On February 7, 2019 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel medical therapy company bringing to market its proprietary CellFX System, reported recent corporate developments, and financial results for the quarter and year-ended December 31, 2018 (Press release, Pulse Biosciences, FEB 7, 2019, View Source [SID1234533132]).

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The Company also announced today treatment of the first of up to 20 patients in a clinical feasibility study to evaluate the CellFX System for acne on the back. This study leverages the unique mechanism of action of the CellFX System in order to target sebaceous glands deep in the dermis, as demonstrated in the previously announced clinical study evaluating NPS for the treatment of facial sebaceous hyperplasia (SH).

Recent Corporate Developments

Demonstrated efficacy of over 99.5% of Sebaceous Hyperplasia (SH) lesions treated with Nano-Pulse Stimulation (NPS) in a clinical feasibility study, the second successful study of a dermatologic application of the Company’s NPS technology platform.
99.5% of the treated lesions were assessed as clear or mostly clear by investigators at the 60-day post-treatment follow-up evaluation.
92% (n=203) of treated lesions were assessed as clear or mostly clear after a single NPS treatment.
Patients rated 78% of lesion outcomes as satisfied or mostly satisfied at study end.
The study data has been accepted for presentation at the upcoming American Academy of Dermatology Annual Meeting by Dr. Girish Munavalli, one of the study’s principal investigators.
Successfully completed a $45 million rights offering, an important financial milestone enabling Pulse Biosciences to accelerate its progress towards commercialization of the CellFX System.
Appointed key personnel focusing on CellFX commercialization:
Promotion of Edward Ebbers to Executive Vice President and General Manager, Dermatology. Mr. Ebbers brings over 35 years of leadership and management experience with major dermatology, pharmaceutical and medical device companies, including extensive experience introducing products with utilization-based revenue models in the private pay aesthetic dermatology market.
Addition of Robert Tyson as Vice President of Sales, North America. Mr. Tyson brings a proven track record as a sales leader with over 20 years of medical technology experience.
"We are pleased with our accomplishments over the past year in advancing our proprietary CellFX System and look forward to achieving key commercialization milestones in 2019," said Darrin Uecker, Pulse Biosciences’ President and Chief Executive Officer.

Acne Clinical Feasibility Study

The objective of the acne clinical feasibility study announced today is to treat up to 20 patients between the ages of 18 and 80 to evaluate the reduction in number and severity of back acne eruptions post CellFX procedures through comparison of the treated to non-treated areas 90-days after the last procedure. Mark Nestor, MD, PhD, managing partner of Skin and Cancer Associates, and Brian Berman, MD, PhD, director of the Center for Clinical and Cosmetic Research in Miami and a past Vice President of the American Academy of Dermatology, are the principal investigators on the study.

"We are very excited to enroll our first back acne patient as chronic acne eruptions can be very difficult to control, and compliance with ongoing use of oral or topical therapies can be problematic," said clinical investigator Brian Berman, MD. "Through this rigorous study, we expect to achieve a meaningful reduction in the number and severity of acne lesions treated with the CellFX System."

Fourth Quarter and Full Year 2018 Financial Highlights

Cash, cash equivalents, and investments totaled $59.6 million at December 31, 2018, compared to $38.1 million at December 31, 2017. Cash use totaled $6.4 million for the fourth quarter of 2018 compared to cash use of $3.9 million for the fourth quarter of 2017. Cash use for 2018 totaled $23.5 million.

Operating expenses for the three-month period ended December 31, 2018 totaled $9.1 million, compared to $8.8 million for the three-month period ended December 31, 2017. Operating expenses for the three-month period ended December, 2018 included non-cash stock-based compensation of $2.4 million, compared to non-cash stock-based compensation of $4.5 million for the three-month period ended December 31, 2017.

Operating expenses for the fiscal year ended December 31, 2018 totaled $38.0 million, compared to $25.8 million for the fiscal year ended December 31, 2017. Operating expenses for the fiscal year ended December 31, 2018 included non-cash stock-based compensation of $12.3 million, compared to non-cash stock-based compensation of $10.9 million for the fiscal year ended December 31, 2017.

