On August 17, 2020 AIM ImmunoTech (NYSE American:AIM), an immuno-pharma company focused on the research and development of therapeutics to treat immune disorders, viral diseases and multiple types of cancers, reported a business and pre-clinical/clinical update for the second quarter ended June 30, 2020 (Press release, AIM ImmunoTech, AUG 17, 2020, View Source [SID1234563711]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter 2020 Financial Highlights:

As of June 30, 2020, AIM had cash, cash equivalents and marketable securities of $40.3 million, as compared to $8.8 million as of December 31, 2019.
Research and development expenses for the second quarter ended June 30, 2020 were $1.46 million, compared to $1.10 million for the second quarter ended June 30, 2019.
General and administrative expenses for the second quarter ended June 30, 2020 were $1.72 million, compared to $1.94 million for the second quarter ended June 30, 2019.
The Company’s complete financial results are available in the Company’s June 30, 2020 Form 10-Q filed with the Securities and Exchange Commission on August 14, 2020, which is available at www.sec.gov and on the Company’s website.

"AIM is engaged in extremely important and potentially groundbreaking pre-clinical and clinical research in critical unmet medical needs such as COVID-19 and cancer-providing us ‘multiple shots on goal’ within large addressable markets. Given these multiple indications, AIM’s strategy to support these trials has been to maximize third-party, non-dilutive funding directly awarded to the clinical sites, which we have accomplished in many of our trials. In addition, we had more than $40 million in cash, cash equivalents, and marketable securities on our balance sheet as of June 30, 2020. As a result, we believe we are extremely well positioned to execute on our strategy going forward, which, in turn, we expect will drive significant value for stockholders," said AIM CEO Thomas K. Equels.

COVID-19 General Updates:

Following the FDA’s authorization of an IND on May 11, 2020, AIM entered into a clinical trial agreement on July 6, 2020, with Roswell Park Comprehensive Cancer Center to support Roswell Park’s Phase 1/2a trial of Ampligen in combination with interferon alfa-2b in cancer patients with COVID-19, the disease caused by SARS-CoV-2. The trial is on track to commence patient enrollment soon.
AIM signed a trilateral material transfer and research agreement with Japan’s National Institute of Infectious Diseases and Shionogi & Co., Ltd., a leading global pharmaceutical company headquartered in Japan, in order to test Ampligen as a potential vaccine adjuvant for COVID-19. Ampligen has been shipped to Japan, to be followed up with an additional shipment.
AIM is currently collaborating with Shenzhen Smoore, the world’s largest vaping device manufacturer, to research the use of their innovative inhalation technology for enhaced delivery of Ampligen deep into the lungs at the first signs of COVID-19. The Company believes this approach may initiate a robust, therapeutic TLR3 response against the SARS-CoV-2 virus throughout the upper and lower respiratory system. Ampligen is scheduled to be shipped to Smoore for testing, pending resolution of various China import regulatory requirements.
Ampligen has been shipped to Utah State University to support the University’s Institute for Viral Research in its pre-clinical testing againast SARS-CoV-2 and testing is underway.
COVID-19-induced Chronic Fatigue-like Illness Update:

Ampligen has proven to be a powerful drug conferring protective survival in SARS-CoV-1 animal experiments. Ampligen has also shown heightened levels of activity in Phase 2 and 3 trials with Chronic Fatigue Syndrome (CFS) patients. Ampligen, while experimental in the United States for CFS, is approved in Argentina and is the only late-stage experimental drug for CFS in the U.S. pipeline. Ampligen is also the first drug approved for severe CFS in the world. AIM is preparing to test Ampligen as a potential therapy for a SARS-CoV-2-induced chronic fatigue-like illness. AIM believes Ampligen may play an important role in addressing this multifaceted disease, including the potential post-infection debilitating aspects.
"There is a significant risk that SARS-CoV-2, the virus that causes COVID-19, will trigger a large number of chronic fatigue-like cases, similar to what occured in the prior SARS-CoV-1 epidemic," said Equels. "Ampligen’s strong history of preclinical outcomes with the SARS-CoV-1 virus gives AIM hope for the drug’s potential as a prophalaxis, as a vaccine adjuvant and as an early-onset treatment for the SARS-CoV-2 virus and for COVID-19-induced chronic fatigue-like illness. This potential therapy may be especially important for cancer patients, who face significantly increased risk of severe symptoms or death from COVID-19."

