On November 6, 2018 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company with a pipeline of immune checkpoint antibodies, cancer vaccines and adoptive cell therapies1, provided a corporate update and reported financial results for the third quarter of 2018 (Press release, Agenus, NOV 6, 2018, View Source [SID1234530830]).

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"We have made substantial operational advances. These are unprecedented for a company of our size but also for the field of I-O," said Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We have shown that our CTLA-4 and PD-1 antibodies are active in the clinic with clinical benefit seen in the majority of the more than 130 patients treated. Recently we met with the FDA to confirm our clinical path to a BLA filing. In addition to these, our discovery engines have produced 4 INDs which have been filed this year, including our next generation CTLA-4. We plan to finish the year with two additional IND filing of first-in-class bispecifics. We also expect the closure of at least one corporate partnership transaction by year end."

Key operational and business updates

Operational Achievements:
PD-1 & CTLA-4 show clinical benefit in majority of patients across multiple solid tumors, including cervical cancer
Clinical benefit rate of 68% and 63% for AGEN2034 & AGEN18842
FDA meeting confirms path to BLA filing for lead molecules
Three trials are ongoing to leverage accelerated approval pathways
New discoveries advance to clinic
Four INDs filed in 2018, including Next-Gen CTLA-4, AGEN1181
Two First-in-class bispecific IND filings on track by year end
2018 Payment milestones triggered in partnerships with Incyte, Merck
LAG-3 (INCAGN02385) and TIM-3 (INCAGN02390) in the clinic with milestones received and to be received in Q4
Undisclosed target with Merck entered clinic also generating a milestone payment
Sales of GSK’s Shingrix, containing QS-21 Stimulon, have significantly exceeded earlier sales projections
Partnership discussions on track to be concluded by year end
Manufacturing Speed and Innovation driving advances to the clinic:
Setting industry records for clinical & pivotal grade material
3-5x faster for lead compounds
First-in-class bispecific, AGEN1223, manufactured at scale in <2 months
AgenTus Cell Therapy Business:
Lead identified for IND filing; private financing and plans for IPO underway
Third Quarter 2018 Financial Results

Cash and cash equivalents were $46.3 million at the end of the 3rd quarter compared to $43.2 million and $60.2 million at June 30, 2018 and December 31, 2017 respectively. Subsequent to the end of 3rd quarter, Agenus announced the completion of a private financing of $40 million with a single investor netting the company approximately $39.9 million.

For the third quarter ended September 30, 2018, we reported a net loss of $34 million or $0.29 per share compared to a net loss for same period in 2017 of $37 million, or $0.37 per share. In the third quarter, we recognized revenue of $13 million which includes a milestone achieved and non-cash royalties earned.

For the nine months ended September 30, 2018, we had a net reported loss of $113 million or $1.04 per share compared to a net reported loss for the same period in 2017 of $86 million or $0.88 per share. The increased net loss reflects reduced revenue during 2018 due to accelerated milestones received during 2017 from Incyte and the 2018 loss on early extinguishment of debt.

Conference Call, Webcast and Prepared Statement Information

Conference Call Information:

Date: Tuesday November 6, 2018

Time: 8:30 a.m. ET

Domestic Dial-in Number: (844) 492-3727

International Dial-in Number: (412) 317-5118

Conference ID: Agenus

Live Webcast: accessible from the Company’s website at View Source or with this link View Source

A replay will be available on the Company’s website approximately two hours after the call and will remain available for 90 days.

On November 6, 2018 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported that it will present results from a study that further demonstrates the ability of the Company’s proprietary Discovery Engine, featuring the Company’s Immune Repertoire Capture (IRC) technology, to identify antibodies from treatment-responsive cancer patients that bind to non-autologous tumor tissue (Press release, Atreca, NOV 6, 2018, View Source [SID1234530932]). The study will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting being held November 7-11, 2018, at the Walter E. Washington Convention Center in Washington, D.C.

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"Atreca has built a proprietary and unique discovery platform that enables us to discover, in a very efficient and industrialized manner from active immune responses, antibodies that can serve as the foundation of therapeutics," said Tito A. Serafini, Ph.D., Chief Strategy Officer and an Atreca founder. "The results to be presented at this conference provide another example of what this Discovery Engine enables in oncology; namely, our ability to identify tumor-targeting antibodies in treatment-responsive patients with the potential to be developed into therapeutics designed to treat large patient groups. Our most advanced program, ATRC-101, which we anticipate entering clinical trials in 2019, is a product of this approach."

In the study, (Abstract #O3; Title: Anti-tumor immune responses in metastatic breast cancer exceptional responder patients) to be presented both as an oral presentation and a poster by William Robinson, M.D., Ph.D., Professor of Medicine at Stanford University and an Atreca Founder, Atreca researchers collaborated with researchers led by Joyce O’Shaughnessy, M.D., at Baylor University Medical Center and Texas Oncology. Atreca researchers investigated the properties of antibodies identified in the active immune response of eleven metastatic breast cancer patients who had exceptional and durable responses to systemic therapy. Of the patient-derived antibodies assessed, over 40% displayed specific immunoreactivity to breast carcinoma tissue from unrelated patients, but not to adjacent tissue, indicating that they bind to public tumor antigens. Multiple antibody lineages, predominantly of the IgG2 subclass, showed evidence of convergent antibody evolution across patients, and a subset of responder antibodies drove killing of tumor cells in in vitro functional assays.

