On November 3, 2020 Aethlon Medical, Inc. (Nasdaq: AEMD), a medical technology company focused on developing products to diagnose and treat life and organ threatening diseases, reported the appointment of Charles J. Fisher, Jr., M.D., as Chief Executive Officer, effective as of October 30, 2020 (Press release, Aethlon Medical, NOV 3, 2020, View Source [SID1234569787]). Dr. Fisher joined Aethlon as a member of Aethlon’s Board of Directors and has served as Chairman of the Board since November 2017. Mr. Ed Broenniman replaced Dr. Fisher as the Chairman of the Board effective as of October 30, 2020. Dr. Fisher brings an impressive record of results in global, strategic and operational roles to Aethlon. Dr. Fisher succeeds Dr. Timothy Rodell, who will serve as a consultant to Aethlon during the transition.

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Dr. Fisher’s experience as Head, Section of Critical Care Medicine at The Cleveland Clinic Foundation and his research in sepsis, inflammation, host defense and endothelial dysfunction led to his recruitment to Eli Lilly & Co., where he led the Xigris (activated Protein C) Global Product Team and successfully registered the first drug approved for the treatment of sepsis. Dr. Fisher served as Vice President for Global Pharmaceutical Development at Abbott Laboratories where, among other accomplishments, he guided the registration of Humira. Dr. Fisher also served as Executive Vice President and Chief Medical Officer at Cardiome Pharma, where he led multiple clinical trials for Brinavess, resulting to its approval in Europe and a global strategic transaction with Merck and Co. for $800 million US dollars. Additionally, Dr. Fisher has served as a member of the Defense Science Research Council and on DARPA panels, including one focused on universal host defense. Aethlon’s Board of Directors believes these experiences will enable Dr. Fisher to guide Aethlon’s development and commercialization of the Hemopurifier.

"We are delighted to begin our next chapter at Aethlon with Dr. Fisher as our CEO," said Mr. Broenniman, Chairman of Aethlon’s Board of Directors. "Chuck’s depth and breadth of experience in financing, structuring corporate deals, clinical development and regulatory strategy, both in the U.S. and internationally, will be of great value as we prepare Aethlon for the next phase of development."

"I am both honored and excited to take over this role at Aethlon at this time," said Dr. Fisher. "I believe the Aethlon Hemopurifier has great potential for treating life-threatening viral infections including Covid-19 and potentially cancer. We are now open to enrolling patients in our first clinical trial in advanced and/or metastatic head and neck cancer at the UPMC Hillman Cancer Center in Pittsburgh, PA. Also under an Investigational Device Exemption (IDE) we are now opening sites for our trial to treat patients with SARS-CoV-2/COVID-19 infection. I look forward to working with the team at Aethlon and its collaborators to continue to advance the science and in an effort to bring important treatments to patients and create value for shareholders."

"I’m proud to have led Aethlon for the past 2 years", said Dr. Rodell. "I am pleased to hand the reins to Chuck to lead the next phase of Aethlon’s growth, and I wish him and the leadership team every success."

Dr. Fisher commented, "On behalf of the Board of Directors, I want to thank Tim for his leadership, commitment and accomplishments as Chief Executive Officer. We wish him continued success in his future endeavors."

On November 3, 2020 Fountain Healthcare Partners ("Fountain") reported the Final Closing of its third fund, Fountain Healthcare Partners Fund III, L.P. ("Fund III") with €125 million of committed capital, exceeding its initial target raise of €100 million (Press release, Fountain Healthcare Partners, NOV 3, 2020, View Source [SID1234569786]). The Fund previously announced a First Closing at €118 million. The Final Closing includes the addition of Japan-based pharmaceutical and biotechnology company Kyowa Kirin Co., Ltd. ("Kyowa Kirin").

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Fund III is a dedicated life science venture capital ("VC") fund and brings Fountain’s total capital under management to €300 million. Within the life science sector, Fund III will primarily focus on therapeutics and medical devices.

The €125 million capital raised was sourced from major domestic and international institutional investors, including fund of funds, sovereign funds, corporate investors and family offices.

