On August 3, 2018 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that it will release second quarter 2018 and six months ended June 30, 2018 earnings results on August 14, 2018 before the market opens (Press release, Athenex, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361991 [SID1234528634]). The Company will host a conference call and live audio webcast on Tuesday, August 14, 2018 at 9:00 a.m. Eastern Time to discuss the financial results and provide a business update.

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To participate in the call, dial 877-407-0784 (domestic) or 201-689-8560 (international) fifteen minutes before the conference call begins and reference the conference passcode 13682063. A replay of the call will be accessible two hours after its completion through August 21 by dialing 844-512-2921 (in the U.S.) or 412-317-6671 (outside the U.S.) and entering passcode 13682063. The live conference call and replay can also be accessed via audio webcast at the Investor Relations section of the Company’s website, located at www.athenex.com.

On August 3, 2018 Trovagene, Inc. (NASDAQ: TROV), a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of leukemias, lymphomas and solid tumor cancers, reported company highlights and financial results for the second quarter ended June 30, 2018 (Press release, Trovagene,AUG 3, 2018, View Source [SID1234528423]). The company is issuing this press release in lieu of conducting a conference call.

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Trovagene is a clinical-stage oncology therapeutics company, developing targeted therapeutics for the treatment of solid tumor cancers and leukemias/lymphomas.

"We are continuing to advance our clinical development of PCM-075 in Acute Myeloid Leukemia (AML) and metastatic Castration-Resistant Prostate Cancer (mCRPC), achieving several key milestones during the second quarter," said Tom Adams, Executive Chairman of Trovagene. "In our AML trial, we have successfully completed treatment of 10 patients with PCM-075, 6 at the first dose level of 12 mg/m2 and 4 at the second dose level of 18 mg/m2, in combination with either low-dose cytarabine (LDAC) or decitabine. I’m also pleased to report that we received Investigational Review Board (IRB) approval for our Phase 2 trial of PCM-075 in combination with abiraterone acetate (Zytiga) in patients with mCRPC from the Harvard Medical Cancer Centers and patient recruitment is underway."

During the second quarter of 2018 the Company has advanced its business with the following activities:

