On October 6, 2020 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported that it will report third quarter financial results after the Nasdaq market closes on Monday, November 9, 2020 (Press release, Neurocrine Biosciences, OCT 6, 2020, View Source [SID1234568152]). Neurocrine will then host a conference call and webcast to discuss its financial results and provide a company update that day at 1:30 p.m. Pacific Time (4:30 p.m. Eastern Time).

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Participants can access the live conference call by dialing 877-830-2596 (US) or 785-424-1744 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine’s website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On October 6, 2020 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported that preliminary financial and operational highlights for the third quarter of 2020 (Press release, NanoString Technologies, OCT 6, 2020, View Source [SID1234568168]).

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Financial Highlights:

Product and Service Revenue was $30.1 million, 14% year-over-year growth. Pro forma growth was 22% and reflects the impact of the Veracyte transaction on revenue recorded for Prosigna IVD kits
Instrument revenue was $12.9 million, 60% year-over-year growth. Instrument revenue includes $7.5 million recognized from sales of our GeoMx Digital Spatial Profiler (DSP)
Consumables revenue was $13.7 million, 11% year-over-year decline. Pro forma for the impact of the Veracyte transaction, consumables revenue was flat. Consumables revenue includes $1.4 million from sales of GeoMx DSP consumables
Service revenue was $3.5 million, 16% year-over-year growth
Cash, cash equivalents and short-term investments were approximately $230 million at September 30, 2020.
Operational Highlights:

Received orders for more than 25 GeoMx DSP instruments in the third quarter, bringing cumulative orders received to more than 150 instruments since launch
Announced the launch of GeoMx DSP compatibility with Illumina’s next generation sequencers, as well as the commercial availability of the Cancer Transcriptome Atlas (CTA), the first in a portfolio of GeoMx DSP products that will utilize NGS read-out
Continued commercial momentum of GeoMx DSP launch during Q3, as evidenced by more than 75 new Technology Access Program (TAP) orders, of which more than 50% included NGS read-out, 5 new peer-reviewed publications utilizing GeoMx DSP technology bringing the cumulative total to 28, and approximately 1,200 leads generated at our virtual Spatial Biology Conference held in September 2020
Grew installed base to approximately 915 nCounter Analysis Systems and approximately 100 GeoMx DSP systems at September 30, 2020
"I’m extremely pleased with our third quarter performance, which included double-digit growth in product and service revenue and more than 25 new orders for our GeoMx DSP platform," said Brad Gray, NanoString’s president and chief executive officer. "We extended our leadership in the spatial genomics market with translational researchers, and we entered the discovery research market in Q3 with the launch of GeoMx DSP read-out capabilities using NGS. In the third quarter, we saw substantial demand from both translational and discovery markets and leading indicators suggest continued success."

The amounts set forth above are preliminary estimates. We are in the process of finalizing the actual results of operations for the three months ended September 30, 2020 and therefore final results are not yet available. These preliminary estimates are based solely upon information available to us as of the date of this press release and our actual results may differ from these estimates due to the completion of our quarter-end closing procedures, final adjustments, review by our independent registered public accounting firm and developments that may arise between now and the time our financial results for the three months ended September 30, 2020 are finalized. Refer to our actual results included in our unaudited consolidated financial statements for the three and nine months ended September 30, 2020 once they become available. The preliminary financial data included in this press release have been prepared by, and are the responsibility of, our management. Ernst & Young LLP has not audited, reviewed, compiled, or applied agreed-upon procedures with respect to the preliminary financial data. Accordingly, Ernst & Young LLP does not express an opinion or any other form of assurance with respect thereto.

In addition, although we expect to experience an operating and net loss for the third quarter of 2020, we are not able to provide an estimate of such results at this time. We expect our operating loss and net loss for the third quarter of 2020 may increase compared to the third quarter of 2019. However, no conclusions should be drawn as to the size of our third quarter of 2020 operating loss or net loss based on the foregoing revenue estimates. Our expectations regarding third quarter of 2020 revenue are not necessarily indicative of results expected in future periods.

Pro Forma Financial Information

As used in this press release, "pro forma" percentages are calculated by comparing the applicable period-over-period financial results to reflect the impact of the Veracyte transaction as if such transaction had occurred on January 1, 2019, the beginning of the earliest period presented. Further disclosure regarding the terms and pro forma impact of the Veracyte transaction can be obtained in the Company’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 4, 2019.

