Veracyte Announces Proposed Public Offering of Common Stock

On February 3, 2021 Veracyte, Inc. (Nasdaq: VCYT) (the "Company") reported that it has commenced an underwritten public offering of $400.0 million in shares of its common stock (Press release, Veracyte, FEB 3, 2021, View Source [SID1234574558]). All of the shares are being offered by Veracyte. In addition, the Company expects to grant the underwriters a 30-day option to purchase up to an additional $60.0 million in shares of its common stock at the public offering price, less underwriting discounts and commissions.

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Veracyte intends to use the net proceeds from the offering, together with its existing cash, to finance its acquisition of Decipher Biosciences, Inc. Veracyte intends to use the remaining net proceeds from the offering for working capital and other general corporate purposes, which may include acquisitions or investments in complementary businesses, technologies or other assets, although it has no present commitments or agreements to do so (other than with respect to Decipher Biosciences, Inc.).

Goldman Sachs & Co. LLC and SVB Leerink LLC are acting as joint lead book-running managers for the offering, William Blair & Company, L.L.C. is acting as a book-running manager and BTIG, LLC, Needham & Company, LLC, and Lake Street Capital Markets, LLC are acting as co-managers.

The shares will be issued pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission (SEC) on February 3, 2021. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained by contacting Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by email at [email protected], or by telephone at (866) 471-2526; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 01220, by email at [email protected], or by telephone at (800) 808-7525, ext. 6105.

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

ORIC Pharmaceuticals to Participate in Upcoming Investor Conferences

On February 3, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that management will participate in the following investor conferences in February (Press release, ORIC Pharmaceuticals, FEB 3, 2021, View Source [SID1234574557]):

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Guggenheim Healthcare Talks 2021 Oncology Day – Participating in a virtual fireside chat on February 11, 2021 at 1:00 p.m. ET/10:00 a.m. PT; and

LifeSci Partners Precision Oncology Day – Hosting virtual investor meetings on February 17, 2021.
A live webcast of the fireside chat will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

Kaleido Biosciences Announces Proposed Public Offering of Common Stock

On February 3, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage healthcare company with a differentiated, chemistry-driven approach to targeting the microbiome to treat disease and improve human health, reported that it intends to sell, subject to market and other conditions, $50 million of shares of its common stock in an underwritten public offering (Press release, Kaleido Biosciences, FEB 3, 2021, View Source [SID1234574556]). Kaleido also intends to grant the underwriters a 30-day option to purchase an additional $7.5 million of shares of its common stock offered in the public offering. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. All of the shares in the proposed offering are to be sold by Kaleido.

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Morgan Stanley and Piper Sandler are acting as joint book-running managers for the offering.

Kaleido intends to use the net proceeds from the offering, in addition to its existing cash resources, to fund its continued research and development activities, including the completion of the ongoing clinical studies of KB109 in patients with mild-to-moderate COVID-19 and the ongoing clinical study of KB295 in patients with mild-to-moderate ulcerative colitis; to conduct additional studies or initiate preparation for commercialization of KB109 if current studies in patients with mild-to-moderate COVID-19 are successful; to generate additional data and/or begin clinical studies in other areas such as immuno-oncology, cardiometabolic and liver diseases and diseases associated with pathogens; to fund any other research and development activities that relate to its current and future clinical and preclinical activities; and the remainder for planned general and administrative expenses, working capital and other general corporate purposes.

The securities described above are being offered by Kaleido pursuant to a shelf registration statement on Form S-3 (No. 333-240323), including a base prospectus. The securities will be offered only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014 and Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by email at [email protected].

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.

Summary of Consolidated Financial Results for the First Nine Months of the Fiscal Year Ending March 31, 2021(PDF?452KB)

On February 3, 2021 Sysmex reported that Summary of Consolidated Financial Results [ IFRS ] for the First Nine Months of the Fiscal Year Ending March 31, 2021(Press release, Sysmex, FEB 3, 2021, View Source [SID1234574554])

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1. Results for the First Nine Months of the Fiscal Year Ending March 31, 2021
(1) Operating results
(2) Financial condition

2. Dividend

3. Financial Forecast for the Year Ending March 31, 20214.

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): 209,396,032 shares as of Dec. 31, 2020; 209,266,432 shares as of Mar. 31, 2020
2) Number of treasury stock at the end of each fiscal period: 446,876 shares as of Dec. 31, 2020; 446,680 shares as of Mar. 31, 2020 3) Average number of outstanding stock for each period (cumulative): 208,881,059 shares for the nine months ended Dec. 31, 2020 208,741,275 shares for the nine months ended Dec. 31, 2019

Note: Quarterly summaries of financial results are excluded from quarterly reviews.
* Explanation regarding the appropriate use of financial forecast and other information

1. Basic earnings per share have been revised from the figures indicated in the consolidated financial forecast announced on November 5, 2020, in accordance with changes in the number of shares of outstanding stock and treasury stock. No other figures in the financial forecast have been revised.