Conference Call Details

Pulse Biosciences will host an investor call on February 7, 2019, at 1:30 p.m. PDT / 4:30 p.m. EDT. The telephone dial-in number for the call is (844) 494-0190 (U.S. toll-free) or (508) 637-5580 (international) using Conference ID 5196202. Listeners will also be able to access the call via webcast available on the Investors section of the Company’s website at www.pulsebiosciences.com.

On February 7, 2019 DXC Technology (NYSE: DXC) reported results for the third quarter of fiscal year 2019, representing the period from October 1 through December 31, 2018 (Press release, DynPort Vaccine Company, FEB 7, 2019, View Source [SID1234533167]).

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"In the third quarter, DXC Technology delivered sequential growth in revenue, bookings, EBIT and earnings per share," said Mike Lawrie, chairman, president and CEO. "We are executing on the accelerated hiring plans we discussed last quarter, and our third-quarter revenue reflects the strong digital bookings from the first half of the year. We continue to invest in growth businesses, including the recently announced acquisition of Luxoft, a global, at-scale digital innovator. During the quarter, we also completed the acquisition of Molina Medicaid Solutions to expand our healthcare position in the Americas, and we acquired BusinessNow and TESM to increase our global reach in ServiceNow."

Financial Highlights – Third Quarter Fiscal 2019

Diluted earnings per share from continuing operations was $1.66 in the third quarter, including $(0.21) per share of restructuring costs, $(0.29) per share of transaction, separation and integration-related costs, $(0.35) per share of amortization of acquired intangible assets, and $0.28 per share of tax adjustment related to U.S. tax reform. This compares with $2.43 in the year ago period.
Non-GAAP diluted earnings per share from continuing operations was $2.23. This compares with $1.86 in the year ago period.
Revenue in the third quarter was $5,178 million. Revenue decreased 5.2% compared with $5,460 million in the prior year, and increased 3.3% compared with $5,013 million in the prior quarter.
Income from continuing operations before income taxes was $469 million in the third quarter, including $(76) million of restructuring costs, $(107) million of transaction, separation and integration-related costs, and $(134) million of amortization of acquired intangibles. This compares with $341 million in the year ago period.
Non-GAAP income from continuing operations before income taxes was $786 million compared with $751 million in the year ago period.
Income from continuing operations was $466 million in the third quarter, including $(58) million of restructuring costs, $(81) million of transaction, separation and integration-related costs, $(98) million of amortization of acquired intangibles, and $77 million of tax adjustment related to U.S. tax reform. This compares with $706 million in the year ago period.
Non-GAAP income from continuing operations was $626 million compared with $541 million in the year ago period.
Adjusted EBIT was $840 million in the third quarter compared with $797 million in the prior year. Adjusted EBIT margin was 16.2% compared with 14.6% in the year ago quarter.
Net cash provided by operating activities was $186 million in the third quarter, compared with $910 million in the year ago period.
Adjusted free cash flow was $503 million in the third quarter.
Global Business Services (GBS)

GBS revenue was $2,169 million in the quarter compared with $2,315 million for the prior year. GBS revenue decreased 6.3% year-over-year, driven by the ongoing headwinds in the traditional Applications Services business. GBS profit margin in the quarter was 18.2%, which was roughly flat year-over-year, reflecting the investments DXC is making to drive Digital growth. New business awards for GBS were $2.3 billion in the third quarter.

Global Infrastructure Services (GIS)

GIS revenue was $3,009 million in the quarter compared to $3,145 million for the prior year. GIS revenues decreased 4.3% year-over-year, reflecting the completion of several large transformation projects and the ongoing decline in legacy infrastructure services. GIS profit margin in the quarter was 17.5%, up from 14.3% in the prior year, reflecting actions DXC has taken to drive greater operating efficiencies, including our Bionix automation program, labor pyramid improvements, supply chain actions, and delivery center rationalization. It also reflects the benefit of final milestone achievement on several contracts. New business awards for GIS were $3.4 billion in the third quarter.

