Y-mAbs Announces Executive Management Changes and Provides 2022 Revenue Guidance and Financial Update

On April 27, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported the following executive management changes: Dr. Claus Moller has stepped down from his positions as Chief Executive Officer and Board Member effective immediately (Press release, Y-mAbs Therapeutics, APR 27, 2022, View Source [SID1234613087]). Thomas Gad, the Company’s Founder, Chairman and President has assumed the role of Interim CEO and Board Member. In addition, Mr. Gad has stepped down as Chairman and Dr. Jim Healy, current Board Member and Chair of the Compensation Committee, has been appointed as Chairman of the Board. The Board has begun a search for Dr. Moller’s successor.

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Dr. Healy said, "On behalf of the Board, we thank Claus for his service and many accomplishments during his tenure as CEO. The Company has made great strategic, commercial, and operational progress. We wish Claus the very best. Claus has assembled a talented and highly capable leadership team, which will ensure continuity while we conduct a search for a permanent replacement."

Thomas Gad further notes, "I want to personally thank Claus for his contribution to building Y-mAbs. At the same time, I am excited about Y-mAbs future. DANYELZA sales are increasing, and we just ended the first quarter of 2022 with net revenues of $10.5 million, which provides us the visibility to issue full year revenue guidance of $45-50 million. The omburtamab BLA was resubmitted on March 31, 2022 and is currently under review with the FDA. Financially, as of March 31, 2022, we believe we are well-positioned with $156.7 million in cash that provides a runway to mid-2024. Upon the potential approval of omburtamab, the Company will be entitled to receive a Priority Review Voucher ("PRV"). Proceeds from monetization of any such PRV and potential omburtamab revenues are currently not included in this guidance. At this point in time, most of the pivotal trials, post marketing commitments and regulatory work for omburtamab are behind us, and we have further adjusted our operating expenditures for 2022, corresponding to operating expenses of $162-167 million and a net cash burn of $78-83 million, to ensure we can deliver on our future milestones."

Preliminary Financial Results

The preliminary financial results set forth above are unaudited and based on management’s initial review of the Company’s results as of and for the quarter ended March 31, 2022, and are subject to revision based upon the Company’s quarter-end closing procedures and the completion of the review by the Company’s external auditors of the Company’s quarter-end financial statements. Actual results may differ materially from these preliminary results as a result of the completion of quarter-end closing procedures, final adjustments, and other developments arising between now and the time that the Company’s financial results are finalized. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the quarter ended March 31, 2022, should not be viewed as a substitute for complete financial statements prepared in accordance with U.S. generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

Allogene Therapeutics to Report First Quarter 2022 Financial Results on May 4, 2022

On April 27, 2022 Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) products for cancer, reported that it will report first quarter 2022 financial results on Wednesday, May 4, 2022 after the close of the market (Press release, Allogene, APR 27, 2022, View Source [SID1234616274]). The announcement will be followed by a live audio webcast and conference call at 2:00 PM Pacific Time/5:00 PM Eastern Time.

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Audio Webcast
The webcast will be made available on the Company’s website at www.allogene.com under the Investors tab in the News and Events section. Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.

Advaxis to Present at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting

On April 27, 2022 Advaxis, Inc. (OTCQX: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that it will present data from the Phase 2 study of ADXS-503 in combination with pembrolizumab in patients with metastatic non-small cell lung cancer and data from the Phase 1 study of ADXS-504 in patients with biochemically recurrent prostate cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually, on June 3-7, 2022 (Press release, Advaxis, APR 27, 2022, View Source [SID1234613022]).

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Presentation Details:

Abstract #1

Title: A phase 2 study of an off-the-shelf, multi-neoantigen vector (ADXS-503) in patients with metastatic non-small cell lung cancer either progressing on prior pembrolizumab or in the first line setting.
Session Type: Poster Session
Abstract Number: 9038
Date and Time: June 6, 2022, 8-11 AM (CDT)

Abstract #2

Title: Immunogenicity and disease control induced by a multi-neoantigen vaccine (ADXS-503) in patients with metastatic non-small cell lung cancer who have progressed on pembrolizumab.
Session Type: Poster Session
Abstract Number: 9042
Date and Time: June 6, 2022, 8-11 AM (CDT)

Abstract #3

Title: A phase I study of ADXS-504, a cancer type specific immunotherapy, for patients with biochemically recurrent prostate cancer.

Session Type: Poster Session
Abstract Number: TPS5115
Date and Time: June 6, 2022, 1:15-4:15 CDT (CDT)

Aligos Therapeutics to Announce First Quarter 2022 Results May 4, 2022

On April 27, 2022 Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, reported that it will report the company’s first quarter 2022 financial results on Wednesday, May 4, 2022 after the close of U.S. financial markets (Press release, Aligos Therapeutics, APR 27, 2022, View Source [SID1234613038]).

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AC Immune to Present at the B. Riley Annual Neuro & Ophthalmology Virtual Investor Conference

On April 27, 2022 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that Company Management will participate in a Fireside chat and one-on-one investor meetings during the B.Riley Annual Neuro & Ophthalmology Virtual Investor Conference, taking place virtually on April 27-28, 2022 (Press release, AC Immune, APR 27, 2022, View Source [SID1234613054]).

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During the Fireside chat, Prof. Andrea Pfeifer, CEO, AC Immune SA, will discuss the Company’s broad development pipeline addressing the full spectrum of neurodegenerative diseases targets and modalities, the recent progress of certain key programs, and the anticipated clinical milestones in 2022. Having already achieved two clinical milestones in the first quarter, Prof. Pfeifer will outline the next five clinical data readouts this year, whilst highlighting their contribution to the company’s precision medicine approach.

The Fireside chat will take place on April 28, 2022, at 11:30 am EDT / 5:30 pm CEST. A webcast of the Fireside chat will be available on the Events Page of AC Immune’s website. Following the Fireside chat, a replay will be archived in the same location.