Google Reverses Ban on Ads for All Stem Cell Therapies, Will Allow FDA-Approved Ones – Gizmodo Australia

Google announced Monday it will allow ads for stem cell treatments approved by the Food and Drug Administration to appear in search results starting in July. The tech giant previously banned any ads for stem cell therapies, FDA-approved or otherwise.

In an update to its policies page first spotted by Gizmodo, the company said that, starting July 11, it will permit search engine ads for stem cell therapies given the thumbs up from the FDA, a very small list of just 23 companies that treat some blood disorders and cancers, according to the FDAs website.

At the same time, Google is clarifying its policy language on stem cell therapy ads, which would allow a global cell or gene therapy company to advertise if the ads are are exclusively educational or informational in nature, regardless of regulatory approval status. Google did not clarify what would constitute educational or informational, nor did the company respond to a request for comment how it will restrict less-than-reputable products from being advertised with its technology going forward. We will update the story if we hear more.

The search engine said it banned all advertising for stem cell treatments back in 2019, proclaiming at the time it was restricting ads that have no established biomedical or scientific basis. In 2021, the company clarified that it was restricting ads for experimental treatments meant for so-called biohacking or other DIY genetic engineering, as well as any cell or gene therapies like stem cell therapy.

Despite the pledge to ban such ads or Mondays announced change, a simple Google search reveals just how easily bad actors can get around the restrictions. Searching for stem cells for neuropathy reveals several misleading ad results for stem cell treatments that are not FDA approved, though at least one maker claims it is FDA registered and another says its treatment is supported by FDA master files.

Paul Knoepfler, a professor at the University of California Davis School of Medicine who researches stem cells and cancer, has written before about Googles problematic search engine ad policies that allow stem cell companies to easily advertise their products in spite of the tech giants rules. In an email, he told Gizmodo he is concerned How effectively the new rule for strictly educational ads would be maintained, particularly given the context of Google Search now so often highly ranking promotional clinic websites arguably presented as educational material.

Stem cells as an industry have grown rapidly in recent years and are expected to continue doing so, with MarketWatch reporting in February the $US2.75 ($4) billion industry is expected to more than double to $US5.72 ($8) billion by 2028.

Stem cell treatments are approved by the FDAs Cellular, Tissue and Gene Therapies Advisory Committee. Though some companies claim in advertising they have FDA approval, being listed on clinicaltrials.gov database or being registered with the FDA isnt full-on approval, according to the agencys guidelines. The fact that companies regularly run around Googles existing policies leaves even more questions on the table. Knoepfler asked whether clinical trial recruitment be allowed, when hes often seen such trials already claiming their treatment already works.

Perhaps good citizens in the regenerative medicine world want the opportunity to run such ads related to clinical trial recruitment, but even exclusively educational ads of that type with good intentions could run into ethical issues, Knoepfler added.

Shoshana Wodinsky contributed reporting.

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Google Reverses Ban on Ads for All Stem Cell Therapies, Will Allow FDA-Approved Ones - Gizmodo Australia

SHORELINE BIOSCIENCES TO PRESENT TWO POSTERS ON INK CELL PLATFORM AT 19TH MEETING OF THE SOCIETY FOR NATURAL IMMUNITY (NK2022) – PR Newswire

SAN DIEGO, May 10, 2022 /PRNewswire/ -- Shoreline Biosciences, Inc. (Shoreline), a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells (iPSCs) utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms, today announced that it will present two posters at the 19thMeeting of the Society for Natural Immunity (NK2022), taking place May 14 17,2022at theHyatt Coconut Point in Bonita Springs, Florida. Shoreline will present two posters demonstrating its novel methodologies to produce iNK cells.

"We are pleased to present our proprietary CAR-NK and iNK methodologies at the NK2022 meeting, which adds to Shoreline's growing contribution to the advancement of the cellular immunotherapy field," said Robert Hollingsworth, Ph.D., CSOof Shoreline. "We believe we can improve upon existing CAR-NK and CAR-T therapies with our novel approach, and we look forward to building our pipeline of iPSC-derived programs and preparing for our next steps as a clinical company."

Details of the poster presentations are below:

Title:"Development of an iPSC-derived NK cell screening platform for discovery of NK cell optimized Chimeric Antigen Receptors (CARs) for next-generation CAR-NK cell immunotherapies"Poster Number: 56, Poster Session I Date: Sunday, May 15, 2022

Title:"A novel method to produce clinical scale induced pluripotent stem cell-derived natural killer (iPSC-NK) cells with improved anti-tumor activity for next-generation allogenic cell therapies"Poster Number:185, Poster Session II Date: Monday, May 16, 2022

For more information, please visit the NK2022 meeting website at NK2022.

About Shoreline Biosciences

Shoreline Biosciences is a biopharmaceutical company developing next-generation cellular immunotherapies based on induced pluripotent stem cells, or iPSCs, utilizing its proprietary iPSC-derived natural killer (iNK) cell and macrophage (iMACs) platforms. The company's platforms are built on a deep understanding of iPSC differentiation, immune cell biology and genetic engineering that enable the development of specific effector cell types, including iNK cells and iMACs as allogeneic "off-the-shelf" cellular immunotherapies designed for durability, scalability, safety and efficacy. Shoreline is advancing a pipeline of programs towards the clinic, on its own and with its strategic partners, Kite, a Gilead Company, and BeiGene, a global pharmaceutical company. Shoreline Biosciences is headquartered inSan Diego, CA.

For more information, please visithttps://shorelinebio.com/and engage with us onLinkedIn.

SOURCE Shoreline Biosciences, Inc.

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SHORELINE BIOSCIENCES TO PRESENT TWO POSTERS ON INK CELL PLATFORM AT 19TH MEETING OF THE SOCIETY FOR NATURAL IMMUNITY (NK2022) - PR Newswire

Medical tourists are travelling the world in search of the elixir of life – The Guardian

Every year millions of people cross borders to undergo medical treatments that are either unavailable in their home country or too expensive. For many, this is a last resort to ease the pain of a debilitating disease or defy a terminal diagnosis; for others the goals are purely cosmetic. But in the past few years a new type of medical tourist has emerged: those seeking to radically extend their lives.

