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 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of next-generation antibody therapeutics, reported the positive results from the GLP toxicology study of PMC-403, the Company’s novel TIE2-activating antibody (Press release, PharmAbcine, APR 26, 2022, View Source;bmode=view&idx=11279911&t=board [SID1234649181]).

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PMC-403 can stabilize and repair damaged and pathologically leaky blood vessels, and it is being developed to treat AMD (Age-related Macular Degeneration), one of the most prevalent neovascular ophthalmology diseases.

With the goal of establishing safety profile in animal models before entering the human trial, the study was conducted to evaluate the toxicokinetics and toxicity of PMC-403. The drug was administered via monthly intravitreal injection to monkeys in different dosing groups.

The result of the study showed that there were no serious safety issues in the test subjects (n=32). There were no unscheduled deaths and no organ weight changes even when PMC-403 was administered with twice the dosage of that of the existing drugs.

"We concluded that PMC-403 is safe enough to be administered in human trials," said Dr. Jin-San Yoo, CEO of PharmAbcine. "The vessel-normalizing mechanism makes PMC-403 a potent drug that can offer longer dosing interval and also be utilized in many other vessel-related diseases, such as chronic kidney diseases, ARDS (Acute Respiratory Distress Syndrome), and sepsis."

Dr. Yoo added, "In addition to the study result, Dr. Quan Dong Nguyen, our newly appointed Scientific Advisory Board member and a world-renowned expert in ophthalmology from Stanford University, will provide tremendous insight to our development efforts. Both of these events are critical milestones in the preparation of PMC-403 for the Phase I clinical trial in ophthalmology. The Company will submit the IND package in 3Q22."

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.

On April 26, 2022 IntelGenx Technologies Corp. (TSX:IGX) (OTCQB:IGXT) ("IntelGenx"), a leader in pharmaceutical films, reported that management will present an update on the Company’s business at the Bloom Burton & Co. Healthcare Investor Conference on Tuesday, May 3, 2022 at 9:30 a.m. Eastern Time at the Metro Toronto Convention Centre (Press release, IntelGenx, APR 26, 2022, View Source [SID1234613051]).

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The presentation will be broadcast live and archived on the Company’s website at www.intelgenx.com under "Webcasts" in the Investors section.

On April 26, 2022 SCYNEXIS, Inc. (Nasdaq: SCYX) reported the closing of its previously announced underwritten public offering of common stock, pre-funded warrants and warrants (Press release, Scynexis, APR 26, 2022, View Source [SID1234613005]). The shares and warrants were sold at a public offering price of $3.00 per share and accompanying warrants, and the pre-funded warrants were sold at a public offering price of $2.999 per pre-funded warrant and accompanying warrants. The total gross offering proceeds to SCYNEXIS from this offering were $45.0 million, before deducting the underwriting discount and other estimated offering expenses, and excluding the exercise of any pre-funded warrants or warrants. All of the shares of common stock, pre-funded warrants and warrants were offered by SCYNEXIS.

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At closing, SCYNEXIS issued 3,333,333 shares of its common stock, pre-funded warrants to purchase an aggregate of 11,666,667 shares of common stock and warrants to purchase an aggregate of 15,000,000 additional shares of its common stock. The pre-funded warrants were issued to certain purchasers who have elected to purchase them in lieu of shares of common stock in this offering, as those purchasers would otherwise have exceeded 19.99% (or such lesser percentage as required by the investor) beneficial ownership of our common stock immediately following the offering. The shares of common stock, pre-funded warrants and warrants were issued separately. The warrants have a seven-year term and an exercise price of $3.45 per share. The pre-funded warrants and the warrants are exercisable immediately. The warrants were certificated and are being delivered to the investors by physical delivery following the closing. There is no established public trading market for the pre-funded warrants or the warrants, and SCYNEXIS does not expect a market to develop.

In addition, SCYNEXIS has granted the underwriters a 30-day option to purchase up to an additional 2,250,000 shares of common stock and/or warrants to purchase up to 2,250,000 shares of common stock, at their respective public offering prices, less the underwriting discounts and commissions.

Guggenheim Securities, LLC and Cantor Fitzgerald & Co. served as joint book-running managers for the offering. Ladenburg Thalmann & Co. Inc. and Maxim Group LLC served as co-lead managers for the offering. Aegis Capital Corp, Brookline Capital Markets, a division of Arcadia Securities, LLC, and WBB Securities LLC served as co-managers for the offering.

A shelf registration statement relating to the securities being sold in this offering was filed with the U.S. Securities and Exchange Commission (the "SEC") on December 31, 2020, and was declared effective on January 8, 2021. The offering was made only by means of a preliminary and final prospectus supplement and accompanying prospectus. Copies of the preliminary and final prospectus supplements and accompanying prospectus relating to the proposed public offering may be obtained by contacting: Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, or by telephone at (212) 518-9544 or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, 4th Floor, New York, New York 10022, or by email at [email protected]. The final terms of the offering were disclosed in the final prospectus supplement filed with the SEC.

This press release shall 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 any such state or jurisdiction.