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Celyad to Present Update on allogeneic and autologous NKG2D-based CAR-T Candidates in Refractory mCRC at ESMO 21st World GI Congress

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Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced that clinical data from the SHRINK and alloSHRINK Phase 1 trials, evaluating the safety of NKG2D-based autologous and allogeneic CAR-T candidates, CYAD-01 and CYAD-101, respectively, will be presented at the upcoming European Society for Medical Oncology (ESMO) 21st World Congress on Gastrointestinal Cancer (WCGIC) to be held on July 3-6, 2019, in Barcelona, Spain.

 “We are delighted for the opportunity to present updated data at the upcoming WCGIC from both our autologous and allogeneic NKG2D-based clinical candidates for the treatment of refractory metastatic colorectal cancer” noted Frédéric Lehmann, Head of Global Clinical Development and Medical Affairs at Celyad. “We continue to build upon our clinical experience in the treatment of solid tumors with these novel immunotherapies and the oral presentation at WCGIC represents a special milestone to highlight preliminary data from the industry’s first trial investigating an ‘off-the-shelf ‘ CAR-T candidate for the treatment of solid tumors. In addition, the comparable trial designs between SHRINK and alloSHRINK as well as the similar CAR constructs provide insight into autologous and allogeneic approaches in an advanced solid tumor indication.”

Presentation Details:

Abstract #631:  Phase 1 studies assessing the safety and clinical activity of autologous and allogeneic NKG2D-based CAR-T therapy in metastatic colorectal cancer

Session:           Short Oral Presentation

Background on CYAD-01 and CYAD-101

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express a chimeric antigen receptor (CAR) based on NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells. CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the NKG2D CAR of CYAD-01 and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). The expression of TIM reduces signalling of the TCR complex which is responsible for Graft versus Host Disease (GvHD).

Background on SHRINK and alloSHRINK Trials

SHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and activity of CYAD-01 administered concurrently with FOLFOX (combination of 5-fluorouracil, leucovorin and oxaliplatin) chemotherapy in patients with metastatic colorectal cancer (mCRC). Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-01 every two weeks.

alloSHRINK is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with refractory mCRC.  Similar to the SHRINK trial for CYAD-01, patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks.

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Celyad’s 2019 R&D Day Highlights shRNA Platform and Pipeline of Next-generation NKG2D-based and Off-the-Shelf Non-gene Edited CAR-T Candidates

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  • shRNA platform complements Company’s all-in-one-vector approach in the design, discovery and development of next-generation CAR-T candidates
  • Allogeneic T-cells derived by shRNA targeting show distinctive profile compared to CRISPR-Cas9 gene edited cells in preclinical assays
  • Plans to initiate several Phase 1 trials to evaluate lead candidates, including next generation, autologous NKG2D-based CYAD-02 and three first-in-class, shRNA-based, non-gene edited allogeneic CAR-T therapies from the CYAD-200 series

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today presented at R&D Day in New York the continued progress of the its pipeline of proprietary CAR-T therapies for the treatment of hematological malignancies and solid tumors, based on its short hairpin RNA (shRNA) platform.

“We are very pleased with the recent progress of our preclinical CAR-T pipeline,” noted Dr. Christian Homsy, CEO of Celyad. “Together with CYAD-101, our next generation allogenic shRNA platform should allow us to leapfrog the competition in the allogeneic CAR-T landscape. In addition, CYAD-02 has shown encouraging preclinical data of increased CAR-T cell expansion, persistence and anti-tumor efficacy. We continue to tap into our deep expertise and knowledge in cell therapy manufacturing and our all-in-one vector approach provides tremendous flexibility, versatility and efficiency in the design of novel, CAR-T therapies.“

