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Fountain Healthcare Partners Announces Final Close of €125 million for Fund III

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."

CURE Media Group Expands Strategic Alliance Partnership Program With 3 New Partners

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]).

"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.

Zymeworks Reports 2020 Third Quarter Financial Results

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]).

"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.

Puma Biotechnology to Present at the Credit Suisse 29th Annual Virtual Healthcare Conference

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.

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.

Five Prime Therapeutics Reports Third Quarter 2020 Results

On November 3, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported results for the third quarter of 2020 in addition to providing an update on the company’s recent activities (Press release, Five Prime Therapeutics, NOV 3, 2020, View Source [SID1234569782]).

"We look forward to achieving three milestones before the end of the year that will inform future development of our pipeline," said Tom Civik, Chief Executive Officer of Five Prime Therapeutics. "Before year end, we expect to report top-line data from the FIGHT Phase 2 trial in front-line gastric cancer. We also expect to have enough FPT155 monotherapy data to inform next steps for the program, and we will present the first data set from our anti-CCR8 program at the upcoming SITC (Free SITC Whitepaper) annual meeting. The Five Prime team has done an excellent job advancing our clinical and research programs despite the many challenges we have all confronted this year."

Third Quarter 2020 Milestones

Clinical Pipeline:

Bemarituzumab (anti-FGFR2b) is a first-in-class isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) being studied in the FIGHT trial as a targeted therapy for front-line FGFR2b+/HER2- gastric and gastroesophageal junction (GEJ) cancer.

The company expects to report top-line data before year end from the double-blind Phase 2 FIGHT study where all 155 patients receive standard mFOLFOX6 chemotherapy and are randomized to receive bemarituzumab or placebo.
The primary endpoint of the Phase 2 FIGHT trial is progression-free survival (PFS), and a secondary endpoint is overall survival (OS).
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion protein that directly engages CD28 and binds to CTLA-4, promoting CD8 T cell activation in the tumor microenvironment.

Patients with warm/hot tumor types continue to be enrolled at the 560mg dose in the ongoing Phase 1a/1b trial, with the aim of generating early clinical data at a potentially active dose to determine next steps for this program.
The first cohort has been cleared and the second cohort is open for enrollment in a dose escalation of FPT155 and pembrolizumab in patients with non-small cell lung cancer.
FPA157 (anti-CCR8) is a novel antibody directed to CCR8, a promising immuno-oncology target that is expressed by a highly immunosuppressive population of T regulatory cells within tumors. Eliminating CCR8-expressing T regulatory cells is anticipated to reduce immunosuppression in the tumor microenvironment and promote development of anti-tumor responses.

The company’s FPA157 late-breaking abstract has been accepted for a poster presentation at the 2020 Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
The company expects to submit an IND application for this program in the first half of 2022.
Summary of Third Quarter 2020 Financial Results and Cash Guidance:

Cash Position: Cash, cash equivalents and marketable securities totaled $112.9 million as of September 30, 2020 compared to $157.9 million as of December 31, 2019. This decrease was primarily attributed to quarterly operating expenses that exceeded quarterly revenues.

Revenue: Collaboration and license revenue for the third quarter of 2020 decreased by $0.9 million, or 31%, to $2.0 million from $2.9 million for the third quarter of 2019. The decrease was primarily the result of a reduction in revenue pursuant to progress achieved toward satisfying performance obligations under the company’s November 2014 cabiralizumab collaboration agreement with BMS. The decrease was partially offset by higher collaboration revenue from Zai Lab that resulted from the company’s decision to amend the FIGHT trial to a Phase 2 design.

R&D Expenses: Research and development expenses for the third quarter of 2020 decreased by $5.5 million, or 20%, to $21.4 million from $26.9 million for the third quarter of 2019. The decrease was primarily due to lower compensation costs resulting from the October 2019 restructuring, lower clinical trial expense and manufacturing costs, along with lower allocated costs, bioanalytics and central lab costs, and a decrease in costs related to preclinical programs. These reductions were partially offset by an impairment charge on right-of-use assets and other fixed assets related to the sublease of a portion of the company’s facility, as well as an increase in companion diagnostics costs related to bemarituzumab.

G&A Expenses: General and administrative expenses for the third quarter of 2020 increased by $0.5 million, or 4%, to $13.7 million from $13.2 million for the third quarter of 2019. The increase was primarily due to an impairment charge taken in the third quarter on the right-of-use asset and other fixed assets related to the sublease of a portion of the company’s facility, as well as higher allocated costs that were offset by lower compensation, depreciation, and other miscellaneous general and administrative costs.

Net Loss: Net loss for the third quarter of 2020 was $26.4 million, or $0.74 per basic and diluted share, compared to a net loss of $36.1 million, or $1.03 per basic and diluted share, for the third quarter of 2019.

Shares Outstanding: Total shares outstanding were 35,620,167 as of September 30, 2020.

Cash Guidance: Five Prime expects full-year 2020 net cash used in operating activities to be between $70 and $75 million and has raised guidance to end 2020 with cash, cash equivalents and marketable securities between $100 and $105 million.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 7757227. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.