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

On May 15, 2018 Prometic Life Sciences Inc. (TSX: PLI, OTCQX: PFSCF) (Prometic) reported its unaudited financial results for the first quarter ended March 31, 2018 (Press release, ProMetic Life Sciences, MAY 15, 2018, View Source [SID1234526654]).

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"Our number one goal for 2018 is to close the gap between the fundamental value created over the last few years and the current share price as it does not reflect, in our view, all the clinical and operational milestones achieved. We have streamlined our clinical development programs to ensure that our most promising clinical assets and their respective indications are prioritized," said Pierre Laurin, President and Chief Executive Officer of Prometic. "We are committed to bringing to market our lead drug candidates for patients, as well as for shareholders. We are working diligently to improve our financial position and time-to-market, by partnering some of our lead drug candidates, in an effort to accelerate and facilitate access to markets."

Commenting on the first quarter 2018 financial results, Bruce Pritchard, Prometic’s Chief Operating Officer and Chief Financial Officer said, "As I outlined at our recent Annual Shareholders’ Meeting, our priorities for the balance of 2018 are clearly established. Our commitment to tightly manage the cash resources is already paying off with less cash used in our operations during the first quarter of 2018, compared to the first quarter of 2017, with the goal of using approximately $15 million less in total for 2018. Our commitment to increase our cash runway is also underway, following the sale of $14 million worth of plasma inventory, early in the second quarter of 2018. We have also completed the review of our clinical and product development programs, concentrating on PBI-4050 in idiopathic pulmonary fibrosis and Alström syndrome, as well as on plasminogen. This allows us to focus our resources, save costs, and work toward partnership activities to increase our cash runway further."

Small Molecule Therapeutics Highlights

PBI-4050 – Mechanism of action and the discovery of a new antifibrotic pathway was published in the American Journal of Pathology
PBI-4050 – Clearance by the US Food and Drug Administration (FDA) for pivotal Phase 3 trial in patients with idiopathic pulmonary fibrosis (IPF), prioritizing IPF as one of our top indications along with Alström syndrome
PBI-4050 – Clinical activity sustained over 52 weeks with reversal of heart and liver fibrosis in Alström syndrome subjects
PBI-4547 – To be advanced in the clinic with a focus on liver fibrosis and metabolic diseases
Plasma Derived Therapeutics Highlights

RyplazimTM (plasminogen) – Comprehensive plan developed to address BLA chemistry, manufacturing and controls (CMC) changes requested by FDA
Inter-Alpha Inhibitor Proteins (IaIp) – Orphan drug and rare pediatric designations secured from the FDA
2018 First Quarter Financial Results

Revenues

Total revenues for the first quarter ended March 31, 2018 were $4.3 million compared to $4.9 million for the first quarter ended March 31, 2017. Revenues from the sale of goods amounted to $3.8 million for the first quarter ended March 31, 2018, compared to $4.4 million for the quarter ended March 31, 2017.

Net Loss

The Corporation incurred a net loss of $34.6 million for the quarter ended March 31, 2018 compared to a net loss for the quarter ended March 31, 2017 of $29.1 million. The increase in net loss year over year is mainly due to the increased finance costs of $2.9 million, the plasma inventory write-down of $1.5 million included in the cost of sales and other production expenses, the reduced margin contribution on the sale of bioseparations products, and the increase in administration, selling and marketing expenses. This was partially offset by the decrease in R&D expenses of $2.0 million during the quarter ended March 31, 2018 compared to the corresponding period in 2017.

Research and Development (R&D)

The Corporation incurred total R&D costs of $22.4 million for the quarter ended March 31, 2018 compared to $24.4 million for the first quarter ended March 31, 2017. R&D expenses include the cost to manufacture plasma-derived therapeutics and small molecule therapeutics to be used in clinical trials and for the development of our production processes. The plasma-derived therapeutics are produced at the Laval plant and the Winnipeg Contract Manufacturing Organization (CMO) where as the small molecule therapeutics are manufactured by a third party pharmaceutical contract manufacturing organization for Prometic. The manufacturing and purchase cost of these therapeutics was $6.3 million during the quarter ended March 31, 2018 compared to $9.2 million during the quarter ended March 31, 2017. The decrease is mainly due to a reduction in production activities during the quarter ended March 31, 2018 compared to the same period in 2017.

Other R&D expenses were $16.1 million during the quarter ended March 31, 2018 compared to $15.2 million for the corresponding period in 2017. The increase of $1.0 million is partially due to an increase in employees working on the clinical trials and at our research centers and in pre-clinical studies of $0.8 million. These increases were partially offset by a decrease in Contract Research Organizations ("CRO") and investigator expenses by $0.4 million.

Administration, Sales & Marketing

Administration, selling and marketing expenses amounted to $7.7 million during the first quarter ended March 31, 2018 compared to $6.9 million during the first quarter ended March 31, 2017. The increase as compared to the first quarter of 2017 was due to the increase in salaries and benefits resulting from an overall increase in headcount, reflecting the build-up of the infrastructure in order to support the eventual sale of commercial product.

Finance Costs

Finance costs were $4.2 million for the quarter ended March 31, 2018 compared to $1.4 million during the corresponding period of 2017, representing an increase of $2.9 million. This increase reflects the higher level of debt during the quarter ended March 31, 2018 compared to the same period of 2017, reflecting the increase in the OID loans and the amounts drawn on the non-revolving credit facility agreement. Total long-term debt on the consolidated statement of financial position was $110.0 million at March 31, 2018 compared to $48.4 million at March 31, 2017.

Additional Information in Respect to the First Quarter Ended March 31, 2018

Prometic’s MD&A and condensed interim consolidated financial statements for the quarter ended March 31, 2018 will be filed on SEDAR (View Source) and will be available on the Company’s website at www.prometic.com.

On May 15, 2018 Personalis, Inc., a provider of advanced genomic sequencing and analytics for immuno-oncology, reported that the State Intellectual Property Office of China has issued patent ZL 2013 8 00748247 for the ACE© Technology Platform (Press release, Personalis, MAY 15, 2018, View Source [SID1234526653]). This is the latest patent issued to Personalis for ACE Technology, following US Patent approval in 2013, and UK Patent approval in 2016. This proprietary technology includes systems and methods for the comprehensive and accurate genomic analysis of tumors, and forms the basis of all Personalis products, including ACE ImmunoID.

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ACE Technology overcomes limitations associated with conventional exome and transcriptome sequencing assays to provide increased assay sensitivity and deeper, more uniform coverage of notoriously difficult-to-sequence genomic regions (Patwardhan et al., Genome Med. 2015; 7:71). The technology improves processes from nucleic acid extraction, to sample preparation and sequencing, to alignment and variant discovery analysis. This allows for the accurate and precise capture of genetic variants including single nucleotide variants and indels from DNA, as well as fusions from RNA.

For immuno-oncology applications such as biomarker discovery and neoantigen identification, Personalis developed its leading immunogenomics platform, ACE ImmunoID, with ACE Technology at its core for enhanced sequencing and analytical performance. ACE ImmunoID uses augmented whole exome and transcriptome assays to provide comprehensive genomic profiling of the tumor, its microenvironment, and tumor-specific neoantigens to help biopharmaceutical companies develop personalized cancer immunotherapies.

"Since its inception, Personalis has recognized the international potential of our advanced genomics technology," said Personalis CEO, John West. "We established our first foreign subsidiary in 2013 and have now served customers in seventeen countries. In parallel with this, we have built a broadly international intellectual property base and are now gratified to see it expanding further with this issuance in China."