On May 8, 2019 Complix, a biopharmaceutical company developing Cell Penetrating Alphabodies (CPABs) to target intracellular disease targets, reported that its Chief Executive Officer, Dr Mark Vaeck, will be presenting at the 20th Annual BioEquity Europe Conference in Barcelona, Spain, May 20-21 (Press release, Complix, MAY 8, 2019, View Source [SID1234535932]).

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In his presentation on Dr Vaeck will provide an overview of Complix’ recent achievements in applying its CPAB platform to develop next-generation therapeutics acting on important but intractable intracellular targets.

The presentation will take place on Monday May 20th at 16.50h CET in room Vivaldi 1 of the Crown Plaza Barcelona Fira Center Hotel.

On May 8, 2019 argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, reported that Tim Van Hauwermeiren, Chief Executive Officer, will present at the Bank of America Merrill Lynch 2019 Health Care Conference on Wednesday, May 15, 2019 at 9:20 a.m. PT in Las Vegas, NV (Press release, argenx, MAY 8, 2019, View Source [SID1234535949]).

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A live webcast of the presentation will be available on the Company’s website at www.argenx.com. A replay of the webcast will be available for 90 days following the presentation.

On May 8, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported its financial results for the first quarter ended March 31, 2019 (Press release, Nektar Therapeutics, MAY 8, 2019, View Source [SID1234535966]).

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Cash and investments in marketable securities at March 31, 2019 were approximately $1.8 billion as compared to $1.9 billion at December 31, 2018.

"Nektar continues to advance our immuno-oncology and immunology pipeline with clinical trials initiating for multiple drug candidates across multiple indications," said Howard W. Robin, President and CEO of Nektar. "We are working with our partner, Bristol-Myers Squibb, to execute on our broad joint development program for bempegaldesleukin in combination with nivolumab, with registrational trials in melanoma, RCC, urothelial and non-small cell lung cancer underway and additional trials planned to begin in the coming months."

"NKTR-181 is under review with the FDA and we are planning for a potential launch later this year," continued Robin. "With respect to NKTR-358, we will report the first data for this exciting drug candidate in an oral presentation at the EULAR Congress in June and our multiple-ascending dose trial in lupus patients is continuing. With our partner Lilly, we continue to advance development of NKTR-358 with two new Phase 1b studies in additional auto-immune disorders planned to start in 2019. We are also completing our IND-enabling activities for our next immuno-oncology candidate, NKTR-255, which activates the IL-15 pathway."

Revenue in the first quarter of 2019 was $28.2 million as compared to $38.0 million in the first quarter of 2018. Revenue in the first quarter of 2019 was lower primarily due to the recognition of $10.0 million received in the first quarter of 2018 from Takeda for the approval of Adynovi in Europe.

Total operating costs and expenses in the first quarter of 2019 were $148.9 million as compared to $124.8 million in the first quarter of 2018. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the first quarter of 2019 was $118.5 million as compared to $99.4 million for the first quarter of 2018. R&D expense was higher in the first quarter of 2019 as compared to the same period in 2018 primarily because of expenses for our pipeline programs, including the continued development of bempegaldesleukin in Phase 2 and registrational studies and related manufacturing costs, costs related to Phase 1 clinical studies of NKTR-358 and IND-enabling activities for NKTR-255.

General and administrative expense was $25.0 million in the first quarter of 2019 as compared to $18.7 million in the first quarter of 2018 and increased primarily due to costs related to commercialization readiness activities for NKTR-181 and increased non-cash stock-based compensation.

In the first quarter of 2019, net loss was $118.5 million, or $0.68 loss per share as compared to net loss of $95.8 million, or $0.60 loss per share in the first quarter of 2018.