There are more older people than ever before and more people in search of longevity. In the UK, people over the age of 65 made up 19% of the population in 2019, a jump of 23% from 2009, in a period when the total population only increased by 7%. And recent advancements in the science of ageing have given them hope that they dont have to go so gently into that good night after all.

But while science has made some promising breakthroughs in studying the causes and implications of ageing, real solutions are some way off. In that gap between supply and demand, a host of fraudsters and scam artists are ready to take advantage of anyone gullible enough to believe they can pay a little extra for a few extra years among the living. Many offer their services abroad, in countries where regulation is light.

Medical tourism has produced a steady stream of horror stories since cheaper air travel kickstarted a rise in its popularity, from botched nose jobs and broken smiles to a fair number of deaths. Despite this, it remains a gigantic industry. According to Patients Beyond Borders, the global medical tourism market was worth $74bn-$92bn (59bn-73bn) in 2019.

A prime example is stem cell therapies, regenerative treatments aiming to use the bodys building-block cells to rejuvenate and fix damage caused by disease or deterioration an area of research with a lot of potential but relatively few established and approved treatments available to patients. However, the potential effects, most often exaggerated or unsubstantiated, lure the desperate to travel far and wide to seek treatments, sometimes from practitioners of ill repute. According to research published last year, the leading countries for stem cell tourism are the US, China, India, Thailand and Mexico. The same report states that stem cell technologies are often associated with inflated expectations of their therapeutic potential.

Stem cell therapies can also help with cancer and other illness, but during my reporting for my book The Price of Immortality: The Race to Live Forever, I found a number of examples of US-based stem cell companies offering miracle cures and solutions to ageing. One clinic in Iowa was found to have made outrageous claims in presentations to potential clients. Anti-Aging: Mesenchymal Stem Cell infusions turned back the hands of Father Time about three years! Would you like to get back three years? read one slide of sales material, collected by the state attorney generals office that was suing the company for false advertising.

Even when prosecuted or disciplined in one country, stem cell practitioners have been known to move on and continue to offer the same services elsewhere. One in Florida had his medical licence revoked in 2015, after two of his patients undergoing stem cell therapy had died. When I looked up the name of the doctor, he was listed as the chief science officer at another stem cell company. A cheerful receptionist told me on a call that the clinic was still operational and carrying out procedures in the Dominican Republic, a medical tourism hotspot.

Stem cell therapies are not the only anti-ageing offerings luring people abroad for treatment. The nascent field of gene therapies is in a similar position, where promising research has yet to result in accessible interventions. I also recently heard from a life extension enthusiast in the US who planned to travel to France to undergo plasmapheresis, a procedure he claimed would rejuvenate his blood and give him a better chance of living until he was 500.

In some cases, patients dont need even need to fly abroad to access drugs that have the potential to make them live longer. I spoke to an elderly woman in London who buys the cancer drug dasatinib from a website in India, and takes it in the hope it will destroy senescent cells, which are thought to play an integral role in the ageing process.

Gerontologists and other researchers find the practice frustrating. Several scientists I spoke to, particularly in the stem cell field, are worried these clinics are making a quick buck on the back of their breakthroughs while damaging the reputation of these nascent medical technologies. They preach patience, a virtue in short supply for people who see the end of their lives on the horizon.

Medical tourism presents clear dangers. Patients may not find the same standard of care they are used to at home, and it is harder to establish that the doctor or clinic is legitimate. Patients can also suffer from side-effects if they fly home too early after a procedure; communication barriers can also cause issues.

For someone seeking treatment they cant afford at home or a last-gasp unapproved cure for a deadly disease, these risks are worth taking. But for people merely seeking to improve their chances of living radically extended lives, the gamble is much larger, particularly when theres no evidence that any medical intervention could work. In a best-case scenario, they leave with a lighter wallet. In the worst, their quest to live a little longer is cut ironically short.

The Price Of Immortality by Peter Ward (Melville House, 20). To support The Guardian and Observer, order your copy at guardianbookshop.com. Delivery charges may apply.

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Medical tourists are travelling the world in search of the elixir of life - The Guardian

ONCOLOGY INSTITUTE, INC. – 10-Q – Management’s Discussion and Analysis of Financial Condition and Results of Operations – Insurance News Net

The following discussion and analysis provides information that managementbelieves is relevant to an assessment and understanding of the consolidatedresults of operations and financial condition of The Oncology Institute, Inc.("TOI") along with its consolidating subsidiaries (the "Company"). Thediscussion should be read together with the unaudited consolidated financialstatements and the related notes that are included elsewhere in this Report. Theinformation in this discussion contains forward-looking statements within themeaning of Section 27A of the Securities Act of 1933, as amended, and Section21E of the Securities and Exchange Act of 1934, as amended. Such statements arebased upon current expectations, as well as management's beliefs and assumptionsand involve a high degree of risk and uncertainty. Any statements containedherein that are not statements of historical fact may be deemed to beforward-looking statements. Statements that include the words "believes,""anticipates," "plans," "expects." "intends," and similar expressions thatconvey uncertainty of future events or outcomes are forward-looking statements.Our actual results could differ materially from those discussed or suggested inthe forward-looking statements herein. Factors that could cause or contribute tosuch differences include those described under the heading "Risk Factors" in ourAnnual Report on Form 10-K for the year ended December 31, 2021. In addition, asa result of these and other factors, our past financial performance should notbe relied on as an indication of future performance. All forward-lookingstatements in this document are based on information available to us as of thefiling date of this Quarterly Report on Form 10-Q and we assume no obligation toupdate any forward-looking statements or the reasons why our actual results maydiffer. All dollar values are expressed in thousands, unless otherwise noted.

Overview

Public Company Costs

Impact of COVID-19

Key Factors Affecting Performance

a recruiting process focused on selecting physicians that want to practice evidence-based medicine;

technology-enabled care pathways ensuring adherence to evidence-based clinical protocols;

strong clinical culture and physician oversight;

care delivered in community clinics versus hospital setting;

clinically appropriate integration of palliative care and hospice aligned with patients' goals for care;

access to clinical trials providing cutting-edge treatment options at low or no cost to patients or payors; and

appropriate provider training on clinical documentation to ensure proper risk adjustment and reimbursement for complex patients.

