On May 10, 2022 Kyowa Kirin Co., Ltd. reported that Consolidated Financial Summary (IFRS) Fiscal 2022 First Quarter(Press release, Kyowa Hakko Kirin, MAY 10, 2022, View Source [SID1234614019])

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1. Consolidated Financial Results for the Three Months Ended March 31, 2022
(1) Consolidated operating results
(2) Consolidated financial position

2. Dividends

3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2022 (from January 1, 2022 to December 31, 2022)

* Quarterly financial results reports are exempt from quarterly review 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

1. Operating Results and Financial Statements
(1) Summary of Consolidated Financial Position  Assets as of March 31, 2022, were ¥907.8 billion, a decrease of ¥14.1 billion compared to the end of the previous fiscal year.  Non-current assets increased by ¥5.8 billion compared to the end of the previous fiscal year, to ¥409.4 billion, due mainly to an increase in deferred tax assets.  Current assets were ¥498.4 billion, a decrease of ¥19.9 billion compared to the end of the previous fiscal year, mainly reflecting a decrease in trade and other receivables as well as a decrease in cash and cash equivalents due to the payment of dividends and income taxes.

 Liabilities as of March 31, 2022, were ¥163.4 billion, a decrease of ¥21.3 billion compared to the end of the previous fiscal year, due mainly to decreases in income taxes payable and trade and other payables.  Equity as of March 31, 2022, was ¥744.5 billion, an increase of ¥7.3 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent as well as an increase in exchange differences on translation of foreign operations resulting from the impact of exchange rates, despite a decrease due to the payment of dividends, etc.

As a result, the ratio of equity attributable to owners of parent to total assets as of the end of the first quarter was 82.0%, an increase of 2.0 percentage points compared to the end of the previous fiscal year.

(2) Summary of Consolidated Business Performance
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 amountFor the three months ended March 31, 2022 (January 1, 2022 to March 31, 2022), revenue was ¥87.8 billion (up 8.2% compared to the same period of the previous fiscal year), and core operating profit was ¥17.3 billion (up 11.8%). Profit attributable to owners of parent was ¥16.0 billion (up 24.1%).

 The increase in revenue was the result of growth of global strategic products in North America and EMEA and a rise in revenue from technology out-licensing, despite lower revenue in Japan. The positive effect on revenue from foreign exchange was ¥3.6 billion.
 Core operating profit rose, despite increases in selling, general and administrative expenses and research and development expenses, due to higher gross profit resulting from an increase in overseas revenue and a rise in revenue from technology out-licensing. The positive effect on core operating profit from foreign exchange was ¥1.2 billion.  Profit attributable to owners of parent increased as a result of an increase in finance income and a decrease in income tax expense in addition to an increase in core operating profit.

On May 10, 2022 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported financial results for the first quarter ended March 31, 2022, and provided an overview of recent developments (Press release, UroGen Pharma, MAY 10, 2022, View Source [SID1234614018]).

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"The first quarter of 2022 saw further commercial, clinical and operational progress as we continued to grow patient access to Jelmyto, advance our clinical-stage candidates and significantly strengthened our financial position in support of our business," said Liz Barrett, President, and Chief Executive Officer of UroGen. "Thus far in 2022, we have begun enrolling patients in the Phase 3 ENVISION pivotal trial of UGN-102 in low-grade, intermediate-risk NMIBC and initiated a first-in-human, multi-arm Phase 1 clinical study of UGN-301 in high-grade NMIBC. Our accomplishments throughout 2021 and early 2022, coupled with our strengthened balance sheet, position us well to continue to execute on our strategic initiatives as we look to accelerate growth and advance our mission of transforming the treatment paradigm for patients with urothelial cancers."

