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Msg  2232 of 2235  at  4/1/2023 10:52:09 AM  by

jerrykrause


Athersys Reports Fourth Quarter and Full Year 2022 Financial Results and Business Hig

Pharma & Healthcare Monitor Worldwide
 
 

Athersys Reports Fourth Quarter and Full Year 2022 Financial Results and Business Highlights

 
 

Athersys, Inc. (NASDAQ: ATHX) today announced financial results for the three and 12 months ended December 31, 2022, and provided a business update.

Fourth Quarter 2022 and Recent Corporate and Operational Highlights

Largely completed the companys restructuring initiative with the goal of significantly reducing expenses, conserving cash, improving focus and making Athersys more attractive to potential financial and strategic partners

Reduced operating expenses below $3 million per month, compared with $7 million per month a year ago

Reduced headcount by 70% to 20 FTEs currently

Closed ReGenesys, Athersys animal health-focused division based in Belgium, and sold all related equipment

Initiated efforts to sublet the Stow, Ohio facility

Reduced and streamlined internal research functions to focus on the pivotal Phase 3 MASTERS-2 clinical trial in ischemic stroke

Appointed experienced biotechnology and pharmaceutical executive Joseph Nolan to the Board of Directors

Raised gross proceeds of $5.5 million in a public offering

Completed enrollment in cohorts 1 and 2 of MATRICS-1, the investigator-initiated Phase 2 trial evaluating MultiStem in patients following resuscitation from hemorrhagic trauma

Announced participation in a Request for Proposal process with the Biomedical Advanced Research and Development Authority (BARDA) to explore the use of MultiStem for acute respiratory distress syndrome (ARDS) and other COVID-19 co-morbidities

Healios announced regulatory agreement on the outline for a clinical trial in Japan with HLCM051 (MultiStem) in patients with pneumonia-induced ARDS, including in patients with COVID-19

Granted first U.S. patent for the SIFU ultracold storage technology

MASTERS-2

Announced planned amendments to MASTERS-2 clinical trial protocol following a successful Type B meeting with the U.S. Food & Drug Administration (FDA)

Proposed modifications establish primary and secondary endpoints that best reflect the full potential benefit of MultiStem treatment for patients with acute, moderate-to-severe ischemic stroke as well as the evolving standard of care

Primary endpoint will become mRS shift analysis at Day 365

Convened a meeting of stroke Key Opinion Leaders (KOLs) to discuss potential changes to the MASTERS-2 trial design, given clinical findings from Healios TREASURE trial in Japan and comparing data results from our Phase 2 MASTERS-1 study

Exceeded 50% enrollment in MASTERS-2 and significantly increased the rate of patient enrollment due in part to increased trial site engagement and opening new sites across more geographies, with more sites expected to be activated throughout 2023

Three sites in the U.S. and eight or nine sites in Europe are expected to be activated in the first half of 2023

Management Commentary

Last year was a transformative year for Athersys that required us to evaluate every aspect of our business, said Dan Camardo, Chief Executive Officer of Athersys. We have worked diligently to reduce the companys historically large cash burn while prioritizing areas where we can deliver the highest value to patients and shareholders. With a leaner organization, key management and board appointments, and reduced expenses, we entered 2023 in a far stronger position.

We remain focused on advancing MASTERS-2 in ischemic stroke and look forward to meeting with FDA and EMA regulators later this month to discuss insights gained from the TREASURE trial conducted in Japan. We also continue to engage with potential global and regional partners to advance MultiStem in ischemic stroke and other potential early-stage indications, he added. We look forward to updating shareholders throughout the year via public disclosures and periodic business update calls.

Fourth Quarter 2022 Financial Results

Revenues for the fourth quarter of 2022 were approximately $0.1 million compared to $0.7 million for the fourth quarter of 2021. Collaboration revenues fluctuate from period to period based on the delivery of services under the arrangement with Healios. As of September 30, 2022, services under the Healios arrangement were largely complete and were limited to close-out activities.

Research and development expenses were $10.9 million for the fourth quarter of 2022 compared with $18.7 million for the comparable period in 2021. The decrease is due to our restructuring efforts which caused a decrease in clinical trial expenses of $4.2 million, personnel costs of $2.8 million, legal costs of $0.04 million and $0.4 million of other costs.

General and administrative expenses were $2.8 million for the fourth quarter of 2022, compared with $3.4 million for the comparable period in 2021. The decrease is primarily related to our restructuring efforts which caused a decrease in personal costs of $0.8 million. This decrease was partially offset by an increase in legal and professional fees of $0.3 million.

Net loss for the fourth quarter of 2022 was $13.0 million, or $0.83 per share, compared with a net loss of $21.7 million, or $2.29 per share, for the comparable period in 2021.

Full Year 2022 Financial Results

Revenues were $5.3 million and $5.5 million for 2022 and 2021, respectively, a decrease of $0.2 million, or 3.6%, reflecting the completion of services under the Healios arrangement.

Research and development expenses decreased to $65.0 million for the year ended December 31, 2022 from $71.1 million for the year ended December 31, 2021. The decrease in research and development expenses year-over-year of $6.1 million is related primarily to our restructuring plan which resulted in decreased clinical trial costs of $1.9 million, legal costs of $1.0 million, and personnel costs of $3.0 million, including stock-based compensation expense, and other expense of $0.2 million. Based on our current restructuring plans, we expect our 2023 annual research and development expenses to be lower compared to 2022, and such costs will vary over time based on clinical manufacturing campaigns, the timing and stage of clinical trials underway, manufacturing process development projects and regulatory initiatives. These variations in activity level may also impact our accounts payable, accrued expenses and prepaid expenses balances from period-to-period. Other than external expenses for our clinical and preclinical programs, we do not track our research expenses by project; rather, we track such expenses by the type of cost incurred.

General and administrative expenses decreased to $15.9 million in 2022 from $20.1 million in 2021. The $4.2 million decrease year-over-year is related primarily to our restructuring plan which resulted in decreased personnel costs of $3.3 million. Additionally, legal costs of $2.3 million decreased due to the legal costs around the Comprehensive Framework that occurred in 2021 but not in 2022. These decreases were partially offset by increases in outside service and consulting expenses of $1.1 million and facility expense of $0.3 million.

Net loss was $72.5 million, or $6.07 per share, and $87.0 million, or $9.69 per share, for 2022 and 2021, respectively.

Net cash used in operating activities was $59.0 million in 2022 compared to $76.2 million in 2021. As of December 31, 2022, Athersys had $9.0 million in cash and cash equivalents, compared to $37.4 million as of December 31, 2021.

In lieu of a fourth quarter earnings conference call, we will hold a business update call in late April. Details for this call will be announced separately at a later date.


 


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