On April 27, 2022 Isofol Medical AB (publ) (Nasdaq Stockholm: ISOFOL), reported that the company’s annual report and corporate governance report for the financial year 2021 are now available on the company’s website, www.isofolmedical.com (View Source) (Press release, Isofol Medical, APR 27, 2022, View Source [SID1234613009]).

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This information is information that Isofol Medical AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 08:00 CEST on April 27, 2022.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global pivotal Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit all patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On April 27, 2022 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical group, reported its sales performance for the first quarter of 2022 (Press release, Ipsen, APR 27, 2022, View Source [SID1234613008]).

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Highlights

A strong first-quarter total-sales performance, with growth of 9.6% at CER [1] (12.5% as reported) to €687.9m, driven by Decapeptyl (triptorelin), Dysport (botulinum toxin type A), Cabometyx (cabozantinib) and Onivyde (irinotecan liposome injection) double-digit growth and flat sales of Somatuline (lanreotide)
Confirmation of full-year guidance for 2022, with total-sales growth greater than 2.0% at CER1 and a core operating margin greater than 35.0% of total sales
Transaction announced in February 2022 for the divestment of the Consumer HealthCare (CHC) business anticipated to be completed by end of Q3 2022

Q1 2022 total sales

Total sales in this announcement are unaudited IFRS consolidated sales and reflect Specialty Care sales only, in accordance with IFRS 5.

David Loew, Chief Executive Officer, commented:

"The execution of our strategy was reflected in our first-quarter performance across the business. The strong sales were in line with our expectations, with Decapeptyl, Dysport, Cabometyx and Onivyde all delivering double-digit growth. Our guidance for the year, which assumes increasing levels of competition for Somatuline, is underpinned by our strong platform of growth across these core and innovative medicines.

Alongside the anticipated U.S. regulatory resubmission for palovarotene in the first half of the year, we look forward to a number of important data readouts in the second half, while our pipeline will continue to be replenished through the external-innovation strategy. It is an exciting time for Ipsen as we deliver on our strategy, produce strong results, expand our pipeline and focus together, for patients and society."

Full-year 2022 guidance

Ipsen today confirms its financial guidance for FY 2022, which excludes any contribution from CHC:

Total-sales growth greater than 2.0%, at CER [2]. Based on the level of exchange rates in Q1 2022, Ipsen anticipates an additional favorable impact of 2% from currencies in the year
Core operating margin greater than 35.0% of total sales, excluding any potential impact of incremental investments from future external-innovation transactions
This guidance incorporates expectations for Somatuline of further launches of generic lanreotide in other countries in the E.U., as well as increased competition in the U.S.

Ongoing conflict in Ukraine

Ipsen is firmly committed to the safety and care of its employees and to providing essential support and access to its treatments and medicines for patients.

Since the beginning of the conflict in Ukraine, Ipsen’s immediate actions have been to ensure that all colleagues are safe and to limit any impact on the supply of medicines. The Company has also provided humanitarian relief via a donation of €1.5m in favor of two highly reputed humanitarian organizations: Tulipe, a pharmaceutical distributor managing donations from health companies to meet the emergency needs of populations in distress, and The Red Cross.

Ipsen’s position is to continue to serve patients with their healthcare needs, regardless of their country origin and in compliance with applicable laws. In Russia, the Company has, however, suspended several promotional activities, including advertising. No new clinical trials will be initiated in Russia.

In 2021, Ipsen’s Specialty Care sales in Russia and Ukraine were less than 3.0% of total Specialty Care sales.

Consumer HealthCare

In February 2022, Ipsen announced that it had entered into exclusive negotiations with Mayoly Spindler for the divestment of its global CHC business, a major step forward in the Company’s execution of its strategic roadmap towards building a more-focused Ipsen, centering on Specialty Care. Ipsen confirms that the transaction is anticipated to close by the end of Q3 2022, subject to regulatory approvals and customary closing conditions.

[1] At constant exchange rates (CER), which exclude any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.

[2] At CER, which excludes any foreign-exchange impact by recalculating the performance for the relevant period by applying the exchange rates used for the prior period.

