On November 10, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for cancer patients suffering from solid tumors, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, TCR2 Therapeutics, NOV 10, 2021, View Source [SID1234595218]).

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"Over the last few months, we continue to treat cancer patients in our ongoing gavo-cel Phase 1 clinical trial and have observed meaningful clinical benefit in three different treatment-refractory solid tumor indications," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "As we prepare for the phase 2 trial to be launched in early 2022, we are expanding our US manufacturing footprint and successfully negotiated a clinical trial collaboration agreement with Bristol Myers Squibb, where we will have the opportunity to evaluate the efficacy and duration of gavo-cel in combination with Opdivo and Yervoy. We anticipate selecting the RP2D before year end and look forward to providing an update on gavo-cel in 1Q22 following review by the US Food and Drug Administration."

Recent Developments

Gavo-cel:

TCR2 announced positive interim data from the first 17 patients treated in the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for mesothelin-expressing solid tumors. 15 of the 16 patients evaluable for efficacy experienced regression of their target lesions including 6 patients that achieved a partial response (PR) by target lesion assessment, 4 of whom met criteria for a PR according to RECIST 1.1 criteria. The maximum tolerated dose (MTD) was declared 5×108/m2after lymphodepletion.
Following identification of the MTD, TCR2 announced the completion of the 3-patient cohort at the new dose level 3.5A (3×108/m2 following lymphodepletion) using a split dosing approach. Two patients were evaluable for safety. In both cases, gavo-cel was well-tolerated with no patients experiencing Grade ≥3 cytokine release syndrome (CRS).
TCR2 announced a clinical trial collaboration agreement with Bristol Myers Squibb (NYSE: BMY) to evaluate gavo-cel in combination with Opdivo (nivolumab) and Yervoy (ipilimumab) in its planned Phase 2 clinical trial in treatment refractory mesothelin-expressing solid tumors.
Corporate:

TCR2 announced at its virtual R&D Day on October 20, 2021, its pipeline prioritization of solid tumors and highlighted programs from its emerging TRuC pipeline including TC-510, its first TRuC-T cell enhanced with a PD1xCD28 switch receptor; TC-520, its lead candidate targeting CD70 expressing an IL-15 enhancement; allogeneic TRuC-T cells; and TRuC Tregs, the first utilization of the TRuC platform in the autoimmune setting.
TCR2 announced the expansion of its manufacturing capacity by exercising an option on a second clean room at ElevateBio BaseCamp which adds to the buildout of clinical and commercial supply currently underway at its Rockville, MD facility. In connection with this expansion, TCR2 proposes to cease manufacturing activities at the Cell and Gene Therapy Catapult (CGT Catapult) in Stevenage, UK.
Anticipated Milestones

TCR2 anticipates the identification of the recommended Phase 2 dose (RP2D) in 4Q21.
TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T cell (targeting mesothelin with a PD1xCD28 switch), in the first quarter of 2022.
TCR2 anticipates initiation of IND-enabling studies for TC-520, an enhanced CD70 targeting TRuC-T cell program in 2022.
TCR2 plans to select a lead candidate for its allogeneic program in 2022.
TCR2 anticipates production of clinical trial material from ElevateBio BaseCamp in anticipation of demand from the Phase 2 expansion trial of gavo-cel in 2022.
Financial Highlights

Cash Position: TCR2 ended the third quarter of 2021 with $295.7 million in cash, cash equivalents, and investments compared to $228.0 million as of December 31, 2020. Net cash used in operations was $19.4 million for the third quarter of 2021 compared to $10.8 million for the third quarter of 2020. TCR2 projects net cash use of $100-105 million for 2021, the lower end of the range previously provided. We expect cash on hand to support operations through 2023.

R&D Expenses: Research and development expenses were $20.3 million for the third quarter of 2021 compared to $12.8 million for the third quarter of 2020. The increase in R&D expenses was primarily due to an increase in headcount, additional lab facilities, and manufacturing facilities.

