Syndax Announces Presentation at B. Riley Securities’ 2022 Oncology Conference

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 [SID1234605644]).

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.

Alpha Tau Announces New Research Collaboration to Study the Potential of Alpha DaRT to Enhance Immune Stimulation in the Treatment of Breast Cancer

On January 20, 2022 Alpha Tau Medical Ltd. ("Alpha Tau"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that it has signed a sponsored research agreement with investigators at The University of Texas MD Anderson Cancer Center ("MD Anderson") to evaluate potential immune stimulation by combining Alpha DaRT with DNA-repair inhibitors and immune checkpoint inhibitors for the treatment of breast tumors (Press release, Alpha Tau Medical, JAN 20, 2022, View Source [SID1234605643]).

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 study will be led by Gabriel Sawakuchi, Ph.D., Associate Professor of Radiation Physics, and Simona Shaitelman, M.D., Associate Professor of Radiation Oncology at MD Anderson, together with Alpha Tau’s translational research and physics teams. The research will focus on the mechanism of alpha radiation, with its higher relative efficiency in killing cancer cells, in comparison to traditional radiation modalities such as protons and photons, to assess any potential synergy in providing immune stimulation for enhanced destruction of breast cancer cells. The investigators will examine whether such a synergy exists between Alpha DaRT, immune checkpoint inhibitors, and biological treatments that inhibit DNA repair in a pre-clinical setting.

Alpha Tau CTO Ronen Segal said, "This is an extremely exciting collaboration for Alpha Tau. We are delighted to work with such an extraordinary team to examine a very promising hypothesis: that Alpha DaRT may be uniquely well-suited to treat what has been a particularly deadly and intractable form of cancer."

About Alpha DaRT
Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the source and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

Spectrum Pharmaceuticals to Participate in B. Riley Securities 2022 Virtual Oncology Conference

On January 20, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will participate in the B. Riley Securities 2022 Virtual Oncology Conference (Press release, Spectrum Pharmaceuticals, JAN 20, 2022, View Source [SID1234605642]). A fireside chat is scheduled for Thursday, January 27, 2022 at 9:30 a.m. ET / 6:30 a.m. PT.

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 will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after the event.

CASI pharmaceuticals partner, Bioinvent, announces BI -1206 granted orphan drug designation by the U.S. FDA for the treatment of patients with follicular lymphoma

On January 20, 2022 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its partner BioInvent International AB, for BI-1206, an investigational anti-FcyRllB antibody, for the treatment of follicular lymphoma (FL), the most common form of slow-growing Non-Hodgkin lymphoma (NHL) (Press release, BioInvent, JAN 20, 2022, View Source;1206-granted-orphan-drug-designation-by-the-us-fda-for-the-treatment-of-patients-with-follicular-lymphoma-301464561.html [SID1234605641]).

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!

BI-1206 is BioInvent’s lead drug candidate and is currently being investigated in two Phase 1/2 trials. One is evaluating the BI-1206 combination with rituximab for the treatment of Non-Hodgkin lymphoma, which includes patients with FL, MCL and marginal zone lymphoma (MZL) who have relapsed or are refractory to rituximab. A second Phase 1/2 trial is investigating BI-1206 in combination with anti-PD1 therapy Keytruda (pembrolizumab) in solid tumors.

Dr. Wei-Wu He, CASI’s Chairman, and CEO commented, "BioInvent continues to make progress with the development and regulatory framework for BI-1206. The CTA approval in China in December 2021 and the recent FDA Orphan Drug Designation demonstrate the strong potential of this first-in-class antibody. CASI has China commercial rights of BI-1026, and our team is preparing for China’s clinical study. CASI and BioInvent are seamless partners and have the common goal to benefit patients with innovative pharmaceutical technologies."

Entry into a Material Definitive Agreement

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.