Corporate Updates

  • Lead asset CYAD-01 continues to advance in clinical trials for the treatment of patients with relapsed/refractory (r/r) acute myeloid leukemia (AML). The Company reported that additional dosing and schedule optimization are under evaluation in the THINK Phase 1 trial. In addition, the Company reported that interim data from the DEPLETHINK Phase 1 trial evaluating CYAD-01 following preconditioning chemotherapy shows the CAR-T cell therapy is well-tolerated at the initial dose levels following preconditioning chemotherapy. Future clinical updates from the Phase 1 THINK and DEPLETHINK trials are anticipated by mid-2019. 
  • Company also highlighted its operational excellence for 2018 including a 94% manufacturing success rate and a twofold increase year-over-year in the number of patients treated.

shRNA Platform

  • In October 2018, Celyad announced it had entered into an exclusive agreement with Horizon Discovery Group for the use of its shRNA technology to generate a novel, next-generation, non-gene-edited allogeneic platform for CAR-T therapies. Horizon Discovery’s SMARTvector technology to express shRNA optimized by Celyad provides an alternate method to knockout the TCR complex in allogeneic CAR-T therapies compared to gene editing techniques as well as the specificity to target a broad range of proteins.
  • Utilization of the shRNA platform allowed the Company to develop the next generation of autologous, NKG2D-based CAR-T candidate, CYAD-02, and the novel, non-gene edited allogeneic CYAD-200 series of CAR-T candidates.
  • In addition, the shRNA platform complements the Company’s strong intellectual property of six U.S. patents related to allogeneic T-cell technology and producing TCR deficient cells expressing a CAR construct.

Autologous CAR-T candidate: CYAD-02

  • CYAD-02 incorporates shRNA technology to target NKG2D ligands MICA/MICB. In preclinical AML models, CYAD-02 shows an encouraging increase in in vitro proliferation and in vivo persistence and anti-tumor activity. The Company plans to generate additional preclinical proof-of-concept data for the program throughout 2019 and plans to submit an Investigational New Drug (IND) application for CYAD-02 in first half 2020.

Non-gene edited allogeneic CAR-T candidates: CYAD-200 series

  • Celyad utilizes two technologies based on non-gene edited approaches to modulate the T-cell receptor (TCR) complex to generate allogeneic CAR-T therapies. The first approach utilizes our TCR-inhibitor molecule (TIM) and is tailored to our NKG2D-based CAR-T clinical candidate CYAD-101. The second approach leverages shRNA technology exclusively licensed from Horizon Discovery to target the CD3ζ component to knockdown the expression of the TCR/CD3 complex on the surface of the T-cell.
  • In vivo data demonstrate that shRNA targeting of CD3ζ effectively protects against Graft-versus-Host Disease (GvHD) to a level equivalent to CRISPR-Cas9 based knock-out.  Furthermore, results from preclinical tests show significant increase in persistence of allogeneic T cells using shRNA targeting when compared to gene editing technologies, such as CRISPR-Cas9.
  • Celyad announced plans to develop three disruptive first-in-class non-gene-edited allogenic CAR-T candidates leveraging the shRNA SMARTvector platform, including:
    • CYAD-211: B-cell maturation antigen (BCMA) targeting CAR-T therapy for the treatment of multiple myeloma, which is expected to enter the clinic by mid-2020.
    • CYAD-221: CD19 targeting CAR-T therapy for the treatment of B-cell malignancies, which is expected to enter the clinic by late 2020.
    • CYAD-231: Dual specific CAR-T targeting NKG2D and an undisclosed membrane protein, which is expected to enter the clinic by early 2021.
  • In addition, the company continues to investigate additional undisclosed targets using the shRNA platform to pair with CARs to develop, differentiated next-generation cell therapies for the treatment of both hematological malignancies and solid tumors.
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Celyad Presents Update on CYAD-01 Hematological Malignancies Clinical Program at 60th ASH Annual Meeting

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  • CYAD-01 without preconditioning chemotherapy was well-tolerated and demonstrated anti-leukemic activity in five out of eight (62%) evaluable patients with relapsed or refractory (r/r) acute myeloid leukemia (AML) evaluable per protocol in THINK Phase 1 trial with three objective responses (CRh/CRi)
  • Second cycle of CYAD-01 demonstrated ability to reduce relevant bone marrow blast in r/r AML patient post-hematological relapse
  • Preliminary safety data from DEPLETHINK Phase 1 trial, evaluating CYAD-01 with preconditioning chemotherapy in r/r AML patients showed administration in the ongoing first dose cohort was well-tolerated with no Grade 3 or 4 treatment-related adverse events (AEs) 

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced updated clinical data for the CYAD-01 program in hematological malignancies presented at the American Society of Hematology (ASH) 60th Annual Meeting.

