On January 10, 2022 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported preliminary financial and operational highlights for the fourth quarter and fiscal year ended December 31, 2021 (Press release, NanoString Technologies, JAN 10, 2022, View Source [SID1234598482]).

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"NanoString exited 2021 on a high note, securing more than 50 new orders for our GeoMx DSP system during the fourth quarter. Our commercial momentum and leadership in spatial biology resulted in GeoMx revenue growth of almost 50% year-on-year, for both the fourth quarter and the full year," said Brad Gray, President and CEO of NanoString. "Our expanding portfolio of spatial biology solutions covers the full spectrum of applications across discovery and translational research, putting us in position for continued growth in the rapidly expanding spatial biology market. We’re already seeing strong early demand for our new CosMx Spatial Molecular Imager, as eager customers have pre-ordered a total of 20 systems ahead of the planned commercial launch later this year."

Operational Highlights

Spatial Biology

GeoMx DSP

Generated record orders for more than 50 GeoMx Digital Spatial Profiler (DSP) systems in the fourth quarter, representing approximately 80% growth as compared to the fourth quarter of 2020
Achieved record GeoMx consumable revenue of $6 million in Q4, representing annualized consumable pull-through of approximately $110,000 per installed system
Installed approximately 30 GeoMx systems in Q4, increasing the GeoMx installed base to approximately 255 systems as of December 31, 2021
CosMx SMI

Secured customer orders for 20 CosMx Spatial Molecular Imager (SMI) systems through a limited program open to existing and new GeoMx customers
Released the first high-resolution, single cell spatial dataset generated from formalin-fixed paraffin-embedded (FFPE) tissue using CosMx SMI
Published a manuscript in the online journal BioRxiv describing the CosMx SMI technology and performance
nCounter

Concluded 2021 with an nCounter installed base of approximately 1,050 systems, an increase of approximately 11% as compared to 2020
Recorded continued research momentum for the nCounter platform, with total scientific publications now exceeding 5,200, representing an increase of approximately 1,200 publications in the last 12 months
Financial Highlights

Total Product and Service Revenue

For the fourth quarter of 2021, product and service revenue is expected to be approximately $42 million, at the upper end of the company’s guidance range of $38 to $42 million and representing 18% growth as compared to the fourth quarter of 2020
For the full year 2021, product and service revenue is expected to be approximately $144 million, at the upper end of the company’s updated annual guidance range of $140 to $144 million and representing 29% growth as compared to the prior year
GeoMx DSP Revenue

For the fourth quarter, GeoMx DSP revenue is expected to be approximately $18 million, above the upper end of the company’s GeoMx revenue guidance range of $15 to $16 million and representing 48% growth as compared to the fourth quarter of 2020
For the full year, GeoMx DSP revenue is expected to be approximately $52 million, above the upper end of the company’s updated GeoMx revenue guidance range of $49 to $50 million and representing 49% growth as compared to the prior year
nCounter Revenue, Inclusive of all Service Revenue

For the fourth quarter, nCounter revenue, inclusive of all service revenue, is expected to be approximately $24 million, near the middle of the company’s nCounter revenue, inclusive of all service revenue guidance range of $23 to $26 million and representing 2% growth as compared to the fourth quarter of 2020
For the full year, nCounter revenue, inclusive of all service revenue, is expected to be approximately $92 million, near the middle of the company’s updated annual nCounter revenue, inclusive of all service revenue guidance range of $91 to $94 million and representing 20% growth as compared to the prior year
Cash, Cash Equivalents and Short-term Investments

As of December 31, 2021, cash, cash equivalents and short-term investments totaled approximately $350 million

On January 10, 2022 Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, reported preliminary financial results for the third quarter of fiscal year 2021 (Press release, Myovant Sciences, JAN 10, 2022, View Source [SID1234598481]). The financial information presented in this press release may be adjusted at a later date following the completion of customary quarterly financial reviews and audit procedures.

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"Myovant delivered on its mission of redefining care for women and for men over the course of calendar-year 2021 as momentum for ORGOVYX and MYFEMBREE launches continued to build, positioning the company for long-term success. Our strong quarterly performance continues to give us the confidence that ORGOVYX and MYFEMBREE have the potential to become standard of care therapies in advanced prostate cancer and uterine fibroids, respectively," said David Marek, Chief Executive Officer of Myovant Sciences, Inc. "We believe we have set the stage for an important year in 2022 as we seek to drive significant revenue growth with continued ORGOVYX adoption and the potential launch of MYFEMBREE in endometriosis, pending FDA approval, while also expanding our pipeline by advancing relugolix lifecycle opportunities and pursuing business development."

