ND CLEARANCE RECEIVED FROM THE US FOOD AND DRUG ADMINISTRATION
(FDA) FOR CHM 1101 (CLTX CAR T) FOR GLIOBLASTOMA

On August 20, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric" or the "Company"), a clinical-stage cell therapy company, reported that the US Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application for CHM 1101 (CLTX CAR T) for patients with recurrent/relapsed Glioblastoma (Press release, Chimeric Therapeutics, AUG 20, 2021, View Source [SID1234586748]).

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CHM 1101 (CLTX CAR T) is a novel CAR T cell therapy that uniquely utilizes Chlorotoxin as its tumour targeting domain. CHM 1101 has shown promising preclinical safety and efficacy and is currently being studied in a single site phase 1 clinical trial.

"The FDA clearance of our IND is a critical milestone for Chimeric as it enables us to expand the development program for CHM 1101 (CLTX CAR T)," said Jennifer Chow, COO Chimeric Therapeutics. "Our first step will be to open new phase 1 clinical trial sites under the current study protocol. This will allow us to accelerate the phase 1 CHM 1101 clinical trial, which will be particularly important as we head towards the expansion phase of the protocol."

With this foundational IND, Chimeric will also further advance plans for a phase 1 basket trial in solid tumours and a phase 2 registration trial in Glioblastoma.

Chlorotoxin is derived from scorpion toxin, which binds preferentially to unique targets on brain cancer cells. CLTX CAR T cells do not target healthy cells and has not elicited adverse side effects when delivered intracranial and through IV routes in brain cancer mouse models. At the same time it has shown to bind to a higher percentage of Glioblastoma tumours than immunotherapies against other targets. Glioblastoma is the most common and aggressive type of brain tumour, with overall survival following first recurrence estimated at only 5-8 months

KYAN Therapeutics Announces Collaboration with Institute of Molecular and Cell Biology for Accelerated Drug Discovery and Development of Nucleic Acids

On August 19, 2021 KYAN Therapeutics, Inc. (KYAN), a developer of optimised therapeutics, reported that the company and the Agency of Science, Technology & Research (A*STAR)’s Institute of Molecular and Cell Biology (IMCB), a premier cell and molecular biology institute, have entered into a collaboration to discover and develop next-generation nucleic acid therapeutics for oncology (Press release, KYAN Therapeutics, AUG 19, 2021, View Source [SID1234632308]). The aim is to develop specific drug combinations that can achieve high clinical response rates and elicit durable responses.

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Nucleic acid therapeutics is an emerging field of deoxyribonucleic acid (DNA) and ribonucleic acid (RNA)-based therapies that are able to treat diseases by inducing long lasting effects by targeting the genes in the genome. This means more effective treatments for diseases such as cancers. In particular, splice-switching oligonucleotides (SSOs), being amenable to complete chemical modifications for in vivo stability and specificity, possess superior specificity and lower toxicity than conventional small molecule drugs, and exhibit more predictable drug treatment and response compared to other nucleic acid modalities.

Leveraging on both parties’ expertise and proprietary platform technologies, the collaboration tackles the challenges in identifying and prioritising effective drug target combos, and developing therapeutics that are able to selectively affect a particular type of cells leading to a desirable effect. KYAN brings to the collaboration, proprietary combination design technology and expertise in cancer therapy, that has been validated in humans and across multiple diseases. A team led by Dr Dave Keng Boon Wee, Principal Investigator, at IMCB, has developed an accurate rational design platform empowering an unprecedented speed of identifying and optimisation of highly specific and effective SSOs, which will be useful to speed up the drug discovery and the development process. Leveraging IMCB’s extensive experience in optimising SSOs for high specificity and efficacy leading to clinical translation, IMCB is well positioned to provide clinically ready SSOs for further development.

"Tailoring the right drug combinations is key for better patient outcomes. We look forward to working with KYAN to implement the drug target combinations by discovering and developing precise RNA therapeutics," stated Dr Wee. "This could potentially open up treatment avenues for more than 50 per cent of cancer patients that have not responded to existing therapies, leading to better health outcomes. The partnership also helps to solidify Singapore’s position as a global innovation hub."

