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Fulcrum Therapeutics® Announces Multiple Presentations on FSHD at the American Academy of Neurology’s Annual Meeting

April 2nd, 2022 1:49 am

Presentations highlight potential of losmapimod to slow or stop progression of FSHD

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Fulcrum Therapeutics® Announces Multiple Presentations on FSHD at the American Academy of Neurology’s Annual Meeting

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Healthy Extracts Reports Fourth Quarter and Full Year 2021 Results

April 2nd, 2022 1:49 am

LAS VEGAS, April 01, 2022 (GLOBE NEWSWIRE) -- Healthy Extracts Inc. (OTCQB: HYEX), a leading innovator of clinically proven plant-based products for heart and brain health, reported results for the fourth quarter and full year ended December 31, 2021.

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Praxis Precision Medicines to Present Data from PRAX-944 for Essential Tremor at 2022 American Academy of Neurology Annual Meeting

April 2nd, 2022 1:49 am

BOSTON, April 01, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced that data from its PRAX-944 essential tremor (ET) program will be presented at the upcoming 2022 American Academy of Neurology (AAN) Annual Meeting, which will take place in Seattle, Washington from April 2 – 7, 2022 and virtually from April 24 – 26, 2022. Abstracts can be accessed on the AAN meeting website.

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Praxis Precision Medicines to Present Data from PRAX-944 for Essential Tremor at 2022 American Academy of Neurology Annual Meeting

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Y-mAbs Announces Submission of Omburtamab Biologics License Application to FDA

April 2nd, 2022 1:49 am

NEW YORK, April 01, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that on March 31, 2022, the Company completed the resubmission of its Biologics License Application (“BLA”) for 131I-omburtamab (“omburtamab”) to the FDA.

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Tricida to Present at the Needham Virtual Healthcare Conference

April 2nd, 2022 1:49 am

SOUTH SAN FRANCISCO, Calif., April 01, 2022 (GLOBE NEWSWIRE) -- Tricida, Inc. (Nasdaq: TCDA) announced today that it will present at the 21st Annual Needham Virtual Healthcare Conference on Monday, April 11, 2022 at 10:30 am Pacific Time / 1:30 pm Eastern Time. Tricida will provide a company overview, business update and progress on its key initiatives.

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BioStem Technologies Inc. Reports December 31, 2021 Year End Financial Results

April 2nd, 2022 1:49 am

POMPANO BEACH, FLORIDA., April 01, 2022 (GLOBE NEWSWIRE) -- BioStem Technologies Inc. (OTC: BSEM), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care market today reported financial results for the year ended December 31, 2021.

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BioStem Technologies Inc. Reports December 31, 2021 Year End Financial Results

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Todos Medical Reports Fourth-Quarter and Full-Year 2021 Financial Results and Corporate Updates

April 2nd, 2022 1:49 am

New York, NY, and Tel Aviv, ISRAEL, April 01, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today reported financial results for the fourth quarter and full-year ended December 31, 2021 and provided corporate updates.

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Todos Medical Reports Fourth-Quarter and Full-Year 2021 Financial Results and Corporate Updates

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Number of voting rights as of March 31, 2022

April 2nd, 2022 1:49 am

Nicox SASociété anonyme with a registered capital of € 43,223,135

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Number of voting rights as of March 31, 2022

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Oxurion Announces Extraordinary and Annual Shareholders’ Meetings

April 2nd, 2022 1:49 am

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Biofrontera Inc. to Report Fourth Quarter and Full Year 2021 Financial Results on April 8, 2022

April 2nd, 2022 1:49 am

WOBURN, Mass., April 01, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today it will report financial results for the three months and full year ended December 31, 2021 before the opening of the U.S. financial markets on Friday, April 8, 2022 and will host a conference call that same day beginning at 11:00 a.m. Eastern time to discuss those results, provide a business update and answer questions.

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Update: Todos Medical Reports Fourth-Quarter and  Full-Year 2021 Financial Results and Corporate Updates

April 2nd, 2022 1:49 am

New York, NY, and Tel Aviv, ISRAEL, April 01, 2022 (GLOBE NEWSWIRE) -- via NewMediaWire -- Todos Medical, Ltd. (OTCQB: TOMDF), a comprehensive medical diagnostics and related solutions company, today reported financial results for the fourth quarter and full-year ended December 31, 2021 and provided corporate updates.

