Actinium Announces Interim Results from Phase 1 Actimab-A CLAG-M Combination Trial in Patients with Relapsed or Refractory AML Accepted for Presentation at ASH 2019

On November 6, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that interim results from a Phase 1 trial studying Actimab-A in combination with CLAG-M have been accepted for presentation at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting that is being held December 7-10, 2019 in Orlando, FL (Press release, Actinium Pharmaceuticals, NOV 6, 2019, View Source [SID1234550432]). This is the first study to combine radioimmunotherapy and intensive chemotherapy in patients with relapsed or refractory AML. Actimab-A is an antibody radiation-conjugate (ARC) comprised of the CD33 targeting antibody lintuzumab labeled with the alpha-emitting radioisotope actinium-225 (Ac-225).

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The ASH (Free ASH Whitepaper) abstract reports on 9 adult patients with relapsed or refractory AML enrolled on the investigator-initiated trial at the Medical College of Wisconsin (MCW). Patients were a median age of 59 and had received a median of 2 (range 1-4) anti-leukemic treatments, including 4 patients who relapsed after receiving a bone marrow transplant (BMT). Patients received the salvage chemotherapy regimen cladribine, cytarabine, G-CSF, and mitoxantrone (CLAG-M) and a single dose of Actimab-A on either day 6, day 7, or day 8. Cohort 1 enrolled 3 patients who received 0.25 uCi/kg of Actimab-A and Cohort 2 enrolled 6 patients who received 0.50 uCi/kg of Actimab-A.

Details and highlights from Actinium’s accepted poster include:

Title: Lintuzumab Ac-225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AML: Interim Results of a Phase I Study

Key Highlights:

83% of patients (5/6) receiving 0.50 uCi/kg of Actimab-A and CLAG-M in the second dosing cohort achieved a Complete Remission (CR), Complete Response with incomplete platelet recovery (CRp) or Complete Response with incomplete hematologic recovery (CRi)
83% remission rate with 0.50 uCi/kg Actimab-A CLAG-M combination significantly higher than the MCW institutional 54% remission rate with CLAG-M alone1
83% remission rate at 0.50 uCi/kg included 50% (3/6) with a CR
33% of patients (3/9) enrolled in the trial subsequently received a bone marrow transplant
Combining lower doses of Actimab-A with CLAG-M appears to have a clinically acceptable safety profile
All patients completed the planned cycle of Actimab-A and CLAG-M
No mortalities were observed on study
Poster Details:
Publication Number: 2605
Session Name: 613. Acute Myeloid Leukemia: Clinical Studies: Poster II
Date: Sunday, December 8, 2019
Presentation Time: 6:00 PM – 8:00 PM
Location: Orange County Convention Center, Hall B

Dr. Mark Berger, Actinium’s Chief Medical Officer, said, "It is quite encouraging to see a high overall response rate with the addition of Actimab-A compared to patients treated with CLAG-M alone. These preliminary results exceed our expectations and compare quite favorably to results seen with recently approved AML therapies, especially in these difficult to treat relapsed or refractory patients. We look forward to seeing additional results from this trial and are excited by the potential to advance the Actimab-A CLAG-M combination to a Phase 2 or potentially pivotal trial. In addition, the ability to combine Actimab-A with a powerful salvage regimen like CLAG-M with a manageable adverse event profile suggests that combinations with other agents, such as venetoclax, may also be tolerable and will lead to improved efficacy."

Sandesh Seth, Actinium’s Chairman and CEO, said, "These results strengthen our conviction in the potentiating and synergistic properties of targeted radiation with other therapeutic modalities. We see opportunities to combine our ARCs with chemotherapy as highlighted in this study, with targeted agents as we have done with our Actimab-A venetoclax combination trial and potentially with immunotherapy. Additionally, the rate of patients going to transplant in this study, despite the low dose levels of Actimab-A administered, gives us great excitement for our Actimab-MDS program that will study significantly higher doses of Actimab-A as a targeted conditioning regimen prior to a bone marrow transplant in patients with high-risk MDS. It is exciting to see our CD33 program development strategy with low-dose combinations and high-dose targeted conditioning generate positive responses and we look forward to additional data from our ongoing and planned clinical trials."

