ATHX Athersys Inc.

2.04
+0.04  (+2%)
Previous Close 2
Open 2
52 Week Low 1.13
52 Week High 4.38
Market Cap $402,703,266
Shares 197,403,562
Float 178,091,846
Enterprise Value $321,996,266
Volume 1,436,317
Av. Daily Volume 2,301,591
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Drug Pipeline

Drug Stage Notes
Multistem
Acute Respiratory Distress Syndrome
Phase 2
Phase 2
Phase 2 enrollment to be completed 4Q 2020.
Multistem
Ischemic stroke
Phase 3
Phase 3
Phase 3 MASTERS-2 trial initiation announced July 31, 2018.
MultiStem - MACOVIA
COVID-19 induced Acute respiratory distress syndrome (ARDS)
Phase 2/3
Phase 2/3
Phase 2/3 enrolment has commenced - noted May 5, 2020.
MultiStem
Trauma patients following hospitalization
Phase 2
Phase 2
Phase 2 initiation announced April 15, 2020.
Multistem
Acute myocardial infarction
Phase 2
Phase 2
Phase 2 enrollment continues but reported May 2018 that enrollment is slower than expected.

Latest News

  1. ARDS program well-positioned for an expedited path to commercialization with RMAT and Fast Track designation

    Athersys, Inc., a leading regenerative medicine company in late-stage clinical development, announced today that MultiStem® cell therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the acute respiratory distress syndrome (ARDS) program. The RMAT designation enables sponsors to work closely with the FDA and receive their guidance on expediting development of their products, including providing advice on generating the evidence needed to support approval in an efficient manner. RMAT designation invites the Company to schedule a Type B meeting with the FDA…

    ARDS program well-positioned for an expedited path to commercialization with RMAT and Fast Track designation

    Athersys, Inc., a leading regenerative medicine company in late-stage clinical development, announced today that MultiStem® cell therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for the acute respiratory distress syndrome (ARDS) program. The RMAT designation enables sponsors to work closely with the FDA and receive their guidance on expediting development of their products, including providing advice on generating the evidence needed to support approval in an efficient manner. RMAT designation invites the Company to schedule a Type B meeting with the FDA to discuss multidisciplinary strategic development plans, including expediting manufacturing development for commercialization to support priority review and/or accelerated approval.

    The RMAT designation for ARDS is granted in addition to the previously obtained Fast Track designation awarded in May 2019. MultiStem is the only cell therapy program for ARDS that has both Fast Track and RMAT designation from the FDA. Also, the Company's partner in Japan, HEALIOS K.K. (Healios), is anticipating the completion of enrollment in its orphan designated ARDS clinical trial (ONE-BRIDGE) by the end of this year.

    "We are very pleased to have received our second MultiStem program RMAT designation," commented Dr. Manal Morsy, Senior Vice President and Head of Global Regulatory Affairs. "We have enjoyed close and highly efficient interactions with the FDA on our RMAT-designated ischemic stroke program and are looking forward to similar benefits and advantages of this Expedited Program for Regenerative Medicine Therapies for Serious Conditions RMAT designation, this time for ARDS."

    The Company has conducted extensive research exploring MultiStem cell therapy for the treatment of pulmonary distress and recently completed an exploratory Phase 1/2 clinical trial for the treatment of ARDS (the MUST-ARDS study). Participants in the randomized, double-blind, placebo-controlled MUST-ARDS study were evaluated through 28 days for the primary clinical assessment and further assessed through a one-year follow-up period. Patients that received MultiStem experienced lower mortality, fewer days on a ventilator, fewer days in the intensive care unit, and reported a higher quality of life after one-year post-ARDS than patients that received the placebo.

    Following the encouraging results of the MUST-ARDS study, the Company began planning for the next stage of clinical evaluation. In response to the COVID-19 pandemic, the Company expedited the initiation of a pivotal Phase 2/3 clinical trial evaluating MultiStem cell therapy for the treatment of COVID-19 induced ARDS (the MACOVIA study), which is now enrolling patients. The primary efficacy endpoint for the randomized, double-blind, placebo-controlled study will compare the number of ventilator-free days through day 28 among MultiStem and placebo treatment groups. Secondary objectives of the study are to evaluate 60-day all-cause mortality, time in the intensive care unit, pulmonary function, tolerability, and QoL among survivors through one-year of follow-up. MultiStem may have the potential to treat ARDS that develops from a variety of causes, including COVID-19, as well as other pathogen-induced or non-infectious causes of severe lung inflammation leading to ARDS because it is not virus- or pathogen-specific. For more detailed information on the Company's ARDS program, please visit the ARDS page on the Athersys website.