Returning Capital to Shareholders

During the third quarter, DXC Technology returned $851 million to shareholders, consisting of $54 million in common stock dividends and $797 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 888-254-3590. Callers who reside outside of the United States should dial +1-323-994-2093. The passcode for all participants is 6249774. 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 February 14, 2019. 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 6249774. 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 February 6, 2019 Cofactor Genomics, pioneers in the field of Predictive Immune Modeling, reported a $100,000 grant program to reward innovations with the Cofactor ImmunoPrismTM Assay (Press release, Cofactor Genomics, FEB 6, 2019, View Source [SID1234533097]). The program was unveiled at the 2019 Immuno-Oncology 360° Conference in New York.

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In December 2018, Cofactor made available the use of its proprietary database of Health Expression Models (HEMs). The Health Expression Models leveraged in the ImmunoPrism Assay enable quantification of immune cells and subtypes in solid tumor tissue, shown to be important in predicting response to immunotherapies. Built using machine-learning, these models have been demonstrated to provide measurable improvements to sensitivity and specificity over single-gene approaches currently used by the field. Access to Cofactor’s database of Health Expression Models has empowered translational and clinical scientists, along with drug development companies to utilize multidimensional biomarkers in their cancer research and clinical trials. Early adopters of Cofactor’s Predictive Immune Modeling technologies include the Fred Hutchinson Cancer Research Center, National Cancer Institute, and Genocea Biosciences.

"We are sitting on the 10 year anniversary of RNA-seq with shelves stuffed full of samples and data, created by cell profiling and analysis, yet we still can’t answer the fundamental question of predicting which immunotherapy will work with a specific patient or certain type of cancer," said Jarret Glasscock, Cofactor CEO and founder. "The new Predictive Immune Modeling Grant is designed to inspire the science, research, and clinical communities to take a different approach to producing highly predictive multidimensional biomarkers to ultimately solve this massive problem."

Cofactor Genomics will be showcasing its Predictive Immune Modeling technology during the Immuno-Oncology 360 conference with a talk in the "Transactional Science & Emerging Biomarkers" track and the panel on "Next Generation Biomarker and Companion Diagnostics for Predicting Response."

Applications for the Grant Program will be accepted through April 15, 2019 and more details may be found here: View Source

On February 6, 2019 Blue Earth Diagnostics, a molecular imaging diagnostics company, reported the upcoming presentation of additional analyses from the LOCATE clinical trial (NCT02680041) (Press release, Blue Earth Diagnostics, FEB 6, 2019, View Source [SID1234533098]). The LOCATE trial is a prospective, U.S., multicenter, open-label study investigating the impact of 18F fluciclovine PET/CT imaging on patient management of biochemically recurrent prostate cancer after initial prostate cancer treatment and negative or equivocal findings on standard-of-care imaging. The presentation will be made at the ASCO (Free ASCO Whitepaper) 2019 Genitourinary Cancers Symposium (ASCO GU), from February 14-16, 2019 in San Francisco, Ca. Details of the presentation to be given by Blue Earth Diagnostics collaborators is listed below.

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Date: Thursday, February 14, 2019
Presentation: Identification of bone involvement in patients with prostate cancer recurrence using 18F-fluciclovine PET/CT and impact on subsequent management
Abstract Number: 248

Presenter: Michael S Kipper, MD, Genesis Healthcare, on behalf of the LOCATE study group
Session Title & Times: Poster Session A: Prostate Cancer
11:30 AM-1:00 PM and 5:30 PM-6:30 PM PT
Location: Moscone West Building, San Francisco, Ca.

Blue Earth Diagnostics invites participants at the ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium 2019 to attend the above presentation and to learn more about the company at Exhibit 36.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at www.axumin.com.

About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues, and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications, such as glioma.

On February 6, 2019 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of precisely targeted oncology therapies, reported the presentation of updated biomarker and clinical results from its two lead programs that target the adenosine pathway, CPI-444, an adenosine A2A receptor antagonist, and CPI-006, an anti-CD73 antibody (Press release, Corvus Pharmaceuticals, FEB 6, 2019, View Source [SID1234533117]). The data were presented by Stephen Willingham, Ph.D., Senior Scientist at Corvus, at the Immuno-Oncology 360° Conference in New York during the "Discovery & Preclinical Science Plenary" session, which focused on tumor microenvironment changing technologies, pegylated cytokines and additional discovery and preclinical data.

