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Cue Biopharma Enters into a Strategic Collaboration and Option Agreement with Ono Pharmaceutical for CUE-401

On February 22, 2023 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body, reported a collaboration and option agreement with Ono Pharmaceutical Co., Ltd. ("Ono"), for CUE-401, a bispecific protein designed to induce and expand regulatory T cells (Tregs) for the treatment of autoimmune and inflammatory diseases (Press release, Cue Biopharma, FEB 22, 2023, View Source [SID1234627534]).

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The strategic collaboration with Ono is an important advancement in Cue Biopharma’s corporate development plan to seek third party support to further develop its CUE-400 series and provides dedicated resources and capabilities to help advance CUE-401 toward the clinic. In preclinical studies, CUE-401 has demonstrated induction and expansion of Tregs, with the potential to address a broad range of autoimmune and inflammatory diseases.

Under the terms of the agreement, Ono will pay Cue Biopharma an upfront payment and fully fund all research activities related to CUE-401 through a specified option period. During this option period Cue Biopharma will be responsible for the research and development of CUE-401. Upon Ono’s exercise of its option to license CUE-401, Cue Biopharma will receive an option exercise payment and be eligible for development and commercial milestone payments up to an aggregate of approximately $220 million, as well as tiered royalties on sales. Upon any such exercise, Ono will receive worldwide rights to develop and commercialize CUE-401, with Cue Biopharma retaining a 50% co-development and co-commercialization right in the United States.

"This strategic collaboration with Ono Pharmaceutical, a leading Japanese pharmaceutical company with a track record of scientific innovation, is a significant accomplishment for Cue Biopharma, as it allows us to further develop this promising biologic through the support of a strategic partner," stated Daniel Passeri, chief executive officer of Cue Biopharma. "Through this important partnership we have secured resources and capabilities necessary to help advance CUE-401 towards the clinic, while preserving potential value to our shareholders through a 50:50 collaboration right for the U.S. market."

"We appreciate Cue Biopharma’s proprietary platform, protein engineering abilities, as an emerging new therapeutic modality and are thrilled to work with Cue Biopharma’s biologics team through this collaboration agreement." said Toichi Takino, Senior Executive Officer/Executive Director, Discovery & Research of Ono Pharmaceutical. "We hope to add CUE-401 into our portfolio to help patients suffering from autoimmune and inflammatory diseases."

About CUE-401
CUE-401 is a preclinical, bispecific fusion protein designed to induce and expand regulatory T cells (Tregs) through the delivery of transforming growth factor beta (TGF-β) and interleukin 2 (IL-2) with therapeutic potential across a range of T-cell mediated autoimmune and inflammatory diseases.

About Ono Pharmaceutical Co., Ltd.
Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. Ono focuses its research on oncology, immunology, neurology and specialty research with high medical needs as priority areas for discovery and development of innovative medicines. For further information, please visit the company’s website at View Source

Adaptimmune to Report Q4 and Full Year 2022 Financial and Business Updates on Monday, March 6, 2023

On February 22, 2023 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported financial results and provide business updates for the fourth quarter and full year ended December 31, 2022, before the US markets open on Monday, March 6, 2023 (Press release, Adaptimmune, FEB 22, 2023, View Source [SID1234627532]). Following the announcement, the Company will host a live webcast at 8:00 a.m. EST (1:00 p.m. GMT) that same day.

The press release will be available in the investor section of Adaptimmune’s corporate website. A live webcast and replay can be accessed at View Source Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.

Beyond Air® Announces Participation at Two Upcoming Investor Conferences in March 2023

On February 22, 2023 Beyond Air, Inc. (NASDAQ: XAIR) ("Beyond Air" or the "Company") a commercial stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and, through its affiliate Beyond Cancer, Ltd., ultra-high concentration nitric oxide (UNO) for the treatment of solid tumors, reported that Steve Lisi, Chairman and Chief Executive Officer of Beyond Air, will participate in two upcoming investor conferences in March 2023 (Press release, Beyond Air, FEB 22, 2023, View Source [SID1234627530]).

35th Annual Roth Conference – March 12-14, 2023
Format: Fireside Chat
Date: Monday, March 13, 2023
Participant: Steve Lisi, Chairman & CEO, Beyond Air
Location: Laguna Niguel, CA
Oppenheimer 33rd Annual Healthcare Conference – March 13-15, 2023
Format: Presentation
Date & Time: Wednesday, March 15, 2023, at 9:20-9:50 AM ET
Participant: Steve Lisi, Chairman & CEO, Beyond Air
Location: Virtual presentation
Webcast Link: Click Here
Please contact your representative at either Roth or Oppenheimer to schedule a one-on-one meeting with Beyond Air during the respective conference.