G&A Expenses: General and administrative expenses were $6.0 million for the third quarter of 2021 compared to $4.4 million for the third quarter of 2020. The increase in general and administrative expenses was primarily due to an increase in personnel costs.

Net Loss: Net loss was $26.2 million for the third quarter of 2021 compared to $16.9 million for the third quarter of 2020.
Upcoming Events

TCR2 Therapeutics management is scheduled to participate at the following upcoming conferences.

Jefferies London Healthcare Conference: Garry Menzel, President and Chief Executive Officer of TCR2 Therapeutics, will present an update on Company progress on Tuesday, November 16, 2021 at 12:20pm GMT (7:20am ET)
Piper Sandler 33rd Annual Virtual Healthcare Conference: management will participate in a fireside chat using a virtual platform on Monday, November 22, 2021 at 10:00am ET

On November 10, 2021 TScan Therapeutics, Inc. (Nasdaq: TCRX), a biopharmaceutical company focused on the development of T-cell receptor (TCR) engineered T cell (TCR-T) therapies for the treatment of patients with cancer, reported financial results for the quarter ended September 30, 2021, highlighted recent program progress, and outlined key upcoming expected milestones (Press release, TScan Therapeutics, NOV 10, 2021, View Source [SID1234595217]).

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"Throughout the third quarter of 2021, we’ve continued to execute on our long-term goals of advancing transformational TCR-T therapy candidates and expect to file IND applications for our lead liquid tumor candidates TSC-100 and TSC-101 by the end of the year," said David Southwell, President and Chief Executive Officer. "We look forward to sharing additional details on our liquid tumor program at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. We also made significant progress across our solid tumor pipeline, particularly the advancement of TSC-200 into IND-enabling studies and the launch of a new TCR program based on the discovery of a novel epitope on the validated solid tumor target MAGE-A1."

Third Quarter 2021 and Recent Business Highlights

TScan recently announced that two abstracts related to lead liquid tumor TCR-T therapy candidates TSC-100 and TSC-101 have been accepted for poster presentations at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held from December 11-14, 2021.

During the third quarter, TScan advanced a lead TCR-T therapy candidate for its TSC-200 program for HPV16 into investigational new drug (IND)-enabling activities and plans to submit an IND for this program in the second half of 2022. HPV is a well validated cancer target found in HPV-positive tumors, including many cases of head & neck and cervical cancers. Using its proprietary ReceptorScan and TargetScan platforms, TScan screened over half a billion T cells from a variety of human donors to identify a naturally occurring, ultra-high affinity TCR that recognizes an HLA-A*02:01-restricted epitope derived from the E7 protein of HPV16. Previously, clinical data from the National Cancer Institute (NCI) demonstrated a favorable safety and efficacy profile for an HPV TCR. TScan intends to build on the positive NCI results by developing an enhanced autologous TCR-T therapy using its T-Integrate cell manufacturing platform and by multiplexing its HPV TCR with additional TCRs in its TSC-2xx series of cell therapy candidates. TScan has used the large cargo capacity of T-Integrate to include in the TSC-200 construct features that enable engineering of both cytotoxic and helper T cells and features designed to help confer resistance to the immunosuppressive micro-environment of solid tumors.

TScan has recently discovered a novel HLA-C*07:02-restricted epitope encoded by the well-known cancer/testis gene MAGE-A1, using its TargetScan platform. This cancer-specific gene is frequently overexpressed in a wide variety of solid tumors. In the U.S., the target is expressed in as many as 45% of head & neck cancer patients, 50% of melanoma patients, 50% of cervical cancer patients and 50% of non-small cell lung cancer patients. The TCR that recognizes this novel epitope was isolated from a patient with head & neck cancer who exhibited an exceptional response to immune checkpoint inhibitor therapy. TScan has launched a new program, TSC-204, that will include multiple TCRs for different HLA-restricted epitopes on this same protein. TScan believes that it is the only company with a disclosed TCR program in MAGE-A1 for HLA types other than A*02:01. The Company has now advanced TSC-204 into lead TCR-T therapy candidate optimization.

