On April 30, 2021 AstraZeneca delivered robust revenue growth of 15% (11% at CER1) in the quarter to $7,320m; excluding the contribution from the pandemic COVID-19 vaccine, revenue growth increased by 11% (7% at CER) to $ (Press release, AstraZeneca, APR 30, 2021, View Source [SID1234578820]).

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The overall results in the quarter further increased the Company’s profitability and cash generation, while the pipeline demonstrated encouraging progress; the Company reiterates full-year 2021 guidance. Pascal Soriot, Chief Executive Officer, commented: "We delivered solid progress in the first quarter of 2021 and continued to advance our portfolio of life-changing medicines. Oncology grew 16% and New CVRM grew 15%. New medicines contributed over half of revenue and all regions delivered encouraging growth.

This performance ensured another quarter of strong revenue and earnings progression, continued profitability, and cash-flow generation, despite the pandemic’s ongoing negative impact on the diagnosis and treatment of many conditions. Given the performance in the first quarter, in line with our expectations, we reiterate our full-year guidance. We expect the impact of COVID to reduce and anticipate a performance acceleration in the second half of 2021. Further significant pipeline advances were achieved as we continued to invest for long-term sustainable growth, including the OlympiA Phase III trial demonstrating Lynparza’s benefit for certain forms of early breast cancer. This sustained pipeline progress and accelerating business performance underlines our commitment to patients and delivering our growth potential, which will be further complemented by the proposed acquisition of Alexion."

Highlights of Total Revenue in the quarter included:-An increase in Product Sales of 15% (11% at CER) to $7,257m. New medicines 7 Total Revenue improved by 30% (26% at CER) in the quarter to $3,891m, including growth in Emerging Markets of 33% (30% at CER) to $874m. Globally, new medicines represented 53% of Total Revenue (Q1 2020: 47%). Q1 2020 benefitted from a low-to-mid single-digit percentage increase in sales following short-term inventory increases in the distribution channel, an indirect effect of the COVID-19 pandemic-Oncology growth of 20% (16% at CER) to $3,024m, an increase in New CVRM8 of 19% (15% at CER) to $1,306m. Respiratory & Immunology (R&I), however, declined by 1% (4% at CER) to $1,546m, predominately reflecting the impact of stocking of an authorised generic version of Symbicort in the US during Q1 2020 and phasing of COVID-19

-An increase in Emerging Markets of 14% (10% at CER) to $2,592m, with China growth of 19% (10% at CER) to $1,679m. In the US, Total Revenue increased by 10% to $2,310m and in Europe by 28% (18% at CER) to $1,546mThe guidance does not incorporate any revenue or profit impact from sales of the pandemic COVID-19 vaccine. Similarly, the guidance excludes the proposed acquisition of Alexion Pharmaceuticals, Inc. (Alexion) which is intended to become AstraZeneca’s rare disease unit and area of expertise. The acquisition is anticipated to close in Q3 2021. AstraZeneca recognises the heightened risks and uncertainties from the impact of COVID19. Variations in performance between quarters can be expected to continue. The Company is unable to provide guidance and indications on a Reported basis because AstraZeneca cannot reliably forecast material elements of the Reported result, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal-settlement provisions. Please refer to the cautionary statements section regarding

forward-looking statements at the end of this announcement. Indications The Company provides indications for FY 2021 at CER:
-AstraZeneca continues its focus on improving operating leverage, while addressing its most important capital-allocation priority of re-investment in the business, namely continued investment in R&D and the support of medicines and patient access in key markets
-A Core Tax Rate of 18-22%. Variations in the Core Tax Rate between quarters are anticipated to continue Currency impact If foreign-exchange rates for April to December 2021 were to remain at the average of rates seen in the quarter, it is anticipated that there would be a low single-digit favourable impact on Total Revenue and Core EPS.

