On November 5, 2020 DXC Technology (NYSE: DXC) reported results for the second quarter of fiscal year 2021 (Press release, DynPort Vaccine Company, NOV 5, 2020, View Source [SID1234574201]). Revenue of $4.55 billion and non-GAAP diluted EPS of $0.64 exceeded the top end of our guidance.

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"We delivered strong second quarter results as the ‘new DXC’, exceeding our revenue and non-GAAP diluted EPS targets. We also improved margins sequentially, and achieved a book-to-bill of 1.1x. We are making good progress on the three key areas of our transformation journey, which are: focus on customers, optimize costs, and seize the market," said Mike Salvino, DXC president and chief executive officer.

"We recently closed the sale of our U.S. State and Local Health and Human Services business for $5.0 billion and paid down $3.5 billion of debt, strengthening our balance sheet. We are also on track to close the sale of our Healthcare Provider Software business to Dedalus by the end of this fiscal year. I want to thank our people for driving the momentum and helping us deliver our strong financial results this quarter and their commitment to delivering for our customers."

Financial Highlights – Second Quarter Fiscal 2021

Revenue in the second quarter was $4,554 million.
Net loss was $246 million for the second quarter including pre-tax special items of $265 million in restructuring costs, $101 million in transaction, separation, and integration-related costs, and $152 million in amortization of acquired intangibles.
Non-GAAP net income was $161 million, excluding those special items, net of tax.
Diluted earnings per share was $(0.96) in the second quarter; non-GAAP diluted earnings per share was $0.64.
Net cash provided by operating activities was $472 million in the second quarter.
Adjusted free cash flow was $237 million in the second quarter.
Financial Information by Segment

Global Business Services (GBS)

GBS bookings for the quarter totaled $2.4 billion for a book-to-bill ratio of 1.1x.
GBS revenue was $2,242 million in the quarter. GBS revenue decreased 1.9% year-over-year.
In constant currency, GBS revenues decreased 3.4% year-over-year and increased 0.5% sequentially.
GBS profit margin in the quarter was 14.1%, an increase of 4.2% vs. the prior quarter. Year-over-year, margins were down 1.6%, reflecting prior terminations and price-downs along with customer settlements that were actioned in the quarter, offset by the timing of cost take out initiatives.
Global Infrastructure Services (GIS)

GIS bookings for the quarter was $2.5 billion for a book-to-bill ratio of 1.1x.
GIS revenue was $2,312 million in the quarter. GIS revenues decreased 9.9% year-over-year.
In constant currency, GIS revenues decreased 11.6% year-over-year and decreased 4.0% sequentially.
GIS profit margin in the quarter was 1.6%, an increase of 0.6% vs. the prior quarter. Year-over-year, margins were down 7.9% due to the impact of prior terminations and price-downs along with customer settlements that were actioned in the quarter.
Earnings

EBIT and adjusted EBIT in the quarter were $(235) million and $283 million, respectively. EBIT and adjusted EBIT margins were (5.2)% and 6.2%, respectively. Adjusted EBIT margin in the quarter was better than anticipated, benefiting from our cost optimization initiatives.
Diluted EPS and non-GAAP diluted EPS were $(0.96) and $0.64, respectively, in the quarter. Diluted EPS and non-GAAP diluted EPS were impacted by a lower than expected tax rate of 24.1%.
Cash Flow

Net cash provided by operating activities was $472 million in the second quarter and adjusted free cash flow was $237 million. Operating cash flow and adjusted free cash flow benefited from working capital management. Adjusted free cash flow also benefited from lower capital expenditures during the quarter.
Earnings Conference Call and Webcast

DXC Technology senior management will host a conference call and webcast to discuss these results today at 4:45 p.m. EST. The dial-in number for domestic callers is 800-367-2403. Callers who reside outside of the United States should dial +1-334-777-6978. The passcode for all participants is 8144357. 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 12, 2020. The replay passcode is 8144357.