Business Highlights:

Jelmyto (mitomycin) for pyelocalyceal solution in low-grade Upper Tract Urothelial Cancer (LG-UTUC):

Generated net product revenue of $13.6 million for the first quarter of 2022, representing 81% growth over the first quarter of 2021.
Continued phased launch of uTRACT patient registry intended to evaluate real-world outcomes of LG-UTUC patients treated with Jelmyto, provide insight into long-term treatment benefits, and evaluate its use in clinical practice in the U.S.
UGN-102 (mitomycin) for intravesical solution:

UroGen began dosing patients in the single-arm Phase 3 ENVISION pivotal trial of UGN-102 for the treatment of low-grade, intermediate-risk NMIBC. The study will enroll approximately 220 patients across 90 sites. Enrollment is expected to be completed by the end of 2022.
ENVISION is similar in design to the previously completed Phase 2b OPTIMA II study which demonstrated a complete response (CR) rate of 65% and probability of remaining in CR 12 months after therapy of 72.5% by Kaplan Meier analysis. Assuming positive findings, UroGen anticipates submitting a New Drug Application (NDA) for UGN-102 in 2024.
UGN-301 (zalifrelimab) for intravesical solution:

UroGen initiated a first-in-human, novel, multi-arm Phase 1 clinical trial of UGN-301, the Company’s anti-CTLA4- antibody, in high-grade NMIBC.
This Phase 1 clinical trial will utilize a Master Protocol to evaluate the safety and tolerability of UGN-301 as monotherapy and in combination with other immunomodulators, including UGN-201, the Company’s proprietary toll-like receptor 7 (TLR7) agonist, as well as other potential chemo and/or immune therapies in patients with NMIBC.
UGN-301 is in development through a strategic collaboration with The University of Texas MD Anderson Cancer Center and represents the Company’s expansion into immunotherapy. The Phase 1 program intends to build upon encouraging nonclinical data showing that intravesical administration of anti-CTLA4 and a TLR agonist leveraging RTGel has the potential to improve mortality in the setting of high-grade NMIBC.
First Quarter 2022 Financial Results:

Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2022 of $13.6 million, compared to $7.5 million in the first quarter of 2021.

R&D Expense: Research and development expenses for the first quarter 2022 were $12.7 million, including non-cash share-based compensation expense of $0.7 million as compared to $10.5 million, including non-cash share-based compensation expense of $1.1 million, for the same period in 2021.

SG&A Expense: Selling, general and administrative expenses for the first quarter 2022 were $21.3 million, including non-cash share-based compensation expense of $2.2 million. This compares to $22.2 million, including non-cash share-based compensation expense of $5.1 million, for the same period in 2021.

Financing on Prepaid Forward Obligation: UroGen reported non-cash financing expense related to the prepaid forward obligation to RTW Investments of $5.8 million for the first quarter 2022. The rate applied to cash payments incurred in 2022 is 13% based on $48 million of global net product sales of Jelmyto in 2021.

Net Loss: UroGen reported a net loss of $28.4 million, or basic and diluted net loss per ordinary share of $1.25, for the first quarter 2022 as compared to $25.9 million, or basic and diluted net loss per ordinary share of $1.17, for the same period in 2021.

Cash & Cash Equivalents: As of March 31, 2022, cash, cash equivalents and marketable securities totaled $137.1 million. This includes the first $75 million tranche of the up to $100 million term loan facility with funds managed by Pharmakon Advisors, which closed in March 2022.

2022 Revenue, Operating Expense and RTW Expense Guidance: The Company reiterates anticipated full year 2022 net product revenues from Jelmyto to be in the range of $70 to $80 million. The Company reiterates anticipated full year 2022 operating expenses in the range of $140 to $160 million, including non-cash share-based compensation expense of $10 to $16 million, subject to market conditions. The Company reiterates anticipated full year 2022 non-cash financing expense related to the prepaid obligation to RTW Investments in the range of $22 to $26 million, of which approximately $9.1 to $10.4 million will be paid in cash.

Conference Call & Webcast Information: Members of UroGen’s management team will host a live conference call and webcast today at 10:00 AM Eastern Time to review the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the Investors section of the Company’s website at View Source Please connect at least 15 minutes prior to the commencement of the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call (855) 765-5685 (U.S.) or (615) 247-5916 (International) to listen to the live conference call. The conference ID number for the live call will be 6687048. An archive of the webcast will be available for two weeks on the Company’s website.

About Jelmyto

Jelmyto (mitomycin) for pyelocalyceal solution, is a drug formulation of mitomycin indicated for the treatment of adult patients with low-grade upper tract urothelial cancer (LG-UTUC). Utilizing the RTGel technology platform, UroGen’s proprietary sustained release, hydrogel-based formulation, Jelmyto is designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Jelmyto is delivered to patients using standard ureteral catheters or nephrostomy tube. The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC. On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.

