On October 4, 2022 Imugene Limited (ASX:IMU), a clinical stage immuno-oncology company, reported the appointment of Dr Giovanni Selvaggi as Chief Medical Officer (CMO) (Press release, Imugene, OCT 4, 2022, View Source [SID1234621683]).

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Dr Selvaggi is a pulmonologist, trained in thoracic malignancies management with a focus on lung cancers and mesothelioma. He brings more than a decade of experience in the pharmaceutical industry which has seen him in clinical development focused roles of increasing responsibility with GlaxoSmithKline (GSK), Novartis Oncology and Bristol Myers Squibb.

Dr Selvaggi held a pivotal role in Novartis successful development and approval of ceritinib (or Zykadia, targeting non-small cell lung cancer/NSCLC) and was part of the immunotherapy team at Bristol Myers Squibb that led to the approval of nivolumab (Opdivo) in third line small cell lung cancer.

His most recent role with US oncology company Xcovery Holdings Inc saw Dr Selvaggi progress from CMO to be appointed CEO and CMO early in 2021. Prior to this Dr Selvaggi also served as Vice President, Clinical Development at Oncolytics Biotech in Canada. Additionally, he has been a well-regarded presenter at major international medical conferences as well as having authored numerous peer reviewed articles in major oncology journals.

Prior to entering the pharmaceutical sector Dr Selvaggi was as an attending physician at Thoracic Oncology-San Luigi Hospital in Turin, Italy. This included being an investigator on various oncology clinical trials.

Dr Selvaggi studied at the Medical School at the University of Torino in Italy, where he also completed his Residency in Respiratory Medicine at the Postgraduate Medical School.

Imugene’s M.D. & CEO, Ms Leslie Chong said: "We are delighted to welcome Dr Selvaggi to the Imugene team as our clinical development activities grow in both number and importance. He brings big pharma prowess that we expect to be very valuable, as well as having an excellent understanding of the experience of the institutions and investigators typically associated with drug development. He’s another excellent appointment to the world-class team we’re building."

On October 4, 2022 Sonnet BioTherapeutics Holdings, Inc. (NASDAQ:SONN) (the "Company" or "Sonnet BioTherapeutics"), a clinical-stage company developing targeted immunotherapeutic drugs, reported that it received notice from The Nasdaq Stock Market LLC (Nasdaq) on October 3, 2022 informing Sonnet that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) (the "Rule") for continued listing on The Nasdaq Capital Market (Press release, Sonnet BioTherapeutics, OCT 4, 2022, View Source [SID1234621682]). In order to regain compliance with the Rule, the Company’s common stock was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days. That requirement was met on September 30, 2022.

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Stockholders’ Equity Deficiency

As previously reported, on August 22, 2022, the Company received notice from Nasdaq advising the Company that it is not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the "Stockholders’ Equity Requirement"). The notice had no immediate effect on the listing of the Company’s common stock and the Company’s common stock continues to trade on The Nasdaq Capital Market under the symbol "SONN," subject to the Company’s compliance with the other continued listing requirements. Pursuant to the notice, Nasdaq has given the Company 45 calendar days, or until October 6, 2022, to submit to Nasdaq a plan to regain compliance. If the Company’s plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance. The Company is currently evaluating various courses of action to regain compliance and plans to timely submit its plan to Nasdaq to regain compliance with the Stockholders’ Equity Requirement.

There can be no assurance that the Company’s plan will be accepted or that if it is, the Company will be able to regain compliance. If the Company’s plan to regain compliance is not accepted, or if it is and the Company does not regain compliance within 180 days from the date of Nasdaq’s letter, or if the Company fails to satisfy another Nasdaq requirement for continued listing, Nasdaq could provide notice that the Company’s common stock will become subject to delisting. In such event, Nasdaq rules would permit the Company to appeal the decision to reject the Company’s proposed compliance plan or any delisting determination to a Nasdaq Hearings Panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing.

On October 4, 2022 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec"), a clinical-stage biotechnology company focused on developing intratumoral immunotherapies to stimulate the patient’s own immune system to target and eradicate cancer, reported a corporate restructuring intended to prioritize development of its lead clinical candidate TAVO (TAVO-EP) a plasmid encoding interleukin 12 (IL-12) delivered by intratumoral electroporation, and extend the Company’s cash runway (Press release, OncoSec Medical, OCT 4, 2022, View Source [SID1234621681]).

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Oncosec is reducing its staff by approximately 45% and prioritizing clinical pipeline activities to reduce operating expenses. The Company and remaining employees will focus clinical activities in melanoma to advance TAVO-EP toward near-term data milestones of the KEYNOTE-695 clinical trial. OncoSec will provide more detail on the financial implications of the restructuring in the Form 10-K due in October.

Updated guidance on the pivotal Phase 2b KEYNOTE-695 trial in metastatic melanoma, is as follows.

Top-line results of the secondary endpoint, Objective Response Rate (ORR) by investigator assessment based on RECIST v1.1, is expected to be announced in the fourth quarter of 2022.
Top-line results of the primary endpoint, Overall Response Rate (ORR) by blinded independent central review (BICR) based on RECIST v1.1, is expected to be announced in the first quarter of 2023.
"Since joining as CEO my focus has been on reviewing all aspects of our technology and pipeline. This led to the conclusion that an operational restructuring and strategic pipeline refocus is the best course of action to accelerate advancing TAVO-EP and preparing for the completion and data readout of our KEYNOTE-695 trial," said Robert H. Arch, Ph.D., OncoSec’s Chief Executive Officer. "It is very unfortunate because this necessary step affects a very talented group of employees that have contributed to our efforts and helped build the company. We are grateful for their contributions."

On October 4, 2022, Verastem, Inc. Presented its corporate presentation (Presentation, Verastem, OCT 4, 2022, View Source [SID1234621680]).

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On October 4, 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its third quarter 2022 financial and operating results on Thursday, November 3, 2022, before the U.S. financial markets open (Press release, Regeneron, OCT 4, 2022, View Source [SID1234621679]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
Participants may access the conference call live via webcast on the ‘Investors and Media’ page of Regeneron’s website at View Source To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.