On May 15, 2018 Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia-inducible factor (HIF), reported that its President and Chief Executive Officer, John P. Butler, will present at the UBS Global Healthcare Conference on Tuesday, May 22, 2018, at 4:00 p.m. Eastern Time, at the Grand Hyatt New York in New York City (Press release, Akebia, MAY 15, 2018, View Source [SID1234526659]).

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A live webcast of the presentation will be available on the company’s website at www.akebia.com. To access the webcast, please log onto the Akebia website at least 15 minutes prior to the webcast to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Akebia’s website following the conference.

On May 15, 2018 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended March 31, 2018 (Press release, Cel-Sci, MAY 15, 2018, View Source [SID1234526658]).The Company also reported key clinical and corporate developments achieved during the quarter.

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Clinical and Corporate Developments included:

CEL-SCI’s Phase 3 head and neck cancer study has been fully enrolled since September 2016. All 928 patients are being followed per the protocol. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone, will be determined after a total of 298 deaths have occurred in the two main comparator arms of the study and have been recorded in the study database. All that remains to be done in this pivotal Phase 3 study is to continue to track patient survival until the 298 deaths have occurred and it can be determined if the primary endpoint has been met.
Closing arguments in the arbitration against the former clinical research organization (CRO) for the Phase 3 trial concluded on April 25, 2018. The parties are now awaiting a decision from the arbitrator.
The U.S. Patent and Trademark Office allowed a patent for CEL-SCI’s LEAPS technology for methods of inducing immune responses.
"We expect two significant and material outcomes in the near term. In the very near term we are awaiting a decision from the arbitrator in our case against our former CRO. The read out of the Phase 3 study is expected to take longer than the decision by the arbitrator, however, based on overall survival data available in the scientific literature for the study’s patient population and the fact that the last patient was enrolled in the study over 1.5 years ago, we believe that the end of the Phase 3 trial is approaching as well," said CEL-SCI’s Chief Executive Officer, Geert Kersten. "Separately, we continue to advance our LEAPS technology through preclinical studies in preparation for human clinical studies. The current work with the Rheumatoid Arthritis vaccine is funded by a $1.5 million grant from the National Institutes of Health."

During the six months ended March 31, 2018, CEL-SCI’s cash increased by approximately $0.7 million. Significant components of this increase include net proceeds from the sale of CEL-SCI’s common stock of approximately $7.1 million offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $6.4 million.

CEL-SCI reported an operating loss of ($4,205,745) for the quarter ended March 31, 2018 versus an operating loss of ($7,906,557) for the quarter ended March 31, 2017. The operating loss was ($9,117,175) for the six months ended March 31, 2018 versus an operating loss of ($12,844,565) for the six months ended March 31, 2017.

The research and development expenses decreased by approximately $4.8 million compared to the six months ended March 31, 2017. The majority of CEL-SCI’s research and development expense relates to its on-going Phase 3 clinical trial. Clinical trial costs tend to be higher during the enrollment phase of the study and because the study is fully enrolled, the expenses incurred over the last six months have decreased. The general and administrative expenses increased by approximately $1.3 million compared to the six months ended March 31, 2017. This increase is primarily due to an increase of approximately $1.0 million in equity based compensation related to the Company’s shareholder approved 2014 Incentive Stock Bonus Plan, and a net increase of approximately $0.3 million in other general and administrative expenses primarily for accounting fees and public relations services.

On May 15, 2018 Agilvax, Inc., a biotechnology company that develops targeted cancer immunotherapies and vaccines, reported that it has completed a Series A1 financing, which complements the Series A round from 2014 (Press release, Agilvax, MAY 15, 2018, View Source [SID1234526657]). Both Series A and A1 were led by Hunt Holdings with a co-investment by Sun Mountain Capital. The funds will be used to expand the pre-IND studies for its lead program AX09 in triple negative breast cancer (TNBC). The Company is also evaluating the use of AX09 in combination with other cancer therapeutics, as well as strengthening its immunotherapy platform.

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Federica Pericle, Ph.D., MBA, Agilvax’s CEO, remarked, "This funding shows the belief our investors have in our progress and platform. With this additional funding, we will move AX09 closer to the clinic for TNBC, a truly unmet need in women’s health. We are also excited to continue to build our platform and pipeline."

TNBC is a histological subtype of breast cancer that is aggressive, with an overall poor prognosis due to a lack of effective treatment options. Chemotherapy remains the primary treatment for TNBC across the different settings: neoadjuvant, adjuvant, and metastatic.