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Update:

AIM received clearance from ANMAT to import the first shipment of commercial grade vials of Ampligen to Argentina. The next steps in the commercial launch of Ampligen include ANMAT conducting a final inspection of the product and release tests before granting final approval to begin commercial sales. AIM has shipped Ampligen to its partner in Argentina, GP Pharm, which is required for testing and ANMAT release. Once final approval by ANMAT is obtained, the commercial launch of Ampligen in Argentina is planned. Further, AIM continues to pursue its Ampligen New Drug Application, or NDA, for the treatment of traditional CFS with the FDA.
Immuno-oncology Update: Equels further noted, "Given the advances in our third-party funded, investigator-sponsored cancer clinical trials, we believe there is real potential for AIM to become a powerhouse in oncology, as clinical data is reported in these trials. The fact that tens of millions of dollars in grants have been provided to world-class investigator/oncologists at top national cancer centers, from such esteemed organizations as Merck, the U.S. Department of Defense and the National Cancer Institute, clearly supports my faith in Ampligen."

Roswell Park Comprehensive Cancer Center and Moffitt Cancer Center have both received "Breakthrough Awards" from the U.S. Department of Defense in Brain Metastatic Breast Cancer. Together, these separate-but-parallel proposed clinical trials are receiving approximately $15 million in federal funding in part with a significant focus upon Ampligen as a potential synergistic agent in combination with several other immunotherapies, including pembrolizumab (Keytruda) and Intron A.
The National Cancer Institute issued an award of $14.5 million to Roswell Park Comprehensive Cancer Center to fund five clinical trials in melanoma, colorectal and ovarian cancers. These trials will test chemokine modulation incorporating Ampligen as an immuno-modulator, as part of a strategy to turn "cold" tumors into "hot" tumors.
Advanced Recurrent Ovarian Cancer – This Phase 1/2 study of Ampligen as an intraperitoneal therapy in advanced recurrent ovarian cancer has completed 12 subjects in Phase 1; the Phase 1 portion established intraperitoneal safety sufficient to proceed with a larger Phase 2 study (See below). (View Source) We are awaiting publication of results. View Source
Advanced Recurrent Ovarian Cancer – Based upon the above, a 45-subject follow-up Phase 2 study of advanced recurrent ovarian cancer is underway principally funded via a Merck grant and using cisplatin, pembrolizumab and Ampligen. Enrollment commenced in January 2019 and numerous patients are now well into treatment. View Source (View Source)
Stage 4 Metastatic Triple Negative Breast Cancer – Phase 2 study of metastatic triple-negative breast cancer using chemokine modulation therapy, including Ampligen and pembrolizumab. All patients have been treated or are near completion of treatment. View Source
Stage 4 Colorectal Cancer Metastatic to the Liver – Phase 2a study of Ampligen as
component of chemokine modulatory regimen on colorectal cancer metastatic to liver; the majority of the 12 planned patients enrolled and treated. View Source
Early-Stage Prostate Cancer – Phase 2 study investigating the effectiveness and safety of aspirin and Ampligen with or without interferon-alpha 2b (Intron A) compared to no drug treatments in a randomized three-arm study of patients with prostate cancer before undergoing radical prostatectomy. Patient enrollment has been initiated in this study designed for up to 45 patients. View Source
Early-Stage Triple Negative Breast Cancer – Phase 1 study of chemokine modulation plus neoadjuvant chemotherapy in patients with early-stage triple negative breast cancer has received FDA authorization; the objective of this study is to evaluate the safety and tolerability of a combination of Ampligen, celecoxib with or without Intron A, when given along with chemotherapy; the goal of this approach is to increase survival. This study is recruiting and is designed for up to 24 patients. View Source
A study of Ampligen as a drug for late-stage pancreatic cancer is complete and the research team at Erasmus M.C. is currently compiling the final data from this early access approval-based study. We are enthusiastically awaiting the publication of these results.
With the nation’s health care system increasingly focused on the COVID-19 pandemic – and with cancer patients especially at risk for the disease – AIM recognizes that all cancer centers, like all medical facilities, must make the pandemic their priority. Therefore, there is the potential for delays in clinical trial enrollment and subsequent reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. However, AIM intends to move forward without delay and we believe the teams at all of the clinical sites are eager to keep forward momentum.

