Duyuru • Jan 20
Scopus BioPharma Files Form 15 Scopus BioPharma Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its common stock under the Securities Exchange Act of 1934, as amended. The par value of the company's common stock was $0.001 per share. Duyuru • Nov 08
Scopus BioPharma Inc. Presents DUET-102 in Combination with PD-1 Blockade Demonstrates Significant Anti-Tumor Activity in Models of Malignant Glioma Scopus BioPharma Inc. and its majority-owned subsidiary, Duet BioTherapeutics Inc., presented compelling new data that DUET-102 in combination with PD-1 blockade demonstrates significant anti-tumor activity in models of malignant glioma. The new data was presented on November 4, 2023 at the 38th Annual Meeting of the Society for Immunotherapy of Cancer ("SITC") by Marcin Kortylewski, Ph.D. Dr. Kortylewski, Professor of Immuno-Oncology at City of Hope, is the Co-Founder and Senior Scientific Advisor of Duet. Duet is developing novel immunotherapies to overcome treatment-resistant cancers. DUET-102 is a double-stranded antisense oligonucleotide ("ASO") STAT3 inhibitor linked to a TLR9 immune activator being developed for the treatment of glioma. Glioma is a common type of tumor originating in the glial cells of the brain. Approximately 20,000 patients are diagnosed in the United States annually, with such patients having a 5-year survival rate of less than 7%, reflecting the need for new therapies to combat this disease. The featured data shows: Intracranially injected DUET-102 sensitizes malignant glioma to systemic PD-1 blockade, triggering complete injection of both orthotopic GL261 and PD-1 refractory QPP8 tumors in the majority of treated mice. DUET-102 creates ideal conditions for PD-1 blockade to recruit cancer-killing effector CD8 positive T cells into the tumor by activating intratumoral dendritic cells, M1 macrophages, and microglia, while concurrently reducing immunosuppressive tumor-associated M2 macrophages, resting microglia, and regulatory T cells. DUET-102, as a monotherapy, inhibited tumor growth and extended survival of mice in U251, GL261, and QPP8 models of glioma. DUET-102 was well tolerated and demonstrated unique suitability for intracranial injection, with optimized activity and tolerability in the brain compared to single-stranded ASO designs. Furthermore, the effectiveness of DUET-102 in releasing immunosuppression may enhance the efficacy of other T-cell based immunotherapies in the context of glioma, including potential combinations of DUET-102 with adoptive cell transfer therapies, such as CAR T-cell therapies. Duyuru • Dec 17
Scopus BioPharma Inc. Announces Update on Deficiency Notification Letters from Nasdaq Regarding Minimum Bid Price Requirement As previously disclosed, Scopus BioPharma Inc. has not satisfied certain requirements for continued listing of the Nasdaq Stock Market LLC (“Nasdaq”), including: (i) the minimum Market Value of Listed Securities; (ii) the minimum Market Value of Publicly Held Shares; and (iii) the minimum closing bid price. As also previously disclosed, the Company had a hearing, on August 25, 2022, with the Nasdaq Hearings Panel (the “Panel”) at which the Panel considered the Company’s plan for regaining compliance with Nasdaq listing standards (the “Compliance Plan”). 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 and that the Company’s common stock would continue to be listed on that market subject to, among other things, the Company satisfying the Compliance Plan. As reported on December 2, 2022, the Company failed to comply with, among other things, milestone dates included in the Compliance Plan. In response to the Company informing the Panel of an inability to complete a specified financing transaction by a subsequent milestone date, the Panel informed the Company, by letter dated December 15, 2022, of its determination to delist the Company’s common stock from Nasdaq. Such letter further informed the Company that Nasdaq will complete the delisting after, among other things, the lapsing of applicable appeal periods and that trading of the Company’s common stock on Nasdaq will be suspended effective at the open of trading on December 19, 2022. The Company anticipates that, upon suspension of trading on Nasdaq, its common stock will commence trading on one of the markets operated by the OTC Markets Group under its existing ticker symbol SCPS". The Company has submitted an application for trading of its common stock on the OTCQB Venture Market (the OTCQB"). The OTCQB requires, among other things, that companies be current with and otherwise satisfy applicable reporting requirements. The Company intends to continue to comply with applicable reporting requirements under the Securities Exchange Act of 1934. There can be no assurance that the Company's application to trade on the OTCQB will be approved on a timely basis or at all or that the Company will be able to satisfy reporting and other applicable requirements. Duyuru • Dec 05
