On February 11, 2019 Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic technology company focused on unmet needs in global health, reported financial results for the third quarter ended December 31, 2018 and provided an update on recent developments (Press release, Aethlon Medical, FEB 11, 2019, View Source [SID1234533224]).

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

Timothy C. Rodell, M.D., FCCP, joined the Company as Interim Chief Executive Officer and as a member of the Board of Directors in December 2018. Along with the recent additions to the Board of Directors of Sabrina Martucci-Johnson and Guy Cipriani, and the appointment of Charles Fisher, M.D. as Chairman, the Company believes it has the team in place with the depth of experience to move through the next stages of development.

The 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 had previously been designed as a Breakthrough Device by the FDA for the treatment of glycosylated viruses, including Ebola and other hemorrhagic fever viruses, and, as previously announced, during this quarter 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….".

While the Company continues to identify potential development pathways in viral diseases, the primary focus remains advancing the Hemopurifier for oncology indications under the Breakthrough Device designation as rapidly as possible.

In support of this development program, the Company is continuing work under an ongoing Small Business Innovation Research (SBIR) grant from the National Cancer Institute entitled "The Hemopurifier Device for Targeted Removal of Breast Cancer Exosomes from Blood Circulation".

Third Quarter Financial Results

The Company’s net loss was approximately $2.0 million, or $(0.11) per share, for the three months ended December 31, 2018, compared to a net loss of approximately $1.2 million, or $(0.08) for the three months ended December 31, 2017.

At December 31, 2018, the Company had a cash balance of approximately $4.8 million.

Consolidated operating expenses for the three months ended December 31, 2018 were approximately $1.96 million, compared to $1.24 million for the three months ended December 31, 2017. This increase of approximately $720,000, or 58.6%, was due to increases in payroll and related expenses of approximately $498,000, professional fees of approximately $148,000, and general and administrative expenses of approximately $79,000.

The $498,000 increase in payroll and related expenses was primarily due to the combination of a $473,000 accrual for separation payments over calendar 2019 for the Company’s former CEO and President and a $22,000 increase in stock-based compensation.

The $148,000 increase in our professional fees was primarily due to increased scientific consulting fees related to ongoing studies.

The $79,000 increase in general and administrative expenses was primarily due to a $45,000 accrual for health insurance payments over calendar 2019 for the Company’s former CEO and President.

The Company had other expense of approximately $55,000 in the three months ended December 31, 2018, compared to other expense of approximately $56,000 in the three months ended December 31, 2017.

The unaudited condensed consolidated balance sheet for December 31, 2018 and the unaudited condensed consolidated statements of operations for the three and nine months ended December 31, 2018 and 2017 follow at the end of this release.

Conference Call

Aethlon will hold a conference call today, Monday, February 11, 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 February 18, 2019. 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 10128677.

On February 11, 2019 Recombinetics reported that named Mark Platt the organization’s Chief Executive Officer (Press release, Recombinetics, FEB 11, 2019, View Source [SID1234533249]).

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!

"Recombinetics is at the forefront of innovative research and development to address issues of global significance, like feeding the hungry, improving population health and the humane treatment of animals," Platt says. "I’m joining at this transformational time to ensure the organization and its strategic investors thrive, with all aligned to positively impact people, places and animals at home and abroad."

"Our organization will benefit greatly from Mark’s leadership experience," says Peter Hajas, chairman of the Board, Recombinetics. "Mark brings an excitement for the possibilities of our innovative work and is the right person to guide our corporate culture and nurture relationships with key stakeholders to achieve goals of improving human lives, feeding the world’s growing population, and reducing animal suffering."

Platt’s experience includes his time as President and CEO of Multistack, LLC, in Sparta, Wis., where he provided strategic long-term direction of the company and was directly involved in emerging technology, research and development. From 2002 to 2012, Mark led the company through its highest period of growth, with total revenue increasing by more than 1,000 percent.

Most recently Executive Sales Leader at the Trane, Inc. Midwest sales office, Platt played a role in doubling the organization’s market share in less than two years. He was also Senior Vice President of Business Services for Gundersen Health System from November 2013 to April 2017. In this role, Platt oversaw business development and marketing, government relations, supply chain, facility operations and community wellness initiatives. He has also served on the Gundersen Board of Trustees.