APPROVED USE FOR JELMYTO

JELMYTO is a prescription medicine used to treat adults with a type of cancer of the lining of the upper urinary tract including the kidney called low-grade Upper Tract Urothelial Cancer (LG-UTUC).

IMPORTANT SAFETY INFORMATION

You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.

Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:

are pregnant or plan to become pregnant. JELMYTO can harm your unborn baby. You should not become pregnant during treatment with JELMYTO. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
Females who are able to become pregnant: You should use effective birth control (contraception) during treatment with JELMYTO and for 6 months after the last dose.
Males being treated with JELMYTO: If you have a female partner who is able to become pregnant, you should use effective birth control (contraception) during treatment with JELMYTO and for 3 months after the last dose.
are breastfeeding or plan to breastfeed. It is not known if JELMYTO passes into your breast milk. Do not breastfeed during treatment with JELMYTO and for 1 week after the last dose.
Tell your healthcare provider if you take water pills (diuretic).
How will I receive JELMYTO?

Your healthcare provider will tell you to take a medicine called sodium bicarbonate before each JELMYTO treatment.
You will receive your JELMYTO dose from your healthcare provider 1 time a week for 6 weeks. It is important that you receive all 6 doses of JELMYTO according to your healthcare provider’s instructions. If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment. Your healthcare provider may recommend up to an additional 11 monthly doses.
JELMYTO is given to your kidney through a tube called a catheter.
During treatment with JELMYTO, your healthcare provider may tell you to take additional medicines or change how you take your current medicines.
After receiving JELMYTO:

JELMYTO may cause your urine color to change to a violet to blue color. Avoid contact between your skin and urine for at least 6 hours.
To urinate, males and females should sit on a toilet and flush the toilet several times after you use it. After going to the bathroom, wash your hands, your inner thighs, and genital area well with soap and water.
Clothing that comes in contact with urine should be washed right away and washed separately from other clothing.
JELMYTO may cause serious side effects, including:

Swelling and narrowing of the tube that carries urine from the kidney to the bladder (ureteric obstruction). If you develop swelling and narrowing, and to protect your kidney from damage, your healthcare provider may recommend the placement of a small plastic tube (stent) in the ureter to help the kidney drain. Tell your healthcare provider right away if you develop side pain or fever during treatment with JELMYTO.
Bone marrow problems. JELMYTO can affect your bone marrow and can cause a decrease in your white blood cell, red blood cell, and platelet counts. Your healthcare provider will do blood tests prior to each treatment to check your blood cell counts during treatment with JELMYTO. Your healthcare provider may need to temporarily or permanently stop JELMYTO if you develop bone marrow problems during treatment with JELMYTO.
The most common side effects of JELMYTO include: urinary tract infection, blood in your urine, side pain, nausea, trouble with urination, kidney problems, vomiting, tiredness, stomach (abdomen) pain.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088. You may also report side effects to UroGen Pharma at 1-855-987-6436.

Please see JELMYTO Full Prescribing Information, including the Patient Information, for additional information.

About Upper Tract Urothelial Cancer (UTUC)

Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S. Between five percent and ten percent of primary urothelial cancers originate in the ureter or renal pelvis and are collectively referred to as upper tract urothelial cancers (UTUC). In the U.S., there are approximately 6,000 – 7,000 new or recurrent low-grade UTUC patients annually. Most cases are diagnosed in patients over 70 years old, and these older patients often face comorbidities. There are limited treatment options for UTUC, with the most common being endoscopic surgery or nephroureterectomy (removal of the entire kidney and ureter). These treatments can lead to a high rate of recurrence and relapse.

About UGN-102

UGN-102 (mitomycin) for intravesical solution is an investigational drug formulation of mitomycin in Phase 3 development for the treatment of low-grade intermediate risk NMIBC. Utilizing the RTGelTM Technology Platform, UroGen’s proprietary sustained release, hydrogel-based formulation, UGN-102 is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. UGN-102 is delivered to patients using a standard urinary catheter. The Company presented results from the Phase 2b OPTIMA II trial in September 2021.