With IMCB’s expertise in the SSO discovery process and KYAN’s accurate and efficient computational optimisation platform, the collaboration has already yielded novel insights into how to develop more effective synthetic lethality treatment approaches. IMCB and KYAN will synergize their efforts to develop new classes of nucleic acid therapeutics towards difficult to treat gastrointestinal cancers, beginning with liver cancer. By focusing on cancers with high prevalence in Asia, this collaboration seeks to transform how cancer is treated both in Singapore and abroad.

"Being the medical hub of Asia, we hope that this collaboration could identify alternative treatment approaches especially for cancers like liver cancer, which has high prevalence in this region but limited therapeutic options. Having easy access to liver cancer patient samples in Singapore would aid in stratifying potential patient responders based on the identified optimal combination of RNA therapeutics" adds Dr Masturah Rashid, Head of Research and Development at KYAN Therapeutics.

The issuer is solely responsible for the content of this announcement.

Entry into a Material Definitive Agreement.

On August 19, 2021, Propanc Biopharma, Inc. (the "Company") reported that 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 $103,750, such principal and the interest thereon convertible into shares of the Company’s common stock at the option of Geneva (Filing, 8-K, Propanc, AUG 19, 2021, View Source [SID1234586870]). The transaction contemplated by the Purchase Agreement closed on or about August 23, 2021. The Company intends to use the net proceeds ($100,000) from the Note for general working capital purposes.

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The maturity date of the Note is August 19, 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 February 16, 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 "Default Amount").

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.

Entry into a Definitive Material Agreement

On August 19, 2021, Palisade Bio, Inc. (the "Company") and Yuma Regional Medical Center (the "Investor") reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") pursuant to which the Investor purchased 1,509,896 shares (the "Shares") of the Company’s common stock, par value $0.01 per share (the "Common Stock") and a warrant to purchase up to 377,474 shares of Common Stock (the "Warrant") for a total purchase price of $5,209,141.20 (Filing, 8-K, Seneca Biopharma, AUG 19, 2021, View Source [SID1234586848]). The Shares were sold at a purchase price of $3.45 per share. The Warrant has an exercise price of $3.45 per share, subject to certain adjustments, and is exercisable for five years.

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Pursuant to the Purchase Agreement, the Company has agreed to file one or more registration statements with the Securities and Exchange Commission (the "SEC") registering the resale of the Shares and the shares of Common Stock issuable upon exercise of the Warrant by the Investor, to have all such registration statements declared effective within the timeframes set forth in the Purchase Agreement, and to keep such registration statements effective for up to five years. The Company will bear all expenses of the registration, excluding fees of legal counsel for Investor.

The Purchase Agreement contains customary representations and warranties of the Company and the Investor. The representations, warranties and covenants contained in the Purchase Agreement were made only for purposes of such Purchase Agreement and are made as of specific dates; are solely for the benefit of the parties (except as specifically set forth therein); may be subject to qualifications and limitations agreed upon by the parties in connection with negotiating the terms of the Purchase Agreement, including being qualified by confidential disclosures made for the purpose of allocating contractual risk between the parties, instead of establishing matters as facts; and may be subject to standards of materiality and knowledge applicable to the contracting parties that differ from those applicable to the investors generally. Investors should not rely on the representations, warranties and covenants or any description thereof as characterizations of the actual state of facts or condition of the Company.

The Investor was a stockholder of the Company prior to the investment described above. Robert J. Trenschel, D.O., is a member of the Company’s board of directors and is the president and chief executive officer of the Investor. Dr. Trenschel does not have any pecuniary interest in the Company’s securities that are owned by the Investor.

New Publication Date for Allarity Therapeutics’ Q2 2021 Interim Report

On August 19, 2021 Allarity Therapeutics A/S ("Allarity" or the "Company") reported a new publication date for the Company’s Q2 2021 Interim Report, which is now being made public on August 23, 2021 (previously: August 31, 2021) (Press release, Allarity Therapeutics, AUG 19, 2021, View Source [SID1234586789]).

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The reason for the change of publication date is to accelerate the Company’s preparations for the transformation and recapitalization as announced on May 21, 2021 as the Company advances towards migration to listing on the U.S. Nasdaq stock market (New York, N.Y.).