vTv Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, vTv Therapeutics, 2017, MAY 13, 2016, View Source [SID1234521344]).

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On May 13, 2016 Enumeral Biomedical Holdings, Inc. (OTCQB: ENUM) ("Enumeral" or the "Company"), a biotechnology company focused on the discovery and development of novel antibody-based immunotherapies to help the immune system fight cancer and other diseases, reported its financial results for the three months ended March 31, 2016 (Press release, ENUMERAL BIOMEDICALORATION, MAY 13, 2016, View Source;p=irol-newsArticle&ID=2168350 [SID:1234512372]).

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Recent Business Highlights

In April 2016, Enumeral entered into a License and Transfer Agreement with Pieris Pharmaceuticals, Inc. and Pieris Pharmaceuticals GmbH. Pursuant to this agreement, Pieris is licensing from Enumeral specified intellectual property related to Enumeral’s anti-PD-1 antibody program ENUM 388D4 for the potential development and commercialization by Pieris of novel multispecific therapeutic proteins comprising fusion proteins based on Pieris’ Anticalins class of therapeutic proteins and Enumeral antibodies in the field of oncology.
In April 2016, Enumeral presented research findings on the Company’s novel class of anti-PD-1 antibodies in a poster at the AACR (Free AACR Whitepaper) Annual Meeting 2016 in New Orleans, noting that Enumeral’s anti-PD-1 antibody ENUM 244C8 appears to elicit cytokine secretion from cell types associated with innate immunity in ex vivo assays using lung biopsy samples from human patients.
First Quarter 2016 Financial Results

Cash and Cash Equivalents: Cash and cash equivalents as of March 31, 2016 were $1,837,304, as compared to $3,596,262 as of December 31, 2015. As of the date of this press release, Enumeral believes that it only has sufficient liquidity to fund operations through June 2016. If Enumeral is unable to raise additional capital on acceptable terms and on a timely basis, Enumeral may be required to downsize or wind down its operations through liquidation, bankruptcy, or a sale of its assets. The Company is currently exploring a range of potential transactions, which may include public or private equity offerings, debt financings, collaborations and licensing arrangements, and/or other strategic alternatives, including a merger, sale of assets or other similar transactions.
Revenue: Revenue increased by $159,735 to $434,457 for the three months ended March 31, 2016, as compared to $274,722 for the three months ended March 31, 2015. This increase in revenue is attributable to the Company’s collaboration agreement with Merck and its grant from the National Cancer Institute.

Research and Development Expenses: Research and development ("R&D") expenses increased by $239,539 to $1,470,043 for the three months ended March 31, 2016, as compared to $1,230,504 for the three months ended March 31, 2015. This increase is primarily due to increased facility expenses in connection with the Company’s office relocation and an increase in stock-based compensation expense associated with stock option grants issued during the three months ended March 31, 2016.
General and Administrative Expenses: General and administrative ("G&A") expenses decreased by $230,609 to $1,194,334 for the three months ended March 31, 2016, as compared to $1,424,943 for the three months ended March 31, 2015. This decrease is primarily due to a decrease in legal costs and a decrease in exit costs associated with the termination of the Company’s former lease in connection with the Company’s office relocation.

Other Income (Expense): Other income decreased by $3,997,651 to $674,868 for the three months ended March 31, 2016, as compared to $4,672,519 for the three months ended March 31, 2015. This decrease is primarily due to a decrease in non-cash income related to the change in the fair value of derivative liabilities associated with the warrants issued in connection with the Company’s July 2014 private placement transaction. The Company expects that future changes in the fair value of the derivative liabilities will be due primarily to fluctuations in the value of the Company’s common stock and potential exercises of outstanding warrants.

Net Income (Loss): Net income (loss) changed by $3,846,846 to ($1,555,052) for the three months ended March 31, 2016, as compared to $2,291,794 for the three months ended March 31, 2015. This change is primarily due to the decrease in other income described above.

On May 12, 2016 GlobeImmune, Inc. (NASDAQ: GBIM) reported an update on the Company’s business and clinical programs and announced financial results for the first quarter 2016 (Filing, Q1, GlobeImmune, 2016, MAY 12, 2016, View Source [SID:1234512345]).

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The Company continues to seek potential strategic transactions. Cantor Fitzgerald & Co. has been retained by the Company to assist in reviewing ways to maximize stockholder value. There is not a defined timeline for the strategic review process and the review may not result in any specific action or transaction.

