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VolitionRx Limited Announces Proposed Underwritten Public Offering of Common Stock

On July 28, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition"), a multi-national epigenetics company, reported that it has commenced an underwritten public offering of its common stock. All of the shares of common stock are being offered by Volition (Press release, VolitionRX, JUN 28, 2022, View Source [SID1234617284]). In addition, Volition intends to grant the underwriter in the offering a 30-day option to purchase up to an additional 15% of the number of shares of common stock offered in the offering at the public offering price, less underwriting discounts and commissions. The final terms of the proposed offering will depend on market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Newbridge Securities Corporation is acting as the sole book-running manager of the offering.

The securities are being offered by Volition pursuant to a "shelf" registration statement on Form S-3 (File No. 333-259783) previously filed with the Securities and Exchange Commission (the "SEC") on September 24, 2021 and declared effective by the SEC on November 8, 2021. The offering is being made only by means of a prospectus supplement and an accompanying base prospectus, as may be further supplemented by any free writing prospectus and/or pricing supplement that the Company may file with the SEC. A preliminary prospectus supplement and an accompanying base prospectus describing the terms of the proposed offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying base prospectus relating to the offering can also be obtained, when available, from Newbridge Securities Corporation, Attn: Equity Syndicate Department, 1200 North Federal Highway, Suite 400, Boca Raton, FL 33432, by email at [email protected], or by telephone at (877) 447-9625. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction.

Elevar Therapeutics Names Dr. Jan M. Van Tornout Chief Medical Officer, Dr. Gordon Schooley Chief Regulatory Officer

On June 28, 2022 Elevar Therapeutics, Inc., a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have limited or inadequate therapeutic options, reported the hiring of Jan M. Van Tornout, M.D., MSc., as chief medical officer, and Gordon Schooley, Ph.D., as chief regulatory officer (Press release, Elevar Therapeutics, JUN 28, 2022, View Source [SID1234616351]).

Van Tornout, an accomplished hematologist-oncologist, genetic epidemiologist and pharma-biotech executive, joins Elevar after serving as acting chief medical officer of biotechnology company Tyme Technologies, Inc. since March 2021. He brings more than 25 years’ experience in the medical industry and related academia, including over 15 years successfully developing drugs across the full spectrum of hematological, oncological and immuno-oncological indications from pre-investigational new drug (IND) meeting through Phase 4.

"Jan Van Tornout’s broad experience and demonstrated leadership in every phase of the clinical development process, and his interest in the potential of drugs that address gaps in critical medical treatments, make him an ideal addition to the Elevar team," said Dr. Saeho Chong, chief executive officer of Elevar. "We are pleased to add him to our leadership team."

Van Tornout’s clinical management and development experience includes work for Moleculin Biotech, Inc., Bright Peak Therapeutics, Cyclacel Pharmaceuticals, GlaxoSmithKline, Puma Biotherapeutics, Maverick Therapeutics, ERT Inc., HUYA Bioscience Int’l, Gradalis Inc., Inovio Pharmaceuticals, Natera Inc., Bristol-Myers Squibb and Amgen. He played an instrumental role in two successful NDAs, led several INDs and has expertise in all phases of clinical trials.

Van Tornout previously held academic appointments at the University of Southern California (USC), with a clinical appointment as attending pediatric hematologist-oncologist at Children’s Hospital Los Angeles. He earned his Doctor of Medicine from the Katholieke Universiteit Leuven (KUL), Leuven, Belgium, a Master of Science in classical philosophy from KUL and a Bachelor of Science from the Faculté Notre-Dame de la Paix, Namur, Belgium. He obtained his certification as a pediatrician from the Gasthuisberg University Hospitals, KUL, and completed his training as a pediatric hematologist-oncologist at Children’s Hospital. Van Tornout earned a Master of Science in applied biometry from USC and completed a post-doctoral fellowship in molecular epidemiology at USC.

