Regeneron has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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On May 6, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported that it had received "Notice of Allowance" from the Mexican Patent and Trademark Office (IMPI) in relation to the company’s patent titled: ‘System and method for high throughput screening of cancer cells’ (Press release, Cannabics Pharmaceuticals, MAY 6, 2021, View Source [SID1234579654]). The decision of the Mexican patent authority follows the European Patent Office (EPO) "Intention to Grant a European Patent" notice to the company from October 2020, concerning the same patent application.

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Eyal Barad, Cannabics Pharmaceuticals’ co-founder and CEO commented: "This patent application is a great example of Cannabics’s innovative and novel approach to the drug discovery process in our field. The patent was already granted in Israel and in South Africa, and we have been notified of intention to grant in Europe and now also in Mexico. This opens many interesting opportunities for the company in these markets, which we intend to develop and grow."

On May 6, 2021 Kyowa Hakko Kirin reported that Consolidated Financial Summary (IFRS) Fiscal 2020 (Press release, Kyowa Hakko Kirin, MAY 6, 2021, View Source [SID1234579492])

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1. Consolidated Financial Results for the Fiscal Year Ended December 31, 2020 (from January 1, 2020 to December 31, 2020)
2. Dividends
3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2021 (from January 1, 2021 to December 31, 2021) These financial results reports are exempt from audit conducted by certified public accountants or an audit corporation.

* Notice regarding the appropriate use of the earnings forecasts and other special comments The forward-looking statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons.

For more information regarding our suppositions that form the assumptions for the earnings forecasts, please see pages 17 and 18 of the attachment, "

(5) Outlook for Fiscal 2021" in "
1. Summary of Business Performance and Financial Position."1. Summary of Business Performance and Financial Position Responding to the massive changes to the business and social environments occurring as a result of the global spread of the novel coronavirus disease (COVID-19), the Kyowa Kirin Group (the "Group") has been striving to provide stable supply of pharmaceuticals, which is a core mission of a pharmaceutical company, as an utmost priority, and while paying meticulous attention to preventing infection, carrying out activities such as information provision. Furthermore, as this fiscal year is the final year of our FY2016-2020 Mid-term Business Plan, we set our sights on achieving a further leap forward as a global specialty pharmaceutical company through various initiatives including efforts to maximize the value of three global strategic products, strengthen global governance, and research and development for future growth. In addition to changes to healthcare environments and restraints on business activities across the globe due to the COVID-19 pandemic, the Group faced other extremely difficult environments, such as the lowering of drug price standards in Japan.

Nevertheless, the Group increased its revenues mainly due to the penetration of three global strategic products in US/EU market. In Japan, the Group launched Duvroq, an oral treatment for renal anemia, in August 2020. By utilizing our abundant experience in the field of renal anemia, we carried out activities to provide information on proper use of medication, giving utmost attention to safety.

The Group is seeing steady progress for the three global strategic products. Regarding Crysvita, we obtained approvals for its additional indication for tumor induced osteomalacia in the United States and for extending its indication to include X-linked hypophosphatemia in older adolescents and adult patients in Europe and there was an increase in formulations for self-administration at home in Japan. Regarding the treatment for mycosis fungoides and Sézary syndrome, POTELIGEO, we commenced sales in Europe, beginning with Germany in June 2020.

Furthermore, regarding NOURIANZ (generic name: Istradefylline (product name in Japan: NOURIAST)), which has already been launched in the United States, our application for approval regarding its indication for combination therapy for Parkinson’s disease was accepted in Europe. Concerning the voluntary recall of mitomycin that occurred in 2019, the Group received the report on the investigation from the Group Investigation Committee spearheaded by a third-party in January 2020, and formulated the recurrence prevention measures. As matters of the highest priority for management, the Group has formulated three key management priorities to strengthen our foundation as a global specialty pharmaceutical company: creation of a strong production and quality assurance system, improvement of risk management and reformation of corporate culture. The Group will work on those management priorities continuously and sincerely over the five-year mid-term business plan commencing 2021.

(1) Summary of Business Performance in Fiscal 2020

1) Overview of results The Group now applies the International Financial Reporting Standards ("IFRS") in line with its policy of expanding business globally, and adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amount.

