City of Hope Becomes One of the First to Offer Tisagenlecleucel CAR T Cell Therapy for Adult Patients with the Most Common Type of Non-Hodgkin Lymphoma

On May 2, 2018 City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that it is one of the first treatment centers certified in the United States to administer tisagenlecleucel (commercial name Kymriah) chimeric antigen receptor (CAR) T cell therapy to adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy (Press release, City of Hope, MAY 2, 2018, View Source [SID1234525988]). The U.S. Food and Drug Administration today approved tisagenlecleucel for its second indication, including the treatment of diffuse large B-cell lymphoma (DLBCL), the most common form of NHL, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

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City of Hope is the only institution in Southern California to currently offer both tisagenlecleucel, which was approved last year for pediatric patients with refractory or relapsed B cell precursor acute lymphoblastic leukemia (ALL), and axicabtagene ciloleucel (commercial name Yescarta), the second CAR T cell therapy approved by the FDA, solidifying City of Hope’s position as a leader in this newest form of cancer immunotherapy.

"City of Hope has an impressive legacy of innovation in the cancer space, and our role in making the science of CAR T cell therapy a reality is an example of our commitment to helping ensure that patients around the world have access to the most advanced therapies," said Stephen J. Forman, M.D., the Francis & Kathleen McNamara Distinguished Chair in Hematology and Hematopoietic Cell Transplantation, and leader of the Hematologic Malignancies and Stem Cell Transplantation Institute. "Today’s supplemental approval for tisagenlecleucel is yet another important advance in CAR T therapy for non-Hodgkin lymphoma patients. In addition to City of Hope’s own clinical development programs, we are proud to be part of an exclusive group of institutions able to provide every commercial CAR T therapy to patients living with these aggressive and difficult-to-treat cancers, where other treatments have failed."

CAR T Expertise at City of Hope

City of Hope is a recognized leader in the advancement of CAR T cell therapies. City of Hope applies its proprietary CAR T cell technology in active preclinical and clinical programs across a range of hematologic cancers and solid tumors, and collaborates with other academic researchers and global biopharmaceutical companies to advance clinical research in areas of high unmet medical need and make their therapies available to patients.

City of Hope’s history with CAR T cell therapy dates back to the late 1990s. Since then, nearly 200 patients have been treated in CAR T trials at City of Hope; the institution was the first to administer CAR T cell therapy locally in the brain to glioblastoma patients through direct injection to the tumor site and/or through infusion in the ventricular system. City of Hope was also the first to offer CAR T trials targeting CD123 in acute myeloid leukemia.

City of Hope, which has one of the most comprehensive CAR T cell clinical research programs in the world, currently has 14 ongoing CAR T clinical trials and plans to open additional solid tumor trials in 2018 for patients with a variety of cancer types, including trials for patients with primary glioblastoma that expresses HER2 protein, patients with HER2-positive breast cancer with metastatic brain disease and patients with prostate cancer. City of Hope’s unique blend of multidisciplinary specialization – encompassing physicians, nurses and intensive care and transfusion medicine experts sharing stem cell transplant expertise – will also benefit CAR T patients, who require intensive medical care after treatment.

Patients interested in learning more about tisagenlecleucel treatment at City of Hope can call 833-310-CART (2278) or visit View Source

About non-Hodgkin Lymphoma

Lymphoma is the most common form of blood cancer, with Hodgkin lymphoma and non-Hodgkin lymphoma (NHL), which accounts for 4 percent of all cancer diagnoses in the United States, being the two main forms. Sixty percent of all NHL cases in the United States are aggressive NHL, with the most common subtype being DLBCL.

Approximately 74,680 people, both children and adults, are expected to be diagnosed with NHL in 2018, according to the American Cancer Society.

NHL includes multiple different subtypes, all originating in the lymphatic system, and occurs when either B or T cell lymphocytes, a type of white blood cell, become abnormal, causing such painful symptoms as enlarged lymph nodes, fever and fatigue. Refractory, or treatment-resistant, aggressive NHL grow quickly over time. Historically, patients have had about a 50 percent chance of surviving six months. Patients who are ineligible for or relapse after autologous stem cell transplant are eligible to receive tisagenlecleucel.

CEL-SCI CORPORATION ANNOUNCES UPCOMING INVESTOR CONFERENCE PRESENTATIONS

On May 2, 2018 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy biopharmaceutical company, reported that Geert Kersten, Chief Executive Officer, will present at the following conferences (Press release, Cel-Sci, MAY 2, 2018, View Source [SID1234525987]):

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Mr. Kersten’s presentation will be available in the Investor Relations section of the Company’s website at www.cel-sci.com/investor_relations.html.

About The 2018 Disruptive Growth & Healthcare Conference

The 2018 Disruptive Growth & Healthcare Conference sponsored by RHK Capital and ReedSmith offers an opportunity to discover life science companies focusing on unmet medical needs with disruptive technologies and business models.

