Entry into a Material Definitive Agreement

On July 22nd, 2019, Mateon Therapeutics, Inc., a Delaware corporation (the "Company") reported that it entered into a note purchase agreement (the "Note Purchase Agreement") with PointR Data, Inc. Pursuant to the Note Purchase Agreement, the Company issued a convertible promissory note (the "Convertible Note") to PointR Data, Inc. in the principal amount of $200,000 (Press release, Mateon Therapeutics, JUL 22, 2019, View Source [SID1234537694]). PointR Data is developing Artificial Intelligence/Deep Learning Platform for multiple business verticals including life sciences.

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The Convertible Note bears interest at a rate of 8% per annum. Interest payments are due monthly on the 15th day of each calendar month (or the next business day thereafter), and are payable, at the option of the Holder, either in cash or in shares of the Company’s common stock, par value $0.01 per share (the "Common Stock"), valued at the closing price of the Common Stock on the principal market on which the Common Stock is either traded or quoted at such time.

The Convertible Note is due and payable on demand by the holder (a) at any time after January 1, 2020 or (b) upon the occurrence of an Event of Default (as defined in the Convertible Note and the Note Purchase Agreement). The Company can prepay the Convertible Note upon notice to the holder without penalty.

All amounts outstanding under the Convertible Note will be automatically be converted into the Company’s securities issued in next equity financing raising gross proceeds of $10 million or more (a "Qualified Financing") at the price per share paid by investors in the Qualified Financing.

The Convertible Note and the Note Purchase Agreement contain customary Events of Default, including nonpayment, breach of warranty or covenant, and bankruptcy. In addition, the Convertible Note is being issued in connection with the preliminary evaluation of the Company’s acquisition of PointR Data, Inc. Discussion are in the early states and there are no definitive agreements or arrangements in place for any such acquisition at this time. It is an Event of Default under the Note Purchase Agreement, and PointR Data, Inc. shall have the right to demand repayment of the Convertible Promissory Note, if the Company ceases to negotiate in good faith for a potential acquisition of PointR Data, Inc.

The Company’s payment obligations under the Convertible Note are secured by certain MRI imaging data and related information (the "Subject Data"). Effective upon an Event of Default, in addition to any other remedies available to PointR Data, Inc. the Company will automatically grant PointR Data, Inc. a perpetual, irrevocable, world-wide, non-exclusive, royalty-free, fully paid-up, sublicensable, and transferable license to use the Subject Data. The license granted to Holder pursuant to this Section 7 shall survive the termination or repayment of this Note (but shall only be effective from and after the occurrence of an Event of Default).

On July 22, 2019, under the terms of the Note Purchase Agreement, the Company issued a $200,000 principal amount Convertible Note to PointR Data, Inc.

Additional information on the terms of the Convertible Note, including the interest rate, payment terms, conversion rights and events of default, is contained in Item 1.01 of this Current Report on Form 8-K, and is incorporated by reference herein.

Item 3.02 Unregistered Sales of Equity Securities.

On July 22, 2019, the Company issued a $200,000 principal amount Convertible Note to PointR Data, Inc.

The Convertible Note was issued in reliance upon the exemption from registration requirements pursuant to Section 4(a)(2) under the Securities Act of 1933, as amended, the rules promulgated thereunder and pursuant to applicable state securities laws and regulations.

References to Agreements

The descriptions of the Note Purchase Agreement and the Convertible Note in this report do not purport to be complete and are qualified in their entirety by reference to the forms of Note Purchase Agreement and Convertible Note, which are attached as Exhibits to this Current Report on Form 8-K, and each of which is incorporated herein by reference.

The agreements have been included to provide investors and stockholders with information regarding their respective terms. Those agreements are not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in those agreements were made only for purposes of those agreements and as of specific dates, were solely for the benefit of the parties to those agreements, may be subject to limitations agreed upon by the contracting parties, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under any of the agreements and should not rely on the representations, warranties or covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the agreements, which subsequent information may or may not be fully reflected in the Company’s public disclosures.