The Company expanded its management team with the appointments of Zoran Zdraveski, J.D., Ph.D., as Chief Legal Officer, and Heather Savelle as Vice President, Investor Relations.

In July 2021, TScan completed its initial public offering, raising $100 million in aggregate gross proceeds, before deducting underwriting discounts and commissions and offering expenses, and began trading on The Nasdaq Global Market. The IPO followed the closing of a Series C preferred stock financing of $100 million in gross proceeds in January 2021.

In July 2021, Gavin MacBeath, Ph.D., TScan’s Chief Scientific Officer, presented findings from TScan’s work to discover the targets of T cells in recovering COVID-19 patients at the Cell-Mediated Therapies for Infectious Disease Summit. The presentation also featured in vitro data comparing several polyepitope T cell vaccine candidates based on the Company’s novel T cell target discoveries. TScan is now advancing these T cell-eliciting vaccine candidates through pre-clinical development with the goal of engineering a COVID-19 vaccine that generates long-term immunity with less susceptibility to resistance from emerging variants. In addition to addressing the current pandemic, this program represents proof-of-concept for a novel class of vaccines that are designed to elicit a long-lasting T cell response to infectious pathogens.

Upcoming Expected Milestones and Key Priorities

Liquid Tumor Programs: TScan’s two lead liquid tumor TCR-T therapy candidates, TSC-100 and TSC-101, are designed to target HA-1 and HA-2, respectively, and treat patients with hematological malignancies who are undergoing allogeneic hematopoietic stem cell transplantation.

TScan will present two posters related to TSC-100 and TSC-101 at the upcoming ASH (Free ASH Whitepaper) Annual Meeting and Exposition.

IND-enabling studies and the submission of IND applications to the U.S. Food and Drug Administration (FDA) are planned for TSC-100 and TSC-101 during the fourth quarter 2021.

Following the IND submissions and pending acceptance by the FDA, clinical trials for TSC-100 and TSC-101 are expected to begin in the first half of 2022 with preliminary data expected in the second half of 2022.

Solid Tumor Programs: TScan’s TSC-200 series of TCR-T therapy candidates include a combination of known targets, such as HPV16 for TSC-200, PRAME for TSC-203, and MAGE-A1 for TSC-204, as well as targets that are novel antigens for TCR-T therapy, such as those for TSC-201 and TSC-202.

TScan plans to present preclinical data of the TSC-2xx series during the first half of 2022.

·TScan plans to progress IND-enabling studies for the TSC-2xx series and submit IND applications during the second half of 2022, including for TSC-200 for HPV, during the second half of 2022. Further INDs are planned for 2023.

Infectious Disease Program

Research is continuing into potential T cell-focused COVID-19 vaccine constructs utilizing TScan’s novel T cell target discoveries.

Third Quarter 2021 Financial Results

As of September 30, 2021, the Company had cash and cash equivalents totaling $182.3 million, excluding restricted cash of $0.6 million. Based on the Company’s current operating plan, TScan expects that cash and cash equivalents as of September 30, 2021, will enable it to fund its operating expenses into 2024.

Research and development expenses for the third quarter 2021 were $14.2 million, compared to $5.8 million for the third quarter 2020.

General and administrative expenses for the third quarter 2021 were $4.0 million, compared to $1.6 million for the third quarter 2020.

Net loss for the third quarter 2021 was $15.8 million or $0.80 per common share, compared to a net loss of $7.2 million or $7.16 per common share for the third quarter 2020. Net loss per share was calculated using 19.9 million weighted average common shares and 1.0 million weighted average common shares outstanding for the third quarter of 2021 and 2020, respectively.