Scopus BioPharma Inc. Announces Update on Deficiency Notification Letters from Nasdaq Regarding Minimum Bid Price Requirement As previously reported, Scopus BioPharma Inc. (the ‘company’) received deficiency notification letters from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (‘Nasdaq’ or the ‘Exchange’) indicating that the Company was not in compliance with Nasdaq’s ‘minimum bid price’ requirement, which requires that the bid price of the stock of listed companies be at least $1.00 per share (the ‘Minimum Bid Price Requirement’) and certain Nasdaq listing rules relating to maintaining a minimum market value of listed securities of $50,000,000 (the ‘MVLS Requirement’) and a minimum market value of publicly held shares of $15,000,000 (the ‘MVPHS Requirement’ and, together with the Minimum Bid Price Requirement and the MVLS Requirement, the ‘Listing Requirements’). Also, as previously disclosed, the Company participated in a hearing on August 25, 2022 with the Nasdaq Hearings Panel (the ‘Panel’) at which the Panel considered the Company’s plan for regaining compliance with Nasdaq listing standards (the ‘Compliance Plan’). Also, as previously disclosed, on September 13, 2022, Nasdaq informed the Company of the Panel’s decision (the ‘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 in full by no later than January 9, 2023. The Company failed to comply with milestone dates set forth in the Compliance Plan and did not timely inform Nasdaq of such failure. By letter dated December 1, 2022, Nasdaq informed the Company that the Panel has determined to grant the Company a final extension to such milestone dates and publicly reprimanded the Company. Such public reprimand, pursuant to Listing Rule 5815(c)(1)(D), was issued to the Company for its failure to comply with Listing Rule 5250(a)(1), requiring it to notify Nasdaq of certain significant developments that led to its prior representations about its ability to satisfy the terms of the Decision and, therefore, the Exchange’s continued listing requirements being inaccurate. While the Company is continuing to use its best efforts to satisfy the Listing Requirements in full by no later than January 9, 2023, there can be no assurance that the Company will be able to do so as set forth in the Compliance Plan, as amended, or at all. Failure to do so would result in the delisting of the Company’s common stock from Nasdaq, which would likely have a material adverse effect on the trading and value of the Company’s common stock. Duyuru • Nov 16
Scopus BioPharma Inc. announced delayed 10-Q filing On 11/15/2022, Scopus BioPharma Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Board Change • Nov 16
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Director Dave Buckel was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Duyuru • Oct 10
Scopus Biopharma Receives Additional Non-Compliance Letter from Nasdaq Scopus BioPharma Inc. announced that on October 4, 2022, the company received additional letter from Nasdaq as the company had not regained compliance with minimum bid price standard as of October 3, 2022. Duyuru • Sep 17
Scopus BioPharma Provides Delisting Update As previously disclosed on a Form 8-K filed on September 2, 2022, Scopus BioPharma Inc., on August 25, 2022, presented its plan (the Compliance Plan") for regaining compliance with continued listing standards of the Nasdaq Stock Market LLC (Nasdaq") to the Nasdaq Hearings Panel (the Panel"). 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 in full by no later than January 9, 2023. While the Company believes that it will be able to implement the Compliance Plan, there can be no assurance that the Company will be able to do so as prescribed, or at all. Failure to do so would result in the delisting of the Company's common stock from Nasdaq, which would likely have a material adverse effect on the trading and value of the Company's common stock. Board Change • Aug 13
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 4 non-independent directors. Independent Director Dave Buckel was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Duyuru • Jul 16
