On August 17, 2020 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the second quarter ended June 30, 2020 and provided a business update (Press release, Adamis Pharmaceuticals, AUG 17, 2020, View Source [SID1234563750]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated,

"Although we continue to be negatively impacted by the pandemic and government required operating restrictions, we are very excited about several developments during the last quarter. First, we finalized our agreement with Sandoz, Inc. to take back U.S. commercial rights for our SYMJEPI products. More importantly, we executed a new agreement with US WorldMeds, LLC (USWM) under which they have assumed U.S. rights to market and distribute the SYMJEPI products and, upon FDA approval which we believe will occur this year, will have commercial rights for our ZIMHITM product. I strongly feel USWM’s commitment to detail SYMJEPI to allergists and high-prescribing physicians will be a catalyst to bring broad awareness and usage within the billion plus dollar anaphylaxis market."

"Also, during the last quarter we acquired rights develop a novel drug compound, Tempol, for certain indications including COVID-19 infections. We believe Tempol could be a powerful therapeutic agent in combating COVID-19 and are committed to working with the FDA and other agencies with a goal to begin testing Tempol in patients as soon as practicable. I believe there are a number of exciting near-term milestones for Adamis and I am very excited about the second half of 2020 and beyond."

Product Updates

SYMJEPI (epinephrine) Injection

On July 1, 2020, Adamis’ new commercial partner, USWM began promoting SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg products through its field sales force in the U.S. USWM expects to focus its sales efforts on the high-prescribing allergists, pediatricians, and primary care physicians.

In addition to the U.S., Adamis continues to seek opportunities to market SYMJEPI into other territories and during the last quarter, through its Australian partner, Emerge Health, Adamis submitted a regulatory dossier to seek clearance to begin marketing both SYMJEPI products in the Australian market.

ZIMHI (naloxone) Injection

On May 11, 2020, Adamis entered into an exclusive distribution and commercialization agreement with USWM for the U.S. commercial rights for ZIMHI (naloxone HCI Injection, USP) 5mg/0.5mL product candidate. Under the terms of the agreement, USWM obtained U.S.

Tempol

In June, the company entered into a license agreement with Matrix Biomed, Inc. (Matrix) to license rights under patents, patent applications and related know-how of Matrix related to Tempol, an investigational drug in the fields of COVID-19 infection, asthma, respiratory syncytial virus influenza infection and as a therapeutic for reducing radiation-induced dermatitis in patients undergoing treatment for cancer.

Since licensing this product, the company has submitted to the FDA a Pre-Investigational New Drug (IND) package, and the FDA has provided detailed comments regarding the prospective use of Tempol in a randomized placebo controlled Phase II study examining Tempol in COVID-19 patients. The company’s goal is to apply for and obtain funding from certain government agencies and programs to enable the necessary trials to determine the efficacy of Tempol as a therapeutic treatment for COVID-19.

Drug Outsourcing Facility

Year to date, sterile and non-sterile revenues from the company’s wholly owned drug outsourcing facility, US Compounding (USC), were adversely affected by slowing demand due to the novel coronavirus outbreak. Revenues decreased by approximately 19% year to date compared to the same period in the prior year.

Second Quarter Financial Results

Year to date revenues were approximately $8.6 million and $10.7 million for the six months ended June 30, 2020 and 2019, respectively, a decrease of approximately 20% at the end of June of 2020 compared to the comparable period of 2019. The COVID-19 pandemic has adversely affected revenues from sales of USC products, in part due to reductions or cancellations of outpatient or elective surgeries and other medical procedures and reductions in office visits to physicians’ offices, healthcare facilities or clinics by patients, and the resulting decreased demand by USC’s customers for certain of USC’s products.

Selling, general and administrative expenses ("SG&A") for the six months ended June 30, 2020 and 2019 were approximately $11.7 million and $15.0 million, respectively. The decrease was primarily attributable to decreases in wages, benefits and other compensation expenses and to a lesser extent by decreases in patent, consulting, outside services, professional fees, depreciation and other related expenses.

