is that UCB can only be collected at the time of delivery. However, among patients and their loved ones, cord blood banking remains something that doesnt quite come to mind when considering health insurance plans for their children. Many parents are under the notion that because they are healthy, their babies are also healthy.

Because of this, they do not see the importance of collecting and storing UCB at birth. Aside from that, they also fail to realise that no one can truly predict when a loved one might need this particular form of treatment in the future. Hence, storing UCB is a form of biological insurance, to ensure that if something were to befall a family member one day, there are means to treat it.

With that said, there are many different types of stem cells. Each of them functions differently to carry out a specific task.

Examples Of Stem Cells In Action

Hematopoietic Stem Cells (HSC) are stem cells that produce red blood cells, white blood cells, and platelets to treat blood disorders.

One of the most effective uses of HSC is in the treatment of childhood Acute Lymphoblastic Leukemia (ALL). With stem cells transplant, more than 90% of cases have been successfully treated. A typical treatment method of ALL is through chemotherapy drugs and radiation.

However, there are times when a higher dosage of drugs and radiation is required to treat certain patients and this can be severely damaging to the patients bone marrow. In these cases, HSC transplants after using higher doses of drugs to kill the cancer cells help the patients to produce normal blood-forming cells to restore the bone marrow functions.

Aside from that, HSC can potentially be very effective in treating blood disorders such as cancer, thalassemia (a blood disorder when the body doesnt make enough of a protein called hemoglobin), and aplastic anemia (a condition that leaves one fatigued and more prone to infections and uncontrolled bleeding).

Another type of stem cells is Mesenchymal Stem Cells (MSC). These can be obtained from Umbilical Cord Lining and Wharton Jelly. These are very versatile and important types of stem cells.

In recent times, doctors have been using MSC to treat patients with severe respiratory syndrome as a result of Covid-19 infection. The results were very promising and the patients showed improvements after their treatment. Because the immune system is now functioning better, we have seen a decrease in the inflammatory response and an improvement in the immune response.

More than that, MSCs have shown a great deal of promise in addressing autism, a disease that did not have a viable cure previously. Currently, many clinical trials are being conducted around the world in universities with stem cell departments, like Duke Universitys Autism trial.

Aside from that, MSCs are also used in clinical trials to study potential cures for neurodegenerative disorders such as Parkinsons and Alzheimers Disease. Another exciting area of research is using MSCs to treat heart conditions, Type 1 Diabetes Mellitus, and cancer.

Stem cell research has definitely come a long way, from the discovery of embryonic stem cells in mice in 1981 by Martin Evans of Cardiff University, to being able to treat an increasing number of diseases over the years.

While there is no guarantee that stem cell transplants will completely cure any particular disease, the potential of stem cells is undeniable. Doctors across the world are working relentlessly to discover more and more of the seemingly endless potential of stem cells.

Dr Menaka Hariharan is the Medical Director of StemLife.

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Unlocking The Unlimited Potential Of Stem Cells - CodeBlue

Stem Cell Treatment Proving Highly Successful In Treating Most Severe Cases Of COVID – Yahoo News

National Review

Law enforcement officials announced Friday that they had arrested the man pictured in a viral photograph sitting in House Speaker Nancy Pelosis office with one leg up on her desk when pro-Trump rioters stormed the U.S. Capitol on Wednesday.Officials said they took 60-year-old Richard Barnett into custody in Little Rock, Ark. and also released details about crimes for which several people will face federal charges.Barnett, who faces charges of violent entry and theft of public property, among other things, told KFSM that he was looking for a bathroom when he saw that the door to Pelosis office was open."I sat down here in my desk. Im a taxpayer. Im a patriot. That aint her desk we loaned her that desk," he told KFSM. "And she aint appreciating the desk, so I thought I would sit down and appreciate the desk."Barnett is being held in the Washington County Detention Center in Fayetteville, Ark., awaiting his initial appearance, according to NBC News.A New York Times reporter on Wednesday shared a video of Barnett, which he said was taken after the Arkansan's time in the speaker's office, and shows him bragging about taking a personalized envelope from the office, which he says he didn't steal.> Heres Mr. Barnett, who goes by Bigo, telling the story in his own words pic.twitter.com/oSyKiCDXgy> > -- Matthew Rosenberg (@AllMattNYT) January 6, 2021"I left a quarter on her desk," he said, and later added that he left a "nasty note" as well."I'll probably be telling them this is what happened all the way to the D.C. jail," he added.Barnett said that he knocked politely on the door to the office, but was then pushed inside by other rioters.Pelosi's aides have said her office was vandalized on Wednesday and that a laptop from a conference room had been stolen, though the equipment was only used for presentations.Officials earlier announced the arrests of 82 people at the state, local and federal levels, according to reports, while the FBI's Washington Field Office on Friday released 40 photos of people who are wanted in connection with the rioting at the Capitol.A state lawmaker from West Virginia was also charged Friday in connection with the riot at the Capitol. Derrick Evans, a Republican, reportedly recorded and then deleted a video of himself joining the crowd, leading to a petition asking for him to step down.Meanwhile, 70-year-old Lonnie Coffman of Falkville, Ala. is accused of having two handguns, an assault rifle and 11 Molotov cocktails that included gasoline and what appeared to be homemade napalm, officials said.Police were able to link Coffman to a suspicious red GMC pick-up truck with Alabama plates, according to NBC News.Mark Leffingwell was charged and is accused of knowingly entering restricted ground and assaulting an officer after entering the Capitol. Leffingwell repeatedly punched a U.S. Capitol Police officer in the helmet and chest, according to court papers.Christopher Michael Alberts of Maryland is accused of illegally entering the Capitolwhile in possession of a loaded Taurus 9mm handgun and a separate magazine filled with ammunition. Alberts, who was wearing a bulletproof vest, is also accused of having a pocketknife at the time.He "immediately tried to flee" before police detained him, according to court papers. Hetold police he had the gun "for personal protection and he did not intend on using the firearm to harm anyone."