THINK Phase 1 Trial Update – Hematological Malignancies

  • Results from the dose-escalation trial were accepted as an oral presentation at ASH and presented by Principal Investigator David A. Sallman, M.D., Department of Malignant Hematology at Moffitt Cancer Center (abstracts #902).  Interim analysis was reported for ten r/r AML patients across the three dose levels of CYAD-01 without preconditioning.
  • Out of eight r/r AML patient evaluable per protocol (at least one cycle of treatment) in the dose escalation segment of the trial:
    • Five patients (62%) showed anti-leukemic activity with three out of eight patients (38%) exhibiting objective response and two patients (25%) exhibiting disease stabilization with relevant bone marrow blasts decrease.
      • As previously reported, one r/r AML patients achieved a complete response with partial hematological recovery (CRh). This patient was bridged to allotransplant and remains in minimal residual disease negative complete response (CRMRD-) for over 14 months. Two r/r AML patients achieved a complete response with incomplete marrow recovery (CRi) with a duration of one month.
      • Two r/r AML patients treated at dose level 2 experienced disease stabilization with relevant bone marrow blast decrease. One patient experienced a decrease in blast counts from 9.8% to 5.5% after an initial cycle of CYAD-01. This patient subsequently received a second cycle of CYAD-01 at dose level 2, with the first injection of the second cycle administered seven weeks after the last injection of cycle one. Treatment with a second cycle of CYAD-01 was associated with relevant reduction in bone marrow blast in the patient from 12.5% to 5.8%, which could be considered as an induction of a partial response (PR) post hematological relapse between the two cycles. Further analysis showed both patients achieved CYAD-01 engraftment in the bone marrow at day 28 of treatment.
    • A sixth r/r AML patient with adverse risk according the 2017 ELN stratification demonstrated a stabilization of disease at two months and is scheduled to initiate a second cycle of CYAD-01.
    • Only two patients evaluable per protocol progressed in the dose escalation phase of the trial.
    • Two additional r/r AML patients have been enrolled at dose level 3 of the trial and full results from these patients are anticipated during first half 2019.
  • CYAD-01 without preconditioning chemotherapy was generally reported to be well-tolerated.
    • Overall, 14 patients with hematological malignancies (AML, myelodysplastic syndrome and multiple myeloma) treated with CYAD-01 in the trial reached the safety follow -up.
    • Overall, six patients experienced grade 3/4 treatment-related AEs, which included cytokine release syndrome (CRS), lymphopenia and thrombocytopenia.
    • CRS occurred in six patients (three grade 1/2 AEs, two grade 3 AEs and one grade 4 AE). Patients experiencing grade 1-3 CRS showed rapid resolution following the appropriate treatment, including tocilizumab.
    • One r/r AML patient experienced a grade 4 CRS, which was considered a dose-limiting toxicity (DLT), following the first injection of CYAD-01 at dose level 3. The single injection resulted in a reduction of peripheral blast counts from 14% to 4%.

Dr. Christian Homsy, CEO of Celyad, commented, “Preliminary data from 14 patients with relapsed or refractory AML enrolled in the THINK trial have exceeded our expectations with five out of eight patients treated with CYAD-01 without preconditioning demonstrating a relevant anti-leukemic activity. In addition, we are encouraged by the initial safety data that shows CYAD-01 is well-tolerated. We are diligently working to enroll additional patients in our multiple ongoing clinical trials evaluating CYAD-01 in patients with acute myeloid leukemia to better assess this CAR T therapy’s ability to drive a potentially meaningful impact on the treatment of the disease.”

