Scopus BioPharma Inc. (SCPS)

[Renee]

SCPS: effective Dec. 19,2022 SCPS delisted from the Nasdaq.

https://otce.finra.org/otce/dailyList?viewType=Additions

[RAlbert]

Wonder why the spike today?

[FACT-MASTER]

SITC started 2 days ago November 8 and ends Saturday November 12

Why announce this, this late and if the data was bad, it certainly wouldn't be announced at SITC.

Sumthi'ngs up imo, might get interesting, depending on the "key data"

[FACT-MASTER]

NEWS SITC 2022 :

https://www.streetinsider.com/Globe+Newswire/Scopus+BioPharma%E2%80%99s+Subsidiary+%E2%80%94+Duet+BioTherapeutics+%E2%80%94+Announces+Key+Scientific+Data+to+be+Presented+at+the+37th+Annual+Meeting+and+Exposition+of+the+Society+for+Immunotherapy+of+Cancer/20829800.html

[FACT-MASTER]

Duet 01 Clinical Trial link here:

https://www.clinicaltrials.gov/ct2/history/NCT04995536?V_8=View#StudyPageTop

[FACT-MASTER]

Duet BioPharma Pipeline:

https://duettx.com/pipeline/

[FACT-MASTER]

Volume RIPPING! Nice close at .3720!

AH Close .3825

[FACT-MASTER]

Bit of a heartbeat here today !

[FACT-MASTER]

Home page for Duet BioTherapeutics:

https://duettx.com/

[FACT-MASTER]

Interesting NEWS OUT!

https://ca.finance.yahoo.com/news/scopus-biopharma-completes-recapitalization-designed-132500830.html

[FACT-MASTER]

Oct.7/22 8K posted here re: Nasdaq compliance

https://www.sec.gov/ix?doc=/Archives/edgar/data/1772028/000110465922107186/tm2227824d1_8k.htm

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



As previously reported on a Form 8-K filed on April 8, 2022, Scopus BioPharma Inc. (the “Company”) received a deficiency notification letter from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) on April 4, 2022 indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company’s common stock had closed below $1.00 per share for the previous 30 consecutive business days (the “Minimum Bid Price Standard”). On October 4, 2022, the Company received an additional letter from Nasdaq because the Company had not regained compliance with the Minimum Bid Price Standard as of October 3, 2022.



Also, as previously disclosed, the Company had scheduled a hearing with the Nasdaq Hearings Panel (the “Panel”) at which the Panel would consider the Company’s plan for regaining compliance with Nasdaq listing standards, including the Minimum Bid Price Standard. Such hearing occurred on August 25, 2022. In anticipation of the expiration of the Minimum Bid Price Standard cure period, the Company addressed the Minimum Bid Price Standard as part of its compliance plan (“Compliance Plan”) during its hearing. By letter dated September 13, 2022, Nasdaq informed the Company of the Panel’s decision directing that the Company’s listing be transferred to the Nasdaq Capital Market, effective at the open of business on September 15, 2022, and the Company’s common stock will continue to be listed on that market subject to, among other things, the Company satisfying the Compliance Plan, including regaining compliance with the Minimum Bid Price Standard, in full by no later than January 9, 2023."

[FACT-MASTER]

Level II TRANSLATION = we are all screwed.


Thanks management

[FACT-MASTER]

Update on estimated trial start date August 1/22

https://www.clinicaltrials.gov/ct2/show/record/NCT04995536?term=scopus+biopharma&recrs=ab&cond=Cancer&cntry=US&draw=2&rank=1&view=record

[FACT-MASTER]

I don't think we will survive Nasdaq

We might be screwed here for a while.

[FACT-MASTER]

That was an outright TEASE !!

MGMT. - Why do you do that?

[FACT-MASTER]

Could also be further financing in the pipeline.

Spike in volume.

MGMT - Good News please.

[FACT-MASTER]

SUUMTH'INS UP, imo.!!