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Stem Cell Treatment Proving Highly Successful In Treating Most Severe Cases Of COVID - Yahoo News

Factor Bioscience spins out a new cell therapy player with eyes on the clinic within 2 years – Endpoints News

The quest for CAR-T 2.0 is gaining an mRNA player, as Cambridge, Massachusetts-based Factor Bioscience sends a spinoff racing toward the clinic.

Factor drew the curtains on Exacis Biotherapeutics on Wednesday morning, with Sollis Therapeutics co-founder Gregory Fiore at the helm of a small immuno-oncology focused team built around Factors technology. The spinoff has the rights to 51 patents and just a bit of seed money from friends and family to get it going but Fiore says an IND submission is on the horizon.

We are 18 to 24 months from an IND submission, and weve identified our first target, which will be CD19, Fiore told Endpoints News.

The company will be unveiling a CD19-targeted CAR-T and CAR-NK, Fiore said, with ROR1 as its next target.

The CEO says Exacis approach is what differentiates it from others in the crowded cell therapy field, beginning with mRNA technology in-licensed from Factor. The process starts with induced pluripotent stem cells (iPSC), which are blood or skin cells that have been engineered back into an embryonic-like stem cell state. Theyre created with mRNA reprogramming, and then edited to avoid host immune surveillance, add a CAR and enhance the cells for potency against tumors.

That iPSC is quite a robust cell. It can handle a lot of editing and the cells are able to recover from a lot of editing and manipulation, Fiore said. And the fact that no viruses or DNA are used significantly decreases the resource requirement for manufacturing, he added later.

The idea of an off-the-shelf CAR-T or CAR-NK therapy as opposed to harvesting a patients cells, engineering them into a cancer attack vehicle and reinjecting them isnt a new one. Allogene released a positive snapshot of their off-the-shelf CAR-T program at ASCO 2020, and CRISPR Therapeutics offered a glimpse at their own CAR-T success in October although it was clouded by the death of a patient given a high dose of the treatment.

Exacis team of four including co-founder James Pan and former MaxiVAX CEO Dimitrios Goundis as CBO is shooting for a Series A in the coming months to bolster its team and pipeline. The company also says its in talks with several potential development partners.

We are working towards a Series A funding to be completed in Q1 of 2021, and well use those funds to build out our internal team and lab, as well as further the development along the lines of differentiation into T and NK, obtaining CARs, really putting together these target cell types, Fiore said.

While Fiore stayed mum about the the specific terms of Exacis licensing deal with Factor, he said that Factor has a majority ownership in exchange for the execution of the license.

The CEO, who was inspired to get into the field by his fathers battle with cancer, said Factor and Exacis incentives were aligned. Theres plenty of opportunity to improve the patient experience as well as outcomes, he said.

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Factor Bioscience spins out a new cell therapy player with eyes on the clinic within 2 years - Endpoints News

Comparison of the efficiency, safety, and survival outcomes in two stem cell mobilization regimens with cyclophosphamide plus G-CSF or G-CSF alone in…

This article was originally published here

Ann Hematol. 2021 Jan 6. doi: 10.1007/s00277-020-04376-w. Online ahead of print.

ABSTRACT

Autologous stem cell transplantation as a frontline treatment for patients with multiple myeloma (MM) requires an adequate peripheral blood stem cell (PBSC) collection before processing. Granulocyte-colony stimulating factor (G-CSF) with or without cyclophosphamide (CTX) is a common regimen for PBSC mobilization; their benefits and risks are controversial. To compare the efficiency, safety, and survival outcomes between the two regimens, we conducted a meta-analysis including 18 studies with 4 prospective and 14 retrospective studies; a total of 2770 patients with MM were analyzed. The CTX plus G-CSF regimen had higher yields of total CD34+ cells (SMD = 0.39, 95% CI (0.30, 0.49)), and higher mobilization rates of the target 2 106/kg (OR = 3.34, 95% CI (1.82, 6.11)) and 4 106/kg (OR = 2.16, 95% CI (1.69, 2.76)) cells. A favorable event-free survival (EFS) (HR = 0.73, 95% CI (0.58, 0.93), p = 0.01) and better 3-year EFS rate (OR = 1.65, 95% CI (1.1, 2.47), p = 0.02) were also reached in the patients with CTX plus G-CSF mobilization, although the risks of admission (OR = 26.49, 95% CI (7.31, 95.97)) and fever (OR = 13.66, 95% CI (6.21, 30.03)) during mobilization were increased, the treatment-related mortality was consistent (p = 0.26). The CTX plus G-CSF regimen was superior to the G-CSF-alone regimen for PBSC mobilization in patients with MM.

PMID:33404694 | DOI:10.1007/s00277-020-04376-w

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Comparison of the efficiency, safety, and survival outcomes in two stem cell mobilization regimens with cyclophosphamide plus G-CSF or G-CSF alone in...

