On August 2, 2019 Boehringer Ingelheim reported updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumours (Press release, Boehringer Ingelheim, AUG 2, 2019, View Source [SID1234538091]).i The GioTag study is a real-world retrospective, observational and unblinded study which examined the impact of treatment with Giotrif/Gilotrif (afatinib) followed by osimertinib in epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations*, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs).

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The GioTag study previously provided only 2 years and 2.5 years OS rates. Now, a subsequent analysis assessed updated data from a sub-set of patients with available electronic health records (from the U.S). The use of electronic data, which facilitated rapid analysis, represented the first step of a two-stage process. After a median follow-up of 30.3 months, median overall survival was almost three and a half years (41.3 months) in patients with acquired EGFR T790M-positive NSCLC treated in a real-world clinical setting, and the updated two-year OS rate was 80%.i

OS is particularly promising in patients with Del19-positive tumours at the onset of afatinib treatment. In these patients, median OS was 45.7 months and the two-year OS rate was 82%. Updated median time on treatment for sequential afatinib and osimertinib was 28.1 months overall, and 30.6 months in patients with Del19-positive tumours. Median time on osimertinib treatment following treatment with afatinib was 15.6 months and 16.4 month for Del19 mutations. i

Dr. Maximilian J. Hochmair, Medical Pulmonologist, Department of Internal Medicine and Pneumology, Krankenhaus Nord, Klinik Floridsdorf and coordinating investigator in the study said, "As many patients with this type of lung cancer eventually acquire resistance to EGFR TKIs, it’s important to consider the order of these therapies to provide patients with as many future treatment options as possible. The updated GioTag study findings provide supportive evidence that afatinib followed by osimertinib is a viable treatment sequence option for patients with EGFR M+ NSCLC."

Dr. Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim, said, "The continued clinical development of new EGFR TKIs provides additional treatment options for patients with EGFR M+ NSCLC, and raises questions about their optimal sequence. Given that, as yet, no established targeted treatment options are available following failure of osimertinib, there is an argument for reserving osimertinib for second-line use after second-generation EGFR TKIs. Real-world data from the GioTag study supports the argument for sequential use of afatinib and osimertinib for patients with EGFR M+ NSCLC who are Del19-positive."

The observational GioTag study provides data on a broad, real-world population of patients. 15.3% had a poor performance status of ECOG PS of ≥2 and 10.3% had stable brain metastases, ordinarily criteria which would preclude these patients from participation in clinical trials. More on the observational GioTag study can be found here. This interim analysis is the first of a two-step process. A final analysis is planned for early 2020 which will include updated data from Asian and European countries.

Boehringer Ingelheim in Oncology
Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.

On August 2, 2019 Boehringer Ingelheim reported updated, interim analysis results from the GioTag study, showing that initiating treatment with afatinib followed by osimertinib provided an overall survival (OS) of almost four years (45.7 months) in patients with Del19-positive tumours (Press release, Boehringer Ingelheim, AUG 2, 2019, View Source [SID1234538091]).i The GioTag study is a real-world retrospective, observational and unblinded study which examined the impact of treatment with Giotrif/Gilotrif (afatinib) followed by osimertinib in epidermal growth factor receptor mutation-positive (EGFR M+) non-small cell lung cancer (NSCLC) patients with acquired T790M mutations*, the most common mechanism of resistance to first- and second-generation EGFR tyrosine kinase inhibitors (TKIs).

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The GioTag study previously provided only 2 years and 2.5 years OS rates. Now, a subsequent analysis assessed updated data from a sub-set of patients with available electronic health records (from the U.S). The use of electronic data, which facilitated rapid analysis, represented the first step of a two-stage process. After a median follow-up of 30.3 months, median overall survival was almost three and a half years (41.3 months) in patients with acquired EGFR T790M-positive NSCLC treated in a real-world clinical setting, and the updated two-year OS rate was 80%.i

OS is particularly promising in patients with Del19-positive tumours at the onset of afatinib treatment. In these patients, median OS was 45.7 months and the two-year OS rate was 82%. Updated median time on treatment for sequential afatinib and osimertinib was 28.1 months overall, and 30.6 months in patients with Del19-positive tumours. Median time on osimertinib treatment following treatment with afatinib was 15.6 months and 16.4 month for Del19 mutations. i

Dr. Maximilian J. Hochmair, Medical Pulmonologist, Department of Internal Medicine and Pneumology, Krankenhaus Nord, Klinik Floridsdorf and coordinating investigator in the study said, "As many patients with this type of lung cancer eventually acquire resistance to EGFR TKIs, it’s important to consider the order of these therapies to provide patients with as many future treatment options as possible. The updated GioTag study findings provide supportive evidence that afatinib followed by osimertinib is a viable treatment sequence option for patients with EGFR M+ NSCLC."