About Actimab-A

Actimab-A (actinium-225 lintuzumab) is an antibody radiation-conjugate that has been studied in over 100 patients in 4 clinical trials at several dose levels. A Phase 2 trial studying Actimab-A as a single agent produced a 69% overall response rate in older unfit patients with newly diagnosed AML. The findings from this study are supporting a development strategy that will study Actimab-A at high doses for targeted conditioning prior to bone marrow transplant in the planned pivotal Actimab-MDS program, and at lower doses in combination with other therapeutic modalities like the combination trial with the Bcl-2 inhibitor venetoclax and the combination trial with the chemotherapy regimen CLAG-M.

Actinium Pharmaceuticals to Present New Clinical Findings from SIERRA Trial Supporting the Iomab-ACT Program for Targeted Lymphodepletion for CAR-T and Adoptive Cell Therapies at ASH 2019

On November 6, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") reported that new findings from its pivotal Phase 3 SIERRA trial for Iomab-B (Iodine-131 apamistamab) that support its Iomab-ACT program for lymphodepletion for CAR-T and adoptive cell therapies has been accepted for presentation at the 2019 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting that is being held December 7-10, 2019 in Orlando, FL (Press release, Actinium Pharmaceuticals, NOV 6, 2019, View Source [SID1234550431]). Lymphodepletion is a necessary step that creates space for the CAR-T cells to be infused and promotes expansion of cells in vivo by creating a favorable homeostatic cytokine environment. Actinium is advancing the development of low dose Iomab-B (Iodine-131 apamistamab), a CD45 targeting antibody radiation-conjugate (ARC), as an alternative to today’s standard practice of chemotherapy-based lymphodepletion regimens like fludarabine/cyclophosphamide (Flu/Cy), which have been implicated in CAR-T toxicities including cytokine release syndrome (CRS) and neurotoxicity.

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Title: Sierra Clinical Trial Dosimetry Results Support Low Dose Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] for Targeted Lymphodepletion Prior to Adoptive Cell Therapy

An analysis was performed on blood samples from 57 patients enrolled in the ongoing pivotal Phase 3 SIERRA trial for Iomab-B to demonstrate the effectiveness of low dose Iomab-B as a modality for targeted transient lymphodepletion. On the SIERRA trial, patients receive a low dosimetry dose of Iomab-B (median dose of 10 mCi with a range of 7-20 mCi) in an outpatient setting per study protocol. The analysis presented in the poster evaluated blood samples at various time points including pre-dosimetric infusion, post-dosimetric infusion, day 1 post-dosimetric infusion, and pre-therapeutic infusion (range 6-14 days post-dosimetry) to assess the impact of low dose Iomab-B on immune cell lymphodepletion and its anti-tumor effect on circulating blasts, as well as to determine its clearance profile from circulation.

Key Highlights:

– A significant but transient reduction in lymphocytes and white blood cells was observed compared to pre-dosimetry infusion levels
– 85% reduction in lymphocytes was observed at the post-dosimetry infusion time point, a 67% decrease at day 1 post-dosimetric infusion, and a 43% decrease one week later just prior to the Iomab-B therapeutic infusion
– 35% reduction in peripheral leukemic blasts was observed at the post-dosimetry infusion time point, suggesting a rapid anti-leukemic effect with single-agent Iomab-B consistent with findings from SIERRA presented at ASCO (Free ASCO Whitepaper) 2019
– The levels of platelets, red blood cells, and neutrophils were unchanged between pre-infusion and post-dosimetry infusion, potentially reflecting the comparatively lower surface antigen levels of CD45 on these cell types
– Based on an analysis of 25 treated patients, a non-myeloablative dose of 75 mCi has been proposed as a starting dose for human clinical testing
– Analysis of the proposed 75 mCi dose of Iomab-B would be sufficiently cleared in 136 hours (5.7 days) to allow for CAR-T administration

Poster Details:

Publication Number: 1958
Session Name: 704. Immunotherapies: Poster I
Date: Saturday, December 7, 2019
Presentation Time: 5:30 PM – 7:30 PM
Location: Orange County Convention Center, Hall B

Dale Ludwig, Ph.D., Actinium’s Chief Scientific Officer, said, "These promising findings from the analysis of clinical data from the SIERRA trial confirm our excitement and support the potential of our Iomab-ACT program as a chemotherapy-free alternative for lymphodepletion. While significant efforts have gone towards innovating CAR-T and cellular therapies, there has been little innovation in the lymphodepletion regimens that they rely on. These results show that the multi-modal mechanism of our CD45 targeting ARC can selectively deplete immune cells and exert an anti-leukemic effect while sparing red blood cells and platelets through a single-dose outpatient administration. It is exciting to see human clinical data produce these promising results and demonstrate that our Iomab-ACT program will fit well within the vein-to-vein time of CAR-T. We look forward to beginning a first-in-man clinical trial that will explore our Iomab-ACT program in conjunction with a CAR-T therapy and we have great confidence in continued positive results."

About the Iomab-ACT program

Iomab-ACT is a lower dose of Actinium’s lead program Iomab-B, which has been studied in over 300 patients and is currently being investigated in a pivotal Phase 3 trial for targeted conditioning prior to a Bone Marrow Transplant (BMT). Iomab-ACT targets CD45, an antigen expressed on many of the cells that are relevant to CAR-T including lymphocytes, macrophages and regulatory T-cells and that have been associated with CAR-T challenges such as durability of response, cytokine release syndrome (CRS) and neurotoxicity. Actinium has generated preclinical data that targeted lymphodepletion via Iomab-ACT has the potential to improve tumor control, selectively deplete necessary cells and be highly differentiated in terms of tolerability compared to chemotherapy-based lymphodepletion regimens, namely fludarabine/cyclophosphamide (Flu/Cy). The Iomab-ACT program may enable lymphodepletion through a single-dose outpatient administration versus Flu/Cy or other chemo-based lymphodepletion regimens that require multiple infusions in an inpatient setting over several days.

AbbVie Announces Launch of Private Offering of Senior Unsecured Notes

On November 6, 2019 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported that it has launched a private offering (the "Offering") of senior unsecured notes (the "Notes") (Press release, AbbVie, NOV 6, 2019, View Source [SID1234550430]).

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The Offering is being conducted in connection with AbbVie’s previously announced acquisition (the "Acquisition") of Allergan plc ("Allergan"). AbbVie expects to use the net proceeds from the Offering to fund a portion of the aggregate cash consideration due to Allergan shareholders in connection with the Acquisition and to pay related fees and expenses, with any remaining net proceeds being used for general corporate purposes. Consummation of the Offering is subject to market and other conditions.

The Notes have not been registered under the Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States, or for the benefit of U.S. persons, except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities or blue sky laws. Accordingly, the Notes are being offered in the United States only to persons reasonably believed to be "qualified institutional buyers," as that term is defined under Rule 144A of the Securities Act, or outside the United States to non-"U.S. persons" in accordance with Regulation S under the Securities Act.

A confidential offering memorandum for the Offering of the Notes, dated as of today, is being made available to such eligible persons. The Offering is being conducted in accordance with the terms and subject to the conditions set forth in such confidential offering memorandum.

This news release does not constitute an offer to sell or purchase, or a solicitation of an offer to sell or purchase, the Notes or any other security. No offer, solicitation, purchase or sale will be made in any jurisdiction in which such an offer, solicitation or sale would be unlawful.

Acceleron Reports Third Quarter 2019 Operating and Financial Results

On November 6, 2019 Acceleron Pharma Inc. (Nasdaq:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Acceleron Pharma, NOV 6, 2019, View Source [SID1234550412]).