Research and development expenses were approximately $5.1 million and $5.0 million for the six months ended June 30, 2020 and 2019, respectively.

Cash and equivalents at the end of the second quarter was approximately $7.9 million.

Targeted Milestones

●Work with USWM to finalize transition of SYMJEPI commercial responsibility from Sandoz;
●FDA approval and U.S. commercial launch of ZIMHI;
●Return USC division back to pre-COVID-19 levels;
●Apply for government and other forms of funding for Tempol trial in COVID-19 patients; and
●Begin Phase 2 trial for Tempol in COVID-19 patients

Conference Call

Adamis will host a conference call and live webcast on Thursday, August 20, 2020 at 1:30 pm Pacific Time to discuss its financial and operating results for the second quarter of 2020 as well as provide an update on business developments and activities.

US Dial-in (Toll Free): 1-877-423-9813

TOLL/International Dial-in: 1-201-689-8573

Conference ID: 13708688

Webcast: View Source

In addition, a telephone playback of the call will be available after approximately 4:30 pm PT on August 20, 2020. To listen to the replay, call toll free 1-844-512-2921 within the United States or 1-412-317-6671 when calling internationally (toll). Please use the replay PIN number 13708688.

On August 17, 2020, Amgen Inc. (the "Company") reported that it completed the early settlement for Old Notes (as defined below) tendered and accepted by the Company in the Company’s previously announced nine separate private offers to exchange (each, an "Exchange Offer" and, collectively, the "Exchange Offers") certain specified series of its outstanding senior notes (collectively, the "Old Notes") for a combination of a cash payment and new 2.770% Senior Notes due 2053 (the "New Notes") (Filing, 8-K, Amgen, AUG 17, 2020, View Source [SID1234563749]).

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Pursuant to the Exchange Offers, the aggregate principal amounts of the Old Notes set forth below were validly tendered and accepted and subsequently cancelled:

$37,335,000 aggregate principal amount of the Company’s 6.90% Senior Notes due 2038 (the "Existing 6.90% Notes");

$73,531,000 aggregate principal amount of the Company’s 6.375% Senior Notes due 2037 (the "Existing 6.375% Notes");

$133,310,000 aggregate principal amount of the Company’s 6.40% Senior Notes due 2039 (the "Existing 6.40% Notes");

$39,022,000 aggregate principal amount of the Company’s 5.75% Senior Notes due 2040 (the "Existing 5.75% Notes");

$71,602,000 aggregate principal amount of the Company’s 5.65% Senior Notes due 2042 (the "Existing 5.65% Notes");

$76,199,000 aggregate principal amount of the Company’s 5.375% Senior Notes due 2043 (the "Existing 5.375% Notes"); and
,000 aggregate principal amount of the Company’s 5.15% Senior Notes due 2041 (the "Existing 5.15% Notes").

No amount of (i) the Company’s 4.95% Senior Notes due 2041 or (ii) the Company’s 4.40% Senior Notes due 2045 were accepted by the Company in the Exchange Offers.

Following such cancellation, the aggregate principal amounts of the Old Notes set forth below remain outstanding:

$253,281,000 aggregate principal amount of the Existing 6.90% Notes;

$478,879,000 aggregate principal amount of the Existing 6.375% Notes;

$333,010,000 aggregate principal amount of the Existing 6.40% Notes;

$373,098,000 aggregate principal amount of the Existing 5.75% Notes;

$415,418,000 aggregate principal amount of the Existing 5.65% Notes;

$184,878,000 aggregate principal amount of the Existing 5.375% Notes; and

$728,887,000 aggregate principal amount of the Existing 5.15% Notes.

In connection with the settlement of the Exchange Offers, the Company has issued $940,000,000 aggregate principal amount of its New Notes and will pay an aggregate of $85,382,998.17 cash consideration, excluding accrued and unpaid interest, in exchange for the validly tendered and accepted Old Notes.

The New Notes were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of August 17, 2020 (the "Officer’s Certificate"), setting forth the terms of the New Notes.