Top 10 ALS Stories of 2020 – ALS News Today

ALS News Today brought you daily coverage of key findings, treatment developments, clinical trials, and other important events related to amyotrophic lateral sclerosis (ALS) throughout 2020, a year marked by the COVID-19 pandemic.

As a reminder of what mattered most to you in 2020, here are the top 10 most-read articles of last year with a brief description of what made them interesting and relevant to the ALS community.

We look forward to reporting more relevant news to patients, family members, and caregivers dealing with ALS throughout 2021.

A team of researchers in Germany found that caffeine and nicotinamide adenine dinucleotide in its oxidized form (NAD+) two powerful antioxidants improved the health of lab-grown motor neurons derived from a mouse model of sporadic ALS.

These benefits, seen in cells derived from mice either in a progressive or a stable disease state, were likely associated with a reduction in oxidative stress, a known contributor to sporadic ALS.

Of note, motor neurons, the specialized nerve cells that control voluntary movement, are progressively lost in people with ALS. Oxidative stress is an imbalance between the natural production of potentially harmful reactive oxygen species and the ability of cells to detoxify them with antioxidant agents.

In an April story, we reported AB Sciences plans to launch a Phase 3 clinical trial (NCT03127267) testing its experimental oral therapy masitinib as an add-on treatment for people with ALS, after the U.S. Food and Drug Administration (FDA) cleared its request for this study.

Masitinib is designed to block the activity of multiple cell types involved in the inflammatory and neurodegenerative processes marking ALS.

The study aims to assess whether add-on treatment with masitinib is superior to placebo at slowing functional decline in up to 495 ALS patients diagnosed in the past two years. Participants functional abilities will be assessed through the ALS functional rating scale-revised (ALSFRS-R). Both masitinib and placebo will be given in combination with Sanofis Rilutek (riluzole), an approved ALS medication.

The trial is currently recruiting patients at a single U.S. clinical site(Johns Hopkins in Maryland), but another site in Ulm, Germany, is expected to open shortly. Should study findings be positive, they are expected to support future requests for regulatory approval of masitinib as an ALS treatment.

Using different mouse models of ALS, a team of researchers in the U.S. discovered a self-destructive mechanism in mitochondria the cells powerhouses that may be one of the first triggers of motor neuron degeneration in ALS.

This mitochondrial suicide was found only in the upper motor neurons those that send messages from the brain to the spinal cord, and whose degeneration is thought to be an early disease event of ALS mice, and before any signs or symptoms of the disease were evident.

These findings suggest that currently available therapies targeting mitochondrial degeneration may help to stop neurodegeneration in ALS, supporting further research in this area.

In July, BrainStorm Cell Therapeutics announced that all ALS patients enrolled in a pivotal Phase 3 clinical trial (NCT03280056) testing NurOwn, its investigational cell-based therapy, had completed dosing.

NurOwn involves expanding and maturing mesenchymal stem cells (MSCs) collected from a patients own bone marrow into cells that produce high levels of molecules promoting nerve cell growth and survival. MSCs are stem cells that can generate a variety of other cell types.

The mature cells called MSC-NTF cells are then injected into the patients spinal canal to promote and support nerve cell repair.

In the U.S.-based trial, 189 patients with rapidly progressing ALS were randomly assigned to either a total of three injections of either NurOwn, or a placebo, given directly into the spinal canal every other month.

The studys main goal was to assess the therapys safety, and whether treatment was superior to placebo at slowing disease progression as measured by the ALSFRS-R at seven months following the first dose.

A couple of months earlier, we reported the results of a preclinical study suggesting that NurOwn may not only boost nerve cell protection and repair, but also suppress the damaging immune responses that contribute to ALS progression by promoting a shift toward an anti-inflammatory state.

BrainStorm researchers found that growing healthy B-cells and T-cells immune cells known to be involved in ALS in the lab with NurOwn suppressed the growth of pro-inflammatory cell subsets, and lowered the levels of pro-inflammatory molecules. At the same time, the therapy increased the numbers of immunosuppressive cell subsets and the levels of a major anti-inflammatory molecule.

BrainStorm announced in June that patient dosing in its Phase 3 trial evaluating NurOwn in people with ALS remained on track, despite occasional treatment scheduling changes due to the COVID-19 pandemic.

The company attributed the trials successful advancement during the pandemic to coordination among its six U.S. clinical sites, support and guidance from the FDA, and the fact that its main goal based on the ALSFRS-R could be assessed by phone.

Top-line data were shared before the years end, as anticipated by BrainStorm, and are under review by the FDA.

In April, ALS News Today reported onSeneca Biopharmas plans to launch a Phase 3 clinical trial to assess the safety and effectiveness of NSI-566, its leading stem cell treatment candidate, in adults with ALS.

The decision was supported by previous positive data from a Phase 1 (NCT01348451) and Phase 2 (NCT01730716) clinical trial and a meeting with the FDA that provided guidance on how to best design and conduct the upcoming late-stage trial.

NSI-566 treatment involves the injection of fetal spinal cord stem cells into a patients spinal cord, where they mature into nerve cells that surround and support motor neurons. These mature cells also produce certain molecules that promote motor neuron growth and survival.

Results from the previous studies confirmed NSI-566s safety, and suggested that the therapy may help to prevent further functional decline in ALS patients, when compared with data from other ALS trials.

A small study in Italy suggested that creatinine kinase a marker of muscle damage could be used as a biomarker to predict the rate of disease progression in people with ALS.