The Company’s foreign-exchange rate sensitivity analysis is contained within the operating and financial review. Financial summary-Total Revenue, comprising Product Sales and Collaboration Revenue, increased by 15% in the quarter (11% at CER) to $7,320m. Product Sales grew by 15% (11% at CER) to $7,257m, driven primarily by the performances of new medicines across Oncology and BioPharmaceuticals, including Tagrisso and Farxiga. Total Revenue included $275m of pandemic COVID-19 vaccine sales-The Reported Gross Profit Margin9 declined by three percentage points to 74.3%, and the Core Gross Profit9 Margin declined by three percentage points in the quarter to 74.6%.

The performance predominantly reflected the significant impact of equitable supply, at no profit to AstraZeneca, of the pandemic COVID-19 vaccine, together with an increasing contribution from profit-sharing arrangements, primarily Lynparza, and the impact of the Chinese National Reimbursement Drug List (NRDL) and the volume-based procurement (VBP) patient-access programmes. A higher proportion of Oncology sales and increasing patient access in China partially offsets these impacts. These variations in gross margin performance between quarters can be expected to continue-

Reported Total Operating Expense increased by 13% (9% at CER) in the quarter to $4,741m and represented 65% of Total Revenue (Q1 2020: 66%). Core Total Operating Expense increased by 15% (11% at CER) to $4,136m and comprised 57% of Total Revenue (Q1 2020: 57%
)-Reported and Core R&D Expense increased by 24% (19% at CER) in the quarter to $1,713m and by 23% (18% at CER) to $1,638m, respectively. The increases primarily reflected the investment in Phase III and the advancement to Phase II of several clinical development programmes, particularly in BioPharmaceuticals. The Company continued to invest in its COVID-19 vaccine and potential medicines to prevent and treat COVID-19 Reported SG&A Expense increased by 8% (4% at CER) in the quarter to $2,929m; Core SG&A Expense increased by 10% (7% at CER) to $2,399m, representing 33% of Total Revenue (Q1 2020: 34%)-Reported Other Operating Income and Expense10 grew by 146% (145% at CER) in the quarter to $1,180m. Core Other Operating Income and Expense increased by 147% (146% at CER) to $1,180m during the period.

The growth predominately reflected the $776m of income from divestment of AstraZeneca’s 26.7% share of Viela Bio, Inc. (Viela) as part of the acquisition by Horizon Therapeutics plc-The Reported Operating Profit Margin increased by seven percentage points in the quarter (eight at CER) to 26%; the Core Operating Profit Margin increased by five percentage points (six at CER) to 34%. The performance predominately reflected the aforementioned one-time benefit from Other Operating Income and Expense10-Reported EPS of $1.19 in the quarter represented an increase of 100% (97% at CER). Core EPS grew by 55% (53% at CER) to $1.63. EPS benefitted from a lower tax rate as a result of a non-taxable gain from the divestment of AstraZeneca’s share of VielaEmerging Markets Total Revenue increased by 14% in the quarter (10% at CER) to $2,592m, however, the performance was offset by the decline of Pulmicort, which included an adverse impact of four percentage points (four at CER) and suppressed the overall Total Revenue growth in the quarter.

China increased 19% (10% at CER) to $1,679m in the quarter and comprised 65% of Emerging Markets Total Revenue. New medicines, primarily driven by Tagrisso in Oncology and Forxiga in New CVRM, delivered particularly encouraging growth. The Total Revenue growth in the quarter, however, included an adverse impact of five percentage points (four at CER) from the reduced sales of Pulmicort which, restricted overall revenue growth in the quarter. Ex-China Total Revenue increased 6% (11% at CER) to $913m, with a particularly strong performance in Middle East and Africa.

Business development Acquisition of Acerta Pharma B.V. (Acerta) shares In December 2015, the Company agreed to acquire 55% of the entire issued share capital of Acerta for an upfront payment of $2.5bn, which was paid in 2016. A further amount of $1.5bn was paid in 2017 on receipt of the first US regulatory approval for Calquence. The agreement included options that, if exercised, provided the opportunity for Acerta shareholders to sell, and AstraZeneca to buy, the remaining 45% of shares in Acerta. The final condition for these options to be exercised was satisfied in November 2020 when Calquence received EU marketing authorisation. AstraZeneca exercised its option to acquire the remaining 45% of shares in Acerta in April 2021.