DEPLETHINK Phase 1 Trial Update

  • In October 2018, Celyad enrolled the first patient in the DEPLETHINK Phase 1 trial (NCT03466320). The open-label, dose-escalation trial will evaluate a single injection of CYAD-01 following treatment with the standard preconditioning regimen of cyclophosphamide (300 mg/m²) and fludarabine (30 mg/m²), or CyFlu.
  • The trial includes two different intervals between lymphodepletion and administration of CYAD-01. In addition, the trial will evaluate two dose levels of CYAD-01 including 100 million and 300 million cells per injection, respectively. Following disease assessment at day 35, patients presenting no signs of progression are eligible to receive a cycle of three CYAD-01 injections without preconditioning with two-week intervals at their initial dose levels. The primary endpoint of the trial is safety and secondary endpoints include clinical activity and pharmacokinetics.
  • As of November 27, 2018, three patients have received an administration of CYAD-01 following preconditioning with CyFlu. Initial data demonstrate that the regimen was well tolerated, with no DLTs nor treatment-related grade 3 or above AEs observed. All three patients were not yet evaluated for clinical response.
  • Preliminary data from the DEPLETHINK Phase 1 trial are expected in mid-2019.

THINK Phase 1 Trial – Schedule Optimization Cohort 10

  • The THINK trial was recently amended to add a cohort to assess a more frequent dosing schedule of CYAD-01 for the treatment of r/r AML. The cohort will evaluate six injections of CYAD-01 without preconditioning over two months of administration. The first cycle (induction) will include three injections of CYAD-01 separated by one-week intervals. The second cycle will include three injections of CYAD-01 separated by two-week intervals. All patients in enrolled in the cohort will received 1 billion cells per injection.
  • Enrollment in the cohort has begun and preliminary data are expected in first half 2019.

EPITHINK Phase 1 Trial Update

  • The EPITHINK trial is a dose-escalation trial designed to evaluate the administration of CYAD-01 concurrently with 5-azacytidine in treatment-naïve and/or elderly AML patients ineligible for intensive treatment.
  • As of November 27, 2018, no patients have been enrolled in the trial.

CYAD-01 and THINK Trial Design

CYAD-01 is an investigational CAR-T therapy in which a patient’s T cells are engineered to express the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells.

The THINK trial (NCT03018405) is an open-label, dose-escalation Phase 1 trial assessing the safety and clinical activity of multiple CYAD-01 administrations without prior preconditioning in two parallel cohorts: i) patients with hematological malignancies, including r/r AML, and ii) patients with metastatic solid tumors. The dose escalation segment of the study evaluates three dose levels (300 million, 1 billion and 3 billion cells per injection) of one cycle of three CYAD-01 administrations with two-week intervals.

Celyad Doses First mCRC Patient in the Phase 1 alloSHRINK Trial Evaluating Non-Gene Edited Allogeneic CAR-T Candidate, CYAD-101

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  • Topline data from alloSHRINK trial are expected in second half of 2019
  • Company regains full development and commercialization rights to CYAD-101 from ONO Pharmaceutical for Japan, Korea and Taiwan

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and Nasdaq: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell-based therapies, today announced the injection of the first patient in the Phase 1 alloSHRINK trial evaluating the Company’s non-gene edited allogeneic CAR-T therapy, CYAD-101, administered concurrently with FOLFOX chemotherapy in the treatment of patients with unresectable metastatic colorectal cancer (mCRC).

“The initiation of the alloSHRINK trial marks a critical milestone for our organization,” said Dr. Christian Homsy, CEO of Celyad. “CYAD-101 represents a potential first-in-class approach to allogeneic CAR-T therapy and continues to build up Celyad’s leadership position in the allogeneic field, which is anchored by the Company’s robust allogeneic patent estate in the United States and complemented by our novel shRNA-based non-gene edited platform.”

