On March 20, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported that Mr. Guy Goldberg, RedHill’s Chief Business Officer, will present a corporate overview at the H.C. Wainwright Annual Global Life Sciences Conference, on Monday, April 9, 2018, at 11:05 am CET, at the Le Meridien Beach Plaza Hotel in Monte Carlo, Monaco (Press release, RedHill Biopharma, MAR 20, 2018, View Source [SID1234524912]).

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A live audio of the presentation will be available on the Company’s website at: View Source A copy of the presentation will be available on the Company’s website and a replay of the webcast will be available on the Company’s website for a period of 30 days.

On March 20, 2018 Affimed N.V. (Nasdaq: AFMD), a clinical stage biopharmaceutical company focused on discovering and developing highly targeted cancer immunotherapies, reported financial results for the quarter and year ended December 31, 2017 (Press release, Affimed, MAR 20, 2018, View Source [SID1234524902]).

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"Our approach of harnessing the power of innate and adaptive immunity showed its first clinical potential in 2017 and early 2018 with very encouraging data becoming available for AFM13 as monotherapy in Hodgkin and CD30-positve lymphomas as well as for AFM13 in combination with Keytruda in Hodgkin lymphoma," said Dr. Adi Hoess, CEO of Affimed. "In addition, we were able to hire outstanding executive managers with Leila Alland as CMO and Wolfgang Fischer as COO, who will be instrumental to the further development of our pipeline towards marketed therapies."

Corporate Updates

· In 2017 and early 2018, Affimed has made important additions to its management team. The Company entered into an agreement with Leila Alland, M.D. who will join Affimed as CMO effective March 26, 2018. Dr. Leila Alland brings to the Company more than 20 years of oncology experience, having held leadership roles in drug development at Tarveda Therapeutics, AstraZeneca, Bristol-Myers Squibb and Novartis. Further strengthening Affimed’s U.S. presence, Dr. Alland will be based in the Company’s New York location along with Cassandra Choe-Juliak, M.D., Vice President, Clinical U.S. and Denise Mueller, Head of Commercial Strategy and Business Development of Affimed.

· In September 2017, Dr. Wolfgang Fischer, former Global Head of Program and Project Management of Sandoz Biopharmaceuticals (Novartis Group) joined Affimed as Chief Operating Officer (COO). Dr. Fischer has over 20 years of R&D experience with a focus on oncology, immunology and pharmacology, as well as a proven track record in drug development.

· In February 2018, Affimed completed an underwritten public offering on the Nasdaq Global Market, raising a total of approximately $24.5 million (€19.7 million) in net proceeds. Proceeds from this transaction, together with existing cash on the balance sheet, are expected to fund operations, including clinical development and early development activities, at least until the fourth quarter of 2019.

Pipeline Updates
NK-cell engager programs

· Enrollment has been completed into Affimed’s Phase 1b combination study of AFM13, a CD30/CD16A-targeting NK cell engager, with Merck’s Keytruda (pembrolizumab) in relapsed/refractory Hodgkin lymphoma (r/r HL) and treatment is ongoing. A total of 24 patients are being treated at the highest AFM13 dose level. In February 2018, Affimed presented interim data from a total of 9 patients in this cohort, demonstrating that AFM13 in combination with Keytruda is well-tolerated, with a 3-month objective response rate (ORR) of 89% comparing favorably to historical ORR of anti-PD-1 antibodies as monotherapy in a similar patient population (58-63%). Furthermore, 4 out of 9 patients (44%) showed complete metabolic responses, compared to complete response rates of 9-22% reported for anti-PD-1 monotherapy in a similar patient population. Affimed expects full 3-month data by mid-year 2018 and intends to provide regular updates at scientific or medical conferences.

· Affimed is supporting an investigator-sponsored translational Phase 1b/2a study of AFM13 in patients with relapsed or refractory CD30-positive lymphoma with cutaneous manifestation led by Columbia University. The study is designed to allow for serial cutaneous biopsies, thereby enabling assessment of NK cell biology and tumor cell killing within the tumor microenvironment. The second cohort has been fully enrolled and recruitment into the third cohort is ongoing. In February 2018, the Company reported an analysis of the first dose cohort (3 patients dosed at 1.5 mg/kg), demonstrating that AFM13 could be safely administered and showed therapeutic activity as a single agent, with an ORR of 66% (2 out of 3 patients). One complete response, one partial response and one stable disease were observed, as determined by global response score. These early data confirm the single-agent activity observed in a previous Phase 2a trial, and further suggest a new opportunity for AFM13 in CD30-positive lymphoma.