On July 20, 2021, the Company issued 6,666,667 shares of common stock in its IPO, raising gross proceeds of $100 million. In addition, upon closing of the IPO, all of the Company’s outstanding shares of convertible preferred stock automatically converted into 15,616,272 shares of common stock (of which 5,143,134 shares are non-voting common stock). This brings the total shares outstanding as of November 5, 2021, to 23,768,036, which consists of 18,624,902 shares of voting common stock and 5,143,134 shares of non-voting common stock.

TScan’s latest presentation is available on the "Events and Presentations" section of the Company’s website, and can be accessed here.

On November 10, 2021 Harpoon Therapeutics, Inc. (Nasdaq: HARP), a clinical-stage immunotherapy company developing a novel class of T cell engagers, reported financial results for the third quarter ended September 30, 2021 and provided a corporate update (Press release, Harpoon Therapeutics, NOV 10, 2021, View Source [SID1234595216]).

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"I look forward to working with the leadership team at Harpoon as we advance our novel immuno-oncology therapies to address the unmet medical needs of patients. We are encouraged by the clinical progress for our four proprietary TriTAC clinical programs, and we are excited to advance our ProTriTAC platform and to announce our third technology platform called TriTAC-XR at SITC (Free SITC Whitepaper)," said Julie Eastland, newly appointed President and Chief Executive Officer of Harpoon Therapeutics. "We remain focused on dose escalation and optimization across all four programs, and we plan to provide a corporate update by year end."

Third Quarter 2021 Business Highlights and Other Recent Developments

Harpoon recently appointed Julie Eastland as President and Chief Executive Officer, effective November 8, 2021. Ms. Eastland succeeds Jerry McMahon, Ph.D., who has resigned from his position as President and Chief Executive Officer and as a member of the company’s Board of Directors and will continue to serve as an advisor. Ms. Eastland joined the Harpoon Board in 2018 and her career spans more than 20 years of executive leadership in biotechnology, immunology, and clinical oncology.

Dose escalation for Harpoon’s four clinical stage programs, HPN424 (PSMA), HPN536 (mesothelin), HPN217 (BCMA) and HPN328 (DLL3) is ongoing and each program is enrolling patients. IND enabling studies are underway for HPN601 (EpCAM targeting ProTriTAC) for potential use in a broad range of solid tumors with high unmet medical need.

Two abstracts have been accepted for poster presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually and in person in Atlanta, Ga. from December 11-14, 2021. One of these presentations will report interim data from the Phase 1/2 study of HPN217, a half-life extended Tri-Specific T Cell Activating Construct (TriTAC) targeting B cell maturation antigen for the treatment of relapsed/refractory multiple myeloma.

The company’s third proprietary technology platform, extended release TriTAC-XR, is designed to mitigate cytokine release syndrome. Preclinical data supporting TriTAC-XR T cell engager platform will be highlighted in a poster presentation at the 36th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). The presentation will be available beginning at 7 a.m. on November 12.

Third Quarter 2021 Financial Results

Harpoon ended the third quarter of 2021 with $154.2 million in cash, cash equivalents, and marketable securities compared to $150.0 million as of December 31, 2020. The increase of $4.2 million to the cash balance at the end of the third quarter includes Harpoon’s follow-on financing that closed on January 11, 2021 resulting in net proceeds of approximately $107.6 million, less cash spend during the nine months on operating expenses.

Our cash used in operating activities for the fiscal year ending December 31, 2021 is expected to be $75 million to $80 million, below our original guidance of $85 million to $95 million that was initially provided in March 2021.

Revenue for the third quarter ended September 30, 2021 was $4.5 million compared to $3.9 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, revenue was $19.3 million compared to $10.0 million for the nine months ended September 30, 2020. For the third quarter ended September 30, 2021, the increase in revenue was primarily due to an increase in revenue recognized related to Harpoon’s Development and Option Agreement with AbbVie, for research and development services performed. For the nine months ended September 30, 2021, the increase in revenue was primarily due to an increase in revenue recognized due to the delivery of the second target under Harpoon’s Amended and Restated Discovery Collaboration Agreement with AbbVie.