Dr. Frédéric Lehmann, VP of Clinical Development & Medical Affairs at Celyad, commented: “CYAD-101 represents Celyad’s second oncology program to enter the clinic for the treatment of metastatic colorectal cancer and balances the Company’s autologous clinical candidate CYAD-01, which has demonstrated encouraging preliminary results in the Phase 1 SHRINK trial. We believe investigating CYAD-101 in the alloSHRINK trial will leverage our clinical experience to date in the treatment of metastatic colorectal cancer as we look to develop novel therapies for this devastating disease.”

Celyad also announced that ONO Pharmaceutical Co., Ltd. has given notice to the Company that it will no longer pursue development of CYAD-101 in Japan, Korea and Taiwan. Celyad and ONO Pharmaceutical entered into an exclusive license agreement for the development and commercialization of CYAD-101 in these specified territories in July 2016. Based on the agreement, ONO Pharmaceutical was required to exercise an option following the initiation of the Phase 1 trial for CYAD-101. The agreement has now expired and Celyad controls worldwide development and commercialization rights to CYAD-101.

CYAD-101 and alloSHRINK Trial Design

CYAD-101 is an investigational, non-gene edited, allogeneic (donor derived) CAR-T therapy that co-expresses the chimeric antigen receptor NKG2D, a receptor expressed on natural killer (NK) cells that binds to eight stress-induced ligands expressed on tumor cells and the novel inhibitory peptide TIM (T cell receptor [TCR] Inhibiting Molecule). TCR signaling is responsible for Graft versus Host Disease (GvHD). The expression of TIM reduces signaling of the TCR complex and could therefore reduce or eliminate GvHD in patients treated with CYAD-101.

The alloSHRINK trial (NCT03692429) is an open-label, dose-escalation trial that will assess the safety and clinical activity of CYAD-101 administered concurrently with FOLFOX chemotherapy in patients with unresectable mCRC.  Patients will receive six cycles of FOLFOX chemotherapy every two weeks and three administrations of CYAD-101 every two weeks 48 hours after the initiation of chemotherapy cycles one, two and three. The three dose levels to be evaluated are 100 million, 300 million and 1 billion cells per injection, respectively. 

Celyad Announces FDA Acceptance of IND Application for CYAD-101, a First-in-Class Non-Gene Edited Allogeneic CAR-T Candidate

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Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CYAD-101, the first non-gene edited allogeneic clinical program.

  • FDA acceptance of IND for world’s first non-gene edited allogeneic CAR-T clinical program
  • First of a family of non-gene edited allogeneic CAR-T, targeting colorectal cancer to build on the experience from the SHRINK autologous CAR T program

Mont-Saint-Guibert, Belgium – Celyad (Euronext Brussels and Paris, and NASDAQ: CYAD), a clinical-stage biopharmaceutical company focused on the development of CAR-T cell therapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for CYAD-101, the first non-gene edited allogeneic clinical program. The FDA has indicated that the Allo-SHRINK trial, evaluating the safety and clinical activity of CYAD-101 in patients with unresectable colorectal cancer in combination with standard chemotherapy, is allowed to proceed.


Dr. Christian Homsy, CEO of Celyad: “We are pleased to have achieved this important milestone. Celyad is the first company clinically evaluating a non-gene edited CAR-T candidate, which, we believe, offers significant advantages over gene edited approaches. Our non-gene edited program consists of a family of technologies aimed at reducing or eliminating T cell receptor (TCR) signaling without requiring genetic manipulation. CYAD-101 is part of a robust clinical development plan, establishing the foundations of next generation CAR-T products.”


