ATHERSYS REPORTS SECOND QUARTER 2022 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE
Company Restructuring Underway and MASTERS-2 Medical Trial Prioritized
Convention name begins at 4:30 p.m. Japanese time as we speak
CLEVELAND, Ohio, August 11, 2022 – Athersys, Inc. (NASDAQ: ATHX) introduced as we speak its monetary outcomes for the three and 6 months ended June 30, 2022 and offered a enterprise replace.
Second quarter 2022 Company and Operational Highlights:
Company Restructuring
•Carried out a restructuring of our group with the intention of considerably decreasing bills, conserving money, bettering focus of the Firm’s actions and turning into extra engaging to potential monetary and strategic companions.
◦Discount in workforce of as much as 70% together with adjustments to management staff
◦Lowered dimension of Board of Administrators from ten to 5 members whereas sustaining essential expertise and enhancing effectivity
◦Suspended costly manufacturing and course of growth initiatives
◦Initiated a course of to sublet the Stow, Ohio facility
◦Lowered inside analysis operate to focus sources on MASTERS-2
•Made key govt appointments to pursue Athersys’ new enterprise technique
◦Engaged Ankura Consulting Group LLC and named monetary knowledgeable Kasey Rosado interim Chief Monetary Officer
◦Operations and supply-chain chief Maia Hansen named Chief Working Officer
•Exploring financing choices to allow us to acquire funds to proceed operations and execute reprioritized enterprise technique
Enterprise Improvement Technique
•Participated in a number of investor conferences to construct consciousness, together with:
◦Maxim Group 2022 Digital Progress Convention
◦Locust Stroll Stem Cell Convention
◦Needham Healthcare Convention
◦Financial institution of America Securities 2022 World Healthcare Convention
◦H.C. Wainwright World Healthcare Convention
•Pursuing a enterprise growth technique targeted on securing regional and/or world MultiStem companions, non-dilutive funding and complementary capabilities throughout medical, regulatory, industrial and manufacturing capabilities
◦Introduced an August twenty ninth webinar to offer a complete evaluation of preclinical analysis throughout a number of indications with MultiStem hosted by Dr. Willie Mays, Government Vice President and Head of Regenerative Medication & Neuroscience Applications, and Dr. Sarah Busch, Vice President, Regenerative Medication & Head of Nonclinical Improvement; beforehand printed preclinical information display that MultiStem holds potential in Alzheimer’s illness, a number of sclerosis, epilepsy, Parkinson’s illness, spinal twine harm, hypoxia and ischemia
◦Introduced preclinical analysis by the Armed Forces Radiobiology Analysis Institute, a Division of Protection analysis laboratory underneath the management of the Uniformed Companies College of the Health Sciences, displaying the good thing about MultiStem in an animal mannequin of acute radiation syndrome
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Second Quarter MultiStem Medical Trial Updates
MASTERS-2 (Section 3 world examine in ischemic stroke)
•Reprioritized MASTERS-2 as growth focus following restructuring
•Elevated enrollment charge, doubling the typical variety of sufferers enrolled per 30 days in 2022 from prior years; enrolled extra topics within the second quarter of 2022 than throughout every other quarter
•Expanded the community of lively trial websites by including 10 new areas, together with key stroke facilities in Germany, the UK, Taiwan and Australia
•Analyzed TREASURE outcomes for potential learn by to MASTERS-2 trial design
TREASURE (Section 2/3 Japan examine in ischemic stroke)
•Trial didn’t attain statistical significance for its major endpoint of Glorious Outcomes at 90-days, but the long-term influence on the standard of life amongst handled sufferers was supported by topline outcomes reported by Healios. The complete information set demonstrated constant enchancment in basically all measured purposeful outcomes over time by one 12 months
•Full outcomes will probably be introduced in a plenary session on the 14th World Stroke Congress in October
MATRICS-1 (Section 2 examine in trauma)
•Collaborating with The College of Texas Health Science Heart at Houston, one of many busiest Stage 1 trauma facilities within the U.S.
