On November 10, 2021 Sysmex Corporation reported that actual financial results during the six months ended September 30, 2021, differed in some respects from the forecast announced on May 12, 2021 (Press release, Sysmex, NOV 10, 2021, View Source [SID1234595043]). In addition, Sysmex has revised its financial forecast for the full fiscal year ending March 31, 2022. These differences are described below.

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1. Differences between Actual and Forecast of Consolidated Financial Results for the Six Months Ended September 30, 2021 (April 1, 2021 to September 30, 2021)
2. Revised Consolidated Financial Forecast for the Fiscal Year Ending March 31, 2022 (April 1, 2021 to March 31, 2022)
3. Reasons for the Differences and Revision
On the consolidated net sales front, in the first six months of the fiscal year ending March 31, 2022, sales were robust both in Japan and overseas. Results outpaced our previous forecast, mainly for this reason and because foreign exchange rates reflected greater-than-expected yen depreciation. On the profit front, in addition to the impact of yen depreciation on foreign exchange rates, selling, general and administrative (SG&A) expenses were lower due to the impact of COVID-19. As a result, operating profit, profit before tax and profit attributable to owners of the parent exceeded our previousforecasts.

As for our forecast for the fiscal year ending March 31, 2022, although there are uncertainties, we expect that sales will be robust continuously and greater-than-expected yen depreciation will continue. For these reasons, we have revised upward our forecast for the full fiscal year ending March 31, 2022, as we now expect net sales, operating profit, profit before tax and profit attributable to owners of the parent to be above our previously forecast figures.

We have revised our foreign exchange assumptions used for calculating financial forecasts from the third quarter onward from our initial assumptions of USD1.00 = JPY106, EUR1.00 = JPY125 and CNY1.00 = JPY16 to USD1.00 = JPY112, EUR1.00 = JPY130 and CNY1.00 = JPY17.

On November 10, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809, NASDAQ: EVO) reported that the Company reached additional programme designations within its neuroscience collaboration with Bristol Myers Squibb (NYSE:BMY) triggering payments of in total US$ 40 m to Evotec (Press release, Evotec, NOV 10, 2021, View Source [SID1234594996]).

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These target-based programme designations further bolster the growing pipeline and are expected to follow EVT8683, which Bristol Myers Squibb opted to license after the successful filing of an IND application with the FDA.

Dr Cord Dohrmann, Chief Scientific Officer of Evotec, said: "Our collaboration with BMS continues to be highly productive. These achievements are a testimony of the great team spirit between Bristol Myers Squibb and Evotec colleagues that enabled us to advance highly challenging programmes to key value inflection points."

The collaboration was initiated in December 2016 with the goal of identifying disease-modifying treatments for a broad range of neurodegenerative diseases. Currently approved drugs only offer short-term management of the patients’ symptoms and there is a huge unmet medical need for therapeutic modalities that slow down or reverse disease progression. The collaboration leverages Evotec’s industrialised iPSC platform using patient-derived disease models, which is one of the largest and most sophisticated platforms in the industry.

On November 10, 2021 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first nine months of 2021 (Press release, Epigenomics, NOV 10, 2021, View Source [SID1234594995]).

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9M 2021 FINANCIAL RESULTS

Total revenue in the first nine months of 2021 increased to EUR 6,022 thousand (9M 2020: EUR 541 thousand), due to the sale of samples from the Company’s "biobank" in the amount of EUR 5,675 thousand. Product revenue decreased from EUR 453 thousand to EUR 330 thousand in the reporting period compared to the same period of the previous year due to the Covid-19 pandemic.
Research and development costs decreased from EUR 3,412 thousand to EUR 2,226 thousand in the nine-month period due to a reduction in clinical study costs related to Covid-19; however, patient enrollment for the Epi pro Colon post-approval study has recently begun to increase closer to pre Covid 19 levels.
Selling and administrative expenses increased slightly from EUR 5,442 thousand to EUR 5,809 thousand primarily due to the costs associated with the sale of the Biobank samples.
EBITDA (before share-based payment costs) improved significantly to EUR -209 thousand in the reporting period compared to EUR -8,090 thousand in the same period of the previous year. This is also primarily due to the biobank samples sale.
The net loss for the period also decreased significantly to EUR -691 thousand (9M 2020: EUR -9,109 thousand); accordingly, the loss per share decreased from EUR 1.59 to EUR 0.07 compared to the same period of the previous year.
Cash consumption decreased to EUR 3,598 thousand in the first nine months of 2021 (9M 2020: EUR 7,492 thousand).
As of 30 September 2021, the Company had cash and cash equivalents (including marketable securities) of EUR 23,555 thousand (31 December 2020: EUR 3,566 thousand).
OPERATIONAL DEVELOPMENTS

Epigenomics initiated clinical trial plans for Epi proColon "Next-Gen", an updated version of the assay that meets CMS reimbursement criteria based upon performance from prospectively collected banked clinical samples. The Company plans to begin enrollment in the summer of 2022.
In addition, Epigenomics executed a EUR 5.7 million sale of samples from the Company’s extensive biobank. The Company has retained the necessary samples to complete development activities for Epi proColon "Next-Gen".
In September the company successfully completed the placement of a subordinated non-interest-bearing mandatory convertible bond that raised EUR 16.5 million in gross proceeds.
OUTLOOK 2021

Revenue

As a result of the sale of the biobank to New Horizon Health Limited, the revenue and earnings guidance for the full year 2021 was adjusted on August 17, 2021: The Company expects revenues of EUR 6.0 million for the financial year 2021 (previously: EUR 0.4 million to EUR 1.0 million).
EBITDA / cash consumption

For EBITDA before share-based payment costs, Epigenomics forecasts a range of EUR -3.0 million to EUR -4.0 million (previously: EUR -7.0 million to EUR -9.0 million) for the full year 2021. Based on the Company’s 2021 business plan, cash consumption is expected to range between EUR 3.5 million to EUR 4.5 million (previously: EUR 7.0 million to EUR 9.0 million).
Further information

The financial report for the first nine months of 2021 is available on the Epigenomics’ website at: View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

The dial-in numbers for the conference call are (for registered participants):

Dial-in number Germany: +49 30 232531508
Dial-in number UK: +44 1635 598058
Dial-in number U.S.A.: +1 516-269-8975

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Company’s website following the call.