About The NYC Oncology Investor Conference 2018

The NYC Oncology Investor Conference 2018 hosted by OneMed Forum, and sponsored by the National Foundation for Cancer Research, the International Cancer Impact Fund, Klosters Innovation Partners, Wilson Sonsini Law Firm, Torreya Partners, and Marcum is the leading conference for early-stage private and public cancer investing.

AmerisourceBergen Reports Fiscal 2018 Second Quarter Results

On May 2, 2018 AmerisourceBergen Corporation (NYSE:ABC) reported that in its fiscal year 2018 second quarter ended March 31, 2018, revenue increased 10.5 percent to $41.0 billion. On the basis of U.S. generally accepted accounting principles (GAAP), diluted earnings per share (EPS) was $1.29 for the March quarter of fiscal 2018, compared to $1.86 in the prior year quarter (Press release, AmerisourceBergen, MAY 2, 2018, View Source [SID1234525986]). Adjusted diluted EPS, which is a non-GAAP measure that excludes items described below, increased 9.6 percent to $1.94 in the fiscal second quarter.

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AmerisourceBergen now believes adjusted diluted EPS for fiscal year 2018 will be at the bottom of its guidance range of $6.45 to $6.65, reflecting growth of 10 percent versus last fiscal year. The Company does not provide forward-looking guidance on a GAAP basis, as discussed below in Fiscal Year 2018 Expectations.

"I am pleased with our performance in the March quarter as associates and businesses within AmerisourceBergen continue to execute. Our distribution businesses are creating significant value for our customers as we grow volumes and help support their businesses in a dynamic healthcare market," said Steven H. Collis, Chairman, President and Chief Executive Officer of AmerisourceBergen.

"Our updated outlook for fiscal 2018 reflects the strong performance of our Pharmaceutical Distribution Services segment, helping to offset a lower contribution from its PharMEDium business. We remain confident in the value, efficiency and safety PharMEDium provides the healthcare system and are committed to providing our customers with the highest quality products and services," Mr. Collis continued. "As we move further into fiscal 2018, we are excited to begin realizing the benefits of investments throughout AmerisourceBergen that further enhance the value and efficiency we offer to our provider customers and manufacturer partners. Our long-term relationships and unique portfolio of integrated pharmaceutical services enable AmerisourceBergen to continue living its purpose as we are united in our responsibility to create healthier futures."

QUANTERIX TO RELEASE FIRST QUARTER 2018 FINANCIAL RESULTS AND HOST CONFERENCE CALL ON WEDNESDAY, MAY 9, 2018

On May 2, 2018 Quanterix Corporation (NASDAQ:QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, reported that it will release its financial results for first quarter 2018 after the close of trading on Wednesday, May 9, 2018 (Press release, Quanterix, MAY 2, 2018, https://www.quanterix.com/resources/press-releases/quanterix-release-first-quarter-2018-financial-results-and-host-conference [SID1234525984]). Company management will host a conference call at 4:30 p.m. ET to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chief Executive Officer, President and Chairman, Quanterix.

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Individuals interested in listening to the conference call may do so by dialing (833) 686-9351 for domestic callers, or (612) 979-9890 for international callers. Please reference the following password: 2576325. A live webcast will be accessible on the investor relations section of Quanterix’ website: View Source The webcast will be available on the Company’s website for one year following completion of the call.

AC Immune Reports First Quarter 2018 Financial Results and Corporate Update

On May 2, 2018 AC Immune SA (NASDAQ: ACIU), a Swiss-based, clinical stage biopharmaceutical company with a broad pipeline focused on neurodegenerative diseases, reported financial results for the first-quarter ended March 31, 2018 (Press release, AC Immune, MAY 2, 2018, View Source [SID1234525983]).

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Prof. Andrea Pfeifer, CEO of AC Immune, commented: "During the first quarter we announced plans to start the first in human study of potentially the first selective alpha-synuclein PET tracer for earlier and more accurate diagnosis of Parkinson’s disease. Furthermore, our Tau small molecules (Tau Morphomers) demonstrated target-specific reduction of pathological Tau as well as cognitive and functional improvement. We also presented a number of scientific updates on our programs at a prestigious scientific conference, demonstrating progress in our key areas. The Company’s financial position remains strong, while we continue to invest in our highly-valued R&D resources as we pursue our mission of being a leader in precision medicine for neurodegenerative diseases.

First Quarter 2018 Company Highlights

First potential PET tracer for Parkinson’s disease
We announced the first in human study for potentially the first alpha-synuclein positron emission tomography (PET) tracer for earlier and more accurate diagnosis of Parkinson’s disease. This new compound is highly selective for alpha-synuclein aggregates, a recognized and known target for Parkinson’s disease and diseases involving alpha-synuclein pathologies. Data was presented at the AAT-AD/PD Focus Meeting 2018 in Torino, Italy on March 15, 2018.