•Funding offered by Medical Expertise Enterprise Consortium and Memorial Hermann Basis
•Accomplished enrollment of the primary affected person cohort
•Initiated dosing with product derived from Athersys’ large-scale bioreactors, offering better scalability and effectivity
MACOVIA (Section 2/3 examine in acute respiratory misery syndrome)
•Quick-track designation by the FDA
•Now have information evaluating two totally different dosing ranges of MultiStem produced by a cell manufacturing unit course of. Evaluation of this information will assist inform the design of the subsequent part of the trial
•With the intention to focus sources on MASTERS-2, MACOVIA has been suspended till we obtain extra financing or set up a partnership to maneuver ahead with the subsequent part of the examine.
Administration Commentary
“My first six months at Athersys have definitely been each difficult and productive,” acknowledged Dan Camardo, Chief Government Officer of Athersys. “Whereas the topline information from the TREASURE examine evaluating MultiStem for the remedy of ischemic stroke performed by our accomplice Healios in Japan didn’t attain statistical significance for its major Endpoint of Glorious End result at 90-days, there have been essential and inspiring takeaways from this trial. We’re notably happy that the examine demonstrated enchancment in different pre-specified measures of purposeful outcomes over time, supporting the long-term influence of MultiStem in ischemic stroke sufferers. The TREASURE trial outcomes had been positively endorsed by stroke key opinion leaders providing additional encouragement as we proceed with our personal MASTERS-2 examine.” Camardo continued, “We additionally carried out a restructuring of our group with the intention of considerably decreasing bills, conserving money, bettering focus of the Firm’s actions and making a constructive influence on enrollment progress in our MASTERS-2 examine. We’re assured that the actions taken over the past two months will higher place Athersys in bringing MultiStem to market and turning into a worldwide chief in regenerative medication.”
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Second Quarter Outcomes
Revenues for the three months ended June 30, 2022 had been $2.3 million in comparison with no revenues for the three months ended June 30, 2021. The revenues within the second quarter of 2022 are related to providers offered to Healios underneath the Framework Settlement. Our collaboration revenues will fluctuate from period-to-period based mostly on the providers offered underneath our association with Healios.
Analysis and growth bills elevated to $20.8 million for the three months ended June 30, 2022 from $17.7 million for the comparable interval in 2021. The $3.1 million enhance is related to an impairment cost of $4.9 million associated to property which are not essential to help future analysis and growth and restructuring prices of $1.5 million. These will increase had been partially offset by decreases in medical trial and manufacturing prices of $2.0 million, inside analysis provides of $0.7 million, consulting charges of $0.4 million and reduces in different analysis growth prices of $0.2 million. Our medical growth, medical manufacturing and manufacturing course of growth bills fluctuate over time based mostly on the timing and stage of medical trials underway, manufacturing campaigns for medical trials and manufacturing course of growth initiatives. These variations in exercise degree may influence our accounts payable, accrued bills, pay as you go bills and deposits balances from interval to interval. Apart from exterior bills for our medical and preclinical applications, we typically don’t monitor our analysis bills by mission; relatively, we monitor such bills by the kind of price incurred. We anticipate our analysis and growth bills to lower in reference to our restructuring plan.
Basic and administrative bills had been $5.2 million for the three months ended June 30, 2022, which was greater than the $4.2 million for the comparable interval in 2021. The rise is primarily associated to restructuring prices of $1.2 million. We anticipate our common and administrative bills to lower in reference to our restructuring plan.
Web loss for the second quarter of 2022 was $23.6 million in comparison with a web lack of $22.6 million within the second quarter of 2021. The distinction primarily outcomes from the above variances.
Through the six months ended June 30, 2022, web money utilized in working actions was $36.6 million in comparison with $37.2 million within the six months ended months June 30, 2021. At June 30, 2022, we had $13.4 million in money and money equivalents, in comparison with $37.4 million at December 31, 2021.
Convention Name
Athersys will host a convention name as we speak at 4:30 p.m. Japanese time to debate these outcomes and reply questions. Stockholders are inspired to pay attention utilizing this Webcast hyperlink. To take part through telephone in the event you intend to ask a query, please pre-register for the convention name utilizing this Name registration hyperlink. Registered stockholders will obtain the toll-free quantity, a direct entry passcode and a registrant ID.
A replay of the occasion will probably be obtainable on the webcast hyperlink at www.athersys.com underneath the buyers’ part roughly two hours after the decision has ended. Stockholders may name in for on-demand listening roughly three hours after the completion of the decision till 11:59 p.m. Japanese time on August 18, 2022, by dialing (888) 330-2506 or (240) 789-2712 and getting into the convention code 70781.
