On July 1, 2019 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health, reported financial results for its fiscal year ended March 31, 2019 and provided an update on recent developments (Press release, Aethlon Medical, JUL 1, 2019, View Source [SID1234537351]).

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Company Updates

Aethlon Medical, Inc. (Company) is continuing the development of its proprietary Hemopurifier, which is a first in class therapeutic device designed for the single use depletion of circulating viruses and cancer-promoting exosomes. The Hemopurifier has previously been designated a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and in late 2018 was additionally designated as a Breakthrough Device "…for the treatment of individuals with advanced or metastatic cancer who are either unresponsive to or intolerant of standard of care therapy, and with cancer types in which exosomes have been shown to participate in the development or severity of the disease…."

Aethlon is currently preparing for the initiation of clinical trials in patients with advanced and metastatic cancers. The Company is initially focused on the treatment of solid tumors, including head and neck cancer, gastrointestinal cancers and other cancers. Aethlon is in active communication with FDA in preparation for the initiation of an early clinical trial in one of these areas.

On June 30, 2019, the Company entered into a cross-licensing agreement with SeaStar Medical, Inc. to jointly develop Aethlon’s and SeaStar’s combined medical devices to address the care and management of critically ill patients.

Financial Results for Fiscal Year Ended March 31, 2019

Aethlon’s net loss was approximately $6.2 million, or $(0.34) per share for the fiscal year ended March 31, 2019, compared to a net loss of approximately $5.7 million, or $(0.46) per share for the fiscal year ended March 31, 2019.

At March 31, 2019, the Company had a cash balance of approximately $3.8 million.

Aethlon’s consolidated operating expenses for the fiscal year ended March 31, 2019 were approximately $6.2 million, compared to $5.0 million for the prior fiscal year. This increase of approximately $1.2 million, was in part due to an accrual of approximately $517,000 to cover separation payments to be paid over calendar 2019 to Aethlon’s former CEO and to its former President. The Company recorded approximately $473,000 of that accrual as payroll and related expenses and the remaining $44,000 fell into the general and administrative expense area.

Net of the $517,000 accrual, the Company’s operating expenses increased by approximately $700,000. The primary driver of the $700,000 increase was a net increase in professional fees of approximately $639,000, primarily due to increased scientific consulting fees related to ongoing studies and increased legal fees.

Aethlon had other expense of approximately $220,000 in the fiscal year ended March 31, 2019, compared to other expense of approximately $869,000 in the fiscal year ended March 31, 2018.

The Company recorded government contract and grant revenue in the fiscal years ended March 31, 2019 and 2018. This revenue arose from work performed under two government contracts with the National Institutes of Health (NIH). In the fiscal year ended March 31, 2018, the Company recorded approximately $150,000 in revenue from its Melanoma Cancer contract with the NIH and in the fiscal year ended March 31, 2019, Aethlon recorded approximately $230,000 in aggregate revenue from the Melanoma Cancer contract and its new Breast Cancer grant.

The unaudited condensed consolidated balance sheet for March 31, 2019 and the unaudited condensed consolidated statements of operations for the fiscal year ended March 31, 2019 and 2018 follow at the end of this release.

Conference Call

Aethlon will hold a conference call today, Monday, July 1, 2019 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.

To listen to the call by phone, interested parties within the U.S. should call 1-844-836-8741 and International callers should call 1-412-317-5442. 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 8, 2019. The replay can be accessed via Aethlon’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 10132719.

On July 1, 2019 Boston Biomedical, Inc. reported that the CanStem111P study evaluating the safety and efficacy of investigational agent napabucasin plus weekly nab-paclitaxel with gemcitabine versus weekly nab-paclitaxel with gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma will be discontinued due to futility (Press release, Boston Biomedical, JUL 1, 2019, View Source [SID1234537350]). This decision is based on a recommendation by the independent Data and Safety Monitoring Board (DSMB), following a pre-specified interim analysis of futility at 50 percent of the total planned events. No new safety concerns were raised by the DSMB.