Delcath Systems Closes $20 Million Private Placement

On July 17, 2019 Delcath Systems, Inc. ("Delcath," the "Company", "we", "our" or "us" (OTCPK: DCTH) reported that it has closed on its previously announced private placement with gross proceeds of $20 million at a combined price of $1,000 per Unit (Press release, Delcath Systems, JUL 17, 2019, View Source [SID1234537659]). Each Unit consists of one preferred share initially convertible into 16,667 shares of common stock at an initial conversion price of $0.06 per share and a common stock purchase warrant. Each whole warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.06 for a period of five years from the date of the Company’s anticipated reverse stock split.

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Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath, said, "This capital investment is our most significant financing in two years. With this transaction we have positioned the Company to complete enrollment for the Registration trial in ocular melanoma liver metastases, which we believe may be able to release top line data in 2020. We have worked very closely with fundamental investors who believe in our therapy and the potential it represents in ocular melanoma."

Roth Capital Partners acted as the sole placement agent for the offering. After the placement agent fees and estimated offering expenses payable by the Company, the Company has received net proceeds of approximately $18.35 million. The offering closed on July 15, 2019.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-1 with the Securities and Exchange Commission by August 21, 2019 for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and upon exercise of the warrants issued in the private placement.

This notice does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Compugen Second Quarter 2019 Conference Call Scheduled for Monday, August 5, 2019 at 8:30 AM ET

On July 22, 2019 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the Company will release its second quarter 2019 financial results on Monday, August 5, 2019 before the U.S. financial markets open (Press release, Compugen, JUL 22, 2019, View Source [SID1234537657]). Management will host a corresponding conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.

HAMLET Pharma Announces Results of First Major Clinical Trial for a New Cancer Killing Molecule

On July 22, 2019 HAMLET Pharma is reported the successful outcome of the Phase I/II trial, aimed at studying the safety and efficacy of Alpha1H in patients with bladder cancer (Press release, HAMLET Pharma, JUL 22, 2019, View Source [SID1234537656]). The first data analysis has revealed highly significant differences between the Alpha1H treated patients and the placebo group, for several crucial efficacy variables. Treatment was also shown to be safe, as no drug-related side effects were observed.

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Alpha1H triggered significant shedding of cells in all tumor patients, who received the treatment (p< 0.0001).In addition, Alpha1H triggered the excretion of whole tumor fragments into the urine (p<0.0001), illustrating the potent effect compared to the placebo group.

"This is a bench-to-bedside moment and we are grateful to all, who have made this possible. The results inspire us to continue the efforts making Alpha1H available to cancer patients," says Catharina Svanborg, founder, CMO and chairman of the board of Hamlet Pharma Ltd.

"This is a very important milestone for the company. We need more evidence but hopefully this could be the gentle chemotherapy of the future," says Mats Persson, CEO of Hamlet Pharma Ltd.

Alpha1H triggered cell death in the tumor, as shown by cytolysis and apoptosis, a beneficial form of cell death. These findings support the key mechanisms of action of Alpha1H discovered in the laboratory and the successful translation from the laboratory to the clinic.

Carefully selected safety variables were recorded according to safety guidelines. The effects of Alpha1H occurred without drug-related side effects in the patients, consistent with the lack of toxicity observed in animal models of bladder cancer.

The clinical trial of 40 patients (20 placebo and 20 with treatment who received 6 infusions over 22 days) has been a technical success, due to the competence and commitment of the different study teams involved. A team of experts at the Motol University Hospital in Prague handled patient enrolment, clinical care, pathology assessments and treatment. The study was monitored by a highly renowned, clinical trial CRO in Prague. Scientific coordination was from Lund University, where research sample analysis was handled and molecular information obtained. Additional study variables will be communicated as soon as data is available.

Notes to Editors

HAMLET Pharma plans to conduct further studies in bladder cancer and several other cancer indications, such as colon cancer and brain tumors; all hard to cure with current therapies. HAMLET Pharma has 35 patents for the manufacturing and use of HAMLET as well as the second-generation Alpha1H derivative of the HAMLET molecule. HAMLET has been found to kill more than forty types of cancer cells to date in laboratories. The work has been published in leading international journals like The New England Journal of Medicine, GUT commented in Nature Reviews Gastroenterology and PNAS (Proceedings of the National Academy of Science, USA).