Schooley, a global regulatory leader with more than 30 years of drug development experience, joins Elevar after nine years as chief regulatory officer for BeyondSpring Pharmaceuticals Inc., a global, clinical-stage biopharmaceutical company that develops immuno-oncology cancer therapies.

"Careful navigation of the road to regulatory approval is so critical to the clinical development process and Gordon Schooley has demonstrated his leadership in this discipline throughout his distinguished career," said Chong. "His addition to the Elevar team adds valuable perspective with respect to both regulatory strategy and execution, and will bolster our efforts to fulfill the unmet needs of patients awaiting new therapeutic options."

Schooley has spent more than a quarter century at the vice president level or higher, working in both startup and large company environments. He’s led global development teams through every clinical development milestone; worked closely with regulatory bodies in several different countries; overseen successful breakthrough designations and accelerated approvals; and managed complex label negotiations for initial product approvals.

Prior to BeyondSpring, Schooley spent seven years as a consultant for drug development activities related to clinical development, biostatistics and regulatory affairs. He previously worked at SkyePharma PLC/Pacira Pharma, Alliance Pharmaceuticals and Allergan/Herbert Labs.

Schooley holds a doctorate in biostatistics from the University of Michigan School of Public Health. He earned a Master of Science in statistics and Bachelor of Science in business management at Brigham Young University.

IDEAYA Announces Development Candidate Nomination of a Potential First-in-Class Pol Theta Helicase Inhibitor in Collaboration with GSK

On June 28, 2022 IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported that selection of a potential first-in-class Pol Theta Helicase development candidate (DC) (Press release, Ideaya Biosciences, JUN 28, 2022, View Source [SID1234616348]).

The Pol Theta Helicase DC is a potential first-in-class small molecule inhibitor of the helicase domain of DNA Polymerase Theta. IDEAYA is collaborating with GSK on IND-enabling studies to support the evaluation of the Pol Theta Helicase DC in combination with niraparib, GSK’s PARP inhibitor, for patients having tumors with BRCA or other homologous recombination (HR) mutations or homologous recombination deficiency (HRD).

"We are excited about potential clinical development opportunities for this potential first-in-class Pol Theta Helicase inhibitor. Pol Theta promotes DNA repair by Microhomology-Mediated End-Joining (MMEJ), an error-prone mutagenic DNA repair pathway, which is active in BRCA mutant and other HRD cancer cells. PARP1 is also involved in MMEJ DNA repair, supporting a hypothesis for synergistic combination of our Pol Theta Helicase DC with niraparib," said Michael White, Senior Vice President and Chief Scientific Officer of IDEAYA Biosciences.

"The development candidate has demonstrated robust in vivo efficacy in combination with niraparib, with significant tumor regressions and durable responses in multiple cancer models. We believe the Pol Theta helicase and niraparib combination has the opportunity to deliver meaningful patient benefit," said Benjamin Schwartz, Ph.D., Vice President, Head of Oncology Synthetic Lethality Research Unit at GSK.

IDEAYA and GSK are targeting an IND submission for the Pol Theta Helicase DC, subject to satisfactory completion of ongoing preclinical and IND-enabling studies, to enable first-in-human studies in the first half of 2023.

IDEAYA and GSK are collaborating on the ongoing IND-enabling studies, and GSK will lead clinical development for the Pol Theta program. GSK holds a global, exclusive license to develop and commercialize the Pol Theta Helicase DC and is responsible for all research and development costs for the program, including those incurred by IDEAYA. IDEAYA is eligible to receive future development and regulatory milestones of up to $485 million aggregate, inclusive of preclinical and clinical milestones of up to $10 million aggregate for advancing this asset through IND effectiveness.

Upon potential commercialization, IDEAYA will be eligible to receive up to $475 million of commercial milestones and tiered royalties on global net sales by GSK, its affiliates and their sublicensees ranging from high single digit to sub-teen double digit percentages, subject to certain customary reductions.