For the fiscal year ended December 31, 2020, revenue was ¥318.4 billion (up 4.1% compared to the previous fiscal year) and core operating profit was ¥60.0 billion (up 1.0%). Profit attributable to owners of parent was ¥47.0 billion (down 29.9%).
 The increase in revenue was the result of steady growth of global strategic products in North America and EMEA and strong sales in Asia, mainly in China, despite the impact of lower revenue in Japan from the reduction in drug price standards and the switching to Darbepoetin Alfa Injection Syringe [KKF], an authorized generic of NESP, a renal anemia treatment drug, among others. The negative effect on revenue from foreign exchange was ¥2.9 billion.
 The increase in core operating profit was the result of an increase in gross profit due to an increase in overseas revenue, despite an increase in selling, general and administrative expenses, and a decrease in share of profit (loss) of investments accounted for using equity method. The negative effect on core operating profit from foreign exchange was ¥1.3 billion.
 Profit attributable to owners of parent decreased as a result of the absence of the profit from discontinued operations recorded in the previous fiscal year, despite lower business restructuring expenses and impairment losses in addition to an increase in core operating profit.
 Revenue in Japan decreased year on year because of the significant impact of switching to Darbepoetin Alfa Injection Syringe [KKF], an authorized generic of NESP, a renal anemia treatment drug whose patent has expired, in addition to the impact of the reductions in drug price standards implemented in October 2019 and April 2020, despite the growth in sales of new product groups.
 Darbepoetin Alfa Injection Syringe [KKF] achieved rapid progress in switching from NESP, a renal anemia treatment drug.
 Duvroq, an oral treatment for renal anemia, was launched in August 2020, and it is penetrating the market favorably.  Revenue from Patanol, anti-allergy eye drops, and ALLELOCK, an anti-allergy agent, decreased as a result of smaller pollen counts and the impact of the suppression of examinations, etc. due to COVID-19.
 Revenue from ORKEDIA, a treatment for secondary hyperparathyroidism, increased. Meanwhile, revenue from REGPARA, a treatment for secondary hyperparathyroidism, decreased due to factors such as switching to ORKEDIA and the impact of rival products.
 Revenue from ROMIPLATE, a treatment for chronic idiopathic thrombocytopenic purpura, increased as a result of receiving approval of its indication for treatment of patients with aplastic anemia who have had an inadequate response to conventional therapy, in June 2019.
 Firm growth in revenue was realized for G-Lasta, an agent for decreasing the incidence of febrile neutropenia, and Rituximab BS [KHK], an anticancer agent.
 In December 2019, Crysvita, a treatment for FGF23-related diseases, and HARUROPI, a Parkinson’s disease treatment patch, were launched and they have been penetrating the market favorably.
 Revenue in North America increased year year due to the steady growth of global strategic products.
 Revenue from Crysvita, a treatment for X-linked hypophosphatemia, has been growing steadily since its launch in 2018. Approval for additional indication for treatment of tumor induced osteomalacia was acquired in June 2020.
 Revenue from POTELIGEO, an anticancer agent, stayed at the same level as in the previous fiscal year, due to the impact of the COVID-19 pandemic.
NOURIANZ (product name in Japan: NOURIAST), an antiparkinsonian agent which was launched in October 2019, has been penetrating the market favorably.
 Revenue in EMEA increased year on year due to the steady growth of global strategic products.
 Revenue from Crysvita, a treatment for X-linked hypophosphatemia, has been growing steadily as the number of countries where it has been released has been increasing since its launch in 2018. Approval for sale with the extended indication for older adolescents and adults was acquired in September 2020.
 In Germany, sales of POTELIGEO an anticancer agent, was launched in June 2020, and it has been penetrating the market favorably as the number of countries where it has been released has been increasing.
 Revenue in Asia/Oceania increased year on year, reflecting strong sales particularly in China.
 Revenue from REGPARA, a treatment for secondary hyperparathyroidism, increased year on year due to market expansion in China.
 Revenue from Others decreased year on year.
 Revenue decreased year on year due to a decline in other income such as original equipment manufacturing despite an increase in technology out-licensing such as royalties revenue from AstraZeneca in relation to benralizumab.
 Core operating profit increased year on year due to an increase in overseas revenue mainly from global strategic products, despite a lower gross profit due to a decrease in revenue in Japan, and an increase in selling, general and administrative expenses associated with sales of global strategic products.