Delaware case settlement would be nice, put that behind us and move forward.

Let's get'er done people!

[FACT-MASTER]

Delaware trial now scheduled for 2023!

https://www.sec.gov/Archives/edgar/data/1772028/000141057822002634/scps-20220630x10q.htm#Item1LegalProceedings_971334

"The Delaware Litigation remains in discovery and a trial is currently anticipated to take place during the first half of 2023"

[FACT-MASTER]

Level II bid side looks interesting at the moment.

Hopefully a decision soon from the Judge at the Chancery Court in Delaware.

[heyitsmeagain]

Loaded

[FACT-MASTER]

speculating - the trial is over, however the written judgement, could take a month or longer to be filed.

[FACT-MASTER]

AH Close .45

[FACT-MASTER]

CASE CLOSED - MORRIS LASTER MD, ET AL v IRA GREENSPAN, ET AL

https://courtconnect.courts.delaware.gov/cc/cconnect/ck_public_qry_main.cp_main_idx

[FACT-MASTER]

SOMETHING IS UP!!

[FACT-MASTER]

Last at .42.5 (+15.87%) Volume = 152,988

[FACT-MASTER]

SCPS - continuing on the road to Nasdaq compliance.

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/88236174/current-report-filing-8-k

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



As previously reported on March 18, 2022, Scopus BioPharma Inc. (the “Company”) received deficiency notification letters from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with Nasdaq’s majority independent director requirement (the “Majority Independent Requirement”) and audit and compensation committee requirements (“Audit and Compensation Committee Requirements”), each as set forth in Nasdaq Listing Rule 5605.



With the previously reported appointment of Raphael Hofstein, Ph.D. to the Board of Directors (the “Board”) on April 29, 2022 and the resignation of Ashish Sanghrajka from the Board on May 4, 2022, the Company had regained compliance with the Majority Independent Requirement and Audit and Compensation Committee Requirements, which was confirmed by Nasdaq on May 16, 2022. With the subsequent resignation of Paul Hopper on May 18, 2022, as previously reported, the Company is no longer in compliance with the Majority Independent Requirement as of such date, but remains in compliance with the Audit and Compensation Committee Requirements. Accordingly, on May 23, 2022, the Company received a deficiency notification letter from Nasdaq indicating that the Company is not in compliance with Nasdaq’s Majority Independent Requirement.



Consistent with Nasdaq Listing Rules 5605(b)(1)(A), Nasdaq has provided the Company a new cure period in order to regain compliance with the Majority Independent Requirement: (i) until the earlier of the Company’s next annual stockholders’ meeting or May 18, 2023, or (ii) if the next annual stockholders’ meeting is held before November 14, 2022, then the Company must evidence compliance no later than November 14, 2022.



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.

[FACT-MASTER]

SCPS - Review of Issues:

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/88165648/quarterly-report-10-q#SCPS-20220331X10Q_HTM_Item1LegalProceedings_971334

"On October 26, 2021, the Adverse Parties filed the Derivative Complaint, purportedly on behalf of the Company, against all of the other members of the Company’s Board, excluding Sanghrajka and Hopper, and certain of their affiliates in the Chancery Court. The Derivative Complaint set forth various assertions and allegations against directors who serve on the Executive Committee (the “Executive Committee Directors”) and certain other directors (the “Independent Directors”). On November 12, 2021, the Company filed a motion to dismiss the Derivative Complaint. On March 11, 2022, the Chancery Court dismissed the Derivative Complaint."