On August 17, 2020 Mateon Therapeutics (OTC.QB: MATN), a leading developer of TGF-β therapeutics, reported financial results for the second quarter ended June 30, 2020 (Press release, Mateon Therapeutics, AUG 17, 2020, View Source [SID1234563710]). Unless otherwise stated, all comparisons are for the second quarter of 2020 compared to the second quarter of 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

We recorded services revenue of $1.4 million during the three months ended June 30, 2020 as compared to no revenues during the same period ended in 2019. The revenue of $0.9 million was recorded from services provided to Golden Mountain Partners (GMP) during the period ended June 30, 2020 in connection with the development of OT-101 for COVID-19. We also recorded $0.5 million in revenues from Autotelic Bio (ATB) upon the successful completion of the in-vivo efficacy studies of OT-101 combination with IL-2 based on the ATB Agreement.

Research and development ("R&D") expenses increased by approximately $0.1 million for the three months ended June 30, 2020 compared to the same period in 2019. The higher R&D cost was primarily due to by higher amortization of intangibles of $0.1 million. The financial information presented does not include any R&D activity for PointR for the period ended June 30, 2019. General and administrative ("G&A") expenses increased by approximately $0.1 million for the three months ended June 30, 2020 compared to the three months ended June 30, 2019, primarily due to increases of approximately $0.1 million due to increase in legal and professional expenses.

As a result of our mergers with Oncotelic and PointR, we expect to increase R&D and G&A expenses, including the initiation of new clinical trials including those for COVID-19, and therefore believe that research and development expenses will increase for the remainder of 2020 compared to research and development expenses in 2019.

"We are pleased to announce that despite the challenges presented by the COVID-19 situation, we were able to achieve revenue of $1.4 million," said Amit Shah, CFO of Mateon. "Additionally, 2020 Financing has resulted in gross proceeds of $2.5 million to the Company. Coupled with the $2.0 million in debt funding by GMP specifically for the COVID-19 trial, the company is in a position to execute on its objectives, including the spinoff of Edgepoint in the coming months and the development of OT-101 and Artemisinin. Overall, the company has raised over $6.0 million between revenues and financing in 1H20."

"Based on the approval accorded by the shareholders of Mateon, we anticipate the name change of the Company to Oncotelic Inc. (Oncotelic) on or before the end of September. The change in name reflects the acquisition of Mateon by Oncotelic back in April 2019", said Dr. Vuong Trieu, CEO of Mateon. "In addition, the assets of the Company, in OT-101 and Artemisinin, are both Oncotelic assets and the Company has been developing them to create shareholder value. The legacy Mateon assets are being repositions as therapeutics for rare pediatric oncology and may be spun off in the future. Over the past year, the Company has been working on development of OT-101, as an Oncology therapeutic as well for COVID-19, as well as Artemisinin for COVID-19. We expect that the development of these drugs will enhance significant shareholder value for the Company. We are also developing technologies within the artificial intelligence space (AI) through our AI division in EdgePoint Inc. (EdgePoint). The Company will develop these technologies in-house and at the appropriate time, consider how to monetize of spin-off of these assets and technologies. We are confident our efforts will create significant shareholder value similar to companies within the similar space.

We expect the EdgePoint spinoff to be completed on or before year end. We are confident that the EdgePoint spinoff will be successful given the early involvement of luminaries such as IBM, Balaji Baktha – Leading Silicon Valley VC, and Dr. Sanjay Jha- the former CEO of Motorola and COO/President of Qualcomm.

