On August 9, 2022 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical therapeutic company focused on developing products to diagnose and treat cancer and life threatening infectious diseases, reported financial results for its first quarter ended June 30, 2022 and provided an update on recent developments (Press release, Aethlon Medical, AUG 9, 2022, View Source [SID1234617969]).

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!

Company Updates

Aethlon Medical is continuing the research and clinical development of its 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.

We recently published a peer-reviewed manuscript demonstrating that Aethlon’s proprietary GNA affinity resin, a key component of the Hemopurifier, 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 findings from this paper suggest that the Hemopurifier should be able to bind any future SARS-CoV-2 variants that may potentially arise. The manuscript is titled "Removal of Clinically Relevant SARS-CoV-2 Variants by An Affinity Resin Containing Galanthus Nivalis Agglutinin" and was published in PLOS ONE on July 28, 2022.

We continue to advance our severe COVID-19 clinical trial for the Hemopurifier under our open Investigational Device Exemption (IDE) for life-threatening viral infections. Since our last update, the first patient has completed the study. Our active sites continue to actively screen patients along with our contract research organization (CRO), PPD, Inc. On July 6, 2022, the U.S. Food and Drug Administration (FDA) approved a supplement to our COVID-19 trial. The newly approved protocol supplement eliminates the inclusion criteria that patients must have a dialysis catheter in place and have tolerated dialysis at the time of screening. This change should improve the feasibility of enrolling new patients into our study. The active sites are currently submitting this supplement to their IRBs, and we expect to have their approvals in August and September 2022.

Medanta Medicity Hospital, a multi-specialty hospital in Delhi NCR, India, has enrolled one patient in our COVID-19 trial in India and continues to actively screen patients. Our CRO, Qualtran LLC, has identified additional potential sites for the trial in India and is currently assessing feasibility.

In addition to our work with COVID-19, we continue to screen patients for our IDE clinical trial in head and neck cancer. We have submitted a protocol supplement to the FDA to request the inclusion of patients who have failed platinum chemotherapy in the trial. If accepted by the FDA, this change would increase the eligible population for the study. We are currently drafting a protocol for a new clinical trial to allow us to examine the effects of the Hemopurifier in multiple tumor types where the cancer has progressed, following a two-month period of checkpoint inhibitor therapy.

Given the ongoing outbreak of monkeypox virus (MPXV), Aethlon is commissioning a new in vitro binding experiment to confirm that the Hemopurifier effectively captures the current strain of that virus. In 2008, we conducted an in vitro study that demonstrated that the Hemopurifier effectively bound and removed MPXV. We believe that the Hemopurifier’s ability to bind the current MPXV strain should not be affected because the mutations present in this strain do not change the mannose sugar in the viral envelope, which is recognized by the GNA within the Hemopurifier resin.

For more context regarding the 2008 study, we commissioned Battelle Memorial Institute to run an MPXV in vitro study using a miniature version of our Hemopurifier. This study demonstrated that high concentrations of MPXV, approximately 35,000s GPUs per mil, were rapidly depleted from cell culture fluids when circulated through the Hemopurifier. The study indicated that the Hemopurifier removed 44% of monkeypox virus in the first hour of testing, 82% after six hours, and 98% after 20 hours. The studies were conducted in triplicate and data verification was provided by real time polymerase chain reaction (PCR).

We continue to monitor MPXV caseload and disease severity. We have contacted the FDA and confirmed the process by which we could provide the Hemopurifier to requesting physicians for single patient emergency use. On August 4, 2022, the U.S. Department of Health and Human Services (DHHS) officially declared Monkeypox a health emergency. An Emergency Use Authorization (EUA) declaration has not yet been made. We plan to submit a pre-EUA package to the FDA so as to be prepared in the event this declaration occurs.

Financial Results for the First Quarter Ended June 30, 2022

As of June 30, 2022, Aethlon Medical had a cash balance of approximately $14.9 million.

