Entry into a Material Definitive Agreement

On September 22, 2021, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with Geneva Roth Remark Holdings, Inc. ("Geneva"), pursuant to which Geneva purchased a convertible promissory note (the "Note") from the Company in the aggregate principal amount of $63,750, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Geneva (Filing, 8-K, Propanc, SEP 28, 2021, View Source [SID1234590377]). The transaction contemplated by the Purchase Agreement will close on or about September 29, 2021. The Company intends to use the net proceeds ($60,000) from the Note for general working capital purposes.

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The maturity date of the Note is September 22, 2022 (the "Maturity Date"). The Note shall bear interest at a rate of 8% per annum, which interest may be paid by the Company to Geneva in shares of common stock, but shall not be payable until the Note becomes payable, whether at the Maturity Date or upon acceleration or by prepayment, as described below. Geneva has the option to convert all or any amount of the principal face amount of the Note, starting on March 21, 2022 and ending on the later of the Maturity Date and the date of payment of the Default Amount (as defined below) is paid if an event of default occurs, for shares of the Company’s common stock at the then-applicable conversion price. The conversion price for the Note shall be equal to the Variable Conversion Price (as defined herein) (subject to equitable adjustments for stock splits, stock dividends or rights offerings by the Company relating to the Company’s securities or the securities of any subsidiary of the Company, combinations, recapitalization, reclassifications, extraordinary distributions and similar events). The "Variable Conversion Price" shall mean 65% multiplied by the Market Price (as defined herein) (representing a discount rate of 35%). "Market Price" means the average of the lowest three (3) Trading Prices (as defined below) for the Common Stock during the ten (10) Trading Day period ending on the latest complete Trading Day prior to the Conversion Date. "Trading Price" means, for any security as of any date, the closing bid price on the OTCQB, OTCQX, Pink Sheets electronic quotation system or applicable trading market (the "OTC") as reported by a reliable reporting service designated by Geneva (i.e. Bloomberg) or, if the OTC is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the "pink sheets". Notwithstanding the foregoing, Geneva shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Geneva and its affiliates, exceeds 4.99% of the outstanding shares of the Company’s common stock.

The Note may be prepaid until 180 days from the issuance date. If the Note is prepaid within 60 days of the issuance date, then the prepayment premium shall be 110% of the face amount plus any accrued interest, if prepaid after 60 days from the issuance date, but less than 91 days from the issuance date, then the prepayment premium shall be 115% of the face amount plus any accrued interest, if prepaid after 90 days from the issuance date, but less than 121 days from the issuance date, then the prepayment premium shall be 120% of the face amount plus any accrued interest, if prepaid after 120 days from the issuance date, but less than 151 days from the issuance date, then the prepayment premium shall be 125% of the face amount plus any accrued interest, and if prepaid after 150 days from the issuance date, but less than 181 days from the issuance date, then the prepayment premium shall be 129% of the face amount plus any accrued interest. So long as the Note is outstanding, the Company covenants not to, without prior written consent from Geneva, sell, lease or otherwise dispose of all or substantially all of its assets outside the ordinary course of business which would render the Company a "shell company" as such term is defined in Rule 144. Pursuant to the terms of the Purchase Agreement, the Company paid Geneva’s fees and expenses in the aggregate amount of $3,750.

Other than as described above, the Note contains certain events of default, including failure to timely issue shares upon receipt of a notice of conversion, as well as certain customary events of default, including, among others, breach of covenants, representations or warranties, insolvency, bankruptcy, liquidation and failure by the Company to pay the principal and interest due under the Note. Additional events of default shall include, among others: (i) failure to reserve at least five times the number of shares issuable upon full conversion of the Note; (ii) bankruptcy, insolvency, reorganization or liquidation proceedings or other proceedings, voluntary or involuntary, for relief under any bankruptcy law or any law for the relief of debtors shall be instituted by or against the Company or any subsidiary of the Company; provided, that in the event such event is triggered without the Company’s consent, the Company shall have sixty (60) days after such event is triggered to discharge such event, (iii) the Company’s failure to maintain the listing of the common stock on at least one of the OTC markets (which specifically includes the quotation platforms maintained by the OTC Markets Group) or an equivalent replacement exchange, the Nasdaq National Market, the Nasdaq Small Cap Market, the New York Stock Exchange, or the American Stock Exchange, (iv) The restatement of any financial statements filed by the Company with the SEC at any time after 180 days after the issuance date for any date or period until this note is no longer outstanding, if the result of such restatement would, by comparison to the un-restated financial statement, have reasonably constituted a material adverse effect on the rights of Geneva with respect to this note or the Purchase Agreement, and (v) the Company’s failure to comply with its reporting requirements of the Securities and Exchange Act of 1934 (the "Exchange Act"), and/or the Company ceases to be subject to the reporting requirements of the Exchange Act.

In the event that the Company fails to deliver to Geneva shares of common stock issuable upon conversion of principal or interest under the Note within three business days of a notice of conversion by Geneva, the Company shall incur a penalty of $1,000 per day, provided, however, that such fee shall not be due if the failure to deliver the shares is a result of a third party such as the transfer agent.

