On November 4, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported strategic actions to reposition the Company with a focus solely on its ENHANZE drug delivery technology (Press release, Halozyme, NOV 4, 2019, View Source [SID1234550258]).

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In order to implement this strategic shift, Halozyme will immediately initiate an organizational restructuring to halt development activities for PEGPH20 and close its oncology operations. As a result, Halozyme expects the following:

Headcount will be reduced by approximately 55%, or approximately 160 positions, with over 80% of the reduction completed in early January 2020.
Restructuring and other cost saving efforts will result in savings of $130 to $140 million in 2020 compared with the Company’s most recent guidance for 2019 operating expenses excluding cost of goods sold.
Upon completion of the restructuring and after booking all related one-time charges, Halozyme anticipates becoming a sustainably profitable company beginning in the second quarter of 2020.
Projected annualized operating expenses excluding cost of goods sold of between $65 million and $75 million will be achieved by the fourth quarter of 2020.
The Company expects to book separation and contract termination fees in the fourth quarter of 2019 and will provide further details during its third quarter 2019 financial results webcast and conference call on Tuesday, November 12.

The go-forward organization will comprise approximately 120 employees focused on driving the continued growth of ENHANZE, specifically in areas that are critical to supporting partners such as manufacturing, quality, regulatory and product development. An additional 12 employees will continue promoting the Company’s commercial drug Hylenex.

The Company’s ENHANZE business continues to grow with three commercial products and 11 products currently in clinical trials. Halozyme will provide a more detailed update for its ENHANZE business during its third quarter financial results webcast and conference call.

Halozyme’s Board of Directors has also authorized the initiation of a capital return program to repurchase up to $350 million of the Company’s outstanding common stock over the next three years. The timing of share repurchases and the number of shares of common stock that are repurchased will depend on market conditions and other factors. Repurchases may be commenced or suspended at any time or from time-to-time at the Company’s discretion without prior notice. Repurchases may be made through both public market and private transactions. The Board will regularly review this capital return policy in connection with a balanced capital allocation strategy.

"Our mission now is to transition our strategy to focus on our high-growth, high-margin ENHANZE drug delivery technology platform," said Dr. Helen Torley, president and CEO of Halozyme. "Our ENHANZE business is well positioned for this growth, supported by strong partnerships with leading brands and a promising development pipeline. As a result, Halozyme now has a clear path to near-term, sustainable profitability with strong cash flows and high growth prospects. In addition, our share repurchase program reflects our continued commitment to creating value for our shareholders and to implementing a capital return philosophy aligned with our new company profile."

Dr. Torley continued, "The results of the well-designed and well-executed HALO-301 study were not what we wanted or expected. I wish to extend my deep appreciation for all who supported this study and made it possible, in particular the patients, their families, our investigators and their staff, our investors and the Halozyme team."

The actions taken by the Company follow the results of its HALO-301 Phase 3 clinical study, which were disclosed in a separate press release issued today.

Conference Call and Webcast Information
Halozyme will webcast a conference call today at 8:30 a.m. ET / 5:30 a.m. PT to discuss its plans to focus strategy on its ENHANZE drug delivery technology. Dr. Helen Torley, president and chief executive officer, will lead the call, which will be webcast live through the "Investors" section of Halozyme’s corporate website and a replay will be available following the close of the call. To access the webcast, please visit www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 824-0907 (domestic callers) or (647) 689-5655 (international callers) using passcode 3069304. A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 3069304.

On November 4, 2019 Mateon Therapeutics, Inc. (OTCQB:MATN) (‘Mateon") reported that they have completed their acquisition of PointR Data Inc. (PointR), a privately-held, developer of high performance cluster computer and artificial intelligence technologies (Press release, Mateon Therapeutics, NOV 4, 2019, View Source [SID1234550276]). This will create a publicly traded artificial intelligence ("AI") and blockchain driven immuno-oncology company to apply machine learning and AI approaches to its pipeline of first in class TGF-β immunotherapies for late stage cancers such as gliomas, pancreatic cancer and melanoma.

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Leveraging its deep partnership with IBM, the PointR team will combine its own AI Vision technology with industry standard Blockchain to transform drug manufacturing and real-world evidence monitoring for clinical trials. The combined system has the potential to automatically record individual key steps in cGMP manufacturing operations including the flow of people, raw materials and operations in trusted perpetual blockchain ledgers that are indisputable. This has the potential to create much more efficient GMP manufacturing operations while simultaneously improving reliability and data security.

