On November 6, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that CFO and Head of Corporate Strategy, John Leaman, M.D., will present at the Stifel Healthcare Conference in New York City at 12:45 p.m. ET on Tuesday, November 13, 2018 (Press release, Selecta Biosciences, NOV 6, 2018, View Source [SID1234530791]). 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 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 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.

On November 6, 2018 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported that clinical and immunological data from the Phase 1 clinical trial of SNS-301 will be highlighted in a poster presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 33rd Annual Meeting, to be held November 9-11, 2018 in Washington, D.C (Press release, Sensei Biotherapeutics, NOV 6, 2018, View Source [SID1234530933]). Data showed rapid and significant antigen-specific B-cell and T-cell responses induced by SNS-301, a first-in-class cancer immunotherapy targeting human aspartate β-hydroxylase (ASPH), a novel tumor-specific embryonic antigen.

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"These data clinically confirm the immunogenicity and mechanism of action of SNS-301, as we see strong, ASPH-targeted activation of the immune system in patients who received the immunotherapy. Taken together, the data indicate that SNS-301 is capable of overcoming central immune tolerance. We plan to target ASPH with both cancer vaccines and cell therapies to benefit different patient populations," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "Based on these encouraging results, we look forward to initiating a Phase 2 trial for SNS-301 in various hematological malignancies and solid tumors in early 2019."

Twelve patients with biochemically recurrent prostate cancer who were screened for ASPH using Sensei’s proprietary companion diagnostic were treated with SNS-301 in the Phase 1, multi-center, proof-of-concept study. SNS-301 was administered every 21 days via intradermal injection using a fixed dose-escalation schema through which patients received between 8 and 23 doses at three different dose ranges, and the recommended Phase 2 dose was determined based on the immunogenicity data and changes seen in prostate specific antigen (PSA) doubling times at the three evaluated doses. Highlights of the immunogenicity data from the SNS-301 Phase 1 study presented at SITC (Free SITC Whitepaper) include:

Natural Killer (NK) cell levels in patients treated with SNS-301 were higher than NK cell levels in healthy donors, indicating activation of the innate immune system.
All patients evaluable for immune profiling experienced dose-dependent, ASPH-specific immune responses including B-cell, T-cell and antibody responses.
Increases in activated interferon gamma (IFN-γ) releasing T cells were demonstrated, and both ASPH-specific CD4+ helper T cells and CD8+ cytotoxic T cells showed dose-dependent activation over the first six cycles of SNS-301 dosing with peak responses often occurring after only three or four doses.
An average of eight to ten-fold increase in the percentage of ASPH-specific CD8+ T cells was observed post-treatment, compared to baseline measurements.
Anti-ASPH antibody titers increased in a dose-dependent manner over the first four to six cycles (80-120 days) after administration of SNS-301. This increase in antibody response correlated with concomitant increases in the percentages of ASPH-specific B cells, as measured by flow cytometry.
An average five to seven-fold increase in the percentage of ASPH-specific B-cell responses was observed post-treatment, compared to baseline measurements.
Eight out of the twelve patients (67%) achieved improvements in PSA doubling time and/or absolute PSA level, leading to decreased PSA velocity and suggesting a disease stabilizing effect of SNS301.
Based on evaluation of the three different dose ranges (2 x 1010, 1 x 1011, 3 x 1011 particles), immune responses occurred more rapidly at the two higher doses, as compared to the lower dose. Immunologic efficacy generally correlated with biochemical responses in these patients.
In the Phase 1 study, SNS301 was well tolerated with a favorable safety profile at all three dose levels with no dose-limiting toxicities or grade 4 or 5 adverse events.

About SNS-301
SNS-301 is a first-in-class cancer immunotherapy targeting human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during embryonic development. Following embryonic development, the protein is no longer expressed in healthy adults. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH alters signaling that occurs through the Notch pathway and its expression levels in various tumors are inversely correlated with disease prognosis. SNS-301 is a bio-engineered, inactivated bacteriophage virus expressing a fusion protein of native bacteriophage gpD (gene product D) and a selected domain of ASPH. SNS-301 is designed to overcome immune tolerance and induce robust and durable ASPH-specific humoral and cellular responses. SNS-301 is paired with a companion diagnostic to ensure appropriate patient selection and is delivered easily through an intradermal injection to aid in generating robust immune response.

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.