By analyzing this enzyme in 126 ALS patients, the researchers found that creatinine kinase levels were significantly higher in people with slow progressing disease compared with those with fast progressing disease, and that these differences were sustained over time.

Further analyses in mouse models of ALS confirmed these findings, and suggested that the slow progression was associated with greater muscle mass and a better ability to counter disease mechanisms for longer periods.

Elevated creatinine kinase blood levels also seemed to be specific to ALS among neurodegenerative diseases, suggesting that the muscle may be a therapeutic target in ALS.

In January, we reported that a Phase 1/2a clinical trial (NCT03482050) testing AstroRx, Kadimastems investigational cell therapy, had completed dosing a second group ofALS patients.

AstroRx delivers healthy, mature astrocytes derived from human embryonic stem cells to a patients spinal cord to compensate for diseased astrocytes and to prevent motor neuron loss. Astrocytes are star-shaped cells that normally support and protect nerve cells, but are abnormal in ALS.

Data from the first group of patients given the lowest therapy dose showed that the treatment was safe and slowed the rate of disease progression over the first three to four months following dosing. Results from the second group (given a higher dose) went on toconfirm these promising three-month findings of a single treatment.

Our most-read article of 2020 concerned the discovery that an abnormal uptake of metals from chromium to zinc during childhood is associated with ALS in adults.

By analyzing teeth samples from 36 ALS patients and 31 unaffected people with a powerful technology, the researchers were able to establish and assess differences in temporal profiles of metal exposure. They found that ALS patients had greater exposure to several metals at various developmental stages, starting as early as birth.

These findings were confirmed in mouse models of ALS, both in their teeth and in their brains, suggesting that abnormal metal metabolism may contribute to several molecular changes that could increase the susceptibility of motor neurons to premature damage.

While deficiencies and excess of essential elements and toxic metals are known to contribute to ALS, researchers were now able to provide an idea of when these metabolic abnormalities start. The results also suggested that metal metabolism could be a viable therapeutic target to prevent or halt ALS.

***

At ALS News Today, we hope these stories and our reporting throughout 2021 help to better inform and improve the lives of everyone affected by ALS.

We wish all our readers a happy 2021.

Marta Figueiredo holds a BSc in Biology and a MSc in Evolutionary and Developmental Biology from the University of Lisbon, Portugal. She is currently finishing her PhD in Biomedical Sciences at the University of Lisbon, where she focused her research on the role of several signalling pathways in thymus and parathyroid glands embryonic development.

Total Posts: 45

Ins holds a PhD in Biomedical Sciences from the University of Lisbon, Portugal, where she specialized in blood vessel biology, blood stem cells, and cancer. Before that, she studied Cell and Molecular Biology at Universidade Nova de Lisboa and worked as a research fellow at Faculdade de Cincias e Tecnologias and Instituto Gulbenkian de Cincia. Ins currently works as a Managing Science Editor, striving to deliver the latest scientific advances to patient communities in a clear and accurate manner.

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Top 10 ALS Stories of 2020 - ALS News Today

Celularity and GX Acquisition Corp. Announce Merger Agreement to Create a Publicly Listed Leader in Allogeneic Cellular Therapy – BioSpace

FLORHAM PARK, N.J. and NEW YORK, Jan. 8, 2021 /PRNewswire/ -- Celularity Inc. ("Celularity"), a clinical-stage biotechnology company, leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic therapies derived from the postpartum human placenta, and GX Acquisition Corp. (Nasdaq: GXGX), a special purpose acquisition company, today announced they have entered into a definitive merger agreement pursuant to which GX Acquisition Corp. will combine with Celularity. Upon the closing of the transaction, which is expected to occur in the second quarter of 2021, GX Acquisition Corp. will be renamed Celularity Inc., and its common stock and warrants are expected to remain listed on Nasdaq under the new ticker symbols "CELU" and "CELUW."

In addition to the approximately $292 million held in GX Acquisition Corp.'s trust account (assuming no stockholder redemptions are effected), a group of existing and other institutional investors have committed to participate in a concurrent equity financing through the sale of approximately $80 million of GX Acquisition Corp. Class A common stock at $10.00 per share. Investors in the PIPE include existing Celularity stockholders or their affiliates including Starr Insurance Companies, Dragasac Limited, Sorrento Therapeutics, as well as unaffiliated institutional investors.

Approximately $372 million of total expected proceeds from the PIPE and cash held in GX Acquisition Corp.'s trust account will be added to the combined company's balance sheet (assuming no stockholder redemptions are effected). The company will operate under the Celularity management team, led by Founder, Chairperson and Chief Executive Officer, Robert J. Hariri, M.D., Ph.D. The boards of directors of both GX Acquisition Corp. and Celularity have unanimously approved the proposed transaction. Completion of the transaction is subject to approval of both GX Acquisition Corp.'s and Celularity's stockholders and the satisfaction or waiver of certain other customary closing conditions.

"I would like to thank the team at Celularity, existing Celularity and GX Acquisition Corp. stockholders, the PIPE investors, and all our advisors for their dedication in preparing for this transaction. We anticipate that the proceeds will provide us added runway and enable us to accelerate the development of innovative, off the shelf allogeneic cell therapies, including genetically modified natural killer (NK) cell therapies and CAR T cell therapies derived from the postpartum placenta. We expect to leverage this transaction and our new state-of-the-art manufacturing facility to advance the delivery of best-in-class cell therapies to patients with unmet medical needs," said Dr. Hariri.

