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ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT

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.

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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.

Entry Into a Material Definitive Agreement

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.

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.

OncoSec Medical Incorporated Announces Pricing of Public Offering

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.

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.

Ascentage Pharma Becomes a Constituent of Three Major Indexes Including Hang Seng Composite Index

On August 16, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the company has been selected as a constituent stock of the Hang Seng Composite Index (HSCI), the Hang Seng Hong Kong-Listed Biotech Index (HSHKBIO) and the Hang Seng Healthcare Index (HSHCI) in accordance with the quarterly adjustment results of the latest index series released by Hang Seng Indexes Company Limited, with effect from September 7th , 2020 (Press release, Ascentage Pharma, AUG 16, 2020, View Source [SID1234563690]).

HSCI is one of the important indexes in the Hong Kong equity market. Adopting the free-float-adjusted market capitalization methodology, the HSCI can be used as a basis for index funds, mutual funds as well as performance benchmarks. It now has 485 component stocks. This index offers a comprehensive Hong Kong market benchmark that covers the top 95th percentile of the total market capitalization of companies listed on the Main Board of the Stock Exchange of Hong Kong. The HSHCI aims to reflect the overall performance of stocks listed in Hong Kong that are related to healthcare businesses. This adjustment adds 12 new constituent stocks. It now has 47 component stocks. The HSHKBIO reflects the overall performance of the biotech companies that are listed in Hong Kong. Six new constituent stocks are selected this time and total 43 high-quality biotech stocks including Ascentage Pharma are included. The aforesaid three indexes provide important references for the Hong Kong equity market. It is particularly noteworthy that five biotechnology companies including Ascentage Pharma listed under Chapter 18A of the Listing Rules are included in HSCI, reflecting that the capital market has paid attention to and recognized this sector. Ascentage Pharma is one of the two biotechnology companies selected as components of the aforesaid three indexes.

Ascentage Pharma was successfully listed in Hong Kong in October 2019 and became the first stock related to small molecule innovative drugs. The company has further advanced global clinical development after listing and made a number of R&D progresses. It submitted the first New Drug Application (NDA) in June this year, making another milestone and taking an important step from a R&D company to a listed company with products.

"The selection of Ascentage Pharma as a constituent stock of the abovementioned index series of Hang Seng Indexes Company Limited represents the capital market’s recognition of and confidence in the company’s business, stock liquidity and development prospects. Additionally, it is expected to be conducive in introducing more diversified investors for the company and to promote the company’s reputation in the capital market," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "Leveraging our core competency in research and development as well as operation, we will continue to seize the major opportunities in the development of the biopharmaceutical industry. Furthermore, we are committed to providing safe and effective treatment options for global patients and endeavor to create value for shareholders."

Vaccinex Reports Second Quarter 2020 Financial Results and Provides Corporate Update

On August 14, 2020 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering novel investigational antibody therapies in Huntington’s disease and cancer, reported financial results for the second quarter ended June 30, 2020 and provided a corporate update (Press release, Vaccinex, AUG 14, 2020, View Source [SID1234569919]).

Pepinemab Clinical Updates:

Huntington’s Disease. The company’s ongoing SIGNAL clinical trial is evaluating its lead drug candidate, pepinemab, for the treatment of Huntington’s disease (HD). The company remains on track to complete the trial within the previously announced time frame. Subsequent to June 30, 2020, the last two patient treatment visits have been completed, and primary efficacy data has been collected from all subjects enrolled. The company continues to anticipate that topline data will be released by early October 2020.
Non-Small Cell Lung Cancer (NSCLC). CLASSICAL-Lung clinical trial. The CLASSICAL-Lung study is evaluating pepinemab in combination with the anti-PD-L1 checkpoint inhibitor BAVENCIO (avelumab) for the treatment of advanced (stage IIIB/IV) NSCLC. Near topline data for this trial presented at the virtual American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conference in late May 2020 suggested that immunotherapy naive and PD-L1 negative or low patients achieved higher response rates with the combination than with avelumab alone.
Head and Neck Cancer. The company is preparing to initiate a new study of pepinemab in combination with an anti-PD-1 checkpoint inhibitor to treat front line head and neck cancer. The Company expects to provide further details on this study in the third quarter of 2020.
Alzheimer’s Disease. After a delay caused by the COVID-19 pandemic, the company expects to initiate enrollment in a clinical trial of pepinemab in Alzheimer’s disease in September 2020.
Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) in additional indications including "window of opportunity" studies being conducted by the Winship Cancer Institute of Emory University to evaluate pepinemab in combination with checkpoint inhibitors in colorectal, pancreatic, head and neck cancer and melanoma.
Other Second Quarter and Recent Accomplishments:

Presented updated interim results from CLASSICAL-Lung), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2020 Annual Meeting and at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting.
Delivered a virtual presentation at the Advances in Alzheimer’s and Parkinson’s Therapies AAT-AD/PD Focus Meeting 2020 highlighting the potential of pepinemab to regulate glial cell activation and neurodegeneration in Alzheimer’s and Huntington’s disease.
"We are rapidly approaching a significant milestone for our company with top-line data from our potentially pivotal SIGNAL trial in Huntington’s disease expected by early October," stated Maurice Zauderer, Ph.D., president and chief executive officer of Vaccinex. "In parallel, we are exploring pepinemab’s potential utility in other slowly progressive neuroinflammatory and neurodegenerative diseases and anticipate commencing enrollment in a Phase 1/2 Alzheimer’s disease trial in September. We are very appreciative of financial support from both the Alzheimer’s Association and from the Alzheimer’s Drug Discovery Foundation to advance this important trial," Dr. Zauderer concluded.

Upcoming Expected Milestones:

Late September/Early October 2020 – Topline data expected from potentially pivotal SIGNAL Huntington’s disease study.
September 2020 – Anticipated enrollment of first patient in Alzheimer’s disease Phase 1/2 study.
Second half 2020 – Preparation expected to commence for Phase 2 study of pepinemab in combination with anti-PD-1 in head and neck cancer.
Financial Results for the Three Months Ended June 30, 2020:

Research and Development Expenses. Research and development expenses for the three months ended June 30, 2020 were $4.6 million, as compared to $7.3 million for the comparable period in 2019. This decrease was primarily attributable to decreases in expenses in the CLASSICAL-Lung and SIGNAL studies as patients have come off study.

General and Administrative Expenses. General and administrative expenses for the three months ended June 30, 2020 were $1.9 million, as compared to $1.5 million for the comparable period in 2019. The increase was due to increased stock-based compensation as a result of new option awards to employees and board members, as well as increased directors and officers insurance premiums.

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on June 30, 2020 were $0.5 million, as compared to $2.8 million on December 31, 2019. Subsequent to the end of the second quarter, the company raised total proceeds, net of discounts and commissions and before expenses, of approximately $19.8 million through four financing transactions: $6.9 million through its existing at-the-market (ATM) equity facility, $8.0 million through the sale of a senior secured convertible debenture, $4.0 million through a private placement transaction, and $300,000 through the company’s existing equity line of credit facility. The company also received $575,000 of the previously announced $750,000 grant from the Alzheimer’s Association under the 2020 Part the Cloud Program.