The relevant terms of the New Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including the forms of the New Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The New Notes will bear interest at a rate of 2.770% per annum, which shall be payable semi-annually in arrears on March 1 and September 1 of each year, beginning on March 1, 2021. The New Notes will mature on September 1, 2053.

In the event of a change in control triggering event, as defined in the Officer’s Certificate attached hereto as Exhibit 4.2, the holders of the New Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of New Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the New Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the New Notes, respectively.

The New Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.

In connection with the sale of the New Notes, the Company entered into a registration rights agreement, dated as of August 17, 2020 (the "Registration Rights Agreement"), with BofA Securities, Inc. and J.P. Morgan Securities LLC, as lead dealer managers, and BNP Paribas Securities Corp., Deutsche Bank Securities Inc., RBC Capital Markets, LLC, Blaylock Van, LLC and Siebert Williams Shank & Co., LLC, as co-dealer managers. Pursuant to the Registration Rights Agreement, the Company has agreed to use its reasonable efforts to file a registration statement with respect to an offer to exchange the New Notes for a new issue of substantially identical notes registered under the Securities Act of 1933, as amended (the "Securities Act"), within 180 days after August 17, 2020, the initial issue date of the New Notes (the "Issue Date"). The Company has also agreed to use its reasonable efforts to cause the registration statement to be declared effective within 270 days after the Issue Date and to use its reasonable efforts to consummate the exchange offer within 310 days after the Issue Date. The Company may be required to provide a shelf registration statement to cover resales of the New Notes under certain circumstances. If the Company fails to satisfy these obligations, it may be required to pay holders of the New Notes additional amounts. A copy of the Registration Rights Agreement is attached hereto as Exhibit 4.3 and is incorporated herein by reference.

The New Notes have not been registered under the Securities Act and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. This current report on Form 8-K does not constitute an offer to sell, or a solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offering would be unlawful.

On August 17, 2020 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company") reported that all proposals related to the proposed merger between DelMar and Adgero were approved by DelMar’s stockholders at a special meeting held on August 14, 2020 (Press release, DelMar Pharmaceuticals, AUG 17, 2020, View Source [SID1234563744]). The holders of a majority of the outstanding shares of common stock of Adgero have also issued their written consent approving the merger. The proposed merger remains subject to further customary closing conditions. DelMar expects the closing of the merger to occur in August 2020.

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Upon closing of the transaction, the combined company will change its name to "Kintara Therapeutics, Inc." and it is anticipated that the shares will commence trading on the Nasdaq Capital Market under the ticker symbol "KTRA."

The final voting results for DelMar’s special meeting of stockholders will be filed with the Securities and Exchange Commission in a Form 8-K.

On August 17, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), reported that the U.S. Food and Drug Administration (FDA) has approved the Prior Approval Supplement (PAS) for Samsung Biologics to produce commercial-scale hRS7, the antibody used in Trodelvy (sacituzumab govitecan-hziy), at its manufacturing facilities in Incheon, South Korea (Press release, Immunomedics, AUG 17, 2020, View Source [SID1234563743]).

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"We want to thank the FDA for working collaboratively with us in expediting this PAS approval in the midst of the COVID-19 pandemic," said John Stubenrauch, Senior Vice President of Global Product Supply. "This approval enhances our ability to supply commercial product to the U.S. market, where the unmet need across our lead indications is very high. We have been using drug product that were produced with antibody manufactured by Samsung in clinical trials in the U.S. over the course of 2020, and we now look forward to further scaling our commercial supply of Trodelvy globally."

Trodelvy is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer. It contains the hRS7 antibody that binds to Trop-2, a cell-surface protein expressed in many solid cancers, and helps Trodelvy deliver the anti-cancer drug, SN-38, to kill the cancer cells.

"The Samsung partnership highlights our overall strategy to scale our supply chain and help ensure we can meet our commitments to patients globally as we seek to broaden the availability of Trodelvy geographically and across tumor types," commented Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics.