Announced Preliminary Clinical Data from First Dosing Cohort Demonstrating Durable Treatment Effect of PCM-075 in Combination with Cytarabine or Decitabine in Patients with Relapsed or Refractory AML
On June 27, 2018, Trovagene announced preliminary clinical data from the first dosing cohort showing a treatment effect with PCM-075 in combination with low-dose cytarabine (LDAC) or decitabine, as measured by decreases in leukemic cells in both peripheral blood and bone marrow in patients in its ongoing Phase 1b/2 trial in relapsed or refractory Acute Myeloid Leukemia (AML). Both blood and bone marrow samples were obtained from patients with relapsed or refractory AML enrolled in the Phase 1b/2 trial prior to, and at timepoints following administration of PCM-075, in combination with cytarabine or decitabine. Among the 6 patients evaluated, no dose-limiting toxicities (DLTs) were observed that would prohibit further escalation of the PCM-075 dosing. Three patients exhibited substantial reductions in the percentage of both circulating leukemic cells within the blood and leukemic cells within the bone marrow. Two of these three patients continued on treatment in the second cycle and further decreases in circulating leukemic cells in the blood and within the bone marrow were observed. One patient had a decrease in his bone marrow blasts from 96% to 40% at the end of cycle 2 and has continued on treatment in cycle 3.
Announced the Start of Recruitment and Enrollment for Phase 2 Clinical Trial of PCM-075 in Combination with Zytiga in Patients with mCRPC
On June 21, 2018, Trovagene announced it has received Institutional Review Board (IRB) approval from Dana-Farber/Harvard Cancer Center and its Phase 2 clinical trial of PCM-075 in combination with Zytiga (abiraterone acetate) and prednisone in mCRPC is officially activated and recruiting patients. The trial is being conducted by Beth Israel Deaconess Medical Center (BIDMC), Dana-Farber Cancer Institute (Dana-Farber), and Massachusetts General Hospital Cancer Center (MGH). David Einstein, MD, Genitourinary Oncology Program at BIDMC, is the principal investigator for the trial.
Announced Completion of First Dosing Cohort of Patients Treated with PCM-075 in Combination with Decitabine in Ongoing Phase 1b/2 AML trial
On June 15, 2018, Trovagene announced completion of the first dose cohort of PCM-075 in combination with decitabine, in its Phase 1b/2 clinical trial in patients with AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with decitabine. The combination of PCM-075 and decitabine was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at 18 mg/m2 of PCM-075 (approximately a 50% increase) in combination with decitabine.
Announced Completion of First Dosing Cohort of Patients in Ongoing Phase 1b/2 AML trial of PCM-075 in Acute Myeloid Leukemia
On May 17, 2018, Trovagene announced the completion of the first dose cohort in its Phase 1b/2 clinical trial of PCM-075 in combination with LDAC, in AML. Three patients were treated with PCM-075 at 12 mg/m2, administered orally, once daily, on days 1-5 of the treatment cycle, in combination with LDAC. Patients eligible for Phase 1b have relapsed or refractory disease and may have received as many as three prior regimens for treatment of their AML. The combination of PCM-075 and LDAC was well tolerated in all patients. The independent Safety Review Committee (SRC) has recommended escalating to the second dose cohort of three patients at PCM-075 at 18 mg/m2 (approximately a 50% increase) in combination with LDAC.
Announced Presentation of Data at AACR (Free AACR Whitepaper) Meeting 2018 on Pharmacodynamic and Tumor Biomarkers During Treatment with PCM-075 and Low-Dose Cytarabine
On April 17, 2018, Trovagene announced the presentation of pharmacodynamic and biomarker data from the first patient to complete a safety treatment cycle in its Phase 1b/2 clinical trial of PCM-075 in AML at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, IL. The poster entitled Pharmacodynamic and Tumor Biomarker Analysis of a PLK1 Inhibitor, PCM-075, in a Phase 1b/2 Trial for Acute Myeloid Leukemia presents the methodology developed to track dynamic changes in blood leukemic cells, genomic alterations and PLK1 inhibition in AML patients treated with PCM-075 in combination with LDAC.
Announced Presentation of data at AACR (Free AACR Whitepaper) Meeting 2018 Showing Synergy of PCM-075 in Combination with FLT3 Inhibitors in Acute Myeloid Leukemia (AML)
On April 16, 2018, Trovagene announced the presentation of data showing that PCM-075 exhibits synergistic activity when combined with FLT3 inhibitors in a human xenograft AML model, at the AACR (Free AACR Whitepaper) Annual Meeting in Chicago, IL. The poster entitled Selective Polo-like Kinase 1 (PLK1) Inhibitor PCM-075 is Highly Active Alone and Shows Synergy When Combined with FLT3 Inhibitors in Models of Acute Myeloid Leukemia (AML) presents data demonstrating that PCM-075 in combination with quizartinib (Daiichi-Sankyo) resulted in 97.3% tumor growth inhibition (TGI), compared to 77.9% with quizartinib and 80.2% with PCM-075 as monotherapy.
Second Quarter 2018 Financial Results