On May 6, 2021 Catalent, the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, and Promethera Biosciences, the leader in advanced therapy development for severe liver diseases, reported that Catalent has acquired Promethera’s cell therapy manufacturing subsidiary, Hepatic Cell Therapy Support SA (HCTS), including its 32,400 square-foot (3,010 square-meter) facility in Gosselies, Belgium (Press release, Catalent, MAY 6, 2021, https://www.catalent.com/catalent-news/catalent-acquires-additional-facility-at-its-gosselies-belgium-campus-for-commercial-scale-plasmid-dna-manufacturing/ [SID1234579491]). The facility will accommodate Catalent’s new commercial-scale plasmid DNA (pDNA) manufacturing and will provide the opportunity for the immediate growth of Catalent’s pDNA service offering, which was recently acquired from Delphi Genetics to support the growing cell and gene therapy pipeline.

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The HCTS facility houses an existing cleanroom infrastructure, process development and quality control laboratories as well as warehouse space, and will be equipped to provide pDNA manufacturing up to a 500-liter scale. This new facility is located on Catalent’s existing campus in Gosselies, adjacent to the Delphi Genetics building. Since the purchase of MaSTherCell in March of 2020, this acquisition is the third that Catalent has made at its Gosselies location, and further expands its cell and gene therapy European Center of Excellence.

Fitting out the facility is expected to begin immediately, and will create more than 200 technical, scientific, and operational new employment positions over the next five years.

Alongside this new expansion in Gosselies, Catalent will also offer commercial-scale pDNA production capabilities at its Rockville, Maryland, facility with the addition of 500-liter scale bioreactor capacity.

"Plasmid DNA manufacturing is a critical component to many biological therapeutics, including viral vectors, mRNA, and cellular therapies. This investment allows Catalent to support these programs from development through to CGMP commercial production, offering the full horizontal supply chain," said Manja Boerman, Ph.D., President, Catalent Cell & Gene Therapy. She added, "The Center of Excellence we have established in Belgium brings critical experience and expertise together on one campus, allowing for key synergies to best support our customers."

"Promethera is thrilled to divest its HCTS facility to Catalent, alongside its new strategy to concentrate activities on its core expertise and breakthrough approach using advanced therapies to restore liver health in patients with life-threatening liver diseases," explained professor Etienne Sokal, President of Promethera.

On May 6, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the first quarter that ended March 31, 2021, and provided a business update (Press release, Merus, MAY 6, 2021, View Source [SID1234579479]).

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"We have made significant progress on our clinical programs this quarter and we are excited to provide a clinical data update on Zeno in an oral presentation at ASCO (Free ASCO Whitepaper) in June, and on MCLA-145 later this year," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "In addition we continue to validate our multispecific platforms with our recent value-generating deal with Loxo Oncology at Lilly, progress with our Incyte collaboration and further development of our own pipeline, including the start of clinical development for MCLA-129."

Clinical Programs

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics)

Oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting
Title: Efficacy and safety of zenocutuzumab in advanced pancreas cancer and other solid tumors harboring NRG1 fusions
Abstract #: 3003
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: June 4, 2021, 11:00 AM-2:00 PM EDT

We plan to present interim efficacy and safety data from the eNRGy trial and Early Access Program (EAP) of Zeno in patients with NRG1 fusion positive (NRG1+) pancreatic, non-small cell lung and other cancers.

Zeno is currently in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancers. We continue to be encouraged by the ongoing trial, observed clinical activity and safety profile and look forward to sharing an interim clinical data update at ASCO (Free ASCO Whitepaper) on June 4.

In the first quarter of 2021, we opened additional clinical trial sites, which are now at more than 35 locations, and we entered into more agreements and collaborations with companies and medical organizations with the goals of raising awareness of the eNRGy trial and providing access to molecular screening opportunities for eligible patients with cancers that may have NRG1 fusions. Merus is now working with more than ten different industry and academic collaborations across Asia, North America and Europe aimed to enhance testing for NRG1 fusions and to raise awareness of the eNRGy trial.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting we presented two posters on the mechanism of action of Zeno. Both posters present preclinical data demonstrating that the Dock & Block activity of Zeno can potently inhibit NRG1 (and NRG1 fusion) signaling through HER3:HER2 and tumorigenesis. In addition, a dose dependent inhibition of tumor growth was observed in NRG1 fusion lung and ovarian cancers in a mouse model.

Both posters can be found on our website.