Scientific updates at AAT- AD/PD Focus Meeting
The Company and its partners provided updates at the AAT-AD/PD Focus Meeting in Torino, Italy, in March 2018: Several posters and oral presentations covered the alpha-synuclein PET tracer being developed together with Biogen; the Company’s in-house SupraAntigenTM vaccine technology; the anti-amyloid-ß antibody crenezumab currently in Phase 3 development with our collaboration partner Genentech, a member of the Roche Group; and the Tau-PET imaging agent PI-2620 being developed with Piramal Imaging.

Selection of Tau Small Molecules for Clinical Development in Alzheimer’s disease
AC Immune has one of the largest Tau pipeline in the industry. Several Tau small molecule candidates, derived from AC Immune’s proprietary MorphomerTM platform and designed to cross the blood brain barrier, have demonstrated target-specific reduction of pathological Tau and cognitive and functional improvement in proof-of-concept studies in Alzheimer’s disease. IND/CTA enabling studies have started and a Phase 1 study will commence by the end of 2018.

Continue to invest in our key R&D programs and resources
During the quarter we added 7.3 FTEs to our R&D operations, as we continue to invest in our non-Alzheimer’s disease research, diagnostics and new discovery programs as we seek to position the Company clearly as a leader in precision medicine for neurodegenerative diseases.

First Quarter 2018 Financial Highlights

Revenues
Our revenues fluctuate as a result of our collaborations with current and potentially new partners, the timing of milestone achievements, and the size of each milestone payment.
AC Immune generated revenues of CHF 1.5 million in the three months ended March 31, 2018, a decrease of CHF 0.5 million over the comparable period in 2017. The decrease in collaboration revenues was principally due to the recognition of a EUR 1 million (CHF 1.1 million) milestone from Piramal for the initiation of the Phase 1 clinical trial in an orphan indication, Progressive Supranuclear Palsy (PSP), which did not reoccur in Q1 2018.

Research & Development (R&D) Expenses
In the first quarter of 2018, AC Immune invested CHF 10.1 million in research and development, compared with CHF 7.5 million for the same period in 2017. The increase in R&D programs is primarily driven by increased investments in our two ACI 24 programs in Alzheimer’s disease (AD) and Down syndrome, our Anti-Tau vaccines for the treatment of AD, our Anti-Tau Morphomers small molecules and alpha-synuclein Antibody program.

General and Administrative (G&A) Expenses
General and administrative expenses amounted to CHF 2.7 million in the three months ended March 31, 2018, compared with CHF 2.4 million in the same period in 2017.

IFRS Loss for the period
For the three months ended March 31, 2018, the Company had a net loss of CHF 11.6 million compared with net loss of CHF 9.4 million for the same period in 2017. The decline in profitability is attributable to the decreased revenues for the periods as a result of prior milestone achievements and an increase in R&D and G&A expenses as outlined above.

Cash position
As of March 31, 2018, AC Immune had total cash of CHF 109.7 million compared to CHF 124.4 million as of December 31, 2017. The decrease of CHF 14.7 million is principally due to the net loss of CHF 11.6 million for the three month period. Net cash flows used in operating activities were CHF 13.3 million, due to the higher investments in our major discovery and development programs, and the continued strengthening of the Company’s infrastructure, systems and organization as a publicly-traded company.

Non-IFRS Financial Measures
In addition to our operating results, as calculated in accordance with International Financial Reporting Standards, or IFRS, as adopted by the International Accounting Standards Board, we use Adjusted Loss and Adjusted Loss per Share when monitoring and evaluating our operational performance. Adjusted Loss is defined as loss for the relevant period, as adjusted for certain items that we believe are not indicative of our ongoing operating performance. Adjusted Loss per Share is defined as Adjusted Loss for the relevant period divided by the weighted-average number of shares for such period.

1 Reflects non-cash expenses associated with share-based compensation for equity awards issued to Directors, Management and employees of the Company. This expense reflects the awards’ fair value recognized for the portion of the equity award which is vesting over the period.

2 Reflects foreign currency remeasurement gains and losses for the period, predominantly impacted by the change in the exchange rate between the US Dollar and the Swiss Franc.

Non-IFRS Expenditures
Adjustments for the three ended March 31, 2018 and 2017 were CHF 0.8 million and CHF 1.7 million in net losses, respectively. These were largely due to foreign currency remeasurement losses of CHF 0.2 million and CHF 1.6 million, respectively, predominantly related to the cash balance of the Company as a result of a weakening of the US Dollar against the Swiss Franc for most of the first half of the year offset by gains in the third quarter.
The Company also recorded CHF 0.6 million and CHF 0.1 million for share-based compensation expenses during the three months ended March 31, 2018 and 2017, respectively