Abstract Title: Anti-tumor immune responses in metastatic breast cancer exceptional responder patients (Abstract #O3)

Oral Presentation

Concurrent Session 216: Role of B cells in Immunotherapy & Toxicity
Date & Time: Saturday, Nov. 10, 6:10 – 6:25 p.m. EST
Location: East Salon ABC
Atreca also has a second presentation. Details are below:

Abstract Title: The identification of potent anti-tumor antibodies applicable for ADC therapeutics from patients undergoing immunotherapy (Abstract #P1)

Poster Display (for both posters)

Date & Time: Friday, Nov. 9, from 8 a.m. – 8 p.m. EST and Saturday, Nov. 10, from 8 a.m. – 12 p.m. EST
Presentation Hours: Friday, Nov. 9, 12:45 – 2:15 p.m. EST and 6:30 – 8 p.m. EST
Location: Hall E

On November 6, 2018 Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, reported that management will present company overviews at the following conferences (Press release, Alnylam, NOV 6, 2018, View Source [SID1234530770]):

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Stifel 2018 Healthcare Conference on Wednesday, November 14, 2018 at 10:15 am ET at the Lotte New York Palace Hotel in New York City
27th Annual Credit Suisse Healthcare Conference on Wednesday, November 14, 2018 at 3:25 pm MT (5:25 pm ET) at the Phoenician Hotel in Scottsdale, Arizona
A live audio webcast of each presentation will be available on the Investors section of the Company’s website, www.alnylam.com. A replay will be available on the Alnylam website within 48 hours after each event.

On November 6, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported multiple presentations showcasing G100, its potent intratumoral TLR4 agonist, at the annual meeting for the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) being held in Washington D.C. this week (Press release, Immune Design, NOV 6, 2018, View Source [SID1234530792]). The presentations, which include both clinical and preclinical study data, further support the activity of G100 in follicular lymphoma patients and the potential combinability of G100 with other novel immune-modulatory agents.

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"These additional positive clinical data continue to support the ability of G100 to trigger a systemic therapeutic effect when injected into a single tumor in follicular lymphoma patients," said Carlos Paya, M.D., President and Chief Executive Officer of Immune Design. "In addition, we are pleased to observe that G100 can be synergistic with novel therapies such as anti-OX40 antibodies and adoptive T-cell therapies."

Key data to be presented:

The higher dose (20ug) of intratumorally-administered G100 is active, as determined by clinical outcomes and increased biomarker activity in patients with follicular lymphoma

Data from a new cohort of 18 follicular lymphoma patients treated with G100 at 20ug with low-dose radiation further confirms that G100 is active in the absence of an anti-PD-1 antibody and continues to have a favorable safety profile.
Comparison of data from these 18 patients treated with G100 at 20ug versus data from 16 patients previously treated with 10ug shows:
Positive trend toward more rapid overall clinical responses, including in abscopal (untreated) lesions.
Increased TILs and decreased lymphoma-associated CD20 cells in tumors following G100 treatment, which are biomarkers previously associated with improved clinical responses.
Higher ORR (60%) is observed in patients stratified by baseline tumor high TLR4 expression.
Consistently favorable safety profile.
Based on these positive data, Immune Design has selected the 20ug dose of G100 for further clinical development.

Synergistic anti-tumor effects of G100 with anti-OX40 antibodies

Combination of intratumoral G100 and systemic anti-OX40 monoclonal antibody is synergistic in aggressive lymphoma and melanoma preclinical models.
Improved anti-tumor activity in comparison to either agent alone.
Increased biomarker levels that correlate with effectiveness, such as TILs and the ratio of CD8/CD4 tumor-specific T cells.

G100 enhances the efficacy of adoptive T-cell therapy

Combination of intratumoral injection of G100 and adoptive T-cell therapy was found to be synergistic in pre-clinical tumor models.
Tumor eradication observed in 70% of mice treated compared to no tumor regression with either approach alone.
Median survival was significantly improved with the combination regimen.
About G100

G100 is Immune Design’s lead product candidate and contains a potent synthetic small molecule toll-like receptor-4 (TLR-4) agonist called Glucopyranosyl Lipid A (GLA). G100 activates innate and adaptive immunity in the tumor microenvironment to generate an immune response against the tumor’s preexisting diverse set of antigens. A growing set of clinical and preclinical data have demonstrated the ability of G100 to activate tumor-infiltrating lymphocytes, macrophages and dendritic cells, and promote antigen-presentation and the recruitment of T cells to the tumor. The induction of local and systemic immune responses has been shown to result in local and abscopal (shrinking of tumors outside the scope of the localized treatment) tumor control. G100 is currently in development to treat patients with relapsed follicular lymphoma (FL), a sub-type of Non-Hodgkin lymphoma. Immune Design intends to start a study in earlier-stage lymphoma patients in combination with rituximab, a standard treatment for lymphomas, and is evaluating studies in other B-cell malignancies beyond FL, as well as potential solid tumor indications

On November 6, 2018 DXC Technology (NYSE: DXC) reported results for the second quarter of fiscal year 2019, representing the period from July 1 through September 30, 2018 (Press release, DynPort Vaccine Company, NOV 6, 2018, View Source [SID1234530872]).

