Perrigo To Release Third Quarter 2021 Financial Results On November 10, 2021

On October 27, 2021 Perrigo Company plc (NYSE; TASE: PRGO) reported that it will release its third quarter 2021 financial results on Wednesday, November 10, 2021 (Press release, Perrigo Company, OCT 27, 2021, View Source,-2021 [SID1234592051]). The Company will also host a conference call beginning at 8:30 A.M. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 6950324. A taped replay of the call will be available beginning at approximately 12:00 P.M. (EST) Wednesday, November 10, until midnight Wednesday, November 17, 2021. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10161334.

Entry into a Material Definitive Agreement

On October 21, 2021, Propanc Biopharma, Inc. (the "Company") reported that it entered into a securities purchase agreement (the "Purchase Agreement") with Sixth Street Lending, LLC ("Sixth Street"), pursuant to which Sixth Street 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 Sixth Street (Filing, 8-K, Propanc, OCT 27, 2021, View Source [SID1234592050]). The transaction contemplated by the Purchase Agreement closed on October 26, 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 October 21, 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 Sixth Street 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. Sixth Street has the option to convert all or any amount of the principal face amount of the Note, starting on April 19, 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 Sixth Street (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, Sixth Street shall be restricted from effecting a conversion if such conversion, along with other shares of the Company’s common stock beneficially owned by Sixth Street 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 Sixth Street, 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 Sixth Street’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 Sixth Street 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 Sixth Street shares of common stock issuable upon conversion of principal or interest under the Note within three business days of a notice of conversion by Sixth Street, 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 Sixth Street, 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 Note and the Purchase Agreement 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 4.1 and 10.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

Monopar Announces First Patient Dosed in Phase 1b Trial Evaluating Camsirubicin for the Treatment of Advanced Soft Tissue Sarcoma

On October 27, 2021 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported that the first patient has been dosed in its open-label dose-escalation Phase 1b clinical trial evaluating camsirubicin for the treatment of advanced soft tissue sarcoma (ASTS) (Press release, Monopar Therapeutics, OCT 27, 2021, View Source [SID1234592049]).

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"We are very pleased to have dosed our first patient so quickly after trial initiation and so soon following our FDA allowance to proceed in early August. The strong interest and support we are seeing within the oncology community for this study adds to our hopeful excitement and anticipation of the potential impact that escalating doses of camsirubicin may have on improving patient outcomes," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

"We are excited to participate in this clinical trial that addresses a high unmet medical need in a cancer which carries a tragic 12 to 15-month life expectancy. There have been no advances in first-line therapies for decades in this patient population, and today’s first camsirubicin treatment in this trial marks an encouraging milestone for the thousands of ASTS patients who may potentially benefit from this drug," said Dr. Sant Chawla, Principal Investigator, Sarcoma Oncology Research Center in Santa Monica, CA.

An estimated 21 patients will be enrolled in the Phase 1b clinical trial, which is active and recruiting in the US. Further information about the camsirubicin trial is available at www.ClinicalTrials.gov under study identifier NCT 05043649.

About Camsirubicin

Camsirubicin is a novel proprietary analog of the widely used cancer drug doxorubicin. It has been investigated previously in ASTS patients in a Phase 1 and a single arm Phase 2 clinical trial. In these studies, no patients developed the irreversible cardiotoxicity common to doxorubicin at higher cumulative doses. The most frequent adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study through the use of prophylactic G-CSF. Based on encouraging clinical results to date, the current Phase 1b trial is designed to test camsirubicin at even higher doses than previously administered while using concomitant prophylactic G-CSF to prevent neutropenia.

About Soft Tissue Sarcoma

Soft tissue sarcomas (STS) are a diverse type of cancer that typically develop in the connective tissue of the body. According to the American Cancer Society, in 2021, an estimated 13,460 new STS cases will be diagnosed in the US alone, and about 5,350 people will not survive their disease. These tend to be the advanced cases – those with sarcomas that are unresectable and/or have metastasized. The average life expectancy from time of diagnosis for those patients with advanced disease (ASTS) is about 12 to 15 months. Doxorubicin is the current standard of care in the 1st-line setting for ASTS, and has been for decades, as there have been no 1st-line therapeutic advancements that have improved overall survival for this patient population.

INOVIO to Report Third Quarter 2021 Financial Results on November 9, 2021

On October 27, 2021 INOVIO (NASDAQ: INO) reported that third quarter 2021 financial results will be released after the market close on November 9, 2021 (Press release, Inovio, OCT 27, 2021, View Source [SID1234592048]). Following the release, INOVIO will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update regarding its DNA Medicines Platform, including the company’s global Phase 3 efficacy trial (INNOVATE) involving its COVID-19 vaccine candidate, INO-4800.

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A live and archived version of the audio presentation will be available online at View Source This is a listen-only event but will include a live Q&A with analysts.

ElevateBio Supercharges Gene Editing and Therapeutic Product Development Capabilities Through Acquisition of Life Edit Therapeutics

On October 27, 2021 ElevateBio, LLC (ElevateBio), a cell and gene therapy technology company focused on powering transformative cell and gene therapies, reported that it has acquired all of AgBiome Delta, LLC’s (AgBiome) shares of Life Edit Therapeutics, Inc. (Life Edit) (Press release, ElevateBio, OCT 27, 2021, View Source [SID1234592046]). Life Edit offers a powerful suite of gene editing technologies that have the potential for any genomic sequence of interest to be removed, added, or altered. Life Edit holds one of the world’s largest and most diverse arrays of novel RNA-guided nucleases and base editors that offer greater specificity and broad genome access. These nucleases were derived from AgBiome’s proprietary non-pathogenic microbe collection, which could potentially reduce immunogenicity risks.

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"ElevateBio’s powerful suite of enabling technologies, which now includes Life Edit’s genome editing capabilities as well as our existing iPSC, viral vector, and cell engineering platforms, is designed to disrupt the rapidly advancing fields of cell and gene therapy," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "Our vision is to build a world-class center of excellence in genome engineering to push the boundaries of therapeutic development and drive innovation for our own therapeutic pipeline as well as provide access to these critical technologies to our growing number of industry partners."

"Genome editing is a central component of all cell and gene therapy development, and access to novel RNA-guided nucleases and base editors that offer specificity and broad genome coverage will be critical. We believe Life Edit’s technology is one of the most versatile in the field, opening up enormous potential," Mitchell Finer, Chief Executive Officer of Life Edit and President, R&D of ElevateBio. "This integration will also enable Life Edit to have greater access to ElevateBio’s drug development and manufacturing capabilities as we build and advance the pipeline, which will initially focus on developing in vivo gene therapies to address neurologic conditions with high unmet need. In addition, by combining Life Edit’s gene engineering capabilities with ElevateBio’s iPSC technology, our goal is to expand the number of therapeutic uses, including potentially making universal or hypoimmune cells that go undetected by the immune system."

Life Edit was spun out of AgBiome in October 2020 and AgBiome continues to retain rights for gene editing outside of human therapeutics.