Consolidated operating expenses for the three months ended June 30, 2022, were approximately $2.91 million, compared to $2.23 million for the three months ended June 30, 2021. This increase of approximately $680,000, or 30%, in the 2022 period was due to increases in our general and administrative expenses of approximately $402,000, in our professional fees of approximately $261,000 and in our payroll and related expenses of approximately $13,000.

The $402,000 increase in our general and administrative expenses in the June 30, 2022, quarter was primarily due to the combination of a $161,000 increase in our clinical trial expenses, a $97,000 increase in supplies, a $91,000 increase in our rent expense and a $27,000 increase in our insurance expense.

The $261,000 increase in our professional fees was primarily due to the combination of a $154,000 increase in our contract labor expense associated with product development and analytical services and a $95,000 increase in professional fees associated with regulatory strategy services

The $13,000 increase in our payroll and related expenses was due to an increase in our stock-based compensation expense of $95,000. Our cash-based compensation expense decreased by $82,000 because our CEO received a $215,000 bonus in the June 2021 period for achieving certain contractual milestones in his employment agreement and there were no bonuses paid out in the June 2022 period.

Aethlon did not record any revenue related to our government contracts with the NIH in the three months ended June 30, 2022, compared to approximately $132,000 in the three months ended June 30, 2021. As of June 30, 2022, the Company had approximately $459,000 of deferred revenue related to those contracts as a result of not achieving certain milestones in those contracts.

As a result of the changes in revenues and expenses noted above, Aethlon’s net loss before noncontrolling interests increased to approximately $2.9 million for the three months ended June 30, 2022, from approximately $2.1 million for the three months ended June 30, 2021.

During the three months ended June 30, 2022, the Company raised approximately $619,000 in net proceeds under our ATM agreement with H.C. Wainwright & Co., pursuant to sales of our common stock. In July and August 2022 to date, the Company raised approximately $8.3 million under our ATM agreement through sales of our common stock.

The unaudited condensed consolidated balance sheet for June 30, 2022, and the unaudited condensed consolidated statements of operations for the three months ended June 30, 2022 and 2021 follow at the end of this release.

Conference Call

The Company will hold a conference call today, Tuesday, Aug. 9, 2022, at 4:30 p.m. EDT 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

Please note that registered participants will receive their dial in number upon registration.

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 2740523.

On August 9, 2022 Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company focused on developing novel drugs for cancer, fibrosis and inflammation, reported that promising interim clinical data from its Phase I study of BBT-176, a fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) (Press release, Bridge Biotherapeutics, AUG 9, 2022, View Source [SID1234617968]). The data, presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (IASLC WCLC 2022), show promising early evidence of efficacy and favorable tolerability in patients with non-small cell lung cancer (NSCLC).

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 oral presentation delivered by Sun Min Lim, M.D., Ph.D., assistant professor at Yonsei University College of Medicine, discussed the correlation between molecular response and radiologic response in patient participants in the study. One patient with advanced NSCLC showing C797S triple mutations, confirmed as one of the partial response (PR) cases, showed up to 53 percent decrease of EGFR mutant allele frequency compared to the baseline. Data from the five patients who had been treated with BBT-176 over 100 days suggested that circulating tumor DNA (ctDNA) analysis enabled with liquid biopsy may be useful not only in identifying those most likely to benefit from fourth-generation EGFR TKI treatments such BBT-176, but also monitoring therapeutic response with treatment of a fourth-generation EGFR TKI.

The study also confirmed the preliminary efficacy of BBT-176 in treating advanced NSCLC patients harboring an EGFR mutation who had previously been treated with at least one EGFR TKI. Adverse events were primarily low grade, with GI toxicities and skin rash being most common, necessitating dose modifications in some patients. The pharmacokinetic profile of BBT-176 was shown to be dose-proportional in the study.

As the study continues, investigators will explore the recommended Phase 2 dose (RP2D) based on the overall safety, efficacy and tolerability information collected. Upon determination of the RP2D, investigators are expected to initiate the Phase 2 study next year.