Both Sanghrajka and Hopper have resigned.


https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87982197/amended-annual-report-10-k-a

"On April 7, 2021, Morris Laster (“Laster”) filed a Schedule 13D (the “13D”) stating, among other things, that Laster intended to vote against the future election of members of Scopus’ then current Board. On May 9, 2021, Laster submitted nominations for Messrs. Levine and Hacham for election to the Board at the 2021 Annual Meeting, which nominations were subsequently disclosed in an amendment to the 13D filed by Laster on May 12, 2021 (the “Amended 13D”). A definitive proxy statement naming Messrs. Levine and Hacham as Laster’s nominees was filed on October 6, 2021. As disclosed in an amended Current Report on Form 8-K filed with the SEC on January 10, 2022, which was filed to disclose the final voting results of the 2021 Annual Meeting, it was disclosed that, on January 3, 2022, the Executive Committee Directors filed a Verified Complaint pursuant to Section 225 of the Delaware General Corporation Law challenging the results of the 2021 Annual Meeting (the “Section 225 Action”), on the basis that, among other things, (i) Laster improperly voted 6,000,000 shares of the company’s common stock at the 2021 Annual Meeting because Laster does not own such shares over which Laster improperly and incorrectly claimed ownership, and (ii) Laster would not have succeeded at the 2021 Annual Meeting but for the fact he improperly voted such shares. If the Executive Committee Directors were to prevail in the Section 225 Action, then the outcome of the 2021 Annual Meeting would be deemed invalid. On April 26, 2022, Joshua Levine and Mordechai Hacham resigned from the Board."

Both Levine and Hacham have resigned

NEXT ITEM:

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87842277/annual-report-10-k

"In April 2021, Laster initiated the Delaware Litigation against the company in the Chancery Court with respect to ownership of 3,500,000 shares of the company’s common stock. Pursuant to a stipulation approved by the Chancery Court in the Delaware Litigation, the parties agreed to, among other things, an expedited timeline for resolving the Delaware Litigation with a trial intended to be held in December 2021. Such stipulation also provided for adjournments or postponements of the company’s 2021 Annual Meeting, such that the Annual Meeting would be held and the vote on the items of business to be considered at the Annual Meeting would take place during a specified time after a decision on the merits by the Chancery Court or a final settlement between the parties. Pursuant to additional proceedings in the Chancery Court, the company became subject to further expedition for document production. The company’s inability to meet such production deadlines, among other things, resulted in the company being sanctioned by the Chancery Court. Laster made several motions relating to such sanctions, including seeking to recover lawyers’ fees. Commencing in January 2022, the Chancery Court, by subsequent hearings and court orders, specified the categories and amounts of legal fees which would be reimbursable. The precise reimbursable amount is not yet finalized and remains subject to a court order, which we anticipate will be finalized in Q2 2022. In an attempt to mitigate the dispute, reduce the ongoing expenses and disruption of expedition, and limit exposure under sanctions, the company has taken steps in an effort to resolve the Delaware Litigation, including facilitating the transfer by the then-record owner to Laster of record ownership of the Disputed Shares and facilitating the delivery of an irrevocable proxy by the then-record owner to Laster to vote such shares. The Delaware Litigation remains in discovery with a trial date scheduled for early June 2022."

[FACT-MASTER]

Departure/Letter of Paul Hopper

https://www.sec.gov/ix?doc=/Archives/edgar/data/1772028/000110465922063480/tm2216209d1_8k.htm

https://www.conferencecalltranscripts.com/summary/?id=10880992

[FACT-MASTER]

SCPS - Q1/2022 Financials

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/88165648/quarterly-report-10-q

- As of May 13, 2022, there were 21,094,264 shares outstanding of the registrant’s common stock.

- Cash, end of period $3,974,794

[FACT-MASTER]

Interesting Institutional Activity:

https://www.nasdaq.com/market-activity/stocks/scps/institutional-holdings

[FACT-MASTER]

