INMUNE BIO, INC. ANNOUNCES $40 MILLION REGISTERED DIRECT OFFERING

On July 14, 2021 INmune Bio, Inc. (NASDAQ: INMB) (the "Company" or "INmune Bio"), a clinical-stage immunology company focused on developing treatments that harness a patient’s innate immune system to fight disease, reported that it has entered into a definitive agreement with one healthcare focused institutional investor and one family office for the purchase and sale of 1,818,182 shares of its common stock at a price of $22.00 per share for gross proceeds of approximately $40 million in a registered direct offering (Press release, INmune Bio, JUL 14, 2021, View Source [SID1234584841]). The closing of the offering is expected to occur on or about July 16, 2021, subject to the satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as the sole placement agent for the offering.

INmune Bio intends to use the net proceeds from this offering for working capital and general corporate purposes and to advance the development of its product candidates and expand its pipeline. This includes the completion and data readout from the Company’s planned Phase 2 clinical trial of its lead clinical candidate, XPro1595, in patients suffering from Alzheimer’s disease, which is expected to commence by the end of 2021. "With this investment, we expect the Company’s Phase II program in Alzheimer’s disease is completely funded" said RJ Tesi MD, CEO of Inmune Bio.

The securities described above will be offered by the Company pursuant to an effective "shelf" registration statement on Form S-3 (File No. 333-254221) previously filed with the Securities and Exchange Commission (the "SEC") on March 12, 2021 and declared effective by the SEC on May 5, 2021. The securities may be offered only by means of a prospectus. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the offering will be filed with the SEC. Electronic copies of the prospectus supplement may be obtained, when available, from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected].

This press release does not constitute an offer to sell or the 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 the registration or qualification under the securities laws of any such state or jurisdiction.

BERG To Present Latest Glioblastoma [GBM] Treatment Data At Society For Neuro-Oncology 2021 Meeting

On July 14, 2021 BERG, a clinical-stage biotech that employs patient biology and artificial intelligence (AI) to research diseases and develop innovative treatments, reported that it will present two poster presentations at the Society for Neuro-Oncology: Basic and Translational Omics of Brain Tumors and Their Microenvironment Conference, on July 15th and 16th, 2021 (Press release, Berg, JUL 14, 2021, View Source [SID1234584860]).

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The first presentation, entitled "Interrogative Biology: Unraveling insights into causal disease drivers by use of a dynamic systems biology and Bayesian AI to identify the intersect of disease and healthy signatures", will emphasize the features of BERG’s proprietary Interrogative Biology Platform. Specifically, the presentation will focus on how BERG’s platform combines Bayesian AI analytics and patient-derived biological samples to generate an unbiased, data-informed network for identifying targets and biomarkers for disease interception, providing the opportunity to better understand and monitor human health in real-time.

The second presentation, entitled "Delivery of Ubidecarenone (BPM 31510) to mitochondria effectuates metabolic reprogramming and redox activated apoptosis in Glioblastoma" will further detail the platform’s utility in biological data-driven clinical development for GBM, including insights on anti-cancer effects of its BPM 31510. The presentation will highlight the use of BERG’s platform in generating comprehensive digital maps of a GBM model in response to BPM 31510 treatment and, in turn, the novel insights leading to potential mechanisms underlying BPM 31510 efficacy in GBM, including targeting mitochondrial function, influencing intermediary metabolism and activation of apoptosis.

"Brain cancers, such as GBM, are destroying patients and their families," said Dr. Niven R. Narain, CEO, President and Co-founder of BERG. "Using Interrogative Biology to guide the development of BERG’s BPM 31510 has allowed us to position the drug for this highly metabolic and aggressive cancer in an effort to potentially address a serious unmet need in medicine."

GBM is a destructive type of brain cancer often recognized for its steep morbidity and mortality rates. There are no effective treatment options for the vast majority of patients available in the marketplace, thus substantiating the urgent need for novel therapeutic approaches to improve outcomes for this disease. BPM 31510 is a unique therapeutic modality, that specifically targets cell metabolism and shifts the cancer’s glycolytic dependency toward mitochondrial oxidative phosphorylation. When applied, it induces oxidative stress and causes cell death, specifically of cancer cells.

"BERG’s pioneering research to deepen our understanding and treatment of GBM continues to be a game changer across the industry," said Dr. Eric J. Nestler, Director of Friedman Brain Institute at Icahn School of Medicine at Mount Sinai and Board director for BERG. "The Interrogative Biology Platform is leading the charge to digitize biology for the future of healthcare, and will empower patients to take back control of their personal care."

Details of BERG Abstracts:

Abstract #: CSAO-1: Interrogative Biology: Unraveling insights into causal disease drivers by use of a dynamic systems biology and Bayesian AI to identify the intersect of disease and healthy signatures – View Source
Abstract #: OMRT-13: Delivery of Ubidecarenone (BPM 31510) to mitochondria effectuates metabolic reprogramming and redox activated apoptosis in Glioblastoma – View Source
The Abstracts are available online and the Posters will be available to registered 2021 SNO Basic and Translational Omics of Brain Tumors and Their Microenvironment Conference attendees starting Thursday, July 15, 2021.

LIPOCINE ANNOUNCES SETTLEMENT WITH CLARUS THERAPEUTICS

On July 14, 2021 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that it has entered into a global settlement and license agreement with Clarus Therapeutics Inc. ("Clarus") to resolve all outstanding claims in the on-going intellectual property litigation between the two companies as well as the on-going interference proceeding between the two companies (Press release, Lipocine, JUL 14, 2021, View Source [SID1234584842]).

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Under the terms of the settlement announced today, Lipocine and Clarus have agreed to dismiss the Lipocine Inc. v Clarus Therapeutics, Inc., No 19-cv-622 (WCB) litigation presently pending in the U.S. District Court for the District of Delaware. Additionally, both parties have reached an agreement on the interference proceedings captioned Clarus Therapeutics, Inc. v. Lipocine Inc., Interference No. 106,128 presently pending in the U.S. Patent and Trademark. The terms of the settlement remain confidential.

Ampio Pharmaceuticals, Inc. to Report Fiscal 2021 Second Quarter Financial Results and Provide Corporate Business Update

On July 14, 2021 Ampio Pharmaceuticals (NYSE American: AMPE), a biopharmaceutical company focused on the advancement of immunology-based therapies for prevalent inflammatory conditions, reported it will host a conference call to discuss financial results for the quarter ended June 30, 2021, and provide a corporate business update on Wednesday, August 4, 2021, at 4:30 pm EDT/ 2:30 pm MT (Press release, Ampio, JUL 14, 2021, View Source [SID1234584861]).

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The conference call will also be available from the Investor Relations section of the Company’s website at www.ampiopharma.com and will be archived there shortly after the live event.

Advaxis to Present at the Non-Small Cell Lung Cancer Drug Development Summit

On July 14, 2021 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products, reported that Andres Gutierrez, M.D., Executive Vice President and Chief Medical Officer of Advaxis, will present data from Part B of the Company’s Phase 1/2 study of ADXS-503 in combination with Pembrolizumab in patients with metastatic squamous or non-squamous non-small cell lung cancer at the virtual Non-Small Cell Lung Cancer Drug Development Summit on July 15th, 2021 (Press release, Advaxis, JUL 14, 2021, View Source [SID1234584843]).

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Presentation Title: Could Neoantigen Immunotherapies Reverse Resistance to PD-1 Inhibitors & Progression in NSCLC?
Session Title: Immunotherapy Strategy for NSCLC
Session Type: Virtual Presentation
Date and Time: 7/15/2021, 9:30 AM (EDT)