Pepscan’s personalized neoantigen peptide pools in phase I trial "PneoVCA with Pembro in Advanced Solid Tumors"

On June 28, 2022 Pepscan, the all-in-one peptide service provider, reported that it will supply personalized peptide pools for six patients in a phase I trial led by Mayo Clinic principal investigator Yanyan Lou, M.D., Ph.D., in collaboration with Keith L. Knutson, Ph.D (Press release, Pepscan Therapeutics, JUN 28, 2022, View Source [SID1234616347]). The trial tests the safety and tolerability of an experimental personalized peptide vaccine when given in combination with pembrolizumab in treating patients with a wide range of advanced solid tumors and tumors that have spread to other places in the body (metastases). The vaccine is designed to target certain proteins (neoantigens) on individuals’ tumor cells. Combination immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer and thereby interfere with the ability of the tumor cells to grow and spread.

"Mayo Clinic is recognized as one of the best hospital groups in the US and we are excited to provide the peptide pools for their investigational phase I study. Supplying top researchers and clinicians worldwide to turn their ideas into better treatment outcomes for patients is what we aim for at Pepscan." says Hans de Backer, CEO of Pepscan.

The primary objective of the study "Personalized Neoantigen Peptide-Based Vaccine in Combination With Pembrolizumab for the Treatment of Advanced Solid Tumors" is to evaluate the safety, side effects, optimal dosages and risks/benefits of a personalized neoantigen peptide vaccine in combination with pembrolizumab in advanced solid cancers. Pepscan will manufacture up to 20 unique peptides and combine them into peptide pools, making up the active pharmaceutical ingredient (API) of the vaccine. All within only 5 weeks to shipment (under quarantine). Besides the manufacturing, Pepscan also supported Mayo Clinic with the CMC (chemistry, manufacturing and control) report, which was submitted as part of Mayo’s Investigational New Drug (IND) Application and has been approved by the FDA. Manufacturing personalized peptides for neoantigen vaccines requires a very specific set of process development and manufacturing skills, facilities and analytical methods. With 25 years of experience in mastering peptides and flexible manufacturing capabilities, Pepscan reliably delivers individual or pooled peptide sets that fit its customers’ timelines.

Aethlon Medical Announces Fiscal Year End Financial Results and Provides Corporate Update

On June 28, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical technology company focused on developing products to diagnose and treat life and organ threatening infectious diseases, reported financial results for its fiscal year ended March 31, 2022 and provided an update on recent developments (Press release, Aethlon Medical, JUN 28, 2022, View Source [SID1234616346]).

Company Updates

Aethlon Medical is continuing the research and clinical development of the Hemopurifier, a therapeutic blood filtration system that can bind and remove life-threatening viruses and harmful exosomes from blood. This action has potential applications in cancer, where cancer associated exosomes may promote immune suppression and metastasis, and in life-threatening infectious diseases, including removal of COVID-19 virus, associated variants, and related exosomes.

As disclosed previously, the Aethlon Hemopurifier has demonstrated binding of the SARS-CoV-2 spike protein and, as reported in a peer reviewed publication, the binding and removal from circulation of SARS-CoV-2 virus from a human patient. That publication also noted that the Hemopurifier has demonstrated the removal of exosomes and exosomal microRNAs associated with coagulopathy and acute lung injury.

We also recently published a pre-print manuscript demonstrating that Aethlon’s proprietary GNA affinity resin was able to bind seven clinically relevant SARS-CoV-2 variants in vitro, including the Delta and Omicron variants. Viral capture efficiency with the GNA affinity resin ranged from 53% to 89% for all variants tested. The GNA affinity resin is a key component of our Hemopurifier. The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus nivalis Agglutinin" and was published in bioRxiv.