SCPS - Letter from Ashish Sanghrajka

https://www.conferencecalltranscripts.com/summary/?id=10847470

"The following excerpt is from the company's SEC filing.
I,
Ashish Sanghrajka, submit this letter as official notification of my intent to resign from my position as Director of Scopus Biopharma
Inc. (the “Company”), effective immediately.
Throughout
my time as a Director, former President, and former CFO of the Company, Ira S. Greenspan, Joshua R. Lamstein, and Robert J. Gibson (the
“HCFP Directors”) were unwilling to provide me with even the most basic information concerning the Company, its programs, and
its finances. I resigned my title as CFO because I was denied the information and authority to perform that role, but continued my efforts
to help the company succeed as its President, and to protect shareholders as a Director, until I was pushed aside in Spring 2020 because
I would not support the HCFP Directors’ unilateral control and self-dealing . Based on my experience, I have come to believe that the
HCFP Directors’ conduct was designed to keep me and certain other Directors from executing our fiduciary duties as Directors.
Regrettably,
I believe that the HCFP Directors have obfuscated facts, published potentially misleading information concerning the Company, omitted
to publish material information that shareholders were entitled to receive, and engaged in self-dealing transactions intended to enrich
themselves at the expense of the Company’s shareholders.
As
a Director, I asked management critical questions relating to the direction and future of the Company, I voiced specific corporate
governance concerns, and I requested access to important information. In response, instead of answering those questions or providing
information, the HCFP Directors became increasingly hostile towards me. In fact, the HCFP Directors initiated a sham
“investigation” and publicly disparaged me, which has now been the subject of litigation for months. By stifling dissent
and maintaining complete control of the Company, the HCFP Directors have made it impossible for the Board to be effective in
providing any oversight function. Several independent directors will have resigned from the Board at different times over a span of
18 months—a fact that should be viewed as a flashing red light concerning the Company’s corporate governance.
Relatedly,
I have also become concerned about the quality of oversight provided by the Audit Committee. For example, based on my review of the Company’s
recent SEC filing, it appears that the Audit Committee approved the issuance of certain warrants to the HCFP Directors to purchase shares
of the Company’s common stock at an unreasonably low price.
In
addition to fundamental governance issues, based on my review of the most recent SEC filings, the Company appears to have serious financial
issues. For example, I have not been informed of any clinical updates on either of the two lead assets (MRI 1867 and CpG-STAT3siRNA)
in almost a year. Moreover, Scopus shares are trading down over 90% in a single year—from $5.15 a year ago to below $.50 per share today.
Despite this dismal financial situation, it appears the HCFP Directors continue to pay themselves handsomely each year.
All
of my efforts to address these issues have been unsuccessful. After the Company refused to address the corporate governance concerns
I raised and refused to provide me with basic information to which I was entitled as a Director, I—along with another Director and the
Company’s largest shareholder and only ever CEO—filed a derivative lawsuit on behalf of all Scopus shareholders in effort to ensure that
the Company reformed its corporate governance and internal procedures. That lawsuit has not brought about any change at the Company.
In
short, I believe the HCFP Directors’ actions have resulted in disabling actual independent Directors from fulfilling their fiduciary
duties and obligations to the Company. I remained on the Board until I felt certain that the HCFP Directors would not permit me and certain
other directors to fulfill our fiduciary duties. I am now certain that this is the case, and that is why I am resigning at this time.
This
letter of resignation is written without prejudice to my rights, including my right to seek advancement and/or indemnification for costs
and fees under the Company’s corporate governance documents and to pursue all other legal remedies and claims .
Regards,"

[FACT-MASTER]

SCPS - Departure of Ashish Sanghrajka.

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/88110577/current-report-filing-8-k#tm2215560d1_ex99-1_htm

[FACT-MASTER]

SCPS - Nasdaq's Listing Rule 5550(a)(2) -minimum bid $1.00/share

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87797492/current-report-filing-8-k

On April 4, 2022, Scopus BioPharma Inc. (the “Company”) received a deficiency notification letter from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) indicating that the Company was not in compliance with Nasdaq Listing Rule 5550(a)(2) because the bid price for the Company’s common stock had closed below $1.00 per share for the previous 30 consecutive business days.

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has 180 calendar days from the date of such notice, or until October 3, 2022, to regain compliance with the minimum bid price requirement. To regain compliance, the bid price for the Company’s common stock must close at $1.00 per share or more for a minimum of 10 consecutive business days.