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Key CPI-444 Biomarker Results
Dr. Willingham’s presentation, titled "Blockade of the Adenosine Pathway: Preclinical, Translational and Clinical Studies with CPI-444, an A2A Receptor Antagonist for Cancer Treatment," reviewed gene expression data of an adenosine gene signature recently announced by Corvus (or AdenoSig), in patients with renal cell carcinoma (RCC) who are participating in Corvus’ ongoing Phase 1/1b study of CPI-444, a selective and potent inhibitor of the adenosine A2A receptor. In particular, the data from the study showed a relationship of this novel biomarker to angiogenesis gene expression data (or angiogenesis signature). Such findings indicate that expression of AdenoSig was inversely related to the angiogenesis signature, which has been well studied by others and correlates with response to vascular endothelial growth factor receptor (VEGFR) inhibitors such as Sutent (sunitib malate) and other tyrosine kinase inhibitors. Low expression of angiogenesis genes predicts a lack of response to VEGFR inhibition. These data suggest that patients with a high AdenoSig are potentially more likely to respond to treatment with CPI-444 and less likely to respond to VEGFR inhibitors.

"Based on these translational data, we expect that we may be able to use the AdenoSig as a predictive biomarker to identify patients for adenosine pathway inhibition and select patients for future trials of CPI-444," said Dr. Willingham. "The gene expression data also may enable us to select the optimum patients for combination therapy with CPI-006, our anti-CD73 antibody, which has demonstrated unique immunologic activity in early clinical trials."

Key CPI-006 Clinical Results
Dr. Willingham also presented updated clinical results from the ongoing Phase 1/1b dose-escalation study of CPI-006 in patients with a variety of advanced cancers, including non-small cell lung cancer (NSCLC), RCC and other cancers who have failed standard therapies. The first arm of the study is evaluating CPI-006 as a monotherapy, a second arm is evaluating CPI-006 in combination with CPI-444, and a third arm is planned to evaluate CPI-006 in combination with pembrolizumab, an anti-PD-1 antibody. In particular, the updated results demonstrated that:

CPI-006 given as a monotherapy activated B cells and led to a redistribution of these cells along with changes in other immune cells (e.g., changes in T helper to T suppressor ratios). These data are consistent with immune stimulation induced by CPI-006.
CPI-006 reacted with an epitope on CD73 that led to blockade of adenosine production and expression of lymphocyte activation antigens that are independent of adenosine.
"We continue to advance our two lead therapeutic programs that target the adenosine-cancer pathway. We believe we are well positioned for a potential pivotal trial of CPI-444 in renal cell carcinoma and other tumors based on the biomarker signature we discovered, and CPI-006 is beginning to show early signs of immunologic activity that may be important in cancer therapy," said Richard A. Miller, M.D., an oncologist and co-founder, president and chief executive officer of Corvus. "Regarding our third pipeline program, we anticipate starting a Phase 1/1b trial of CPI-818, an ITK inhibitor for T-cell lymphoma, during the first quarter of 2019."

About CD73 and Adenosine
CD73 is a cell surface enzyme whose function is to convert adenosine monophosphate (AMP) to adenosine by removing phosphate from AMP. CD73 is expressed on cells of the immune system, including T-cells and B-cells. CD73 is also present on many tumors, including lung, renal, melanoma, colon, prostate, breast and others. In the tumor microenvironment, CD73 produces adenosine, which binds to the adenosine A2A receptor on immune cells and inhibits various immune responses including those directed against the tumor. Tumors utilize this immunosuppressive mechanism to escape attack by the immune system.

About CPI-006
CPI-006 is a potent humanized monoclonal antibody that reacts with the active site of CD73, blocking the conversion of AMP to adenosine. In vitro studies of CPI-006 have shown it is capable of substantially inhibiting the production of adenosine by blocking the CD73 enzyme and leads to activation of peripheral blood B cells.

About CPI-444
CPI-444 is a small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity. CD39 and CD73 are enzymes on the surface of tumor cells and immune cells. These enzymes work in concert to convert ATP to adenosine. In vitro and preclinical studies have shown that dual blockade of CD73 and the A2A receptor may be synergistic.