As the result of the acquisition, Saran Saund, former CEO of PointR, will assume the role of Chief Business Officer (CBO)/ General Manager of AI Division at Mateon and Burcak Beser, former CTO of PointR, will assume the role of Sr. VP/CTO of AI Division at Mateon.

Silicon Valley entrepreneur, Saran has been founder, CEO and GM at startups and public companies. Passionate about applying technology innovations to real world markets, he successfully founded an AI consortium to accelerate enterprise adoption of AI which engaged leading universities and technology vendors. A startup veteran, his track record includes senior leadership roles at companies that were acquired by leaders such as Marvell (MRVL) and Qualcomm (QCOM). His startup Cybercash (CYCH) had a successful IPO on NASDAQ. Saran started his career at Xerox PARC pushing 1’s and 0’s as a software engineer.

In the last 20 years, as a Silicon Valley technologist, Burcak has founded startups and established multi-site cross-organizational teams that led to designs and deployments of world-class systems. With 144 patent applications, of which 88 have been issued, Burcak’s innovative solutions are connecting billions of people in the world together. Passionate about AI, he sees working on AI as an opportunity to solve problems that were considered insurmountable. Burcak spends most of his time building systems to make these solutions a reality. He finished his Masters in Artificial Intelligence in 1991, winning the best thesis-of-the-year award and highest honors.

"The PointR acquisition is clearly transformative for Mateon Therapeutics," said Vuong Trieu, Ph.D., Chairman and Chief Executive Officer of Mateon. "We welcome the addition of Saran Saund and Burcak Beser to our management team, their engagement greatly enhances our ability to move forward as the biotech company of the future."

"With the completion of the acquisition of PointR, we will be working hard at the commercialization and monetization of PointR Data technologies," said Saran Saund, CBO of Mateon, "Since the signing of the definitive agreement in August, we have been exploring implementation of AI and Blockchain technologies into Mateon’s workflow – in particular the application of PointR Data Vision AI in pharmaceutical manufacturing and patient monitoring. We look forward to announcing multiple collaborations in the near future."

Leading Silicon Valley VC and Chairman of PointR, Balaji Baktha said, "The traditional drug discovery process can take up to a decade of development timeline costing over a billion dollars and yet has a track record of a 90 percent failure rate for new drugs entering clinical development. AI and blockchain technologies can dramatically improve the process and help millions of under-served patients. This merger promises to transform the industry by reducing the overall timelines and costs."

On November 4, 2019 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biopharmaceutical company creating a new class of drugs based on targeted protein degradation, reported financial results for the third quarter of 2019 and provided a corporate update (Press release, Arvinas, NOV 4, 2019, View Source [SID1234550226]).

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"We recently became the first company to present clinical data on a targeted protein degrader, sharing initial data on our first two oncology programs. In addition, we shared preclinical data demonstrating that brain-penetrant PROTAC protein degraders could degrade pathologic tau in vivo, further demonstrating the potential of our PROTAC platform," said John Houston, Ph.D., Chief Executive Officer of Arvinas. "We look forward to the continued progress of our lead programs and pipeline, and ultimately to making a difference in the lives of patients."

Business Highlights and Recent Developments

Presented initial data from the company’s ongoing Phase 1 clinical trials of ARV-110 and ARV-471. The initial data showed dose proportionality for ARV-110 and that exposures of both ARV-110 and ARV-471 have reached levels associated with tumor growth inhibition in preclinical studies. In addition, both ARV-110 and ARV-471, at each dose tested to date, were well tolerated, with no dose-limiting toxicities and no observed grade 2, 3, or 4 adverse events related to treatment.
Presented preclinical data from the company’s alpha-synuclein (a-synuclein)-targeted PROTAC protein degrader program. The data showed that the company has created a-synuclein-targeted degraders that degrade oligomeric a-synuclein. In addition, the company has created a-synuclein-targeting PROTAC protein degraders that cross the blood-brain barrier following parenteral (peripheral) administration.
Announced that six new oncology and neurology thought leaders in the areas of oncology and neurological disorders have joined the company’s scientific advisory board (SAB). The new members are Tomasz M. Beer, M.D., F.A.C.P., Adam L. Boxer, M.D., Ph.D., Sara Courtneidge, Ph.D., Lennart Mucke, M.D., Benjamin G. Neel, M.D., Ph.D., and Lillian L. Siu, M.D. For full details on our new SAB members, visit www.arvinas.com.
Initiated patient dosing in its ongoing Phase 1 clinical trial of ARV-471, which is evaluating the safety, tolerability, and pharmacokinetics of ARV-471 in patients with locally advanced or metastatic ER positive / HER2 negative breast cancer.
Anticipated Milestones and Expectations