Key Business Metrics

$ 69

(1) Includes independent oncology practices to which we provide limited management services, but do not bear the operating costs.

The Company defines adjusted EBITDA as net income (loss) excluding:

Depreciation and amortization,

Changes in fair value of liabilities,

Stock-based compensation,

Practice acquisition-related costs,

Consulting and legal fees,

Public company transaction costs, and

Other specific charges.

The Company includes adjusted EBITDA because it is an important measure upon which our management uses to assess the results of operations, to evaluate factors and trends affecting the business, and to plan and forecast future periods.

Components of Results of Operations

Revenue

Capitation

Fee-for-service revenue

Clinical trials revenue

Dispensary cost

Dispensary cost primarily includes the cost of oral medications dispensed in the TOI PCs' clinic locations.

Selling, general and administrative expense

Results of Operations

Comparison of the Three Months Ended March 31, 2022 and 2021

Dispensary

Clinical trials & other

The increase in clinical trials and other revenue was primarily due to an increase in clinical trials volumes which were negatively impacted in the prior year due to the COVID-19 pandemic.

Dispensary cost

Selling, general and administrative expense

The decrease in interest expense was due to the pay-off of our term loan balance in Q4 2021.

Change in fair value of liabilities

Gain on debt extinguishment

Other, net

The change in other, net was primarily due to Provider Relief Funding under the CARES Act received during the three months ended March 31, 2021.

Liquidity and Capital Resources

General

Cash Flows

The following table presents a summary of the Company's consolidated cash flows from operating, investing, and financing activities for the periods indicated.

Cash and restricted cash at end of period $ 95,534 $ 27,412

Cash used by accounts payable, accrued expenses and income taxes payable increased $3,371 for the three months ended March 31, 2022 as compared to the three months ended March 31, 2021 primarily due to an increase in vendor payables due to the growth in the Company's business; and

Material Cash Requirements

Total material cash requirements $ 9,728 $ 14,264

$ 5,817 $ 2,505 $ 32,314

(1) Other is comprised of finance leases and directors and officers insurance premiums.

Leases

Variable Interest Entities

Segment Reporting

1.Identification of the contract, or contracts, with a customer.

2.Identification of the performance obligations in the contract.

3.Determination of the transaction price.

4.Allocation of the transaction price to the performance obligations in the contract.

5.Recognition of revenue when, or as, the entity satisfies a performance obligation.

Capitation

Fee For Service

Clinical Research

Direct Costs of Sales

Goodwill and Intangible Assets

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ONCOLOGY INSTITUTE, INC. - 10-Q - Management's Discussion and Analysis of Financial Condition and Results of Operations - Insurance News Net

The Oncology Institute Reports First Quarter 2022 Financial Results and Confirms Full Year 2022 … – KULR-TV

CERRITOS, Calif., May 11, 2022 (GLOBE NEWSWIRE) -- The Oncology Institute, Inc. (NASDAQ: TOI), one of the largest value-based community oncology groups in the United States, today reported financial results for its first quarter ended March31, 2022.

"We are pleased with the results we achieved in Q1 2022, driven by our expansion in new markets and continued investment in a value-based approach to oncology. Our financial results reflected strong growth, with Q1 2022 revenue of $55 million, growing 14% compared to Q1 2021. We were thrilled to announce three new value-based partnerships in Q1 2022, one of which is with a new partner, MaxHealth in the Tampa and St. Petersburg markets, which has great potential for growth in the future, said Brad Hively, CEO of TOI. We also launched our 11th market in Polk County, Florida and opened a new clinic in Culver City, California as we continue to solidify our position in the Los Angeles market. We also recently announced our acquisition of Womens Cancer Care in Fresno, which will be our 12th market. We continue to strengthen our M&A pipeline which is expected to lead to positive growth throughout the rest of 2022. We are optimistic about the year ahead and continue to see strong partnership demand for our innovative model of oncology care."

First Quarter 2022 Operational Highlights

Initiated three new value-based partnerships, including our third gain share contract in Florida with MaxHealthHired five new clinicians, ending the period with 84 clinicians, representing a 24% growth compared to Q1 2021Commenced expansion of our radiation oncology site in Long Beach, California, added a new Radiation Oncology Medical Director and expanded our payor contractsOpened two new de novo clinics in Culver City, California and Polk County, Florida

First Quarter 2022 Results

Consolidated revenue for Q1 2022 was $55 million, a 13.5% increase compared to Q1 2021.

Revenue for the Patient Services segment was $35 million, up 18.3% compared to Q1 2021. Growth in Patient Services was driven by an increase in capitated contracts entered into in the latter half of 2021 as well as growth in FFS revenue due to practice acquisitions in Q4 2021 and an overall increase in clinic count. Dispensary revenue growth lagged the growth in Patient Services largely due to the Medical Rx transition. Despite the Medical Rx transition, dispensary revenue increased 6.0% compared to Q1 2021 due to an increase in the average revenue per script fill. Clinical Trials & Other revenue increased by 6.3% year-over-year due to an increase in clinical trials volumes.

Gross profit in Q1 2022 was $12 million, an increase of 20.8% compared to Q1 2021. The increase was driven by improved cost management of our oral and IV drugs and enhanced rebate opportunities.

SG&A expenses in Q1 2022 were $30 million or 54.0% of revenue, compared with $11 million, or 23.0% of revenue, in the same quarter last year. During Q1 2022, share-based compensation expense was $9 million and SG&A related to transaction costs was $1 million. The remainder of the SG&A growth was due to headcount and other costs associated with operating as a public company and to support revenue growth.

Net income for Q1 2022 was $19 million, increasing $20 million over the same quarter last year primarily due to the change in the fair value of the earnout liabilities. Adjusted EBITDA was $(5) million, a decrease of $5 million compared to Q1 2021, primarily as a result of our growth in SG&A as we prepare for expansion into new markets, as well as SG&A expenses necessary for TOI to operate as a public company.