About the Phase 3 ENVISION Trial

The Phase 3 ENVISION trial is a single-arm, multinational, multicenter study evaluating the efficacy and safety of UGN-102 (mitomycin) as primary chemoablative therapy in patients with low-grade, intermediate-risk NMIBC. The Phase 3 ENVISION trial is expected to enroll approximately 220 patients across 90 sites and study participants will receive six once-weekly intravesical instillations of UGN-102. The planned primary endpoint will evaluate the complete response rate at three months after the first installation, and the key secondary endpoint will evaluate durability over time in patients who achieve complete response at the three-month assessment. Based on discussions with the FDA, and enrollment expected by the end of 2022, assuming positive findings, UroGen anticipates submitting an NDA for UGN-102 in 2024.

On May 10, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a clinical trial collaboration agreement with Oslo University Hospital (OUS) to run a phase 1/2 study testing polyvalent mutant RAS vaccine TG01 in multiple myeloma (MM) following standard of care (SoC) therapy (Press release, Targovax, MAY 10, 2022, View Source [SID1234614005]).

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Oncogenic mutations in the RAS family of genes drive up to 30% of all cancers and remain a major unmet medical need with few good treatment alternatives. Targovax was recently awarded two prestigious research grants from Innovation Norway and the Norwegian Research Council, totaling NOK 18m, to advance its TG mutant RAS cancer vaccine program. These grants include funding towards several clinical studies, of which the first to open will be a TG01 phase 1/2 trial in MM patients with relevant KRAS and NRAS mutations (approx. 15-20% of MM patients) to be run in Oslo, Norway.

The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated MM patients who continue to have measurable disease after completion of SoC treatment. The aim is to assess whether anti-RAS T-cell priming induced by TG01 can enhance the clinical response. OUS will sponsor and be responsible for running and funding the trial, with Dr. Schjesvold as the principal investigator. Targovax will provide TG01 drug supply, scientific support and financial contribution.

Dr. Fredrik Schjesvold, Founder and Leader Oslo Myeloma Center, at Oslo University Hospital, and President of the Nordic Myeloma Study Group, said: "RAS-mutant multiple myeloma has poor prognosis and there are currently no available targeted treatment options for this patient population. Prior data clearly demonstrates the capability of TG01 to induce robust anti-RAS T-cell responses and eliminate residual disease in cancer patients, and suggest that TG vaccination could be a valuable tool to deepen and prolong responses in multiple myeloma. Being a Norwegian product makes it particularly interesting, and we very much look forward to collaborating with Targovax to test this concept in practice at our center."

Earlier in 2022, Targovax announced a collaboration with Agenus to utilize their proprietary vaccine adjuvant QS-21 STIMULON as an immune-stimulatory component of the TG vaccines for future development and commercialization. QS-21 has consistently demonstrated powerful antibody and cell-mediated immune responses both in cancer trials and commercially as a component of the Shingrix and Mosquirix vaccines. QS-21 should further potentiate the TG vaccines by driving stronger anti-RAS T-cell responses. The OUS trial will be the first study in patients of TG01 adjuvanted by QS-21.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "Following promising data from the first generation TG01 vaccine in pancreatic cancer, we have focused on enhancing our mutant RAS platform and establishing a cost-efficient, collaborative development plan to bring the program forward. We are now ready to bring TG01 back into the clinic in a new and improved format and are excited to work with Dr. Schjesvold and his team to assess the potential of TG01 in multiple myeloma. This trial will be the first step in a broader exploratory program with multiple collaboration partners aimed at testing TG01 vaccination in various RAS mutant cancer types and treatment combinations."

On May 10, 2022 Step Pharma, a biotech company developing CTPS1 inhibitors for the safe and effective oral treatment of cancer, reported that it has strengthened its clinical development team with the appointment of Dr. Brian Schwartz as Chief Medical Officer and Dr. Maureen Higgins as Vice President and Head of Clinical Operations, as it continues to advance STP938, its lead CTPS1 inhibitor, towards clinical studies in haematological malignancies (Press release, Step Pharma, MAY 10, 2022, View Source [SID1234614004]).

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Dr. Brian Schwartz brings more than 25 years of experience in drug development in the pharmaceutical and biotechnology industries, in areas including oncology, haematology and rare diseases. Dr. Schwartz previously served for twelve years at ArQule, where he was Chief Medical Officer and Head of Research and Development and led clinical development of the BTK inhibitor ARQ 531 before the company’s $2.7 billion acquisition by Merck in 2020. His previous roles also include CMO and Senior Vice President, Clinical and Regulatory Affairs at Ziopharm, where he oversaw the development of new cancer drugs. Earlier in his career, he held leadership roles at Bayer Healthcare and Leo Laboratories. Alongside his role at Step Pharma, Brian will continue to act as a consultant to other biotech companies, and also serve on the boards of Mereo BioPharma, Enlivex, Cyclacel Pharmaceuticals and Infinity Pharmaceuticals.