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"With the FDA’s decision on the luspatercept regulatory submission for the treatment of beta-thalassemia expected in less than one month, we are close to achieving a major company milestone-the potential approval for the first Acceleron-discovered medicine," said Habib Dable, President and Chief Executive Officer of Acceleron. "Alongside our global collaboration partner, Celgene, we are preparing for luspatercept’s potential commercial launch in the U.S. We also await the FDA’s decision on our BLA for the MDS indication in April 2020 and the European Medicines Agency’s decision on the MAA for both indications, which is expected in the second half of 2020. We continue to advance our ongoing clinical trials in first-line lower-risk MDS-, non-transfusion-dependent beta-thalassemia- and myelofibrosis-associated anemia. In addition, we are looking forward to presenting luspatercept updates on our Phase 3 MEDALIST and BELIEVE trials, as well as interim results from the ongoing Phase 2 myelofibrosis trial at the upcoming ASH (Free ASH Whitepaper) meeting in December."

Added Mr. Dable: "While our hematology program continues to grow, we are also advancing our two Acceleron-led clinical programs in pulmonary and neuromuscular disease. We anticipate reporting results in the first quarter of 2020 for both our PULSAR Phase 2 sotatercept trial in patients with PAH, and our ACE-083 trial in patients with CMT."

Development Program Highlights

Hematology

Luspatercept: Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)
Luspatercept is an investigational first-in-class erythroid maturation agent designed to address a late-stage erythroid maturation defect that results in chronic anemia and the need for regular red blood cell transfusions in adults with serious hematologic diseases. Luspatercept is part of the global collaboration between Acceleron and Celgene.

The U.S. Food and Drug Administration’s (FDA) review of the Biologics License Application (BLA) for luspatercept is ongoing for the treatment of anemia in adult patients with very low- to intermediate-risk MDS, who have ring sideroblasts and require red blood cell (RBC) transfusions, and for the treatment of anemia in adult patients with beta-thalassemia, who require regular RBC transfusions.

The FDA’s target action date for the beta-thalassemia indication is December 4, 2019, and April 4, 2020 for the MDS indication.

The European Medicines Agency’s (EMA) review of the Marketing Authorization Application (MAA) for luspatercept for the treatment of anemia in adult patients with MDS or beta-thalassemia is ongoing. The EMA decision on the MAA is expected in the second half of 2020.

Six clinical abstracts of luspatercept have been accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Orlando on December 7-10, 2019, including

Five clinical abstracts highlighting new and updated analyses from the MEDALIST and BELIEVE Phase 3 trials;

One clinical abstract including interim results from the ongoing Phase 2 trial in MF.

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Enrollment is ongoing in the COMMANDS Phase 3 trial in patients with treatment-naïve, lower-risk MDS.

The BEYOND Phase 2 trial in adult patients with non-transfusion-dependent beta-thalassemia is ongoing, with topline results expected by year-end 2020.

Pulmonary Disease

Sotatercept: Pulmonary Arterial Hypertension (PAH)
Sotatercept is an investigational agent designed to be a selective ligand trap for members of the TGF-beta superfamily to rebalance BMPR2 signaling, which is a key molecular driver of PAH. In preclinical studies of PAH, sotatercept (RAP-011) reversed pulmonary vessel muscularization and improved indicators of right heart failure.

The FDA granted Orphan Drug Designation to sotatercept for the treatment of patients with PAH.

Topline results from the PULSAR Phase 2 trial in patients with PAH are expected in the first quarter of 2020.

Enrollment is ongoing in the exploratory SPECTRA trial in patients with PAH, with preliminary results expected in 2020.

Neuromuscular Disease

ACE-083: Charcot-Marie-Tooth Disease (CMT) and Facioscapulohumeral Muscular Dystrophy (FSHD)
ACE-083 is an investigational locally-acting therapeutic designed to have a concentrated effect on muscle mass and strength in target muscles for diseases that cause focal muscle weakness. ACE-083 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta superfamily ligands involved in muscle formation.

Topline results from Part 2 of the Phase 2 trial in patients with CMT are expected in the first quarter of 2020.