The Company has three ongoing clinical trials being conducted by the Company’s corporate collaborators, Gilead Sciences, Inc. and Celgene Corporation. GS-US-330-1401, the GS-4774 Phase 2 clinical trial in patients with chronic HBV infection who are currently not receiving treatment, is fully enrolled and the 48-week results are projected to be available in the second half of 2016. The 24-week results for this trial did not show a statistical difference between control and treatment arms. The results from a GI-6207 Phase 2 trial in subjects with medullary thyroid cancer are projected to be available in the second half of 2016. A Phase 2 clinical trial designed to investigate the safety and efficacy of evaluating GI-6301 in combination with radiation therapy in patients with chordoma is still enrolling patients.

Financial Results – First Quarter Ended March 31, 2016

GlobeImmune reported a net loss of $0.9 million for the three months ended March 31, 2016 compared to $1.6 million for the same period in 2015. The decrease in net loss for 2016 was due to lower compensation expense due to layoffs in research and development and general and administrative expenses. GlobeImmune reported a loss applicable to common stockholders of $0.15 per share, for three months ended March 31, 2016 compared to loss applicable to common stockholders of $0.27 per share for the same period in 2015.

Research and development for proprietary programs expense for the three months ended March 31, 2016 was $0.3 million compared to $0.4 million for the same period in 2015, a decrease of $0.1 million. The decrease was primarily due to a decrease in salary expense due to layoffs in 2015. Costs of manufacturing services for the three months ended March 31, 2016 were $0 compared to $0.2 million for the same period in 2015. The decrease was primarily due to a decrease in expenses relating to manufacturing services for Gilead for the Phase 2 HBV trial. Costs of collaboration license and services for the three months ended March 31, 2016 was $0.5 million compared to $0.9 million for the same period in 2015, a decrease of $0.4 million. The decrease was primarily due to a decrease in expenses related to the clinical trial for GS-4774 and reduction in salary expense due to layoffs in 2015. General and administrative expense for the three months ended March 31, 2016 was $0.9 million compared to $1.2 million for the same period in 2015, a decrease of $0.3 million. The decrease was due to a reduction in salary expense due to layoffs in 2015.

At March 31, 2016, GlobeImmune had cash and equivalents of $8.7 million. The Company believes it has sufficient cash to operate the company as a going concern through the middle of 2017 as it continues to evaluate strategic alternatives. If a strategic alternative is not found in the near future, we could decide to wind down the operations of the Company which will consume cash faster than currently planned as a going concern.

On May 12, 2016 Epizyme, Inc. (NASDAQ: EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for people with cancer, reported that data from four abstracts from the Company’s clinical development program in support of tazemetostat for use in non-Hodgkin lymphoma (NHL) will be presented during the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting on Lymphoma Biology, to be held in Colorado Springs, CO, from June 18 to June 21, 2016 (Press release, Epizyme, MAY 12, 2016, View Source [SID:1234512293]).

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Tazemetostat is a first-in-class EZH2 inhibitor currently in phase 2 studies in advanced B-cell non-Hodgkin lymphoma (NHL) and certain genetically defined solid tumors. Among the data to be presented is the first interim report from the Company’s ongoing phase 2 study in patients with NHL.

Planned Presentations:

Oral Presentation: EZH2 as a target for non-Hodgkin lymphoma and beyond: tazemetostat experience; from bench to bedside and back to the bench
Speaker: Vincent Ribrag, MD, Institut Gustave-Roussy, Paris, France
Session Title: Exciting New Mechanisms-Targeted Therapies and Clinical Trials
Date: June 21, 2016
Time: 10:20 a.m. – 10:50 a.m. Mountain Time

Poster: Tazemetostat treatment drives wild-type and mutant EZH2 DLBCL cell lines to a cell fate decision between apoptosis or differentiation (Poster #39)
Author: Michael Thomenius, Ph.D., Epizyme
Date: June 19, 2016
Time: 3:45 p.m. – 5:15 p.m. Mountain Time

Poster: Initial report from a phase 2 multi-center study of tazemetostat (EPZ-6438), an inhibitor of enhancer of zeste-homolog 2 (EZH2), in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (Poster #98)
Author: Franck Morschhauser, MD, PhD, Centre Hospitalier Régional Universitaire de Lille, Lille, France
Date: June 20, 2016
Time: 3:45 p.m. – 5:15 p.m. Mountain Time

Poster: Chromatin flow cytometry based assessment of H3K27me3 pharmacodynamics in blood from diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) patients following exposure to the EZH2 inhibitor tazemetostat reveals disparate response profiles in specific PMBC subpopulations (Poster #38)
Author: Christopher Plescia, Epizyme
Date: June 20, 2016
Time: 3:45 p.m. – 5:15 p.m. Mountain Time

About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing phase 2 programs in both non-Hodgkin lymphoma and certain genetically defined solid tumors, including INI1-negative and SMARCA4-negative tumors and synovial sarcoma.