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About Athersys
Athersys is a biotechnology firm engaged within the discovery and growth of therapeutic product candidates designed to increase and improve the standard of human life. The Firm is growing its MultiStem® cell remedy product, a patented, adult-derived “off-the-shelf” stem cell product, initially for illness indications within the neurological, inflammatory and immune, and different essential care indications and has two ongoing medical trials evaluating this potential regenerative medication product. Athersys has cast strategic partnerships and a broad community of collaborations to additional advance MultiStem cell remedy. Buyers and others ought to be aware that we could put up details about the Firm on our web site at www.athersys.com and/or on our accounts on Twitter, Fb, LinkedIn or different social media platforms. It’s potential that the postings might embody data deemed to be materials data. Subsequently, we encourage buyers, the media and others within the Firm to evaluation the data we put up on our web site at www.athersys.com and on our social media accounts. Comply with Athersys on Twitter at www.twitter.com/athersys. Info that we could put up in regards to the Firm on our web site and/or on our accounts on Twitter, Fb, LinkedIn or different social media platforms could include forward-looking statements inside the that means of the Non-public Securities Litigation Reform Act of 1995 that contain dangers and uncertainties. You shouldn’t place undue reliance on forward-looking statements contained on our web site and/or on our accounts on Twitter, Fb, LinkedIn or different social media platforms, and we undertake no obligation to publicly replace forward-looking statements, whether or not because of new data, future occasions or in any other case.
Ahead-Trying Statements
This press launch accommodates forward-looking statements inside the that means of the Non-public Securities Litigation Reform Act of 1995 that contain dangers and uncertainties. These forward-looking statements relate to, amongst different issues, the anticipated timetable for growth of our product candidates, our development technique, and our future monetary efficiency, together with our operations, financial efficiency, monetary situation, prospects, and different future occasions. We’ve tried to establish forward-looking statements by utilizing such phrases as “anticipates,” “believes,” “can,” “proceed,” “might,” “estimates,” “expects,” “intends,” “could,” “plans,” “potential,” “ought to,” “counsel,” “will,” or different related expressions. These forward-looking statements are solely predictions and are largely based mostly on our present expectations.
As well as, various identified and unknown dangers, uncertainties, and different components might have an effect on the accuracy of those statements. A number of the extra vital identified dangers that we face are the danger that we are going to be unable to boost capital to fund our operations within the close to time period and long run, together with our capability to acquire funding by public or non-public fairness choices, debt financings, collaborations and licensing preparations or different sources, on phrases acceptable to us or in any respect, and to proceed as a going concern and our capability to efficiently resolve the cost points with our major contract producer and acquire entry to our medical product. The next dangers and uncertainties could trigger our precise outcomes, ranges of exercise, efficiency, or achievements to vary materially from any future outcomes, ranges of exercise, efficiency, or achievements expressed or implied by these forward-looking statements: our collaborators’ capability and willingness to proceed to satisfy their obligations underneath the phrases of our collaboration agreements and generate gross sales associated to our applied sciences; the potential of unfavorable outcomes from ongoing and extra medical trials involving MultiStem; the danger that constructive ends in a medical trial might not be replicated in subsequent or confirmatory trials or success in an early stage medical trial might not be predictive of ends in later stage or massive scale medical trials; our capability to regain compliance with the requirement to take care of a minimal closing bid value of $1.00 per share as set forth in Nasdaq Itemizing Rule 5550(a)(2); the timing and nature of outcomes from MultiStem medical trials, together with the MASTERS-2 Section 3 medical trial evaluating the administration of MultiStem for the remedy of ischemic stroke; our capability to fulfill milestones and earn royalties underneath our collaboration agreements, together with the success of our collaboration with Healios; the success of our MACOVIA medical trial evaluating the administration of MultiStem for the remedy of ARDS induced