2022 Outlook

Results for the first quarter of 2022 came in as expected and our outlook for 2022 remains unchanged.

(1) Adjusted EBITDA is a non-GAAP metric. See "Financial Information: Non-GAAP Financial Measures" below. TOI is not reasonably able to provide a reconciliation to net (loss) income due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, which cannot be done without unreasonable efforts, including uncertainties regarding taxes, share-based compensation and other non-cash items. TOI expects interest expense in the range of $0.5 million and $1 million, other adjustment add backs in the range of $4 million and $6 million and depreciation and amortization in the range of $4 million and $6 million. TOI is not adding back new clinic startup or acquisition cost for this non-GAAP metric. The presentation of this financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. The Company's fiscal 2022 adjusted EBITDA guidance is merely an outlook and is not a guarantee of future performance. Stockholders should not rely or place an undue reliance on such forward-looking statements. See "Forward-Looking Statements" below for additional information.

(2) Represents lives under capitation and gain sharing contracts. Our achievement of the anticipated results is subject to risks and uncertainties, including those disclosed in our filings with the SEC. The outlook does not take into account the impact of any unanticipated developments in the business or changes in the operating environment, nor does it take into account the impact of our acquisitions, dispositions or financings during 2022. Our outlook assumes a largely reopened global market, which would be negatively impacted if closures or other restrictive measures persist or are reimplemented.

Webcast and Conference Call

TOI will host a conference call on Wednesday, May 11, 2022 at 5:00 p.m. (Eastern Time) to discuss first quarter results and managements outlook for future financial and operational performance.

The conference call can be accessed live over the phone by dialing 1-877-407-0789, or for international callers, 1-201-689-8562. A replay will be available two hours after the call and can be accessed by dialing 1-844-512-2921, or for international callers, 1-412-317-6671. The passcode for the live call and the replay is 13728629. The replay will be available until May 18, 2022.

Interested investors and other parties may also listen to a simultaneous webcast of the conference call by logging onto the Investor Relations section of TOI's website at https://investors.theoncologyinstitute.com.

About The Oncology Institute, Inc.

Founded in 2007, TOI is advancing oncology by delivering highly specialized, value-based cancer care in the community setting. TOI offers cutting-edge, evidence-based cancer care to a population of approximately 1.5 million patients including clinical trials, stem cell transplants, transfusions, and other care delivery models traditionally associated with the most advanced care delivery organizations. With 80+ employed clinicians and more than 600 teammates in over 50 clinic locations and growing, TOI is changing oncology for the better. For more information visit http://www.theoncologyinstitute.com.

Forward-Looking Statements

This press release includes certain statements that are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally are accompanied by words such as preliminary, believe, may, will, estimate, continue, anticipate, intend, expect, should, would, plan, project, predict, potential, guidance, approximately, seem, seek, future, outlook, and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding projections, anticipated financial results, estimates and forecasts of revenue and other financial and performance metrics and projections of market opportunity and expectations. These statements are based on various assumptions and on the current expectations of TOI and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by anyone as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Many actual events and circumstances are beyond the control of TOI. These forward-looking statements are subject to a number of risks and uncertainties, including the accuracy of the assumptions underlying the 2022 outlook discuss herein, the outcome of judicial and administrative proceedings to which TOI may become a party or governmental investigations to which TOI may become subject that could interrupt or limit TOIs operations, result in adverse judgments, settlements or fines and create negative publicity; changes in TOIs clients preferences, prospects and the competitive conditions prevailing in the healthcare sector; failure to continue to meet stock exchange listing standards; the impact of COVID-19 on the TOIs business; those factors discussed in the documents of TOI filed, or to be filed, with the SEC, including the Item 1A. "Risk Factors" section of TOI's Annual Report on Form 10-K for the year ended December 31, 2021. If the risks materialize or assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that TOI does not presently know or that TOI currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. In addition, forward-looking statements reflect TOIs, plans or forecasts of future events and views as of the date of this press release. TOI anticipates that subsequent events and developments will cause TOIs assessments to change. TOI does not undertake any obligation to update any of these forward-looking statements. These forward-looking statements should not be relied upon as representing TOIs assessments as of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Financial Information; Non-GAAP Financial Measures

Some of the financial information and data contained in this press release, such as Adjusted EBITDA, have not been prepared in accordance with United States generally accepted accounting principles (GAAP). TOI believes that the use of Adjusted EBITDA provides an additional tool to assess operational performance and trends in, and in comparing our financial measures with, other similar companies, many of which present similar non-GAAP financial measures to investors. TOIs non-GAAP financial measures may be different from non-GAAP financial measures used by other companies. The presentation of non-GAAP financial measures is not intended to be considered in isolation or as a substitute for, or superior to, financial measures determined in accordance with GAAP. The principal limitation of Adjusted EBITDA is that it excludes significant expenses and income that are required by GAAP to be recorded in TOI's financial statements. Because of the limitations of non-GAAP financial measures, you should consider the non-GAAP financial measures presented in this press release in conjunction with TOIs financial statements and the related notes thereto.

TOI defines Adjusted EBITDA as net (loss) income plus depreciation, amortization, interest, taxes, non-cash items, share-based comp and other adjustments to add-back the following: board fees, consulting and legal fees related to acquisitions, one-time consulting and legal fees related to certain advisory projects, software implementations and debt or equity financings, severance expense and temp labor and recruiting charges to build out our corporate infrastructure. A reconciliation of Adjusted EBITDA to net loss, the most comparable GAAP metric, is set forth below.

(1) During the three months ended March 31, 2022, non-cash addbacks were primarily comprised of bad debt write-offs of $154, non-cash rent of $29 and other miscellaneous charges of $14. During the three months ended March 31, 2021, non-cash addbacks were primarily comprised of a $13 tenant improvement allowance.

(2) Practice acquisition-related costs were comprised of consulting and legal fees incurred to perform due diligence, execute, and integrate acquisitions of various oncology practices.