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Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

April 2nd, 2022 1:49 am

BOSTON, April 01, 2022 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and other public health threats for civilian, government and military use, today announced that on March 31, 2022, the Company granted stock options and restricted stock units to ten new employees of the Company. These awards were granted pursuant to the Paratek Pharmaceuticals, Inc. 2017 Inducement Plan, as amended, which was approved by the Company's board of directors on June 15, 2017, under Rule 5635(c)(4) of the NASDAQ Listing Rules, for equity grants to employees entering into employment or returning to employment after a bona fide period of non-employment with the Company, as an inducement material to such individuals entering into employment with the Company.

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Paratek Announces Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

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TCR² Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

April 2nd, 2022 1:49 am

CAMBRIDGE, Mass., April 01, 2022 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from solid tumors, today announced that on March 31, 2022 (the “Grant Date”), the Compensation Committee of the Board of Directors of TCR2’s approved the grant of inducement stock options covering an aggregate of 73,000 shares of TCR2’s common stock to 9 new non-executive employees. The stock options were granted as an inducement material to the employees’ acceptance of employment with TCR2 in accordance with Nasdaq Listing Rule 5635(c)(4).

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G1 Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

April 2nd, 2022 1:49 am

RESEARCH TRIANGLE PARK, N.C., April 01, 2022 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the grant of inducement stock options exercisable for an aggregate of 25,800 shares of G1’s common stock and an aggregate of 11,200 restricted stock units (RSUs) to four hired employees under the Amended and Restated G1 Therapeutics, Inc. 2021 Inducement Equity Incentive Plan (the “Amended and Restated 2021 Plan”). These equity awards were granted as an inducement material to the new employee’s becoming an employee of G1 in accordance with Nasdaq Listing Rule 5635(c)(4).

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ASLAN Pharmaceuticals Announces Receipt of Nasdaq Deficiency Notice Regarding Minimum Bid Price Requirement

April 2nd, 2022 1:49 am

MENLO PARK, Calif. and SINGAPORE, April 01, 2022 (GLOBE NEWSWIRE) -- ASLAN Pharmaceuticals (NASDAQ: ASLN) ("ASLAN" or the "Company"), announced today that on March 28, 2022, it received a written notice (the "Notice") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with the US$1.00 minimum bid price requirement under the Nasdaq Listing Rules (the "Listing Rules"). Based on the closing bid price of the Company's listed securities for the last 30 consecutive business days from February 11, 2022 to March 25, 2022, the Company has not met the minimum bid price requirement set forth in Listing Rule 5550(a)(2) during that period. The Notice is only a notification of deficiency and has no immediate effect on the listing of the Company’s American Depositary Shares (“ADS”). The Company’s ADSs will continue to trade on the Nasdaq Global Market at this time. The Company’s receipt of the Notice does not impact the Company’s business, operations or reporting requirements with the Securities and Exchange Commission.

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Oncternal Therapeutics Reports Granting of Inducement Award Under Nasdaq Listing Rule 5635(c)(4)

April 2nd, 2022 1:49 am

SAN DIEGO, April 01, 2022 (GLOBE NEWSWIRE) -- Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, today announced that it has granted an inducement award to one new employee, Rachel Monet Kenny, who joined the Company as Associate Director, CMC and Clinical Supply Chain.

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Reversing hearing loss with regenerative therapy | MIT News | Massachusetts Institute of Technology – MIT News

April 2nd, 2022 1:49 am

Most of us know someone affected by hearing loss, but we may not fully appreciate the hardships that lack of hearing can bring. Hearing loss can lead to isolation, frustration, and a debilitating ringing in the ears known as tinnitus. It is also closely correlated with dementia.

The biotechnology company Frequency Therapeutics is seeking to reverse hearing loss not with hearing aids or implants, but with a new kind of regenerative therapy. The company uses small molecules to program progenitor cells, a descendant of stem cells in the inner ear, to create the tiny hair cells that allow us to hear.

Hair cells die off when exposed to loud noises or drugs including certain chemotherapies and antibiotics. Frequencys drug candidate is designed to be injected into the ear to regenerate these cells within the cochlea. In clinical trials, the company has already improved peoples hearing as measured by tests of speech perception the ability to understand speech and recognize words.

Speech perception is the No. 1 goal for improving hearing and the No. 1 need we hear from patients, says Frequency co-founder and Chief Scientific Officer Chris Loose PhD 07.

In Frequencys first clinical study, the company saw statistically significant improvements in speech perception in some participants after a single injection, with some responses lasting nearly two years.