MCLA-158 (Lgr5 x EGFR Biclonics): Solid Tumors

Phase 1 trial continues with dose expansion cohorts

Phase 1 clinical trial of MCLA-158 is ongoing in the dose expansion phase of the open-label, multicenter trial. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues and preliminary evidence of antitumor activity has been observed.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors

Phase 1 trial clinical data will be presented 2H21

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing and consists of dose escalation followed by dose expansion. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation, which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Biclonics platform. Merus has full rights to develop and commercialize MCLA-145 if approved in the United States and Incyte is responsible for its development and commercialization outside the United States.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors

First patient dosed in the phase 1/2 trial

Enrollment is on-going in the phase 1/2 dose escalation and expansion trial evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics, which binds to EGFR and c-MET and is being investigated for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.

At the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting, we presented data that demonstrate in preclinical models MCLA-129 blocks EGF and HGF binding to their respective receptors EGFR and c-MET and MCLA-129’s enhanced Fc is capable of potent promotion of antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. The data also show MCLA-129 potently inhibits NSCLC tumor growth as monotherapy and in combination with an EGFR TKI and overcomes HGF-mediated EGFR-TKI resistance in preclinical models.

The poster can be found on our website.

Corporate Activities

In May, Merus promoted Cecile Geuijen, Ph.D, to Chief Scientific Officer. Cecile joined Merus twelve years ago as Senior Scientist. Dr. Geuijen has over two decades of experience in discovering and developing antibodies as medicines for clinical evaluation. "We are delighted to have Cecile join our Management Team as CSO," said Bill Lundberg, M.D. CEO of Merus. "She is an outstanding scientist and leader, having a pivotal role in the discovery, design and development of each of Merus’ current clinical-stage assets and many of our preclinical programs." Before joining Merus, Cecile worked on the identification of new therapeutic targets in oncology at Crucell and evaluated new therapeutic targets in oncology at Genmab. She holds a Ph.D. in Biology from the University of Utrecht, was a Marie Curie Fellow at the Duve Institute in Brussels and completed Post-Doctoral studies in cancer biology at the Dutch NKI.

Expanding Collaborations

In January 2021 Merus and Loxo Oncology at Lilly, a research and development group of Eli Lilly and Company (Lilly) announced a research collaboration and exclusive license agreement that will leverage Merus’ proprietary Biclonics platform along with the scientific and rational drug design expertise of Loxo Oncology at Lilly to research and develop up to three CD3-engaging T-cell re-directing bispecific antibody therapies. Merus received an upfront cash payment of $40 million, as well as an equity investment by Lilly of $20 million in Merus common shares. Merus is also eligible to receive up to $540 million in potential development and commercialization milestones per product, for a total of up to approximately $1.6 billion for three products, as well as tiered royalties ranging from the mid-single to low-double digits on product sales should Lilly successfully commercialize a therapy from the collaboration. Under the terms of the agreement, Merus will lead the discovery and early-stage research and Loxo Oncology at Lilly will be responsible for subsequent research, development and commercialization activities.

Cash Runway extended, Merus expects to be funded to at least 2H 2024 through its second follow-on offering and Lilly upfront cash payment and equity investment

On January 21, 2021, Merus successfully priced its second follow-on offering since its 2016 IPO, raising a total of approximately $129.4 million in net proceeds. Based on the Company’s current operating plan, we expect our existing cash, cash equivalents and marketable securities inclusive of the proceeds of $60.0 million from the collaboration with and equity investment by Lilly in January 2021 and aggregate net proceeds from the January follow-on offering will fund Merus’ operations at least into the second half of 2024.

Annual General Meeting and Board of Directors

The Company’s annual general meeting of shareholders (AGM) is planned to be held on May 28, 2021.

First Quarter 2021 Financial Results

We ended the first quarter with cash, cash equivalents and marketable securities of $374.4 million compared to $207.8 million at December 31, 2020. The increase was primarily the result of net proceeds from our follow-on offering and proceeds from the collaboration with and equity investment by Lilly, net of cash used in operations and other items.

Collaboration revenue for the three months ended March 31, 2021 increased by $2 million as compared to the three months ended March 31, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $1.4 million that commenced in the first quarter, and $0.8 million increases related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended March 31, 2021 increased by $3.8 million as compared to the three months ended March 31, 2020, primarily as a result of an increase in external and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the three months ended March 31, 2021 increased by $0.4 million as compared to the three months ended March 31, 2020, which is not a significant change and no significant offsetting items in the period.

Other income, net for the three months ended March 31, 2021 was $11.7 million as compared to $3.2 million for the three months ended March 31, 2020. Other income, net consists of interest earned on the Company’s cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange gains on the Company’s foreign denominated cash, cash equivalents and marketable securities.