On April 27, 2022 Deciphera Pharmaceuticals, Inc. (NASDAQ: DCPH), a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines to improve the lives of people with cancer, reported the pricing of an underwritten public offering of 5,251,239 shares of its common stock at a public offering price of $10.00 per share (Press release, Deciphera Pharmaceuticals, APR 27, 2022, View Source [SID1234613007]). In addition, in lieu of common stock to certain investors, Deciphera is offering pre-funded warrants to purchase 9,748,761 shares of its common stock at a purchase price of $9.99 per pre-funded warrant, which equals the public offering price per share of the common stock less the $0.01 exercise price per share of each pre-funded warrant. The aggregate gross proceeds to Deciphera from this offering are expected to be approximately $150 million, before deducting underwriting discounts and commissions and other estimated offering expenses. In addition, Deciphera has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock at the public offering price per share of the common stock, less underwriting discounts and commissions. The offering is expected to close on April 29, 2022, subject to the satisfaction of customary closing conditions. All of the shares of common stock and pre-funded warrants are being offered by Deciphera.

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Deciphera intends to use the net proceeds from the offering to continue to fund the development of vimseltinib including in its pivotal Phase 3 MOTION study of vimseltinib in tenosynovial giant cell tumor patients currently underway, additional clinical trials as well as clinical research outsourcing and manufacturing of clinical trial material and pre-commercial and medical affairs capabilities related to vimseltinib; to fund the development of DCC-3116 including multiple Phase 1b combination studies and potential Phase 2 expansion combination cohorts in multiple tumor types as well as clinical research outsourcing and manufacturing of clinical trial material; to fund the research and development of Deciphera’s pan-RAF program and other new research activities for potential drug candidates from its proprietary kinase switch control inhibitor platform; and the remainder for working capital purposes, including general operating expenses.

J.P. Morgan and Jefferies are acting as joint book-running managers for the offering.

The securities described above are being offered by Deciphera pursuant to a shelf registration statement on Form S-3 (No. 333-236389) that was declared effective by the Securities and Exchange Commission (SEC) on March 10, 2022. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering was filed with the SEC on April 26, 2022, and is available on the SEC’s website located at www.sec.gov. A copy of the final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 866-803-9204, or by email at [email protected]; or Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.

On April 27, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for fiscal year 2021 (FY2021) ended March 31, 2022 (Press release, Astellas, APR 27, 2022, View Source [SID1234613006]).

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1. Overview of business performance and others
(1) Overview of business performance for FY2021
1) Overview of consolidated financial results for FY2021 Consolidated financial results (core basis) in FY2021 are shown in the table below. While revenue increased, core operating profit and core profit for the year decreased

Established a new account, which includes gain on sale of rights of in-market products or pipeline assets, in the third quarter of FY2021

Revenue
-Main products XTANDI for the treatment of prostate cancer, XOSPATA for the treatment of acute myeloid leukemia, PADCEV for the treatment of urothelial cancer and EVRENZO for the treatment of renal anemia showed steady growth. In addition, the sales growth of Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") and EVENITY for the treatment of osteoporosis contributed to revenue growth as well.
-Moreover, another factor for the increase in sales in FY2021 was the sales of pharmacologic stress agent Lexiscan returning to pre-pandemic levels which decreased mainly in the first quarter of the previous fiscal year by 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 agreements 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 FY2021 increased by 3.7% compared to those in the previous fiscal year ("year-on-year") to ¥1,296.2 billion. Core operating profit / Core profit for the year-Gross profit increased by 4.0% year-on-year to ¥1,043.2 billion. The cost-torevenue ratio fell by 0.2 percentage points year-on-year to 19.5%, mainly due to changes in product mix, despite the foreign exchange rate impact from the elimination of unrealized gains in intra-group transactions.-Selling, general and administrative expenses increased by 8.8% year-on-year to ¥548.8 billion.