[FACT-MASTER]

SCPS - Nasdaq’s majority independent director requirement:

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87650585/current-report-filing-8-k

On December 20, 2021, the Company held its annual meeting (the “Annual Meeting”) where, based on the election results certified on January 5, 2022 (the “Election Results Certification”), two independent incumbent directors were not re-elected and were replaced by two new directors (the “New Directors”). To date, the Company has not been able to determine the independence of the New Directors. Since the independence status of the New Directors is unclear, the Company no longer complies with the Majority Independent Requirement. The Company has 45 days from receipt of the deficiency notification letters on March 18, 2022 to submit to Nasdaq a plan for regaining compliance. If such plan is accepted, Nasdaq can grant an extension of up to 180 calendar days from March 18, 2022 for the Company to evidence compliance.

Further, one of the independent incumbent directors that was not re-elected at the Annual Meeting was a member of the Company’s Audit Committee and Compensation Committee and, upon his leaving such committees in connection with the Election Results Certification, the Company’s Audit Committee and Compensation Committee are no longer compliant with the Audit and Compensation Committee Requirement. Consistent with Nasdaq Listing Rules 5605(c)(4) and 5605(d)(2), Nasdaq has provided the Company a cure period in order to regain compliance: (i) until the earlier of the Company’s next annual stockholders’ meeting or January 5, 2023, or (ii) if the next annual stockholders’ meeting is held before July 5, 2022, then the Company must evidence compliance no later than July 5, 2022.

[FACT-MASTER]

Mount Scopus

https://www.timesofisrael.com/history-on-high-at-mount-scopus/

[FACT-MASTER]

A greeting to Dr. Raphael (Rafi) Hofstein.

https://www.citybiz.co/article/258201/scopus-biopharma-appoints-raphael-hofstein-ph-d-to-its-board-of-directors/


Dr. Hofstein stated, “I am delighted to resume serving on the Board of Scopus. Having founded and nurtured many successful biotech companies, I am extremely excited about the Duet Platform, which encompasses an exceptional and comprehensive portfolio of immuno-oncology assets.”

[FACT-MASTER]

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/88021364/scopus-biopharma-announces-biotechnology-industry

[FACT-MASTER]

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/88013525/current-report-filing-8-k

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.



On April 28, 2022, a vacancy on the Board of Directors (the “Board”) of Scopus BioPharma Inc. (the “Company”) was filled with the appointment of Raphael (Rafi) Hofstein, Ph.D. Dr. Hofstein will serve as a Class A director until the Company’s 2024 Annual Meeting of Stockholders or until his successor is duly elected and qualified or until his earlier death, resignation, disqualification or removal. Dr. Hofstein was also appointed to serve on the Audit Committee of the Board, the Compensation Committee of the Board and the Nominating Committee of the Board. Dr. Hofstein previously served on the Board from December 2020 to January 2022.



There were no arrangements or understandings between Dr. Hofstein and any other persons pursuant to which he was selected as a director, and there are no related person transactions within the meaning of Item 404(a) of Regulation S-K promulgated by the Securities and Exchange Commission between Dr. Hofstein and the Company required to be disclosed herein.

[FACT-MASTER]

SCPS = on track to resolution, imo.

1. Independent Directors/Audit Committee - check

2. Delaware Intervention Complaint - on track for trial June/22 (or earlier on settlement)

3. Regain min.$1/share - post Delaware Case /...2022

Hoping the SCPS story continues to a satisfactory resolution for all parties involved.

Thank you.

[FACT-MASTER]

cont'd Delaware case

"Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

As set forth in the Original 10-K, on December 16, 2021, HCFP/Capital Partners VIB LLC (“VIB”) filed a Motion to Intervene and attached its Complaint in Intervention (the “Intervention Complaint”), which alleges, among other things, that although Laster claims to have acquired 6,000,000 shares of our common stock in June 2017, Laster never owned or acquired those shares because he did not sign or agree to VIB’s operating agreement, which is the only way he could have obtained such shares. If VIB prevails in its Intervention Complaint, then VIB would be the beneficial and record owner of all such 6,000,000 shares of our common stock."