(3) Consulting and legal fees were comprised of a subset of the Companys total consulting and legal fees during the three months ended March 31, 2022 and 2021, and related to certain advisory projects, software implementations, and legal fees for debt financing and predecessor litigation matters.

(4) Other, net is comprised of severance expenses resulting from cost rationalization programs of $18 and $0, as well as temporary labor of $485 and $223, recruiting expenses to build out corporate infrastructure of $424 and $155 and other miscellaneous charges of $26 and $0 during the three months ended March 31, 2022 and 2021, respectively. During the three months ended March 31, 2022 and 2021 such expenses were partially offset by $0 and $1,023, respectively, of stimulus funds received under the CARES Act.

(1) Includes independent oncology practices to which we provide limited management services, but do not bear the operating costs.

Condensed Consolidated Balance Sheets (in thousands except share data)

Condensed Consolidated Statements of Income (Operations) (Unaudited) (in thousands except share data)

Condensed Consolidated Statements of Cash Flows (Unaudited) (in thousands)

Contacts

Media The Oncology Institute, Inc. Julie Korinke juliekorinke@theoncologyinstitute.com (562) 735-3226 x 88806

Revive Michael Petrone mpetrone@reviveagency.com (615) 760-4542

Investors Solebury Trout investors@theoncologyinstitute.com

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The Oncology Institute Reports First Quarter 2022 Financial Results and Confirms Full Year 2022 ... - KULR-TV

Tackling chronic disease with gene and cell therapies – The Irish Times

The repair of old, damaged, or diseased tissues using gene or cell therapies promises a future where people live longer, healthier lives and Ireland is well placed to become a manufacturing hub for products based on this technology.

Gene therapy is the technology used to correct a gene defect that is causing an inherited genetic disease. Cell therapy is the use of living cells from the patient or a donor, to repair tissue or treat an inflammatory condition or disease. These therapies can be used alone or combined for greater effect.

Weve been interested, for a very long time in the development of new treatments for patients involving cell and gene therapy, says professor of cellular therapy at NUI Galway Frank Barry a co-founder of the Regenerative Medicine Institute (Remedi) in 2004.

Over the last several decades there have been some extraordinary, transformative developments in medicine; for example, antibiotics and monoclonal antibodies and these have had a dramatic impact on how diseases were treated, says Barry. Many people believe that cell and gene therapy represent the next transformative innovation that will change medicine.

There are many examples of outstanding success stories, where diseases which were previously untreatable are now actually being treated and were very anxious to continue to play a role in this, says Barry.

The combination of cell and gene therapy has been successful in treating cancers that were thought incurable. For example, stem cells have been taken from the blood of patients with specific cancers, genetically modified so they target a particular cancer, and are delivered back into the patients blood.

Gene therapy has had a troubled history with some adverse outcomes reported from early clinical trials two decades ago. Most notably, and tragically, was the case of 18-year-old Jesse Gelsinger, who died in 1999 during a University of Pennsylvania run gene therapy trial. Jesse suffered from a genetic disease affecting his liver which meant that he was unable to metabolise ammonia.

The learnings from that have proven to be very helpful not to diminish the impact of his death on his family and the tragedy of that, says Prof Tim OBrien, head of medicine at NUI Galway, an Irish pioneer of this field.

In Ireland, the origins of cell and gene therapy research go back to 2004, when Remedi was set up with funding from Science Foundation Ireland (SFI). Then in 2014, the Centre for Cell Manufacturing in Ireland (CCMI) was established. Barry and OBrien have been the key figures driving the process.

From the beginning, the dream of Barry and OBrien was to convert promising gene and cell therapy research into new therapies that could then be tested in clinical trials. Galway was a good place to do it, as it was known as a leading hub for medical device research and manufacturing, and it had the laboratories, hospital tissue facilities and clinical trial expertise that would be required.

Almost two decades down the road, the next step, they say, requires putting in place a national plan for developing a cell and gene therapy industry across the island similar to what has been achieved for medical devices and other high areas dependent on advanced technology, like ICT and pharmaceuticals. The UK offers a model of what can be achieved as it benefits from a decision by government to heavily invest in gene and cell therapy 15 years ago through an independent body it established called the Cell and Gene Therapy Catapult.

The opportunity for gene and cell therapy to grow here in coming years helped attract Dr Meadhbh Brennan, a post-doctoral researcher at Harvard University, back to Ireland. She also worked at the National Institute of Health and Inserm in France before returning to NUIG to set up her own research group.

In France, Brennan had worked on a clinical trial using stem cells to treat bone defects, while in the US her research focused on factors secreted by stem cells which could be used as a therapeutic. While in the US, she was awarded funding from SFI and that provided impetus for her move home, to take up a position at NUIG working at the interface between engineering and medicine.

She has a European Research Council starting grant award to investigate ways of regenerating bone defects, building on her work in this area. There are more than one million bone grafting procedures performed annually in Europe, and after blood, bone is the most transplanted tissue. There are issues with these procedures, however, as bone tissue is limited in quantity and quality and there is often pain at the surgical site for patients.

Brennan and her team are seeking alternatives to bone grafting through the use of byproducts from the manufacturing of stem cells called extracellular vesicles (EVs). These EVs are tiny biological packages that each contain a therapeutic cargo that has been shown to be capable of enhancing healing processes in tissues by delivering healing messages from cell to cell.

Up to now, EVs have been disposed of as waste products from commercial stem cell manufacturing. We want to divert these discarded products and harness their therapeutic potential, Brennan says, This will make the whole stem cell manufacturing process more efficient and sustainable.

Remedi scientists have experience running patient cell therapy trials, with a trial to treat arthritis of the knee using patients own cells having finished and its results set to be reported during 2022. We dont have the formal results yet, but every piece of information that weve seen about this kind of effort suggests that there is a positive benefit associated with delivering cells to these arthritic joints, Barry says. The next step would be to conduct a larger, well controlled, multinational trial of the therapy, which could be led in Ireland.