Dr. Schwartz, who practiced medicine prior to his career in the biopharmaceutical industry, holds a medical degree from the University of Pretoria, South Africa, and completed a fellowship at the University of Toronto, Canada.

Dr. Maureen Higgins has 30 years of experience in clinical research in project management, clinical operations, and business development within both the pharmaceutical and CRO sectors. Dr. Higgins was previously VP for Project Management at Precision for Medicine. Prior to that, she served as Director for Project Management at Chiltern Oncology, overseeing studies and leading project managers in the conduct and delivery of early phase oncology studies, and as Project Director at PRA Health Sciences, UK, where she project-managed early- and late-phase oncology, and neurology studies. She was also Director for Business Development at CroMedica and an Internal Business Consultant at Quintiles, where she also served as Head of Operations in South Africa.

Dr. Higgins holds a B.Sc. in Biology from Bristol Polytechnic, a Ph.D. in Molecular Developmental Genetics from the University of Edinburgh, where she also completed her post-doctoral fellowship in Molecular Biology and an MBA from Strathclyde Graduate Business School.

Andrew Parker, Chief Executive Officer of Step Pharma, commented: "On the eve of Step Pharma progressing into the clinic with STP938, we are delighted to have made such strong clinical operations appointments in Brian and Maureen. Step Pharma are the world leaders in CTPS1 inhibition, a novel approach that we believe could allow us to selectively target cancer cells, not only in our core focus of haematological cancers but in a combination setting in solid tumours as well."

Dr. Brian Schwartz, Chief Medical Officer, commented: "Researchers have been trying to target pyrimidine synthesis for decades to treat cancer without success, but with Step Pharma’s CTPS1 approach I believe we have the breakthrough. I am delighted to be joining such an experienced team at this pivotal time for the company."

Dr. Higgins, VP, Head of Clinical Operations, commented: "Step Pharma is the world leader in CTPS1 research and with its strong scientific heritage, outstanding team and high-quality investors has the clear recipe for success. I am excited to support the company take the next important clinical step in its development."

On May 9, 2022 Ingenium Therapeutics reported that it has applied to the Ministry of Food and Drug Safety for phase 2 clinical trials of ‘Memory-NK’ cell therapy for relapsed acute myeloid leukemia (AML) (Press release, Ingenium Therapeutics, MAY 9, 2022, View Source [SID1234643521]).

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This phase 2 will be conducted at three medical institutions in Korea, including Asan Medical Center in Seoul, Samsung Medical Center, and St. Mary’s Hospital in Seoul. The goal is to complete clinical trials and receive conditional approval in 2024.

According to the company, chimeric antigen receptor T cell (CAR-T) treatment is commercially available for lymphocytic leukemia, but there is currently no specific treatment for relapsed AML. Accordingly, it is expected that Memory-NK treatment will provide an innovative treatment method.
Ingenium’s Memory-NK cell therapy product is expected to have strong anti-cancer properties due to its high expression level of surface-activated receptors and high levels of ‘interferon gamma (IFN-r)’. It was said that cell viability was also high, overcoming the problem of short in vivo survival period, known as a limitation of existing NK cell treatments.

Ingenium said that it confirmed the therapeutic efficacy and safety of Memory-NK cells in a clinical trial conducted by researchers on about 100 patients with recurrent AML. It was said that the anti-cancer treatment potential was also confirmed in animal test models of solid cancers such as lung cancer, liver cancer, and colon cancer. Ingenium plans to formulate and conduct clinical trials of Memory-NK for the treatment of solid tumors in the future.

In addition, basic research on ‘CAR-NK’ and ‘NK engager’ is also being conducted to increase the effectiveness of Memory-NK. Preclinical research is also underway for a self-developed peptide (IGTN13) that has been shown to increase the anti-cancer effect of NK cells. We plan to begin clinical trials of additional candidate substances sequentially within two years.

Ingenium completed ‘Pre-Series A’ funding worth 5.7 billion won in March. We plan to recruit investors for Series A by September.