On May 15, 2018 Cancer Genetics, Inc. (Nasdaq:CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported financial and operating results for the first quarter ended March 31, 2018 as well as an update on its strategic direction and key organizational initiatives (Press release, Cancer Genetics, MAY 15, 2018, View Source [SID1234526639]).

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John A. Roberts, Chief Executive Officer of Cancer Genetics said, "Our progress during the first quarter aligned with our transformation strategy for 2018, which focuses on leveraging our core competencies and market-leading portfolio of diagnostics to accelerate the path to profitability and improve our competitive position.

"We are particularly pleased with the expansion of our Biopharma and Discovery Services businesses, where we are continuing to capitalize on the significant synergies that exist to add new clients and expand revenue among existing clients. Our oncology-focused testing, genomic services and biomarker insight capabilities are among the strongest in the industry, and add substantive value to our partners’ development efforts. We are currently supporting over 300 clinical trial and discovery projects, including 101 clinical trials that are focused on the growing trends associated with immuno-oncology product development, and are continuing to add more as we expand our capabilities and further establish ourselves as a major player in this space.

Mr. Roberts added, "In addition to expanding Biopharma and Discovery Services activities, there are two other keys to executing this strategy, which we believe will drive revenue growth and operating cost reductions. These were the divestiture of certain non-strategic assets and the reduction of our geographic footprint. We advanced both of these initiatives since the beginning of 2018."

"In an effort to further optimize efficiency across the organization, we recently completed the sale of our India operation to REPROCELL Incorporated and made the strategic decision to consolidate our Los Angeles laboratory operations, relocating our comprehensive solid tumor test portfolio and capabilities to our New Jersey and North Carolina facilities during the second and third quarters of 2018. These actions represent an important step in focusing our business, simplifying our operating structure and generating monetary value for the Company, and are consistent with the execution of the transformation strategy."

Mr. Roberts concluded, "Overall, we are pleased with the advancements we have made since the beginning of 2018. We are continuing to leverage synergies and implement strategies aimed at accelerating growth, while reducing expenses associated with non-core activities. We remain committed to optimizing our proprietary and unique test and service offerings to drive a leadership position in precision oncology."

FIRST QUARTER 2018 AND RECENT OPERATIONAL HIGHLIGHTS

Received special 510(k) clearance from the FDA for the Tissue of Origin (TOO) test to identify tumor origin and differentiate between metastatic, poorly differentiated, or undifferentiated cancers.
Completed sale of wholly-owned subsidiary BioServe Biotechnologies (India) Private Limited to REPROCELL for $1.9 million in April 2018.
As part of 2018 transformation strategy, began the consolidation of the west coast molecular profiling laboratory and relocation of most of these activities to New Jersey and North Carolina laboratories. The consolidation of this facility is expected to reduce operating expenses by over $4 million annually once completed, with completion planned for September 2018.
FIRST QUARTER 2018 FINANCIAL RESULTS

On January 1, 2018 the Company adopted the FASB Accounting Standards Codification Topic 606 "Revenue from Contracts with Customers" ("ASC 606"). The Company also adopted several FASB Accounting Standards Updates ("ASUs"). Financial information for the three months ended March 31, 2017 has not been restated and continues to be reported under the accounting standards in effect for that period. Additional information on the recently adopted accounting standards is included in the Company’s quarterly report on Form 10-Q for the period ended March 31, 2018.

The Company reported total revenue of $7.7 million for the first quarter of 2018 compared to revenue of $7.0 million in the first quarter of 2017, an increase of 10% or $0.7 million.

Biopharma services revenue totaled $3.7 million in the first quarter, flat compared to $3.7 million during the first quarter 2017. Biopharma projects are dependent on the timing, size and duration of our contracts with pharmaceutical and biotech companies and clinical research organizations, and can fluctuate in comparable periods. The Company increased the number of clinical studies and trials it is supporting to 241, up from 140 in Q1 2017. The Company’s book-to-bill ratio moved from 1.2 in Q1 2017 to 1.3 in Q1 2018.

​Clinical Services revenue decreased by approximately $0.7 million in the first quarter of 2018 compared to the same period in 2017, from $3.0 million to $2.3 million. The decrease in revenue was primarily related to the adoption of ASC 606, and a 16% decline in test volume in the NJ lab.

The Company’s Discovery Services contributed $1.7 million in revenue for the first quarter of 2018, an increase of approximately $1.4 million compared to $0.3 million in the first quarter of 2017. The increase was driven by a full quarter of vivoPharm revenue following its acquisition in August 2017, as well as growing demand for the Company’s early-stage discovery and bioinformatics analysis capabilities.