Dr. Victoria Zazulina, Corporate Vice President and Global Head of Oncology, Medicine, at Boehringer Ingelheim, said, "The continued clinical development of new EGFR TKIs provides additional treatment options for patients with EGFR M+ NSCLC, and raises questions about their optimal sequence. Given that, as yet, no established targeted treatment options are available following failure of osimertinib, there is an argument for reserving osimertinib for second-line use after second-generation EGFR TKIs. Real-world data from the GioTag study supports the argument for sequential use of afatinib and osimertinib for patients with EGFR M+ NSCLC who are Del19-positive."

The observational GioTag study provides data on a broad, real-world population of patients. 15.3% had a poor performance status of ECOG PS of ≥2 and 10.3% had stable brain metastases, ordinarily criteria which would preclude these patients from participation in clinical trials. More on the observational GioTag study can be found here. This interim analysis is the first of a two-step process. A final analysis is planned for early 2020 which will include updated data from Asian and European countries.

Boehringer Ingelheim in Oncology
Cancer takes. Takes away time. Takes away loved ones. At Boehringer Ingelheim Oncology, we are giving patients new hope, by taking cancer on. We are dedicated to collaborating with the oncology community on a shared journey to deliver leading science. Our primary focus is in lung and gastrointestinal cancers, with the goal of delivering breakthrough, first-in-class treatments that can help win the fight against cancer. Our commitment to innovation has resulted in pioneering treatments for lung cancer and we are advancing a unique pipeline of cancer cell directed agents, immune oncology therapies and intelligent combination approaches to help combat many cancers.

On August 2, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported financial results and business highlights for the second quarter ended June 30, 2019 (Press release, Stemline Therapeutics, AUG 2, 2019, View Source [SID1234538084]).

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"We are very excited with the progress we continue to make on the ELZONRIS U.S. launch. Our commercial team continues to generate strong momentum, as evidenced by robust sales, steady increases in new patient starts and a broadening prescriber base," stated Robert Francomano, SVP and Global Head of Commercial. "Our entire organization is focused on ensuring patients with BPDCN gain access to ELZONRIS, and given the trends we are seeing, we remain poised for a successful 2019 and beyond."

Ivan Bergstein, M.D., CEO of Stemline Therapeutics, commented: "We are very pleased with the continued strong commercial performance and the rapid, broad-based adoption of ELZONRIS in the marketplace. We are executing our commercial plan, including pursuing ongoing efforts to unlock additional value from ELZONRIS in other indications as well as from our entire pipeline, all with the goal of building a leading biopharmaceutical company and improving the lives of patients with cancer around the world."

Second Quarter 2019 Financial Results Review
Net revenue for ELZONRIS was $13.0 million for the quarter ended June 30, 2019. Stemline began commercial sales of ELZONRIS within the United States in January 2019.

Stemline ended the second quarter with $103.9 million in cash, cash equivalents and investments. For the second quarter, Stemline had a net loss of $16.8 million. The net cash expenditures for the second quarter of 2019 was $20.5 million.

Research and development expenses were $10.9 million for the second quarter of 2019, which reflects a decrease of $0.3 million compared with $11.2 million for the second quarter of 2018. The lower costs in the current period were primarily due to expenses in the prior year related to our biologics license application (BLA) filing for ELZONRIS with the FDA.

Selling, general and administrative expenses were $19.0 million for the second quarter of 2019, which reflects an increase of $10.4 million compared with $8.6 million for the second quarter of 2018. The increase in costs were primarily attributable to pre-launch and launch expenses in support of the commercialization of ELZONRIS in the U.S. and potential launch in the European Union.

Recent Business Highlights

Commercial

Net revenue of ELZONRIS were $13.0 million during the second quarter, representing a 157% increase over last quarter.

The Centers for Medicare and Medicaid Services (CMS) recently assigned a J-Code for ELZONRIS, which happened one quarter earlier than we expected. The J-Code is a permanent code assigned to ELZONRIS by CMS and used by Medicare, Medicaid, and commercial payers for billing and claims processing. With a permanent J-code, ELZONRIS billing becomes more efficient, particularly in the outpatient setting.