    About RMAT

    Established under the 21st Century Cures Act, RMAT designation is a dedicated program designed to expedite the development and review processes for promising regenerative medicine therapies, which are defined as a cell therapy, a therapeutic tissue engineering product, or a human cell and tissue product. An investigational drug is eligible for RMAT designation if it is intended to treat, modify, reverse, or cure a serious or life-threatening disease; and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. Advantages of the RMAT designation include all the benefits of the fast track and breakthrough therapy designation programs, including early interactions with FDA that may be used to discuss potential surrogate or intermediate endpoints to support accelerated approval.

    About ARDS

    ARDS is a serious respiratory condition characterized by widespread inflammation in the lungs. ARDS can be triggered by pneumonia, sepsis, trauma, or other events and represents a major cause of morbidity and mortality in the critical care setting. ARDS is associated with a high mortality rate and significant long-term complications and disability among survivors. Among survivors, the condition prolongs ICU and hospital stays and often requires extended convalescence in the hospital and rehabilitation care settings. There are limited interventions and no effective drug treatments for ARDS. There is a large unmet need for a safe treatment that can reduce mortality and improve Quality of Life (QoL) for those surviving ARDS. Additionally, given the high healthcare resource burden associated with treatment of ARDS patients, a successful therapy could be expected to generate significant savings for the healthcare system by reducing days on a ventilator and in the ICU, or in the setting of a widespread high pathogenicity respiratory virus pandemic, make those resources more rapidly available to other patients.

    About MultiStem®

    MultiStem® cell therapy is a patented regenerative medicine product candidate in clinical development that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of therapeutic factors in response to signals of inflammation and tissue damage. MultiStem therapy's potential for multidimensional therapeutic impact may distinguish it from traditional biopharmaceutical therapies focused on a single mechanism of benefit. MultiStem represents a unique "off-the-shelf" stem cell product candidate that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. Based upon favorable efficacy data, its novel mechanisms of action, and favorable and consistent tolerability data in clinical studies, we believe that MultiStem therapy could provide a meaningful benefit to patients, including those suffering from serious diseases and conditions with unmet medical need.

    About Athersys

    Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "suggest," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations, including but not limited to, our ability to access our traditional financing sources on the same or reasonably similar terms as were available to us before the COVID-19 pandemic; our ability to successfully finalize and implement an alliance with BARDA, and the terms of any such alliance, including the amount, if any, of funding that we might receive; the timing and nature of results from MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial evaluating the administration of MultiStem for the treatment of ischemic stroke, and the Healios TREASURE and ONE-BRIDGE clinical trials in Japan evaluating the treatment in stroke and ARDS patients, respectively; the success of our MACOVIA clinical trial evaluating the administration of MultiStem for the treatment of COVID-19 induced ARDS, and the MATRICS-1 clinical trial being conducted with The University of Texas Health Science Center at Houston evaluating the treatment of patients with serious traumatic injuries; the impact of the COVID-19 pandemic on our ability to complete planned or ongoing clinical trials; the possibility that the COVID-19 pandemic could delay clinical site initiation, clinical trial enrollment, regulatory review and the potential receipt of regulatory approvals, payment of milestones under our license agreements and commercialization of one or more of our product candidates, if approved; the availability of product sufficient to meet commercial demand shortly following any approval, such as in the case of accelerated approval for the treatment of COVID-19 induced ARDS; the impact on our business, results of operations and financial condition from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of infectious disease in the United States; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the impact of the COVID-19 pandemic on the production capabilities of our contract manufacturing partners and our MultiStem trial supply chain; the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints, contamination, operational restrictions due to COVID-19 or other public health emergencies, labor constraints, regulatory issues or other factors which could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for neurological, inflammatory and immune, cardiovascular and other critical care indications; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in North America, Europe and Japan; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; the success of our competitors and the emergence of new competitors; and the risks mentioned elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 under Item 1A, "Risk Factors" and our other filings with the SEC. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

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  2. Management to host conference call at 4:30 pm EDT today

    Athersys, Inc. (NASDAQ:ATHX) announced today its financial results for the three months ended June 30, 2020.

    Highlights of the second quarter of 2020 and recent events include:

    • Initiated and advanced enrollment in the Phase 2/3 COVID-19 induced acute respiratory distress syndrome (ARDS) clinical trial (the MACOVIA study) and currently evaluating the safety, tolerability and dose levels of MultiStem® cell therapy in this indication;
    • Continued interactions with the Biomedical Advanced Research and Development Authority (BARDA) regarding a potential collaboration;
    • HEALIOS K.K. (Healios), our Japanese partner, enrolled the first COVID-19 induced ARDS patient in its ONE-BRIDGE arm…

    Management to host conference call at 4:30 pm EDT today

    Athersys, Inc. (NASDAQ:ATHX) announced today its financial results for the three months ended June 30, 2020.

