On February 20, 2020 Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) reported that Amit D. Munshi, President and Chief Executive Officer, will present at the upcoming investor conferences (Press release, Arena Pharmaceuticals, FEB 20, 2020, View Source [SID1234554583]):

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SVB Leerink 9th Annual Global Healthcare Conference – Presenting on Tuesday, February 25, at 3:00 PM ET, in New York City
Cowen and Company 40th Annual Healthcare Conference – Presenting on Wednesday, March 4, at 10:40AM ET, in Boston
A live audio webcast of the presentations will be posted under the investor relations section of Arena’s website at www.arenapharm.com. A replay of the presentation will be available for 30 days following the event.

On February 20, 2020 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its fourth quarter and year-to-date 2019 financial results on Thursday, February 27, 2020, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, FEB 20, 2020, View Source [SID1234554582]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

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Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Thursday, February 27, 2020. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 4783883.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 4783883.

On February 20, 2020 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter and full year ended Dec. 31, 2019 (Press release, NuVasive, FEB 20, 2020, View Source [SID1234554581]).

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Fourth Quarter 2019

Revenue increased 7.6% to $310.4 million, or 7.8% on a constant currency basis;
GAAP operating margin of 13.6%; Non-GAAP operating margin of 16.4%; and
GAAP diluted earnings per share of $0.55; Non-GAAP diluted earnings per share of $0.73.
Full Year 2019

Revenue increased 6.0% to $1.168 billion, or 6.6% on a constant currency basis;
GAAP operating margin of 10.5%; Non-GAAP operating margin of 15.8%; and
GAAP diluted earnings per share of $1.23; Non-GAAP diluted earnings per share of $2.47.
"NuVasive delivered strong financial results in 2019 with consistent, above-market growth of 6.0% over prior year," said J. Christopher Barry, chief executive officer of NuVasive. "In 2020, our primary growth drivers include continuing to lead in lateral spine surgery, further innovation in targeted spine segments and achieving scale in key global markets to drive value and deliver on our long-term commitments."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

Fourth Quarter 2019 Results
NuVasive reported fourth quarter 2019 total revenue of $310.4 million, a 7.6% increase compared to $288.3 million for the fourth quarter 2018. On a constant currency basis, fourth quarter 2019 total revenue increased 7.8% compared to the same period last year.

For the fourth quarter 2019, both GAAP and non-GAAP gross profit was $227.1 million and GAAP and non-GAAP gross margin was 73.2%. These results compared to GAAP and non-GAAP gross profit of $202.2 million and GAAP and non-GAAP gross margin of 70.1%, for the fourth quarter 2018.

The Company reported GAAP net income of $29.9 million, or diluted earnings per share of $0.55, for the fourth quarter 2019 compared to GAAP net income of $12.2 million, or diluted earnings per share of $0.23, for the fourth quarter 2018. On a non-GAAP basis, the Company reported net income of $38.5 million, or diluted earnings per share of $0.73, for the fourth quarter 2019 compared to non-GAAP net income of $36.1 million, or diluted earnings per share of $0.69, for the fourth quarter 2018.

Full Year 2019 Results
NuVasive reported full year 2019 total revenue of $1.168 billion, a 6.0% increase compared to $1.102 billion for the full year 2018. On a constant currency basis, full year 2019 total revenue increased 6.6% compared to the full year 2018.

For the full year 2019, both GAAP and non-GAAP gross profit was $855.7 million and GAAP and non-GAAP gross margin was 73.3%. These results compared to GAAP and non-GAAP gross profit of $790.6 million and $791.6 million, respectively, and GAAP and non-GAAP gross margin of 71.8% and 71.9%, respectively, for the full year 2018. For the full year 2019, GAAP and non-GAAP operating expenses were $732.7 million and $670.7 million, respectively. These results compared to GAAP and non-GAAP operating expenses of $736.4 million and $624.8 million, respectively, for the full year 2018.