We continued to advance our severe COVID-19 clinical trial for the Hemopurifier under our open Investigational Device Exemption (IDE) for life-threatening viral infections. In June 2022, the first patient in this study was enrolled and has completed the Hemopurifier treatment phase of the protocol. We now have nine fully activated hospitals that are actively screening patients for the trial, including Louisiana State University (LSU) Shreveport, Valley Baptist Medical Center in Texas, Loma Linda Medical Center, Hoag Irvine and Newport Beach in Southern California, University of California Davis, University of Miami Medical Center, Cooper Medical and Thomas Jefferson Medical Center. We are in the site activation process with additional U.S. medical centers. Our contract research organization (CRO) for this trial is Pharmaceutical Product Development, also known as PPD.

We also obtained ethics review board approval and entered into an agreement with Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, to initiate a COVID-19 clinical trial. We have completed all site initiation activities and this site is now open for enrollment and is actively screening patients. One patient recently completed participation in the study.

In addition to our work with COVID-19, we continue to screen patients for our IDE clinical trial in head and neck cancer. We are working to increase the number of trial sites to accelerate patient recruitment and we are also considering initiating additional trials, both domestically and abroad, to investigate the Hemopurifier as a treatment for other forms of cancer.

Aethlon also recently announced the appointment of Angela Rossetti to the Aethlon Board of Directors, effective April 1, 2022. Ms. Rossetti is a senior biopharmaceutical executive who brings more than 20 years of industry experience.

Financial Results for the Fiscal Year Ended March 31, 2022

At March 31, 2022, Aethlon Medical had a cash balance of approximately $17.1 million.

Aethlon recorded approximately $294,000 of revenue related to our government contracts with the NIH in the fiscal year ended March 31, 2022, compared to approximately $659,000 in the fiscal year ended March 31, 2021. At March 31, 2022, the Company had approximately $345,000 of deferred revenue related to those contracts as a result of not achieving certain milestones in those contracts.

Consolidated operating expenses for the fiscal year ended March 31, 2022 were approximately $10.72 million, compared to approximately $8.55 million for the fiscal year ended March 31, 2021, an increase of approximately $2.17 million in fiscal year ended March 31, 2022. The $2.17 million increase in the 2022 period was due to increases in payroll and related expenses of approximately $1.17 million and in general and administrative expense of $1.0 million, which were partially offset by a decrease of approximately $4,000 in professional fees.

The $1.17 million increase in the fiscal year ended March 31, 2022 in payroll and related expenses was due to an increase in cash-based compensation of approximately $1.2 million, which was partially offset by a decrease in stock-based compensation of approximately $29,000. The $1.2 million increase in cash-based compensation was primarily due to increases of approximately $826,000 and $721,000 in general and administrative payroll and in research and development payroll, respectively, due to headcount increases, and approximately $203,000 in relocation-related compensation to two senior executives that relocated to San Diego, California as a condition of their employment. Those increases were partially offset by the combination of a $452,000 accrual in the 2021 period related to the separation agreement with the former CEO, with no comparable expense in the 2022 period, and a net decrease of approximately $135,000 in cash bonuses.

The $1.0 million increase in the fiscal year ended March 31, 2022 in general and administrative expenses primarily arose from increases of $453,000 in clinical trial expenses, $209,000 in rent expense and $195,000 in insurance expense

As a result of the changes in revenues and expenses noted above, Aethlon’s net loss before noncontrolling interests increased to approximately $10.4 million for the fiscal year ended March 31, 2022, from approximately $7.9 million for the fiscal year ended March 31, 2021.

The unaudited condensed consolidated balance sheet for March 31, 2022 and the unaudited condensed consolidated statements of operations for the fiscal years ended March 31, 2022 and 2021 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Tuesday, June 28, 2022 at 4:30 p.m. Eastern Time to review financial results and recent corporate developments. Following management’s formal remarks, there will be a question and answer session.

Interested parties can register for the conference by navigating to View Source

All callers should ask for the Aethlon Medical, Inc. conference call.

A replay of the call will be available approximately one hour after the end of the call through July 28, 2022. The replay can be accessed via Aethlon Medical’s website or by dialing 1-877-344-7529 (domestic) or 1-412-317-0088 (international) or Canada Toll Free at 1-855-669-9658. The replay conference ID number is 4234353.