On November 5, 2020 Gritstone Oncology, Inc. (Nasdaq: GRTS), a clinical-stage biotechnology company developing the next generation of cancer immunotherapies to fight multiple cancer types, reported financial results for the third quarter ended September 30, 2020 and reviewed business highlights (Press release, Gritstone Oncology, NOV 5, 2020, View Source [SID1234573684]).

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"This year we have made important clinical and scientific progress in advancing our two immunotherapies, GRANITE and SLATE," said Andrew Allen, M.D., Ph.D., co-founder, president and chief executive officer of Gritstone Oncology. "Recently, we began enrolling cancer patients in Phase 2 expansion cohorts for both programs. These cohorts are designed to build upon the evidence of clinical benefit seen in our Phase 1 studies, and we are expanding at dose level four, the highest dose level studied in Phase 1, which continues to be well-tolerated by patients. Our clinical work has confirmed the differentiated ability of our vaccine vectors to consistently drive robust CD8 T cell responses specific to administered antigens. Our clinical work with SLATE has demonstrated that certain antigens are immunodominant and can drive focused immune responses. With our strategy to develop two versions of an off-the-shelf cassette, we can be more specific to a patient’s mutations and address this phenomenon prospectively, ensuring that dominant neoantigens are not permitted to impair immune responses to other neoantigens."

Select Accomplishments

Presented preliminary efficacy, immunogenicity, and safety data up to dose level 3 from the ongoing Phase 1 study evaluating GRANITE in combination with immune checkpoint blockade for the treatment of patients with advanced solid tumors, including microsatellite stable colorectal cancer (MSS-CRC), gastroesophageal (GEA) cancer, metastatic non-small cell lung cancer (NSCLC), and bladder cancer
• Demonstrated consistent, strong neoantigen-specific CD8+ T cells generated in all patients tested and evidence of clinical benefit, as well as a favorable safety profile
Presented the same data types from the Phase 1 study evaluating SLATE in combination with immune checkpoint blockade for the treatment of patients with metastatic NSCLC, pancreatic ductal adenocarcinoma and MSS-CRC, as well as in patients with other solid tumor types who have relevant mutation/human leukocyte antigen (HLA) combinations
• Induced CD8+ T cells against multiple KRAS driver mutations, with the most pronounced response against immunodominant neoantigens such as TP53mut, and demonstrated a favorable safety profile
Initiated single-arm Phase 2 expansion cohorts with GRANITE for patients with MSS CRC who have progressed on FOLFOX/FOLFIRI therapy and a second cohort for patients with GEA who have progressed on chemotherapy
Initiated single-arm Phase 2 expansion cohorts with SLATE v1 in NSCLC patients with relevant KRAS mutations who have progressed on prior immunotherapy, and patients with tumors where a relevant TP53 mutation exists
Anticipated Upcoming Milestones

Nominate a lead bispecific antibody development candidate directed towards a novel solid tumor-specific HLA-peptide complex by the end of 2020
Present additional efficacy and safety data from the Phase 1 GRANITE study, including at the higher GRANITE dose level, in the first half of 2021
Present data from Phase 2 SLATE cohorts (v1 cassette) in the first half of 2021
Launch a SLATE v2 cassette into clinical trials in NSCLC patients in the first half of 2021, optimized for KRAS neoantigens (leveraging insights into immunodominance derived from v1 cassette)
Present data from Phase 2 GRANITE cohorts in the second half of 2021
Report data from SLATE v2 cassette in the second half of 2021
Third Quarter 2020 Financial Results
For the three months ended September 30, 2020, Gritstone reported a net loss of $26.1 million, compared to a net loss of $27.5 million for the three months ended September 30, 2019.

Collaboration revenue was $0.8 million for the three months ended September 30, 2020, compared to $1.0 million for the three months ended September 30, 2019. Collaboration revenue was due to the Research Collaboration and License Agreement with bluebird bio Inc and another small collaboration agreement.

Total research and development expenses were $22.1 million for the three months ended September 30, 2020, compared to $24.9 million for the three months ended September 30, 2019. The decrease was primarily attributable to a decrease in milestone and license payments and outside services and consultants, offset by increases in manufacturing-related expenses, lab supplies and research and development personnel.