AX09 is a virus-like particle (VLP) that displays a portion of the extracellular domain of the cystine-glutamate antiporter system protein xCT (SLC7A11), which has been found to be overexpressed in cancer stem cells. TNBC is enriched in cancer stem cells, which contributes to the aggressive nature of TNBC. Cancer stem cells have unique biological properties that represent a key cellular reservoir for relapse, metastatic progression and therapeutic resistance. Thus, the development of therapies that eliminate cancer stem cells is paramount to creating a durable response.

On May 15, 2018 vTv Therapeutics Inc. (Nasdaq:VTVT) reported financial and operational results for the first quarter that ended March 31, 2018 (Press release, vTv Therapeutics, MAY 15, 2018, View Source;p=RssLanding&cat=news&id=2349259 [SID1234526656]).

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"We continue to make progress on all of our major programs," said Steve Holcombe, chief executive officer, vTv Therapeutics. "While our initial readout of the results of our STEADFAST Part A Study was not what we had hoped for, we are pleased with the results of our subgroup analysis and are continuing our work in preparation for the Part B readout with a new prospectively-defined target population. We also are continuing to move our diabetes compounds into Phase 2 studies. Our GKA activator is now enrolling patients in a Phase 2 trial for type 1 diabetes and we expect interim results by year-end. We also continue to work with Huadong Medicine in China on the commencement of a Phase 2b study for our GLP-1r compound to test lower dosing levels. We remain enthusiastic for the success of these programs."

Pre-specifying New Subgroup with the FDA for Part B Readout Expected in June

Last week, the company announced that, based on post hoc analyses of the data from Part A of the company’s Phase 3 STEADFAST study of the investigational medication azeliragon in people with mild Alzheimer’s disease, despite not meeting co-primary endpoints, it had identified a subpopulation that showed statistically significant benefit (unadjusted for multiple post hoc comparisons) from azeliragon relative to placebo on ADAS-cog. The identified subpopulation consisted of participants with peak azeliragon blood plasma concentration of less than 7.5 ng/mL.

Based on the subpopulation data analyses from the Part A Study and the prior azeliragon trials, the company will submit a revised Statistical Analysis Plan (SAP) to the Food and Drug Administration for the Part B Study that pre-specifies a target population for the primary study analysis and expects to report Part B topline efficacy results based on 12 month data in June 2018.

The patients in the identified subgroup (n=~48) had a -1.9 point improvement in ADAS-cog relative to the placebo group (n=200) which was statistically significant (unadjusted for multiple post hoc comparisons) (p = 0.02), and a 0.5 point improvement on CDR-sb relative to placebo (p = .06) despite the smaller sample size.

First Quarter 2018 Financial Results

Cash Position: Cash and cash equivalents as of March 31, 2018, were $6.5 million compared to $11.8 million as of December 31, 2017.
R&D Expenses: Research and development expenses were $8.9 million in the first quarter of 2018, compared to $10.1 million in the fourth quarter of 2017. The decrease in research and development expenses were primarily driven by decreased costs related to certain azeliragon preclinical studies which were completed in the fourth quarter of 2017. Additionally, research and development expenses related to compound manufacturing costs for azeliragon as well as the STEADFAST and OLE studies were lower during the first quarter of 2018.
G&A Expenses: General and administrative expenses were $2.3 million and $2.9 million, for the first quarter of 2018 and the fourth quarter of 2017, respectively. The decrease in general and administrative cost was primarily due to lower incentive compensation costs in the first quarter of 2018 as well as lower expenses related to professional services. The cost of professional services were higher in the fourth quarter of 2017 due to the license transactions that were entered into in December 2017.
Net Loss Before Non-Controlling Interest: Net loss before non-controlling interest was $10.0 million for the first quarter of 2018 compared to net loss before non-controlling interest of $14.6 million for the fourth quarter of 2017.
Net Loss per Share: GAAP net loss per share was $0.30 and $0.44 for the three months ended March 31, 2018 and December 31, 2017, respectively, based on weighted-average shares of 9.7 million in each period. Non-GAAP net loss per fully exchanged share was $0.30 and $0.44 for the three months ended March 31, 2018 and December 31, 2017, respectively, based on non-GAAP fully exchanged weighted-average shares of 32.8 million in each period.

On May 15, 2018 Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) ("Valeant") reported that Paul S. Herendeen, executive vice president, Finance and chief financial officer, and Arthur J. Shannon, senior vice president and head of Investor Relations and Communications, are scheduled to participate at the Barclays High Yield Bond and Syndicated Loan Conference in Colorado Springs, Colo. on May 22, 2018 at 10:10 a.m. MDT (12:10 p.m. EDT) (Press release, Valeant, MAY 15, 2018, http://ir.valeant.com/news-releases/2018/05-15-2018-130406481 [SID1234526655]).

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A live webcast and audio archive of the event will be available on the Investor Relations page of the Valeant web site at: http://ir.valeant.com/events-and-presentations/2018