    Highlights of the second quarter of 2020 and recent events include:

    • Initiated and advanced enrollment in the Phase 2/3 COVID-19 induced acute respiratory distress syndrome (ARDS) clinical trial (the MACOVIA study) and currently evaluating the safety, tolerability and dose levels of MultiStem® cell therapy in this indication;
    • Continued interactions with the Biomedical Advanced Research and Development Authority (BARDA) regarding a potential collaboration;
    • HEALIOS K.K. (Healios), our Japanese partner, enrolled the first COVID-19 induced ARDS patient in its ONE-BRIDGE arm and continues to advance this study and the TREASURE stroke study, both studies expected to complete enrollment in Q4 of 2020;
    • Following the authorization from the Food and Drug Administration (FDA) and the Institutional Review Board (IRB) approval, The University of Texas Health Science Center at Houston (UTHealth) submitted the protocol for the Phase 2 clinical trial evaluating MultiStem Administration for Trauma Related Inflammation and Complications (MATRICS-1) to the Human Research Protection Office (HRPO) for approval to initiate this important trial;
    • Advanced our partnering discussions with companies interested in MultiStem commercialization rights in Europe and other regions;
    • Participated in several events throughout the second quarter, including the Bank of America Healthcare Conference, the Alliance for Regenerative Medicine webinar, the International Society of Cell & Gene Therapy, and a CEO round table at LifeScience Leader, and participated in several media interviews and podcasts;
    • Continued to advance the enrollment of the MASTERS-2 ischemic stroke study despite the impacts of COVID-19;
    • New research coverage initiated by covering analysts at Bank of America and SMBC Nikko Securities;
    • Advanced manufacturing technical transfer operations and bioreactor scaling to prepare for commercial readiness;
    • Successfully attracted new talent and added new employees to the dedicated staff to help meet the corporate goals; including Mr. Ivor Macleod as Chief Financial Officer and Ms. Maia Hansen as Senior Vice President and Head of Operations and Supply Chain;
    • Raised gross proceeds of approximately $57.6 million, before deducting the underwriting discount and offering expenses, through an underwritten public offering of 25,587,500 shares of common stock, providing additional working capital for general corporate purposes, including the initiation of the MACOVIA trial, further advancement of process development and manufacturing projects, and other key initiatives;
    • Recognized net loss of $18.4 million, or $0.10 net loss per share, for the quarter ended June 30, 2020; and
    • Ended the second quarter with $80.7 million of cash and cash equivalents.

    "Over the past quarter, we have made additional progress in our key clinical programs, partnering discussions and efforts regarding the establishment of key infrastructure to support our planned transition to becoming a commercial stage company. While the COVID-19 pandemic continues to have a global impact and has impacted many patients and their families, as well as disrupted operations and clinical trials for many companies, we have continued to move forward and are in the strongest financial position in the history of the Company," commented Dr. Gil Van Bokkelen, Chairman and CEO of Athersys. "We remain focused on supporting our partner Healios while it approaches completion of enrollment in both the TREASURE and ONE-BRIDGE trials in Japan, while we advance towards the establishment of new alliances in other key geographies, including Europe.

    "A major focus for the Company in 2020 has been to advance our planning and preparation related to the establishment of infrastructure that will support our commercialization objectives, as well as the addition and integration of personnel and capabilities that will support the evolution. Despite the challenges posed by the COVID-19 pandemic, we are on track to achieve our core objectives in the second half of the year," concluded Dr. Van Bokkelen.

    Second Quarter Results

    Revenues were $0.1 million for the three months ended June 30, 2020 compared to $4.3 million for the three months ended June 30, 2019. The revenues in both periods were primarily generated from our collaboration with Healios related to manufacturing services performed. We expect our collaboration revenues to vary over time as we contract with Healios to perform manufacturing services and as we potentially enter into new collaborations.

    Research and development expenses increased to $13.8 million for the three months ended June 30, 2020 from $11.1 million for the comparable period in 2019. The $2.7 million net increase is associated with increases in clinical trial and manufacturing process development costs of $0.8 million, research supplies of $0.5 million, stock compensation costs of $0.5 million, personnel costs of $0.3 million, outside services of $0.3 million and other research and development costs of $0.3 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

    General and administrative expenses increased to $4.4 million for the three months ended June 30, 2020 compared to $2.9 million in the comparable period in 2019. The $1.5 million increase was primarily due to increased personnel costs, outside services, professional fees, consulting costs and stock compensation costs.