Clinical development of ACE-083 in patients with FSHD has been discontinued following the Phase 2 topline results.
Financial Results

Cash Position – Cash, cash equivalents and investments as of September 30, 2019 were $468.3 million, as compared to $291.3 million as of December 31, 2018.
Based on the Company’s current operating plan and projections, it believes that current cash, cash equivalents and investments will be sufficient to fund projected operating requirements until such time as it expects to receive significant royalty revenue from luspatercept sales.

Revenue – Revenue for the third quarter of 2019 was $4.2 million. This revenue was derived from the Company’s collaboration partnership with Celgene and is largely related to expenses incurred by the Company in support of luspatercept.

Costs and Expenses – Total costs and expenses for the third quarter of 2019 were $53.1 million. This includes R&D expenses of $37.6 million and G&A expenses of $15.5 million.

Net Loss – The Company’s net loss for the third quarter of 2019 was $45.4 million.

Conference Call and Webcast

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The Company will host a webcast and conference call to discuss its third quarter 2019 financial results and provide an update on recent corporate activities on November 6, 2019, at 10:00 a.m. EST.

The webcast will be accessible under "Events & Presentations" in the Investors/Media page of the Company’s website at acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the "Acceleron Third Quarter 2019 Earnings Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

Adaptimmune Reports Third Quarter 2019 Financial Results and Business Update

On November 6, 2019 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported financial results and business highlights from Q3 2019 (Press release, Adaptimmune, NOV 6, 2019, View Source [SID1234550411]).

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"The sarcoma community has been very supportive following the ESMO (Free ESMO Whitepaper) presentation in which we showed a clear benefit for ADP-A2M4. This increases our confidence that we can accelerate enrollment in SPEARHEAD-1 as we progress toward commercialization in 2022," said Adrian Rawcliffe, Adaptimmune’s Chief Executive Officer. "We continue to see evidence of antitumor activity with our SPEAR T-cells across other indications. We are executing with our ADP-A2AFP trial, now dosing in Cohort 3, as well as our next-gen SURPASS trial, and we plan on updating data throughout 2020. We continue to prioritize resources to enable us to deliver data from our ongoing trials."

COMMERCIAL READINESSS FOR ADP-A2M4 IN SARCOMA WITH AIM TO LAUNCH IN 2022

·Data presented at ESMO (Free ESMO Whitepaper) 2019 demonstrating a clear benefit of ADP-A2M4 for patients with synovial sarcoma showing:

oOverall response rate of 58% with 7 out of 12 evaluable patients with clinical responses

oDisease control rate (best overall responses of partial response or stable disease) of 92% with 11 out of 12 evaluable patients showing clinical benefit

These data will be updated at CTOS on November 16th

·Enrolling patients in SPEARHEAD-1 (Phase 2 trial in synovial sarcoma and myxoid/ round cell liposarcoma) across several leading clinical trial centers

·US FDA granted Orphan Drug Designation to SPEAR T-cells targeting MAGE-A4 (the ADP-A2M4 program) for the treatment of soft tissue sarcomas

·Produced first in-house GMP viral vector batch, augmenting the Company’s external supply with internal manufacturing capabilities

FOCUSED ON EXECUTION IN OTHER CLINICAL TRIALS

·Dosing in the SURPASS trial with ADP-A2M4CD8 – the first next-generation trial at several clinical trial centers with data updates anticipated in 1H 2020

oPreclinical data show that these next-generation SPEAR T-cells may improve long term T-cell function as well as antitumor activity

·Enrolling in Cohort 3 in the ADP-A2AFP trial in liver cancer at target doses of 5 billion SPEAR T-cells (range 1.2 to 6 billion), after Safety Review Committee endorsed dose escalation

Continuing enrollment in the radiation sub-study of the Phase 1 ADP-A2M4 trial

·Based on emerging translational data to be presented at SITC (Free SITC Whitepaper) on November 8th, will initiate a clinical trial combining ADP-A2M4 with a PD-1 pathway inhibitor in 2020

PRECLINICAL PROGRESS

·Continued progress with stem-cell derived allogeneic program, which is applicable to all T-cells (including both CAR-T and TCR T-cells) with data updates next year

·Initiated collaboration with Noile-Immune to develop further next-generation products

OTHER CORPORATE NEWS

·Michael Garone appointed as Interim Chief Financial Officer

·The Company is recruiting for a permanent Chief Medical Officer and Chief Financial Officer

Financial Results for the three-month period ended September 30, 2019

·Cash / liquidity position: As of September 30, 2019, Adaptimmune had cash and cash equivalents of $39.4 million and Total Liquidity1 of $102.9 million. The Company also received $15.8 million for UK R&D Tax Credits in October 2019.

