Incyte to Report Third Quarter Financial Results

On October 11, 2018 Incyte Corporation (Nasdaq:INCY) reported that it has scheduled its third quarter 2018 financial results conference call and webcast for 8:00 a.m. ET on Tuesday, October 30, 2018 (Press release, Incyte, OCT 11, 2018, View Source [SID1234529863]).

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The schedule for the press release and conference call/webcast is as follows:

Q3 2018 Press Release: October 30, 2018 at 7:00 a.m. ET

Q3 2018 Conference Call: October 30, 2018 at 8:00 a.m. ET

Domestic Dial-In Number: 877-407-3042

International Dial-In Number: 201-389-0864

Conference ID Number: 13683637

If you are unable to participate, a replay of the conference call will be available for thirty days. The replay dial-in number for the U.S. is 877-660-6853and the dial-in number for international callers is 201-612-7415. To access the replay you will need the conference ID number 13683637.

The live webcast with slides can be accessed at www.incyte.com under For Investors, Events and Presentations and will be available for replay for 30 days.

West to Host Third-Quarter 2018 Conference Call

On October 11, 2018 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release third-quarter 2018 financial results before the market opens on Thursday, October 25, 2018, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, OCT 11, 2018, View Source [SID1234529864]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 8341499.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the site three hours after the live call and will be available through Thursday, November 1, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 8341499.

Spherix to Merge with CBM BioPharma Pharmaceutical Company

On October 11, 2018 Spherix Incorporated (Nasdaq: SPEX) reported that it has entered into a merger agreement with CBM BioPharma, Inc. ("CBM") that will transform Spherix into an innovative pharmaceutical company with pioneering drugs and treatments focused on the multibillion dollar oncology therapeutics market.

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CBM is a privately held pharmaceutical company with exclusive drug development rights from world-renowned partners including Wake Forest Innovations and the University of Texas at Austin. CBM has a team of leading drug development scientists who will be joining Spherix as advisors to advance the technology. The CBM platform focuses on the treatment of numerous cancers, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), and pancreatic cancer.

Two specific proprietary drugs that are currently being researched are:

KPC34 (Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia)

Developed at Wake Forest School of Medicine, AML and ALL drug, KPC34, is a next generation treatment designed to overcome multiple resistance challenges observed with the current standard of care. KPC34 has also been shown to be more effective in AML relapse cases, notably increasing the lifespan of mice treated with the drug.

One competitive benefit of KPC34 includes its ability to be orally administered. This is critical for patients that are unable to tolerate repeated cycles of chemotherapy. In addition, it has served to double the mean survival time versus the current standard of care treatments in a mouse model of leukemia.
DHA-dFdC (Pancreatic Cancer Drug)

Developed at the University of Texas at Austin, DHA-dFdC has shown positive results in preclinical studies, inhibiting pancreatic tumor growth in clinically relevant transgenic mouse models. DHA-dFdC also overcomes tumor cell resistance to current chemotherapeutic drugs. Pancreatic cancer is a deadly disease that affects millions of people around the world.

The following doctors will be supporting the efforts of Spherix, after the completion of the merger:

Dr. Timothy S. Pardee, MD, PhD, an Associate Professor of Internal Medicine, Section on Hematology and Oncology and Cancer Biology and Director of Leukemia Translational Research at Wake Forest School of Medicine. Dr. Pardee stated, "I am very excited at the possibility of bringing KPC34 to the clinic in early phase clinical trials. As a physician scientist who treats acute leukemia patients, I know firsthand the clear unmet medical need for relapsed patients."

Dr. Gregory Kucera, a Professor of Internal Medicine at the Wake Forest University School of Medicine with over 28 years of research experience on novel therapeutics for cancer treatment. His laboratory has expertise in synthesizing therapeutics, lipid biochemistry, and in vitro drug testing. Dr. Kucera stated, "As a research scientist, the satisfaction of seeing a compound like KPC34 go from the laboratory to an early stage clinical trial is immense. I have a great sense of pride in knowing that the work done by our research team has produced a drug that may benefit cancer patients in the very near future."

Joining Spherix as Chief Science Officer to oversee clinical advancement of these drugs is Dr. Tom Wilkie who is an Associate Professor of Pharmacology at the University of Texas Southwestern Medical Center in Dallas. He earned both his BA at the University of California Berkeley and his PhD with Richard Palmiter at UW Seattle, in biochemistry. Wilkie has published 74 primary research papers and reviews, serves on NIH, CIRM, and AACR (Free AACR Whitepaper) grant review study sections. He reviews manuscripts for multiple journals, and is Director of the first-year graduate student core course at UT Southwestern.

Dr. Wilkie stated, "I’m delighted to join Spherix as Chief Science Officer. The agreement between Spherix Incorporated and CBM BioPharma will advance the exciting potential for improving the lives of patients, family, friends, and ultimately, all of us. Proposals for the next phase of testing are underway."

Dr. Robert J. Vander Zanden, Spherix’s Chairman of the Board, stated, "Spherix is extremely pleased to announce this merger with CBM, as we believe it serves as a necessary step in our transition to a diversified biopharmaceutical company. This deal builds upon our investment in Hoth Therapeutics, which owns several exciting assets in various stages of development."

Anthony Hayes, CEO of Spherix stated, "We are very excited to welcome CBM BioPharma and its team to Spherix. It is an exciting and transformational time for the Company. Spherix will pay $16.5 million in stock for 100% of CBM by issuing 15 million Spherix shares to CBM at a fixed price of $1.10 per share. I look forward to sharing more information with our shareholders about the merger in the upcoming weeks, via investor outreach and our upcoming SEC filings."

