Athersys, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Ethersys third quarter 2020 results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. Thank you. I'll now turn the conference server to Karen Hannity. You may begin.

Thank you, and good afternoon, everyone. I'm Karen Kennedy, Director of Corporate Communications and Investor Relations for Athersys. Thank you for joining today's call. If you do not have a copy of the press release issued at the close of market, it is available on the Athersys website at athersys.com. Ivor McLeod, Chief Financial Officer, is here to provide us with the financial updates, and Gil VanBochelen, Chairman and Chief Executive Officer, will be providing our corporate updates. Today's call is expected to last 30 to 45 minutes, and a webcast of the audio will be available three hours after the call's conclusion on our website under the Events section. The access information for the replay is also in today's press release. Any remarks that we may make about future expectations, plans, and prospects constitute forward-looking statements for purposes of the safe harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by the forward-looking statements as a result of various important factors, including those discussed in our Forms 10-Q, 10-K, and other public FDC filings. We anticipate that subsequent events and developments may cause our Outlook to change. While we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. For the benefit of those who may be listening to the replay, this call was held and recorded on November 9th of 2020. Since then, we may have made announcements related to the topics discussed, so please reference our most recent press releases and SEC funding. With that, I'd like to turn the call over to Ivor McLeod. Ivor?

Thank you, Karen. Good afternoon, everybody, and once again, thank you for joining today's call. I am Ivan McLeod, Chief Financial Officer of AFASIS, and it is my pleasure to give you an overview of the financial results for the third quarter of 2020. For the three months ended September 30th, 2020, we recognized $86,000 in revenues compared to negative revenues of $361,000 for the three months ended September 30th, 2019. primarily related to our collaboration with Helios. During our evaluation of variable consideration in the third quarter of 2019, we determined that the estimated transaction price of certain product supply provided to Helios decreased due to a reduction in the underlying cost of those of the product supply occurring during the quarter. In addition, The number of doses of clinical product requested by Helios was amended, further reducing our revenues during the period. Our collaboration revenues may fluctuate over time as we contract with Helios to perform manufacturing or other services, and as we potentially enter into new collaborations. Research and development expenses were $18.5 million for the third quarter of 2020. compared to $8.9 million for the comparable period in 2019. The $9.6 million increase is primarily associated with increases in clinical trial and manufacturing process development costs of $6.9 million, as well as increases in research supplies, personnel costs, stock compensation costs, and other research and development costs. 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. We expect our annual 2020 research and development expenses to increase compared to 2019. General and administrative expenses were $3.7 million for the three months ended September 30th, 2020. This represents an increase of $700,000 when compared to expenses of $3 million in the comparable period in 2019. This increase was primarily due to increased personnel costs, outside services, professional fees, and stock compensation costs. The net loss for the third quarter of 2020 was $22.5 million compared to a net loss of $12 million in the third quarter of 2019. The difference is primarily a consequence of the previously mentioned variances. During the nine months ended September 30th, 2020, net cash used in operating activities was $44.5 million. compared to $25.2 million in the nine months ended September 30, 2019. Net cash used in operating activities may fluctuate significantly on a quarter-to-quarter basis, as it has over the past several years, primarily due to the timing of receipts of fees from our collaborators and our payments of clinical trial costs, such as clinical manufacturing campaigns, contract research organization costs, and manufacturing process development projects. At September 30th, 2020, we have $61.7 million in cash and cash equivalents, compared to $35 million at December 31st, 2019. With that, I will turn the call over to Gil VanBochelen for the corporate update. Gil?