·Revenue: Revenue for the three and nine months ended September 30, 2019 was $0.2 million and $0.4 million respectively, compared to $40.8 million and $58.0 million for the same periods in 2018. The revenue in the three and nine months ended 2019 is due to the commencement of development under the third target nominated by GSK under the Collaboration and License Agreement, whereas the development and license revenue for the same periods in 2018 was recognized due to the performance under the NY-ESO transition program and the PRAME development plan, which were completed in 2018.

·Research and development (R&D) expenses: R&D expenses for the three and nine months ended September 30, 2019 were $29.6 million and $77.1 million, respectively, compared to $23.5 million and $75.5 million for the same periods of 2018. The three and nine month periods ended September 30, 2019 include the impact of recognized purchase commitments for clinical materials of $5.0 million, and in process research and development payments relating to the collaboration agreements with Alpine Immune Sciences, Inc of $2.0 million in May 2019 and Noile-Immune Biotech, Inc of $2.5 million in August 2019. These increases were partially offset by a decrease in share-based compensation expense due to option forfeitures in both periods, an increase in reimbursements for research and development tax and expenditure credits in both periods, and, during the nine months ended September 30, 2019, a reduction in expenditure associated with the NY-ESO program, which was transferred to GSK on July 23, 2018.

·General and administrative (G&A) expenses: G&A expenses for the three and nine months ended September 30, 2019 were $10.7 million and $32.7 million respectively, compared to $10.3 million and $32.8 million for the same periods of 2018.

·Other income (expense), net: Other income (expense), net for the three and nine months ended September 30, 2019 was income of $0.3 million and an expense of $0.6 million respectively, compared to expenses of $2.2 million and $10.5 million for the same periods of 2018. Other income (expense), net primarily comprises unrealized foreign exchange losses, which fluctuate depending on exchange rate movements and the amount of foreign currency assets and liabilities. Management determined that, effective from July 1, 2019, an intercompany loan was of a long-term investment nature and therefore, from that date, foreign exchange differences on this intercompany loan have subsequently been reported within other comprehensive income (loss).

·Net (loss) income: Net (loss) income attributable to holders of the Company’s ordinary shares for the three and nine month periods ended September 30, 2019 was losses of $39.3 million and $107.8 million respectively, and $(0.06) and $(0.17) per ordinary share respectively, compared to income of $5.2 million and a loss of $59.3 million respectively, and $0.01 and $(0.10) per ordinary share respectively in the same periods of 2018.

1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

Financial guidance

The Company believes that its existing cash, cash equivalents and marketable securities will fund the Company’s current operations through the third quarter of 2020. As further detailed in the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2019, to be filed with the Securities and Exchange Commission following this earnings release, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the financial statements are issued. The Company concluded that there are factors that raise substantial doubt about its ability to continue as a going concern for at least one year from the issuance of the September 30, 2019 quarterly condensed consolidated financial statements. In the immediate future, the Company plans to continue to prioritize and review ongoing clinical development projects and costs with the aim of focusing operations on the ADP-A2M4 SPEARHEAD-1, ADP-A2M4CD8 SURPASS, and ADP-A2AFP trials. The Company believes that a combination of targeted clinical progress together with accessing additional capital and/or cost reductions will enable the Company to continue as a going concern for the next twelve months. The Company’s financial results are presented as though it would continue as a going concern.

Conference Call and Webcast Information
The Company will host a live teleconference at 8:00 a.m. EST (1:00 p.m. GMT) today, November 6, 2019. The live webcast of the conference call will be available in the investor section of Adaptimmune’s corporate website at www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (3997944).