"At Celularity we believe the next evolution in allogeneic cell therapy entails the delivery of rapidly scalable, high quality and economical solutions. It is in the continued spirit of evolution that today we announce our plans for becoming a public company," Dr. Hariri added.

John Sculley, Vice Chairman of the Board of Celularity, former CEO of Apple Inc., and former President of Pepsi Cola, further speaks to the Company's dynamic footprint: "Bob is creating systemic change with Celularity he started with his insight of the incredible power of the placenta, something that is being discarded, as the source material to come up with immuno-oncology therapies that would touch many types of cancer, and be scalable to reach millions of people."

Dean C. Kehler, Co-Chairman and CEO at GX Acquisition Corp., added, "We are excited to partner with the management of Celularity to create a new publicly-traded cell therapy company. Most importantly, this transaction will help to continue the decades of innovation by Dr. Hariri and his seasoned team, with the goal of developing new immunotherapies to treat cancer and other diseases."

Celularity is a clinical-stage biotechnology company leading the next evolution in cellular medicine with the development of allogeneic placental-derived cell therapy products, including genetically engineered placental-derived natural killer ("NK") cells and unmodified NK cells; placental-derived T cells engineered with a chimeric antigen receptor ("CAR -T cells"); and mesenchymal-like adherent stromal cells ("ASCs"). The cell therapy products are being developed to target indications across cancer, infectious and degenerative diseases.

Celularity believes that by harnessing the placenta's unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.

Proceeds of the business combination and PIPE are expected to be used, among other things, to support Celularity's research and clinical development programs, including:

Celularity also plans to use the funding from the transaction to bolster the continued build-out of internal discovery capabilities, enhance business development activities and support general corporate activities.

Celularity's current science is the product of over two decades of discovery, research, and development. Celularity has its roots in Anthrogenesis Corporation ("Anthrogenesis"), a company founded in 1998 by Dr. Hariri and acquired in 2002 by Celgene Corporation ("Celgene"). The team continued to hone its discoveries and expertise in the field of placental-derived cells at Celgene through August 2017, when Celularity, led by Dr. Hariri, acquired Anthrogenesis from Celgene.

Celularity benefits from Celgene's twenty-plus years' investment in developing technologies and capabilities to enable the manufacture cellular products at scale, with consistent and reliable quality.

Celularity has a robust global intellectual property portfolio comprised of over 1,500 patents and patent applications around the Celularity IMPACT platform, covering its processes, technologies, and key cell therapy programs. In 2020, Celularity completed construction of its 150,000 square foot purpose-built manufacturing and research facility located in Florham Park, New Jersey. This facility incorporates a world-class cGMP-ready manufacturing center, research and product development laboratories and biorepository, along with dedicated office space and space for shared services. Celularity's facility includes nine Grade C/ISO-7 and six Grade D/ISO-8 manufacturing suites designed for the parallel commercial production of multiple cellular therapy products and advanced biomaterials.

Summary of Transaction

The transaction will be effected pursuant to a merger of Celularity with a wholly owned subsidiary of GX Acquisition Corp. In the merger, outstanding shares of Celularity capital stock, options and warrants will be converted into shares of common stock, options and warrants, respectively, of the combined company at an implied Celularity equity value of $1.25 billion.

Advisors

Ardea Partners LP is serving as lead financial advisor to Celularity. Morgan Stanley & Co. is also serving as a financial advisor. Truist Securities and Oppenheimer & Co. Inc. are acting as capital markets advisors to Celularity. Cooley LLP is serving as legal counsel to Celularity.

Credit Suisse is serving as lead capital markets advisor and lead private placement agent on the PIPE to GX Acquisition Corp. Cantor Fitzgerald is also serving as capital markets advisor to GX Acquisition Corp. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal counsel to GX Acquisition Corp.

Conference Call Information

January 8, 2021 at 8:00 a.m. EDT Stream Recording: https://celularity.com/joint-investor-conference-call/

About GX Acquisition Corp.

GX Acquisition Corp. is a blank check company incorporated in Delaware for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization, or similar business combination with one or more businesses or entities. GX Acquisition Corp. is led by Jay R. Bloom and Dean C. Kehler, who serve as Managing Partners of Trimaran Capital Partners.

About Celularity

Celularity is a clinical stage biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placenta-derived allogeneic cell therapies, including genetically-modified NK cells, T cells engineered with a CAR (CAR T-cells), and ASCs, targeting indications across cancer, infectious and degenerative diseases. Celularity believes that by harnessing the placenta's unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics. Celularity currently has four active and enrolling clinical trials and plans to submit three additional investigational new drug ("IND") applications in 2021. The Celularity IMPACT platform capitalizes on the benefits of placental-derived cells to target multiple diseases, and provides seamless integration, from bio-sourcing through manufacturing cryopreserved and packaged allogeneic cells, which Celularity handles at its purpose-built U.S.-based 150,000 square foot facility in Florham Park, NJ. Celularity believes the use of placental-derived cells sourced from full-term healthy informed consent donors have potential inherent advantages, both from an economic and a scientific perspective. Relative to adult-derived cells, placental-derived cells demonstrate greater stemness, which means the ability to expand and persist. Further, their immunological navet, meaning having an immune system that has never been exposed to a specific antigen, may allow for an improved safety profile. Celularity's placental-derived cells are allogeneic, meaning they are intended for use in any patient, as compared to autologous cells, which are derived from an individual patient for that patient's sole use. Celularity believes this a key difference that will enable readily available off-the-shelf treatments that can be delivered faster, more reliably, at greater scale and to more patients.