On August 16, 2020, Immune Therapeutics, Inc. (the "Company" or "Immune") and Cytocom, Inc. ("Cytocom") reported that closed on an agreement for the Company to sublicense Lodonal ("LDN") and Methionine Enkephalin ("MENK") for emerging markets (Filing, 8-K, TNI BioTech, AUG 16, 2020, View Source [SID1234563748]). Under the terms of the agreement, Cytocom will assume approximately $5,200,000 in the Company’s note, loan and other financial obligations. Separate from the sublicensing agreement, the Company owns an equity stake of approximately 15% in Cytocom.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the sublicensing agreement, Cytocom will assume the following approximate obligations of the Company: $1,051,000 in accrued liabilities and accounts payable, $3,038,000 in notes and loans payable, and $1,111,000 in obligations owed to former Immune employees.

The Company’s Board of Directors believes that despite the difficulty of the decision to take these actions, they are in the clear best interest of the Company and its shareholders and consistent with the Company’s forward-looking transition strategy of improving Immune’s financial position.

On August 16, 2020, OncoSec Medical Incorporated (the "Company"), reported that it entered into a Securities Purchase Agreement (the "Purchase Agreement") with certain new and existing investors (the "Purchasers"), pursuant to which the Company agreed to issue and sell in a registered direct offering (the "Offering") an aggregate of 4,608,589 shares (the "Shares") of common stock of the Company, par value $0.0001 (the "Common Stock"), at an offering price of $3.25 per share, for gross proceeds of approximately $15 million before the deduction of placement agent fees and offering expenses (Filing, 8-K, OncoSec Medical, AUG 16, 2020, View Source [SID1234563737]). The Shares are being offered by the Company pursuant to a shelf registration statement on Form S-3 (File No. 333-233447), which was initially filed with the Securities and Exchange Commission (the "Commission") on August 23, 2019, amended on June 23, 2020, and was declared effective by the Commission on June 26, 2020, as supplemented by a prospectus supplement, dated August 17, 2020, relating to the Offering.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The closing of the Offering is subject to satisfaction of customary closing conditions set forth in the Purchase Agreement and is expected to occur on or about August 19, 2020.

In addition, on August 16, 2020, the Company entered into an placement agency agreement (the "Placement Agreement") with ThinkEquity, a division of Fordham Financial Management, Inc. and Torreya Capital LLC (the "Placement Agents"), pursuant to which the Placement Agents agreed to serve as the exclusive placement agents for the Company, on a best efforts basis, in connection with the Offering. The Company has agreed to pay the Placement Agents and other financial advisors an aggregate cash fee equal to 8.0% of the gross proceeds received in the Offering.

The summaries of the Purchase Agreement and the Placement Agreement set forth above do not purport to be complete and are subject to and qualified in their entireties by reference to the text of such Purchase Agreement and Placement Agreement. A form of the Purchase Agreement is filed herewith as Exhibit 10.1, and a copy of the Placement Agreement is filed herewith as Exhibit 10.2. The Purchase Agreement and Placement Agreement include customary representations, warranties, closing conditions and covenants by the Company and the Purchasers.

On August 16, 2020 OncoSec Medical Incorporated (NASDAQ: ONCS) (the "Company" or "OncoSec") reported that in connection with its previously announced offering of common stock, it has entered into purchase agreements for the purchase of an aggregate 4,608,589 shares of the Company at an offering price of $3.25 per share for aggregate gross proceeds of approximately $15 million, before placement agent fees and other offering expenses (Press release, OncoSec Medical, AUG 16, 2020, View Source [SID1234563709]). The offering is expected to close on or about August 19, 2020.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company intends to use the net proceeds from this offering for clinical, regulatory, manufacturing and, if and when approved, potential commercial activities of its product candidates; research and development activities, including potential acquisitions and in-licensing; and other general corporate purposes.

ThinkEquity, a division of Fordham Financial Management, Inc., and Torreya Capital, LLC are acting as the exclusive placement agents for the offering.

All of the common stock in this offering were offered on a best efforts, any and all basis pursuant to an effective shelf registration statement on Form S-3 (File No. 333-233447). A prospectus supplement relating to the offering will be filed by the Company with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the final prospectus supplement and accompanying prospectus may also be obtained from ThinkEquity, 17 State Street, 22nd Floor, New York, NY 10004, by telephone at (877) 436-3673, by email at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.