The agreement initially provided that the remaining 45% of shares in Acerta would be acquired at a price of approximately $3bn net of certain costs and payments incurred by AstraZeneca and net of agreed future adjusting items, using a pre-agreed pricing mechanism. In October 2019, an amendment agreement came into effect which was disclosed as part of year-to-date and Q3 2019 results, changing the timing of payments and reducing the maximum consideration required to be made to acquire the remaining outstanding shares of Acerta if the options were exercised. The payments are to be made in similar annual instalments in 2022, 2023 and 2024.

The changes to the terms were reflected in the assumptions that were used to calculate the amortised cost of the option liability as of 31 March 2021 of $2,336m. Sustainability summary Recent developments and progress against the Company’s sustainability priorities are reported below: a) Access to healthcare AstraZeneca and its sublicensee, Serum Institute of India Pvt. Ltd. (SII), delivered over 48 million doses of its pandemic COVID-19 vaccine to more than 120 countries through COVAX11, the multilateral facility co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations, and the World Health Organization (WHO), with c.80% of the doses going to low and middle-income countries. b) Environmental protection During the period, the Company was recognised for its leadership in building sustainable business models, as one of the top 7% of companies on CDP’s 2020 Supplier Engagement Rating Leaderboard. By working with suppliers to reduce their emissions, AstraZeneca is helping to drive science-based climate action across the value chain, a key component of the Company’s Ambition Zero Carbon strategy.) Ethics and transparency The Company released its seventh annual Sustainability Report and Sustainability Data Summary via its website and social media.

The report was released in conjunction with the Annual Report and Form 20-F Information 2020. The report outlined progress and challenges and aims for the future. A more extensive sustainability update is provided later in this announcement

On April 30, 2021 Glycotope GmbH, a biotechnology company developing antibodies against proteins carrying tumor-specific carbohydrate structures, reported it will present two posters at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held virtually this year due to COVID-19 (Press release, Glycotope, APR 30, 2021, View Source [SID1234578819]).

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Poster details are as follows:

Poster 2254
Title: Safety and tolerability results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody Gatipotuzumab with the anti-EGFR Tomuzotuximab or Panitumumab in patients with refractory solid tumors
Session: Poster Session: Developmental Therapeutics—Immunotherapy
Abstract ID: 332635

Poster 2252
Title: Activity results of the GATTO study, a phase Ib study combining the anti-TA-MUC1 antibody Gatipotuzumab with the anti-EGFR Tomuzotuximab or Panitumumab in patients with refractory solid tumors
Session: Poster Session: Developmental Therapeutics—Immunotherapy
Abstract ID: 329709

Due to the virtual format, all oral, poster, and poster discussion sessions, as well as track-based Clinical Science Symposia, will be available on demand, beginning 4 June 2021 at 9 a.m. EDT, for registered attendees of the conference.

About GATTO
The multicenter, open label phase Ib GATTO study explored the feasibility, tolerability and preliminary activity of combining Gatipotuzumab, a novel humanized monoclonal antibody binding to a tumor-associated epitope of mucin-1 (TA-MUC1) and an anti-EGFR antibody. Based on compelling preclinical evidence suggesting a complex interaction between EGFR and TA-MUC1 expressed on the tumor cell surface in driving carcinogenesis, this study assessed the tolerability, safety and preliminary activity of targeting EGFR and TA-MUC1 with glyco-engineered antibodies. In this study, 50 patients with refractory solid tumors were treated with both antibodies in 5 centers in Germany, Italy and Spain.

The results analysis demonstrated that combination of TA-MUC1 and EGFR targeting antibody is safe and feasible. Encouraging anti-tumor activity was observed in heavily pretreated CRC and NSCLC patients. Levels of soluble TA-MUC1 may have predictive value and potentially be a companion biomarker for further development of the combination.