Trovagene received gross proceeds of approximately $18.0 million from the sale of 9,140,000 shares of its common stock, 20,700,000 shares of warrants, and 8,600 shares of Series B Convertible Preferred Stock through an underwritten public offering that closed on June 12, 2018.
Trovagene reported a net loss of $3.7 million and a net loss of $6.5 million attributable to common shareholders, or $0.88 per diluted share in the second quarter of 2018, as compared to a net loss of $8.0 million and a net loss of $8.1 million attributable to common shareholders, or $3.12 per diluted share for the same quarter of 2017. The Company recorded a $2.8 million one-time, non-cash deemed dividend related to the beneficial conversion feature arising from the issuance of Series B Convertible Preferred Stock. Adjusted net loss per common share (non-GAAP) was $0.44 in the second quarter of 2018, as compared to adjusted net loss per common share (non-GAAP) of $3.12 for the same quarter of 2017. There will be no need to account for any subsequent, similar one-time, non-cash deemed dividends for Series B Convertible Preferred Stock issued in the June public offering.
Total operating expenses were approximately $4.6 million for the three months ended June 30, 2018, a reduction of $1.4 million from $6.0 million for the same period in 2017. The decrease in cash used in operating activities is attributed to having completed the transition from diagnostics to therapeutics and primary focus on advancing development of PCM-075.
Net cash used in operating activities in the second quarter of 2018 was $3.3 million, compared to $4.6 million in the second quarter of 2017. The year-over-year reduction of $1.3 million can be attributed primarily to the elimination of expenses associated with diagnostic programs and focus on therapeutics and the clinical development of its lead drug candidate, PCM-075.
Net cash provided by financing activities in the second quarter of 2018 was $15.1 million as compared to $16.7 million used in financing activities in the same period of 2017. Financing activities during the three months ended June 30, 2018 related primarily to the proceeds from sales of common stock and warrants.
Research and development expenses increased by approximately $1.0 million to $2.0 million for the three months ended June 30, 2018 from $1.0 million for the same period in 2017. The overall increase in research and development expenses was primarily due to the increased outside service costs for clinical studies related to the development of our drug candidate, PCM-075. We expect increases in research and development costs as we continue to advance the development of PCM-075.
Selling, general and administrative expenses decreased by approximately $2.5 million to $2.2 million for the three months ended June 30, 2018 from $4.7 million for the same period in 2017. The significant components of the decrease were primarily due to the decrease in legal fees of approximately $2.1 million related to former CEO and CFO litigation settlement.
The weighted average diluted shares of common stock outstanding used to calculate per share results for the three months ended June 30, 2018 was 7.4 million.
As of June 30, 2018, Trovagene had approximately $18.5 million of cash and cash equivalents.

On August 3, 2018 Zenyaku Kogyo Co., Ltd. (Japanese-only website) and Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Zenyaku filed an application for approval with the Ministry of Health, Labour and Welfare for the anti-CD20 monoclonal antibody RITUXAN injection 100 mg and 500 mg [generic name: rituximab (genetical recombination)] for the treatment of "CD20-positive chronic lymphocytic leukemia (CLL) (Press release, Chugai, AUG 3, 2018, View Source [SID1234528819]). RITUXIAN is co-marketed by the two companies in Japan.

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Zenyaku received a request from the MHLW to develop RITUXAN for the treatment of CD20-positive CLL issued on April 6, 2012, as a result of the evaluation by the "11th Review Committee on Unapproved Drugs and Indications with High Medical Needs" held on March 23, 2012, and has been preparing to file for the addition of this indication. On March 20, 2018, the orphan drug designation was granted for RITUXAN for CD20-positive CLL as the estimated number of newly diagnosed CLL patient per year is about 400.

CLL is a disease in which small mature B lymphocytes proliferate monoclonally and proliferate in peripheral blood, bone marrow, lymph nodes and spleen, many of which progress slowly. This rare disease is mostly prevalent in elderly people, and considered as difficult to cure with current treatments while many patients often experience recurrence and progression repeatedly. The number of patients in Japan is small, reportedly about 0.3 to 100,000 people per year. The age of onset is typically over 50 years, and rarely seen in people under 30 years of age. In patients with CLL, the ratio of females to males is higher at about 1.5 or 2 to 1*.

Zenyaku and Chugai will continue to work for the early approval of the product to provide RITUXAN for CLL patients and medical professionals who are waiting for a new treatment option.

On August 3, 2018 Oncolytics Biotech Inc. (Nasdaq: ONCY) (TSX: ONC), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported financial results and operational highlights for the quarter ended June 30, 2018 (Press release, Oncolytics Biotech, AUG 3, 2018, View Source [SID1234528878]). All dollar amounts are Canadian unless otherwise noted.