    Net loss for the second quarter of 2020 was $18.4 million compared to a net loss of $9.7 million in the second quarter of 2019. The difference primarily results from the above variances.

    During the six months ended June 30, 2020, net cash used in operating activities was $24.8 million compared to $17.0 million in the six months ended June 30, 2019. At June 30, 2020, we had $80.7 million in cash and cash equivalents, compared to $35.0 million at December 31, 2019.

    Conference Call

    Gil Van Bokkelen, Chairman and Chief Executive Officer, Ivor Macleod, Chief Financial Officer, and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:

    Date

     

    August 10, 2020

    Time

     

    4:30 p.m. (Eastern Time)

    Live webcast registration

     

    Webcast Link

    Phone registration

     

    Call Registration Link

    We encourage shareholders to listen using the webcast link above, also available on www.athersys.com under the Investors section. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will be provided the call details and a registrant ID.

    About Athersys

    Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "suggest," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations, including but not limited to, our ability to access our traditional financing sources on the same or reasonably similar terms as were available to us before the COVID-19 pandemic; our ability to successfully finalize and implement an alliance with BARDA, and the terms of any such alliance, including the amount, if any, of funding that we might receive; the timing and nature of results from MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial evaluating the administration of MultiStem for the treatment of ischemic stroke, and the Healios TREASURE and ONE-BRIDGE clinical trials in Japan evaluating the treatment in stroke and ARDS patients, respectively; the success of our MACOVIA clinical trial evaluating the administration of MultiStem for the treatment of COVID-19 induced ARDS, and the MATRICS-1 clinical trial being conducted with The University of Texas Health Science Center at Houston evaluating the treatment of patients with serious traumatic injuries; the impact of the COVID-19 pandemic on our ability to complete planned or ongoing clinical trials; the possibility that the COVID-19 pandemic could delay clinical site initiation, clinical trial enrollment, regulatory review and the potential receipt of regulatory approvals, payment of milestones under our license agreements and commercialization of one or more of our product candidates, if approved; the availability of product sufficient to meet commercial demand shortly following any approval, such as in the case of accelerated approval for the treatment of COVID-19 induced ARDS; the impact on our business, results of operations and financial condition from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of infectious disease in the United States; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the impact of the COVID-19 pandemic on the production capabilities of our contract manufacturing partners and our MultiStem trial supply chain; the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints, contamination, operational restrictions due to COVID-19 or other public health emergencies, labor constraints, regulatory issues or other factors which could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for neurological, inflammatory and immune, cardiovascular and other critical care indications; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in North America, Europe and Japan; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; the success of our competitors and the emergence of new competitors; and the risks mentioned elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 under Item 1A, "Risk Factors" and our other filings with the SEC. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

    (Tables Follow)

    Athersys, Inc.

    Condensed Consolidated Balance Sheets

    (In thousands)

     

     

    June 30,

    2020

     

    December 31,

    2019

     

     

    (Unaudited)

     

    (Note)

    Assets

     

     

     

     

    Cash and cash equivalents

     

    $

    80,707

     

     

    $

    35,041

     

    Accounts receivable

     

    24

     

     

    17

     

    Accounts receivable from Healios

     

    96

     

     

    945

     

    Prepaid expenses, deposits and other

     

    2,446

     

     

    2,781

     

    Equipment, net

     

    3,163

     

     

    2,882

     

    Total assets

     

    $

    86,436

     

     

    $

    41,666

     

    Liabilities and stockholders' equity

     

     

     

     

    Accounts payable, accrued expenses and other

     

    $

    15,787

     

     

    $

    11,924

     

    Accounts payable to Healios

     

    1,068

     

     

    1,068

     

    Deferred revenue - Healios

     

    65

     

     

    65

     

    Advance from Healios

     

    5,338

     

     

    5,338

     

    Total stockholders' equity

     

    64,178

     

     

    23,271

     

    Total liabilities and stockholders' equity

     

    $

    86,436

     

     

    $

    41,666

     

    Note: The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.