Scopus BioPharma Provides Non-Compliance Update As previously reported, on January 13, 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 5500(b)(2) requiring listed securities to maintain a minimum Market Value of Listed Securities of $50,000,000. On July 13, 2022, the Company received an additional letter from Nasdaq stating that because the Company had not regained such compliance as of July 12, 2022, trading of the Company's common stock on Nasdaq would be suspended on July 22, 2022 and removed from listing and registration, unless the Company were to request an appeal to a Nasdaq hearings panel by July 20, 2022. The Company has been in contact with Nasdaq regarding the listing of its common stock and intends to pursue such an appeal. The Company believes that, until the hearings panel renders a decision on the Company's appeal, this delisting action would be stayed and the Company's common stock would continue to be listed on Nasdaq. Duyuru • May 21
Scopus BioPharma Inc. Announces Resignation of Paul Hopper from Board of Directors Scopus BioPharma Inc. announced that on May 18, 2022, Paul Hopper tendered a letter of resignation from the Board of Directors of the Company effective immediately. Duyuru • May 15
Scopus Biopharma Inc. Announces Resignation of Ashish Sanghrajka from the Board of Directors with Effect from May 11, 2022 Scopus BioPharma Inc. announced resignation of Ashish Sanghrajka from the Board of Directors with effect from May 11, 2022. Duyuru • May 14
Scopus BioPharma Inc. announced delayed 10-Q filing On 05/13/2022, Scopus BioPharma Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Duyuru • May 06
Scopus BioPharma Inc. Appoints Raphael Hofstein to its Board of Directors Scopus BioPharma Inc. announced the appointment of Raphael (Rafi) Hofstein to its Board of Directors (Board). Dr. Hofstein is a global leader in the biopharmaceutical and biotechnology industries. Over his career, Dr. Hofstein has been instrumental in the founding and/or leadership of over 60 biopharmaceutical and biotechnology companies. These companies include Fibrocor Therapeutics, a precision medicine company; BioLineRx; and Encycle Therapeutics. Dr. Hofstein is Chairman of Fibrocor, which has strategic partnerships with Evotec SE and Galapagos NV. Dr. Hofstein has been a director of BioLineRx since its inception. Encycle was acquired by Zealand Pharma A/S in 2019. Dr. Hofstein has also played key leadership roles in establishing industry partnerships and strategic alliances with leading global biopharmaceutical, biotechnology and pharmaceutical companies, including Amgen, Baxter, Celgene/Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer and Takeda. Dr. Hofstein fills a vacancy on the Board created by the voluntary resignations of directors who joined the Board as a result of the contested election relating to the 2021 Annual Meeting of Stockholders. The results of the contested election are being challenged in an action pursuant to Section 225 of Delaware’s General Corporation Law in the Delaware Court of Chancery. Duyuru • May 02
Scopus Biopharma Inc. Announces Board Resignations On April 26, 2022, Joshua Levine and Mordechai Hacham each tendered a letter of resignation from the Board of Directors of Scopus BioPharma Inc., effective immediately. Duyuru • Apr 09
Scopus BioPharma Receives Non-Compliance Letter from Nasdaq 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. Nasdaq's written notice has no effect on the listing or trading of the Company's common stock at this time, and the Company is currently evaluating its alternatives to resolve this listing deficiency. Duyuru • Apr 03
Scopus BioPharma Inc. announced delayed annual 10-K filing On 04/01/2022, Scopus BioPharma Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Duyuru • Jan 22
Scopus BioPharma Receives a Deficiency Notification Letter from the Listing Qualifications Staff of the Nasdaq Stock Market On January 13, 2022, Scopus BioPharma Inc. 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. Executive Departure • Jul 14
Independent Director Paul Hopper has left the company On the 2nd of July, Paul Hopper's tenure as Independent Director ended after 1.1 years in the role. We don't have any record of a personal shareholding under Paul's name. A total of 2 executives have left over the last 12 months. The current median tenure of the management team is 3.63 years. Duyuru • Jul 02
Scopus BioPharma Inc. (NasdaqGM:SCPS) acquired Olimmune Inc. Scopus BioPharma Inc. (NasdaqGM:SCPS) entered into an agreement to acquire Olimmune Inc. for $14.3 million on June 25, 2021. The consideration paid Scopus issued to Olimmune stockholders 1,000,000 shares of common stock of the Company. We also issued 100,000 shares of common stock of the Company to COH as additional consideration for the two license agreements.
