AnPac Announces regaining Compliance with Nasdaq Listing Requirement

On November 30, 2022 AnPac Bio-Medical Science Co., Ltd. (Nasdaq: ANPC) ("AnPac Bio" or the "Company"), a biotechnology company with operations in the United States and China focused on early cancer screening and detection, reported that the company has been notified by the Office of the General Counsel of The Nasdaq Stock Market LLC that the Company has regained compliance with the minimum $1 per share bid price requirement of Listed Securities required for continued listing as set forth in Listing Rule 5450(a)(1) (Press release, Anpac Bio, NOV 30, 2022, View Source [SID1234624585]). The Company will remain under the Mandatory Panel Monitor until June 9, 2023, imposed by a previous Hearings Panel’s decision on June 9, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On June 9, 2022, AnPac Bio-Medical Science Co., Ltd. (the "Company") received the determination from The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the requirements to remain listed in The Nasdaq Capital Market subject to a one-year Mandatory Panel Monitor of the Company’s ongoing compliance with such requirements as set force in Listing Rule 5815(d)(4)(B). If, within that one-year monitoring period, Listing Qualifications staff ("Staff") finds the Company again out of compliance with the requirement that was the subject of the exception, notwithstanding Rule 5810(c)(2), the Company will not be permitted to provide the Staff with a plan of compliance with respect to that deficiency and Staff will not be permitted to grant additional time for the Company to regain compliance with respect to that deficiency, nor will the company be afforded an applicable cure or compliance period pursuant to Rule 5810(c)(3). Instead, Staff will issue a Staff Delist Determination and the Company will have an opportunity to request a new hearing with the initial Hearings Panel or a newly convened Hearings Panel if the initial Hearings Panel is unavailable. The Company will have the opportunity to respond/present to the Hearings Panel as provided by Listing Rule 5815(d)(4)(C). If the hearing is unsuccessful, the Company’s securities may be at that time delisted from Nasdaq.

On September 9, 2022, the Company received a Staff determination letter (the "Letter") from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market due to its failure to regain compliance with the $1 Bid Rule within the 180 calendar day Compliance Period.

On September 16, 2022, the Company filed a request for a hearing before the NASDAQ Hearings Panel to present its financial data including Shareholders’ Equity and plan with the applicable listing requirements. This request was due to a Staff determination letter (the "Letter") on September 9, 2022 from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") notifying the Company of the Staff’s determination to delist the Company’s securities from The Nasdaq Capital Market due to the Company’s failure to regain compliance with the $1 per share bid price requirement of Listed Securities required for continued listing as set forth in Listing Rule 5450(a)(1) (the "$1 Bid Rule"), following the 180 calendar day compliance period set forth in Listing Rule 5810(c)(3)(A) (the "Compliance Period"). On September 16, 2022, Company received a letter from Nasdaq granting the appeal and scheduling the Nasdaq Hearings Panel for October 20, 2022.

During the hearing held on October 20, 2022, the Company presented its plan (including share reverse split) to regain compliance with $1 Bid Rule, and the Company’s request for continued listing on The Capital Market has been granted on the condition that before November 23, 2022, the Company shall demonstrate compliance with Listing Rule 5550(a)(2), the $1 Bid Price Rule.

Aileron Therapeutics Regains Compliance with Nasdaq Listing Requirements

On November 30, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company that aspires to make chemotherapy safer and thereby more effective to save more patients’ lives, reported that it received written notice on November 28, 2022 from The Nasdaq Stock Market noting that Aileron has regained compliance with the minimum bid price requirement under Listing Rule 5550(a)(2), which requires the company to maintain a minimum closing bid price of $1.00 per share, and the matter is now closed (Press release, Aileron Therapeutics, NOV 30, 2022, View Source [SID1234624583]). Nasdaq staff made this determination after Aileron’s closing bid price was above $1.00 per share for 10 consecutive business days from November 11, 2022 to November 25, 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!


Agios to Participate in December Investor Conference

On November 30, 2022 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, reported that the company is scheduled to present at the Bank of America 2022 Virtual Biotech SMID Cap Conference on Wednesday, December 7, 2022, at 11:25 a.m. ET (Press release, Agios Pharmaceuticals, NOV 30, 2022, View Source [SID1234624580]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentations can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

Vivesto announces that Christer Nordstedt will remain as acting CEO during a transition period

On November 30, 2022 Vivesto AB, an oncology-focused specialty pharma company, reported that the company’s acting CEO Christer Nordstedt will remain in his position part-time until Vivesto’s new permanent CEO Erik Kinnman takes up his position (Press release, Vivesto, NOV 30, 2022, View Source [SID1234624576]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On November 21, 2022, Vivesto announced that Erik Kinnman was appointed as the new CEO of Vivesto, effective no later than May 20, 2023. Vivesto has today agreed with Christer Nordstedt that he will remain in his current position as acting CEO of Vivesto on a part-time basis until Erik Kinnman takes office.

"We are very pleased that Christer can remain in his role as acting CEO of Vivesto. During the short time he has been with us, Christer has demonstrated his broad competence and long experience from the industry, and we look forward to a seamless transition until Erik Kinnman takes office. It is also gratifying that Christer will continue to contribute to the company’s development as a senior advisor in R&D," said Peter Zonabend, Chairman of the Board of Vivesto.

As of December 1, 2022, Christer Nordstedt will also hold the position as CEO of Oblique Therapeutics AB.

ISA Completes Enrolment in Randomized Double Blind Phase 2 Clinical Trial of ISA101b in HPV16 induced Oropharyngeal Cancer

On November 30, 2022 ISA Pharmaceuticals B.V., a clinical stage biotech company developing immunotherapies to treat cancers and infectious diseases, reported that it has completed enrolment in its Phase 2 clinical trial named OpcemISA (Press release, ISA Pharmaceuticals, NOV 30, 2022, View Source [SID1234624575]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The OpcemISA trial has enrolled 194 patients and is a large randomized, double blind, placebo-controlled Phase 2 clinical trial. The trial will evaluate the efficacy and safety of the addition of ISA101b to checkpoint inhibitor therapy in patients with metastatic/advanced 1st and 2nd line HPV16 positive OPC. Primary endpoints will demonstrate overall response rate (ORR) and safety. Secondary endpoints include duration of response (DOR) and overall survival (OS). This trial is part of an extensive clinical development program of ISA101b in collaboration with US biotechnology company Regeneron.

"This large proof of concept trial of ISA101b has the potential to demonstrate for the first time that the combination of an HPV16-directed therapeutic vaccine with checkpoint inhibitor immunotherapy improves the short-term outcome and longer-term survival of difficult to treat head and neck cancer patients. The completion of enrolment is a major milestone for ISA Pharmaceuticals as it continues development of its SLP technology platform. We look forward to presenting top line interim data from this trial in the third quarter of next year." said Dr. Leon Hooftman, Chief Medical Officer of ISA Pharmaceuticals.

Head-and-neck cancer can be a severe and life-threatening disease. HPV16 is a major cause of head-and-neck cancer. Recurrent and metastatic HPV16 positive OPC is a form of head-and-neck cancer with a high unmet medical need. In September 2021 ISA101b was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent and metastatic HPV16 positive oropharyngeal cancer (OPC).