2019 Business Highlights

In April, Nektar presented positive preclinical data on its immuno-oncology pipeline candidates, bempegaldesleukin and NKTR-255, an IL-15 receptor agonist, at the 2019 AACR (Free AACR Whitepaper) Annual Meeting.
In March, Nektar presented preliminary immune activation, safety and clinical activity data from the ongoing dose-escalation stage of the REVEAL study at the 2019 ASCO (Free ASCO Whitepaper)-SITC Meeting. The REVEAL Phase 1/2 study is evaluating the safety and efficacy of NKTR-262, a novel TLR agonist, in combination with bempegaldesleukin.
In February, Nektar presented clinical data from first-line Stage IV urothelial carcinoma patients enrolled in the PIVOT-02 study of bempegaldesleukin with nivolumab at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
The company also announced upcoming presentations at the following scientific congresses during the second quarter of 2019:

4th Drug Discovery Nexus, Boston, MA:

Presentation: "Harnessing cytokines to develop immune therapeutic agents"
Presenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
Date: Friday, May 17, 2019, 9:30 a.m. Eastern Daylight Time
4th Annual Advances in Immuno-Oncology Congress 2019, London, U.K.:

Presentation: "Bempegaldesleukin (NKTR-214): Targeting the IL-2 Pathway for Immuno-Oncology Applications"
Presenter: Jonathan Zalevsky, Ph.D., Nektar Therapeutics
Session: Immuno-Oncology Therapeutic Approaches, Clinical Research & Clinical Trials
Date: Tuesday, May 21, 2019, 16:30 British Summer Time
American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2019 Annual Meeting, Chicago, IL:

Oral Abstract # 11010: "Pilot study of bempegaldesleukin (NKTR-214) and nivolumab in patients with sarcomas"
Presenter: Sandra D’Angelo, M.D., Memorial Sloan-Kettering Cancer Center
Session: Clinical Science Symposium: Emerging Combinations in Sarcoma Immunotherapy
Date: Monday, June 3, 2019, 11:30 a.m. – 1:00 p.m. Central Daylight Time
Poster #228/Abstract # 2584: "Overcoming genetically-based resistance mechanisms to PD-1 blockade", Torrejon, D., et al.
Session: Developmental Immunotherapy and Tumor Immunobiology
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Daylight Time
Poster #267/Abstract # 2623: "Baseline tumor immune signatures associated with response to bempegaldesleukin (NKTR-214) and nivolumab", Hurwitz, M., et al.
Session: Developmental Immunotherapy and Tumor Immunobiology
Date: Saturday, June 1, 2019, 8:00 a.m. – 11:00 a.m. Central Daylight Time
Poster #416b/Abstract # TPS4595: "A phase III randomized open label study comparing bempegaldesleukin (NKTR-214) plus nivolumab to sunitinib or cabozantinib (investigator’s choice) in patients with previously untreated advanced renal cell carcinoma", Tannir, N., et al.
Session: Genitourinary (Nonprostate) Cancer
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Daylight Time
Poster 168b/Abstract # TPS9601: "A phase III, randomized, open-label study of bempegaldesleukin (NKTR-214) plus nivolumab (NIVO) versus NIVO monotherapy in patients (pts) with previously untreated, unresectable or metastatic melanoma (MEL)", Khushalani, N., et al.
Session: Melanoma/Skin Cancers
Date: Monday, June 3, 2019, 1:15 p.m. – 4:15 p.m. Central Daylight Time
Pharmaceutical & Bioscience Society Symposium: Advances in Immuno-Oncology, Foster City, CA:

Presentation: "Bempegaldesleukin (NKTR-214), a first-in-class, CD122-preferential IL-2 pathway agonist"
Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
Date: Tuesday, June 11, 2019, 8:45 a.m. Pacific Daylight Time
24th Congress of European Hematology Association (EHA) (Free EHA Whitepaper), Amsterdam, Netherlands:

Abstract # PS1208: " Effects Of NKTR-255, A Polymer Conjugated Human IL-15, on Efficacy of CD19 CAR T Cell Immunotherapy in a Preclinical Lymphoma Model"
Presenter: Cassie K. Chou, M.D., Ph.D., Fred Hutchinson Cancer Research Center
Session: Gene therapy, cellular immunotherapy and vaccination – Biology & Transitional Research
Date: Saturday, June 15, 2019, 17:30 – 19:00 Central European Summer Time
Poster Pitch: Saturday, June 15, 2019, 16:30 – 16:45 Central European Summer Time
Location: Hall G106
Annual European Congress of Rheumatology (EULAR) 2019, Madrid, Spain:

Abstract # OP0195: "Selective Expansion of Regulatory T-Cells in Humans by a Novel IL-2 Conjugate T-reg Stimulator, NKTR-358, Being Developed for the Treatment of Autoimmune Diseases"
Presenter: Brian Kotzin, M.D., Nektar Therapeutics
Session: Genetics, epigenetics and immunity
Date: Thursday, June 13, 2019, 11:15 Central European Summer Time
Conference Call to Discuss First Quarter 2019 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Daylight Time/2:00 p.m. Pacific Daylight Time, Wednesday, May 8, 2019.