[FACT-MASTER]

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87982197/amended-annual-report-10-k-a

"The Nasdaq deficiency notification letters require the company to regain compliance with the Majority Independent Requirement and the Audit Committee and Compensation Committee Requirements in a timeframe specified by Nasdaq. As a result of the reconstitution of the Board and Audit Committee and Compensation Committee resulting from the resignations of two directors whose independence could not be assessed and the addition of Dr. Hofstein to the Board, the company believes, subject to a determination by Nasdaq, that it has regained compliance with the Audit Committee and Compensation Committee Requirements. As required by Nasdaq, the company intends to submit its plan for regaining compliance with the Majority Independent Requirement shortly."

Nice work SCPS mgmt., imo.

Next - Delaware Intervention Complaint case. ( if i'm not mistaken, coming up in June/22)

[FACT-MASTER]

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87967350/current-report-filing-8-k

" On April 26, 2022, Joshua Levine and Mordechai Hacham each tendered a letter of resignation from the Board of Directors (the “Board”) of Scopus BioPharma Inc. (the “Company”), effective immediately. A copy of each of Messrs. Levine and Hacham’s letters of resignation which state their reasons for resigning are furnished herewith as Exhibits 99.1 and 99.2, respectively. The Company disagrees with Messrs. Levine and Hacham’s substantive assessments and characterizations set forth in their respective letters of resignation."

[FACT-MASTER]

https://www.clinicaltrials.gov/ct2/show/record/NCT04995536?term=scopus+biopharma&recrs=ab&cond=Cancer&cntry=US&draw=2&rank=1&view=record

Recruitment Status: Recruiting

[FACT-MASTER]

SCPS (120 days from Y/E is April 30/22)

Hopefully this will shed some light on a resolution to the legal proceedings re: Delaware Litigation, imo.


From the 10K-A:

Documents Incorporated by Reference

The registrant intends to file an amendment to this Annual Report on Form 10-K (“Form 10-K/A”) within 120 days of the end of its fiscal year ended December 31, 2021. Portions of such Form 10-K/A are incorporated by reference into Part III of this Annual Report on Form 10-K.


PART III

Item 10. Directors, Executive Officers and Corporate Governance.

The information required by this Item 10 is incorporated by reference to an amendment to this Form 10-K to be filed with the SEC within 120 days of the fiscal year ended December 31, 2021.

Item 11. Executive Compensation.

The information required by this Item 11 is incorporated by reference to an amendment to this Form 10-K to be filed with the SEC within 120 days of the fiscal year ended December 31, 2021.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

The information required by this Item 12 is incorporated by reference to an amendment to this Form 10-K to be filed with the SEC within 120 days of the fiscal year ended December 31, 2021.

Item 13. Certain Relationships and Related Transactions, and Director Independence.

The information required by this Item 13 is incorporated by reference to an amendment to this Form 10-K to be filed with the SEC within 120 days of the fiscal year ended December 31, 2021.

Item 14. Principal Accountant Fees and Services.

The information required by this Item 14 is incorporated by reference to an amendment to this Form 10-K to be filed with the SEC within 120 days of the fiscal year ended December 31, 2021.

