On April 30, 2021 Alkermes plc (Nasdaq: ALKS) reported that it has reached an agreement with Sarissa Capital Management LP ("Sarissa Capital"), a beneficial owner of approximately 5% of the company’s outstanding ordinary shares, pursuant to which Sarissa Capital has the right to designate a director to the company’s Board of Directors (the "Board")(Press release, Alkermes, APR 30, 2021, View Source [SID1234584050]).

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This agreement follows constructive dialogue between the parties related to the company’s strategic priorities and ongoing Board refreshment efforts. Alkermes initiated a robust board refreshment program two years ago and has since added four new independent directors to the Board. This agreement with Sarissa Capital is a continuation of those efforts.

"We view our Board as one of Alkermes’ strategic assets. We value the opinions and input of Sarissa Capital and our other shareholders in identifying qualifications for new directors to help advance our business strategy to create shareholder value," said Richard Pops, Chief Executive Officer and Chairman of Alkermes. "Our considerable and thoughtful board refreshment efforts over the last two years demonstrate our commitment to maintaining a strong, independent board with expertise and skills to develop and support our strategic priorities."

Alex Denner, Ph.D., Founder and Chief Investment Officer of Sarissa Capital, stated, "Alkermes has attractive and underappreciated assets that can drive meaningful value creation. We look forward to working with the Board to focus on optimal capital allocation and operational excellence and to create shareholder value.

On April 30, 2021 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical-stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that the Company’s first quarter 2021 financial results will be released on Thursday, May 6, 2021 (Press release, Calithera Biosciences, APR 30, 2021, View Source [SID1234578886]). Company management will host a conference call on Thursday, May 6, 2021 at 2:00 p.m. Pacific Time/ 5:00 p.m. Eastern Time to discuss the financial results and other recent corporate highlights.

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The press release and live audio webcast can be accessed via the Investor section of the Company’s website at www.calithera.com. The conference call can be accessed by dialing (855) 783-2599 (domestic) or (631) 485-4877 (international) and refer to conference ID 2073385. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived webcast will remain available for replay on Calithera’s website for 30 days.

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 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) reported financial results for the first quarter of 2021 (Press release, Alexion, APR 30, 2021, View Source [SID1234578891]). Total revenues in the first quarter were $1,636.5 million, a 13 percent increase compared to the same period in 2020. The positive impact of foreign currency on total revenues year-over-year was less than 1 percent inclusive of hedging activities. On a GAAP basis, diluted EPS attributable to Alexion in the first quarter of 2021 was $2.86, a 14 percent increase versus the first quarter of 2020. Non-GAAP diluted EPS attributable to Alexion for the first quarter of 2021 was $3.52, a 9 percent increase versus the first quarter of 2020.

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"We are off to a strong start in 2021, with continued advancement of our LEAD-EXPAND-DIVERSIFY strategy to progress our commercial portfolio as well as our many development programs," said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. "I am so proud of our teams’ ongoing dedication and execution, which are further advancing our mission of delivering life-changing medicines to people with rare diseases and devastating conditions. We are well positioned to build on our success and momentum as the year progresses and once we become part of AstraZeneca."

First Quarter 2021 Financial Highlights

Net product sales were $1,635.7 million in the first quarter of 2021, compared to $1,444.6 million in the first quarter of 2020.
SOLIRIS net product sales were $1,027.6 million, compared to $1,022.9 million in the first quarter of 2020, representing a 0.5 percent increase.
ULTOMIRIS net product sales were $346.9 million, compared to $222.8 million in the first quarter of 2020, representing a 56 percent increase.
STRENSIQ net product sales were $197.5 million, compared to $172.2 million in the first quarter of 2020, representing a 15 percent increase.
KANUMA net product sales were $34.8 million, compared to $26.7 million in the first quarter of 2020, representing a 30 percent increase.
ANDEXXA/ONDEXXYA net product sales were $28.9 million in the first quarter of 2021.
GAAP cost of sales was $125.4 million, compared to $111.7 million in the first quarter of 2020. Non-GAAP cost of sales was $113.8 million, compared to $108.6 million in the first quarter of 2020.
GAAP R&D expense was $289.1 million, compared to $200.9 million in the first quarter of 2020. Non-GAAP R&D expense was $267.0 million, compared to $185.7 million in the first quarter of 2020.
GAAP SG&A expense was $342.9 million, compared to $319.9 million in the first quarter of 2020. Non-GAAP SG&A expense was $292.2 million, compared to $259.1 million in the first quarter of 2020.
GAAP income tax expense was $113.4 million, compared to income tax expense of $106.0 million in the first quarter of 2020. Non-GAAP income tax expense was $145.7 million, compared to income tax expense of $141.2 million in the first quarter of 2020.
GAAP diluted EPS attributable to Alexion was $2.86, compared to $2.50 in the first quarter of 2020. Non-GAAP diluted EPS attributable to Alexion was $3.52, compared to $3.22 in the first quarter of 2020.
Research and Development