This press release and a live audio-only Webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Monday, June 10, 2019.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 8249707 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On May 8, 2019 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers for patient enrichment, reported financial results and provided a corporate update for the first quarter ended March 31, 2019 (Press release, Jounce Therapeutics, MAY 8, 2019, View Source [SID1234535905]).

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"We have made significant progress in recent months by applying our Translational Science Platform and reverse translational approach to advance both our ongoing clinical and preclinical programs. Most importantly, at AACR (Free AACR Whitepaper), we presented promising new progression free and overall survival data from the ICONIC trial for patients stratified by our vopratelimab pharmacodynamic biomarker, ICOS hi CD4 T cells in the blood. Additionally, we presented validating preclinical data from our lead tumor-associated macrophage program, JTX-8064," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "With these key accomplishments in hand, we look forward to advancing our broader pipeline with the goal of three immunotherapies in the clinic in 2019. We remain focused on the underlying mechanistic science of our immunotherapies and understanding of the characteristics of responding patients in our mission to bring meaningful and long-lasting benefit to cancer patients with unmet needs."

Pipeline Highlights:
Vopratelimab (JTX-2011)

Key data presented at AACR (Free AACR Whitepaper) 2019: In April 2019, Jounce presented two posters on vopratelimab at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Highlights from the poster presentations include:

Patients in the ICONIC trial with the emergence of ICOS hi CD4 T cells demonstrated improved progression free survival (PFS) and overall survival (OS) compared to patients with ICOS lo CD4 T cells, based on an analysis of a subgroup of patients with multiple solid tumor types including PD-1 inhibitor naive and PD-1 inhibitor experienced patients.

The characteristics of ICOS hi CD4 T cells associated with vopratelimab treatment via translational analyses demonstrated that vopratelimab stimulates only primed CD4 T cells with high levels of ICOS. The translational data shows that vopratelimab, unlike PD-1 inhibitors, leads to expansion and activation of peripheral CD4 T effector cells, and that these are observed in patients with clinical benefit.

On track for planned initiation of Phase 2 clinical studies: Based on the recently-presented AACR (Free AACR Whitepaper) data, Jounce plans to initiate additional Phase 2 clinical studies focusing on settings in which ICOS hi CD4 T effector cells exist or emerge and are primed to respond to vopratelimab, potentially leading to clinical benefit. The first of these studies will be a clinical trial of

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vopratelimab in combination with ipilimumab in PD-1 inhibitor experienced patients in two tumor types, non-small cell lung cancer and bladder cancer. Additionally, Jounce expects to initiate a clinical trial of vopratelimab in combination with ipilimumab in PD-1 inhibitor naive patients with bladder cancer and a separate predictive biomarker study. Jounce expects to report preliminary efficacy data in 2020.

JTX-4014

On track to complete enrollment of Phase 1 study: Jounce remains on track to assess safety and select the recommended Phase 2 dose for JTX-4014, its PD-1 inhibitor, in 2019.

JTX-8064

New validating preclinical data presented at AACR (Free AACR Whitepaper) 2019: In April 2019, Jounce presented new preclinical data demonstrating the properties of JTX-8064, Jounce’s lead tumor associated macrophage candidate. JTX-8064 is an inhibitor of LILRB2 (leukocyte immunoglobulin like receptor B2; ILT4) and is believed to reprogram tumor-associated macrophages within the tumor microenvironment. Highlights from the poster presentation include:

When LILRB2 binds to its ligands, it maintains macrophages in the M2 or immuno-suppressive state.

When JTX-8064 blocks ligand binding to LILRB2, it induces an immune activating state in macrophages that may lead to the enhancement of the anti-tumor immune response.