On the private payer side, ELZONRIS now has favorable coverage for over 100 million lives, with coverage policy decisions to the label for key commercial payers.

We continue to execute on our disease awareness efforts which are designed to raise the profile of BPDCN and underscore the importance of CD123 testing.
Market Expansion Efforts

Blastic plasmacytoid dendritic cell neoplasm (BPDCN)

• Stemline announced today that the Phase 2 investigator-sponsored clinical trial of ELZONRIS in patients with BPDCN as maintenance therapy post-stem cell transplant (SCT) has been granted regulatory authorization to proceed. The trial will evaluate the safety and feasibility of ELZONRIS in the maintenance setting for patients with BPDCN after SCT. We expect to provide further program updates later this year.

Chronic myelomonocytic leukemia (CMML)

• ELZONRIS clinical data from its ongoing Phase 2 clinical trial in patients with CMML were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois and at the 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam, Netherlands.

• We plan to open an additional single-arm cohort, Stage 3, of patients with previously-treated CMML to the currently enrolling trial later this year. In the first part of Stage 3 (Stage 3a), enrichment strategies and certain efficacy endpoints, including spleen size reduction and bone marrow complete response with partial hematologic recovery, will be assessed for potential inclusion in the confirmatory cohort (Stage 3b), that will aim to provide the primary evidence of efficacy to support potential registration.

Myelofibrosis (MF)

• ELZONRIS clinical data from its ongoing Phase 2 clinical trial in patients with MF were presented at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago, Illinois and at the 24thCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Amsterdam, Netherlands.

• The trial continues to enroll and we expect to provide further program updates later this year.

Systemic sclerosis

• ELZONRIS preclinical results in systemic sclerosis, an autoimmune disorder in which CD123+ plasmacytoid dendritic cells (pDCs) play a role in disease pathogenesis, were presented at the Annual European Congress of Rheumatology (EULAR) in Madrid, Spain.

Acute myeloid leukemia (AML) and others

• ELZONRIS in combination with other agents is currently being evaluated in an investigator-sponsored Phase 1/2 trial of patients with AML and high-risk myelodysplastic syndrome (MDS). Additional investigator-sponsored trials of ELZONRIS in combination with other agents in patients with subsets of AML that are enriched for CD123+ and/or BPDCN-like features are targeted to open in the 4Q19/1H20 timeframe. Other indications are also under consideration.
Ex-U.S.

Stemline continues to build out a European commercial infrastructure in advance of potential approval by the European Medicines Agency (EMA). The ELZONRIS marketing authorization application (MAA) is under review on a standard timeline. In June 2019, we received the day 120 list of questions relating to chemistry, manufacturing and controls (CMC), quality, non-clinical, and all stages of the clinical trial, including stage 4 largely involving lyophilized drug product. We have requested, and received, a clock stop extension. A scientific advisory group meeting is being planned. Based on this timeline, we expect an opinion from the Committee for Medicinal Products for Human Use (CHMP) in 1H20. In anticipation of potential regulatory success, we have started to hire personnel to meet the needs of a possible mid-2020 European commercial launch.

Stemline has instituted a global Early Access Program (EAP) whereby physicians may seek access to ELZONRIS outside of a clinical trial and/or before it is commercially available.

ELZONRIS clinical trial data in patients with BPDCN continue to be featured at prominent international hematological conferences with recent presentations in Europe and an upcoming oral presentation at a major medical meeting in Asia.
Additional Pipeline Candidates

Stemline continues to advance its clinical stage assets, including SL-801 (felezonexor), a reversible inhibitor of XPO1. Updated Phase 1 data were selected for presentation at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting. Stemline is also developing its preclinical assets SL-1001 (RET kinase inhibitor) and SL-901 (kinase inhibitor), both of which are in IND-enabling studies and are expected to enter the clinic next year.
Conference Call Information
Stemline will host a conference call and live webcast today at 8:00 a.m. ET to discuss second quarter 2019 financial results and recent business activities. The conference call can be accessed by dialing 1-888-220-8451 (domestic) or 1-323-794-2588 (international) and referring to conference ID 7887580.

The webcast can be accessed via the company’s website (www.stemline.com), at the bottom of the "Investors & Media" section in the "News & Events" page, and will be available live and for replay shortly after the event.