Upon the occurrence and during the continuation of certain events of default, the Note will become immediately due and payable and the Company will pay Geneva, in full satisfaction of its obligations in the Note an amount equal to 150% of an amount equal to the then outstanding principal amount of the Note plus any interest accrued upon such event of default or prior events of default.

The Note was issued, and any shares to be issued pursuant to any conversion of the Note shall be issued, in a private placement in reliance upon an exemption from registration provided by Section 4(a)(2) of the Securities Act and/or Regulation D promulgated thereunder.

The foregoing description of the Purchase Agreement and the Note does not purport to be complete and is qualified in their entirety by reference to the full text of the Purchase Agreement and the Note, which are filed as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)

On September 28, 2021 Novartis reported that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the company’s New Drug Application (NDA) for 177Lu-PSMA-617, an investigational targeted radioligand therapy for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in the post androgen receptor pathway inhibition, post taxane-based chemotherapy setting (Press release, Novartis, SEP 28, 2021, View Source [SID1234590375]). With Priority Review, the Prescription Drug User Fee Act (PDUFA) date is anticipated in the first half of 2022. Priority Review is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions, as determined by the FDA1.

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Priority Review is based on positive data from the pivotal, Phase III VISION study showing 177Lu-PSMA-617 plus standard of care (SOC), significantly improved overall survival and radiographic progression-free survival for men with progressive PSMA-positive mCRPC compared to SOC alone2
Two additional studies with 177Lu-PSMA-617 in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating clinical utility in the pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition)3,4
The FDA previously granted Breakthrough Therapy designation for 177Lu-PSMA-617 for the treatment of mCRPC. Data from the VISION study were published in The New England Journal of Medicine (NEJM)2. Novartis is also evaluating additional opportunities to investigate 177Lu-PSMA-617 in earlier stages of prostate cancer.

Scopus BioPharma’s Subsidiary — Duet Therapeutics — Set to Release Scientific Data During the 17th Annual Meeting of the Oligonucleotide Therapeutics Society

On September 28, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS"), a clinical-stage biopharmaceutical company developing transformational therapeutics for serious diseases with significant unmet medical need, reported that Duet Therapeutics, a wholly-owned subsidiary of Scopus, will release scientific data during the 17th Annual Meeting of the Oligonucleotide Therapeutics Society. The meeting will conclude on Wednesday, September 29, 2021.

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Alan Horsager, Ph.D., President and Chief Executive Officer of Duet and President — Immuno-Oncology of Scopus, will present DUET-01: Bispecific Oligonucleotide Targeting TLR9 and STAT3 Signaling for B Cell Lymphoma Immunotherapy as part of Session VIII: Oligonucleotide Preclinical I.

Dr. Horsager has also presented Bifunctional Oligonucleotides for Systemic Treatment of Immunologically Cold Solid Tumors as an Industry Talk.

Duet has also released a video depicting the mechanism of action for its proprietary CpG-STAT3 inhibitors, which can be viewed here, to coincide with Duet’s presentations at the OTS Meeting.

About the Duet Platform

Duet Therapeutics integrates the immunotherapy assets of Scopus and Olimmune, creating the Duet Platform. Olimmune was acquired by Scopus in June 2021. Duet is a wholly-owned subsidiary of Scopus.

The Duet Platform is comprised of three distinctive, complementary CpG-STAT3 inhibitors:

• RNA silencing CpG-STAT3siRNA ("DUET-01")
• Antisense CpG-STAT3ASO ("DUET-02")
• DNA-binding inhibitor CpG-STAT3decoy ("DUET-03")
DUET-01 is in a Phase 1 clinical trial, as a monotherapy, for B-cell non-Hodgkin lymphoma. Duet expects to file two INDs for DUET-02 in Q4 2022 in genitourinary and head & neck cancers, with clinical Phase 1 trials beginning in Q1 2023 in the United States. Duet is also evaluating combination therapies with checkpoint inhibitors.

MannKind Corporation to Participate at Lytham Partners Fall 2021 Investor Conference

On September 28, 2021 MannKind Corporation (Nasdaq: MNKD), a company focused on the development and commercialization of inhaled therapeutic products for patients with endocrine and orphan lung diseases, reported that it will be participating at the Lytham Partners Fall 2021 Investor Conference on Tuesday, October 5, 2021 at 11:45 am (ET) (Press release, Mannkind, SEP 28, 2021, View Source [SID1234590369]). Presenting from the Company will be its Chief Executive Officer, Michael Castagna, PharmD.

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Interested parties can access a link to the live webcast of the presentations from the Events & Presentations section of the Company’s website at View Source The webcast replay may be accessed at the same location for 14 days following the live presentation.

Kineta Announces Poster Presentation at the 2021 American Association for Cancer Research Conference on Tumor Immunology and Immunotherapy

On September 28, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported that it will present a poster on the company’s new anti-CD27 agonist antibody program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Special Conference: Tumor Immunology and Immunotherapy, to be held on October 5-6, 2021 (Press release, Kineta, SEP 28, 2021, View Source;utm_medium=rss&utm_campaign=kineta-announces-poster-2021-aacrc [SID1234590368]).

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Title: A promising cancer immunotherapy target: Novel fully human agonist antibodies against the human T-cell costimulatory receptor CD27
Date Poster Available: October 5, 2021