Inhibiting LILRB2 induces pro-inflammatory cytokine secretion and a unique transcriptional profile suggestive of an M1-like shift in human macrophages to an immune stimulatory state.

On track to file IND and initiate Phase 1 clinical trial: Jounce expects to file an investigational new drug (IND) application and initiate a Phase 1 clinical trial of JTX-8064 in 2019.

First Quarter 2019 Financial Results:

Cash Position: As of March 31, 2019, cash, cash equivalents and investments were $173.2 million, compared to $195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period.

Collaboration Revenue: Collaboration revenue was $11.0 million for the first quarter of 2019, compared to $11.2 million for the same period in 2018. Collaboration revenue represents non-cash revenue recognition relating to the $225.0 million upfront payment received in July 2016 upon the execution of Jounce’s global strategic collaboration with Celgene.

Research and Development Expenses: Research and development (R&D) expenses were $17.3 million for the first quarter of 2019, compared to $18.2 million for the same period in 2018. The decrease in R&D expenses was primarily due to $1.5 million of decreased external research and development costs attributable to JTX-4014 IND-enabling expenses incurred during the first quarter of 2018, partially offset by $0.5 million of increased employee compensation costs.

General and Administrative Expenses: General and administrative (G&A) expenses were $7.2 million for the first quarter of 2019, compared to $6.8 million for the same period in 2018. The increase in G&A expenses was primarily due to $0.7 million of increased employee compensation costs, including $0.3 million of increased stock-based compensation expense.

jouncelogosmaller.jpg

Net Loss: Net loss was $12.4 million for the first quarter of 2019, or a basic and diluted net loss per share of $0.38. Net loss was $13.0 million for the same period in 2018, or a basic and diluted net loss per share of $0.40. The decrease in net loss and net loss per share was primarily attributable to the decrease in operating expenses from the first quarter of 2018 to the first quarter of 2019.

Financial Guidance:
Jounce reiterates its expectation that cash burn on operating expenses and capital expenditures for the full year 2019 will be approximately $80.0 million to $95.0 million. Jounce expects to record approximately $50.0 million to $60.0 million in non-cash collaboration revenue in 2019 from the recognition of the Celgene upfront payment received in 2016.

Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast today at 8:00 a.m. ET. To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 5789371. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days.

Cautionary Note Regarding Forward-Looking Statements:
Various statements in this release concerning Jounce’s future expectations, plans and prospects, including without limitation, Jounce’s expectations regarding operating expenses, capital expenditures, collaboration revenue and other financial results; the timing, progress and release of data for Phase 2 clinical studies of vopratelimab; the timing, progress and results of the Phase 1 trial of JTX-4014; the filing of an IND and initiation of a Phase 1 trial of JTX-8064 and the timing, progress and results of preclinical studies and clinical trials for Jounce’s product candidates and any future product candidates may constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws and are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these forward-looking statements, which often include words such as "anticipate," "believe," "estimate," "expect," "intend," "may," "on track," "plan," "predict," "target," "potential" or similar terms, variations of such terms or the negative of those terms. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates and future product candidates; the preclinical and clinical results for its product candidates, which may not support further development and marketing approval; the potential advantages of Jounce’s product candidates; the development plans of its product candidates and any companion or complementary diagnostics; actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Jounce’s product candidates; Jounce’s ability to obtain, maintain and protect its intellectual property; Jounce’s ability to manage operating expenses; Jounce’s ability to maintain its collaboration with Celgene and those risks more fully discussed in the section entitled "Risk Factors" in Jounce’s most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission as well as discussions of potential risks, uncertainties, and other

jouncelogosmaller.jpg

important factors in Jounce’s subsequent filings with the Securities and Exchange Commission. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

On May 8, 2019 Athersys, Inc. (NASDAQ: ATHX) reported its financial results for the three months ended March 31, 2019 (Press release, Athersys, MAY 8, 2019, View Source [SID1234535933]).