About ELZONRIS
ELZONRIS (tagraxofusp-erzs), a CD123-directed cytotoxin, is approved by the U.S. Food and Drug Administration (FDA) and commercially available in the U.S. for the treatment of adult and pediatric patients, two years or older, with blastic plasmacytoid dendritic cell neoplasm (BPDCN). For full prescribing information in the U.S., visit www.ELZONRIS.com. In Europe, a marketing authorization application (MAA) is under review by the European Medicines Agency (EMA). ELZONRIS is also being evaluated in additional clinical trials in other indications including chronic myelomonocytic leukemia (CMML), myelofibrosis (MF), and acute myeloid leukemia (AML).

About BPDCN
BPDCN is an aggressive hematologic malignancy with historically poor outcomes and an area of unmet medical need. BPDCN typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera. The BPDCN cell of origin is the plasmacytoid dendritic cell (pDC) precursor. The diagnosis of BPDCN is based on the immunophenotypic diagnostic triad of CD123, CD4, and CD56, as well as other markers. For more information, please visit the BPDCN disease awareness website at www.bpdcninfo.com.

About CD123
CD123 is a cell surface target expressed on a wide range of myeloid tumors including blastic plasmacytoid dendritic cell neoplasm (BPDCN), certain myeloproliferative neoplasms (MPNs) including chronic myelomonocytic leukemia (CMML) and myelofibrosis (MF), acute myeloid leukemia (AML) (and potentially enriched in certain AML subsets), myelodysplastic syndrome (MDS), and chronic myeloid leukemia (CML). CD123 has also been reported on certain lymphoid malignancies including multiple myeloma (MM), acute lymphoid leukemia (ALL), hairy cell leukemia (HCL), Hodgkin’s lymphoma (HL), and certain Non-Hodgkin’s lymphomas (NHL). In addition, CD123 has been detected on some solid tumors as well as autoimmune disorders including cutaneous lupus and scleroderma.

On August 2, 2019 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported financial results for the quarter ended June 30, 2019 (Press release, ImmunoGen, AUG 2, 2019, View Source [SID1234538082]).

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"In the second quarter, we took important steps towards finalizing the design of the registration study for mirvetuximab soravtansine in folate receptor alpha (FRα)-high platinum-resistant ovarian cancer, prioritizing our portfolio of earlier-stage product candidates, and extending our cash runway with the completion of our operational review," said Mark Enyedy, ImmunoGen’s President and Chief Executive Officer. "Over the back half of 2019, we plan to meet with regulators regarding the final design of the registration study for mirvetuximab with the goal of initiating enrollment by end of year. Additionally, we look forward to presenting the full FORWARD I data and initial FORWARD II triplet data evaluating mirvetuximab in combination with carboplatin and Avastin (bevacizumab) at ESMO (Free ESMO Whitepaper)."

Enyedy continued, "In parallel, we have determined a recommended Phase 2 dose and schedule for IMGN632 and filed a protocol to support combination studies, as well as evaluate single-agent safety and efficacy in acute myeloid leukemia (AML) patients with minimal residual disease (MRD+) following frontline induction therapy. With the benefit of approximately $240 million on the balance sheet and the completion of our operational review, we are in a strong financial position to execute across our prioritized portfolio."

RECENT PROGRESS

Presented mature data demonstrating significant anti-tumor activity, as well as favorable safety and tolerability, from the FORWARD II expansion cohort evaluating mirvetuximab in combination with bevacizumab in patients with FRα-positive platinum-resistant ovarian cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.
Accelerated enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in ovarian cancer patients for whom a non-platinum-based regimen would be an appropriate next therapy.
Determined the recommended Phase 2 dose and schedule for IMGN632 and filed the protocol to initiate combination studies with Vidaza (azacitidine) and Venclexta (venetoclax) in relapsed/refractory AML patients and to evaluate IMGN632 in MRD+ patients following frontline induction therapy.
Continued enrollment in the Phase 1 expansion study of IMGN632 in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).
Advanced IND-enabling activities for IMGC936, a novel ADAM9-targeting ADC in co-development with MacroGenics.
Completed operational review expected to extend the Company’s cash runway through the readout of the mirvetuximab pivotal study in platinum-resistant ovarian cancer.
ANTICIPATED UPCOMING EVENTS