    Athersys, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (In Thousands, Except Per Share Amounts)

     

     

    Three months ended

    June 30,

     

     

    2020

     

    2019

    Revenues

     

     

     

     

    Contract revenue from Healios

     

    $

    77

     

     

    $

    4,193

     

    Grant revenue

     

    7

     

     

    69

     

    Total revenues

     

    84

     

     

    4,262

     

    Costs and expenses

     

     

     

     

    Research and development

     

    13,767

     

     

    11,139

     

    General and administrative

     

    4,432

     

     

    2,867

     

    Depreciation

     

    222

     

     

    157

     

    Total costs and expenses

     

    18,421

     

     

    14,163

     

    Loss from operations

     

    (18,337)

     

     

    (9,901)

     

    Other income (expense), net

     

    (35)

     

     

    213

     

    Net loss and comprehensive loss

     

    $

    (18,372)

     

     

    $

    (9,688)

     

    Net loss per share, basic and diluted

     

    $

    (0.10)

     

     

    $

    (0.06)

     

    Weighted average shares outstanding, basic and diluted

     

    191,317

     

     

    150,163

     

     

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  3. Athersys, Inc. (NASDAQ:ATHX) will release its second quarter 2020 financial results at approximately 4:00 PM Eastern Time on Monday, August 10, 2020, and will host a conference call shortly thereafter at 4:30 PM Eastern Time to review the results. Members of the management team will host the call as follows:

    Date

    August 10, 2020

    Time

    4:30 p.m. (Eastern Time)

    Live webcast registration

    Webcast link

    Phone registration

    Call registration link

    We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive an email with the toll-free…

    Athersys, Inc. (NASDAQ:ATHX) will release its second quarter 2020 financial results at approximately 4:00 PM Eastern Time on Monday, August 10, 2020, and will host a conference call shortly thereafter at 4:30 PM Eastern Time to review the results. Members of the management team will host the call as follows:

    Date

    August 10, 2020

    Time

    4:30 p.m. (Eastern Time)

    Live webcast registration

    Webcast link

    Phone registration

    Call registration link

    We encourage shareholders to listen using the webcast link above. If you would like to dial in using the phone to ask a question, please register for the conference call ahead of time using the call registration link above. Once registered, you will receive an email with the toll-free number, a direct entry passcode and a registrant ID. A reminder email will be sent the day before the live call with the above details.

    A replay of the event will be available on the webcast link at www.athersys.com under the investors section approximately three hours after the call has ended. Shareholders may also call in for on-demand listening approximately three hours after the completion of the call until 11:59 PM Eastern Time on August 17, 2020 by dialing (800) 585-8367 or (416) 621-4642 and entering the conference code 7985439.

    About Athersys

    Athersys is a biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.

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  4. Company will participate in three events at the largest global translation-focused cell and gene therapy meeting

    Athersys, Inc. (NASDAQ:ATHX) announced today its participation in several sessions at this year's International Society for Cell and Gene Therapy (ISCT) virtual conference taking place May 28 – 29, 2020. ISCT 2020 is the largest global translation-focused cell and gene therapy (CGT) meeting and is expected to draw delegates from more than 50 countries in the virtual event. Dr. Anthony Ting, Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs and co-chair for the Strategies for Commercialization track at the ISCT 2020 virtual conference, will take an active role in three separate events.

    Dr. Ting pre-recorded…

    Company will participate in three events at the largest global translation-focused cell and gene therapy meeting

    Athersys, Inc. (NASDAQ:ATHX) announced today its participation in several sessions at this year's International Society for Cell and Gene Therapy (ISCT) virtual conference taking place May 28 – 29, 2020. ISCT 2020 is the largest global translation-focused cell and gene therapy (CGT) meeting and is expected to draw delegates from more than 50 countries in the virtual event. Dr. Anthony Ting, Vice President of Regenerative Medicine and Head of Cardiopulmonary Programs and co-chair for the Strategies for Commercialization track at the ISCT 2020 virtual conference, will take an active role in three separate events.

    Dr. Ting pre-recorded a talk titled "MultiStem® for Acute Respiratory Distress Syndrome (MUST-ARDS study)" for the "State of the Art: Success and Failure of Cell Therapy Clinical Trials for Acute and Chronic Lung Diseases" session, which will be available for on-demand listening for all registered participants. Dr. Ting presented the data from the Company's completed Phase 1/2 acute respiratory distress (ARDS) study.

    Dr. Ting will also serve as the chair for the live session titled "Strategies for Commercialization Plenary Session - Is Big Pharma Ready for Industrial Scale Cell and Gene Therapy?" taking place on May 29 at 8:00 AM PDT, in addition to speaking at the live session titled "ISCT CSO Global Showcase on COVID-19, Part II - A New Hope" on May 29 at 4:00 PM PDT. Dr. Ting will speak on the topic of Industry-led Cell Therapy Clinical Trials for COVID-19 that will include the Company's recently initiated MACOVIA (MultiStem® Administration for COVID-19 Induced Acute Respiratory Distress Syndrome) trial.