On April 30, 2021 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon) reported its financial results for the twelve month period ending December 31, 2020, prepared in accordance with IFRS as endorsed by the European Union (Press release, Vivoryon Therapeutics, APR 30, 2021, View Source [SID1234578818]). The Financial Statements are available on the company website (www.vivoryon.com/investors-news/financial-information/).

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HIGHLIGHTS: January – December 2020

Initiation of research and development collaboration between Vivoryon and Nordic Bioscience
Start of development program for meprin protease inhibitors with intended therapeutic use in fibrosis, cancer and Alzheimer’s Disease
Progress in US and EU Alzheimer’s Disease clinical trial program with varoglutamstat (PQ912)
Enrollment of first patient in VIVIAD, the European Phase 2b Alzheimer’s Disease study with varoglutamstat (PQ912)
Approval of Investigational New Drug (IND) application for varoglutamstat‘s (PQ912) Phase 2 study in Alzheimer’s Disease
Conversion of Vivoryon Therapeutics AG into Vivoryon Therapeutics N.V. (Naamloze Vennootschap) under Dutch law
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POST-PERIOD HIGHLIGHTS: January – April 2021

Appointment of Florian Schmid as new CFO and re-appointment of Ulrich Dauer as CEO at EGM.

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Comment from Dr. Ulrich Dauer, Chief Executive Officer at Vivoryon Therapeutics:

"2020 will certainly go down in history as marking the beginning of the COVID-19 pandemic. The global collaboration and response to fight the virus provided a glimpse into the future of medical progress and highlighted the importance of the biotech industry at large. In an effort to contribute to the continued improvement of global health, the Vivoryon team strives to consequently pursue its mission to pioneer precision intervention medicines.

Our first-in-class, highly specific and potent small molecule inhibitor of glutaminyl cyclase (QC, QPCT), varoglutamstat (PQ912), made great progress in 2020. We kicked-off the new year by announcing our research and development collaboration with Nordic Bioscience for the clinical development of varoglutamstat (PQ912) for Alzheimer’s Disease as well as for the development of blood-based biomarkers for the identification of specific patients that may benefit most from treatment with varoglutamstat (PQ912). We also entered into a collaboration with Winterlight Labs, a company that has developed a proprietary, tablet-based technology to assess cognitive health including memory, thinking, and reasoning by analyzing hundreds of language markers from short snippets of speech. This collaboration will enable Vivoryon to perform an additional non-invasive, cognitive test on patients which will further enhance the full data package yielded from the European Phase 2b clinical trial, VIVIAD.

In mid-2020, we received the International Nonproprietary Name (INN), varoglutamstat, for PQ912 from the World Health Organization (WHO) and announced later that year, that the first patient was enrolled in VIVIAD, the Phase 2b, randomized and multi-center clinical study in Europe. This study will evaluate the safety and efficacy of our lead candidate, varoglutamstat, in patients with Alzheimer’s Disease. Prof. Dr. Scheltens from the VU Amsterdam will act as principal investigator for VIVIAD.

Based on our clinical development efforts and the approval of the IND application for varoglutamstat, we are now able to initiate our Phase 2 clinical trial program in the US as planned. Varoglutamstat is a first-in-class inhibitor of the enzyme glutaminyl cyclase that addresses a very distinct disease pathway and provides a mode of action affecting multiple pathology hallmarks at once in contrast to many other Alzheimer’s Disease drug candidates in development.

From a research and development perspective, we extended our portfolio during the first half of the year by acquiring patents from the Fraunhofer Institute for Cell Therapy and Immunology (IZI) for the further development of meprin protease inhibitors. These small molecules have the potential to treat a range of indications including acute and chronic kidney disease and multiple organ fibrosis in addition to targeting the symptoms of these disorders.

In November 2020, Vivoryon was successfully converted into a Naamloze Vennootschap (N.V.) under Dutch law. This milestone reflects Vivoryon’s continued international focus. We are convinced that this corporate transformation will be a gateway to new international investors and may also provide access to additional capital markets. We look forward to the continued implementation our growth strategy and to the additional opportunities gained by this corporate conversion.