The company has dosed more than 200 patients to date and has seen clinically meaningful improvements in speech perception in three separate clinical studies. Another study failed to show improvements in hearing compared to the placebo group, but the company attributes that result to flaws in the design of the trial.

Now Frequency is recruiting for a 124-person trial from which preliminary results should be available early next year.

The companys founders, including Loose, MIT Institute Professor Robert Langer, CEO David Lucchino MBA 06, Senior Vice President Will McLean PhD 14, and Harvard-MIT Health Sciences and Technology affiliate faculty member Jeff Karp, are already gratified to have been able to help people improve their hearing through the trials. They also believe theyre making important contributions toward solving a problem that impacts more than 40 million people in the U.S. and hundreds of millions more around the world.

Hearing is such an important sense; it connects people to their community and cultivates a sense of identity, says Karp, who is also a professor of anesthesia at Brigham and Womens Hospital. I think the potential to restore hearing will have enormous impact on society.

From the lab to patients

In 2005, Lucchino was an MBA student in the MIT Sloan School of Management and Loose was a PhD candidate in chemical engineering at MIT. Langer introduced the two aspiring entrepreneurs, and they started working on what would become Semprus BioSciences, a medical device company that won the MIT $100K Entrepreneurship Competition and later sold at a deal valued at up to $80 million.

MIT has such a wonderful environment of people interested in new ventures that come from different backgrounds, so were able to assemble teams of people with diverse skills quickly, Loose says.

Eight years after playing matchmaker for Lucchino and Loose, Langer began working with Karp to study the lining of the human gut, which regenerates itself almost every day.

With MIT postdoc Xiaolei Yin, who is now a scientific advisor to Frequency, the researchers discovered that the same molecules that control the guts stem cells are also used by a close descendant of stem cells called progenitor cells. Like stem cells, progenitor cells can turn into more specialized cells in the body.

Every time we make an advance, we take a step back and ask how this could be even bigger, Karp says. Its easy to be incremental, but how do we take what we learned and make a massive difference?

Progenitor cells reside in the inner ear and generate hair cells when humans are in utero, but they become dormant before birth and never again turn into more specialized cells such as the hair cells of the cochlea. Humans are born with about 15,000 hair cells in each cochlea. Such cells die over time and never regenerate.

In 2012, the research team was able to use small molecules to turn progenitor cells into thousands of hair cells in the lab. Karp says no one had ever produced such a large number of hair cells before. He still remembers looking at the results while visiting his family, including his father, who wears a hearing aid.

I looked at them and said, I think we have a breakthrough, Karp says. Thats the first and only time Ive used that phrase.

The advance was enough for Langer to play matchmaker again and bring Loose and Lucchino into the fold to start Frequency Therapeutics.

The founders believe their approach injecting small molecules into the inner ear to turn progenitor cells into more specialized cells offers advantages over gene therapies, which may rely on extracting a patients cells, programming them in a lab, and then delivering them to the right area.

Tissues throughout your body contain progenitor cells, so we see a huge range of applications, Loose says. We believe this is the future of regenerative medicine.

Advancing regenerative medicine

Frequencys founders have been thrilled to watch their lab work mature into an impactful drug candidate in clinical trials.

Some of these people [in the trials] couldnt hear for 30 years, and for the first time they said they could go into a crowded restaurant and hear what their children were saying, Langer says. Its so meaningful to them. Obviously more needs to be done, but just the fact that you can help a small group of people is really impressive to me.

Karp believes Frequencys work will advance researchers ability to manipulate progenitor cells and lead to new treatments down the line.

I wouldn't be surprised if in 10 or 15 years, because of the resources being put into this space and the incredible science being done, we can get to the point where [reversing hearing loss] would be similar to Lasik surgery, where you're in and out in an hour or two and you can completely restore your vision, Karp says. I think we'll see the same thing for hearing loss.

The company is also developing a drug for multiple sclerosis (MS), a disease in which the immune system attacks the myelin in the brain and central nervous system. Progenitor cells already turn into the myelin-producing cells in the brain, but not fast enough to keep up with losses sustained by MS patients. Most MS therapies focus on suppressing the immune system rather than generating myelin.

Early versions of that drug candidate have shown dramatic increases in myelin in mouse studies. The company expects to file an investigational new drug application for MS with the FDA next year.

When we were conceiving of this project, we meant for it to be a platform that could be broadly applicable to multiple tissues. Now were moving into the remyelination work, and to me its the tip of the iceberg in terms of what can be done by taking small molecules and controlling local biology, Karp says.