Gross profit margin was 33.7% or $2.6 million in Q1 2018, compared to 40% or $2.8 million in the first quarter 2017. Gross profit and gross margin percentage were impacted by a reduction in the number of non-revenue generating test validations, an increased focus among clinical and medical staff on customer-driven initiatives, and the continued rationalization of the Company’s cost structure from prior acquisitions and efforts to introduce greater efficiency in its laboratory operations.

Total operating expenses for the first quarter of 2018 were approximately $7.5 million, an increase of 35.5% compared to $5.6 million during the first quarter of 2017. The increase in total operating expenses is primarily related to the addition of SG&A expenses from the vivoPharm acquisition of $0.9 million, increases in sales and marketing costs of $0.4 million in the comparable periods as the Company ramped up clinical sales during the second half of 2017, non-cash charges associated with severance related payroll and benefit costs of $0.5 million in Q1 2018 and an increase in bad debt reserve of $0.5 million related to its Clinical Services business.

Net loss was $(4.5) million or $(0.16) per share for the first quarter of 2018, compared to a net loss of $(9.6) million or $(0.51) per share for the first quarter of 2017.

Cash and cash equivalents, excluding restricted cash of $0.4 million as of March 31, 2018 totaled $4.0 million, compared to $9.9 million as of December 31, 2017.

As announced on April 2, 2018, the Company engaged Raymond James & Associates, Inc. as a financial advisor to assist with evaluating options for the Company’s strategic direction. These options may include raising additional capital, the acquisition of another company and / or complementary assets, the sale of the Company, or another type of strategic partnership.

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 Celsius Therapeutics, a company translating single-cell genomic insights into precision therapeutics for autoimmune diseases and cancer, reported with a $65 million Series A financing led by Third Rock Ventures with participation from GV (formerly Google Ventures), Heritage Provider Network, Casdin Capital, Alexandria Venture Investments and other key investors (Press release, Celsius Therapeutics, MAY 15, 2018, View Source [SID1234526810]). Celsius is charting a new course of target and drug discovery by understanding the specific cells, among many others, that are key players in disease and by identifying the genes that are triggering their malfunction.

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Celsius’ fundamentally new approach aims to combine the power of single-cell genomic sequencing with computational algorithms to discover first-in-class precision therapies that have a transformative impact on the lives of patients with autoimmune diseases and cancer. To do this, the company applies a systematic approach, starting with single-cell sequencing on defined patient samples to identify and understand the individual cells and their interactions that cause dis-ease.

By analyzing single cells, Celsius’ approach has the potential to understand the causes of disease at an entirely new level of resolution that overcomes limitations of traditional genomic sequencing approaches. Celsius believes this approach could be the key to bring precision medicines to autoimmune diseases for the first time. These cellular insights could also allow Celsius to identify the right combination of treatments for the right patients and build on the promising results seen in the field of immunooncology.

Celsius was co-founded by Aviv Regev, Ph.D., core institute member, chair of the faculty and director of the Klarman Cell Observatory at the Broad Institute of MIT and Harvard, Professor of Biology at MIT and an investigator at the Howard Hughes Medical Institute. Her research revealed that many diseases are driven by the combined dysfunction of several specific cell types, and the interactions between them. Traditional genomic sequencing cannot identify these individual contributions, as only the average can be seen and key critical causes can be missed. For the first time, with the approaches discovered by Aviv and Celsius’ other founders, the company will combine massive datasets of unprecedented size and complexity with sophisticated machine learning algorithms. Celsius will be able to distinguish the specific cells, among many others, that play a key role in disease and identify the genes that are triggering their malfunction. This approach will allow the company to more efficiently identify specific targets for treating diseases in specific patients and ultimately develop medicines for those targets.

"When first meeting with Aviv and her colleagues and learning about the significance of this new technology, we knew this had to become a company. We formed Celsius with the goal of bringing a novel precision medicine approach to underserved patients with autoimmune diseases and certain cancers," said Christoph Lengauer, Ph.D., co-founder and president of Celsius and venture partner at Third Rock Ventures. "With the new level of clarity provided by single-cell sequencing, our team will be able to address many of the challenges of the current treatments and introduce a new class of medicines that will lead to better outcomes and potential cures."

Expert Team of Scientists and Clinicians

Celsius’ founders are established leaders with experience across the company’s entire product engine, from single-cell RNA sequencing to computational biology, disease biology and drug discovery.