Fountain will invest a majority of the capital in Fund III within Europe but expects to also make investments in the US market. Fund III is expected to make up to 10 investments in predominantly private life science companies and has already completed three deals:

Mainstay Medical, developing a novel, implantable neuromodulation device to treat chronic lower back pain. In June 2020 the company received FDA approval for its ReActiv8 device in the US.
Inotrem, a biotechnology company focused on innate immunity whose lead asset nangibotide is in a Phase II clinical study for the treatment of sepsis.
Priothera, a Phase IIb/III clinical stage company developing a drug to reduce relapse and mortality rates in leukemia patients undergoing stem cell transplants.
Fountain also recently announced the following:

Roche’s acquisition of portfolio company Inflazome for €380 million ($450 million) upfront and undisclosed future milestone payments. Inflazome is a Phase II ready company with potential application in the area of inflammatory disease such as Parkinson’s, asthma, Alzheimer’s, COPD and osteoarthritis.
Bayer’s acquisition of portfolio company KaNDy Therapeutics for $425 million upfront and potential future milestone payments of $475 million. KaNDy is entering Phase III trials with an oral, once daily non-hormonal drug for menopause symptoms.
Dr Manus Rogan, co-Founder and Managing Partner at Fountain, commented:

"Fountain’s investment strategy focuses on building a balanced portfolio of companies with complementary risk and return profiles within the life science sector. This strategy has resulted in a strong portfolio of investments for both Fund I, Fund II and now Fund III. We are pleased to have now reached our Fund hard cap of €125 million and are delighted to welcome such a high calibre strategic investor as Kyowa Kirin to Fountain."

Aidan King, co-Founder and Managing Partner at Fountain, added:

"Life sciences continues to be one of the most attractive sectors for investors. Fountain has demonstrated the ability to identify companies in this sector that are developing transformative therapeutics and devices to address unmet medical needs and in doing so to generate attractive investment returns. We appreciate the support of Kyowa Kirin as we select the remaining companies for Fund III."

Takeyoshi Yamashita, Ph.D, Executive Officer, Director of Corporate Strategy & Planning at Kyowa Kirin, said:

"Fountain Healthcare Partners’ Fund III and its focus on innovative technologies and products that address high unmet medical needs, give us a fantastic opportunity to support start-ups and emerging companies in the life science sector. This investment underlines our shared ambition to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies."

On November 3, 2020 CURE Media Group reported that it has added the Lung Cancer Research Foundation, the Cutaneous Lymphoma Foundation and the Rare Cancer Research Foundation to its Strategic Alliance Partnership (SAP) program (Press release, CURE Media Group, NOV 3, 2020, View Source [SID1234569785]).

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"We are very pleased to expand our strategic alliance partnership program with these three amazing foundations," said Mike Hennessy Jr., president and CEO of MJH Life Sciences, parent company of CURE Media Group. "Each organization focuses on a different cancer community, but all share our goal of improving life and outcomes for cancer patients. We are proud to be working with each of them."

The Lung Cancer Research Foundation strives to improve lung cancer outcomes through funding research for prevention, diagnosis, treatment and cure of lung cancer. Over the last several years, the foundation has merged with other organizations to grow their reach and resources to continue fighting to improve the lives of those with lung cancer.

The Cutaneous Lymphoma Foundation, a nonprofit patient advocacy organization, is dedicated to promoting awareness of cutaneous lymphoma by providing education and fostering research on the disease. The organization aims to give patients the best quality of life possible at all stages of the disease.

The Rare Cancer Research Foundation’s mission is to cure rare cancers through investments and collaborations that facilitate effective research and accelerate deployment of promising therapies. The foundation has a growing roster of more than 200 organizations it works with to help develop cures for rare cancers. The foundation’s goal is for each rare cancer to have its own research and infrastructure.

The SAP program is a community of advocacy groups, medical associations and medical institutions that foster collaboration and an open exchange of information among trusted peers for the benefit of patients and their families. As part of this joint effort, CURE Media Group will work with the partners to share information and support the different cancer communities they support.

On November 3, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the quarter ended September 30, 2020 (Press release, Zymeworks, NOV 3, 2020, View Source [SID1234569784]).