For now, Karp is already thrilled with Frequencys progress, which hit home the last time he was in Frequencys office and met a speaker who shared her experience with hearing loss.

You always hope your work will have an impact, but it can take a long time for that to happen, Karp says. Its been an incredible experience working with the team to bring this forward. There are already people in the trials whose hearing has been dramatically improved and their lives have been changed. That impacts interactions with family and friends. Its wonderful to be a part of.

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Reversing hearing loss with regenerative therapy | MIT News | Massachusetts Institute of Technology - MIT News

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Penn Researchers Discover New Cell Type in Human Lung with Regenerative Properties – Penn Medicine

April 2nd, 2022 1:49 am

Human ES cell derived RASC (respiratory airway secretory cell) transitioning to an Alveolar type 2 cell over time in culture

PHILADELPHIA A new type of cell that resides deep within human lungs and may play a key role in human lung diseases has been discovered by researchers at the Perelman School of Medicine at the University of Pennsylvania.

The researchers, who report their findings today in Nature, analyzed human lung tissue to identify the new cells, which they call respiratory airway secretory cells (RASCs). The cells line tiny airway branches, deep in the lungs, near the alveoli structures where oxygen is exchanged for carbon dioxide. The scientists showed that RASCs have stem-cell-like properties enabling them to regenerate other cells that are essential for the normal functioning of alveoli. They also found evidence that cigarette smoking and the common smoking-related ailment called chronic obstructive pulmonary disease (COPD) can disrupt the regenerative functions of RASCshinting that correcting this disruption could be a good way to treat COPD.

COPD is a devastating and common disease, yet we really dont understand the cellular biology of why or how some patients develop it. Identifying new cell types, in particular new progenitor cells, that are injured in COPD could really accelerate the development of new treatments, said study first author Maria Basil, MD, PhD, an instructor of Pulmonary Medicine.

COPD typically features progressive damage to and loss of alveoli, exacerbated by chronic inflammation. It is estimated to affect approximately 10 percent of people in some parts of the United States and causes about 3 million deaths every year around the world. Patients often are prescribed steroid anti-inflammatory drugs and/or oxygen therapy, but these treatments can only slow the disease process rather than stop or reverse it. Progress in understanding COPD has been gradual in part because micethe standard lab animalhave lungs that lack key features of human lungs.

In the new study, Morrisey and his team uncovered evidence of RASCs while examining gene-activity signatures of lung cells sampled from healthy human donors. They soon recognized that RASCs, which dont exist in mouse lungs, are secretory cells that reside near alveoli and produce proteins needed for the fluid lining of the airway.

With studies like this were starting to get a sense, at the cell-biology level, of what is really happening in this very prevalent disease, said senior author Edward Morrisey, PhD, the Robinette Foundation Professor of Medicine, a professor of Cell and Developmental Biology, and director of the Penn-CHOP Lung Biology Institute at Penn Medicine.

Observations of gene-activity similarities between RASCs and an important progenitor cell in alveoli called AT2 cells led the team to a further discovery: RASCs, in addition to their secretory function, serve as predecessors for AT2 cellsregenerating them to maintain the AT2 population and keep alveoli healthy.

AT2 cells are known to become abnormal in COPD and other lung diseases, and the researchers found evidence that defects in RASCs might be an upstream cause of those abnormalities. In lung tissue from people with COPD, as well as from people without COPD who have a history of smoking, they observed many AT2 cells that were altered in a way that hinted at a faulty RASC-to-AT2 transformation.

More research is needed, Morrisey said, but the findings point to the possibility of future COPD treatments that work by restoring the normal RASC-to-AT2 differentiation processor even by replenishing the normal RASC population in damaged lungs.

The research was supported by the National Institutes of Health (HL148857, HL087825, HL134745, HL132999, 5T32HL007586-35, 5R03HL135227-02, K23 HL121406, K08 HL150226, DK047967, HL152960, R35HL135816, P30DK072482, U01HL152978), the BREATH Consortium/Longfunds of the Netherlands, the Parker B. Francis Foundation, and GlaxoSmithKline.

Penn Medicineis one of the worlds leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of theRaymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nations first medical school) and theUniversity of Pennsylvania Health System, which together form a $9.9 billion enterprise.

The Perelman School of Medicine has been ranked among the top medical schools in the United States for more than 20 years, according toU.S. News & World Report's survey of research-oriented medical schools. The School is consistently among the nation's top recipients of funding from the National Institutes of Health, with $546 million awarded in the 2021 fiscal year.