Additional Information about the Business Combination and Where to Find It

GX Acquisition Corp. intends to file the Registration Statement with the SEC, which will include a preliminary proxy statement to be distributed to holders of GX Acquisition Corp.'s common stock in connection with GX Acquisition Corp.'s solicitation of proxies for the vote by GX Acquisition Corp.'s stockholders with respect to the business combination and other matters as described in the Registration Statement, and a prospectus relating to the offer of the securities to be issued to Celularity's stockholders in connection with the business combination. After the Registration Statement has been filed and declared effective, GX Acquisition Corp. will mail a definitive proxy statement and other relevant documents to its stockholders as of the record date established for voting on the business combination and the other proposals regarding the business combination set forth in the Registration Statement.GX Acquisition Corp.'s stockholders and other interested persons are advised to read, once available, the Registration Statement, including the preliminary proxy statement / prospectus contained therein, and any amendments thereto and, once available, the definitive proxy statement / prospectus, in connection with GX Acquisition Corp.'s solicitation of proxies for its special meeting of stockholders to be held to approve, among other things, the business combination, because these documents will contain important information about GX Acquisition Corp., Celularity and the business combination.Stockholders may also obtain a copy of the preliminary or definitive proxy statement/prospectus, once available, as well as other documents filed with the SEC regarding the business combination and other documents filed with the SEC by GX Acquisition Corp., without charge, at the SEC's website located at http://www.sec.gov or by directing a request to GX Acquisition Corp., 1325 Avenue of the Americas, 25th Floor, New York, NY 10019.

Participants in the Solicitation

GXAcquisition Corp., Celularity and their respective directors and officers may be deemed participants in the solicitation of proxies of GXAcquisition Corp.'s stockholders in connection with the business combination. GXAcquisition Corp.'s stockholders and other interested persons may obtain, without charge, more detailed information regarding the directors and officers of GXAcquisition Corp. in GXAcquisition Corp.'s Annual Report onForm10-Kfor the fiscal year ended December31, 2019, which was filed with the SEC on March24, 2020, and GXAcquisition Corp.'s Definitive Proxy Statement on Schedule 14A, which was filed with the SEC on December 4, 2020. Information regarding Celularity's directors and officers will be set forth in the Registration Statement for the business combination.

Information regarding the persons who may, under SEC rules, be deemed participants in the solicitation of proxies of GXAcquisition Corp.'s stockholders in connection with the business combinationand other matters to be voted upon at the special meeting will be set forth in the Registration Statement for the business combination. Additional information regarding the interests of participants in the solicitation of proxies in connection with the business combinationwill be included in the Registration Statement for the business combination.

Non-Solicitation

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the potential transaction and shall not constitute an offer to sell or a solicitation of an offer to buy the securities of Celularity, the combined company or GX Acquisition Corp., nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act.

Special Note Regarding Forward-Looking Statements

This press release contains, or incorporates by reference, "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to, statements regarding GX Acquisition Corp.'s, GX Acquisition Corp.'s management team's, Celularity's and Celularity's management team's expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words "anticipate," "believe," "can," "contemplate," "continue," "could," "estimate," "expect," "forecast," "intends," "may," "might," "outlook," "plan," "possible," "potential," "predict," "project," "seek," "should," "strive," "target," "will," "would" and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements in this press release may include, for example: (i) the ability to consummate the business combination, (ii) the expected benefits of the business combination; (iii) the financial and business performance of Celularity, (iv) the inability to complete the PIPE Investment; (v) the success and timing of Celularity's cellular therapeutic development activities and initiating clinical trials; (vi) the success and timing of Celularity's planned clinical trials; (vii) Celularity's ability to obtain and maintain regulatory approval of any of Celularity's therapeutic candidates; (viii) Celularity's plans to research, discover and develop additional therapeutic candidates, including by leveraging genetic engineering and other technologies and expanding into additional indications; (ix) Celularity's ability to expand its manufacturing capabilities, and to manufacture Celularity's therapeutic candidates and scale production; (x) Celularity's ability to meet certain milestones; (xi) changes in Celularity's strategy, future operations, financial position, estimated revenues and losses, projected costs, prospects and plans; (xii) the implementation, market acceptance and success of Celularity's business model; (xiii) developments and projections relating to Celularity's competitors and industry; (xiv) the impact of health epidemics, including the COVID-19 pandemic, on Celularity's business and the actions Celularity may take in response thereto; (xv) Celularity's expectations regarding its ability to obtain and maintain intellectual property protection and not infringe on the rights of others; (xvi) expectations regarding the time during which GX Acquisition Corp. will be an emerging growth company under the JOBS Act; (xvii) Celularity's future capital requirements and sources and uses of cash; (xviii) Celularity's ability to obtain funding for its operations; (xix) Celularity's business, expansion plans and opportunities; and (xx) the outcome of any known and unknown litigation and regulatory proceedings. These forward-looking statements are based on information available as of the date of this press release, and current expectations, forecasts and assumptions, and involve a number of judgments, risks and uncertainties. These risks and uncertainties may be amplified by the COVID- 19 pandemic, which has caused significant economic uncertainty. If any of these risks materialize or underlying assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that neither GX Acquisition Corp. nor Celularity presently know, or that GX Acquisition Corp. or Celularity currently believe are immaterial, that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect GX Acquisition Corp.'s and Celularity's expectations, plans, or forecasts of future events and views as of the date of this press release. GX Acquisition Corp. and Celularity anticipate that subsequent events and developments will cause GX Acquisition Corp.'s and Celularity's assessments to change. Accordingly, forward-looking statements should not be relied upon as representing GX Acquisition Corp.'s or Celularity's views as of any subsequent date, and GX Acquisition Corp. does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. Additional risks and uncertainties are identified and discussed in GX Acquisition Corp.'s reports filed with the SEC and available at the SEC's website at http://www.sec.gov.