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"Pancreatic cancer is an area of high unmet need and our hope was to develop a new therapeutic option for patients. We are disappointed with the results of this interim analysis and would like to express gratitude to the trial participants, their families, investigators and staff for their efforts and contributions to this study," said Patricia S. Andrews, Chief Executive Officer, Boston Biomedical, Inc. "Boston Biomedical and our parent company, Sumitomo Dainippon Pharma Co., Ltd., remain committed to CanStem303C, a phase 3 trial of napabucasin in metastatic colorectal cancer, and to oncology as a key priority for the organizations."

Boston Biomedical intends to work with study investigators to complete a full evaluation of the CanStem111P trial results. The data and analyses of this study will be provided to regulatory authorities and will be presented and published for the oncology community.

About Napabucasin
Napabucasin is an orally-administered investigational agent that is bioactivated by NQO1, which generates reactive oxygen species (ROS) to affect multiple oncogenic cellular pathways, including the STAT3 pathway, which is expected to result in cancer cell death.1

Napabucasin is being investigated in CanStem303C, a phase 3 trial for metastatic colorectal cancer (NCT02753127). It is also being investigated in earlier phase trials in multiple solid malignancies.

On July 1, 2019 Morphic Holding, Inc. ("Morphic"), a biopharmaceutical company discovering and developing oral small-molecule integrin therapeutics, reported the closing of its initial public offering of 6,900,000 shares of its common stock at a price to the public of $15.00 per share, which includes 900,000 shares sold upon full exercise of the underwriters’ option to purchase additional shares of common stock (Press release, Morphic Therapeutic, JUL 1, 2019, View Source [SID1234537349]). The shares began trading on The Nasdaq Global Market on June 27, 2019 under the symbol "MORF." Morphic received gross proceeds, before deducting underwriting discounts and commissions and other estimated offering expenses, of approximately $103.5 million.

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Jefferies LLC, Cowen and Company, LLC, BMO Capital Markets Corp. and Wells Fargo Securities, LLC acted as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on June 26, 2019. The offering was made only by means of a prospectus. A copy of the final prospectus relating to the offering may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected], from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (631) 592-5973 or by email at [email protected]; from BMO Capital Markets Corp. at 3 Times Square, New York, NY 10036, Attention: Equity Syndicate Department, by telephone at (800) 414-3627 or by email to [email protected]; or from Wells Fargo Securities, LLC 375 Park Avenue, New York, New York 10152, Attention: Equity Syndicate Department, or by calling (800) 326-5897, or by emailing [email protected].

This press release shall 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 registration or qualification under the securities laws of any such state or jurisdiction.

On July 1, 2019 Foundation Medicine, Inc. reported it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx to be used as a companion diagnostic for LYNPARZA (Olaparib) for first line maintenance therapy in BRCA-mutated advanced ovarian cancer (Press release, Foundation Medicine, JUL 1, 2019, View Source [SID1234537348]). FoundationOne CDx is an FDA-approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostics. FoundationOne CDx detects tumor BRCA1 and BRCA2 mutations including both germline (inherited) and somatic (acquired) mutations.i FoundationOne CDx may help identify more women who could benefit from Lynparza as compared to conventional testing methods that only identify germline BRCA mutations. Germline-only BRCA1/2 testing identifies approximately half of all BRCA1/2 mutations.ii,iii

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"Foundation Medicine is proud to receive FDA approval for another important companion diagnostic on FoundationOne CDx, our broad companion diagnostic test that is clinically and analytically validated for all solid tumors," stated Brian Alexander, M.D., M.P.H. Foundation Medicine’s Chief Medical Officer. "It is imperative that women with advanced ovarian cancer receive rigorous testing for BRCA1/2 mutations such as FoundationOne CDx, which includes both germline and somatic mutations, to determine if they are a candidate for PARP inhibitors."

In December of 2018, AstraZeneca (LSE/STO/NYSE: AZN) and Merck & Co., Inc. announced that the FDA approved Lynparza for use as maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to 1st-line platinum-based chemotherapy.