The University of Pennsylvania Health Systems patient care facilities include: the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Centerwhich are recognized as one of the nations top Honor Roll hospitals byU.S. News & World ReportChester County Hospital; Lancaster General Health; Penn Medicine Princeton Health; and Pennsylvania Hospital, the nations first hospital, founded in 1751. Additional facilities and enterprises include Good Shepherd Penn Partners, Penn Medicine at Home, Lancaster Behavioral Health Hospital, and Princeton House Behavioral Health, among others.

Penn Medicine is powered by a talented and dedicated workforce of more than 52,000 people. The organization also has alliances with top community health systems across both Southeastern Pennsylvania and Southern New Jersey, creating more options for patients no matter where they live.

Penn Medicine is committed to improving lives and health through a variety of community-based programs and activities. In fiscal year 2021, Penn Medicine provided more than $619 million to benefit our community.

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Healios K K : Joint Research with the Division of Regenerative Medicine, the Institute of Medical Science for Developing a Mass Production Method of…

April 2nd, 2022 1:49 am

April 1st, 2022

Company Name: Representative:

HEALIOS K.K.

Hardy TS Kagimoto, Chairman & CEO

(TSE Mothers Code: 4593)

Joint Research with the Division of Regenerative Medicine, the Institute of Medical Science for Developing a Mass Production Method of UDC Liver Buds

HEALIOS K.K. ("Healios") is currently developing a regenerative medicine treatment whereby liver organ buds created from iPS cells are injected into the liver and grown into functioning liver tissue, with the aim of improving or restoring the function of a damaged liver (development code: HLCL041). This treatment could potentially replace the need for an organ transplant for certain patients. Liver buds are created by co-culturing liver progenitor cells, which can differentiate into hepatocytes; MSCs, which have the ability to develop into various types of connective-tissues; and vascular endothelial cells, which form blood vessels. Healios has pursued research and generated data on functional assessments and quality standards for these component cells and the liver buds created from them, and it is also proceeding with the development of mass culturing and manufacturing methods.

In addition, as announced on October 20th, 2020, Healios established Universal Donor Cells ("UDCs")*, which are next-generation iPS cells created with gene-editing technology that have a reduced risk of immune rejection regardless of a patient's HLA type, and its proprietary clinical-grade UDC line. We are currently conducting research both internally and through joint collaborations with several institutions on new treatments for diseases for which there is no existing cure.

As part of these efforts, Healios is pleased to announce that it has entered into a joint research agreement with the Division of Regenerative Medicine (Prof. Hideki Taniguchi) of the Institute of Medical Science at the University of Tokyo, to advance HLCL041 utilizing UDCs. In this joint research, we plan to establish a new method for inducing differentiation of liver buds using UDCs and to develop a highly efficient and scalable cell culturing and mass manufacturing system.

For many diseases where the only effective treatment is an organ transplant, Healios believes that organ buds created from iPSCs, which have the potential to restore organ function, hold significant promise as an alternative to organ transplants and as a means to address the perennial shortage of organ donors.

This agreement does not have a material impact on our consolidated financial results for the current fiscal year. We will promptly make an announcement on any matter that requires disclosure in the future.

Outline of the Collaboration Partner

Name of the Collaborator: Division of Regenerative Medicine, The Institute of Medical Science Adress:4-6-1 Shirokanedai Minato-ku, Tokyo, 108-8639, Japan

Representative: Professor Taniguchi Hideki

* UDCs

UDCs are iPS cells created using gene-editing technology that allows them to avoid and / or reduce the body's immune rejection response. The production of Healios' UDCs involve the removal of certain HLA genes that elicit a rejection response, the introduction of an immunosuppression gene to improve immune evasion, and the addition of a suicide gene serving as a safety mechanism, each in an allogeneic iPS cell. This next-generation technology platform allows for the creation of regenerative medicine products with enhanced safety and a lower risk of immune rejection, while preserving the inherent ability of iPS cells to replicate themselves continuously and their pluripotency in differentiating into various other kinds of cells.