Platt received his bachelor’s degree in electrical engineering from Vanderbilt University, Nashville, Tenn. He was also a commissioned officer in the U.S. Air Force with 17 years of service and held the rank of captain in the U.S. Air Force Reserve.

Tammy Lee, who served as President and CEO of Recombinetics since August 2017, is taking a leave of absence from the company. Recombinetics thanks Lee for her leadership, which included securing $34 million for the company’s Series A financing round.

On February 11, 2019 3SBio Inc. ("3SBio") (HKEX:1530) and Verseau Therapeutics, Inc. ("Verseau") reported a partnership agreement focused on the development and commercialization of novel monoclonal antibodies in the field of immuno-oncology for a broad range of cancers (Press release, Verseau Therapeutics, FEB 11, 2019, View Source [SID1234542367]). Verseau’s proprietary drug discovery platform generates first-in-class macrophage checkpoint modulators (MCMs) to benefit patients with cancer, immune and inflammatory diseases.

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!

Under the terms of the agreement, 3SBio will receive an exclusive license to develop and commercialize a select number of MCM antibodies for all human oncology indications in Greater China, including mainland China, Taiwan, Hong Kong and Macau ("Territory"). Verseau will be responsible for discovery and optimization of MCM antibodies for each program. 3SBio will fund and conduct antibody development, GMP manufacturing, and commercialization in the Territory. Verseau and 3SBio will be eligible to receive certain milestone payments and royalties on product sales both in the Territory and globally. 3SBio will also purchase $15 million of Verseau Series B preferred stock. Additional financial terms were not disclosed.

"Recent advances in immuno-oncology have produced unprecedented benefit to patients; however, many people with cancer still require more effective treatment options," said Dr. Jing Lou, Chief Executive Officer of 3SBio. "Our collaboration with Verseau provides 3SBio with access to novel and differentiated immune-modulating antibodies that will complement our growing innovative oncology portfolio. We look forward to partnering with the Verseau team."

"3SBio is an ideal partner for Verseau to rapidly advance our novel, first-in-class macrophage checkpoint modulators in immuno-oncology," said Dr. Christine Bunt, Chief Executive Officer and Chairman of the Board of Verseau. "3SBio is a pioneer in China’s biotechnology industry with a fully-integrated R&D, manufacturing and commercial platform."

About Macrophage Checkpoint Modulators

Verseau is broadening the therapeutic potential of immunotherapy by developing macrophage checkpoint modulators (MCMs) that regulate the functional shift to make macrophages more inflammatory or more tolerogenic depending on the disease context. While PD-1 inhibitors have provided great clinical successes, they are only effective in 10-15% of cancer patients. Macrophages demonstrate one of the highest infiltration rates in human tumors (~75%). MCMs cause tumors to turn highly inflammatory and stimulate multiple immune cell types, including T cells. Verseau’s therapies have the potential to significantly expand the number of patients benefitting from immunotherapy, including those unresponsive to PD-1 inhibitor therapies. Through its proprietary all-human translational system Verseau has validated more than two dozen targets amenable to different therapeutic modalities, including monoclonal antibodies (mAbs).

On February 11, 2019 Enzo Biochem, Inc. (the "Company"), along with its subsidiary Enzo Life Sciences, Inc. reported that it has entered into a Settlement Agreement as of February 5, 2019 (the "Agreement") with Roche Diagnostics GmbH and Roche Molecular Systems, Inc. (together, "Roche") with respect to an action between the Company and Roche before the U.S. District Court, Southern District of New York, Case No 04-CV-4046. Roche has agreed to pay $21,000,000 in settlement pursuant to the Agreement (Press release, Enzo Biochem, FEB 11, 2019, View Source [SID1234533206]). This settlement does not affect Enzo’s civil action for patent infringement against Roche in the U.S. District Court for the State of Delaware, Enzo Life Sciences Inc. v. Roche Molecular Systems Inc., et al., civil action no. 12-cv-00106, which remains pending on appeal. The Agreement is filed with this current report as Exhibit 10.1 and incorporated herein by reference.

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!