Research and development expense for the third quarter ended September 30, 2021 was $17.0 million compared to $13.1 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, R&D expense was $51.5 million compared to $37.5 million for the nine months ended September 30, 2020. The increase for both periods, primarily arose from higher clinical development and personnel-related expense, which included conducting preclinical studies and clinical trials for HPN424, HPN536, HPN217 and HPN328.

General and administrative expense for the third quarter ended September 30, 2021 was $4.2 million compared to $4.4 million for the quarter ended September 30, 2020. For the nine months ended September 30, 2021, G&A expense was $13.1 million compared to $12.3 million for the nine months ended September 30, 2020. For the third quarter ended September 30, 2021, the decrease was primarily attributable to a decrease in legal expenses associated with the Maverick litigation, partially offset by an increase in personnel expenses due to an increase in headcount. For the nine months ended September 30, 2021, the increase was due to an increase in personnel expenses related to an increase in headcount and other professional services to support our operations as a public company, partially offset by a decrease in legal expenses associated with Maverick litigation.

Net loss for the third quarter ended September 30, 2021 was $16.7 million compared to $13.3 million for the quarter ended September 30, 2020. The net loss for the nine months ended September 30, 2021 was $95.2 million compared to $38.6 million in the first nine months of the prior year. Net loss for the nine months ended September 30, 2021, includes Maverick litigation settlement of $50.0 million.
COVID-19 Business Update

In response to the ongoing COVID-19 pandemic, Harpoon has established testing and other protocols for personnel access to its headquarter offices and laboratory although the majority of the company’s employees continue to telecommute. Harpoon is currently continuing its clinical trials, and has not experienced any material delays or impacts as a result of the COVID-19 pandemic. In addition, Harpoon’s third-party contract manufacturers continue to operate at or near normal levels. Harpoon continues to assess the potential impact of the COVID-19 pandemic on its business and operations, including its programs, expected timelines, expenses, manufacturing activities and preclinical and clinical trials. The full extent to which the COVID-19 pandemic may have a negative impact on Harpoon’s business, assets, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted.

On November 10, 2021 Kureha Corporation reported that (Press release, Kureha Corporation, NOV 10, 2021, View Source [SID1234595215])

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1. Consolidated Financial Results for the Second Quarter of the Fiscal Year Ending March 31, 2022 (From April 1, 2021 to September 30, 2021)
(1) Consolidated Operating Results
(2) Consolidated Financial Position

2. Dividends
2. Consolidated Earnings Forecast for the Fiscal Year Ending March 31, 2022 (From April 1, 2021 to March 31, 2022)

1. Advanced Materials In the advanced plastics category, revenue and operating profit rose on higher sales of polyvinylidene fluoride (PVDF) used as a binder material for lithium-ion secondary batteries, polyglycolic acid (PGA) products used in the process of shale oil and gas fracking, polyphenylene sulfide (PPS), and other processed plastics products. In the carbon products category, revenue rose on higher sales of carbon fiber used in heat insulating material for high-temperature furnaces and sliding material for automotive parts, but operating profit was flat year on year. As a result, revenue in Advanced Materials was 28,794 million yen (up 54.9% year on year), and operating profit was 2,600 million yen (versus operating loss of 760 million yen in the six months ended September 30, 2020).

2. Specialty Chemicals Revenue increased in the agrochemicals and pharmaceuticals category owing to higher sales of Kremezin (therapeutic agent for chronic renal failure) as well as agricultural and horticultural fungicides. However, operating profit was flat year on year. In the industrial chemicals category, revenue rose due to higher sales of organic chemicals, and earnings recovered to an operating profit from an operating loss recorded in the same period the previous year. Consequently, revenue in Specialty Chemicals was 12,804 million yen (up 15.7% year on year), resulting in an operating profit of 1,168 million yen (up 32.3% year on year).