• Jeffrey Bluestone, Ph.D., president and chief executive officer, Parker Institute for Cancer Immunotherapy, University of California, San Francisco; A.W. and Mary Margaret Clausen Distinguished Professor

• Vijay Kuchroo, D.V.M., Ph.D., Samuel L. Wasserstrom professor of neurology, Harvard Medical School; senior scientist, neurology, Brigham and Women’s Hospital; associate member, Broad Institute; director, Evergrande Center for Immunologic Diseases, Harvard Medical School and Brigham and Women’s Hospital

• Christoph Lengauer, Ph.D., venture partner, Third Rock Ventures; president, Celsius Therapeutics; adjunct associate professor, Sidney Kimmel Comprehensive Cancer Center at the Johns Hopkins University School of Medicine

• Aviv Regev, Ph.D., Chair of the Faculty and core institute member, and director, Klarman Cell Observatory, Broad Institute; professor, Department of Biology, MIT; Investigator, Howard Hughes Medical Institute

• Ramnik Xavier, M.D., chief of gastroenterology, Massachusetts General Hospital; institute member, Broad Institute; Kurt Isselbacher professor of medicine, Harvard Medical School

Celsius has licensed key technologies from the Broad Institute based on the work of Drs Regev and Kuchroo, including non-exclusive licenses to single-cell technologies and an exclusive license to early stage therapeutic programs.

"Each of us is made up of tens of trillions of cells. At the core of founding Celsius was the new ability to see something we could not see before. We can now see the dysfunction of key cells and their interactions within their neighborhood. Diseases that we have struggled to understand now can become crystal clear. With that clarity, we hope to create novel precision medicines," said Alexis Borisy, partner at Third Rock Ventures and chairman of Celsius Therapeutics. "We believe this approach and the incredible group that has been assembled by the founders have the unique potential to deliver a powerful new class of medicines and make a meaningful difference for patients."

On May 15, 2018 Nordic Nanovector ASA (OSE: NANO) reported its first quarter 2018 results on Wednesday, 30 May 2018 (Press release, Nordic Nanovector, MAY 15, 2018, View Source [SID1234553504]).

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First Quarter 2018 Results Presentation and Webcast

A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CEST on 30 May at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2018 from 7:00 am CEST the same day.

Results presentation in Norwegian

As announced in April, a separate presentation of the results in Norwegian, to be hosted by Nordic Nanovector’s CFO and Interim CEO, and its VP IR & Corporate Communications, will take place on Thursday, 31 May 2018 at 8:30 am CEST at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: VIPPETANGEN

To attend the meeting please email – [email protected]

The presentation will NOT be recorded as a webcast

On May 15, 2018 Atossa Genetics Inc. (NASDAQ:ATOS) ("Atossa" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics and delivery methods to treat breast cancer and other breast conditions, reported that it has received a second positive interim safety review on its Phase 1 study of topical Endoxifen in men, which is being developed to address gynecomastia (or male breast enlargement), a common condition in patients being treated for prostate cancer (Press release, Atossa Genetics, MAY 15, 2018, View Source [SID1234526610]). The Independent Safety Committee reviewed the blinded data generated from the second group in the study (eight subjects) and concluded that the study may advance to the final dosing level.

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Dr. Steven Quay, Ph.D., MD, President and CEO of Atossa commented, "We can now advance to the next level of the study which is to escalate the dosage in the third and final cohort of subjects as we continue to monitor safety and tolerability in the first and second cohorts of the study. We plan to complete enrollment this quarter and announce results from the study next quarter," added Dr. Quay.

The objectives of this double-blinded, placebo-controlled, repeat dose study of 24 healthy male subjects is to assess the pharmacokinetics of proprietary formulations of topical endoxifen dosage forms over 28 days, as well as to assess safety and tolerability. The study is being conducted on behalf of Atossa by CPR Pharma Services Pty Ltd., Thebarton, SA, Australia.

About Gynecomastia

Gynecomastia is male breast enlargement and accompanying pain. It is the most common male breast disorder and is caused by a hormone imbalance where testosterone is low compared to estrogen. In prostate cancer treatment, testosterone is suppressed resulting is higher estrogen levels that usually triggers gynecomastia. Prophylactic breast bud irradiation is commonly used in prostate cancer patients, but must often be repeated. One recent study indicates that up to 90% of men taking androgen deprivation therapy suffer from gynecomastia and breast pain (Handoo Rhee, et al., October 18, 2014, BJU International).

According to the Mayo Clinic, although it can affect men at almost any age, it is most prevalent in men ages 50-69, affecting at least 1 in 4 men in this age group. Gynecomastia is caused by, among other things, any number of commonly prescribed medications, such as androgen deprivation therapy to treat prostate enlargement and prostate cancer; anti-anxiety medications; cancer treatments (chemotherapy), and some heart medications. Gynecomastia is not only painful and embarrassing, it can also cause men to stop taking these important medications.

There are no FDA-approved therapeutics for gynecomastia. Breast-bud irradiation, use of compression garments and plastic surgery are the most common approaches used to treat gynecomastia.