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"The second quarter began with clinical updates at three scientific conferences and an agreement with the FDA for our Special Protocol Assessment, followed by the announcements of two combination studies with Merck’s Keytruda and culminated in the company’s relisting on Nasdaq," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "The immuno-oncology data we have presented at recent conferences, as well as the data we expect from recently announced studies supports the potential for combination with checkpoint inhibitors and other immunotherapy and anticancer agents as we broaden our pipeline to demonstrate the ultimate value of pelareorep. Our Nasdaq listing has already raised our profile with institutional investors focusing on biotech and we hope to see additional analyst coverage out of the U.S."

Selected highlights since April 1, 2018

Clinical Updates

Reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the protocol design, clinical endpoints and statistical analysis approach for the company’s phase 3 study evaluating pelareorep for the treatment of metastatic breast cancer.

Announced two combination studies with Merck’s Keytruda:

Investigating pelareorep in combination with Keytruda to treat second line pancreatic cancer patients. The study, run by Dr. Devalingham Mahalingam, will plan to enroll approximately 40 patients with advanced pancreatic cancer and will be conducted at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University.

Investigating pelareorep in combination with Keytruda, Velcade and dexamethasone to treat multiple myeloma patients. The study, facilitated by Dr. Kevin Kelly, Associate Professor of Clinical Medicine, will be conducted at the USC Norris Comprehensive Cancer Center.

Presented poster highlights from pelareorep studies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2018 Annual Meeting. The presentation demonstrated that pelareorep promotes the expression of gene signatures predictive of a response to immunotherapy in breast cancer and hepatocellular carcinoma and that the tumor inflammation promoting effects in breast cancer models provide a compelling explanation for the significant overall survival benefit in hormone receptor positive metastatic breast cancer patients in the phase 2, IND 213, study.

Presented posters highlighting data from pelareorep studies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2018. The presentations showed preclinical models demonstrating pelareorep increased PD-L1 expression in microsatellite stable (MSS) colorectal cancer cells (CRC) and demonstrated efficacy for pelareorep and anti-PD1 agent combination.

Presented positive pelareorep data in combination with Keytruda and anti-CD73 at the International Oncolytic Virus Conference 2018. The poster highlighted the effectiveness of pelareorep in combination with Keytruda and/or an anti-CD73 immunotherapy in prostate cancer cell lines.

Corporate Updates

Announced a share consolidation on the basis of 1 new common share for every 9.5 outstanding common shares.

Announced the listing of the company’s shares of common stock on the Nasdaq Capital Market and commenced trading on June 1, 2018, under the symbol "ONCY".

Closed an underwritten public share offering of 1,532,278 common shares at a purchase price of USD $5.83 for gross proceeds of approximately USD $8.9 million.

Expanded the clinical development team in San Diego, including Senior Medical Personnel.

Anticipated Milestones

Initiate a phase 2 window of opportunity study of pelareorep in combination with a checkpoint inhibitor and/or the standard of care in the neoadjuvant breast cancer setting in 2H 2018.

Initiate a phase 2 study in combination with Merck’s Keytruda in multiple myeloma in 2H 2018.

Initiate a phase 2 study in combination with Merck’s Keytruda in advanced pancreatic cancer in 2H 2018.

Data from window of opportunity study in mBC in 1H 2019.

Data from Keytruda combination study in multiple myeloma in 2H 2019.

Preliminary data from Keytruda combination study in advanced pancreatic cancer in 1H 2020.

Financial

At June 30, 2018, the company reported $18.7 million in cash and cash equivalents.

As at August 2, 2018, the company had an unlimited number of authorized common shares with 16,531,956 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,153,080 options and share units.

About REOLYSIN/Pelareorep
REOLYSIN, also known as pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On August 3, 2018 Intrexon Corporation (NYSE: XON), a leader in the engineering and industrialization of biology to improve the quality of life and health of the planet, reported Robert Walsh, Senior Vice President, Energy and Fine Chemicals Platforms, will present at the Jefferies 2018 Global Industrials Conference in New York City on Tuesday, August 7, 2018 at 8:00 am Eastern (Press release, Intrexon, AUG 3, 2018, View Source [SID1234528378]). Mr. Walsh’s presentations will highlight Intrexon’s proprietary methane bioconversion platform to convert natural gas into high-value fuels and chemicals through microbial fermentation.

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