Kazia to test GDC-0084 with Radiotherapy in Phase I Clinical Trial at Leading US Cancer Center

On July 22, 2019 Kazia Therapeutics Limited (ASX: KZA;NASDAQ: KZIA), an Australian oncology-focused biotechnology company, is reported that Memorial Sloan Kettering Cancer Center (MSK) in New York, NY will investigate the potential use of Kazia’s investigational new drug, GDC-0084, in combination with radiotherapy in a phase I clinical trial for cancer that has spread to the brain (brain metastases and leptomeningeal metastases) (Press release, Kazia Therapeutics, JUL 22, 2019, View Source [SID1234537655]). This research will explore a new use of GDC-0084 and will run concurrently with other ongoing studies in different forms of brain cancer.

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Dr James Garner, Chief Executive Officer of Kazia Therapeutics commented, "MSK is one of the world’s leading cancer treatment centers, and we are privileged to be supporting them in this state-of-the-art project. Many cancers have the potential to spread to the brain, and they become very difficult to treat when they do. The work being done at MSK will investigate whether GDC-0084 has the potential to enhance the effects of radiotherapy, which remains the current standard of care in most cases."

Key Points

MSK will initiate a phase I clinical trial of GDC-0084 in combination with radiotherapy for patients with solid tumor brain metastases (cancer that has spread to the brain) and leptomeningeal metastases that harbors a genetic alteration in the PI3K pathway.
The trial is expected to recruit 18-30 patients and will take about two years to complete.
The trial will be led by MSK, with Kazia providing support including study drug and a financial grant.
Initiation of this study brings to five the total number of ongoing clinical trials with GDC-0084, each in different forms of brain cancer.
Up to 30% of patients with metastatic cancer will develop secondary tumors (metastases) in the brain. Radiotherapy remains the standard of care, but 30-50% of patients will progress within one year, despite best available treatment. In animal models of certain cancers, activation of the PI3K pathway has been shown to contribute to radiotherapy resistance. GDC-0084 is a PI3K inhibitor that can cross the blood-brain barrier, and as such it may be able to reduce the problem of resistance to radiotherapy. This clinical trial has been developed to test that hypothesis.

The trial is expected to recruit 18-30 patients, all of whom will have cancer that has spread to the brain. Patients will be genetically tested for a specific alteration in the PI3K pathway, and only those with a relevant mutation will be enrolled. This is an example of an approach to clinical research that is sometimes referred to as ‘precision medicine’ or ‘personalized medicine’, in which treatments are carefully targeted to those patients most likely to benefit. It is expected that the trial will begin recruitment in the second half of calendar 2019.

The study in two parts. The first part will aim to determine the maximum tolerated dose (MTD) of GDC-0084 when given together with radiotherapy. Once that dose has been determined, the second part of the study will enroll an additional twelve patients at that dose to explore preliminary signals of efficacy.

The Principal Investigator for the study is Dr T Jonathan Yang, Director of Metastatic Disease Program in MSK’s Department of Radiation Oncology. Dr Yang is a graduate of Yale University School of Medicine and a Board-certified radiation oncologist, with a specialist interest in treating tumors of the central nervous system. He is an extensively-published clinical researcher who has participated in a substantial number of clinical trials in brain cancer.

The initiation of the study brings to five the number of ongoing clinical trials with GDC-0084:

Sponsor

Phase

Indication

Registration

Kazia Therapeutics

II

Glioblastoma

NCT03522298

Alliance for Clinical Trials in Oncology

II

Brain metastases

NCT03994796

Dana-Farber Cancer Institute

II

Breast cancer brain metastases

(with Herceptin)

NCT03765983

St Jude Children’s Research Hospital

I

DIPG (childhood brain cancer)

NCT03696355

Memorial Sloan Kettering Cancer Center

I

Brain metastases

(with radiotherapy)

(TBA)

It is expected that the study will take approximately two years to complete. Kazia will provide support, including a financial grant for a portion of the costs. The study will be conducted under an ‘investigator IND’ with the US FDA, in which the primary regulatory responsibilities for the study will be assumed by MSK. Implementation of the study is conditional upon approval from the Institutional Review Board at MSK, and this approval has yet to be obtained.