There is a huge need for new therapies to treat bone defects, given that about 10 per cent of all bone fractures wont heal if left alone, while bone infection and surgery can leave big voids in bone that need to be healed. This is where new approaches based on EVs can come in, says Brennan. These tiny particles hold huge promise for regenerating not only bone tissue, but also older tissues and organs, and have healing potential in other diseases too.

A key challenge to sort out with EV-based therapies is to find a way to safely transport them from the stem cell manufacturing facility to the clinic. Brennan and her team are investigating ways to allow the vesicles to be stored for longer durations at room temperature. The ultimate goal is to develop novel EV treatments that are inexpensive and available off the shelf when a patient has an injured or damaged tissue or needs an anti-inflammatory treatment.

The whole idea about these technologies is that they are regenerative, stimulate repair or correct defects which are chronic, Barry notes. If they work then you are saving years and years of care associated with chronic illness. The economics of this make an awful lot of sense, and the investment that is needed is very much worth it in terms of the long term.

This is a huge new industry which is exploding worldwide and will require advanced manufacturing capacity in all corners of the world, Barry points out. There is an opportunity for Ireland to become a major centre of this, and we have the people, expertise, and infrastructure to allow the industry to develop here. We need to move with lightning speed to capture the opportunity.

The idea of Ireland becoming a global hub for cell and gene therapy and manufacturing is something we should talk about seriously, he adds.

Read more here:
Tackling chronic disease with gene and cell therapies - The Irish Times

Gamida Cell Announces Results of New Health Economic and Outcome Study Reporting Improved Health Equity – BioSpace

BOSTON--(BUSINESS WIRE)-- Gamida Cell Ltd.. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with solid and hematological cancers and other serious diseases, today announced the results of a new study demonstrating the potential impact of access to omidubicel on health disparities in allogeneic hematopoietic stem cell transplant in a poster presentation at the 2022 Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR Tandem Meetings (TCT), being held in Salt Lake City, UT, April 23-26, 2022.

The study, titled Projected Impact of Omidubicel on Racial and Ethnic Disparities in Allogeneic Hematopoietic Cell Transplant Access and Outcomes for Patients with Hematologic Malignancies in the US, leveraged a decision-tree model to project allo-HCT access and clinical outcomes in a hypothetical population of 10,000 allo-HCTeligible patients in the U.S. with hematologic malignancies without an available match-related donor. The study concluded that broad use of omidubicel will extend access for allo-HCT-eligible patients, decrease time to transplant and improve clinical outcomes, notably among racial and ethnic groups with worse status quo outcomes. Projected increases in one-year overall survival ranged (with 20% omidubicel use among allo-HCTeligible patients) from 2.5% for whites patients to 6.3% for Black patients. The study also concluded that higher levels of modeled omidubicel uptake were associated with greater improvements in clinical outcomes and greater reductions in racial disparities.

Previous studies indicate that non-white patients have a lower likelihood of finding an appropriate match in the U.S. public donor registries, with Black patients have a 16-20% chance of finding an appropriate match. Given that an allogeneic stem cell transplant is intended as a curative option, if patients cannot find an appropriate match they will not have access to allogeneic stem cell transplant, a potentially curative treatment. The Phase 3 study of omidubicel demonstrated the ability of the therapy to be used as a donor source for racially and ethnically diverse patients with 40% of patients enrolled in the study being non-white.

Today, minority groups comprise only about 30% of all allogeneic hematopoietic stem cell transplant transplants, indicating that lack of access to a matched donor is a significant barrier to treatment in the current landscape, said Julian Adams, Ph.D., Chief Executive Officer of Gamida Cell. This study is encouraging in that it projects that broad access to omidubicel has the potential to open up allo-HSCT as an effective treatment for more patients and address the barriers that have contributed to this alarming health disparity. These data are particularly encouraging as we continue to advance our rolling BLA submission to the FDA and move closer to bringing the therapy to more patients in need.

Gamida Cell initiated a rolling Biologics License Application (BLA) submission for omidubicel in the first quarter of 2022 and is on-track to complete submission of all modules of the BLA in the second quarter of 2022.

In addition to this poster, two oral presentations and four additional poster presentations on omidubicel and a poster presentation on GDA-201, the companys leading NK cell therapy program, will be shared during the conference. All poster presentations will be publicly available at http://www.ASTCT.org. Details below:

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status and orphan drug designation by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). For more information on clinical trials of omidubicel, please visit the Gamida Cell website.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we are able to enhance, expand and metabolically modulate multiple cell types including stem cells and natural killer cells with appropriate growth factors to maintain the cells active phenotype and enhance potency. This allows us to administer a therapeutic dose of cells that may help cancer patients live longer better lives.

About Gamida Cell

Gamida Cell is pioneering a proprietary NAM-enabled immunotherapy pipeline of diverse potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. We apply a proprietary platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK cells to create therapies with potential to redefine standards of care. These include omidubicel, an investigational product with potential as a life-saving alternative for patients in need of transplant, and a line of modified and unmodified NAM-enabled NK cells targeted at solid tumor and hematological malignancies. For additional information on Gamida Cell, please visit http://www.gamida-cell.com or follow Gamida Cell on LinkedIn, Twitter, Facebook or Instagram at @GamidaCellTx.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, including with respect to timing of initiation and progress of, and data reported from, the clinical trials of Gamida Cells product candidates (including GDA-201), anticipated regulatory filings and the potentially life-saving or curative therapeutic and commercial potential of omidubicel. Any statement describing Gamida Cells goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to a number of risks, uncertainties and assumptions, including those related to the impact that the COVID-19 pandemic could have on our business, and including the scope, progress and expansion of Gamida Cells clinical trials and ramifications for the cost thereof; clinical, scientific, regulatory and technical developments; and those inherent in the process of developing and commercializing product candidates that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such product candidates. In light of these risks and uncertainties, and other risks and uncertainties that are described in the Risk Factors section and other sections of Gamida Cells Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 24, 2022, as amended, and other filings that Gamida Cell makes with the SEC from time to time (which are available at http://www.sec.gov), the events and circumstances discussed in such forward-looking statements may not occur, and Gamida Cells actual results could differ materially and adversely from those anticipated or implied thereby. Although Gamida Cells forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Gamida Cell. As a result, you are cautioned not to rely on these forward-looking statements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220425005348/en/

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Gamida Cell Announces Results of New Health Economic and Outcome Study Reporting Improved Health Equity - BioSpace

We have found an antibody against cancer stem cells. Its less exciting than it seems – InTallaght

This week, a piece of news about cancer has found its way into the dense web of current political, economic and military information: an international consortium led by the Barcelona Institute for Biomedical Research (IRB) has just completed the pre-clinical studies that place the MCLA-158 antibody at the head of the race to find the first drug to target cancer stem cells from solid tumors.

