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]).

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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.

Aptorum Group Receives FDA Orphan Drug Designation for its SACT-1 Repurposed Drug For The Treatment of Neuroblastoma

On January 20, 2022 Aptorum Group Limited (Nasdaq: APM, Euronext Paris: APM) ("Aptorum Group" or "Aptorum"), a clinical-stage biopharmaceutical company, reported that the United States Food and Drug Administration (FDA) Office has granted Orphan Drug Designation to SACT-1, a repurposed small molecule compound for the treatment of patients with Neuroblastoma (Press release, Aptorum, JAN 20, 2022, View Source [SID1234605672]). Aptorum Group plans to file an Investigational New Drug Application (IND) to commence a phase 1b/2a clinical trial for SACT-1 to test the drug in neuroblastoma patients in 2022.

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Mr. Darren Lui, President and Executive Director of Aptorum Group says, "The granting of orphan drug designation for SACT-1 for the treatment of neuroblastoma is another important step forward in the development of our drug candidate and reflects both the FDA’s and Aptorum’s commitment to addressing the unmet clinical needs of patients with neuroblastoma." Further to our recently announced completion of Phase 1 clinical trial and patent grant for SACT-1, we are currently focusing on our IND preparation for entering into the exciting Phase Ib/2a clinical trials for SACT-1 in the United States."

About SACT-1
SACT-1 is an orally administered repurposed small molecule drug to target neuroblastoma. SACT-1’s mechanism has been investigated in our preclinical studies to enhance tumor cell death and suppress MYCN expression (a common clinical diagnosis in high-risk or relapsed neuroblastoma patients where an amplification of MYCN is usually observed). SACT-1 is designed to be used especially in combination with standard-of-care chemotherapy.

About Neuroblastoma
Neuroblastoma is one of the most prevailing solid tumor cancers in children, representing 8% – 10% of all childhood tumors, accounting for c. 15% of all cancer related deaths in the pediatric population1. For the high-risk patient group, the 5-year survival rate of this condition is around 40-50% as observed by the American Cancer Society2 based on existing treatment.

1 View Source,deaths%20in%20the%20pediatric%20population.

2 View Source

Lilly Confirms Date and Conference Call for Fourth-Quarter and Full-Year 2021 Financial Results Announcement

On January 20, 2022 Eli Lilly and Company (NYSE: LLY) will report its fourth-quarter and full-year 2021 financial results on Thursday, Feb. 3, 2022 (Press release, Eli Lilly, JAN 20, 2022, View Source [SID1234605623]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

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]).

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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."

Tachyon Presents New Data Supporting the Development of TACH101, a Novel KDM4 Inhibitor, as a Potential Therapy for Gastrointestinal Cancers at the 2022 ASCO-GI Conference

On January 20, 2022 Tachyon Therapeutics, Inc. ("Tachyon" or "the Company"), a private biotechnology company creating novel therapeutics to unlock new pathways to treat advanced cancers, reported the presentation of data from its TACH101 program in a virtual poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancer Symposium being held from January 20-22, 2022 (Press release, Tachyon Therapeutics, 20 20, 2022, View Source [SID1234605673]).

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The data demonstrate the potent anti-cancer activity of TACH101, a first-in-class small molecule inhibitor of KDM4 histone demethylase, in preclinical models of gastrointestinal (GI) cancers. KDM4 is a novel target for cancer therapy, playing an important role in the self-renewal of cancer stem cells and regulating epigenetic processes. Overexpression of KDM4 can lead to inhibition of apoptosis, genetic instability, uncontrolled gene expression and cell proliferation, and metastasis. The Company plans to initiate a first-in-human Phase 1 clinical trial in the first half of 2022.

"These preclinical data for TACH101 highlight its potent anti-tumor activity in gastric, esophageal, and colorectal xenograft models and provide support for KDM4 as an important new target for cancer therapy," said Frank Perabo, MD, PhD, CEO of Tachyon Therapeutics. "There is a significant unmet need for new therapeutic options for patients with GI cancers, and we are excited about advancing TACH101 into a first-in-human clinical trial and develop it as a potential new treatment for GI cancers."

Highlights from the ASCO (Free ASCO Whitepaper)-GI poster presentation (Abstract #132) are summarized below:

TACH101 showed potent anti-proliferative activity in GI cancer cell lines and organoid models with IC50 as low as 0.001 µM.
Further evaluation in a panel of colorectal cancer (CRC) patient-derived xenograft (PDX) and organoid models showed a strong correlation of TACH101 sensitivity with MSI-H status (IC50 ranging from 0.001 – 0.270 µM).
TACH101 induced apoptosis in human CRC (HT-29) and esophageal (KYSE-150) cancer cell lines with EC50s of 0.033 μM and 0.092 μM, respectively.
In vivo, TACH101 triggered effective tumor control (≥70%) in xenograft models of CRC (SU60), esophageal (KYSE-150) and gastric (GXA-3036) cancers.
TACH101 treatment caused 86% repression of PNUTS mRNA (a direct target of KDM4) as well as a 51% increase in H3K9me3 (a mark of repressed transcription).
The virtual poster presentation titled, "TACH101, a First-in-Class KDM4 Inhibitor for Treatment of Gastrointestinal Cancers," is available for on-demand viewing beginning at 9 am EST on January 20 by conference attendees on the ASCO (Free ASCO Whitepaper)-GI conference website at View Source