In summary, 2020 was a pivotal year for Vivoryon. I would therefore like to extend our sincere thanks to our shareholders for all their support throughout our transformation as well as to the whole Vivoryon team. We look forward to additional opportunities that await us in 2021 and believe that we have the resources and clear objectives in place to positively impact the lives of patients battling difficult-to-treat diseases."

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FINANCIAL PERFORMANCE 2020

Research and development expenses increased to EUR 13,210 thousand (2019: EUR 4,789 thousand). This increase is primarily attributable to a EUR 7,851 thousand increase in CRO and CMO costs related to VIVIAD in connection with the clinical trial Phase 2b in patients with Alzheimer’s Disease.

General and administrative expenses decreased to EUR 2,807 thousand (2019: EUR 3,062 thousand) mainly due to reduced legal and consulting fees. Legal and consulting fees decreased in 2020 compared to 2019, because of higher costs in connection with the capital increase in 2019.

Net loss for the year 2020 was EUR 16,510 thousand or EUR 0.83 per common share, compared to EUR 7,823 thousand or EUR 0.62 per common share for the year 2019.

On December 31, 2020, the Company’s total cash and cash equivalents were EUR 26,306 (2019: 41,524 EUR thousand).

Cash Flow used in operating activities increased to EUR 14,012 thousand in the year ended December 31, 2020, from EUR 11,608 thousand in the year ended December 31, 2019, mainly due to the increase of research and development expenditures in connection with the VIVIAD study.

Additional information regarding these results and other relevant information is included in the notes to the financial statements as of December 31, 2020 which is included in Vivoryon`s Annual Report as filed with the Dutch Authority for the Financial Markets (AFM).

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OUTLOOK

The mid-term focus of Vivoryon’s business activities can be summarized as follows:

Initiate Phase 2a/b clinical study program for Varoglutamstat (PQ912) in the US
Continue the development of QPCTL inhibitors in oncology
Conclude one or more industrial partnerships
Further scientific analysis of potential indications for the use of QC inhibitors
Further strengthening Vivoryon’s financial resources
As a result of the continuing costs being incurred for development activities and the running Phase 2b study in Europe as well as the start of the Phase 2a/b study in the US, which are not yet off-set by any sales, the Company also projects a net loss for the financial year 2021 which, based on the current budget, is expected to be higher than that of 2020
Due to its business model, Vivoryon is dependent upon additional capital to implement its development strategy until such time at which an industrial partnership is concluded and potentially beyond that. This can be provided in the form of equity on the basis of a capital increase or via alternative financing forms such as loans, convertible bonds, option bonds, etc. All appropriate provisions (e.g., approving sufficient authorized and conditional capital, eliminating pre-emptive rights) have been approved at the annual shareholders’ meeting to provide the Company with sufficient flexibility to react to potential options
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ANNUAL FINANCIAL REPORT 2020

Vivoryon Therapeutics has finalized its financial statements for the year ended December 31, 2020 according to IFRS. The auditor KPMG has issued an unqualified auditor’s report for both statements. The reports are available on the company website (View Source).

FINANCIAL CALENDAR

June 01, 2021 Interim Management Statement Q1 2021
June 28, 2021 Annual General Meeting 2021
September 21, 2021 Interim Report, Half Year Results 2021
November 23, 2021 Interim Management Statement Q3 2021
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CONFERENCE CALL AND WEBCAST

Vivoryon Therapeutics will host a conference call and webcast open to the public today, April 30, 2021, at 3:00 pm CET (09:00 am EDT). The presentation will also be available on the company website. The call will be held in English followed by a Q&A session. To participate in the conference call, please dial in via one of the following numbers 10 minutes prior to commencement.

A live webcast and slides will be made available at: View Source

Approximately a day after the call, a slide-synchronized audio replay of the conference will be available on: View Source

On April 30, 2021 Treadwell Therapeutics, a clinical-stage biotechnology company developing novel, cross-modality medicines for unmet needs in cancer, reported the initiation of patient dosing in TWT-202, its Phase 1b/2 study to evaluate its CFI-400945, an oral, first-in-class inhibitor of Polo-like kinase 4 (PLK4) in patients with Leukemia as a monotherapy or in combination with hypomethylating agents (Press release, Tio Bioventures, APR 30, 2021, View Source [SID1234578817]). Dosing of the first patient in the trial commenced April 16th at the University of Texas MD Anderson Cancer Center, Houston, TX.