For the ARV-110 program, Arvinas expects to next share completed Phase 1 dose escalation clinical data in the first half of 2020.
For the ARV-471 program, Arvinas expects to next share clinical data in the second half of 2020.
Financial Guidance

Based on its current operating plan, Arvinas expects its cash, cash equivalents, and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into the second half of 2021.

Financial Highlights

Cash, Cash Equivalents, and Marketable Securities Position: As of September 30, 2019, cash, cash equivalents, and marketable securities were $190.5 million as compared to $187.8 million as of December 31, 2018. The increase in cash, cash equivalents and marketable securities of $2.7 million in the first nine months of 2019 primarily related to aggregate proceeds of $51.5 million from a collaboration and license agreement with Bayer and the issuance of common stock to Bayer, partially offset by the purchase of lab equipment and leasehold improvements of $4.5 million and cash used to fund operations of $49.7 million.

Research and Development Expenses: Research and development expenses were $16.6 million for the quarter ended September 30, 2019, as compared to $13.1 million for the quarter ended September 30, 2018. The increase in research and development expenses for the quarter primarily related to expenses associated with our ongoing Phase 1 clinical trial of ARV-110 and the initiation of our Phase 1 clinical trial of ARV-471 as well as increased personnel and other expenses related to our platform research and exploratory programs research.

General and Administrative Expenses: General and administrative expenses were $8.0 million for the quarter ended September 30, 2019, as compared to $4.3 million for the quarter ended September 30, 2018. The increase in general and administrative expenses for the quarter was primarily related to increased employee expenses and other compliance costs associated with becoming a public company in the fourth quarter of 2018.

Revenues: Revenue was $30.1 million for the quarter ended September 30, 2019, as compared to $3.4 million for the quarter ended September 30, 2018. Revenue for the quarter ended September 30, 2019 included $24.7 million of revenue recognized from the Arvinas contribution of the license to the joint venture between Bayer and Arvinas to pursue the PROTAC technology in agricultural applications (the "Joint Venture"). The remaining revenue of $5.4 million for the quarter was generated from the license and rights to technology fees and research and development activities related to the collaboration and license agreement with Bayer that was initiated in July 2019, the collaboration and license agreement with Pfizer that was initiated in January 2018, and the amended and restated option, license and collaboration agreement with Genentech that was initiated in November 2017.

Loss from Equity Method Investment: Loss from equity method investment for the quarter ended September 30, 2019 was $24.7 million, which related to the loss from the equity method investment in the Joint Venture. The loss was generated from the Joint Venture’s expensing the values associated with the contributed intellectual property from the Joint Venture partners.

Net Loss: Net loss was $17.7 million for the quarter ended September 30, 2019, as compared to $13.4 million for the quarter ended September 30, 2018. The increased revenue that related to the Joint Venture was offset by the loss from equity method investment in the Joint Venture for the quarter ended September 30, 2019 and as such, the increase in net loss for the quarter was primarily due to increased research and development expenses and increased general and administrative expenses.

About ARV-110
ARV-110 is an orally-bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). Arvinas’ Phase 1 trial of ARV-110 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

ARV-110 has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

About ARV-471
ARV-471 is a PROTAC protein degrader designed to specifically target and degrade the estrogen receptor (ER) for the treatment of women with metastatic breast cancer. Arvinas’ Phase 1 trial of ARV-471 will assess its safety, tolerability, and pharmacokinetics, and will also include measures of anti-tumor activity and pharmacodynamic readouts as secondary endpoints.

In preclinical studies, ARV-471 demonstrated near-complete ER degradation in tumor cells, induced robust tumor shrinkage when dosed as a single agent in multiple ER-driven xenograft models, and showed superior anti-tumor activity as a single agent and in combination with a CDK4/6 inhibitor when compared to a standard of care agent, fulvestrant (as a single agent and in combination with a CDK4/6 inhibitor).