Foundation Medicine, AstraZeneca and Merck have an ongoing collaboration to support the development of companion diagnostics for Lynparza in prostate cancer.

About FoundationOne CDx
FoundationOne CDx is a next-generation sequencing based in vitro diagnostic device for detection of substitutions, insertion and deletion alterations (indels), and copy number alterations (CNAs) in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed paraffin embedded (FFPE) tumor tissue specimens. FoundationOne CDx is intended as a companion diagnostic to identify patients who may benefit from treatment with certain targeted therapies in accordance with their approved therapeutic product labeling. Additionally, FoundationOne CDx is intended to provide tumor mutation profiling to be used by qualified health care professionals in accordance with professional guidelines in oncology for patients with solid malignant neoplasms. For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit View Source

On July 1, 2019 Amphivena Therapeutics highlighted initial data from the dose-escalation portion of the First-in-Human Phase 1 trial evaluating AMV564 in patients with relapsed or refractory acute myeloid leukemia (AML, AMV564-101, NCT03144245) in an oral presentation June 15 at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) meeting in Amsterdam (Abstract S877) (Press release, Amphivena Therapeutics, JUL 1, 2019, View Source [SID1234537347]). The oral presentation of data from 33 patients treated within 9 cohorts demonstrated that AMV564 is active in relapsed or refractory AML and expanded upon the data from 26 patients presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in December 2018. AMV564 is a bivalent, bispecific (2:2) T cell engager that binds CD33 and CD3 resulting in T cell directed lysis of leukemic blasts and myeloid-derived suppressor cells (MDSCs) without affecting monocytes and neutrophils.

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Gail Roboz, M.D., Professor of Medicine, Director of the Leukemia Program, and a member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and NewYork-Presbyterian/Weill Cornell Medical Center and a Principal Investigator for the study, presented on behalf of the study team. "While this is a Phase 1 study," she said, "we believe that AMV564 has demonstrated promising monotherapy activity, including a CR, CRi and PR and evidence of durability in a high risk, older patient population on a 14-day dosing regimen. The data show that AMV564 is well-tolerated with no dose limiting toxicities through 250 mcg and only Grade 1 and Grade 2 cytokine release syndrome distinguishing the safety of AMV564 from other drugs in development for myeloid malignancies."

"AMV564 has demonstrated novel clinical activity for a T cell engager by rapidly and selectively eliminating leukemic blasts and rare immature, granulocytic and monocytic MDSCs while sparing normal CD33-expressing cells, including neutrophils and monocytes. High levels of circulating MDSCs are associated with poor prognosis for cancer patients. Our drug’s ability to selectively eliminate MDSCs rather than modulating MDSC pathways provides a unique opportunity to evaluate the role of these immune suppressive cells in cancer," said Jeanmarie Guenot, Ph.D., Amphivena Chief Executive Officer and President.

Dr. Roboz has served as a consultant for Amphivena, Celgene, Bayer, Otsuka, Pfizer, Astellas Pharmaceuticals, Argenx, Astex Pharmaceuticals, Hoffman-La Roche, Janssen, Novartis, AbbVie, Sandoz, Eisai, Jazz Pharmaceuticals, Celltrion, Orsenix and Daiichi Sankyo.

About AMV564-101

AMV564-101 is a First-in-Human dose escalation and dose expansion Phase 1 trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AMV564 in patients with relapsed or refractory AML after 1-2 prior induction regimens (with a standard anthracycline-based regimen or hypomethylating agent) and no more than 2 prior salvage regimens. The Phase 1 study is currently open at Washington University School of Medicine, MD Anderson Cancer Center, NewYork-Presbyterian/Weill Cornell Medical Center and Weill Cornell Medicine, Fred Hutchinson Cancer Research Center, The Ohio State University Wexner Medical Center, University of Pennsylvania Medical Center, Northwestern Memorial Hospital, and The Johns Hopkins Hospital.