2. The forecasts and future projections contained herein have been prepared on the basis of rational decisions given the information available as of the date of announcement of this document. These forecasts do not represent a commitment by the Company, and actual performance may differ substantially from forecasts for a variety of reasons. Please refer to

"3) Consolidated financial forecast" within "

1. Qualitative information on quarterly financial results" on page 5 of the attachment to this document for cautionary statements concerning the conditions and performance forecasts that serve as the basis for these forecasts.
3. Supplementary financial materials (in Japanese and English) will be posted on the Sysmex website on Wednesday, February 3, 2021.

1. 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 nine months of the fiscal year ending March 31, 2021, economic activity in Japan was down substantially as the result of the COVID-19 pandemic.

Although this activity gradually picked up after the first state of emergency declaration was lifted, the winter brought a resurgence in infections, making the outlook increasingly uncertain. Overseas, further waves of infections prompted countries in Europe and other areas to reimpose and reinforce lockdowns, leading to mounting concern that economic activity would slump again. On the healthcare front, Japan’s medical and healthcare field is expected to remain robust due to an aging society and increasingly diverse health and medical needs.

Looking overseas, the populations of developed countries are aging, while economic growth in emerging markets is causing healthcare demand to increase and prompting higher levels of healthcare quality and service enhancements. These trends are promoting efficient healthcare, with structural changes brought about by artificial intelligence, information and communications technology, and other breaking technologies. However, with the number of COVID-19 cases rising globally, considerations about healthcare systems and public health capable of responding to pandemics like we are currently experiencing are exerting pressure and are likely to cause a major transformation of the healthcare environment itself.

As COVID-19 infections increased, restrictions on outings and other activities in individual countries led to a decline in demand, including a drop in the number of tests conducted at medical institutions. A pause in the growth of infections prompted an easing of restrictions on movement, which did cause demand to resurge somewhat. However, performance could be affected by another resurgence in the pandemic. Against this backdrop, Sysmex obtained regulatory approval in Japan for the HISCLTM SARSCoV-2 Ag Reagent, a SARS coronavirus antigen kit to detect antigens of SARS-CoV-2, the strain of coronavirus that causes COVID-19.

The kit has received insurance coverage, and we have commenced sales. This kit enables detection of SARS-CoV-2 antigens in samples from nasopharyngeal swabs and nasal swabs. Meanwhile, through joint research Sysmex and the National Center for Global Health and Medicine have identified IFN-λ3, which is a useful biomarker for identifying patients who are at high risk of worsening symptoms. We obtained regulatory approval in Japan for the HISCL IFN-λ3 Assay Kit, an interferon λ3 kit for measuring IFN-λ3 in blood. As blood concentrations of IFN-λ3 are known to increase several days before the level of severity rises, IFN-λ3 is reported to be clinically useful for predicting the onset of severe symptoms and for assisting with follow-up.1,2 Sysmex’s kit is used in combination with HISCL-5000/HISCLTM800 automated immunoassay systems to provide highly reliable testing results. Sysmex remains committed to the establishment of diagnosis/treatment methods for COVID-19 by way of diverse testing, including PCR tests, antigen tests, antibody tests and cytokine tests, as well as hematology and coagulation tests. Sales to medical institutions in Japan commenced for the hinotori Surgical Robot System, a surgical robot unit, and HF series instruments (hinotoriTM), reusable active endotherapy devices.

This robotic assisted surgery system was developed by Medicaroid Corporation, which was jointly established by Kawasaki Heavy Industries, Ltd. and Sysmex. The first made-in-Japan roboticassisted surgery system, hinotori features a compact design and is offered in conjunction with introduction/maintenance plans that benefit hospital management, lowering the barriers to introduction and operation. hinotori offers high levels of operability and is equipped with a network support system for the monitoring of operating conditions, helping medical professionals conduct operations with greater precision. As the general agent for Medicaroid products, Sysmex has exclusive global sales and service rights. To begin, we are working toward an early introduction targeting the Japanese urology market.

1 Sugiyama M. et al., Gene 766, (2021) 145145 2 National Center for Global Health and Medicine. "Identification of humoral factors that predict-3-exacerbation of COVID-19: Seeking the early diagnosis of COVID-19 by blood test." September 24, 2020 View Source (Japanese only) In Japan, sales of reagents and services increased in the life science field.

However, reagent sales were down in the hematology field, due primarily to the impact of COVID-19. In other fields, sales of instruments related to large orders were down. Also, sales of reagents were down in the urinalysis and immunochemistry fields. As a result, sales in Japan fell 2.1% year on year, to ¥33,295 million. Overseas, instrument sales increased in the urinalysis, hemostasis and immunochemistry fields. Mainly because of the COVID-19 pandemic, however, reagent sales were down, centered on the hematology, urinalysis and immunochemistry fields. Consequently, overseas sales decreased 3.0% year on year, to ¥178,553 million.