Session and Presentation Information
Title: BBT-176, a 4th-generation EGFR TKI, for Progressed NSCLC after EGFR TKI Therapy: PK, Safety and Preliminary Efficacy from Phase 1 Study
Session Title: Overcoming Resistance to EGFR Inhibitors
Session Number: MA07.09
Presentation Session: August 8, 2022, 12:52 pm CET
Presenting Author: Sun Min Lim, M.D., Ph.D., Yonsei University College of Medicine
Session Discussant: Pasi A. Jänne, M.D., Ph.D., Dana-Farber Cancer Institute

On August 9, 2022 Catalent, Inc. (NYSE: CTLT), the global leader in enabling biopharma, cell, gene, and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, reported that it has reached an agreement to acquire Metrics Contract Services (Metrics), a full-service specialty Contract Development and Manufacturing Organization (CDMO) with a facility in Greenville, North Carolina, for $475 million from Mayne Pharma Group Limited (ASX: MYX) (Mayne Pharma) (Press release, Catalent, AUG 9, 2022, View Source [SID1234617965]). Upon completion, the acquisition will strengthen Catalent’s capabilities in integrated oral solid formulation development, manufacturing, and packaging to help customers simplify and accelerate their programs, while also expanding Catalent’s capacity to handle highly potent compounds.

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 333,000 square-foot Greenville facility features comprehensive capabilities to accelerate and de-risk customer programs from early development through commercial launch through a streamlined one-site solution. Over the past five years, the facility has seen more than $100 million in capital improvements and now includes 16 manufacturing suites, with 11 designed to handle highly potent compounds, as well as two packaging lines that can support a large variety of development and commercial supply programs. The facility’s estimated annual production capacity exceeds one billion oral solid dose units.

"This acquisition will further expand Catalent’s ability to meet our customers’ expectations in fast-growing areas of the business and patient need. The experienced team and consistently improved, state-of-the-art facility in Greenville will provide Catalent’s customers with immediate, fit-for-scale capacity for in-demand highly potent drugs and other oral solid small-to-mid-size batch needs. This capacity is particularly important for customers with R&D pipelines featuring accelerated, orphan, and rare disease programs for oncology and other important therapeutic areas," said Dr. Aris Gennadios, Group President of Catalent’s Pharma & Consumer Health segment.

"Over the past several years, Metrics has undergone a period of transformational change to expand its footprint and service offering, becoming a global end-to-end novel oral solid CDMO. Catalent, a global leader in advanced drug development and manufacturing, is well-positioned to continue to invest in and accelerate the growth of Metrics and we believe this transaction will be extremely positive for our Greenville team and customers," said Scott Richards, Chief Executive Officer of Mayne Pharma.

The new facility will seamlessly integrate into Catalent’s industry-leading oral development and manufacturing network, which includes flagship sites for large-scale and controlled release oral solids manufacturing in Winchester, Kentucky; softgel development and manufacturing in St. Petersburg, Florida; and additional facilities with bioavailability enhancement technologies and complex oral solids manufacturing platforms.

The acquisition is expected to close before the end of this calendar year, subject to customary closing conditions, and the entire team of over 400 employees will join Catalent. Mayne Pharma and Catalent have also agreed on the terms of a long-term supply agreement whereby the Greenville facility will continue to manufacture multiple Mayne Pharma products. Catalent will pay the purchase price for this all-cash acquisition using a combination of cash on hand, existing credit facilities, and, depending on market conditions, potentially new debt financing. The closing of the acquisition is not contingent on any financing activity.

On August 9, 2022 HCA Healthcare, Inc. (NYSE: HCA), one of the nation’s leading healthcare providers, reported that it will collaborate with Johnson & Johnson to address key healthcare industry issues (Press release, Johnson & Johnson, AUG 9, 2022, View Source [SID1234617964]).