3. Specialty Plastics Both revenue and operating profit increased in the consumer goods category as sales of New Krewrap plastic wrap for household use and Seaguar fluorocarbon fishing lines increased. In the packaging materials category, revenue and operating profit also increased due to higher sales of polyvinylidene chloride (PVDC) film and heat-shrink multilayer film. As a result, revenue in Specialty Plastics was 22,942 million yen (up 8.8% year on year), and operating profit was 5,140 million yen (up 38.1% year on year).

4. Construction In Construction, private-sector construction projects were on par with the previous year, but delays of public-sector construction starts caused both revenue and operating profit to decline year on year. Consequently, revenue in Construction was 5,524 million yen (down 5.2% year on year), and operating profit was 414 million yen (down 10.5% year on year).

5. Other Operations In the environmental engineering category, despite higher volumes of industrial waste treatment and processing including low-concentration PCB waste, revenue and operating profit declined on the completion of the natural disaster-related waste treatment and processing conducted during the same period the previous year. In the logistics category, both revenue and operating profit remained flat year on year. In the hospital operations category, both revenue and operating loss remained flat year on year. As a result, revenue in Other Operations was 9,003 million yen (down 4.9% year on year), and operating profit was 1,799 million yen (down 10.2% year on year).

(2) Overview of Financial Position for the Period under Review Total assets as of September 30, 2021 were 264,557 million yen, up 7,634 million yen compared to March 31, 2021. Current assets totaled 91,804 million yen, up 5,567 million yen from March 31, 2021, due to increases in cash and cash equivalents and trade receivables. Non-current assets stood at 172,752 million yen, up 2,066 million yen from March 31, 2021. Contributing factors to the rise in non-current assets were increases in the valuation of investment securities, intangible assets, assets related to equity method investments, and retirement benefit asset, which offset the 2,280 million yen decline in property, plant and equipment to 117,891 million yen from the reduction entry accompanying receipt of government subsidy. Total liabilities were 70,859 million yen, down 542 million yen compared to March 31, 2021. This primarily reflects the repayment of loans payable, which minimized the interest-bearing debt by 2,042 million yen to 27,464 million yen, more than absorbing the increase in trade payables. Total equity was 193,698 million yen, up 8,176 million yen compared to March 31, 2021. This was mainly due to the recording of 8,328 million yen in profit attributable to owners of the Company and an increase in other components of equity, which offset the dividend payments of 1,659 million yen from retained earnings. As of September 30, 2021, the COVID-19 pandemic has had no impact on the Group’s capacity to secure liquidity or collect accounts receivable.

(3) Outlook for the Fiscal Year Ending March 2022 and beyond In light of recent performance trends, the Company has revised its consolidated earnings forecast for the fiscal year ending March 31, 2022 from the figures announced on May 12, 2021. For details, please refer to the "Notice of Revised Financial Forecast and Revised Dividend Forecast" released today (November 9, 2021)

On November 10, 2021 Sysmex reported that (Press release, Sysmex, NOV 10, 2021, View Source [SID1234595214])

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1. Results for the First Six Months of the Fiscal Year Ending March 31, 2022
(1) Operating results
(2) Financial condition

2. Dividend
3. Financial Forecast for the Year Ending March 31, 20224.

Other Information
(1) Changes in significant consolidated subsidiaries (which resulted in changes in scope of consolidation):
No (2) Changes in accounting policies and accounting estimates
1) Changes in accounting policies required by IFRS:
No 2) Other changes in accounting policies:
No 3) Changes in accounting estimates:
No (3) Number of outstanding stock (common stock)

1) Number of outstanding stock at the end of each fiscal period (including treasury stock): 209,485,632 shares as of Sep. 30, 2021; 209,443,232 shares as of Mar. 31, 2021
2) Number of treasury stock at the end of each fiscal period: 447,055 shares as of Sep. 30, 2021; 446,876 shares as of Mar. 31, 2021
3) Average number of outstanding stock for each period (cumulative): 209,014,581 shares for the six months ended Sep. 30, 2021 208,859,643 shares for the six months ended Sep. 30, 20201.