ImmunoGen Announces Webcasts of Presentations at Upcoming Conferences

On February 22, 2023 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, FEB 22, 2023, View Source [SID1234627529])

Cowen 43rd Annual Health Care Conference
March 8 at 9:10am ET

Barclays Global Healthcare Conference
March 15 at 10:15am ET

A webcast of each presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

VERACYTE ANNOUNCES FOURTH QUARTER AND FULL-YEAR 2022 FINANCIAL RESULTS

On February 22, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Veracyte, FEB 22, 2023, View Source [SID1234627528]).

"We had an outstanding fourth quarter, driving record revenue and operating cash flows, achieving the best quarter ever for both our Decipher prostate and Afirma thyroid tests," said Marc Stapley, Veracyte’s chief executive officer. "Moreover, throughout 2022, we invested in our long-term growth drivers to deliver on our promise of empowering clinicians with high-value insights to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Moving into 2023, we have a clear strategy, strong financial position, and significant momentum to advance our vision of transforming cancer care for patients all over the world."

Key Business Highlights:

Grew total test volume to 28,001 in the fourth quarter and 102,524 for the full-year 2022, an increase of 26% and 30%, respectively, compared to the prior year.
Launched an updated Decipher Genomics Resource for Intelligent Discovery (GRID) patient report, providing physicians who order the Decipher Prostate Genomic Classifier with expanded precision-medicine insights, on a Research Use Only basis.
Submitted the Envisia Genomic Classifier to the Notified Body for CE marking in the European Union, ahead of schedule.
Published data in the International Journal of Radiation Oncology, Biology, Physics demonstrating that the Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer.
Published a meta-analysis of 13 independent studies for the Afirma Genomic Sequencing Classifier in the Journal of Clinical Endocrinology & Metabolism, confirming the test’s strong real-world performance in informing thyroid nodule diagnosis.
Published data in Frontiers in Endocrinology suggesting that insights derived from Veracyte’s comprehensive thyroid nodule database of whole-transcriptome sequencing may help personalize care for patients with thyroid nodules.
Generated $9.7 million in cash from operating activities in the fourth quarter and $7.5 million for the full-year 2022. Ended the fourth quarter of 2022 with cash, cash equivalents and short-term investments of $178.9 million, compared to $177.2 million at the beginning of 2022.
Promoted Annie McGuire to General Counsel and Chief People Officer.
Fourth Quarter 2022 Financial Results

Total revenue for the fourth quarter of 2022 was $80.3 million, an increase of 19% compared to $67.3 million in the fourth quarter of 2021. Testing revenue was $70.3 million, an increase of 32% compared to $53.4 million in the fourth quarter of 2021 driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $3.2 million, an increase of 17% compared to $2.8 million in the fourth quarter of 2021. Biopharmaceutical and other revenue was $6.8 million, a decrease of 39% compared to $11.2 million, driven primarily by a milestone payment received in the prior year period.

Total gross margin for the fourth quarter of 2022, including the amortization of acquired intangible assets, was 61%, compared to 59% in the fourth quarter of 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 67% compared to 66% in the fourth quarter of 2021.

Operating expenses, excluding cost of revenue, were $58.9 million, an increase of 4% compared to the fourth quarter of 2021. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, were $51.1 million compared to $46.2 million in the fourth quarter of 2021.

Net loss for the fourth quarter of 2022 was $3.8 million, an improvement of 63% compared to the fourth quarter of 2021. Basic and diluted net loss per common share was $0.05, an improvement of 67% compared to the fourth quarter of 2021.

Full Year 2022 Financial Results

Total revenue for 2022 was $296.5 million, an increase of 35% compared to $219.5 million in 2021. Testing revenue was $250.5 million, an increase of 33% compared to $188.2 million in 2021 driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $12.6 million, an increase of 10% compared to $11.5 million in 2021. Biopharmaceutical and other revenue was $33.4 million, an increase of 68% compared to $19.9 million in 2021, driven primarily by the contribution of the HalioDx acquisition.

Total gross margin for the full year 2022, including the amortization of acquired intangible assets, was 59%, compared to 60% in 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 66%, flat to 2021.

Operating expenses, excluding cost of revenue, were $236.0 million, an increase of 4% compared to 2021. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, were $200.3 million compared to $158.4 million in 2021.

Net loss for the full year 2022 was $36.6 million, an improvement of 52% compared to 2021. Basic and diluted net loss per common share was $0.51, an improvement of 54% compared to 2021. Net cash provided by operating activities in 2022 was $7.5 million, an improvement of $39.2 million compared to 2021.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2023 Financial Outlook

Veracyte is initiating 2023 annual total revenue guidance of $325 million to $335 million, assuming currency rates as of February 22, 2023. This range includes mid-teens year-over-year growth of testing and product revenue, and a decline in Biopharmaceutical and other revenue for fiscal 2023 compared to fiscal 2022.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BIbe54a1af06be4083968e88a7edfb6679