CYAD-101, Celyad’s first allogeneic CAR-T cell product, encodes both the company’s auto-logous CYAD-01 CAR-T and a novel peptide, TIM (TCR Inhibiting Molecule), an inhibitor of TCR signaling. TCR signaling is responsible for the Graft versus Host Disease (GvHD), and tampering or eliminating its signaling could therefore reduce or eliminate GvHD. In CYAD-101, the TIM peptide is encoded alongside the CAR construct allowing allogeneic T cell production through a single transduction step. CYAD-101 benefits from using a manufac-turing process that is highly similar to Celyad’s well established process for its clinical au-tologous CAR-T cell products.


While autologous CAR-T therapies now have well established efficacy in B cell malignancies, the approach can be more challenging for some patients, especially those where the quality of the apheresis is poor. Allogeneic CAR-T cell therapy may provide an alternative approach for this patient population, utilizing cells manufactured from a healthy donor which could allow greater reproducibility and reduced manufacturing costs.

Information on the total number of voting rights and shares

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Cardio3 BioSciences SA (NYSE Euronext Brussels and NYSE Euronext Paris: CARD), discloses the information required under article 15, § 1 of the Law of 2 May 2007 regarding the disclosure of important shareholdings in listed companies.

Figures – modified on 17 July 2013
Company’s share capital : 22.138.007,93 €
Total number of shares with voting rights: 6.332.792
Total number of voting rights (= denominator): 6.332.792

Thresholds – unchanged
Legal thresholds resulting in notification: 5%, 10%, 15%, 20% and so on by increments of 5%. Cardio3 BioSciences does not impose statutory tresholds for participation.

Contact person for regulated information (financials, transparency etc.): Patrick Jeanmart, Chief Financial Officer (CFO)
Phone+32 (0)10 39 41 00;
investors@c3bs.com

For general information: Anne Portzenheim, Communication Manager
Phone+32 (0)10 39 41 00;
aportzenheim@c3bs.com

www.c3bs.com

About Cardio3 BioSciences

Cardio3 BioSciences is a leading Belgian biotechnology company focused on the discovery and development of regenerative and protective therapies for the treatment of cardiac diseases. The company was founded in 2007. Cardio3 BioSciences leverages research collaborations in the US and in Europe with, amongst other, Mayo Clinic and the Cardiovascular Centre Aalst, Belgium. 

The Company’s lead product candidate C-Cure® is an innovative pharmaceutical product that is being developed for heart failure indication. C-Cure® consists of a patient’s own cells that are harvested from the patient’s bone marrow and engineered to become new cardiac progenitor cells that behave like those cells lost to heart disease. This reprogramming process is known as Cardiopoiesis. 

Cardio3 BioSciences has also developed C-Cath®ez, a technologically advanced injection catheter with superior efficiency of delivery of biotherapeutic agents into the myocardium. 

Cardio3 BioSciences’ shares are listed on NYSE Euronext Brussels and NYSE Euronext Paris under the ticker symbol CARD.

In accordance with the Bayh-Dole Act, Mayo Clinic has licensed the technology underlying C-Cure® to Cardio3 BioSciences and received an equity position in the company in the context of the license. Mayo Clinic and the inventors of the technology, Drs. Andre Terzic and Atta Behfar, have a financial interest associated with the technology related to this research. While no royalties have accrued to date, Mayo Clinic has rights to receive future royalties which will be shared with Drs. Terzic and Behfar in accordance with the Mayo Clinic Royalty sharing policy.

C3BS-CQR-1, C-Cure® , C-Cath, Cardio3 BioSciences and the Cardio3 BioSciences and C-Cath logos are trademarks or registered trademarks of Cardio3 BioSciences SA, in Belgium, other countries, or both. In addition to historical facts or statements of current condition, this press release contains forward-looking statements, which reflect our current expectations and projections about future events, and involve certain known and unknown risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. These forward-looking statements are further qualified by important factors, which could cause actual results to differ materially from those in the forward-looking statements, including timely submission and approval of anticipated regulatory filings; the successful initiation and completion of required Phase III studies; additional clinical results validating the use of adult autologous stem cells to treat heart failure; satisfaction of regulatory and other requirements; and actions of regulatory bodies and other governmental authorities. 

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