Meet with the United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) in the second half of this year to review the design of the next Phase 3 study of mirvetuximab soravtansine.
Complete enrollment in the FORWARD II mirvetuximab plus bevacizumab combination cohort in the third quarter.
Present full FORWARD I data (oral presentation) and initial FORWARD II triplet data (poster presentation) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in late September.
Initiate the Phase 3 registration study of mirvetuximab as a monotherapy for women with FRα-high, platinum-resistant ovarian cancer by the end of this year.
Commence enrollment in the IMGN632 combination and single-agent MRD+ Phase 2 cohorts.
Present preclinical combination and updated monotherapy data for IMGN632 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Congress.
FINANCIAL RESULTS

Revenues for the quarter ended June 30, 2019 were $15.5 million, compared with $9.3 million for the quarter ended June 30, 2018. Revenues in the second quarter of 2019 included $10.4 million in non-cash royalty revenues, compared with $7.2 million for the second quarter of 2018. License and milestone fees of $5.1 million for the second quarter of 2019 included recognition and receipt of a $5 million milestone pursuant to a license agreement with Genentech, a member of the Roche Group, compared to $1.3 million of upfront license fees recognized in the second quarter of 2018. Revenues for the prior year period also included $0.4 million of research and development (R&D) support fees and $0.3 million of clinical materials revenue, compared with $0.1 million of similar fees earned in the current period.

Operating expenses for the second quarter of 2019 were $56.6 million, compared with $48.0 million for the same quarter in 2018. The increase was driven by a $19.3 million restructuring charge recorded in the current period resulting from the operational changes announced on June 27, 2019, which includes a one-time severance charge, retention costs, and losses recorded on laboratory equipment, compared to a $0.7 million charge recorded in the second quarter of 2018 related to the decommissioning of the Company’s Norwood facility. R&D expenses were $28.6 million in the second quarter of 2019, compared with $38.7 million for the second quarter of 2018. This decrease was primarily due to lower personnel expenses driven by adjustments made in the current quarter to bonus and stock compensation expense as a result of the restructuring of the business, lower clinical trial costs in the current period driven by patient enrollment in the FORWARD I Phase 3 clinical trial during the prior year period, and lower external manufacturing costs. General and administrative expenses were flat at $8.7 million in the second quarter of both 2019 and 2018.

ImmunoGen reported a net loss of $43.4 million, or $0.29 per basic and diluted share, for the second quarter of 2019, compared with a net loss of $41.6 million, or $0.31 per basic and diluted share, for the same quarter last year. Weighted average shares outstanding increased to 148.1 million from 134.4 million in those quarters.

ImmunoGen had $239.8 million in cash and cash equivalents as of June 30, 2019, compared with $262.3 million as of December 31, 2018, and had $2.1 million of convertible debt outstanding in each period. Cash used in operations was $20.8 million for the first six months of 2019, compared with cash used in operations of $85.3 million for the same period in 2018. The current period benefited from $65.2 million of net proceeds generated from the sale of the Company’s residual rights to Kadcyla (ado-trastuzumab emtasine) royalties in January 2019. Capital expenditures were $2.4 million and $2.1 million for the first six months of 2019 and 2018, respectively.

FINANCIAL GUIDANCE

Following the completion of its operational review in June 2019, ImmunoGen has updated its financial guidance for 2019 as follows:

revenues between $40 million and $45 million;
operating expenses between $175 million and $180 million; and
cash and cash equivalents at December 31, 2019, between $165 million and $170 million.
ImmunoGen expects that its current cash, together with expense reductions resulting from the operational changes previously announced and anticipated cash receipts from partners, will fund operations through the release of top-line results from the upcoming mirvetuximab Phase 3 study in platinum-resistant ovarian cancer, which are expected in the first half of 2022.

CONFERENCE CALL INFORMATION

ImmunoGen will hold a conference call today at 8:00 a.m. ET to discuss these results. To access the live call by phone, dial +1-323-794-2093; the conference ID is 9100112. The call may also be accessed through the Investors and Media section of the Company’s website at www.immunogen.com.

On August 2, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that company management will be presenting at the following investor conference and invited investors to participate by webcast (Press release, Exact Sciences, AUG 2, 2019, View Source [SID1234538081]).

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Canaccord Genuity Annual Growth Conference, Boston
Fireside Chat on August 7, 2019, at 9:00 a.m. EDT

The webcast can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.