On October 29, 2021 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first six months (April 1, 2021 – September 30, 2021) of the fiscal year 2021 (FY2021) ending March 31, 2022 (Press release, Astellas, OCT 29, 2021, View Source [SID1234592166]).

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1. Qualitative information on consolidated financial results for the first six months of FY2021
(1) Business performance
Consolidated financial results (core basis) in the first six months of FY2021 are shown in the table below. While revenue increased, core operating profit and core profit decreased.

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia and PADCEV for the treatment of urothelial cancer showed steady growth as expected. In addition, the sales growth of EVRENZO for the treatment of renal anemia and Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") contributed to revenue as well.
-Moreover, other factor for the increase in sales in the first six months of FY2021 was the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic level which decreased mainly in the first quarter of the previous fiscal year because of the impact of the spread of COVID-19.
-The sales growth of the products above offset the sales decrease mainly due to the termination of sales and distribution for Celecox for the treatment of inflammation and pain and Lipitor for the treatment of hypercholesterolemia, and the divestiture of Eligard for the treatment of prostate cancer.

As a result of the above, revenue in the first six months of FY2021 increased by 5.9% compared to those in the corresponding period of the previous fiscal year ("year-on-year") to ¥651.7 billion.

Core operating profit / Core profit
-Gross profit increased by 6.3% year-on-year to ¥526.9 billion. The cost-to-revenue ratio fell by 0.3 percentage points year-on-year to 19.1%, mainly due to changes in product mix
.-Selling, general and administrative expenses increased by 11.7% year-on-year to ¥270.5 billion. The total amount increased mainly due to the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥10.2 billion year-on-year), investment in systems associated with globalization (increase of approximately ¥5.0 billion year-on-year), the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥3.0 billion year-on-year), and the impact of the foreign exchange rates (increase of ¥8.4 billion year-on-year).

Excluding co-promotion fees of XTANDI in the United States, selling, general and administrative expenses increased by 10.0% year-on-year to ¥199.4 billion.-Research and development (R&D) expenses increased by 6.6% year-on-year to ¥119.1 billion. While there was a decrease in development expenses for fezolinetant, a selective neurokinin-3 receptor antagonist, for which patient enrollment in Phase III trials in the United States and Europe has been completed, the total amount increased mainly due to increases in development expenses for zolbetuximab, an anti-Claudin 18.2 monoclonal antibody and R&D investment for Rx+ business (related to iota).

-Amortisation of intangible assets increased by 7.2% year-on-year to ¥12.4 billion. 3

As a result of the above, core operating profit decreased by 3.8% year-on-year to ¥125.3 billion, and core profit decreased by 7.0% year-on-year to ¥98.8 billion.

Impact of exchange rate on financial results
The exchange rates for the yen in the first six months of FY2021 are shown in the table below. The resulting impacts were a ¥24.5 billion increase in revenue and a ¥11.5 billion increase in core operating profit compared with if the exchange rates of the first six months of FY2020 were applied.

On October 28, 2021 AbClon (CEO Jong-seo Lee) and Lee Ensage (CEO Lee Bong-hee) reported business partnership agreement for joint development of CAR-NK cell therapy using gene editing technology (MOU) (Press release, AbClon, OCT 28, 2021, View Source;wr_id=150 [SID1234638632]).

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AppClone developed CAR-T through joint research with Ensage. Beyond platform technology CAR-NK expanding the scope of research and development with technology, In particular, the strategy is to target the cell therapy market from various angles by combining the company’s antibody discovery technology with Nsage’s gene scissors technology.

CAR-NK Cell therapy is a recombinant antigen receptor(CAR, Chimeric Antigen Receptor) Natural killer cells(NK cell) It is a cell therapy product that combines, NK cells and destroys abnormal cells or cancer. Responsible for immunity.

CAR-NK NK cells used to manufacture cell therapy products are isolated from the blood of healthy people. After culturing, these cells are GVHD (graft-versus-host disease), which is a rejection reaction to injection of other cells,Side effects The advantage is that it is low and mass production is possible. CAR-NK cell therapy has not yet been approved at home or abroad, but , is a pipe that global Big Pharma is trying to dominate. As a line, a lot of research and development is underway worldwide.

NSAGE uses a large amount of gene editing Cas12a material and Automated factory-type cell therapy production platform ‘Harmony’ Holds. NSAGE’s gene editing platform is a technology that targets specific targets for incurable diseases, existing stem cells. It is evaluated that it can overcome the limitations of treatment. Major The pipeline is a hemophilia target CAR-NK cell therapy.

AbClone is a new epitope(Epitope, antigenic determinant) Antibody discovery technology targeting ‘NEST (Novel Epitope Screening) Technology)’ has a platform. The NESTplatform provides a large-scale antibody database. It is a technology that can be used in the development of various cell gene therapy products,the company utilizes this to develop antibodies suitable for the purpose. We plan to select CAR-NK and apply it to the development of cell therapy. past 6month IND Blood cancer applied CAR-T Cell therapy ‘AT101’also NEST platform It was discovered through.

Jong-seo Lee, CEO of AppClon, said "the cooperation between the two companies and Through technological convergence, CAR-NK expands the pipeline to cell therapy CAR We will lay the foundation to lead the related industry by upgrading our technology"he emphasized.