    All sessions are only available to those that have registered for the ISCT Conference. Non-members who register will include a complimentary 2020 ISCT E-Membership. ISCT 2020 Paris Virtual will be accessible remotely and on-demand, including live and recorded, in addition to networking events, poster halls, and 1-on-1 partnering opportunities. A peer curated scientific program addressing timely and critical topics across the full cell and gene therapy development and translation spectrum, including 35 sessions with over 50 hours of both live and on demand streaming, and access to a global line-up of leading experts in CGT and six live broadcasted Plenary Sessions will focus on the latest translation advancements from basic research, pre-clinical studies and clinical trials for a variety of therapeutic modalities.

    For more information and to register, please visit www.ISCT2020.com.

    About the International Society for Cell & Gene Therapy

    Established in 1992, the International Society for Cell & Gene Therapy (ISCT) is a global society of clinicians, regulators, researchers, technologists and industry partners with a shared vision to translate cellular and gene therapy into safe and effective therapies to improve patients' lives worldwide.

    ISCT is the global leader focused on pre-clinical and translational aspects of developing cell and gene-based therapeutics, thereby advancing scientific research into innovative treatments for patients. ISCT offers a unique collaborative environment that addresses three key areas of translation: Academia, Regulatory and Commercialization. Through strong relationships with global regulatory agencies, academic institutions and industry partners, ISCT drives the advancement of research into standard of care.

    Comprised of over 1800 cell and gene therapy experts across five geographic regions and representation from over 60 countries, ISCT members are part of a global community of peers, thought leaders and organizations invested in cell and gene therapy translation. For more information about the society, key initiatives and upcoming meetings, please visit: www.isctglobal.org / @ISCTglobal.

    About Athersys

    Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem® cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.

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  5. Management to host conference call at 4:30 pm EDT today

    Athersys, Inc. (NASDAQ:ATHX) announced today its financial results for the three months ended March 31, 2020.

    Highlights of the first quarter of 2020 and recent events include:

    • Received authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2/3 COVID-19 induced acute respiratory distress syndrome (ARDS) clinical trial; completed site initiation and began enrolling patients in this trial referred to as the MACOVIA study;
    • Received FDA authorization to initiate a Phase 2 clinical trial with The University of Texas Health Science Center at Houston (UTHealth) titled MultiStem® Administration for Trauma Related Inflammation and Complications (MATRICS-1); funded…

    Management to host conference call at 4:30 pm EDT today

    Athersys, Inc. (NASDAQ:ATHX) announced today its financial results for the three months ended March 31, 2020.

    Highlights of the first quarter of 2020 and recent events include:

    • Received authorization from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2/3 COVID-19 induced acute respiratory distress syndrome (ARDS) clinical trial; completed site initiation and began enrolling patients in this trial referred to as the MACOVIA study;
    • Received FDA authorization to initiate a Phase 2 clinical trial with The University of Texas Health Science Center at Houston (UTHealth) titled MultiStem® Administration for Trauma Related Inflammation and Complications (MATRICS-1); funded by a grant from the Medical Technology Enterprise Consortium (MTEC) and the Memorial Hermann Foundation;
    • Announced positive one-year results from our exploratory clinical study of MultiStem cell therapy for ARDS; MultiStem treated patients reported consistent improvement in quality of life over the one-year evaluation period and showed marked improvements in key clinical metrics, including intensive care unit-free days, ventilator-free days and mortality compared to placebo, especially in patients with pneumonia-induced ARDS;
    • Furthered discussions with the Biomedical Advanced Research and Development Authority (BARDA) to establish a collaboration to advance our MultiStem program;
    • Appointed Mr. Ivor Macleod as our Chief Financial Officer and Ms. Maia Hansen as Senior Vice President, Operations and Supply Chain, adding their expertise to our leadership team to help plan and execute our strategy as we approach potential product commercialization;
    • Initiated new sites for the MASTERS-2 ischemic stroke study while continuing to enroll new patients into the trial;
    • Advanced through our Japanese partner, HEALIOS K.K. (Healios), its ARDS and ischemic stroke programs, with Healios disclosing its intent to finish enrollment of both its ONE-BRIDGE ARDS study and its TREASURE stroke study this year;
    • Engaged in partnering discussions with companies interested in MultiStem commercialization rights in Europe and other regions;
    • Received an additional $7.0 million investment from Healios resulting from its exercise in full of a warrant to purchase additional shares of Athersys common stock;
    • Raised gross proceeds of approximately $57.6 million, before deducting the underwriting discount and offering expenses, through an underwritten public offering of 25,587,500 shares of common stock, providing additional working capital for general corporate purposes, including the initiation of the MACOVIA trial, further advancement of process development and manufacturing projects, and other key initiatives;
    • Recognized net loss of $15.6 million, or $0.10 net loss per share, for the quarter ended March 31, 2020; and
    • Ended the first quarter with $32.7 million of cash and cash equivalents, which excludes the impact of the Healios warrant exercise and proceeds from the recent underwritten public offering.