General and administrative expenses were $5.0 million for the three months ended September 30, 2020, compared to $4.6 million for the three months ended September 30, 2019. The increase was primarily attributable to an increase in personnel-related expenses.

Cash, cash equivalents, marketable securities and restricted cash were $72.1 million as of September 30, 2020, compared to $128.8 million as of December 31, 2019.

On November 5, 2020 Genome & Company (314130, CEO: Bae Bae and Hansoo Park), a leading global immunotherapy drug company, reported that it submits a stock report to the Financial Services Commission for listing on the KOSDAQ on the 5th and initiates an IPO (Press release, Genome & Company, NOV 5, 2020, View Source [SID1234571040]). It plans to further strengthen its R&D competitiveness through listing on the KOSDAQ and focus on commercialization and overseas market expansion.

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The total number of shares offered by Genome & Company is 2,000,000 shares, and the scope of the offer price ranges from 36,000 won to 40,000 won. The raised funds are used for research and development, facility funds, and operating funds. In particular, it will focus on strengthening the competitiveness of each pipeline through clinical development, securing excellent researchers and research facilities, and promoting new and overseas projects.

The company conducts demand forecasting for institutional investors on the 30th and December 1st to determine the final public offering price, and accepts general subscriptions on the 7th and 8th of next month. It is expected to be listed within this year, and the subject of listing is Korea Investment & Securities.

Established in September 2015, Genome & Company is a research and development company for immunity and anticancer medicines and consumer products that utilizes microbiome based on antibody research and genome technology. In addition to the microbiome pipeline, with the aim of developing innovative new drugs to overcome unmet needs, which were insufficient in the existing market, it is also a new immune checkpoint inhibitor pipeline that utilizes its own novel target. It is expanding its territory.

In the case of immune anticancer microbiome treatment (GEN-001), a major pipeline, domestic patent registration was completed in August last year, and in December of last year, a technology transfer license agreement was signed with LG Chem in East Asia (Korea, China, and Japan) to commercialize it. Building a cooperative relationship. In October, the first phase 1 clinical trial was conducted for US patients, and the clinical trial began in earnest.

In August of this year, it acquired Scioto Biosciences, a US microbiome biotech, and secured a new global pipeline, the brain disease microbiome treatment (SB-121). Cyoto is planning to discover the optimal clinical design through cooperation with Genome & Company, and to begin phase 1 clinical trials in earnest in the first half of next year.

Bae Bae Bae, CEO of Genome & Company, said, "We decided that now is the right time to be listed on the KOSDAQ for strategic investment in clinical tasks, new business, and global market expansion for each pipeline we are pursuing." We will strive to increase our performance and maximize our competitiveness."

On the other hand, Genome & Company completed the KOSDAQ listing process in earnest as it passed the technical evaluation in July, applied Fast Track, and obtained preliminary examination approval in October. ‘Fast Track’ is a rapid transfer listing system that shortens the KOSDAQ preliminary examination period from 45 business days to 30 business days for companies with certain conditions in the KONEX market.

On November 5, 2020 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported that the Company will present at the Wolfe Virtual Healthcare Conference on Thursday, November 19 at 11:25 a.m. ET (Press release, PerkinElmer, NOV 5, 2020, View Source [SID1234570417]).

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Prahlad Singh, president and chief executive officer of PerkinElmer, will provide an update of the Company and its strategic priorities.

A live audio webcast of the presentation will be available on the Investors section of the Company’s website at www.perkinelmer.com. A replay of the presentation will be posted on the PerkinElmer website after the event and available for 90 days following.

On November 5, 2020 Kadmon Holdings, Inc. (Nasdaq: KDMN) reported financial and operational results for the third quarter of 2020 (Press release, Kadmon, NOV 5, 2020, View Source [SID1234570298]).

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"The submission of our belumosudil New Drug Application to the FDA represents a significant achievement for Kadmon and advances our efforts to make this therapy available to patients living with chronic GVHD," said Harlan W. Waksal, M.D., President and CEO of Kadmon. "We look forward to presenting 12-month safety, efficacy and durability data from our ongoing ROCKstar pivotal trial of belumosudil at the ASH (Free ASH Whitepaper) Annual Meeting in December 2020."