Unaudited preliminary revenue results:

Total revenue for the three months ended December 31, 2021 is estimated to be in the range of $54.0-$55.0 million. There was $1.4 million of total revenue recorded in the three months ended December 31, 2020. Estimated total revenue consisted of the following:

Net product revenue is estimated to be in the range of $28.8-$29.8 million in fiscal third quarter 2021. There was no such revenue recorded in the comparable prior year period. Estimated net product revenue consists of the following:
ORGOVYX net product revenue is estimated to be in the range of $24.2-$24.6 million for fiscal third quarter 2021, reflecting 40% sequential volume growth compared to fiscal second quarter 2021, partially offset by a lower net price due to higher gross-to-net discounts. There were no material changes in channel inventory for ORGOVYX over the course of fiscal third quarter 2021.
MYFEMBREE net product revenue is estimated to be in the range of $2.3-$2.6 million for fiscal third quarter 2021. New-to-brand prescription (NBRx) share among GnRH antagonists FDA-approved for the treatment of uterine fibroids was 45% in December 2021 compared to 20% in September 2021, reflecting steadily increasing demand for the differentiated clinical profile of MYFEMBREE while growing the class. There were no material changes in channel inventory for MYFEMBREE over the course of fiscal third quarter 2021.
RYEQO net product revenue related to product supply and royalties from Gedeon Richter, Myovant’s commercialization partner for RYEQO in Europe and certain other international markets, is estimated to be in the range of $2.3-$2.6 million for fiscal third quarter 2021.
Pfizer collaboration revenue in fiscal third quarter 2021 was $25.2 million, reflecting the partial recognition of the upfront payment Myovant received from Pfizer in December 2020 and of the regulatory milestone payment that was triggered upon the FDA approval of MYFEMBREE for the management of heavy menstrual bleeding associated with uterine fibroids in May 2021. Pfizer collaboration revenue for fiscal third quarter 2020 was $1.4 million and represents the partial amortization of the upfront payment received from Pfizer.
Unaudited capital resources:

Cash, cash equivalents, marketable securities, and amounts available under the Sumitomo Dainippon Pharma Loan Agreement totaled approximately $569.1 million as of December 31, 2021, and consisted of approximately $527.8 million of cash, cash equivalents, and marketable securities and $41.3 million of remaining available borrowing capacity under the Sumitomo Dainippon Pharma Loan Agreement.

Myovant to present at 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022

David Marek, Chief Executive Officer of Myovant Sciences, will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:00 p.m. Eastern Time. A live webcast of the presentation can be accessed by visiting the investor relations page of Myovant’s website at investors.myovant.com. The webcast will be archived on Myovant’s Investor Relations website following the presentation.

About Relugolix
Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. ORGOVYX (relugolix 120 mg) was approved in the U.S. by the FDA in December 2020 as the first and only oral GnRH receptor antagonist for the treatment of adult patients with advanced prostate cancer, and relugolix (120 mg) is also under regulatory review in Europe for men with advanced prostate cancer. MYFEMBREE (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) was approved in the U.S. by the FDA in May 2021 as the first and only once-daily oral treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months, and by the European Commission and the Medicines and Healthcare products Regulatory Agency in July 2021 and August 2021, respectively, as RYEQO for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use. In September 2021, the FDA accepted Myovant Sciences’ supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis, setting a target action date of May 6, 2022. MYFEMBREE is also being assessed for contraceptive efficacy in women with endometriosis or uterine fibroids who are 18 to 50 years of age and at risk for pregnancy.

On January 10, 2022 Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company with a pipeline of assets designed to modulate immunological pathways across a spectrum of diseases, reported a corporate update and announced anticipated milestones for 2022 (Press release, Kiniksa Pharmaceuticals, JAN 10, 2022, View Source [SID1234598480]).

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"2021 was a transformational year for Kiniksa. We progressed to a commercial-stage company with the successful launch of ARCALYST for the treatment of recurrent pericarditis. We are pleased with the strong physician and patient adoption and expect to provide annual guidance along with fourth quarter and full-year 2021 financial results," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "This year, we look forward to continued commercial excellence with ARCALYST, as well as reporting data from the Phase 2b trial of vixarelimab in prurigo nodularis, and conducting the Phase 2 trial of KPL-404 in rheumatoid arthritis."

