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Tag: ATHX

  • Athersys Inc. (ATHX) Announces Restructuring and Lay-offs, What’s Going on with the company?

    The challenging year that 2022 has been so far, has caused equities a great hurt with the stock market nearing bear territory. The threat of a recession is imminent as Russia continues its war on Ukraine, inflation and interest rates cross 40-year highs, and the global supply chain is constrained. The macroeconomic situation has been deteriorating fast with geopolitical crises further fueling it. However, the wider downturn in the market has been much harsher on biotechnology companies still working on their pipeline to produce a viable drug/treatment. Many such biotechs have resorted to restructuring this year to help reserve some capital and find a means to survive. Some have come out victorious while others have closed doors for good after failing to find an alternative. Joining in on the restructuring spree is also the Cleveland-based biotechnology firm, Athersys Inc. (ATHX).

    Athersys Inc. (ATHX) Overview

    ATHX stock has been severely beaten down with over 86% decline in the past twelve months and 75% this year. The losses have been much more severe in the past month with a return of over 64%. Currently, the stock is trading at a price of just 22 cents a share as per the premarket on June 3, 2022.

    In addition to the gloomy market situation, factors contributing to its downfall include a failing study, concerns over another, dwindling cash reserves, and the latest restructuring and layoffs. This comes at a time when the company is already struggling with keeping its share price above $1.00 to be compliant with listing requirements.

    Restructuring Plan

    Source: Fotolia

    Following a number of concerning events in the company’s timeline, the regenerative medicine company has finally resorted to restructuring. In order to reduce costs and work on its lead programs, the company has decided to lay off up to 70% of its workforce. Expected to be completed by the end of this month, the lay-offs are only the first step in ATHX’s cost reduction plan. The company said yesterday that it is trying to become more attractive to financial and strategic partners.

    Moreover, at the end of May, president and Chief Operating Officer William (B.J.) Lehmann left the company which was also said to be a part of the restructuring. Additionally, Executive VP & Chief Scientific Officer Dr. John Harrington as well as Chief Financial Officer Ivor Macleod would be leaving the company by the end of this month.

    Following the huge layoffs and other steps to curb costs during the restructuring, ATHX would still be short on capital for the continuation of its trials. Thus, even after the restructuring, the company would require to raise additional funds to carry out its study programs.

    Disappointing Study Results

    The company’s lead platform product is MultiStem cell therapy which is an allogeneic stem cell product. ATHX has collaboration and license agreements with Healios K.K. for developing the MultiStem therapy for ischemic stroke, ARDS (acute respiratory distress syndrome), and other indications in Japan. In the last week of May, Healios shared the top-line data from the phase II/II TREASURE study of MutiStem in ischemic stroke patients in Japan. The study failed to achieve its primary endpoint which sent the shares of the company tumbling down by over 65% in just one session. The MultiStem therapy was in the most advanced stage of study in the ischemic stroke indication which disappointed big time.

    In the restructuring announcement, the company said it is planning a conference call regarding the data and interpretations with a highly regarded independent neurologist.

    Given the failure of the study, it is now more likely that the phase III MASTER-2 study will also disappoint. The MASTERS-2 study is evaluating MultiStem in the U.S., Europe, and Asia-Pacific, in the same patient group while the TREASURE study had relatively older patients. However, the company is confident that the results of the MASTER-2 study would be much better as age was a factor that played role in the TREASURE study.

    Financial Position

    The company’s latest quarterly results reported a net loss of $22.2 million with an increase in R&D expenses and a decrease in G&A expenses. Revenues for the quarter came at $2.9 million.

    Net cash used in operating activities increased to $20.2 million while cash reserves at the end of the quarter were just $21.8 million.

    Conclusion

    Before the company shared the disappointing trial results, ATHX had been getting upgrades as approval for MultiStem in Japan was expected to help the company tap into additional non-dilutive financial options. However, disappointing big time on the Japan study, shares were downgraded to Underperform from Neutral by Bank of America.

    While the company did say that it will continue the partnership with Healios and work on developing MultiStem therapy, there are now many concerns regarding it. Even after the restructuring, the company would still need more capital to continue the R&D programs. Thus, at the present, things are looking very bleak for the company. Only time will tell if the company will share the fate of those who shut doors for good or emerge victorious.

  • Athersys Inc. (ATHX) Rebounds Only to Fall Once Again. What’s Going on?

    On April 11, Athersys Inc. (ATHX) stock rebounded after a long fall to increase by 63.00% during the regular trading session. But the uptrend could not last any longer as the stock fell under corrections in the after-hours to shed 11.51%. Thus, after reaching $0.8600 in regular trading, ATHX plunged down to $0.7610 in the after-hours on Monday.

    What’s going on with ATHX?

    ATHX had been on a downward trend since the company’s partner HEALIOS K.K announced delaying its plan to seek regulatory approval for ARDS therapy. Continuing to fall over more than a week, the stock finally rebounded on Monday. The stock reported its new 52-week low of $0.4977 during the session. Since there is no other official news from the company, the rebound seems to have been caused by external factors. Thus, the stock rallied big on Monday as investors continued to buy the dip. But alas, the rebound could only last so long, and hence, the stock succumbed to corrections in the after hours.

    HEALIOS Updates

    Source: Stem Cell Transplant

    On April 4, the company shared updates from two clinical trials of its partner Healios. The clinical programs evaluating MultiStem® cell therapy are Phase 2/3 TREASURE study in ischemic stroke and ONE-BRIDGE trial in ARDS. Healios has exclusive rights and license to MultiStem for ARDS and ischemic stroke in Japan.