Dr. Waksal continued, "Beyond cGVHD, we were pleased to announce that the FDA granted Orphan Designation to belumosudil for the treatment of systemic sclerosis, currently in Phase 2 clinical development. Additionally, we continue to enroll patients with metastatic or locally advanced solid tumors in our Phase 1 clinical trial of KD033, our novel anti-PD-L1/IL-15 immuno-oncology fusion protein. We successfully completed enrollment in the first cohort of this trial; enrollment in the second cohort is ongoing. I am thrilled with the progress we are making across our clinical programs and look forward to sharing updates as we achieve new milestones."

Upcoming Milestones:

Belumosudil (KD025)

Present 12-month data from ROCKstar pivotal trial at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on December 6, 2020; the presentation will include updated efficacy and safety data and key secondary endpoints including duration of response, Failure-Free Survival, steroid dose reductions and quality-of-life improvements

Continue ongoing dialogue with the U.S. Food and Drug Administration (FDA) as they review the New Drug Application (NDA) under their Real-Time Oncology Review (RTOR) pilot program,

which aims to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible

Continue progressing belumosudil commercial launch readiness activities in anticipation of potential FDA approval in 2021

The Company expects to share an update on the path forward for belumosudil in Europe in 1H 2021

Continue enrollment in ongoing placebo-controlled Phase 2 clinical trial in diffuse cutaneous systemic sclerosis (KD025-209); the Company continues to work with sites and trial coordinators to facilitate patient enrollment amid the COVID-19 pandemic

Initiate small (12-15 patient), open-label Phase 2 clinical trial of belumosudil in patients with diffuse cutaneous systemic sclerosis in Q1 2021

KD033

The first 3-patient dose cohort was successfully completed in the ongoing dose-escalation Phase 1 clinical trial of KD033, Kadmon’s anti-PD-L1/IL-15 fusion protein, in patients with metastatic or locally advanced solid tumors; enrollment is ongoing in the next dose level (cohort 2)

KD045

Continue ongoing Investigational New Drug Application (IND)-enabling activities of KD045, Kadmon’s next-generation ROCK inhibitor for the treatment of fibrotic diseases

Financial Results

Third Quarter 2020 Results

Loss from operations for the three and nine months ended September 30, 2020 was $28.0 million and $71.0 million, respectively, compared to $23.2 million and $70.8 million for the same periods in 2019.

The increase in loss from operations for the three months ended September 30, 2020 as compared to 2019 was primarily due to an increase in development costs for belumosudil.

Liquidity and Capital Resources

At September 30, 2020, the Company’s cash, cash equivalents and marketable debt securities totaled $150.5 million, compared to $139.6 million at December 31, 2019. The increase primarily reflects $50.0 million in gross proceeds the Company accessed through its At-The-Market (ATM) facility in May 2020 along with $19.8 million in non-dilutive financing the Company accessed through the divestiture of 1.4 million ordinary shares of MeiraGTx Holdings plc during the nine months ended September 30, 2020. As of September 30, 2020, the Company held approximately 0.7 million ordinary shares of MeiraGTx Holdings plc, a clinical-stage gene therapy company.

About Belumosudil (KD025)

Belumosudil (KD025) is a selective oral inhibitor of Rho-associated coiled-coil kinase 2 (ROCK2), a signaling pathway that modulates inflammatory response and pro-fibrotic processes. The Company has submitted an NDA for belumosudil for the treatment of patients with cGVHD and the NDA is being reviewed under the FDA’s RTOR pilot program. The FDA has granted Breakthrough Therapy Designation to belumosudil for the treatment of patients with cGVHD after failure of two or more lines of systemic therapy. The FDA has also granted Orphan Drug Designation to belumosudil for the treatment of cGVHD. In addition, belumosudil is in Phase 2 clinical development in patients with diffuse cutaneous systemic sclerosis (SSc). The FDA has granted Orphan Drug Designation to belumosudil for the treatment of systemic sclerosis