PHASE 3/4

SOLIRIS – Guillain-Barre Syndrome (GBS): SOLIRIS in GBS has been granted SAKIGAKE designation by Japan’s Ministry of Health, Labour and Welfare (MHLW). In February 2021, Alexion initiated a Phase 3 study of SOLIRIS in GBS in Japan and dosing is underway.
ULTOMIRIS – 100 mg/mL: An application for approval of the ULTOMIRIS 100 mg/mL formulation for PNH and aHUS is under review in Japan. This higher concentration formulation is designed to reduce infusion time by more than 60 percent to approximately 45 minutes.
ULTOMIRIS – Subcutaneous: The Phase 3 study of weekly subcutaneous (SC) ULTOMIRIS demonstrated PK-based non-inferiority versus intravenous ULTOMIRIS. Pending collection of 12-month safety and drug-device combination data, Alexion plans to file for approval in the U.S. for the ULTOMIRIS SC formulation and device combination in PNH and aHUS in the third quarter of 2021, and in the EU in the first quarter of 2022.
ULTOMIRIS – Paroxysmal Nocturnal Hemoglobinuria (PNH): The U.S. FDA granted priority review for ULTOMIRIS in children and adolescents with PNH and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 7, 2021.
ULTOMIRIS – gMG: Enrollment is complete in the Phase 3 study of ULTOMIRIS in adults with gMG. Study results are expected in the second half of 2021.
ULTOMIRIS – NMOSD: In March 2021, Alexion completed enrollment in the Phase 3 study of ULTOMIRIS in NMOSD.
ULTOMIRIS – Amyotrophic Lateral Sclerosis (ALS): In March 2021, Alexion completed enrollment in the Phase 3 study of ULTOMIRIS in ALS. Study results are expected in the first half of 2022.
ULTOMIRIS – Hematopoietic Stem Cell Transplant-Associated Thrombotic Microangiopathy (HSCT-TMA): Phase 3 studies of ULTOMIRIS in adults and children with HSCT-TMA are underway.
ULTOMIRIS – Complement Mediated Thrombotic Microangiopathy (CM-TMA): Alexion plans to initiate a Phase 3 study of ULTOMIRIS in CM-TMA in the second quarter of 2021.
ULTOMIRIS – Severe COVID-19: Further enrollment in a Phase 3 trial of ULTOMIRIS in adults hospitalized with severe COVID-19 requiring mechanical ventilation is paused, due to lack of efficacy, pending further analysis of the data. Alexion continues to provide ULTOMIRIS for the ongoing TACTIC-R platform study led by Cambridge University Hospitals NHS Foundation Trust, which is evaluating the potential of earlier immune modulatory treatment (hospitalized patients not requiring mechanical ventilation) in preventing progression of the virus.
ULTOMIRIS – Dermatomyositis (DM): Alexion plans to initiate a Phase 2/3 study of ULTOMIRIS in DM in the second half of 2021, pending regulatory feedback.
ALXN1840 – Wilson Disease: Enrollment and dosing are complete in a Phase 3 study of ALXN1840 in Wilson disease. Study results are expected in the third quarter of 2021.
CAEL-101 – Caelum Biosciences: Alexion and Caelum Biosciences are conducting the Cardiac Amyloid Reaching for Extended Survival (CARES) Phase 3 clinical program to evaluate CAEL-101, a first-in-class amyloid fibril targeted therapy, in combination with standard-of-care therapy in AL amyloidosis. Two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease – are underway.
ALXN2060 (AG10): Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Eidos is currently evaluating AG10 in two Phase 3 studies in the U.S. and Europe – one for ATTR cardiomyopathy (ATTR-CM) and one for ATTR polyneuropathy (ATTR-PN). Alexion is conducting a Phase 3 bridging study of ALXN2060 for patients with ATTR-CM in Japan.
ALXN2040 (Danicopan) – PNH with Extravascular Hemolysis (EVH): A Phase 3 study of ALXN2040 as an add-on therapy for PNH patients with EVH is underway.
ANDEXXA/ONDEXXYA – Acute Intracranial Hemorrhage (ICH): The Phase 4 ANNEXA-I study – designed to provide clinical data supporting full approval – is underway to assess ANDEXXA compared to usual standard of care in patients presenting with acute intracranial hemorrhage while taking an oral Factor Xa inhibitor. In addition, a supplemental Biologics License Application (sBLA) is under review by the U.S. FDA to enable the addition of edoxaban and enoxaparin to the U.S. label. In February 2021, Alexion filed for regulatory approval of ONDEXXYA in Japan.
PHASE 1/2