On November 4, 2019 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a biotechnology company focused on developing cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that it is closer to submitting an Investigational New Drug application (IND) to the U.S. Food & Drug Administration (FDA) (Press release, PharmaCyte Biotech, NOV 4, 2019, View Source [SID1234550242]). PharmaCyte and its partner, Austrianova Singapore (Austrianova), has successfully completed encapsulation of the cells from PharmaCyte’s Master Cell Bank (MCB) in the second of two staggered and back-to-back manufacturing runs for the production of PharmaCyte’s clinical trial product. This product will be used for PharmaCyte’s planned clinical trial in patients with locally advanced, inoperable pancreatic cancer (LAPC).

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PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, commented, "The encapsulation process was performed last week at Austrianova’s manufacturing facility in Thailand. After reviewing the first pictures of the encapsulated cells, we’re confident that this manufacturing run is progressing as well as our first successful manufacturing run.

"We are anxiously awaiting the completion of the second of the two back-to-back manufacturing runs and the results from the FDA required testing on each of those runs. Once the information from that testing is available, it will be incorporated into our Investigational New Drug application (IND) for submission to the FDA."

Most of the work needed for PharmaCyte to submit an IND to the FDA has been completed. The rate limiting factor is and always has been for Austrianova to complete successfully two back-to-back manufacturing runs. During PharmaCyte’s recent shareholder update call, the company reported on Austrianova’s work to encapsulate successfully PharmaCyte’s genetically modified human cells that will be used to treat patients suffering from LAPC.

After months of extensive research and development (R&D) by a team of experts from Austrianova and PharmaCyte, a total of eight different changes were made to the manufacturing process. It was not until the eighth and final change was made that the encapsulated cells grew as well in Austrianova’s manufacturing facility in Thailand as they grew at Austrianova’s R&D facility in Singapore.

Once the recently encapsulated cells in this second of two manufacturing runs have completely filled the capsules, they will be placed into PharmaCyte’s clinical trial syringes and then frozen. A representative sample of those syringes will be thawed and undergo the FDA required "release testing." All "release testing" related to safety of the encapsulated cells is being outsourced by PharmaCyte to independent third-party laboratories in Europe. All "release testing" related to functionality of the encapsulated cells is being handled by Austrianova at its GMP facility in Thailand.

To learn more about PharmaCyte’s pancreatic cancer treatment and how it works inside the body to treat locally advanced inoperable pancreatic cancer, the company encourages you to watch its documentary video complete with medical animations at: View Source

On November 4, 2019 RhoVac AB ("RhoVac") reported that the first patient has been screened for the company’s clinical phase IIb study in prostate cancer, a study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, NOV 4, 2019, View Source [SID1234550259]). The screening took place at the Odense University Hospital.

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BRaVac is a randomized, placebo-controlled and double-blinded study in prostate cancer, with the primary end-point of evaluating if and to what extent treatment with the drug candidate RV001 can prevent or limit the development of cancer measured as a more limited development of PSA (prostate specific antigen) in treated patients compared to the control group (placebo group). The clinical phase IIb study is an international, multicenter study, which is expected to recruit over 175 patients in six European countries (Denmark, Finland, Sweden, United Kingdom, Belgium and Germany), as well as the United States. The first patient is now screened for the study and the ambition is that all patients will be recruited in Q3 2020. The study results on the primary end-points are expected to be reported in 2021.

Anders Ljungqvist, COO: "It has been a challenge to start this large clinical phase IIb study in the summer holiday period, and it is therefore particularly gratifying that the first patient is now screened at Odense University Hospital. Other clinical sites in Denmark are ready to screen patients and Finland is the next country to open up for screening."

Anders Månsson, CEO: "The last few months have been very intense at RhoVac – we have received approval from the Danish authorities to start the clinical phase IIb study, and FDA has also stated, in a pre-IND, a positive opinion on starting the clinical phase IIb trial in the United States. We have also received approval to start the study in Finland. In addition, only a few months ago we completed a new rights issue that will fund the current clinical study, and we applied for and also received a grant of EUR 2.5 million from the EU Research and Innovation Fund Horizon2020. In July 2019, we presented the 12-month follow-up study from the clinical phase I/II-study showing good and stable results over time. The fact that we now have screened our first patient for the clinical phase IIb trial is an extremely important milestone for RhoVac! I would also like to extend my gratitude to all employees and consultants who have worked tirelessly to take the project to the point where it is today. Phase IIb is extremely well prepared, and with this, RhoVac is entering its last development phase, and as a result of this the partnering discussions will advance further."