On April 28, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that two abstracts highlighting preliminary results from the Phase 1b study of ORIC-101 in combination with nab-paclitaxel have been accepted for poster presentations during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, to be held June 4 – 8, 2021 (Press release, ORIC Pharmaceuticals, APR 28, 2021, View Source [SID1234578637]).

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"We are pleased to participate in the 2021 ASCO (Free ASCO Whitepaper) program and report initial data from the ongoing Phase 1b study of ORIC-101, our glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors," said Jacob Chacko, M.D., president and chief executive officer. "This represents the first of two data readouts from our two ongoing Phase 1b trials of ORIC-101. We expect to report initial data from the second trial, ORIC-101 in combination with enzalutamide in prostate cancer, in the second half of this year."

Poster Presentations:

Presentation Title: Initial results from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 2553

Presentation Title: Biomarker results supporting selection of RP2D from a Phase 1b study of ORIC-101, a glucocorticoid receptor antagonist, in combination with nab-paclitaxel in patients with advanced solid tumors
Date and Time (On-Demand): June 4, 2021 (6:00 am PT)
Abstract Number: 3110

The posters will be available at www.oricpharma.com/publications following presentation at the meeting.

On April 28, 2021 GSK reported that Q1 sales of £7.4 billion -18% AER, -15% CER Total EPS 21.5p, -32% AER, -25% CER; Adjusted EPS 22.9p -39% AER, -33% CER (Press release, GlaxoSmithKline, APR 28, 2021, View Source [SID1234578654])

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Highlights
Strong growth in new pharmaceutical products offset by stocking and pandemic disruption
Pharmaceuticals £3.9 billion -12% AER, -8% CER, with growth in new and specialty products (+3% CER) including: Respiratory +24% CER; Immuno-inflammation +26% CER; and Oncology +38% CER partly offsetting decline in Established Products -17% CER. HIV -11% CER impacted by 2020 stocking and tender phasing; HIV two-drug regimen sales +41% CER
Vaccines £1.2 billion -32% AER, -30% CER (Shingrix -47% CER) reflecting government prioritisation of COVID-19 vaccinations. Continue to expect strong growth from Shingrix in H2
Consumer Healthcare £2.3 billion -19% AER, -16% CER (-9% excluding divestments/brands under review) reflecting year-on-year "pantry-loading" comparison and weak cold/flu season
Effective cost control supports delivery of adjusted earnings per share of 22.9p
Total Group operating margin 22.8%. Total EPS 21.5p -32% AER, -25% CER
Adjusted Group operating margin 25.4%. Adjusted EPS 22.9p -39% AER, -33% CER
Q1 net cash flow from operations £331 million. Free cash outflow £3 million
Continued R&D delivery and strengthening of Biopharma pipeline
Launch of Cabenuva, the world’s first and only long-acting HIV treatment
Approvals of Rukobia and Jemperli (dostarlimab) and positive regulatory opinion for Benlysta
Phase III trial starts for RSV older adults vaccine and GSK ‘294 for severe asthma
Positive data for antibody treatment VIR-7831 with EUA filed in US and EU
Phase III trial start with Medicago for adjuvanted COVID-19 vaccine
On track to create New GSK and standalone Consumer Healthcare company in 2022
Consumer Healthcare JV commercial integration broadly complete; separation activities advancing
Pharmaceutical portfolio rationalisation continues with cephalosporin divestment announced
New GSK Investor Update on 23 June to outline strategy, growth outlooks (2022-2031), capital allocation priorities and timing and approach to separation
Reconfirming full-year 2021 EPS guidance and 2022 outlook
Continue to expect 2021 Adjusted EPS to decline by a mid to high-single digit percentage in CER
2022 outlook unchanged with meaningful improvements expected in revenues and margins
Dividend of 19p declared for Q1 2021. Continue to expect 80p/share for 2021

Emma Walmsley, Chief Executive Officer, GSK said:
"Our first quarter results are in line with our expectations and reflect the anticipated impacts of COVID-19. We continue to expect a significant improvement in performance over the remainder of the year and reconfirm our guidance for 2021 and 2022 outlook. The launch of Cabenuva for HIV and Phase III starts for our RSV vaccine and a new long-acting treatment for severe asthma are key milestones as we continue to strengthen our growth prospects. Separation plans are also well underway and we look forward to sharing our strategy and growth outlook for New GSK with investors in June."