On October 6, 2020 Guardant Health, Inc. (Nasdaq: GH) ("Guardant Health"), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics, reported the commencement of a proposed underwritten public offering of 7,000,000 shares of its common stock being offered for sale by SoftBank Investment Advisers (Press release, Guardant Health, OCT 6, 2020, View Source [SID1234568169]). In addition, SoftBank Investment Advisers expects to grant the underwriter a 30-day option to purchase up to 700,000 additional shares of common stock at the public offering price, less underwriting discounts and commissions. Guardant Health is not selling any of its shares in the offering and will not receive any of the proceeds from the sale of shares in the offering by SoftBank Investment Advisers. The proposed offering is subject to market and other conditions, and 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.

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J.P. Morgan Securities LLC is acting as sole book-running manager of the offering.

The public offering is being made pursuant to an automatic shelf registration statement on Form S-3 that was filed by Guardant Health with the U.S. Securities and Exchange Commission (the "SEC") and automatically became effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus may be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected].

On October 6, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it has entered into a license agreement with argenx that grants argenx worldwide non-exclusive rights for Chugai’s antibody engineering technologies (Press release, Chugai, OCT 6, 2020, View Source [SID1234568132]).

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Under the terms of the agreement, argenx will receive the rights to use two Chugai’s antibody engineering technologies (SMART-Ig and ACT-Ig) for their research activities, and option to develop and market therapeutic antibodies applying those technologies. In return for the license, Chugai will receive a fee for technology access. In case argenx creates a candidate antibody and exercises the option, Chugai will receive upfront payment, milestone payment according to the development status, and royalty payment if the compound is launched as an approved antibody drug.

On October 6, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the first patient was successfully dosed with allogeneic cord blood-derived natural killer (cbNK) cells preloaded with AFM13 and has moved on to the AFM13 monotherapy phase of the treatment cycle (Press release, Affimed, OCT 6, 2020, View Source [SID1234568154]). This therapy was developed through a research collaboration with The University of Texas MD Anderson Cancer Center.

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This is the first in human study to combine an NK cell product with an antibody whose primary mechanism is designed to specifically bind and activate NK cells and tumors cells in a bispecific fashion. This novel combination approach could lay the groundwork for future cellular therapy combinations with Affimed ICE constructs.

"Engaging the innate immune system is a novel and promising therapeutic approach in oncology and our ICE products are designed to tap into this, which, thus far, has largely remained untapped in this field," said Dr. Andreas Harstrick, Chief Medical Officer at Affimed. "Pre-loading innate immune cells with an ICE takes this idea a step further and potentially intensifies the treatment’s effect, especially in patients who have an impaired immune system or low NK cell numbers."

An NK cell armed with AFM13 is designed to direct NK cells to the tumor site in order to target cancer cells. Pursuant to the study design, after dosing with the preloaded NK cells, AFM13 is subsequently administered as monotherapy in order to maintain the activation of the infused cbNK cells and engage the patients’ own innate immune system (NK cells and macrophages), a distinct feature of Affimed’s ICE products.

Further Study Background
Although larger numbers of NK cells in patients is associated with better outcomes, the adoptive transfer of non-targeted NK cells has shown only limited clinical benefit. Target recognition of cancers by NK cells remains a substantial barrier to broad application of an NK cell therapy. In preclinical models, combining AFM13 with adoptive NK cell transfer has been shown to enhance the efficacy of NK cells. AFM13 exhibited a much longer binding to CD16A on NK cells as compared to CD30 binding monoclonal antibodies, both wildtype and ADCC enhanced, forming the basis to produce a stable AFM13 pre-loaded NK cell product. The study, which aims to enroll approximately 30 patients, is an investigator-initiated study at MD Anderson. The study is an open-label, non-randomized, single-center, dose escalation trial to evaluate the combination of AFM13 with cord blood-derived NK cells in adult patients with recurrent/refractory CD30-positive lymphomas. The primary objective of the study is to establish the safety and the recommended Phase 2 dose of AFM13-preloaded cbNK cells, followed by weekly treatment with intravenous AFM13. Secondary objectives include assessing the overall, complete and partial response rates. More details about the study can be found at www.clinicaltrials.gov using the identifier NCT04074746.

About AFM13
AFM13 is a first-in-class CD30/CD16A ROCK-derived bispecific innate cell engager (ICE) that induces specific and selective killing of CD30-positive tumor cells by engaging and activating natural killer (NK) cells and macrophages, thereby leveraging the power of the innate immune system. AFM13 is Affimed’s most advanced ICE clinical program, and it is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma (REDIRECT). The study is actively recruiting and can be found at www.clinicaltrials.gov using the identifier NCT04101331.