The total amount increased mainly due to the impact of the foreign exchange rates (increase of ¥25.0 billion year-on-year), the increase of copromotion fees associated with the growth of sales of XTANDI in the United States (increase of ¥11.3 billion year-on-year), investment in Digital Transformation (increase of approximately ¥8.0 billion year-on-year), and the increase in sales promotion expenses for new product launch readiness (increase of approximately ¥5.0 billion year-on-year), despite a decrease in expenses due to the global optimization of personnel aligned with transformation of product portfolio (decrease of approximately ¥9.0 billion year-on-year). Selling, general and administrative expenses, excluding co-promotion fees of XTANDI in the United States, increased by 6.6% year-on-year to ¥409.5 billion.

-Research and development (R&D) expenses increased by 9.6% year-on-year to ¥246.0 billion. The total amount increased mainly due to the impact of the foreign exchange rates and also 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 19.0% year-on-year to ¥28.3 billion. 3-Gain on divestiture of intangible assets was ¥24.2 billion, including transfer of five products to Cheplapharm which were sold in Europe and other regions (¥12.3 billion), transfer of a pipeline asset (¥9.2 billion) and transfer of Bendamustine (¥2.0 billion) in the third quarter of FY2021.

As a result of the above, core operating profit decreased by 2.6% year-on-year to ¥244.7 billion, and core profit for the year decreased by 9.2% year-on-year to ¥190.6 billion. Impact of exchange rate on financial results The exchange rates for the yen in FY2021 are shown in the table below.

The resulting impacts were a ¥59.6 billion increase in revenue and an ¥18.5 billion increase in core operating profit compared with if the exchange rates of FY2020 were applied.

On April 26, 2022 BioEclipse Therapeutics (BioEclipse), a privately held, clinical-stage biopharmaceutical company with a proprietary platform for developing next-generation cancer immunotherapies, reported it has been awarded a $7,999,689.00 grant by the California Institute for Regenerative Medicine (CIRM) to support its ongoing clinical study: A Phase 1, open-label, dose-escalation study of CRX100 in patients with advanced solid tumors (Press release, BioEclipse Therapeutics, APR 26, 2022, View Source;utm_medium=rss&utm_campaign=bioeclipse-therapeutics-awarded-almost-8-million-grant-by-california-institute-for-regenerative-medicine-cirm-to-fund-ongoing-phase-1-crx100-cancer-immunotherapy-clinical-trial [SID1234613503]).

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BioEclipse is performing a Phase 1 clinical study evaluating the safety and tolerability of CRX100, a first-in-class immunotherapy that pairs the power of an oncolytic virus with the tumor-locating ability of cytokine-induced killer (CIK) cells. These immune cells naturally locate and destroy cancer cells and when combined with our oncolytic virus create a powerful cancer immunotherapy to treat patients who are resistant to standard of care treatments and have recurring disease.

BioEclipse President and CEO Pamela Reilly Contag, Ph.D. and Principal Investigator of the grant, said, "We believe the best way to cure cancer is by developing new, multi-mechanistic therapies that are safe, effective, and accessible to diverse populations. Our technology harnesses two distinct methods of action using immune cells loaded with a cancer-killing virus that targets cancer tissue but spares healthy tissue. Immunotherapies such as CRX100 are an extremely powerful approach to give oncologists another tool to improve outcomes, while giving the body tools to fight a relapse and recurrence. We extend our sincerest appreciation to CIRM. Their support has validated our technology and expertise, and we welcome opportunities with partners and investors moving forward as we work towards achieving our goals."

Oliver Dorigo, M.D., Ph.D., Principal Investigator of the clinical trial and Director of the Gynecologic Cancer Service at Stanford University, said, "CRX100 addresses a significant unmet medical need in fatal conditions for which there are limited treatment options. CRX100, which migrates to the tumor site, targets tumor cells and delivers the cancer-destroying virus, has the potential to significantly help those with chemotherapy-resistant or refractory solid tumors—including colorectal cancer, triple-negative breast cancer, ovarian cancer, gastric cancer, hepatocellular carcinoma, and osteosarcoma." The trial locations also include HonorHealth Research Institute in Scottsdale, Arizona, and UC San Diego Moores Cancer Center in La Jolla, California.