Cancer stem cells? Until recently, we believed that cancer was essentially a homogeneous mass of rapidly proliferating cells. For this reason, the therapies that were emerging focused on that: on eliminating those highly proliferative cells. In recent decades, we have learned that there is enormous diversity in cancer cells. Both in proliferation and differentiation.

Whats more, in recent years, we discovered cancer stem cells. A small subset of cells that, as in the case of normal stem cells, have the capacity to renew and generate the variety of proliferating and differentiated cells that make up the bulk of the tumor. The problem is that they are not affected by the therapies we used. To put it metaphorically, we were attacking the soldiers, but the factory was still running.

How to differentiate a normal stem cell from a cancerous one? Every time we discovered this problem, researchers have focused on finding mechanisms that allow us to attack some cells without compromising the rest. In this case, MCLA-158 is a bispecific antibody that recognizes two characteristic proteins of cancer stem cells (EGFR and LGR5). The idea of the team led by Eduard Batlle is that, precisely for this reason, it should not interfere with the functioning of the bodys healthy stem cells, which are essential for the proper functioning of tissues.

Still far from the clinic. This is a very important discovery and there are indications that the data is strong, but we need to temper our enthusiasm. These are preclinical data. We have known for a long time that only 5% of all drugs that have demonstrated their effectiveness in preclinical phases reach the market. As I say, this is not an argument against this antibody; it is rather an argument against overly sensational narratives.

welcome organoids. However, there is something for which this work is interesting beyond what happens in the future: the use of organoids. The researchers built a biobank that features organoids derived from colon cancer patients, organoids from colon cancer metastases in the liver, and organoids from normal, noncancerous tissue.

Organoids explained to us a few years ago Benjamin Freedman, professor of medicine at the University of Washington and an expert in kidney organoids are collections of cells on a support, like a plate, that resemble a tissue or organ of the body . This means that, by incorporating them in the earliest phases of drug generation, he helps identify those that are effective for most patients or even for tumors that carry a particular mutation. It allows us to go faster.

At least that was what we believed. Now, with the good results of this study and the development of a clear methodology for the use of organoids, we can confirm it. In this way, the work of Batlle and his team opens the door to better, faster and more efficient cancer science. Even if the antibody ultimately failed to reach hospitals, its contribution would have been enormous.

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We have found an antibody against cancer stem cells. Its less exciting than it seems - InTallaght

I would not be here were it not for the blood: Duval residents describe impact of blood donation – Yahoo News

Community members are speaking out about the role blood donation has played in their personal lives.

This comes as Action News Jax and our Family Focus partners have teamed up for our annual Spring Into Action Blood Drive.

Jacksonville resident Penelope McGowan told Action News Jax reporter Kennedy Dendy that having the opportunity to give blood is an honor. My father needed a life-saving procedure, so it became more important to me to start giving blood, McGowan said.

She then became a regular giver, knowing the impact donation truly has.

That allowed him the time to spend time with his grandchildren, McGowan said. He walked his granddaughter down the aisle and got to see some of his great-grandchildren.

McGowan said blood donation made that moment possible.

Now that hes passed away, I want to give that gift of time to other families, McGowan said. So, its so important to me to give blood.

RELATED: OneBlood, Action News Jax team up for the Spring into Action Blood Drive

Action News Jax also spoke with John Dean, who is a patient at the Mayo Clinic. Hes from South Carolina but has been living in Jacksonville since January.

I got the bone marrow transplant, which is basically a stem cell infusion on January 17th, Dean said. I have been dealing with myelodysplastic syndrome.

Dean said its a form of bone marrow cancer hes been battling since 2017.

During that time, I had become increasingly dependent upon blood because the syndrome destroys my bodys ability to make red blood cells, Dean said. So when the blood numbers drop, I get very very sick.

He said the transplant was designed to cut down on his need to get the blood, but that hasnt happened yet.

Ive been more blood dependent since January than I had been before I came down here, Dean said.

Dean spoke with me just moments after he received a blood transfusion at the hospital -- but he wanted one message out there.

Youre transmitting a miracle, Dean said. Im a living example of that. I would not be here were it not for the blood.

Story continues

OneBlood said to donate youll need an ID, and you must be 16 years and older.

Randy Varner donated double red blood cells at Tuesdays drive.

My wife has had to have two heart valves replaced, so shes had to have blood before at the hospital -- so I try to help out when I can, Varner said.

Varner shared that if youre able to -- you should give.

Theres nothing to it, Varner said. You go in there. You answer a few questions. You lay down. You can take a little nap if you have to.

Nicole Payne is the Senior Program and Membership Director with the Brooks Family YMCA, one of the many sites for the drive.

Theres always a lack of blood available for people that come into any traumatic situation, Payne said. We want to make sure that we can hopefully combine some of the best parts of Jacksonville -- and thats through OneBlood being here to help people have access to donate.

The Spring into Action Blood Drive kicked off Tuesday and runs through Friday.

When you donate you will receive a free t-shirt, a $20 e-gift card, and an additional gift depending on the location where you donate.

CLICK HERE to find out when and where you can donate.