    According to the updates, the 365-day follow-up of the last patient in the TREASURE study has been completed. The topline results and disclosures are expected in the next month.

    Furthermore, Healios also reported feedback from PMDA (Pharmaceuticals and Medical Devices Agency- JAPAN) regarding the application for MutliStem approval for ARDS based on the ONE-BRIDGE study. While agreeing with the efficacy and safety of the study, PMDA suggested the need for additional supporting data. Resultantly, the company decided not to pursue approval in Q2 2022 and to continue discussions for early application.

    Penny Stocks and ATHX

    Penny stocks are almost always trending as the slightest change in the market or indication of the company causes huge movements. But they come with high volatility due to their below $5 price level. ATHX is one of the penny stocks that has been trending lately as it continues sharing developments.

    ATHX has seen some improvements recently with the new CEO taking charge of the company. According to Daniel A. Camardo (CEO of ATHX), the company is looking ahead to a transformational year in 2022 with its cell therapy development well underway.

  • Athersys Inc. (ATHX) stock Rebounds After Hours. What’s Happening?

    Athersys Inc. (ATHX) stock rebounded in the after-hours on Friday, to gain 8.90%. No news from the company is responsible for driving the stock up.

    During the previous regular session, ATHX stock traded in the red with a loss of 0.25%. The stock closed the session at $0.8724 on January 07. As soon as the after-market session started, the stock rebounded to reach $0.95 at 173.59K shares.

    Currently, the company’s 235.24 million outstanding shares trade at a market capitalization of $205.22 million.

    What’s happening with ATHX?

    ATHX stock has been trading in the red for the past few days. After losing for four days, the stock finally recovered in the after-hours on Friday. Hence, ATHX started trading in the green in Friday’s after-hours session. No news from the company is responsible for the stock’s recent movements, as the latest news date back to November 30.

    In the past five days, the stock has decreased by 3.35% and 13.62% last month. Moreover, the stock stands at a loss of 55.49% in the past year.

    MUST-ARDS Clinical Trial

    The company has been conducting Phase ½ MUST-ARDS clinical trials in acute respiratory distress syndrome (ARDS) patients. The randomized, double-blind, placebo-controlled trial was designed to evaluate the safety and efficacy of MultiStem® (invimestrocel) cell therapy in the patients. Furthermore, the study enrolled patients at 12 intensive care units in the United Kingdom and the United States. According to the study, in the early course of moderate to severe ARDS, the intravenous administration of the therapy was well-tolerated. Further, several efficacy points were also evaluated in the trial. These include mortality liberation from mechanical ventilation, discharge from ICU, and quality of life among survivors over one full year of recovery.

    The ATHX’s ARDS program was granted Regenerative Medicine Advanced Therapy (RMAT) and Fast Track Designation by the FDA.

    On November 30, the company announced that a report on the ATHX’s MUST-ARDS clinical trial has been published in the Intensive Care Medicine journal. The report in the peer-reviewed journal includes previously disclosed data from the MUST-ARDS clinical trial.

    ATHX’s Financial Highlights

    The company disclosed its third-quarter 2021 financial results on November 15.

    In the third quarter of 2021, the company generated revenues of $4.8 million, against $0.1 million in Q3 of 2020.

    ATHX suffered from a net loss of $16.2 million in the third quarter of 2021, against $22.5 million in the year-ago quarter.

  • Athersys, Inc. (ATHX) stock Rises in Pre-Market: Let’s find out why.

    Athersys, Inc. (ATHX) stock saw a more push in today’s pre-market trading session after the spread of the news that Athersys partner HEALIOS K.Khas completed the enrollment in the ONE-BRIDGE study in Japan. ATHX stock price saw an uptrend of  3.66% to reach $1.70 a share at the time of this writing. ATHX stock seemed green at the previous trading session and closed with a 1.86% gain. Let’s understand the current happenings.

    The ONE-BRIDGE study:

    One Bridge Study suggests the evaluation of the MultiStem® (invimestrocel) in patients who are suffering from acute respiratory distress syndrome (ARDS) which is mainly caused by pneumonia. One Bridge study comprises two patient groups. One group includes 30 patients who are suffering ARDS due to pneumonia. The second group consists of 5 patients suffering from ARDS due to COVID-19. The main objective is to compare the results of the safety and efficacy of Multistem treatment in both groups.HEALIOS will analyze this data after the follow-up period and then further announce the results.

    Athersys is conducting its study named MACOVIA in the united states in order to analyze the results of Multstem against the treatment of COVID-19 induced ARDS patients. One thing is to remember that FDA had given both Fast Track and Regenerative Medicine Advanced Therapy approval to the ARDS program.

    Financial View of ATHX stock

    ATHX announced its fourth quarter and fiscal year 2020 results in which ATHX stock generated $1.3 million in the last three months of 2020 as compared to the same period in 2019 while full-year revenue decreased to $1.4 million as compared to $5.6 million revenue in 2019.R&D expenses increased significantly to $18.7 million in the fourth quarter of 2020 as compared to $7.6 million in the prior year while overall R&D expenses for the full year 2020 reached $63 million as compared to $39 million in 2019. General and administrative expenses of ATHX stock were $4.3 million in the last three months while these were $15.9 for the full year of 2020.

    As of December 31, 2020, Athersys stock had 51.5 million in cash and cash equivalents while these were $35.0 million on December 31, 2019.

    Conclusion:

    It seems that momentum was already built for ATHX stock in the previous trading session and recent news of ATHX stock has added more hype to it. The earnings report suggests that Athersys contract revenue from its collaboration with Healios has decreased over the year, but operational expenses show that ATHX stock has progressed over the year. In a nutshell, investors should analyze ATHX stock both fundamentally and technically.