Qualitative information on quarterly financial results
1) Operating performance analysis Future-related information contained in the text below is based on the judgement as of the end of the fiscal period under review. During the first six months of the fiscal year ending March 31, 2022, the Japanese economy was affected by the COVID-19 pandemic. Despite progress with rolling out vaccines, social activity and personal consumption remained sluggish, due to reissuing the state of emergency and the priority preventative measures. Overseas, economic deregulation led to a gradual economic recovery, albeit with variations among countries and regions. Even so, the outlook remains uncertain due to the gradual shrinking of fiscal and monetary policies and the impact of the global shortage of semiconductors. On the healthcare front, we are seeing major changes in the healthcare environment due to the COVID-19 pandemic, as well as an aging society and increasingly diverse health and medical needs.

In Japan, expectations are mounting for new medical services to address the "new normal," such as resolving the pressure on medical systems due to a rise in the number of infections, stable supplies of necessary supplies and a response to digitalization in the medical field. Looking overseas, aging populations in developed countries are driving demand for the moderation of medical systems. In emerging markets, healthcare demand is increasing, and demand is rising for higher levels of healthcare quality, service enhancements and preventive medicine. As a result, we are seeing rapid advances in the application of artificial intelligence, big data analysis and other leading-edge technologies, which are expected to provide further opportunities for growth. Against this backdrop, Sysmex continued to expand its product portfolio in the hematology field. We launched a next-generation flagship model, XR-Series Automated Hematology Analyzer, and a compact three-part differential model, the XQ-Series Automated Hematology Analyzer in Japan. We will continue with a global sales rollout after receiving regulatory approval in individual countries.

We aim to contribute optimization of laboratory operations according to regional characteristics and facilities’ needs. In the life science field, we formed a strategic alliance related to joint development and global business with QIAGEN N.V., which has extensive experience in the development of companion diagnostics*1 in the field of oncology. By leveraging QIAGEN’s experience in developing companion diagnostics, Sysmex expects to strengthen its global relationships with pharmaceutical companies. We will work toward the early development and clinical implementation of companion diagnostics. "Genetic diagnosis and counseling for inherited retinal dystrophy (IRD)*

2 using a genetic testing system (tentatively named the IRD Panel Testing System), which Sysmex and the Kobe City Eye Hospital have been developing jointly, has received Advanced Medical Care B*3 approval. Going forward, we will commence this testing at the Kobe City Eye Hospital. In addition, we will increase the number of cooperating facilities for advance medical care that can perform this test, in the aim of increasing opportunities for patients to receive medical care. As the global general distributor, Sysmex continued to market hinotori to medical institutions in Japan. (The hinotori Surgical Robot System is the first made-in-Japan robotic-assisted surgery system.) We are working with Medicaroid Corporation, a joint venture between Sysmex and Kawasaki Heavy Industry, Ltd., to obtain regulatory approval overseas, and we will begin introducing the system in overseas markets, as well.

*1 Companion diagnostics: Testing to predict the efficacy or risk of side effects of specific drugs before prescription. *2 Inherited retinal dystrophy (IRD): IRD is an inherited progressive disease thought to be caused by genetic mutations. The main symptoms are night blindness, narrowing of the visual field, and loss of vision, which can lead to blindness in some cases. Several diseases with similar symptoms are collectively referred to as inherited retinal dystrophy.
*3 Advanced medical care B: Advanced medical care is new experimental medical technology whose effectiveness and safety have not yet been evaluated, and which has been designated by the Ministry of Health, Labor and Welfare as a medical technology to be evaluated for effectiveness and safety in order to determine whether it should be covered by insurance in the future. Within this category, Advanced medical care B may be conducted only at medical institutions that meet the facility criteria set for each medical technology.