STAY UPDATED: Download the Action News Jax app for live updates on breaking stories

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I would not be here were it not for the blood: Duval residents describe impact of blood donation - Yahoo News

Quell Therapeutics and Cellistic enter a strategic collaboration to develop an iPSC-derived allogeneic T-regulatory (Treg) cell therapy platform – PR…

- Collaboration combines Quell's pioneering autologous multi-modular Treg cell therapy platform and Cellistic's expertise in iPSC cell therapy platform development and scale-up

- Aims to accelerate the development of a next-generation allogeneic Treg platform that could open significant opportunities for Quell's creation of off-the-shelf Treg cell therapies targeting a wide range of diseases driven by immune dysregulation

- First announced collaboration for Cellistic, Ncardia's recently formed cell therapy process development and manufacturing services business

LONDON and GOSSELIES, Belgium, April 27, 2022 /PRNewswire/ --Quell Therapeutics Ltd ("Quell"), a leader in developing engineered T-regulatory (Treg) cell therapies for serious medical conditions driven by the immune system, and Cellistic,the iPSC-focused cell therapy process development & manufacturing partner recently launched by Ncardia to make large-scale allogeneic cell therapy production a reality,announce they have entered into a strategic collaboration for the co-development of an iPSC-derived Treg cell therapy platform. The goal of the partnership is to facilitate the future expansion of Quell's autologous Treg cell therapy pipeline by adding off-the-shelf, allogeneic Treg cell therapy products, leveraging Cellistic's expertise in differentiation and scale-up of iPSC processes for allogeneic cell therapy applications.

Iain McGill, Chief Executive Officer, Quell Therapeutics,said: "Quell has made significant progress advancing the first candidate from our autologous multi-modular Treg cell therapy platform into the clinic, with the initiation of our LIBERATE study of QEL-001 to prevent liver transplant rejection. We believe there is significant opportunity to transform outcomes for patients with QEL-001 and other autologous Treg cell therapy products in our pipeline. Our collaboration with Cellistic is a key building block in our investment towards a future, next-generation allogeneic Treg cell platform, which could significantly expand our opportunities to develop novel off-the-shelf treatments across a wide range of diseases driven by immune dysregulation. We highly respect the expertise and experience of Ncardia and the Cellistic team, and its track record in developing rapidly scalable iPSC cell therapy processes."

Stefan Braam, Chief Executive Officer, Cellistic,said: "Our partnership with Quell is emblematic of why we started Cellistic to bring together our focus and expertise in the development and implementation of iPSC cell therapy platforms with companies like Quell that have an equal depth of expertise in therapeutic development and share our vision for the future of cell therapy. We are excited to collaborate with the Quell team, both to develop the platforms, and to support Quell's long-term supply needs as they deliver impactful therapeutics to patients."

Under the terms of the agreement, Quell and Cellistic will collaborate in joint research to develop a process for differentiating iPSCs into highly functional Treg cell therapy products. Quell will contribute its Treg expertise and engineering technologies, as well as characterizing resulting Treg cells, while Cellistic will be responsible for the iPSC process science and development activities.

Based on a successful research phase, the collaboration will enter a product development phase with Quell having exclusive rights under the co-developed iPSC-Treg process for the development of multiple allogeneic iPSC-Treg cell therapeutics, and Cellistic as the exclusive CDMO partner for Quell's iPSC-Treg product pipeline, leveraging Cellistic's ongoing investment in downstream GMP capabilities.

Tracey Lodie, Chief Scientific Officer, Quell Therapeutics,added: "We have learnt in cell therapy development that the continuity from the R&D phase into the manufacturing phase is a critical success factor in achieving robust, scalable cell product processes. Cellistic emerged as a best-in-class and complementary partner to enable our path to an iPSC Treg cell therapy platform, and its ongoing investment in GMP capabilities provides the potential for a long-term partnership to accelerate the future development of allogeneic Treg cell therapies for patients."

About Quell Therapeutics

Quell Therapeutics is the world leader in developing engineered T-regulatory (Treg) cell therapies that aim to harness, direct and optimize their immune suppressive properties to address serious medical conditions driven by the immune system.

The Company is leveraging its pioneering phenotype lock technology, unique multi-modular platform and integrated manufacturing capabilities to design and develop a pipeline of highly engineered Treg cell therapies with greater potential for persistence, potency and stability than earlier generations of Treg cell therapy approaches.

Quell's lead candidate QEL-001 is being developed to induce operational tolerance following liver transplantation, with the potential to protect the post-transplant liver without the need for chronic immunosuppressive medications. Quell is also advancing additional programs in neuroinflammatory and autoimmune diseases. http://www.quell-tx.com.

About Cellistic

Launched in April 2022, Cellistic specializes in process development and manufacture of cell therapies based on human induced pluripotent stem cell (iPSC) technology. Its focus and expertise in iPSC reprogramming, differentiation, and expansion protocol development positions the business to be the partner of choice for innovative cell therapy developers to commercialize novel advanced therapies. Leveraging more than a decade of Ncardia's scientific and technical knowledge and experience, Cellistic possesses unique capabilities for the design and optimization of proprietary manufacturing platforms for iPSC-based cells that deliver quality products at scale. For more information, visit http://www.cellistic.com.

About Ncardia

Ncardia is a leader in contract research, development and manufacture of iPSC-based solutions for early and preclinical drug discovery. Its goal is to enable pharmaceutical and therapeutics companies to make more confident decisions in discovery and development by integrating iPSC technologies into their screening processes. Ncardia's capabilities include disease modeling, manufacturing, assay development and high-throughput screening especially for cardiac and neurodegenerative diseases. Ncardia was founded in 2011 and is majority-owned by KINICITI a private equity-backed advanced therapies platform. For more information, visit http://www.ncardia.com

Contacts for Quell TherapeuticsLuke Henry, Chief Business Officer Quell Therapeutics[emailprotected]

Media: Mark Swallow, Sandi Greenwood, Eleanor Perkin MEDiSTRAVA Consulting+44 203 928 6900 [emailprotected]

Investors: Christina Tartaglia Stern Investor Relations, Inc.+1 212 362 1200 [emailprotected]

Contacts for Ncardia/CellisticAndy Holt, Chief Commercial Officer Cellistic[emailprotected]

SOURCE Quell Therapeutics and Cellistic

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Quell Therapeutics and Cellistic enter a strategic collaboration to develop an iPSC-derived allogeneic T-regulatory (Treg) cell therapy platform - PR...