· The Company’s investigator-sponsored Phase 2a monotherapy study of AFM13 in HL led by the German Hodgkin Study Group (GHSG) is open and recruiting, including patients pre-treated with both brentuximab vedotin (B.V.) and anti-PD1. In May 2017 Affimed reported data from a subset of patients enrolled under the original study protocol (minimum of 3 lines of treatment including B.V., anti-PD-1-naïve) suggesting that AFM13 is efficacious as single agent in this heavily pre-treated group of patients.

· In Affimed’s collaboration with The University of Texas MD Anderson Cancer Center (MDACC), evaluating the Company’s NK cell engager AFM13 in combination with MDACC’s NK cell product, preclinical research activities are progressing. These are intended to be followed by a Phase 1 clinical trial.

· Affimed has generated tetravalent bispecific NK cell engager product candidates for AFM24 (EGFR/CD16A) with different pharmacokinetic profiles. Differentiating from current EGFR-targeted therapeutics, the Company’s molecules are designed with the potential to widen the therapeutic window in solid tumor therapy and to address patient populations that are resistant to EGFR-targeting agents. Affimed anticipates completing IND-enabling studies by mid-year 2019.

· The NK cell engager AFM26 (BCMA/CD16A), is designed to address the medical need of eliminating minimal residual disease (MRD) in multiple myeloma. In particular, Affimed aims to leverage BCMA as a target in autologous stem cell transplant (ASCT)-eligible patients. Affimed is developing different tetravalent bispecific antibody formats and continues to advance its lead candidate in IND-enabling studies.

· Discovering and assessing additional opportunities to harness innate and adaptive immunity, Affimed recently published data in Cancer Immunology Research, together with its collaboration partner, the German Cancer Research Center (DKFZ). The Company presented evidence of AFM13 sensitizing NK cells to IL-2 and/or IL-15 stimulation. In this study, after exposure to AFM13, the NK cells showed enhanced IL-2- and IL-15-mediated proliferation and cytotoxicity. These data corroborate initial findings the Company had presented at the AACR (Free AACR Whitepaper) Annual Meeting in April 2017 and support the approach of combining Affimed’s NK cell engagers with IL-2- or IL-15 to potentially achieve deeper clinical responses.

T-cell engager programs

· Affimed is conducting two clinical Phase 1 dose-escalation trials with AFM11, a CD3/CD19-targeting tetravalent bispecific T cell engager, in patients with r/r acute lymphocytic leukemia (ALL) and with r/r non-Hodgkin lymphoma (NHL), respectively. In the Company’s NHL study, the third dose cohort has recently been completed and Affimed’s ALL trial is currently recruiting patients into the fifth dose cohort.

· Amphivena Therapeutics, Inc. continues to recruit patients into its first-in-human Phase 1 dose escalation study of AMV564 in r/r acute myeloid leukemia (AML). Amphivena also plans to launch a Phase 1 clinical study in patients with myelodysplastic syndrome (MDS) and is

exploring the utility of AMV564 in solid tumors. AMV564 is a CD33/CD3-specific T cell engagers based on Affimed’s technology platform. Affimed owns approximately 18.5% of Amphivena (fully diluted).

Financial Highlights

(Figures for the fourth quarter of 2017 and 2016 represent unaudited figures)

Cash and cash equivalents and financial assets totaled €39.8 million as of December 31, 2017 compared to €44.9 million as of December 31, 2016. Affimed was able to fund its operational expenses in 2017 with existing cash, the issuance of new shares and the usage of an additional loan tranche.

Net cash used in operating activities for the fourth quarter of 2017 was €4.9 million compared to €6.6 million for the fourth quarter of 2016. Net cash used in operating activities was €25.5 million for the twelve months ended December 31, 2017 compared to €32.1 million for the twelve months ended December 31, 2016. The year-over-year decrease was primarily related to lower cash expenditure for research and development (R&D) in connection with our development and collaboration programs.