GX Acquisition Corp. Contact:

Caroline Luz Lambert & Co. cluz@lambert.com

Celularity Investor Contacts:

Carlos Ramirez Celularity carlos.ramirez@celularity.com

Alexandra Roy Solebury Trout aroy@troutgroup.com

Celularity Media Contact:

media@celularity.com

View original content:http://www.prnewswire.com/news-releases/celularity-and-gx-acquisition-corp-announce-merger-agreement-to-create-a-publicly-listed-leader-in-allogeneic-cellular-therapy-301203341.html

SOURCE Celularity

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Celularity and GX Acquisition Corp. Announce Merger Agreement to Create a Publicly Listed Leader in Allogeneic Cellular Therapy - BioSpace

Results Show Promising Efficacy in MCL With Next-Generation BTK Inhibitor LOXO-305 – Cancer Network

Results of a phase 1/2 trial that were presented at the 2020 American Society of Hematology Annual Meeting and Exposition showed that patients with mantle cell lymphoma (MCL) and other B-cell malignancies had promising response rates when treated with LOXO-305.

A highly selective Bruton tyrosine kinase (BTK) inhibitor that targets both wild-type and C481-mutant BTK, LOXO-305 could be a viable treatment option for patients with difficult-to-treat hematologic malignancies, such as MCL and Waldenstrm macroglobulinemia (WM).

LOXO-305 demonstrates promising efficacy in [patients with MCL and other non-Hodgkin lymphomas (NHLs)] previously treated with all classes of available therapy, Michael Wang, MD, professor in the Department of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center, said during a presentation of the data. Responses were observed across all dose levels and efficacy was independent of prior therapy.

The agents use in patients with various B-cell malignancies, including those with chronic lymphocytic leukemia/small lymphocytic lymphoma, was examined in the dose-escalation, dose-expansion BRUIN trial (NCT03740529). Patients had to have received at least 2 prior regimens, given as a combination or sequentially, or 1 prior BTK inhibitorcontaining regimen. LOXO-305 was administered orally in cycles of 28 days according to a 3 + 3 design, with a starting dose of 25 mg daily.

The primary end points of the trial were determining the maximum tolerated dose in the phase 1 portion and preliminary antitumor activity and safety in phase 2. In total, 323 patients were enrolled as of the September 2020 cutoff, 61 of whom had MCL, 26 with WM, and 66 with other NHLs.

The median number of prior therapies for patients with MCL and WM was 3, of whom 93% and 69%, respectively, previously received a BTK inhibitor. Those with other NHLs received an average of 4 prior therapies. Interestingly, progressive disease following chimeric antigen receptor (CAR) T-cell therapy was seen in 5% of patients with MCL and 14% of those with other NHLs.

Overall response rates (ORR) varied by disease cohort. Of note, those with MCL who were evaluable for response (n = 56) had an ORR of 52%, and this remained true when the cohort of patients was reduced to just those who had prior BTK inhibitor therapy (n = 52). Complete responses accounted for 25% of both groups, as well. In those with prior stem cell transplant (n = 14) or prior CAR T-cell therapy (n = 2), ORRs were 64% and 100%, respectively. At a median follow-up of 6 months, most of those with MCL who responded to therapy (83%; 24 of 29 patients) had an ongoing response.

In response-evaluable patients with WM (n = 19), the ORR was 68% and was consistent when only those with prior BTK inhibitor therapy were examined (n = 13; 69%). Responses in both groups were comprised exclusively of partial responses and 77% of patients overall had an ongoing response at data cutoff. ORRs in other NHL subtypes included 75% for Richter transformation (RT), 50% for follicular lymphoma, 24% for diffuse large B-cell lymphoma, and 22% for marginal zone lymphoma. A large majority of patients with RT (83%) had an ongoing response at the median follow-up of 6 months.

Of note, there were no dose-limiting toxicities noted in the study and the maximum-tolerated dose was not reached. Only 5 patients (1.5%) discontinued treatment due to treatment-related adverse events and 200 mg was selected as the recommended phase 2 dose.

Longer follow-up is needed to better understand the LOXO-305 safety profile associated with chronic administration, Wang said.

Reference:

1. Wang M, Shah NN, Alencar AJ, et al. LOXO-305, a next generation, highly selective, non-covalent BTK inhibitor in previously treated mantle cell lymphoma, Waldenstrm's macroglobulinemia, and other non-Hodgkin lymphomas: results from the phase 1/2 BRUIN study. Blood. 2020;136(suppl 1):8-10. Abstract 117. doi:10.1182/blood-2020-134314

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Results Show Promising Efficacy in MCL With Next-Generation BTK Inhibitor LOXO-305 - Cancer Network

BlueRock Therapeutics in Collaboration with Memorial Sloan Kettering Cancer Center Receives IND Clearance for DA01 in Parkinson’s Disease – BioSpace

CAMBRIDGE, Mass., Jan. 7, 2021 /PRNewswire/ -- BlueRock Therapeutics, a preclinical stage biopharmaceutical company and wholly-owned subsidiary of BayerAG,in collaboration withMemorialSloan Kettering Cancer Center(MSK), announcedtodaythat the U.S. Food and Drug Administration (FDA) has clearedtheirInvestigational New Drug (IND) application toproceedwith aPhase 1(Ph1)study in patients with advanced Parkinson's disease (PD).This is the first trial in the United States to study pluripotent stem cell-derived dopaminergic neurons in patients with Parkinson's disease.Under the IND, BlueRockand MSK willexecute aPh1 clinical trial to evaluate the safety, tolerability andpreliminaryefficacyof DA01 in patients with PD.