On November 9, 2021 CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on the research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, and DotBio Pte. Ltd ("DotBio"), a biotech company specialized in next generation antibody therapies, reported that they have entered into a collaboration agreement (Press release, DotBio, NOV 9, 2021, View Source [SID1234646737]). This collaboration represents the first project to be settled at CStone Global R&D Headquarters and Industrialization Base in Suzhou. CStone will lead the design of target combination based on the intended mechanism of action and DotBio will lead the molecular design and engineering. It will become a source of innovative preclinical candidates to support CStone’s Pipeline 2.0 strategy, further accelerating drug discovery with denovo design.

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Under the partnership, the two sides will jointly develop up to three first-in-class or best-inclass next-generation antibody therapies, including multi-functional antibodies and antibodydrug conjugates (ADCs). CStone will take an equity position in DotBio and has the option to acquire global rights to the molecules at predefined terms.

DotBio’s proprietary DotBody technology platform is based on the concept of modular design. By prefabricating antibody modules with specific functions, DotBio is able to combine them on demand to build multi-functional antibodies quickly and efficiently, improving antibody quality, development success rate and efficiency. This high throughput process allows DotBio to generate multi-specific antibodies, ADCs and intracellular antibodies in a matter of months as opposed to over a year. The DotBody platform has been optimized for autonomous folding, better stability, high expression levels, high concentration, and low aggregation.

Dr. Archie Tse, Chief Scientific Officer of CStone, said: "In our organic research model, we utilize the scientific expertise and clinical insights of our experienced R&D team to select targets and design projects, while leveraging external synergies, particularly by working with platform companies with unique technological advantages, to develop high-quality innovative drugs. Technology platform collaborations of this nature, among other sources of innovation, will become an integral part of CStone’s discovery research engine. We are very excited about the potential of DotBio’s domain therapeutic antibody platform which is a perfect strategic fit to the modular, multi-specific, and multi-functional nature of the biologic products in our Pipeline 2.0. We believe that the collaboration between us will help advance the development of next-generation antibody therapies and bring the most effective medicines to cancer patients as early as possible."

Dr. Ignacio Asial, CEO and founder of DotBio, said, "DotBio aims to accelerate the development of next-generation cancer therapies through our modular design, multi-functional antibody discovery platform. This collaboration with CStone, a company with a wealth of expertise in cancer biology and clinical development, is an important step towards achieving this goal. The incubation of DotBio at CStone’s Global R&D Headquarters and Industrialization Base will offer both our teams a unique opportunity to work closely together. At the same time, this will provide DotBio with a strong foundation to expand into the China market. We are very excited about this collaboration and look forward to working with CStone to deliver more effective, DotBody-based treatments to patients."

Under the agreement, CStone will provide DotBio with a fully functional lab space and in-kind
resource sharing at CStone Global R&D Headquarters and Industrialization Base during the
collaboration period. DotBio will be eligible to earn milestone payments as the drug candidates
advance through development. If approved, DotBio is eligible for royalty payments.

On November 9, 2021 Takara Bio Inc. (Takara Bio), reported that it has decided jointly with Otsuka Pharmaceutical Co., Ltd. (Otsuka), to terminate agreements on co-development and exclusive marketing of the drug candidates oncolytic virus HF10 (development code: TBI-1401, INN: canerpaturev) and CD19 targeted CAR gene therapies (development code: TBI-1501) (Press release, Takara Holdings, NOV 9, 2021, View Source [SID1234611429]).
Takara Bio and Otsuka will continue to co-develop NY-ESO-1・siTCRTM gene therapy product (development code: TBI-1301).

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1.Reasons for the termination

Oncolytic virus HF10
Both Takara Bio and Otsuka have discussed development plans for pancreatic cancer and other malignancies after the Phase I clinical trial for pancreatic cancer, however, in consideration of the time required for future development and other factors, two companies have decided to terminate the agreement.

CD19-targeted CAR gene therapies
Both companies have been conducting a Phase I/II trial for adult acute lymphoblastic leukemia, however, in consideration of the lengthy period for clinical development and the competitive landscape, the two companies have decided to terminate the agreement.

2.Details of the termination agreement
Under this termination, Takara Bio regains technical, intellectual property and other rights granted by Takara Bio to Otsuka. In addition, in the future Takara Bio will not receive lump-sum payments upon achievement of milestones under this agreement or receive any sales proceeds for clinical trial product sales.

3.Overview of the other party to terminate this agreement

[1] Company name

Otsuka Pharmaceutical Co., Ltd.

[2] Head office

2-9, Kanda-Tsukasamachi, Chiyoda-ku, Tokyo 101-8535, Japan

[3] URL
View Source

4.　Schedule
Corporate resolution, date of the termination agreement: November 9, 2021

5.　Future Outlook
The impact of the termination of these agreements on the consolidated financial results of the Company for the FY2022 ending March, 2022 will be minor.