ULTOMIRIS – Renal Diseases: A proof-of-concept study of ULTOMIRIS in patients with IgA nephropathy and lupus nephritis is underway.
ALXN1830: Due to COVID-19, Alexion discontinued the Phase 2 study of ALXN1830, administered intravenously, in warm autoimmune hemolytic anemia (WAIHA) and the Phase 1 study of a subcutaneous formulation of ALXN1830 in healthy volunteers. In March 2021, Alexion initiated a new Phase 1 study of subcutaneous ALXN1830 in healthy volunteers. Following successful completion of this Phase 1 study, Alexion plans to initiate Phase 2 studies of subcutaneous ALXN1830 in gMG and WAIHA in 2021, pending regulatory feedback.
ALXN2040 – Geographic Atrophy (GA): In March 2021, Alexion submitted an Investigational New Drug (IND) application for ALXN2040 in GA and plans to initiate a Phase 2 study in the second half of 2021.
ALXN2040 – COVID-19: Alexion has agreed to provide ALXN2040 to the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, for the ACTIV-5 Big Effect Trial in adults hospitalized with COVID-19. This Phase 2 platform trial is comparing different investigational therapies to a common control arm with the intent of identifying promising treatments to enter a more definitive study.
ALXN2050 – PNH: Alexion has re-initiated additional enrollment in the Phase 2 study of ALXN2050 monotherapy in PNH patients, following the receipt of Phase 1 data that support further dose escalation in the Phase 2 study.
ALXN2050 – Renal Diseases: Alexion plans to initiate a proof-of-concept study of ALXN2050 in patients with various renal diseases in 2021, pending regulatory feedback.
ALXN1720: The Phase 1 healthy volunteer study of ALXN1720, a novel anti-C5 albumin-binding bi-specific mini-body that is designed to bind and prevent activation of human C5, has been paused for a second time due to COVID-19, but is expected to resume in the second quarter of 2021. Additional cohorts have been added to the study to explore higher doses and enable the initiation of a Phase 3 study in gMG, pending successful completion of the Phase 1 study as has been agreed with the U.S. FDA. Data from the Phase 1 study are expected in the second half of 2021. Alexion also plans to initiate a study of ALXN1720 in DM.
ANDEXXA – Urgent Surgery: ANDEXXA is currently being evaluated in a single-arm, open-label Phase 2 study in patients taking apixaban, rivaroxaban, edoxaban, or enoxaparin who require urgent surgery. The results of this study will inform the design of a randomized controlled Phase 3 clinical trial to expand the label in this population.
ALXN2075 (cerdulatinib): Acquired as part of the Portola acquisition, ALXN2075 is a dual spleen tyrosine kinase and janus kinase (SYK/JAK) inhibitor being evaluated in a Phase 1/2a study in patients with relapsed/refractory chronic lymphocytic leukemia or B-cell or T-cell non-Hodgkin lymphoma. Data are expected in the second quarter of 2021.
ALXN1820: A Phase 1 study of ALXN1820, Alexion’s bi-specific anti-properdin mini-body, is underway in healthy volunteers.
ALXN1850 – Hypophosphatasia (HPP): Alexion plans to initiate a Phase 1 study of ALXN1850 in adults with HPP in the second quarter of 2021, pending regulatory feedback.
COVID-19

We continue to take steps to proactively respond to the evolving COVID-19 pandemic and to plan for related uncertainties. We remain focused on continuing to serve patients, protecting the health and safety of our employees and the communities in which we live and work, and supporting patients in clinical trials. We are also focused on minimizing potential interactions that could contribute to the spread of the virus and put additional strain on healthcare systems through the use of innovative virtual means where possible.

Clinical Trials: We have implemented a pandemic response business continuity plan designed to protect patients and site staff safety while continuing our clinical trials with limited interruption to the extent we are able. The COVID-19 impact has varied by study and program, but there has been little timing impact on fully-enrolled trials and the majority of studies that had been temporarily paused due to the pandemic have resumed. A small number of clinical trial sites are restricting site visits and imposing restrictions on the initiation of new trials and patient visits to protect both site staff and patients from possible COVID-19 exposure. Based on local dynamics where these studies are being conducted, there has been, and may continue to be, an impact to the timing of trials that are enrolling patients and activating sites, or have not yet started to do so. We are actively implementing remote and local procedures under the guidance of regulatory authorities.
Business Impact: We continue to take proactive measures designed to mitigate the risk of potential interruptions in supply and/or access to patients’ customary site-of-care locations. Treatment compliance rates across all our medicines have remained strong. We have also seen the predicted slowing of new patient initiations and delays in treatment starts, and we are continuing to closely monitor this environment as the pandemic continues.
Conference Call/Earnings Materials:

Given the agreement for Alexion to be acquired by AstraZeneca, Alexion will not be hosting a conference call. Earnings materials are available publicly on the Investor Relations page of our website at View Source Questions may be directed to the Investor Relations team via e-mail at [email protected] or the contact information below.

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.