Revenue for the fourth quarter of 2017 was €0.6 million compared to €1.4 million for the fourth quarter of 2016. Revenue for the full year 2017 was €2.0 million compared to €6.3 million for the full year 2016. Revenue for the full year and the fourth quarter 2017 was primarily derived from AbCheck services. Revenue for the full year 2016 related to a large extent to Affimed’s collaborations with Amphivena and LLS while revenue for the fourth quarter 2016 was derived from AbCheck services.

R&D expenses for the fourth quarter of 2017 were €4.6 million compared to €5.7 million for the fourth quarter of 2016. For the full year 2017, R&D expenses were €21.5 million compared to €30.2 million for the full year 2016. The decrease was primarily related to lower expenses for AFM13 related CMC activities, preclinical programs and infrastructure.

G&A expenses for the fourth quarter of 2017 were €1.9 million compared to €2.1 million for the fourth quarter of 2016. For the full year 2017, G&A expenses were slightly lower with €8.0 million compared to €8.3 million for the full year 2016.

Net loss for the fourth quarter of 2017 was €6.4 million, or €0.14 per common share, compared to a net loss of €5.4 million, or €0.19 per common share, for the fourth quarter of 2016. Net loss for the full year 2017 was €30.2 million, or €0.69 per common share, compared to a net loss of €32.2 million, or €0.97 per common share, for the full year 2016. The decrease in net loss for the full year 2017 was primarily related to decreased spending on R&D for AFM13 related CMC

activities, preclinical programs and infrastructure, partially offset by lower revenue and higher finance costs. Additional information regarding these results is included in the notes to the consolidated financial statements as of December 31, 2017 and "Item 5. Operating and Financial Review and Prospects," which will be included in Affimed’s Annual Report on Form 20-F as filed with the SEC.

Including the proceeds from the equity offering in February 2018, the Company’s operations, including clinical development and early development activities, are expected to be funded at least until the fourth quarter of 2019.

Note on IFRS Reporting Standards

Affimed prepares and reports the consolidated financial statements and financial information in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB). None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles (GAAP) in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information

Affimed’s management will host a conference call to discuss the company’s financial results and recent corporate developments today at 8:30 a.m. ET. A webcast of the conference call can be accessed in the "Events" section on the "Investors & Media" page of the Affimed website at View Source A replay of the webcast will be available on Affimed’s website shortly after the conclusion of the call and will be archived on the Affimed website for 30 days following the call.

On March 20, 2018 Selecta Biosciences, Inc. (Nasdaq:SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by avoiding unwanted immune responses, reported that CEO and President Werner Cautreels, Ph.D., will be presenting at the 17th Annual Needham Healthcare Conference in New York City at 9:30 a.m. ET on Tuesday, March 27, 2018 (Press release, Selecta Biosciences, MAR 20, 2018, View Source [SID1234524913]). A live and archived webcast of the presentation can be accessed via the Investors & Media section of the company’s website, View Source

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On March 20, 2018 Athersys, Inc. (NASDAQ:ATHX) announced today that Gil Van Bokkelen, Chairman and CEO, will present a corporate overview at the 17th Annual Needham Healthcare Conference at The Westin Grand Central Hotel in New York City. The presentation is scheduled for Wednesday, March 28, 2018 at 9:30 am ET.

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Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investors Section on the Company’s website at www.athersys.com. An archived replay of the webcast will be available on the Company’s website after the conference for a limited time.

On March 20, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that the U.S. Food and Drug Administration (FDA) has approved ADCETRIS (brentuximab vedotin) in combination with chemotherapy in adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (Press release, Seattle Genetics, MAR 20, 2018, View Source;p=RssLanding&cat=news&id=2338996 [SID1234525470]). The approval is based on the successful outcome of the phase 3 ECHELON-1 clinical trial that compared ADCETRIS plus AVD (Adriamycin, vinblastine and dacarbazine) to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine). In addition, data from the ECHELON-1 trial converted the U.S. accelerated approval of ADCETRIS for the treatment of adults with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen to regular approval. In October 2017, the FDA granted Breakthrough Therapy Designation (BTD) to ADCETRIS in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma. The FDA also granted Priority Review for the supplemental Biologics License Application (BLA), and the Prescription Drug User Fee Act (PDUFA) target action date was May 1, 2018.