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"Zanidatamab’s clinical development continued to expand this quarter, having opened new sites across the globe for the pivotal trial in HER2-amplified biliary tract cancers toward our first potential BLA submission," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "We are well-resourced to achieve this milestone for zanidatamab, along with advancing the development of ZW49 into expansion cohorts and beyond."

Third Quarter 2020 Business Highlights and Recent Developments

Zanidatamab Pivotal Trial Expands to Europe and Asia-Pacific Region
Sites are active and recruiting in North America, Europe, and Asia in the global pivotal trial of single agent zanidatamab in previously-treated HER2 gene-amplified biliary tract cancers. This study aims to support accelerated approval and may enable filing of a Biologics License Application (BLA) as early as 2022.
ZW49 Continues Dose Escalation
Zymeworks’ second clinical candidate, ZW49, a bispecific antibody-drug conjugate targeting HER2, continues to be evaluated across multiple dosing regimens in the dose-escalation portion of a Phase 1 clinical trial.
Zymeworks Implements Expanded Access Program (EAP) for Patients not Eligible for Existing Trials
Zymeworks’ EAP or Compassionate Use program will enable critically ill patients who are not eligible for the Company’s clinical trials and who may not have options for alternative therapies to be considered for access to Zymeworks’ pipeline of investigational medicines. More on Zymeworks’ EAP: View Source
First Patients Dosed in Investigator-Initiated Trial of Zanidatamab in Endometrial Cancers
Dr. Vicky Makker at Memorial Sloan Kettering Cancer Center is conducting a Phase 2 trial to evaluate single agent zanidatamab in HER2-overexpressed advanced endometrial cancers and carcinosarcomas. This study is expected to enroll up to 25 patients with the primary endpoint of assessing the overall response rate.
Financial Results for the Quarter Ended September 30, 2020

Revenue of $2.6 million for the three months ended September 30, 2020 related to research support and other payments from our partners. For the same period in 2019, revenue of $7.9 million included $7.5 million for a commercial license option milestone from BMS and $0.4 million in research support payments from our partners.

Research and development expenses were $53.5 million for the three months ended September 30, 2020 compared to $29.3 million for the same period of 2019. The increase related primarily to additional clinical trial activities and associated drug manufacturing for zanidatamab as well as an increase in internal headcount. Expenses also increased during this period due to higher development activity for ZW49, licensing and milestone payments and stock-based compensation expense. Research and development expenses included non-cash stock-based compensation expense of $6.0 million comprised of $3.6 million from equity-classified awards and $2.4 million related to the non-cash mark-to-market revaluation of certain historical liability-classified awards.

General and administrative expenses were $22.8 million for the three months ended September 30, 2020 compared to $12.2 million for the same period in 2019. The change was primarily due to an $8.1 million increase in non-cash stock-based compensation expense. Expenses also increased during this period due to higher headcount and insurance expenses. General and administrative expenses included non-cash stock-based compensation expense of $12.6 million comprised of $4.4 million from equity-classified awards and a $8.2 million expense related to the non-cash mark-to-market revaluation of certain historical liability-classified awards.

Net loss for the three months ended September 30, 2020 was $72.6 million as compared to $30.5 million for the same period of 2019. This was primarily due to the increases in research and development expenses and general and administrative expenses referred to above as well as lower revenue recognized during current period.

Zymeworks expects research and development expenditures to increase over time in line with the advancement and expansion of the Company’s clinical development of its product candidates, as well as its ongoing preclinical research activities. Additionally, Zymeworks anticipates continuing to receive revenue from its existing and future strategic partnerships, including technology access fees and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

As of September 30, 2020, Zymeworks had $497.0 million in cash resources consisting of cash, cash equivalents, short-term investments and certain long-term investments.

On November 3, 2020 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will provide an overview of the Company at 1:15 p.m. EST on Tuesday, November 10, at the Credit Suisse 29th Annual Healthcare Conference (Press release, Puma Biotechnology, NOV 3, 2020, View Source [SID1234569783]). The conference will be held virtually.

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A live webcast of the presentation will be available on the Company’s website at www.pumabiotechnology.com. The presentation will be archived on the website and available for 30 days.