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"In the second quarter, DXC Technology delivered year-over-year and sequential growth in earnings per share and margins," said Mike Lawrie, chairman, president and CEO. "We continue to see strong demand for our digital solutions, and we are helping clients leverage efficiency gains in their existing IT environment to reinvest in digital transformations. We also continue to strengthen our industry-leading partner network, and we are making strategic investments in the business, including our recent acquisitions of argodesign, Molina Medicaid Solutions, TESM, and BusinessNow."

Financial Highlights – Second Quarter Fiscal 2019

Diluted earnings per share from continuing operations was $0.92 in the second quarter, including $(0.41) per share of restructuring costs, $(0.34) per share of transaction, separation and integration-related costs, and $(0.35) per share of amortization of acquired intangible assets. This compares with $0.67 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $2.02. This compares with $1.67 in the year ago period.
Revenue in the second quarter was $5,013 million. Revenue decreased 8.1% compared with $5,453 million in the prior year, reflecting a stronger dollar, completion of several large transformation projects, and slower ramp-up on a few large Digital contracts.
Income from continuing operations before income taxes was $332 million in the second quarter, including $(157) million of restructuring costs, $(128) million of transaction, separation and integration-related costs, and $(132) million of amortization of acquired intangibles. This compares with $284 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $749 million compared with $683 million in the year ago period.
Income from continuing operations was $259 million in the second quarter, including $(116) million of restructuring costs, $(98) million of transaction, separation and integration-related costs, and $(100) million of amortization of acquired intangibles. This compares with $205 million in the year ago period.
Non-GAAP income from continuing operations was $573 million compared with $492 million in the year ago period.
Adjusted EBIT was $799 million in the second quarter compared with $740 million in the prior year. Adjusted EBIT margin was 15.9% compared with 13.6% in the year ago quarter.
Net cash provided by operating activities was $412 million in the second quarter, compared with $991 million in the year ago period.
Adjusted free cash flow was $604 million in the second quarter.
Global Business Services (GBS)

GBS revenue was $2,111 million in the quarter compared to $2,311 million for the prior year. GBS revenue decreased 8.7% year-over-year, primarily driven by a decline in the traditional application maintenance and management business. This was partially offset by growth in the Enterprise and Cloud Applications business. GBS profit margin in the quarter was 18.9%, up from 16.0% in the prior year, reflecting ongoing cost actions including the in-sourcing of contract labor and shift to near-shore and low-cost locations. New business awards for GBS were $2.2 billion in the second quarter.

Global Infrastructure Services (GIS)

GIS revenue was $2,902 million in the quarter compared to $3,142 million for the prior year. GIS revenues decreased 7.6% year-over-year, reflecting the timing of client migrations from traditional to cloud environments. GIS profit margin in the quarter was 16.3%, up from 14.3% in the prior year, reflecting the impact of actions taken to drive greater operating efficiencies. These include broader deployment of our Bionix automation program and the ongoing rationalization of hardware, software, and maintenance spend. New business awards for GIS were $2.5 billion in the second quarter.

Returning Capital to Shareholders

During the second quarter, DXC Technology returned $181 million to shareholders, consisting of $54 million in common stock dividends and $127 million in share repurchases.

Earnings Conference Call and Webcast

DXC Technology senior management will host a conference call and webcast to discuss these results today at 5 p.m. EDT. The dial-in number for domestic callers is 877-260-1479. Callers who reside outside of the United States should dial +1-334-323-0522. The passcode for all participants is 4189723. The webcast audio and any presentation slides will be available on DXC Technology’s Investor Relations website.

A replay of the conference call will be available from approximately two hours after the conclusion of the call until November 13, 2018. The replay dial-in number is 888-203-1112 for domestic callers and +1-719-457-0820 for callers who reside outside of the United States. The replay passcode is also 4189723. A replay of this webcast will also be available on DXC Technology’s Investor Relations website.

Non-GAAP Measures

In an effort to provide investors with supplemental financial information, in addition to the preliminary and unaudited financial information presented on a GAAP basis, we have also disclosed in this press release preliminary non-GAAP information including: constant currency, earnings before interest and taxes ("EBIT"), adjusted EBIT, adjusted EBIT margin, adjusted free cash flow, and non-GAAP results including non-GAAP income from continuing operations before taxes, non-GAAP income from continuing operations and non-GAAP EPS from continuing operations.