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Highlights of the first quarter of 2019 and recent events include:

Announced positive results from our exploratory clinical study of MultiStem cell therapy for treatment of acute respiratory distress syndrome ("MUST-ARDS"), showing reduced mortality and greater ventilator-free and ICU-free days in patients with moderate to severe ARDS;

The MUST-ARDS study has been selected for presentation at the American Thoracic Society International Conference on May 20, 2019;

Our partner in Japan, HEALIOS K.K. ("Healios"), announced its first patient enrolled in the ONE-BRIDGE study in Japan, evaluating MultiStem cell therapy treatment of patients who suffer from pneumonia-induced ARDS;

Advanced ischemic stroke program, supporting Healios’ TREASURE study and ramping up our MASTERS-2 Phase 3 registrational study;

Announced plans to host an investor day in New York City on May 14, 2019 that will highlight the Company’s capabilities and technologies, as well as progress made developing the MultiStem product platform and future plans;

Participated in several investor conferences and media interviews, including "The Stem Cell Podcast" and the "Forbes Book Podcast" as the featured guest; also featured live on TD Ameritrade’s "The WatchList";

Launched a revamped website with a simplified design, improved functionality and enhanced content to help educate our visitors;

Recognized revenues of $1.4 million for the quarter ended March 31, 2019 and net loss of $13.0 million, or $0.09 net loss per share, for the quarter ended March 31, 2019; and

Ended the 2019 first quarter with $51.0 million of cash and cash equivalents.
"We made continued progress in the first quarter of 2019 in advancing our key initiatives, reflected by the release of results from our ARDS study and the continued progress of enrollment in our Phase 3 MASTERS-2 trial and the TREASURE registrational study being conducted by our partner in Japan for treating ischemic stroke," commented Dr. Gil Van Bokkelen, Chairman & CEO at Athersys. "We are working collaboratively with Healios in multiple areas, which includes supporting their initiation of the ONE-BRIDGE study for ARDS, and we further strengthened our core capabilities."
"In addition, we have maintained a solid balance sheet as we continue to implement our strategic plan, working toward the achievement of our key goals on behalf of our shareholders and the patients we are committed to helping," concluded Dr. Van Bokkelen.

First Quarter Results
Revenues increased to $1.4 million for the three months ended March 31, 2019 compared to $1.1 million for the three months ended March 31, 2018. Our revenues are generally derived from license fees, manufacturing-related activities for Healios, other royalty and related contract revenue from our collaborations, and grant revenue. Revenues from our collaboration with Healios increased quarter-over-quarter related to our manufacturing services. Royalty revenues from RTI Surgical, Inc. have concluded with its discontinuation of distribution of the licensed product.
Research and development expenses increased to $11.4 million for the three months ended March 31, 2019 from $8.9 million for the comparable period in 2018. The $2.5 million increase is primarily associated with increased clinical trial and manufacturing process development costs of $1.9 million, increased personnel costs of $0.4 million, and increased stock compensation costs of $0.1 million. Included in our clinical costs are costs associated with providing manufacturing services to Healios, which are invoiced to Healios in accordance with the collaboration agreements.
General and administrative expenses increased to $3.1 million for the three months ended March 31, 2019 from $2.7 million in the comparable period in 2018. The $0.4 million increase was due primarily to increased legal and professional fees, consulting services, and stock compensation costs compared to the same period last year.
Net loss for the first quarter was $13.0 million in 2019 compared to a net loss of $10.2 million in 2018. The difference of $2.8 million reflects the above variances, as well as a decrease of $0.2 million in other income.
In the three months ended March 31, 2019, net cash used in operating activities was $5.5 million compared to $5.7 million in the three months ended March 31, 2018. At March 31, 2019, we had $51.0 million in cash and cash equivalents, compared to $51.1 million at December 31, 2018.

Conference Call
William (B.J.) Lehmann, President and Chief Operating Officer, and Laura Campbell, Senior Vice President of Finance, will host a conference call today to review the results as follows:

Date

May 8, 2019
Time

4:30 p.m. (Eastern Time)
Telephone access: U.S. and Canada

(877) 396-3286
Telephone access: International

(647) 689-5528
Access code

6595362
Live webcast

www.athersys.com, under the Investors section

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 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 15, 2019 by dialing (800) 585-8367 or (416) 621-4642 and entering Encore passcode 6595362.