The overseas sales ratio fell 0.1 percentage point, to 84.3%. Selling, general and administrative expenses declined 5.7% year on year, to ¥58,204 million, largely because of activities at all destinations being restricted in the face of the COVID-19 pandemic. As a result, during the first nine months of the fiscal year ending March 31, 2021, the Group recorded consolidated net sales of ¥211,848 million, down 2.9% year on year. Operating profit declined 11.2%, to ¥35,907 million; profit before tax decreased 10.6%, to ¥33,286 million; and profit attributable to owners of the parent fell 12.1%, to ¥23,288 million. Performance by segment

(1) Japan In Japan, sales of reagents and services increased in the life science field. However, reagent sales were down in the hematology field, due primarily to the impact of COVID-19. In other fields, sales of instruments related to large orders were down. Reagent sales also decreased in the urinalysis and immunochemistry fields. As a result, sales in Japan fell 1.5% year on year, to ¥36,154 million. On the profit front, although SG&A and R&D expenses declined, lower sales and a deteriorating cost of sales ratio caused gross profit to worsen. Accordingly, segment profit (operating profit) fell 17.5%, to ¥21,780 million.

(2) Americas Sales were down in North America. Although instrument sales rose in the hemostasis field, instrument and reagent sales declined in the hematology field, mainly because of the COVID-19 pandemic. In Central and South America, sales were down due to lower sales of hematology instruments and reagents. As a result, sales in the Americas came to ¥42,403 million, down 9.8% year on year. Segment profit (operating profit) fell 42.5% year on year, to ¥959 million, despite lower SG&A-4-expenses, as the result of lower gross profit stemming from lower sales and a deteriorating cost of sales ratio.

(3) EMEA Sales in the EMEA region rose 3.3% year on year, to ¥60,141 million. Reagent sales were down in the hematology, urinalysis and life science fields, mainly due to the spread of the COVID-19 pandemic. However, instruments sales increased in the hematology field, and reagent sales expanded in other fields due to the launch of a novel coronavirus antigen testing kit in Germany. Despite a deteriorating cost of sales ratio, segment profit (operating profit) grew 18.4%, to ¥7,503 million, due to higher gross profit on higher sales and a decrease in SG&A expenses.

(4) China In China, sales fell 0.4% year on year, to ¥56,317 million. Instrument sales increased in the hematology, urinalysis and immunochemistry fields, and the hemostasis field saw higher instrument and reagent sales. Mainly due to the impact of COVID-19, however, reagent sales were down in the hematology, urinalysis and immunochemistry fields. Segment profit (operating profit) decreased 28.6% year on year, to ¥3,051 million, despite lower SG&A expenses, as gross profit declined due to lower sales and a worsening cost of sales ratio.

(5) Asia Pacific Mainly because of COVID-19, sales of reagents decreased in the hematology and urinalysis fields. As a result, sales in the Asia Pacific region decreased 14.7% year on year, to ¥16,832 million. Segment profit (operating profit) fell 44.0% year on year, to ¥1,723 million. SG&A expenses fell, but lower sales and a deteriorating cost of sales ratio caused gross profit to fall. 2) Financial conditions analysis

(1) Financial conditions As of December 31, 2020, total assets amounted to ¥392,731 million, up ¥3,439 million from March 31, 2020. As main factors, inventories rose ¥2,143 million, and intangible assets were up ¥4,099 million, while property, plant and equipment were down ¥3,096 million. Meanwhile, total liabilities as of December 31, 2020 were ¥101,232 million, down ¥9,711 million from March 31, 2020. Principal decreases included trade and other payables, which were down ¥6,561 million, income taxes payable, down ¥2,306 million, and accrued bonuses, down ¥1,890 million. Total equity came to ¥291,498 million, up ¥13,150 million from March 31, 2020. Among principal reasons, retained earnings rose ¥8,245 million, while other components of equity increased ¥3,799 million. Equity attributable to owners of the parent to total assets rose 2.7 percentage points, from 71.3% on March 31, 2020 to 74.0% on December 31, 2020.

