On August 3, 2018 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial results for the second quarter that ended June 30, 2018, and provided an update on recent achievements and upcoming events (Press release, vTv Therapeutics, AUG 3, 2018, View Source;p=RssLanding&cat=news&id=2361982 [SID1234528671]).

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"Since our announcement regarding the topline results from Part B of the STEADFAST Study, we have continued to analyze the results from Parts A and B and are encouraged by our findings," said Steve Holcombe, chief executive officer, vTv Therapeutics. "In addition, our other programs, including our glucokinase activator currently in clinical development for type 1 diabetes and our GLP-1R program that is being developed in partnership with Huadong Medicine for type 2 diabetes, continue to make steady progress."

Recent Achievements and Outlook

Azeliragon data analysis continues in order to move development of the therapy forward in consultation with our scientific advisory board and the FDA.
SimplicT-1 Study enrolling patients with type 1 diabetes. The adaptive Phase 1/2 SimplicT-1 Study has begun dosing patients with type 1 diabetes in a 12 week study to evaluate TTP399 as an add-on to insulin therapy. TTP399 has previously demonstrated statistically significant reductions in HbA1c levels in the AGATA Study, a phase 2 study in type 2 diabetes.
Advancing PDE4 program with Newsoara. During the second quarter, vTv licensed rights to its PDE4 program to Newsoara Biopharma Co., Ltd. to further its development and potential commercialization in China and other Pacific Rim countries. Newsoara is developing vTv’s PDE4 compounds as a potential therapeutic for COPD, a chronic illness affecting nearly 100 million people in China.
Additional Investment by MacAndrews & Forbes Incorporated. MacAndrews & Forbes provided vTv an additional $10 million capital line.
Upcoming Events

vTv will participate in the following upcoming investor conferences:

H.C. Wainwright Annual Healthcare Conference, September 4-6, New York.
vTv will also participate in the following upcoming scientific conferences:

11th Clinical Trials on Alzheimer’s Disease (CTAD), October 24-27, Barcelona.
Second Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents as of June 30, 2018, were $1.2 million compared to $6.5 million as of March 31, 2018.
R&D Expenses: Research and development expenses were $8.6 million in the second quarter of 2018, compared to $8.9 million in the first quarter of 2018. The decrease in research and development expenses was primarily driven by the termination of the STEADFAST and open label extension studies during the second quarter of fiscal 2018.
G&A Expenses: General and administrative expenses were $2.7 million and $2.3 million, for the second quarter of 2018 and the first quarter of 2018, respectively. The change in general and administrative cost was driven by lower incentive compensation costs in the first quarter of 2018 related to a reduction in the expected probability of payment of the remaining amount of fiscal 2017 incentive bonuses.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $9.6 million for the second quarter of 2018 compared to net loss before non-controlling interest of $10.0 million for the first quarter of 2018.
Net Loss per Share: GAAP net loss per share was $0.31 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on weighted-average shares of 10.0 million and 9.7 million for the three month periods ended June 30, 2018 and March 31, 2018, respectively. Non-GAAP net loss per fully exchanged share was $0.29 and $0.30 for the three months ended June 30, 2018 and March 31, 2018, respectively, based on non-GAAP fully exchanged weighted-average shares of 33.1 million and 32.8 million for the three months ended June 30, 2018 and March 31, 2018, respectively.

On August 3, 2018 IMPACT Therapeutics, Inc. (IMPACT), a China-based clinical-stage biopharmaceutical company dedicated to the discovery and development of "best-in-class" medicine for the treatment of cancer and other life-threatening diseases, reported the completion of $30 million in series C financing (Press release, Impact Therapeutics, AUG 3, 2018, View Source [SID1234528890]). The series C round was led by Decheng Capital (Decheng), with participation from existing investor Lilly Asian Ventures (LAV). Proceeds from the series will be used for the clinical development of IMP4297, a potential best-in-class PARP inhibitor, and to advance IMPACT’s integrated programs targeting DNA Damage Response (DDR).

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PARP inhibitors are targeted therapies for cancer patients with defects in DNA repair mechanisms, such as with BRCA1 and BRCA2 mutations. Three PARP inhibitors, which have been shown to be tolerable and effective in clinical studies, have already been approved for marketing outside of China. IMP4297 has demonstrated an excellent safety profile and good preliminary efficacy in phase I clinical trials in Australia and China, which is consistent with the high potency and large therapeutic window found in pre-clinical studies.

"We are grateful for the faith our new and existing investors have shown in us, and for sharing our vision of developing the best potential treatments for cancer patients with DNA repair defects," commented Dr. Ye Edward Tian, CEO of IMPACT. "Decheng and LAV are renowned global VC firms in the biomedical industry. With the capital and resources provided by Decheng and LAV, we will be able to advance the clinical development of IMP4297 and enrich our pipeline."

"IMPACT is committed to the discovery and development of best-in-class therapeutics to treat cancer and other life-threatening diseases. Our data indicates that IMP4297 could be more efficacious and/or less toxic than other PARP inhibitors currently in the market, making it a potential best-in-class drug," added Dr. Sui Xiong Cai, SVP and CTO of IMPACT. "With this series C financing, we are well-positioned to achieve key data milestones as we accelerate the clinical development of IMP4297, in the hope of bringing it to market and patients soon."

"IMP4297 has shown potential to be a best-in-class drug in both pre-clinical studies and clinical trials. IMPACT is an excellent Chinese company with products that can compete globally," said Dr. Xiangmin Cui, Founder and Managing Director of Decheng. "We are very happy to collaborate with the IMPACT team and to support IMPACT’s growth."

"IMPACT is advancing its IMP4297 program steadily," said Dr. Fei Chen, Managing Partner of LAV. "We have seen excellent results from the clinical trials of IMP4297. As an existing investor from the previous two rounds of financing, LAV will continue to support IMPACT with capital and resources."

About Decheng Capital

Founded in 2012, Decheng is a leading VC firm investing in the biomedical and healthcare sectors. With more than $1 billion in capital under management, Decheng provides financial and strategic support to entrepreneurs, innovators and startup companies to take advantage of opportunities in China’s fast-growing healthcare, biomedical and pharmaceutical industries. Well placed to capitalize on revolutionary breakthroughs in life-science innovation worldwide, Decheng has offices in Shanghai and Silicon Valley.

About Lilly Asia Ventures

Founded in 2008 and headquartered in Shanghai, LAV is a leading VC firm investing in the biomedical, pharmaceutical and medical devices/diagnostics industries. LAV provides early-to-growth-stage companies with capital, professional expertise and valuable resources. LAV has offices in northern California, Shanghai and Hong Kong.

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.