Corporate Update

Kiniksa’s resources are currently focused on growing the ARCALYST franchise and progressing the clinical trials of vixarelimab in prurigo nodularis and KPL-404 in rheumatoid arthritis.
Kiniksa’s year-end 2021 cash, cash equivalents and short-term investments of approximately $182 million (unaudited) are expected to fund its current operating plan into 2024.
Portfolio Update
ARCALYST (IL-1α and IL-1β cytokine trap)

Kiniksa expects to provide full-year 2022 ARCALYST net revenue guidance with its fourth quarter and full-year 2021 financial results.
Mavrilimumab (monoclonal antibody inhibitor targeting GM-CSFRα)

As previously reported, the Phase 3 portion of the Phase 2/3 trial of mavrilimumab in COVID-19-related acute respiratory distress syndrome (ARDS) did not meet its primary efficacy endpoint of the proportion of patients alive and free of mechanical ventilation at Day 29.
Kiniksa continues to believe in the potential broad utility of mavrilimumab and is evaluating next steps for the molecule.
Vixarelimab (monoclonal antibody inhibitor of signaling through OSMRβ)

Kiniksa expects data from the Phase 2b dose-ranging clinical trial of once-monthly subcutaneous vixarelimab in prurigo nodularis in the second half of 2022.
KPL-404 (monoclonal antibody inhibitor of CD40-CD154 signaling)

Kiniksa is enrolling and dosing patients in a Phase 2 clinical trial of KPL-404 in rheumatoid arthritis which is designed to enable potential development in a spectrum of autoimmune diseases believed to be mediated by the CD40-CD154 pathway.
40th Annual J.P. Morgan Healthcare Conference
Sanj K. Patel, Chief Executive Officer and Chairman of the Board of Kiniksa will provide a corporate presentation at the 40th Annual J.P. Morgan Healthcare Conference today, Monday, January 10, 2022, at 1:30 p.m. Eastern Time. A live webcast of Kiniksa’s presentation will be accessible through the Investors & Media section of the company’s website at www.kiniksa.com. A replay of the webcast will also be available on Kiniksa’s website within approximately 48 hours after the event.

On January 10, 2022 Adaptive Biotechnologies Corporation (Nasdaq: ADPT) reported preliminary, unaudited revenue for the year ended December 31, 2021 (Press release, Adaptive Biotechnologies, JAN 10, 2022, View Source [SID1234598479]). Total revenue for the year ended December 31, 2021 is estimated to be in the range of $153 million to $154 million, representing an approximate increase of 56% at the mid-point of the range compared to $98.4 million for the year ended December 31, 2020.

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"The Adaptive team delivered strong results in 2021, setting the stage to accelerate our immune medicine and MRD business areas," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "Our goal is to transform the genetics of the adaptive immune system into novel diagnostics and therapeutics. We are in a strong position and poised for sustainable future growth."

These preliminary, unaudited results are based on management’s initial analysis of operations for the year ended December 31, 2021 and are subject to change. Adaptive Biotechnologies expects to issue full financial results for the year ended December 31, 2021 on or around February 15, 2022.

Adaptive further announced that Chad Cohen, chief financial officer, will be resigning from his role, effective on or about February 15, 2022, following the filing of Adaptive Biotechnologies’ Annual Report on Form 10-K for the year ended December 31, 2021. Adaptive Biotechnologies’ principal accounting officer, Kyle Piskel, will serve as interim CFO after Mr. Cohen’s resignation. Adaptive Biotechnologies has initiated a search for a permanent CFO with the capabilities and qualifications to help accelerate the development and commercialization of products resulting from the insights provided by its proprietary immune medicine platform. Mr. Cohen will continue to work with Adaptive Biotechnologies and Mr. Piskel in a consulting capacity to ensure a smooth transition.

"I’d like to thank Chad Cohen for his excellent contributions to both the financial and operational success at Adaptive over the last seven years," said Chad Robins, chief executive officer and co-founder of Adaptive Biotechnologies. "We wish him all the best and we look forward to working with him through the transition."

On January 10, 2022 ImmunoPrecise reported that it will be attending the 21st Annual PepTalk 2022, the Protein Science and Production Week, from January 17-19th, 2022 (Press release, ImmunoPrecise Antibodies, JAN 10, 2022, View Source [SID1234598478]). PepTalk is the largest annual gathering of protein science researchers in the world. The conference focuses on intensive learning to discover new opportunities, apply alternative solutions and develop promising partnerships through keynote speakers, seminars and short courses.

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Location:
San Diego Hilton Bayfront, San Diego, CA

Dates:
January 17-19, 2022

Booth #213