On August 1, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it will host a second quarter 2018 investor call on Thursday, August 9, 2018 at 8:00 AM (EDT) to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, AUG 1, 2018, View Source [SID1234528288]).

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To access the call, participants may dial 877-407-8920 (US & Canada) or 412-902-1010 (International) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing 877-660-6853 (Toll Free US & Canada) or 201-612-7415 (International) and providing the Conference ID #13661472.

On August 1, 2018 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the second quarter ended June 30, 2018 (Press release, Vanda Pharmaceuticals, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361415 [SID1234528307]).

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"We are excited with the year to date HETLIOZ sales performance, which demonstrates continued strength, and our HETLIOZ life cycle management program, which positions the product well for additional future growth," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. "We are focused on our upcoming clinical milestones from the tradipitant gastroparesis study and the HETLIOZ Smith-Magenis Syndrome study."

Key Highlights:

Total net product sales from HETLIOZ and Fanapt were $47.4 million during the second quarter of 2018, a 9% increase compared to $43.6 million in the first quarter of 2018 and a 13% increase compared to $42.1 million in the second quarter of 2017.
HETLIOZ (tasimelteon)

HETLIOZ net product sales were $28.0 million in the second quarter of 2018, a 10% increase compared to $25.4 million in the first quarter of 2018 and a 25% increase compared to $22.5 million in the second quarter of 2017.
Fanapt (iloperidone)

Fanapt net product sales were $19.3 million in the second quarter of 2018, a 6% increase compared to $18.2 million in the first quarter of 2018 and a 1% decrease compared to $19.5 million in the second quarter of 2017.
Research and Development

HETLIOZ

Results from the JET study, a 3-night transatlantic Phase II study of the effects of tasimelteon on jet lag disorder showed effectiveness in treating travelers who flew from the US to the UK. Vanda expects to submit a supplemental New Drug Application to the U.S. Food and Drug Administration for HETLIOZ for the treatment of jet lag disorder by the end of 2018.
Enrollment in the Smith-Magenis Syndrome clinical study is ongoing. Results are expected by the end of 2018.
Tradipitant

In June 2018, Vanda initiated EPIONE, a Phase III study of tradipitant for chronic pruritus in atopic dermatitis.
A tradipitant clinical study for the treatment of gastroparesis is ongoing. Results are expected by the end of 2018.
VTR-297 (histone deacetylase (HDAC) inhibitor)

A VTR-297 Phase I study (1101) in patients with hematologic malignancies is expected to begin by the end of 2018.
Cash, cash equivalents and marketable securities (Cash) were $231.2 million as of June 30, 2018. During the second quarter of 2018, Cash decreased by $17.6 million and included a $25.0 million milestone payment based on cumulative HETLIOZ net product sales.

Non-GAAP Financial Results

For the second quarter of 2018, Non-GAAP net income was $7.7 million, or $0.15 per share, compared to Non-GAAP net income of $1.6 million, or $0.03 per share, for the second quarter of 2017.

Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information."

2018 Financial Guidance

Vanda reiterates its prior 2018 net product sales guidance and provides an update to Non-GAAP Operating Expenses and Year-End 2018 Cash guidance and expects to achieve the following financial objectives in 2018

Vanda has scheduled a conference call for today, Wednesday, August 1, 2018, at 4:30 PM ET. During the call, Vanda’s management will discuss the second quarter 2018 financial results and other corporate activities. Investors can call 1-800-708-4539 (domestic) or 1-847-619-6396 (international) and use passcode 47289344. A replay of the call will be available on Wednesday, August 1, 2018, beginning at 7:00 PM ET and will be accessible until Wednesday, August 8, 2018, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The passcode number is 47289344.

The conference call will be broadcast simultaneously on Vanda’s website,
www.vandapharma.com
. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

Non-GAAP Financial Information

Vanda believes that the Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. Vanda’s "Non-GAAP Selling, general and administrative expenses" and "Non-GAAP Research and development expenses" exclude stock-based compensation. Vanda’s "Non-GAAP Net income (loss)," "Non-GAAP Net income (loss) per share" and "Non-GAAP Operating expenses excluding Cost of goods sold" exclude stock-based compensation and intangible asset amortization.

Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business, as well as Vanda’s use of financial resources and its long-term performance.

This press release includes a projection of 2018 Non-GAAP Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading "2018 Financial Guidance." This Non-GAAP financial measure is determined by excluding cost of goods sold, stock-based compensation and intangible asset amortization. Vanda is unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact of these adjustments.

These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.

The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure.

On August 1, 2018 RhoVac AB ("RhoVac") reported positive top-line results on safety and on immune activation in their phase I/II clinical trial RhoVac-001 in prostate cancer patients (Press release, RhoVac, AUG 1, 2018, View Source [SID1234528369]).

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In totally 22 prostate cancer patients received RV001 treatment over a period of approximately 30 weeks. The regimen was well tolerated and there were no treatment related grade 3, 4 or 5 reactions according to CTCAE (Common Terminology Criteria for Adverse Events). The primary end-point of the study was therefore achieved. No related allergic reactions to treatment and no treatment related SAEs (Serious Adverse Events) were reported. Local injection site reactions were noted; however, these reactions were all expected and the study confirmed that the reactions are reversible. In conclusion, the study meets its endpoint.

Totally 21 of the 22 enrolled patients were eligible for immune response assessment based on IFNγ ELIspot analysis, while analytical results from one patient were non-conclusive and therefore excluded from the final assessment. The immune response was analysed before -, two time during – and once, one month after completion of treatment. The result is that 86% (18 of 21 of the eligible patients) show a significant immune response to RV001 in samples taken during or after treatment. To qualify as a Confirmed Immune Responder in RhoVac-001 protocol, patients are required to show a significant response in two of the three samples taken during or after treatment. This was the case for all 18 patients showing significant immune response. In conclusion, the results confirm that a vaccine mediated immune response is established following treatment with RV001 and the dose administered in the study is biologically active.

Comments from RhoVac´s CEO, Anders Ljungqvist
-We are very excited about the results! In addition to the very high responder rate to the vaccination, we also saw that the responses were consistent over time, and we found that the vaccinations were safe and well tolerated by the patients. At this time, I would like to thank the Copenhagen Prostate Cancer Center at the University Hospital, Copenhagen, the phase-I unit Zelo at Bispebjerg and Frederiksberg Hospital plus DanTrials ApS and the T-cell monitoring group, Department of Immunology at the University of Tübingen, for a highly professional, timely and dedicated work. It has been an outstanding collaboration. Finally, but not least, I would like to thank the enrolled patients for participating in this clinical trial. Your commitment and compliance to treatment and planned visits have ensured that the trial have been completed on time and that data can be clearly interpreted.

The clinical trial
The clinical trial RhoVac-001 (ClinicalTrials.gov identifier: NCT03199872) is a phase I/II first-in-man trial studying the therapeutic cancer vaccine RV001. Patients prostatectomised, due to histologically verified adenocarcinoma of the prostate gland who were not being treated, were enrolled in the study and recruitment of the 22 patients was completed in July 2017. The primary endpoint of the study is to evaluate the safety and tolerability of the RV001 cancer vaccine and the secondary endpoint is to investigate the RV001-specific immunological response before, during and after vaccination. In addition to the now reported results, all patients treated are monitored for duration of immune response over a 12-month period following completion of treatment. This part of the study is ongoing and the results are expected to be reported mid-2019.

RV001 cancer vaccine
RV001 is a peptide based therapeutic cancer vaccine targeting the protein RhoC, which is known to be overexpressed in practically all cancer cells having a metastatic potential. The basic concept with RV001 cancer vaccine is to develop a treatment against initial formation and spread of metastatic cancer cells, specifically targeting the prevention against cancer relapse.