Scopus BioPharma Inc. (NasdaqGM:SCPS) completed the acquisition of Olimmune Inc. on June 30, 2021. Duyuru • May 25
Scopus BioPharma Announces FDA Approval of IND Application for Lead Drug Candidate Scopus BioPharma Inc. announced the approval of an investigational new drug application (“IND”) by the United States Food and Drug Administration (“FDA”) for CpG-STAT3siRNA, the company’s distinctive immuno-oncology RNA therapy for the treatment of multiple cancers A Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will be initiated at City of Hope. Scopus is a biopharmaceutical company developing transformational therapeutics based on scientific and medical discoveries. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California. CpG-STAT3siRNA encompasses both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. This highly-distinctive drug candidate was developed in the City of Hope laboratories of Hua Yu, Ph.D. and Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer Immunotherapeutics Program and Billy and Audrey L. Wilder Professor in Tumor Immunotherapy. Kortylewski is a professor in the Department of Immuno-Oncology. Duyuru • Apr 27
Scopus BioPharma Announces IND Submission to FDA for Lead Drug Candidate Scopus BioPharma Inc. announced the submission of an investigational new drug application to the United States Food and Drug Administration for its immuno-oncology RNA therapy for the treatment of multiple cancers. The IND filing is a key milestone for the planned Phase 1 clinical trial for B-cell non-Hodgkin lymphoma to be initiated at City of Hope. The company's lead drug candidate encompasses both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. This highly-distinctive drug candidate was developed in the City of Hope laboratories of Hua Yu, Ph.D. and Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer Immunotherapeutics Program and Billy and Audrey L. Wilder Professor in Tumor Immunotherapy. Kortylewski is an associate professor in the Department of Immuno-Oncology. Duyuru • Mar 21
Scopus Biopharma Inc. Announces Change of Board Committees Scopus BioPharma Inc. announced that Dr. Raphael Hofstein became a member of the Audit Committee of the company, filling a vacancy created by the resignation of Dr. Lesley Russell, for reasons unrelated to the operations, policies, or practices of the company, accepted and/or ratified on March 15, 2021 and/or March 18, 2021, as the case may be. Dr. Hofstein assumes this position in addition to his role as a member of each of the Compensation Committee and Nominating Committee. In this connection, Dr. Hofstein also assumed the role of Chair of the Compensation Committee. Dr. Hofstein is considered to be an “independent director” under the rules of the Nasdaq Stock Market, which is defined generally as a person other than an officer or employee of the company or its subsidiaries or any other individual having a relationship, which, in the opinion of the company’s board of directors would interfere with the director’s exercise of independent judgment in carrying out the responsibilities of a director. Duyuru • Mar 17
Scopus BioPharma Inc. Finalizes Arrangements for Submission of IND Package Scopus BioPharma Inc. announced the finalization of arrangements for the completion of the investigational new drug ("IND") package for the company's lead drug candidate and its submission to the United States Food and Drug Administration ("FDA"). The IND submission is expected in second quarter of 2021. The company's lead drug candidate is highly distinctive, encompassing both gene therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. Duyuru • Jan 28
Scopus BioPharma Inc. has completed a Follow-on Equity Offering in the amount of $9 million. Scopus BioPharma Inc. has completed a Follow-on Equity Offering in the amount of $9 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,000,000
Price\Range: $9 Duyuru • Jan 20
Scopus BioPharma Inc. Announces Completion of Clinical Lot Manufacturing Fulfilling the Requirements for the Planned Phase 1 Clinical Trial for Non-Hodgkin's Lymphoma Scopus BioPharma Inc. announced the completion of clinical lot manufacturing fulfilling the requirements for the planned Phase 1 clinical trial for non-Hodgkin's lymphoma. This is a key milestone to enable finalization of the investigational new drug ("IND") package for submission to the United States Food and Drug Administration ("FDA"). Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. The company's lead drug candidate is a novel, targeted immuno-oncology gene therapy for the treatment of multiple cancers. The company's lead drug candidate is highly distinctive, encompassing both gene therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. An additional near-term milestone is a status report under the company's sponsored research agreement relating to its lead drug candidate in combination with checkpoint inhibitors. Duyuru • Dec 30
Scopus BioPharma Inc Announces Appointment of Additional Directors Scopus BioPharma Inc. announced the appointment of additional members to its Board of Directors. The new directors are: Raphael ("Rafi") Hofstein, Ph.D. Dr. Hofstein is a global leader in the biopharmaceutical and biotechnology industries. Over his career, Dr. Hofstein has been instrumental in the founding and/or leadership of over 60 biopharmaceutical and biotechnology companies. Most recently, these companies include: Fibrocor Therapeutics; Encyte Therapeutics (acquired by Zealand Pharma A/S); and Notch Therapeutics, a biotechnology company focused on gene-edited T cell therapies, which has a strategic partnership with Allogene Therapeutics. Lesley Russell, MB.Ch.B, MRCP (UK). Dr. Russell has extensive leadership experience across diverse disciplines at numerous private and public biopharmaceutical, biotechnology and pharmaceutical companies. David S. Battleman, M.D. Dr. Battleman has extensive experience across academia; the biopharmaceutical, pharmaceutical and medical technology industries; and pharmaceutical and healthcare management consulting. David A. Buckel, CMA. Mr. Buckel has extensive experience as a senior executive officer, including chief financial officer and principal accounting officer, of numerous private and Nasdaq-listed public companies. Mr. Buckel is the President and Managing Director of BVI Venture Services, a provider of financial, accounting and management services to private and public companies. David Weild IV. Mr. Weild is a globally recognized leader in capital formation and capital markets structure. Mr. Weild authored and co-authored a number of definitive white papers that were key catalysts for new legislation and regulatory reforms, including the JOBS Act. Mr. Weild is Chairman and Chief Executive Officer of Weild & Co., a boutique investment bank focused on enhancing capital access for emerging growth companies.