Kitov Appoints Gil Efron as Deputy Chief Executive Officer and Chief Financial Officer

On October 11, 2018 Kitov Pharma (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company, reported the appointment of Gil Efron as the Company’s new Deputy Chief Executive Officer and Chief Financial Officer (Press release, Kitov Pharmaceuticals , OCT 11, 2018, View Source [SID1234530234]). Simcha Rock, who has served as Kitov’s Chief Financial Officer since 2013, will retire from that position following a transition with Mr. Efron, and will continue to serve on the Company’s Board of Directors and as a strategic advisor.

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"On behalf of the entire Board and management team at Kitov, I am immensely grateful to Simcha Rock for his dedication and valuable contributions to Kitov since its inception, including playing a key role in the growth of our business and leading our initial public offering on the NASDAQ. I am deeply appreciative that Simcha will remain with Kitov to help facilitate a smooth leadership transition, and we are pleased to continue to benefit from his expertise and strategic advice. We all wish him all the best in his retirement," stated Kitov CEO, Isaac Israel. "We are fortunate to be able to welcome Gil Efron, a highly regarded and seasoned public company executive, into the Deputy CEO and CFO position."

Gil Efron brings over 25 years of experience in public company and financial management positions. Most recently, he served as Deputy CEO and CFO of Kamada, a NASDAQ and TASE dual-listed plasma-derived protein therapeutics company. Previously, he was CFO of NASDAQ listed RRsat Global Communications LTD where he led its listing on NASDAQ; prior to that Mr. Efron served in various finance executive positions. Mr. Efron holds a BA degree in Economics and Accounting and an MA degree in Business Administration from the Hebrew University of Jerusalem, and was granted a certified public accountant’s license in Israel.

"Gil has proven his leadership and business acumen in the biotech space. He played a key role in building Kamada into a leading, profitable, international biopharmaceutical company with over $100 million in annual revenues, where he led Kamada’s IPO on NASDAQ," Isaac Israel said.

"Following the recent FDA approval of our lead drug, Consensi, Kitov is well positioned to benefit from Gil’s experience and skills in growing biotech companies from the clinical trial phase into successful commercialization networks and profitability," Isaac Israel concluded.

Gil and Simcha will work together in the coming months until the complete transition of responsibilities, which is planned by year-end.

Immune Design Announces Program Updates & Portfolio Prioritization for G100 and CMB305

On October 11, 2018 Immune Design (Nasdaq: IMDZ), an immunotherapy company focused on next-generation therapies in oncology, reported program updates for its G100 intratumoral TLR4 agonist and CMB305 cancer vaccine programs in development for the treatment of cancer (Press release, Immune Design, OCT 11, 2018, View Source [SID1234530255]).

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The company has completed a portfolio review and determined that, given advances in G100 and its broad potential, new CMB305 data, and existing capital, it should focus on accelerating and expanding the development of G100.

G100 has a unique mechanism of action that differs from current therapies in lymphoma. It triggers an immune-mediated anti-tumor effect with a favorable safety profile that could position G100 as a pillar of chemo-free regimens for the treatment of lymphomas and beyond.

Immune Design’s first goal is to develop G100 in combination with pembrolizumab in follicular lymphoma patients who have received three prior lines of systemic therapy. These patients may represent an unmet medical need, which may allow for an accelerated approval path in this indication.

The company will evaluate the clinical activity based on Objective Response Rate (ORR) in an open label setting.

To accelerate enrollment, Immune Design plans to use both an open IND and submit a new IND for this specific unmet medical need population, as requested by the FDA.

The data from both INDs would be combined in a potential BLA filing.

Based on existing ORR data, approximately 100 patients may be required. The final sample size will be adapted depending on the ORR observed in the initial patients.

Given its broad potential reach, Immune Design’s second goal is to evaluate G100 beyond late-stage follicular lymphoma.

Immune Design intends to evaluate G100 in earlier-stage follicular lymphoma patients in combination with rituximab, the backbone treatment for lymphomas in multiple lines of therapy.

The company also plans to explore G100 in combination with other agents in both indolent and aggressive lymphomas that are known to express TLR4.

Finally, the company plans to evaluate the safety and efficacy of G100 in solid tumors, initially through supporting investigator-sponsored studies.

Based on a recent review of the CMB305 program, including an early analysis of the ongoing Phase 2 study that showed the combination of CMB305 and Tecentriq (atezolizumab) is not likely to show a survival benefit in relapsed synovial sarcoma patients, the company has decided to discontinue the SYNOVATE trial. Immune Design will seek external collaborations to explore the continued development of CMB305 in sarcoma.

This portfolio prioritization and an associated company re-structuring extends Immune Design’s cash runway into 2021, which enables significant potential value creation from the focus on, and expanded development of, G100.

Conference Call Information

Immune Design will host a conference call and live audio webcast this afternoon at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss these program updates.

The live call may be accessed by dialing (844) 266-9538 for domestic callers and (216) 562-0391 for international callers. A live webcast of the call will be available online from the investor relations section of the Immune Design website at View Source and will be archived there for 30 days. A telephone replay of the call will be available for five days by dialing (855) 859-2056 for domestic callers or (404) 537-3406 for international callers and entering the conference code 7095731.

An archived copy of the webcast will be available on Immune Design’s website beginning approximately two hours after the conference call. Immune Design will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.