On February 11, 2019 Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, reported that the US Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for Precigen’s PRGN-3005, a first-in-class investigational therapy using autologous chimeric antigen receptor T (CAR-T) cells to treat advanced-stage platinum-resistant ovarian cancer patients (Press release, Intrexon, FEB 11, 2019, View Source [SID1234533229]).

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!

PRGN-3005 is the second candidate to clear IND utilizing Precigen’s transformative UltraCAR‑T platform that reduces manufacturing time to less than two days following non-viral gene transfer. PRGN-3005 UltraCAR-T is a multigenic CAR-T cell treatment utilizing Precigen’s clinically-validated Sleeping Beauty system to co-express a chimeric antigen receptor, membrane-bound interleukin‐15 (mbIL15), and a kill switch for better precision and control in targeting advanced ovarian cancer. This is an open-label, first-in-human Phase 1 dose escalation study to evaluate the safety and maximal tolerated dose of PRGN‐3005 UltraCAR-T.

"This patient population has limited treatment options and ovarian cancer remains one of the most challenging with minimal advances in long-term survival for patients with advanced disease," said Mary L. (Nora) Disis, MD, professor of medicine at the University of Washington and lead investigator for the PRGN-3005 study. "Clinical advancements and new research, including the PRGN-3005 UltraCAR-T study, are needed to make progress in fighting this intractable disease."

Precigen’s UltraCAR-T platform has the potential to disrupt the CAR-T treatment landscape by increasing patient access through shortening manufacturing time, decreasing manufacturing-related costs, and improving outcomes using advanced approaches for precise tumor targeting and control of the immune system. The platform brings several key advancements:

Non-viral gene transfer using multigenic vectors for expression of multiple effector genes leads to better precision and control of tumor targeting and eliminates the need for virus;
Sustained persistence and desired phenotype of infused UltraCAR-T helps address T-cell exhaustion, a common issue with current CAR-T therapies;
T-cell control by incorporation of kill switch technology to potentially improve the safety profile; and
Rapid manufacturing of UltraCAR-T cells using our proprietary non-viral gene transfer process, eliminates the need for ex vivo propagation, thus dramatically reducing wait times for patients from weeks to less than two days.
"We are pleased our PRGN-3005 UltraCAR-T investigational therapy received clearance from the FDA to advance into the clinic. This is an exciting milestone as it represents the first UltraCAR-T to enter the clinic targeting solid tumors," said Helen Sabzevari, PhD, President of Precigen. "This is an important step for patients and our dedicated employees who continue to work with urgency to execute our important mission of creating innovative medicines with meaningful benefit for patients."

About Ovarian Cancer
Worldwide, nearly 300,000 women are diagnosed with ovarian cancer every year1 and around 22,000 are diagnosed in the US2. Five-year survival rates depend on stage and type of ovarian cancer; however, stage IV survival can drop to as low as 20 percent.3.

Precigen : Advancing Medicine with Precision
Precigen is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cellular therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. Precigen also follows the science opportunistically in pursuit of promising programs in emerging therapeutics. Our technologies enable us to find innovative solutions for affordable biotherapeutics in a controlled manner. Precigen operates as an innovation engine progressing a preclinical and clinical pipeline of well-differentiated unique therapies toward clinical proof-of-concept and commercialization. Precigen was founded as a wholly-owned subsidiary of Intrexon Corporation (NASDAQ: XON) and leverages Intrexon’s proprietary technology platforms to advance human health. For more information about Precigen, visit www.precigen.com.

1World Health Organization, International Agency for Research on Cancer, Global Cancer Observatory. Cancer Today, Estimated number of new cases in 2018, worldwide, both sexes, all ages. Accessed December 2018 via WHO IARC GCO website.
2American Cancer Society Ovarian Cancer Special Section. Access December 2018 via ACS website.
3American Cancer Society. Survival Rates for Ovarian Cancer, by Stage. Accessed December 2018 via ACS website.

Safe Harbor Statement
Some of the statements made in this press release are forward-looking statements. These forward-looking statements are based upon our current expectations and projections about future events and generally relate to plans, objectives and expectations for the development of our business, including the timing and progress of preclinical and clinical trials and discovery programs. Although management believes that the plans and objectives reflected in or suggested by these forward-looking statements are reasonable, all forward-looking statements involve risks and uncertainties and actual future results may be materially different from the plans, objectives and expectations expressed in this press release.