[FACT-MASTER]

Answer: DUET-01 is in a Phase 1 clinical trial, as a monotherapy, for B-cell non-Hodgkin lymphoma (“NHL”). On March 2, 2022, the clinical trial sponsor publicly updated to May 2022 the possible start date for enrollment. The design of the existing investigator-sponsored clinical protocol for DUET-01, including the number of study visits, together with constraints on mobility and travel due to the COVID-19 pandemic, has caused delays in enrollment. The company has been engaged in ongoing discussions with the sponsor, who has been evaluating the applicable protocol with a view to reducing and/or more closely concentrating subject visits. As a small interfering RNA (“siRNA”)-based technology, DUET-01 is delivered intratumorally. Pursuant to a sponsored research agreement, research is being initiated to evaluate increasing the stability of novel siRNA-based molecules to enable systemic delivery. DUET-02 is being developed for systemic delivery. We are, through Duet, developing DUET-02, which has a similar mechanism of action to DUET-01, except the STAT3 inhibitor is an antisense (“ASO”) RNA molecule rather than a small interfering RNA (“siRNA”). The STAT3ASO molecule binds directly to the STAT3 mRNA, recruiting ribonuclease H1 (“RNase H1”) to degrade the STAT3 mRNA. The use of ASO permits other chemical modifications resulting in greater stability in human blood. This allows for systemic treatment of harder-to-reach solid tumors such as prostate or kidney cancers. Dose-range finding studies, good laboratory practice (“GLP”) toxicology studies, and good manufacturing process (“GMP”) manufacturing of the drug substance and product are all currently in process. Duet expects to file an investigational new drug application (“IND”) for DUET-02 in Q4 2022 in advanced solid malignancies, with Phase 1 clinical trials anticipated to begin in Q1 2023 in the United States. DUET-03 uses an alternative to the destruction of mRNA to silence STAT3 activity, such as with DUET-01 and DUET-02, instead targeting the actual STAT3 transcription factor protein. Duet is also evaluating combination therapies with checkpoint inhibitors. On an ongoing basis, the company continues to refine, update and enhance its immuno-oncology pipeline and target indications, including prioritizing solid tumor indications. The company also continually evaluates the possibilities of additional studies with a view to enhancing, among other things, the effectiveness and method of delivery of our drug candidates and identifying additional protections for our intellectual property.

[FACT-MASTER]

Question: Chairman Messr. Lamstein, is the phase 1 clinical trial still on schedule for May/22?

An update on that subject, including recruitment status, via press release, imo is warranted.

Thank you.

[FACT-MASTER]

Resolve the issues now please, for the greater good SCPS has to offer to oncology patients.

In this instance imo, the parties have reverted to acting like children.

I've seen this in some court cases, unreasonable parties can't see past their immature demands. So what happens? The case keeps moving toward trial, which appears to be scheduled for June/22.

All that means, is that they need the Judge to decide for them, because they were unable to resolve the issue.

We are in discovery, so hopefully some realty is going to set in soon, and the parties will resolve, instead of going full trial.

[FACT-MASTER]

In an attempt to mitigate the dispute, reduce the ongoing expenses and disruption of expedition, and limit exposure under sanctions, the Company has taken steps in an effort to resolve the Delaware Litigation, including facilitating the transfer by the then-record owner to Laster of record ownership of the 3,500,000 shares of common stock and facilitating the delivery of an irrevocable proxy by the then-record owner to Laster to vote such shares. The Delaware Litigation remains in discovery with a trial date scheduled for early June 2022.


https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87842277/annual-report-10-k

[FACT-MASTER]

13.Subsequent Events

Other than what is disclosed below, or elsewhere in these notes, there are no material subsequent events requiring additional disclosure.

On April 7, 2022, we entered into a sponsored research agreement (the “Kortylewski SRA”) with COH for research to be conducted by Marcin Kortylewski, Ph.D., a Co-Founder and Senior Advisor of Duet and Professor in the Department of Immuno-Oncology at COH. Pursuant to the Kortylewski SRA, Dr. Kortylewski and his lab will be evaluating novel chemical structures and formulations to increase the stability of siRNA-based molecules to enable systemic delivery. The research under the Kortylewski SRA is expected to be conducted over a two-year period at a cost of approximately $200,000 per year.

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87842277/annual-report-10-k

[FACT-MASTER]

Cash, end of period $7,942,971

https://ih.advfn.com/stock-market/NASDAQ/scopus-biopharma-SCPS/stock-news/87842277/annual-report-10-k