    "We have achieved a number of important milestones recently, including obtaining FDA authorization to move two important trials forward. The first of these, the MACOVIA study for treating patients suffering from COVID-19 induced ARDS and related complications, represents our second pivotal trial, alongside our ongoing MASTERS-2 trial evaluating the administration of MultiStem for treating ischemic stroke. Working in collaboration with the FDA and our clinical partners, we were able to get the MACOVIA trial designed, authorized and up and running very quickly, and we thank everyone for their tremendous commitment and effort over the past several months," commented Dr. Gil Van Bokkelen, Chairman and CEO of Athersys. "In addition, we recently announced authorization to initiate the MATRICS-1 trial for evaluating administration of MultiStem to patients suffering from serious traumatic injury, which is being supported by MTEC, the funding arm of the Department of Defense, and UTHealth. We thank the FDA, MTEC and our clinical collaborators for their support in these advancements.

    "Following the successful completion of the recent fundraising and the full exercise of the outstanding warrant by our partner, Healios, we have strengthened our financial position, and are focused on making further progress in our important programs and core capabilities. Despite the challenging and chaotic environment created by the COVID-19 pandemic, we have maintained our commitment to the advancement of our portfolio of critical care programs and to helping patients in areas of significant unmet clinical need. I'd like to thank each of our employees for their dedication, determination and extraordinary effort," concluded Dr. Van Bokkelen.

    First Quarter Results

    There were no revenues for the three months ended March 31, 2020 compared to $1.4 million for the three months ended March 31, 2019. The revenues in the prior period were generated from our collaboration with Healios related to manufacturing services performed. We expect our collaboration revenues to vary over time as we contract with Healios to perform manufacturing services and as we potentially enter into new collaborations.

    Research and development expenses increased to $12.1 million for the three months ended March 31, 2020 from $11.4 million for the comparable period in 2019. The $0.7 million net increase is associated with increases in research supplies of $0.7 million, personnel costs of $0.3 million, outside services of $0.2 million, consulting costs of $0.1 million, stock compensation costs of $0.1 million and other research and development costs of $0.2 million with such increases partially offset by decreases in clinical trial and manufacturing process development costs of $0.9 million. Our clinical development, clinical manufacturing and manufacturing process development expenses vary over time based on the timing and stage of clinical trials underway, manufacturing campaigns for clinical trials and manufacturing process development projects.

    General and administrative expenses increased to $3.5 million for the three months ended March 31, 2020 compared to $3.1 million in the comparable period in 2019. The $0.4 million increase was primarily due to increased personnel costs, outside services and stock compensation costs.

    Net loss for the first quarter of 2020 was $15.6 million compared to a net loss of $13.0 million in the first quarter of 2019. The difference primarily results from the above variances.

    During the three months ended March 31, 2020, net cash used in operating activities was $12.1 million compared to $5.5 million in the three months ended March 31, 2019. At March 31, 2020, we had $32.7 million in cash and cash equivalents, compared to $35.0 million at December 31, 2019.

    Conference Call

    Gil Van Bokkelen, Chairman and Chief Executive Officer, Ivor Macleod, Chief Financial Officer, and Karen Hunady, Director of Corporate Communications and Investor Relations will host a conference call today to review the results as follows:

    Date

     

    May 7, 2020

    Time

     

    4:30 p.m. (Eastern Time)

    Telephone access: U.S. and Canada

     

    (877) 396-3286

    Telephone access: International

     

    (647) 689-5528

    Access code

     

    6575418

    Live webcast

     

    webcast link

    We encourage shareholders to listen using the webcast link and to use the phone line if you intend to ask a question. A replay will be available on the webcast at www.athersys.com under the Investors section approximately two hours after the call has ended. Shareholders may also call in for on-demand listening shortly after the completion of the call until 11:59 PM Eastern Time on May 14, 2020 by dialing (800) 585-8367 or (416) 621-4642 and entering Encore passcode 6575418.

    About Athersys

    Athersys is an international biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem cell therapy product, a patented, adult-derived "off-the-shelf" stem cell product, initially for disease indications in the neurological, inflammatory and immune, cardiovascular, and other critical care indications and has several ongoing clinical trials evaluating this potential regenerative medicine product. Athersys has forged strategic partnerships and a broad network of collaborations to further advance the MultiStem cell therapy toward commercialization. More information is available at www.athersys.com. Follow Athersys on Twitter at www.twitter.com/athersys.