"This is a big step for the stem cell field to finally test a truly "off-the-shelf" dopamine neuron product in human PD patients," said Lorenz Studer, MD, scientific co-founder of BlueRock and Director, Center for Stem Cell Biology at MSK. "We are also grateful for the visionary support by NYSTEM, the NY state-sponsored stem cell program that supported the earlier stages of this project."

"This trial is the culmination of a decade of arduous collaborative work that is based on very rigorous science. It is an important milestone on the road towards regenerative brain repair," said Viviane Tabar, MD, founding investigator of BlueRock and Chair of MSK's Department of Neurosurgery. "It is a real privilege and very exciting to be able to participate in both the bench science and the actual surgical intervention, here at MSK. Our collaborators at Weill Cornell Neurology will also be an integral part of the trial."

"Today, thereisno disease-modifying treatment for Parkinson's. Through this trial and those to follow, we hope to change that,"stated EmileNuwaysir, Ph.D., President and Chief Executive Officer of BlueRock. "Our therapy is intended to replace the midbrain dopaminergic neurons lost in the degenerative condition to rebuild the neural circuit, and thereby restore motor controlto Parkinson's patients. This could shift the treatment paradigm for millions ofPD patients, as well as demonstrate for the first time that degenerative disease is, in principle, reversible. We believe this would represent an enormous step forthe PD community worldwide, and formedicine."

The trial plans to enroll ten patients starting with a first clinical site at Weill Cornell Medicinein the initial open-label study. The primary objective of thePh1study is to assess the safety and tolerability of DA01 cell transplantation at one-year post-transplant. The secondary objectives of the study are to assess the evidence of transplanted cell survival and motor effects at one- and two-years post-transplant, to evaluate continued safety and tolerability at two years, and to assess feasibility of transplantation.

About Parkinson's Disease Parkinson's disease is a progressive neurodegenerative disorder caused by nerve cell damage in the brain, leading to decreased dopamine levels. The worsening of motor and non-motor symptoms is caused by the loss of dopamine-producing neurons. At diagnosis, it is estimated that patients have already lost 60-80% of their dopaminergic neurons.Parkinson's disease often starts with a tremor in one hand. Other symptoms are rigidity, cramping and dyskinesias. Parkinson's disease is the second most common neurodegenerative disorder, impacting more than 7.5 million people, including 1.3 million people in North America.

About BlueRock Therapeutics BlueRock Therapeutics is a leading engineered cell therapy company with a mission to develop regenerative medicines for intractable diseases. BlueRock Therapeutics' cell+gene platform harnesses the power of cells to create new medicines for neurology, cardiology and immunology indications. BlueRock Therapeutics' cell differentiation technology recapitulates the cell's developmental biology to produce authentic cell therapies, which are further engineered for additional function. Utilizing these cell therapies to replace damaged or degenerated tissue brings the potential to restore or regenerate lost function. BlueRock Therapeutics was founded in 2016 by Versant Ventures and Bayer AG and capitalized with one of the largest-ever Series A financings in biotech history by Bayer AG (through its Leaps by Bayer unit) and Versant Ventures. The company was fully acquired by Bayer in 2019. BlueRock Therapeutics' culture is defined by scientific innovation, the highest ethical standards and an urgency to bring transformative treatments to all who would benefit. For more information, visit bluerocktx.com.

About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to benefit people by supporting efforts to overcome the major challenges presented by a growing and aging global population. At the same time, the Group aims to increase its earning power and create value through innovation and growth. Bayer is committed to the principles of sustainable development, and the Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2019, the Group employed around 104,000 people and had sales of 43.5 billion euros. Capital expenditures amounted to 2.9 billion euros, R&D expenses to 5.3 billion euros. For more information, visit bayer.com.

Disclosures Dr. Studer has intellectual property rights and interests and financial interests related to BlueRock. Dr. Tabar has financial interests related to BlueRock. Researchers at Memorial Sloan Kettering Cancer Center, including Dr. Studer, developed stem cell-derived dopaminergic neurons for the treatment of neurodegenerative diseases, and MSK licensed this intellectual property to BlueRock. MSK has institutional financial interests related to this intellectual property and BlueRock.

Forward-Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimate" and "intend," among others. These forward-looking statements are based on BlueRock's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the timing of our clinical trial for DA01; our results regarding the safety, tolerance and efficacy of DA01 cell transplantation for patients with Parkinson's disease; and ongoing FDA and other regulatory requirements regarding the development of DA01. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Except as expressly required by law, BlueRock does not undertake an obligation to update or revise any forward-looking statement. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.

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Stem Cell Therapy Market Size, Share & Trends Analysis Report By Product Types, And Applications Forecast To 2026 – Farming Sector

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Adipose Tissue-Derived Mesenchymal SCs Bone Marrow-Derived Mesenchymal SCs Embryonic SCs Other Sources

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