Prostate cancer
Prostate cancer is the fourth most common cancer in both sexes combined and the second most common cancer in men. An estimated 1.1 million men worldwide were diagnosed with prostate cancer in 2012, accounting for 15% of the cancers diagnosed in men, with almost 70% of the cases (759,000) occurring in more developed regions. The RV001 cancer vaccine is focussing on patients having completed treatment of the primary tumor, which commonly is surgical removal of all or part of the prostate gland. The adjuvant treatment is aiming at blocking or limiting relapse of prostate cancer.

On August 1, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) (Press release, Daiichi Sankyo, AUG 1, 2018, View Source [SID1234528390]).

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"There have been limited advances over the past several decades for the treatment of relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis. Quizartinib is the first FLT3 inhibitor to significantly improve overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory AML with FLT3-ITD, an underlying driver of this subtype of AML," said Arnaud Lesegretain, Vice President, Oncology Research and Development and Head, AML Franchise, Daiichi Sankyo. "We are excited that quizartinib has received Breakthrough Therapy designation and we look forward to working closely with the FDA to bring this potential new treatment option to patients as quickly as possible."

Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial benefit over currently approved treatments, in order to more quickly bring new treatment options to patients with serious diseases. Significant unmet medical need exists in relapsed/refractory AML, as available treatment options are limited and there are no approved targeted therapies for patients with relapsed/refractory FLT3-ITD AML.

The designation was granted based on the results of the pivotal phase 3 QuANTUM-R study of quizartinib, which were presented during the plenary program at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June 2018. QuANTUM-R is the first randomized phase 3 study to show that a FLT3 inhibitor, quizartinib, prolongs overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML.

The safety profile observed in QuANTUM-R appears consistent with that observed at similar doses in the quizartinib clinical development program. Incidence of treatment-emergent adverse events was comparable between patients who received single agent quizartinib (n=241) and those who received salvage chemotherapy (n=94). The most common adverse events (>30 percent, any Grade) in patients treated with quizartinib included nausea, thrombocytopenia, fatigue, musculoskeletal pain, pyrexia, anemia, neutropenia, febrile neutropenia, vomiting and hypokalemia.

About Quizartinib
Quizartinib, the lead investigational agent in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, is an oral selective FLT3 inhibitor currently in phase 3 development for relapsed/refractory (QuANTUM-R) and newly-diagnosed (QuANTUM-First) FLT3-ITD AML in the U.S., EU and Japan, and phase 2 development for relapsed/refractory FLT3-ITD AML in Japan.

In addition to Breakthrough Therapy designation, quizartinib has been granted Fast Track designation by the FDA for the treatment of relapsed/refractory AML. Quizartinib also has been granted Orphan Drug designation by both the FDA and the European Medicines Agency (EMA) for the treatment of AML. Quizartinib is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About FLT3-ITD Acute Myeloid Leukemia
AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.1 In the U.S. this year, it is estimated that there will be more than 19,000 new diagnoses of AML and more than 10,000 deaths from AML.2 The five-year survival rate of AML reported from 2005 to 2011 was approximately 26 percent, which was the lowest of all leukemias.1

FLT3 gene mutations are one of the most common genetic abnormalities in AML.3 FLT3-ITD is the most common FLT3 mutation, affecting approximately one in four patients with AML.4,5,6,7 Patients with FLT3-ITD AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse and a higher likelihood of relapse following hematopoietic stem cell transplantation as compared to those without this mutation.8,9

On August 1, 2018 Selecta Biosciences, Inc. (Nasdaq: SELB), a clinical-stage biopharmaceutical company focused on unlocking the full potential of biologic therapies by mitigating unwanted immune responses, reported that it plans to issue its second quarter 2018 financial results before the open of the U.S. financial markets on Wednesday, August 08, 2018 (Press release, Selecta Biosciences, AUG 1, 2018, View Source [SID1234528289]).

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At 8.30 a.m. ET that day, Selecta Biosciences will host a conference call via live webcast to discuss these results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844)-845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10122287.