About the Division of Regenerative Medicine, The Institute of Medical Science:

Regenerative medicine is a challenging scientific field that is going to convert the pioneering knowledge of developmental biology and stem cell biology to clinical application. For patients with end-stage organ failure, organ transplantation is the only effective treatment; however, the paucity of transplantable organs hinders the application of this treatment for most patients. Recently, regenerative medicine with transplantable organs has attracted attention. Our laboratory is developing a novel therapeutic strategy to substitute organ transplantation. We have established novel organoid culture technologies to reconstruct human organs from stem cells, including human induced pluripotent stem cells (iPSCs), and we are going to realize transplantation of human liver primordia (liver buds [LBs]) generated from iPSCs for the treatment of liver diseases. https://stemcell-imsut.org/laboratory/?id=en#labo1

About Healios:

Healios is Japan's leading clinical stage biotechnology company harnessing the potential of stem cells for regenerative medicine. It aims to offer new therapies for patients suffering from diseases without effective treatment options. Healios is a pioneer in the development of regenerative medicines in Japan, where it has established a proprietary, gene-edited "universal donor" induced pluripotent stem cell (iPSC) line to develop next generation regenerative treatments in immuno-oncology, ophthalmology, liver diseases, and other areas of severe unmet medical need. Healios' lead iPSC-derived cell therapy candidate, HLCN061, is a next generation NK cell treatment for solid tumors that has been functionally enhanced through gene-editing. Its near-term pipeline includes the somatic stem cell product HLCM051, which is currently being evaluated in Japan in Phase 2/3 and Phase 2 trials in ischemic stroke and acute respiratory distress syndrome (ARDS), respectively. Healios was established in 2011 and has been listed on the Tokyo Stock Exchange since 2015 (TSE Mothers: 4593). https://www.healios.co.jp/en .

Contact:

Department of Corporate Communications, HEALIOS K.K.

E-mail:ir@healios.jp

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New gene- and cell-therapy manufacturing facility to launch in Hamilton with $580-million commitment – The Globe and Mail

April 2nd, 2022 1:48 am

Ontario says it will provide a $40-million loan to the Centre for Commercialization of Regenerative Medicine for its planned $580-million Hamilton facility where life-science companies can develop and commercialize cell and gene therapies.

The CCRM, a non-profit industry group, said Thursday that the facility will be run by a new subsidiary called OmniaBio Inc., which will operate what it hopes to become the largest contract development and manufacturing facility for these therapies in Canada. Up to 2,000 people could be employed at the planned 400,000-square-foot facility by 2026, and it is expected to it take on life-sciences companies of all sizes as clients.

The Alliance for Regenerative Medicine, an international advocacy group for the sector, said in 2021 that there are nearly 1,200 cell- and gene-therapy developers worldwide with more than 1,300 continuing clinical trials. This growing field of therapies treats or prevents diseases with technologies that alter genes or cells in the human body.

CCRM said the new facility would help improve the supply of cells and other biological tools for these therapies and trials in a market where demand for them is five times greater than whats currently available.

Michael May, the chief executive officer of CCRM, said in an interview that his organization has been working toward such a facility since launching nearly a decade ago. From Day 1, we understood that to drive commercialization and create companies that stay in Ontario, we needed to build manufacturing capability and capacity, he said.

The organization has built that capacity gradually, including through a partnership with the MaRS Discovery District entrepreneurship centre and the University Health Network to manufacture therapeutics for use in clinical trials. CCRM has been working over the past three years on developing the Hamilton facility, which was first announced in 2020. There is already a pipeline of potential customers, added Mr. May, who is also OmniaBios chair.

Of the $580-million costs, he said that $480-million would come from the private sector for real estate and construction at the McMaster Innovation Park. The remaining $100-million would be directed toward OmniaBios operations, and includes the $40-million loan from the province and a further $60-million from the private sector.

Economic Development Minister Vic Fedeli said that OmniaBio was the first-ever client for the provinces new Invest Ontario agency, which has earmarked $400-million to encourage businesses to set up in the province over the next four years. He told The Globe and Mail that he hoped the loan would be a signal to other businesses that his government wants to establish Ontario as a biomanufacturing hub.

It tells all of the vaccine and medical manufacturers that were open for business, he said. But it also tells the Ontario patients that theyre going to be able to have access to breakthrough technology, innovative medicines, right here with a with a made-in-Ontario stamp on it.

The provincial Progressive Conservatives used the Thursday OmniaBio news to announce they would make efforts to encourage life-sciences companies to set up in Ontario, establishing a council of medical experts and private-sector leaders to guide its work. The government said it plans to bring more vaccine, medicine, personal-protective-equipment and medical-supply manufacturing to the province.

The province also said it would work to encourage more Ontario businesses to commercialize their research, and to more easily allow locally made innovations to be used in the health care system removing roadblocks that Mr. Fedeli acknowledged in March could be a problem for innovators in the province.

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