by COVID-19 and different pathogens, and the MATRICS-1 medical trial being performed with The College of Texas Health Science Heart at Houston evaluating the remedy of sufferers with severe traumatic accidents; the supply of product enough to fulfill our medical wants and potential industrial demand following any approval; the potential of delays in, hostile outcomes of, and extreme prices of the event course of; our capability to efficiently provoke and full medical trials of our product candidates; the potential of delays, work stoppages or interruptions in manufacturing by third events or us, reminiscent of resulting from materials provide constraints, contamination, operational restrictions resulting from COVID-19 or different public well being emergencies, labor constraints, regulatory points or different components that might negatively influence our trials and the trials of our collaborators; uncertainty relating to market acceptance of our product candidates and our capability to generate revenues, together with MultiStem cell remedy for neurological, inflammatory and immune, cardiovascular and different essential care indications; adjustments in exterior market components; adjustments in our trade’s general efficiency; adjustments in our
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enterprise technique; our capability to guard and defend our mental property and associated enterprise operations, together with the profitable prosecution of our patent purposes and enforcement of our patent rights, and function our enterprise in an surroundings of speedy know-how and mental property growth; our potential incapacity to understand commercially helpful discoveries in our collaborations with pharmaceutical and different biotechnology firms; the success of our efforts to enter into new strategic partnerships and advance our applications; our potential incapacity to execute our technique resulting from adjustments in our trade or the financial system typically; adjustments in productiveness and reliability of suppliers; the success of our rivals and the emergence of recent rivals; and the dangers talked about elsewhere in our Annual Report on Kind 10-Okay for the 12 months ended December 31, 2021 underneath Merchandise 1A, “Threat Elements” and our different filings with the SEC. You shouldn’t place undue reliance on forward-looking statements contained on our web site and/or on our accounts on Twitter, Fb, LinkedIn or different social media platforms, and we undertake no obligation to publicly replace forward-looking statements, whether or not because of new data, future occasions or in any other case.
Contacts:
Athersys
Ellen Gurley
Supervisor of Company Communications and Investor Relations
ir@athersys.com
LHA Investor Relations
Tirth T. Patel
212-201-6614
tpatel@lhai.com
(Tables Comply with)
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Athersys, Inc.
Condensed Consolidated Steadiness Sheets
(In 1000’s)
June 30, 2022 |
December 31, 2021 |
|||
(Unaudited) | (Be aware) | |||
Belongings | ||||
Money and money equivalents | $ | 13,378 | $ | 37,407 |
Accounts receivable from Healios, billed and unbilled | 3,594 | 4,414 | ||
Pay as you go bills, deposits and different | 5,916 | 5,711 | ||
Working right-of-use property, web | 8,448 | 8,960 | ||
Property and tools, web | 3,868 | 3,692 | ||
Whole property | $ | 35,204 | $ | 60,184 |
Liabilities and stockholders’ fairness | ||||
Accounts payable, accrued bills and different present liabilities | $ | 31,123 | $ | 24,391 |
Deferred income – Healios | – | 3,340 | ||
Working lease liabilities | 9,263 | 9,766 | ||
Accounts payable to Healios | 1,119 | 1,119 | ||
Advance from Healios | 5,199 | 5,199 | ||
Different long-term liabilities | 238 | – | ||
Whole stockholders’ fairness | (11,738) | 16,369 | ||
Whole liabilities and stockholders’ fairness | $ | 35,204 | $ | 60,184 |
Be aware: The Condensed Consolidated Steadiness Sheet Knowledge has been derived from the audited monetary statements as of that date.
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Athersys, Inc.
Condensed Consolidated Statements of Operations and Complete Loss
(Unaudited)
(In Hundreds, Besides Per Share Quantities)
Three Months Ended June 30, |
||||
2022 | 2021 | |||
Revenues | ||||
Contract income from Healios | $ | 2,316 | $ | – |
Whole revenues | 2,316 | – | ||
Prices and bills | ||||
Analysis and growth | 20,794 | 17,691 | ||
Basic and administrative | 5,162 | 4,158 | ||
Depreciation | 618 | 723 | ||
Whole prices and bills | 26,574 | 22,572 | ||
Loss from operations | (24,258) | (22,572) | ||
Different earnings (loss), web | 610 | (27) | ||
Web loss and complete loss | $ | (23,648) | $ | (22,599) |
Web loss per share, primary and diluted | $ | (0.09) | $ | (0.10) |
Weighted common shares excellent, primary and diluted | 259,570 | 222,436 |
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