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"The standard of care for treating newly diagnosed advanced Hodgkin lymphoma has not changed in more than four decades. For years, the physician community has been conducting clinical trials to identify improved regimens that are both less toxic and more effective to no avail," said Joseph M. Connors, M.D., FRCPC, Clinical Director, Center for Lymphoid Cancer at BC Cancer in Vancouver, Canada. "The ECHELON-1 study results demonstrated superior efficacy of the ADCETRIS plus chemotherapy regimen when compared to the standard of care while removing bleomycin, an agent that can cause unpredictable and sometimes fatal lung toxicity, completely from the regimen. This represents a meaningful advance for this often younger patient population."

This is the fifth FDA-approved indication for ADCETRIS, which also has regular approval for adult patients with: (1) classical Hodgkin lymphoma (cHL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (2) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (3) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (4) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

"Currently, up to 30 percent of newly diagnosed advanced-stage classical Hodgkin lymphoma patients will experience disease progression after treatment with the current standard of care, representing a significant need for improved treatment options for these often younger patients," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "The ECHELON-1 trial was a bold, five-year effort to redefine the frontline treatment of Stage III/IV classical Hodgkin lymphoma and provide patients with a more effective treatment regimen. In the ECHELON-1 study, ADCETRIS plus AVD was shown to have superior efficacy to ABVD. With today’s FDA approval, the physician and patient community have a new treatment option for previously untreated Stage III or IV Hodgkin lymphoma patients. We want to thank all of the patients, physicians and their staff who participated in the ECHELON-1 trial which supported the FDA approval of this novel regimen."

The FDA approval is based on positive results from a phase 3 trial called ECHELON-1 that were presented at the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2017 with simultaneous publication in the New England Journal of Medicine. Results from the ECHELON-1 trial in 1,334 Stage III or IV classical Hodgkin lymphoma patients included:

The trial achieved its primary endpoint with the combination of ADCETRIS plus AVD resulting in a statistically significant improvement in modified progression-free survival (PFS) versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (HR 0.77; 95% CI, 0.60-0.98; p-value=0.035). This corresponds to a 23 percent reduction in the risk of progression, death or need for additional anticancer therapy in patients not in complete response (CR) after frontline treatment.
Overall survival (OS) was a key secondary endpoint and the rate of CR per IRF assessment at the end of the randomized regimen was a secondary endpoint. At the time of the modified PFS analysis, an interim OS analysis trended in favor or the ADCETRIS plus AVD arm, but did not demonstrate significant difference (HR 0.72; 95% CI, 0.44-1.17; p-value=0.19). The CR rate was 73 percent on the ADCETRIS plus AVD arm and 70 percent on the ABVD arm.
The safety profile of ADCETRIS plus AVD in the ECHELON-1 trial was generally consistent with that known for the single-agent components of the regimen.
The most common adverse events of any grade that occurred in at least 10 percent of patients in the ADCETRIS plus AVD arm were: anemia, neutropenia, peripheral sensory neuropathy, constipation, vomiting, diarrhea, pyrexia, decreased weight, stomatitis, abdominal pain, febrile neutropenia, bone pain, insomnia, decreased appetite, back pain, rashes/eruptions/exanthemas, dyspnea, peripheral motor neuropathy, and increased alanine aminotransferase. In both the ADCETRIS plus AVD and ABVD arms, the most common Grade 3 or 4 events were neutropenia, febrile neutropenia, and anemia.
Based on ECHELON-1 clinical trial results, prophylactic growth factors (G-CSF) should be administered starting at cycle one for Stage III or IV classical Hodgkin lymphoma patients receiving ADCETRIS plus AVD.
About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the American Cancer Society, approximately 8,500 cases of Hodgkin lymphoma will be diagnosed in the United States during 2018 and more than 1,000 will die from the disease. Approximately half of all newly diagnosed Hodgkin lymphoma patients have Stage III/IV disease. According to the Lymphoma Coalition, over 62,000 people worldwide are diagnosed with Hodgkin lymphoma each year and approximately 25,000 people die each year from this cancer.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including two ongoing phase 3 studies: the ECHELON-2 trial in frontline mature T-cell lymphomas and the CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA regular approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 71 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.