The Company has announced plans to initiate additional clinical evaluations of tazemetostat in 2016, including both a combination study with R-CHOP and a combination study with an immune checkpoint inhibitor in patients with NHL, as well as a monotherapy study in patients with mesothelioma.

On May 12, 2016 Argos Therapeutics, Inc. (Nasdaq:ARGS), an immuno-oncology company focused on the development and commercialization of individualized immunotherapies for the treatment of cancer based on the Arcelis technology platform, reported financial results for the first quarter ended March 31, 2016 and provided an update on the Company’s clinical programs (Press release, Argos Therapeutics, MAY 12, 2016, View Source [SID:1234512326]).

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"We have gotten off to a strong start in 2016. In the first quarter, we were able to accomplish a number of critical activities," said Jeff Abbey, president and chief executive officer. "The most significant of these was securing a financing agreement for up to $60 million. This financing, if fully funded, would provide us with funding for our operations into the second quarter of 2017, which is when we anticipate having a sufficient number of events to permit the primary analysis and assessment of overall survival to occur from the Phase 3 ADAPT trial of our lead product, AGS-003, in metastatic renal cell carcinoma. We look forward to the upcoming review of ADAPT trial data at the meeting of the Independent Data Monitoring Committee (IDMC) in June."

"Also, during the quarter, Dr. Lee Allen joined Argos as our chief medical officer. His experience and guidance have already made an impact on the development of AGS-003, including, in particular, with our preparation for the submission of our Biologics License Application (BLA) that would follow completion of the ADAPT trial, in addition to helping facilitate investigator-initiated trials of AGS-003," Mr. Abbey continued. "Lastly, and to that end, we announced that an investigator-initiated trial of AGS-003 in non-small cell lung cancer opened for enrollment during the quarter. We are excited for this first trial of AGS-003 outside of kidney cancer as we explore the potential activity of this novel immunotherapy in other solid tumors. These developments are all meaningful stepping stones as we continue on the pathway to achieving our goal of becoming a fully-integrated commercial biotechnology company."

First Quarter 2016 Operational Highlights:

In January 2016, Dr. Lee F. Allen joined the Company as chief medical officer
In March 2016, the Company entered into an equity financing agreement for up to $60 million
Will take place in up to three tranches: approximately $20 million in March 2016, approximately $30 million subject to and following the June 2016 IDMC meeting and a company controlled option for up to an additional $10 million subject to and following the late 2016 IDMC meeting
In March 2016, investigator-initiated Phase 2 study of AGS-003 in non-small cell lung cancer opened for enrollment at the Cancer Research Network of Nebraska (CRNN)
Selected First Quarter 2016 Financial Results

Net loss for the three months ended March 31, 2016 was $12.8 million, or $0.57 per share, compared to a net loss of $17.5 million, or $0.89 per share, for the same period in 2015.

Revenue for the three months ended March 31, 2016 totaled $0.1 million compared to $0.2 million for the same period in 2015.

Research and development expenses for the three months ended March 31, 2016 totaled $9.5 million compared to $14.8 million for the same period in 2015. General and administrative expenses for the three months ended March 31, 2016 totaled $3.0 million compared to $2.4 million for the same period in 2015.

As of March 31, 2016, Argos’ cash, cash equivalents and short-term investments totaled $13.8 million compared to $7.2 million as of December 31, 2015.

Conference Call and Webcast Details

Argos executive management will host a conference call beginning at 4:30 p.m. Eastern Time today to discuss these results and to answer questions.

To participate by telephone, please dial (855) 433-0930 (Domestic) or (484) 756-4271 (International). The conference ID number is 7392695. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.argostherapeutics.com. The archived webcast will remain available on the Company’s website for twelve (12) months following the call.

About the Arcelis Technology Platform
Arcelis is a precision immunotherapy technology that captures mutated and variant antigens that are specific to each patient’s disease. It is designed to overcome immunosuppression by producing a durable memory T-cell response without adjuvants that may be associated with toxicity. The technology is potentially applicable to a wide range of different cancers, and is designed to overcome many of the manufacturing and commercialization challenges that have impeded other personalized cancer immunotherapies. The Arcelis process uses only a small tumor or blood sample and the patient’s own dendritic cells, which are optimized from cells collected by a single leukapheresis procedure. The proprietary process uses RNA isolated from the patient’s disease sample to program dendritic cells to target disease specific antigens. The activated, antigen-loaded dendritic cells are then formulated with the patient’s plasma and administered via intradermal injection.