On August 17, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, pre-clinical nucleic acid-based therapeutic drug candidates, supply chain security, anti-counterfeiting and anti-theft technology, reported that it has filed a nonprovisional patent application with the United States Patent and Trademark Office (USPTO) entitled "Methods and Systems of PCR-Based Recombinant Adeno-Associated Virus (AAV) Manufacture" (the "Patent") (Press release, Applied DNA Sciences, AUG 17, 2020, View Source [SID1234563742]). The Patent claims priority to a previously filed provisional patent application filed with the USPTO in August of 2019.

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AAV is utilized to deliver a therapeutic gene of interest to a patient or a patient’s cells to cause the expression of the necessary protein to address a targeted disease. Reflective of its potential as one of the most promising delivery vehicles for genetic medicines, there are approximately 80 active or enrolling clinical trials that utilize AAV. With its new patent application, Applied DNA seeks to leverage its LinearDNA platform to give gene and redirected cell therapy developers the ability to greatly improve the manufacture and quality of their AAV-vectored medicines that have the potential to address many diseases, including COVID-19.

"AAV is generally accepted as the preferred vector for gene therapy, and so, has an enormous breadth as a therapeutic gene delivery system. AAV vectors are manufactured utilizing multiple plasmid DNAs as starting materials, and as the number of gene therapy programs increase, and with improving levels of clinical success and progression of therapies into late-phase clinical studies, the field is being challenged by the need for larger manufacturing scales," said Dr. James A. Hayward, president and CEO of Applied DNA Sciences. "At Applied DNA, we believe we have solved the linear DNA production challenge and can make the DNA sequences at scale for gene therapies. Utilizing our LinearDNA platform to manufacture amplicons, we can deliver gene therapy constructs that potentially lower the risks that come with the use of plasmid-based AAV manufacture. As one of the only companies in the marketplace commercializing a scaled linear DNA manufacturing platform, we believe we are uniquely positioned to deliver linear DNA as an alternative to plasmids, and with this patent filing, we expand our addressable market to including AAVs."

AAV is manufactured by the triple transfection of three plasmid DNA constructs into packaging cell lines to produce recombinant adeno-associated virus. This triple transfection requires large amounts of DNAs that are currently manufactured via plasmids – circular DNA constructs which are propagated in bacteria. The three DNA constructs necessary for successful AAV production are: (i) AAV Rep and Cap; (ii) AAV Helper; and (iii) the therapeutic cargo (transgene) flanked on either side by inverted terminal repeat sequences (ITR). The manufacture of plasmid DNA for the production of AAV, however, presents a number of significant challenges, including scalability, fidelity, mis-incorporation of plasmid-derived DNA sequences, high costs, and long lead times for cGMP production.

Concluded Dr. Hayward, "The ITRs serve as the viral origins of replication and for packaging signals to assemble AAV in the host cell. But the triple transfection of the required plasmids, and in the strict stoichiometries required for AAV assembly, we believe adds enormously to the cost of traditional AAV manufacturing, limiting the availability of many gene therapies. Our success in simplifying the production of the critical plasmid genes for AAV production we believe enable AAV production with minimal or absent plasmids, potentially greatly enhancing production and lowering costs. The use of LinearDNA potentially lowers the risks that come with plasmids, including off-target DNA, contamination by the genes for antimicrobial resistance or other bacterial DNA, endotoxin contamination and the use of antibiotics."

The Patent claims methods for the use of specialized LinearDNATM amplicons, instead of plasmids, to manufacture AAV. The patent also claims methods and systems for the PCR-based manufacturing of AAV transgene constructs flanked on either side by the necessary ITR sequences via the Company’s LinearDNA platform. Due to their complex secondary structures, the ITR sequences necessary for AAV production have historically been very challenging to amplify via PCR. Leveraging the Company’s PCR expertise, the methods and systems claimed in the Patent utilize specialized PCR techniques and primer designs to mitigate the challenges caused by the ITR secondary structures, allowing for the high yield and high-fidelity manufacture of transgene –ITR amplicons.