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as "anticipates," "believes," "can," "continue," "could," "estimates," "expects," "intends," "may," "plans," "potential," "should," "suggest," "will," or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as therapeutics, including the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues. The following risks and uncertainties may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements: our ability to raise capital to fund our operations; our ability to successfully finalize and implement an alliance with BARDA, and the terms of any such alliance, including the amount, if any, of funding that we might receive; the success of our MACOVIA study and MATRICS-1 clinical trial; the timing and nature of results from MultiStem clinical trials, including the MASTERS-2 Phase 3 clinical trial, the Phase 2 clinical trial conducted by The University of Texas Health Science Center at Houston at the Memorial Hermann-Texas Medical Center evaluating MultiStem cell therapy for the early treatment of traumatic injuries, and the HEALIOS K.K. (Healios) TREASURE and ONE-BRIDGE clinical trials in Japan; the impact on our business, results of operations and financial condition from the ongoing and global COVID-19 pandemic, or any other pandemic, epidemic or outbreak of infectious disease in the United States; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials of our product candidates; the possibility of delays, work stoppages or interruptions in manufacturing by third parties or us, such as due to material supply constraints, contaminations, or regulatory issues, which could negatively impact our trials and the trials of our collaborators; uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem cell therapy for the treatment of ischemic stroke, ARDS, acute myocardial infarction and trauma, and the prevention of graft-versus-host disease and other disease indications; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect and defend our intellectual property and related business operations, including the successful prosecution of our patent applications and enforcement of our patent rights, and operate our business in an environment of rapid technology and intellectual property development; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones and earn royalties under our collaboration agreements, including the success of our collaboration with Healios; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements and generate sales related to our technologies; the success of our efforts to enter into new strategic partnerships and advance our programs, including, without limitation, in North America, Europe and Japan; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; the success of our competitors and the emergence of new competitors; and the risks mentioned elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2019 under Item 1A, "Risk Factors" and our other filings with the Securities and Exchange Commission. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

    (Tables Follow)

    Athersys, Inc.

    Condensed Consolidated Balance Sheets

    (In thousands)

     

     

     

    March 31,

    2020

     

    December 31,

    2019

     

     

    (Unaudited)

     

    (Note)

    Assets

     

     

     

     

    Cash and cash equivalents

     

    $

    32,692

     

     

    $

    35,041

     

    Accounts receivable

     

    17

     

     

    17

     

    Accounts receivable from Healios

     

    259

     

     

    945

     

    Prepaid expenses, deposits and other

     

    3,061

     

     

    2,781

     

    Equipment, net

     

    3,039

     

     

    2,882

     

    Total assets

     

    $

    39,068

     

     

    $

    41,666

     

    Liabilities and stockholders' equity

     

     

     

     

    Accounts payable, accrued expenses and other

     

    $

    13,589

     

     

    $

    11,924

     

    Accounts payable to Healios

     

    1,068

     

     

    1,068

     

    Deferred revenue - Healios

     

    65

     

     

    65

     

    Advance from Healios

     

    5,338

     

     

    5,338

     

    Total stockholders' equity

     

    19,008

     

     

    23,271

     

    Total liabilities and stockholders' equity

     

    $

    39,068

     

     

    $

    41,666

     

    Note: The Condensed Consolidated Balance Sheet Data has been derived from the audited financial statements as of that date.

    Athersys, Inc.

    Condensed Consolidated Statements of Operations and Comprehensive Loss

    (Unaudited)

    (In Thousands, Except Per Share Amounts)

     

     

     

    Three months ended

    March 31,

     

     

    2020

     

    2019

    Revenues

     

     

     

     

    Contract revenue from Healios

     

    $

     

     

    $

    1,441

     

    Grant revenue

     

     

     

    4

     

    Total revenues

     

     

     

    1,445

     

    Costs and expenses

     

     

     

     

    Research and development

     

    12,095

     

     

    11,415

     

    General and administrative

     

    3,474

     

     

    3,106

     

    Depreciation

     

    190

     

     

    184

     

    Total costs and expenses

     

    15,759

     

     

    14,705

     

    Loss from operations

     

    (15,759

    )

     

    (13,260

    )

    Other income, net

     

    115

     

     

    304

     

    Net loss and comprehensive loss

     

    $

    (15,644

    )

     

    $

    (12,956

    )

    Net loss per share, basic and diluted

     

    $

    (0.10

    )

     

    $

    (0.09

    )

    Weighted average shares outstanding, basic and diluted

     

    162,715

     

     

    145,964

     

     

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