On January 20, 2022 Mabwell (Shanghai) Bioscience reported a $547 million IPO on Shanghai’s STAR Board (Press release, Mabwell Biotech, JAN 20, 2022, View Source [SID1234605619]). Established in 2017, Mabwell is a clinical-stage antibody developer with 15 assets in its pipeline: three are in BLA stage, three in pivotal trials and six in Phase I/II trials. The company’s lead candidates are biosimilars. It develops therapies for indications in auto-immune diseases, oncology, metabolic disorders, ophthalmologic diseases and infectious diseases. The company has a wholly-owned US subsidiary, Mabwell Therapeutics, in San Diego. Mabwell’s shares have fallen 22% below their IPO price.

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 January 20, 2022 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of its management team will participate in a fireside chat at B. Riley Securities’ 2022 Oncology Conference on Thursday, January 27, 2022 at 12:00 p.m. ET (Press release, Syndax, JAN 20, 2022, View Source [SID1234605640])

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 fireside chat can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.

On January 20, 2022 Bluestar Genomics, Inc., an early cancer detection company leading the development and commercialization of next-generation liquid biopsy approaches initially focused on non-invasive detection of high-mortality cancers, reported positive performance evaluation study results for its pancreatic cancer test (Press release, Bluestar Genomics, JAN 20, 2022, View Source [SID1234605671]). These data confirm that its pancreatic cancer test detects the disease with 55.2% sensitivity and 98.4% specificity in patients with and without diabetes. The study results will be presented on January 21 at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers (ASCO GI) Symposium in San Francisco.

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 new results underscore the importance of earlier pancreatic cancer detection when effective therapies are still possible. Research shows that one in four people diagnosed with pancreatic cancer were first diagnosed with Type 2 diabetes. For the hundreds of thousands of people with new-onset Type 2 diabetes who are potentially at risk for pancreatic cancer, early pancreatic cancer detection could help prevent a late-stage cancer diagnosis.

"Building on the previous data that led to FDA’s breakthrough device designation for our pancreatic cancer test, we continue to focus on addressing the deadliest of cancers with early detection," said Samuel Levy, Ph.D., chief scientific officer at Bluestar Genomics. "Now, with more than a dozen scientific publications and presentations, the precision of our proprietary 5-hydroxymethylcytosine-based platform is evident."

Bluestar Genomics’ pancreatic cancer test uses a standard blood draw to assess whether an individual has an abnormal epigenomic signal associated with pancreatic cancer. With no existing clinical standard of care for screening for pancreatic cancer, Bluestar Genomics’ groundbreaking epigenomics technology platform employs state-of-the-art machine learning coupled with the DNA-based 5-hydroxymethylcytosine (5hmC) biomarker, as a novel method to detect cancer earlier.

The study, which included 1,433 men and women between 45- and 75-years old from 146 sites in the U.S., evaluated the performance of the test in detecting pancreatic cancer signal in new-onset diabetes using Bluestar Genomics’ proprietary epigenomic platform technology based on plasma-derived cell-Free DNA 5-hmC signatures.

"Pancreatic cancer accounts for only three percent of new cancer cases, yet it is the third leading cause of cancer-related death in the United States," said Kelly Bethel, M.D., practicing pathologist at a major medical center in San Diego, and chief medical officer at Bluestar Genomics. "With pancreatic cancer having the poorest overall survival of all the major cancer types, it is imperative that we change the paradigm of late diagnosis depriving patients of potentially curative treatments."

With the prevalence of diabetes increasing worldwide, it is estimated that by 2025, more than 37 million patients will have been diagnosed with diabetes in the U.S. This growing prevalence highlights the need for a non-invasive early pancreatic cancer detection approach.

On January 20, 2022 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, President and Chief Executive Officer, will participate in the following upcoming conferences (Press release, Curis, JAN 20, 2022, View Source [SID1234605620]):

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!

B. Riley Virtual Oncology Conference, Thursday, January 27, 2022 at 1:30 p.m. ET

SVB Leerink 11th Annual Global Healthcare Conference, Friday, February 18, 2022 at 11:20 a.m. ET

Live webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. Archived replays of the webcasts will be available on the Curis website for 90 days following the event.

On January 20, 2022 Scopus Biopharma reported that as previously updated, on November 21, 2021, Scopus BioPharma Inc. ("Scopus," the "Company", "we," "our," or "us") entered into certain securities purchase agreements (the "Original Purchase Agreements"), dated as of November 21, 2021, and certain registration rights agreements (the "Original Registration Rights Agreements"), dated as of November 21, 2021, with certain institutional investors named therein (the "Investors") (Filing, 8-K, Scopus BioPharma, JAN 20, 2022, View Source [SID1234605639]).

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 January 14, 2022, the Company entered into amendments (the "Amendments") to each of the Original Purchase Agreements and each of the Original Registration Rights Agreements with the Investors, pursuant to which the parties (i) agreed to remove the requirement that the Company hold a shareholder meeting to increase the amount of authorized Common Stock in the Company’s Certificate of Incorporation (the effectiveness of such increase, the "Authorized Share Increase Date") and (ii) agreed to have the Series B Additional Investment Options issued in connection with the Original Purchase Agreements be immediately exercisable upon effectiveness of that certain Registration Statement of Form S-3 (File No 333-261991) (such date, the "Effectiveness Date") rather than the Authorized Share Increase Date. In addition, as a result of the Amendments, those certain Placement Agent Additional Investment Options issued in connection with the Original Purchase Agreements also become immediately exercisable upon the Effectiveness Date and the restriction on the Company conducting subsequent equity sales for a period of 60 days contained in the Original Purchase Agreements shall run from the date of the Effectiveness Date rather than the date of the Authorized Share Increase Date.

The foregoing descriptions of the Amendments are not complete and are subject to, and qualified in their entirety by, the full text of such documents, forms of which are attached as Exhibits 10.1 and 10.2 to this Current Report on Form 8-K and are incorporated herein by reference.

Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.

On January 13, 2022, the Company received a deficiency notification letter from the Listing Qualifications Staff of the Nasdaq Stock Market LLC ("Nasdaq") indicating that the Company is not in compliance with Nasdaq Listing Rule 5550(b)(2) requiring listed securities to maintain a minimum Market Value of Listed Securities ("MVLS") of $50,000,000 (the "MVLS Requirement").

The Company has 180 calendars days, expiring July 12, 2022, to regain compliance with the MVLS Requirement. If the Company maintains a MVLS at or greater than $50,000,000 for a minimum of ten consecutive business days, it will regain compliance. If the Company does not regain compliance within 180 calendar days, it will receive a written notification from Nasdaq that its securities are subject to delisting, and may have the opportunity to transfer its listing to The Nasdaq Capital Market ("Capital Market") if it meets the Capital Market’s continued listing requirements and pays the applicable fee.

The Company intends to monitor its MVLS and may, if appropriate, consider implementing available options to regain compliance with the MVLS Requirement. There can be no assurance that the Company will be able to regain compliance with the MVLS Requirement or maintain compliance if the Company regains compliance.

This Current Report on Form 8-K is filed to satisfy the obligation under Nasdaq Listing Rule 5810(b) and Item 3.01(a) of Form 8-K that the Company publicly disclose the deficiency within four (4) business days after the date of the deficiency letter.