On April 28, 2021 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, reported that the Company intends to release its operational highlights and financial results for the quarter ended March 31, 2021 on Wednesday, May 5, 2021, and to host a conference call the same day at 4:30 p.m. ET (Press release, Synthetic Biologics, APR 28, 2021, View Source [SID1234578676]). The dial-in information for the call is as follows:

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Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archived replay of the call will be available for approximately ninety (90) days at the same URL, View Source beginning approximately one hour after the call’s conclusion.

On April 28, 2021 Samsung Biologics (KRX: 207940.KS), the world’s leading contract development and manufacturing organization, reported financial results for the first quarter of fiscal 2021 (Press release, Samsung BioLogics, APR 28, 2021, View Source [SID1234578696]).

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John Rim, CEO of Samsung Biologics, stated, "Our first-quarter financial performance was in line with our expectations and provides us with a strong start to the 2021 fiscal year. We have maintained a solid performance, and continue to see momentum from our expanding CDMO business globally while simultaneously making continuous advancements in our biosimilar subsidiary and new business models. As the world continues to navigate the difficult times amid COVID-19, we remain committed to supporting our clients and patients in delivering life-saving therapeutics in a timely manner."

FIRST QUARTER 2021 RESULTS

First quarter 2021 revenue was KRW 260.8 billion, an increase of 26% from KRW 207.2 billion reported for the first quarter in the previous year, attributable to the expanded sales volume at Plant 3 for its full-scale operation.

First quarter 2021 operating profit was KRW 74.3 billion, 19% higher than the prior-year period due to Plant 1 and 2’s stable operation and the gradual increase in Plant 3 operation for its early lock-in orders.

First quarter 2021 net profit reached KRW 61 billion, an increase of KRW 24.2 billion from KRW 36.8 billion in the first quarter a year ago, showing a direct reflection on improved profitability and sales at Plant 3.

FISCAL YEAR 2021 OUTLOOK

Continuing on the strong performance from the fiscal year 2020, all existing Samsung Biologics plants are at near full operation. The construction of Plant 4 remains on track with active pre-sales discussions. The US R&D Center is fully equipped and operational, and the company’s growth plans remain active.

Since there have been no disruptions to business continuity caused by the challenges amid COVID-19, the company has maintained stable business operations and is currently able to continue as planned with key strategic growth projects and long-term investments.

For more detail on performance and financials, please refer to the Earnings Release.

On April 28, 2021 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies (tumor-infiltrating lymphocyte, TIL, and peripheral-blood lymphocyte, PBL), reported that clinical data for lifileucel alone and in combination with pembrolizumab for advanced melanoma will be highlighted at the upcoming ASCO (Free ASCO Whitepaper) 2021 Annual Meeting, to be held June 4-8, 2021 (Press release, Iovance Biotherapeutics, APR 28, 2021, View Source [SID1234578619]). The abstract titles are as follows:

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Title: Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
Authors: James M. G. Larkin, et al.
Session Title: Melanoma/Skin Cancers
Session Type: Oral Abstract Session
Abstract Number: 9505
Session Date and Time: Sunday, June 6, 2021 from 8:00 – 11:00 a.m. ET

Title: Safety and efficacy of lifileucel (LN-144), an autologous, tumor infiltrating lymphocyte cell therapy in combination with pembrolizumab for immune checkpoint inhibitor naïve patients with advanced melanoma.
Authors: Sajeve Samuel Thomas, et al.
Session Title: Melanoma/Skin Cancers
Session Type: ePoster Session
Abstract Number: 9537
ePoster Viewing: on demand beginning Friday, June 4, 2021 at 9:00 a.m. ET