Nsage CEO Lee Bong-hee said "AppClone’s Antibody discovery technology and CAR-T technology and our Cas12a gene scissors technology and NK automated production using domain libraries for cell activation, etc., Based on close cooperation between the two companies, highly effective and low-cost allogeneic CAR-NK cells for target cancers such as lung cancer remedy He said that he expects to be able to secure the pipeline early".

On October 28, 2021 PharmaMar Group (MSE: PHM) reported that recurring revenues, comprising net sales plus royalties received from sales by our partners, increased by 31% year-on-year to €119 million for the first 9 months of the year (Press release, PharmaMar, OCT 28, 2021, View Source [SID1234596672]).

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As in previous quarters, the increase in recurring revenues was mainly driven by the good performance of our oncology business unit. Oncology sales revenues reached €88.7 million year-to-date in 2021, an increase of 21% compared with the same period last year.

It is worth highlighting the growth in revenues from Zepzelca (lurbinectedin) in Europe under the compassionate use authorization program, which amounted to €23.3 million through September 30th. This represents an increase of 77.7% when compared with the same period last year. Yondelis (trabectedin) sales remained stable in 9M 2021, €56.5 million compared to €57.1 million in 9M 2020.

Royalty revenues amounted to €27.2 million in 9M 2021, compared to €7.4 million over the same period in 2020. This significant increase was mainly driven by royalties received from our partner Jazz Pharmaceuticals, which accounted for €25.2 million and have been entirely generated as a result of sales of lurbinectedin in the US. As our partner Jazz Pharmaceuticals has not reported its 3Q 2021 results yet, our recorded 3Q 2021 royalties are an estimate based on our conservative, best available information.

Revenues from licensing agreements refer, both in 2020 and in 2021, to the licensing agreement signed with Jazz Pharmaceuticals in 2019, reaching €24.4 million in 3Q 2021, and €130.4 million in 3Q 2020. This difference is due to the recording as revenue of the upfront payment for the license agreement, as well as the milestone for the approval of lurbinectedin in the US. Both events occurred in the first half of 2020 and are being recognized on the income statement, based on the degree of progress of the contractual commitments.

PharmaMar plans to commence a confirmatory trial with lurbinectedin in second-line recurrent Small-Cell Lung Cancer at the end of 2021. This will be a three-arm clinical trial comparing lurbinectedin in monotherapy or in combination with irinotecan, versus the investigators’ choice of irinotecan or topotecan. If positive, this trial will be used with the US FDA to confirm the benefit of lurbinectedin in the treatment of Small-Cell Lung Cancer when patients progress after first-line treatment with a platinum-based regimen, as well as with the European Medicine Agency as a registration trial in Europe.

GENOMICA, PharmaMar Group’s molecular diagnostics company, reported net revenues of €3.5 million up to September 30th, 2021, compared to €10.5 million in the same period of 2020. This difference was mainly due to increased competition in the market for COVID-19 tests, both PCR, lateral flow and antibody tests, which led to lower prices. Similarly, the decrease in the incidence of COVID-19 has considerably reduced the use of these tests.

As a result, PharmaMar Group’s total revenues for the first 9 months of 2021 amounted to €143.9 million, compared to €222.2 million over the same period of 2020, which, as mentioned above, included the upfront payment for the licensing agreement with Jazz Pharmaceuticals and the milestone payment for the approval of
lurbinectedin in the US.

The Group’s R&D expenditure increased by 21.2% to €47.4 million during the first nine months of 2021, compared with €39.1 million in the same period last year.

As a result, PharmaMar Group posted a net profit of €54.7 million on September 30th, 2021.

As of September 30th, 2021, the PharmaMar Group had cash, and cash equivalents, plus financial investments of €222.0 million and a total debt of €50.7 million. As a result, total net cash amounted to €171.3 million.

Earnings conference call for analysts and investors

PharmaMar will hold a conference call with analysts and investors on Friday, October 29th at 1:00 pm (CEST). The numbers to connect to the teleconference are +34 91 901 16 44 (from Spain), +1 646 664 1960 (from the US or Canada) or +44 20 3936 2999 (other countries). Participant access code: 296923.

The teleconference and recording will be available on PharmaMar’s website, by visiting the Events Calendar section of the company’s website at www.pharmamar.com.

On October 28, 2021 Pascal Biosciences Inc. reported a non-brokered private placement financing of up to 9,000,000 units (each a "Unit") of securities at a price of $0.10 per Unit for aggregate gross proceeds of up to $900,000.00 (the "Offering") (Press release, Pascal Biosciences, OCT 28, 2021, View Source [SID1234596244]). Each Unit will be comprised of one (1) common share and one (1) non-transferable common share purchase warrant, with each whole warrant entitling the holder to purchase one additional common share at a price of $0.15 for two years from the closing date of the private placement. The exercise term of the warrant will be accelerated in the event the closing price of the Shares is above $0.20 for ten consecutive days and will be exercisable for a period of 15 days from the date of receipt by investors of a Notice of Acceleration. Finder’s fees of up to 10% may be paid.

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The Company is continuing with the process of raising the funds and has filed for conditional acceptancy by the TSX.V

All securities issued will be subject to a four month holding period which will expire on the date that is four months and one day from the date of issue.

Our agreement with SoRSE Technology, which was initiated August 15, 2020, was completed on Nov. 15.

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