(2) Cash flows As of December 31, 2020, cash and cash equivalents amounted to ¥54,737 million, down ¥1,855 million from March 31, 2020. Cash flows from various activities during the first nine months of the fiscal year are described in more detail below. (Cash flows from operating activities) Net cash provided by operating activities was ¥39,752 million (up ¥4,597 million). As principal factors, profit before tax provided ¥33,286 million (down ¥3,938 million), depreciation and amortization provided ¥18,877 million (up ¥1,066 million), a decrease in trade receivables provided ¥3,189 million (up ¥968 million), an increase in inventories used ¥1,277 million (down ¥10,023 million), a decrease in trade payables used 4,390 million (up ¥2,998 million), and income taxes paid used ¥11,661 million (down ¥3,468 million). (Cash flows from investing activities) Net cash used in investing activities was ¥23,080 million (up ¥5,085 million). Among major factors, purchases of property plant and equipment used ¥6,499 million (down ¥3,623 million), purchases of intangible assets used ¥12,044 million (up ¥2,410 million), payments resulting in an increase in long-term prepaid expenses used ¥3,089 million (up ¥1,340 million), and proceeds from-5-withdrawal of time deposits provided ¥1,078 million (down ¥6,144 million). (Cash flows from financing activities) Net cash used in financing activities was ¥19,425 million (up ¥423 million). This was mainly due to dividends paid of ¥15,037 million (up ¥9 million) and repayment of lease liabilities, which used ¥4,936 million (up ¥759 million).

3) Consolidated financial forecast The Company maintains its consolidated financial forecasts, as announced on November 5, 2020. These forecasts are based on information available as of the date of this release. Actual results may differ materially from these forecast due to unforeseen factors and future events.

2. Condensed quarterly consolidated financial statements and notes

1) Condensed quarterly consolidated statement of financial position

2) Condensed quarterly consolidated statement of income

3) Condensed quarterly consolidated statement of other comprehensive income

4) Condensed quarterly consolidated statement of changes in equity

5) Condensed quarterly consolidated statement of cash flows6) Notes to the condensed quarterly consolidated financial statements

1. Notes related to the going concern assumption Not applicable

2. Segment information
1) Overview of reportable segments The Group’s reportable segments are the constituent business units of the Group for which separate financial data are available and that are examined on a regular basis for the purpose of enabling the Managing Board to allocate managerial resources and evaluate results of operations. The Group is primarily engaged in the manufacture and sale of diagnostic instruments and reagents.

These businesses are conducted in Japan by the Company, and in the Americas, EMEA, China and the Asia Pacific by regional headquarters established in those regions. These companies formulate overarching strategies tailored to regional characteristics and conduct business activities accordingly. Regional headquarters and other domestic and overseas subsidiaries are independent management units that handle production and sales for each region. Accordingly, the Group has five reportable segments comprising geographical segments based on manufacturing and sales systems. These are "Japan," the "Americas," "EMEA," "China," and the "Asia Pacific."

2) Segment profit and operating results Profit and operating results from continuing operations by reportable segment of the Group are as follows; Intersegment sales are determined based on market prices or costs of goods manufactured. Accounting policies of reporting segments are consistent with the Group’s accounting policies indicated in the consolidated financial statements for the previous fiscal year.

Cannabics Pharmaceutical’s Interim in-vivo Study Results Show a 27% Lower Tumor Volume in Mice Treated with Company’s Proprietary Drug Candidate for Colorectal Cancer

On February 3, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicines, reported that it has obtained interim results for its ongoing in-vivo study evaluating the efficacy of the company’s proprietary drug candidate RCC-33 for Colorectal cancer in nude-mice (Press release, Cannabics Pharmaceuticals, FEB 3, 2021, View Source [SID1234574553]). The interim results show a 27% reduction in tumor volume in mice exposed to RCC-33 in comparison with sham control mice. Both groups were
inoculated with colorectal cancer cells. Daily doses of intraperitoneal (IP) delivery of RCC-33 or sham were initiated on day 5. Differences in tumor volume between the
two groups were first observed after 5 days of treatment (day 10). Interim results of a 27% reduction in tumor volume were recorded after 12 days of treatment (day 17),
with p-value=0.022. Study is ongoing.

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Effect of Cannbics TM RCC-33 on Tumor Development in Mice Inoculated with Human Colorectal Cancer Cells

Effect of Cannbics TM RCC-33 on Tumor Development in Mice Inoculated with Human Colorectal Cancer Cells
Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO said: "Developing innovative formulations to combat colorectal cancer is a worthy cause. Colorectal cancer is the third most diagnosed cancer worldwide and the second most lethal. That said, 67% of colorectal cancer patients undergoing currently available treatments survive for 5 years or longer. Accordingly, our objective with RCC-33 is to be able to demonstrate its efficacy and enter an official FDA track, eventually reaching a position where we can potentially help a large group of people get better and live longer; this is our ultimate goal and today marks an important step in the right direction."

Dr. Eyal Ballan, Cannabics Pharmaceuticals Co-founder and CTO said: "Today’s interim results mark an important milestone for the company. Seeing our formulation cause attenuation in tumor growth, in-vivo, and already within 12 days of treatment, is a clear indicator and an encouragement for us to continue with our focus and efforts in the direction we chose and believe in."