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"Oral PLK4 inhibition opens a completely new approach to target therapeutic vulnerability in high risk MDS and AML and is very amenable to combination with other effective therapeutic agents," said Principal Investigator, Dr. Gautam Borthukar, MD, Professor, Department of Leukemia, Division of Cancer Medicine, MD Anderson Cancer Center.

"We are excited about the initiation of TWT-202 with our highly potent PLK4 inhibitor," said Dr. Michael Tusche, Treadwell co-CEO. "Previous clinical studies have shown that CFI-400945 can lead to single agent complete remissions in high-risk refractory AML patients. We look forward to continuing the development of this agent with the goal of delivering first in class medicines to patients in need."

The Phase 1b/2 clinical trial of CFI-400945, is an open-label, multi-center, dose optimization study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CFI-400945 as a single agent or in combination with azacytidine or decitabine in patients with acute myeloid leukemia, myelodysplastic syndrome or chronic myelomonocytic leukemia. The trial will enrol approximately 72 patients at up to 20 sites in North America and Asia. It will involve 3 arms including monotherapy and combination dose optimization and expansion, as well as a food effect study.

About CFI-400945

CFI-400945 is a highly potent and selective inhibitor of the serine/threonine kinase PLK4, a cell cycle kinase known to be the master upstream regulatory of centriole duplication and is critical for the maintenance of genomic integrity. PLK4 is overexpressed in a variety of solid tumors and elevated expression is associated with poor clinical outcomes. Depletion of PLK4 expression in cancer cells by RNA interference leads to mitotic defects and cell death. PLK4 was identified as a drug target based on functional screening to identify vulnerabilities of genomically unstable cancers. Anti-tumor activity of CFI-400945 has been shown in mice bearing human cancer xenografts, including robust tumor growth inhibition and durable tumor regression in primary tumor xenografts from breast cancer. CFI-400945 is a potent, selective, orally administered, first-in-class inhibitor of the serine/threonine kinase, polo-like kinase 4 (PLK4). CFI-400945 is currently in multiple investigator-initiated studies in solid and liquid malignancies,

On April 29, 2021 Zelluna Immunotherapy AS reported an exclusive research collaboration with Etcembly Ltd to discover T cell receptors immune pattern recognition system EMLy (Press release, Etcembly, APR 29, 2021, View Source [SID1234612570]).

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Zelluna Immunotherapy, the company pioneering allogeneic "off the shelf" TCR based natural killer (TCR-NK) cells for the treatment of cancer, and Etcembly, a start-up developing innovative machine learning techniques in immune pattern recognition for in silico discovery of novel TCR specificities, today announce an exclusive collaboration to discover TCRs with an initial focus on a widely expressed and well-validated solid cancer antigen.

TCR-NK products are a novel class of allogeneic cellular therapies that combine the inherent killing mechanism, efficiency, and the allogeneic nature of NK cells with the targeting capabilities of TCRs. TCR engineered NK cells may unlock the potential to treat a wide range of currently untreatable cancers.

Luise Weigand, Head of Research at Zelluna said…

"I am delighted that we have the opportunity to combine our proprietary TCR-NK platform with the high potential of Etcembly’s innovative approach to TCR discovery through the application of artificial intelligence. We are looking forward to working with the Etcembly team on breaking new ground in the discovery of highly potent TCRs for cancer immunotherapy. This collaboration forms part of our wider strategy for discovering TCRs which includes in-licensing and our own recently initiated discovery efforts."
Dr Michelle Teng, Founder CEO of Etcembly continues…

"We relish this unprecedented opportunity to work with Zelluna at such an early stage of our company – a testament to the confidence in our immune prediction platform EMLy. This is the start of an exciting collaboration in pursuit of defining a new paradigm of learn drug discovery for immunotherapy."