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 two leading healthcare companies initially will focus on improving health equity, enhancing nursing support, and improving patient outcomes:

HCA Healthcare and Johnson & Johnson will collaborate on a scalable program to improve health outcomes through early-stage lung cancer detection for the Black community. Lung cancer is the number one cause of cancer death among Black patients1, and the two companies will begin to work together on a pilot program in the coming months to increase early identification.
HCA Healthcare, which has more than 93,000 nurses in its system, and Johnson & Johnson have a long-standing commitment to advocating for and supporting nurses. The two healthcare leaders will work together to incorporate Johnson & Johnson’s nursing resources within HCA Healthcare and its affiliate Galen College of Nursing. The companies will work together on health equity issues focused on educational programming, training and other programs that elevate and support nurses with a goal of enriching the nursing experience and skillsets and improving patient outcomes.
HCA Healthcare, through its HCA Healthcare Research Institute, and Johnson & Johnson will collaborate on cardiovascular health initiatives including a retrospective analysis of patients who suffer from heart arrhythmia, as well as research to understand the role digital health technology plays in impacting clinical outcomes for patients with Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD) diseases.
"HCA Healthcare and Johnson & Johnson have had a long and productive relationship, and both companies have worked very hard to address many of our country’s healthcare challenges," said Sam Hazen, chief executive officer of HCA Healthcare. "We believe strongly in the power of strategic partnerships, and we are excited to collaborate to advance health equity, enhance patient care and provide even greater support to our nurses."

"No one company can solve society’s most pressing health challenges alone — it takes collaboration," said Joaquin Duato, chief executive officer of Johnson & Johnson. "That’s why we’re working with HCA Healthcare to improve patient access and outcomes, address the nursing crisis, and advance health equity. We are united in our focus to improve patient care."

HCA Healthcare uses data from more than 35 million annual patient encounters to continually improve care. In addition, with more than 93,000 Registered Nurses (RN), HCA Healthcare is one of the country’s top employers of RNs and invests significantly in nurses and nursing through education and professional development, equipment and technology, resources to promote their physical and emotional wellbeing, and representation at every level of the organization from the bedside to senior leadership.

On August 9, 2022 BioMarker Strategies reported that the journal CANCER BIOTHERAPY AND RADIOPHARMACEUTICALS has published a manuscript by the Company’s scientists entitled "Functional Profiling of Head and Neck/Esophageal Squamous Cell Carcinoma to Predict Cetuximab Response" (Press release, BioMarker Strategies, AUG 9, 2022, View Source [SID1234617963]). The manuscript describes the company’s progress in identifying predictive dynamic biomarkers to help identify the subset of patients with head and neck/esophageal squamous cell carcinoma (SCC) who may benefit from treatment with cetuximab (Erbitux) and biosimilars.

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!

Cetuximab is an antibody that targets an epidermal growth factor receptor (EGFR), and remains the only targeted therapy approved by the U.S. Food and Drug Administration (FDA) for SCC of head and neck/esophagus. For primary SCC, cetuximab is approved for use in combination with radiation. In metastatic SCC, it is approved for use in combination with platinum chemotherapy and fluorouracil.

The authors note that responses to cetuximab can be dramatic, but the response rate was only about 15% in the landmark clinical trial. The authors also note that cetuximab therapy is accompanied by a risk of serious adverse events that results in interrupted therapy in 3%-10% of patients. The cost of treatment is approximately $100,000 per patient. Additionally, immune checkpoint inhibitors are now an option in SCC. Therefore, methods to identify patients who are most likely to respond to cetuximab are needed.

SCC is the world’s sixth most common cancer. Worldwide, there are approximately 900,000 new cases and 450,000 deaths per year. In the United States alone there are approximately 66,630 new cases and 14,620 deaths per year.

"To minimize risk and maximize the therapeutic benefit of cetuximab, predictive tests to better identify patients likely to be responsive to cetuximab therapy are clearly an important need," said Jerry Parrott, President and CEO of BioMarker Strategies. "From my perspective, based on the results reported here, I would agree with the authors that further studies are warranted to test in more complex samples, including patient-derived tumor tissues."

The research described in the manuscript discussed here was supported by a Small Business Innovation Research (SBIR) award from the National Cancer Institute (NCI) of the National Institutes of Health (NIH).