The Company reported GAAP net income of $65.2 million, or diluted earnings per share of $1.23, for the full year 2019 compared to GAAP net income of $12.5 million, or diluted earnings per share of $0.24, for the full year 2018. On a non-GAAP basis, the Company reported net income of $129.8 million, or diluted earnings per share of $2.47, for the full year 2019 compared to non-GAAP net income of $116.6 million, or diluted earnings per share of $2.23, for the full year 2018.

Annual Financial Guidance for 2020
The company estimates full year 2020 revenue growth to be in the range of 4.0% to 6.0%, GAAP diluted earnings per share in the range of $1.15 to $1.25 and non-GAAP diluted earnings per share in the range of $2.55 to $2.65.

On February 20, 2020 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the full fiscal year ended December 31, 2019 (Press release, VolitionRX, FEB 20, 2020, View Source [SID1234554580]). Volition management will host a conference call tomorrow, February 21, at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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Cameron Reynolds, President and Chief Executive Officer of Volition, upon releasing these results commented, "During 2019, we, together with our collaborators, have made very strong progress, particularly in assay and platform development, with our Nu.Q(TM) Capture program and epigenetic toolkit, Nu.Q(TM) Vet in collaboration with Texas A&M University and, most recently, with the acquisition of the epigenetics reagents company, Octamer GmbH. It is very encouraging that our field of epigenetics is now getting what we believe is long overdue recognition."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer.

Mr. Reynolds added "We strengthened our balance sheet throughout 2019 with existing investors exercising over $16 million in outstanding warrants to purchase shares of our common stock, receipt of additional non-dilutive funding and maintaining a low cash burn rate and therefore start the new year in a strong position to achieve our key 2020 milestones."

Company Highlights

Financial

Cash and cash equivalents as of December 31, 2019 totalled $17 million compared to $13.4 million as of the end of 2018.
Existing investors exercised $16.5 million in aggregate amount of outstanding warrants to purchase shares of our common stock.
Received additional $3.3 million in non-dilutive funding taking our total non-dilutive funding (grants and loans) to date to over $7.5 million.
Continue to manage cash carefully with a monthly burn (or cash used in operating activities) of approximately $1.2 million during 2019.
Assay Development

Volition has completely re-engineered its Nu.Q(TM) assays to now use a magnetic particle-based assay format leading to a step-change improvement in analytical performance. Volition expects this enhanced analytical performance to translate into improved clinical performance in the studies to be carried out and reported in the coming months.

Relative to Volition’s ELISA plate Nu.Q(TM) assay format, the magnetic particle-based assay format demonstrates:

A 10 to 20-fold improvement in analytical sensitivity of the assays.
Typical within-day reproducibility of quantitative test results below 3% (previously <10%).
Decrease in test result turnaround time from 6 hours to approximately 1 hour and 20 minutes, allowing much higher throughput.
The ability to be developed and processed on fully-automated Random-Access platforms (enabling the use of a wide range of commercial automated platforms).
In terms of clinical accuracy, over the past twelve months as we have been working on the aforementioned assay development, we have completed some proof of concept studies to assess clinical performance. While this work is yet to be completed for the finalized assays, preliminary results were extremely encouraging that for even the development assays we saw our highest ever Area Under the Curve performance in Blood Cancer at 91% and in Lung Cancer at 85% in addition to reporting positive data in colorectal cancer.

Epigenetic Toolbox

Volition has developed and is seeking patents on its novel Nu.Q(TM) Capture based epigenetic tools, in addition to its ongoing efforts regarding its bead-based Nu.Q(TM) assay format, to decipher the epigenetic and environmental profiles of cancer nucleosomes with the aim of using:

Nu.Q(TM) Capture methods to enrich cancer nucleosomes and simplify sequencing based "liquid biopsies".
Nu.Q(TM) Capture methods to isolate intact nucleosomes from plasma for mass spectrometry analysis in the framework of both biomarker discovery and clinical diagnostics.
Nu.Q(TM) Capture to measure global methylation patterns in a simple platform.
Nu.Q(TM) Capture to concentrate nucleosomal markers prior to our Nu.Q(TM) assays to increase accuracy.
Nu.Q(TM) platform to detect and measure circulating nucleosomes and transcription factors with potential to be tissue specific, and therefore cancer specific. This, if successful could result in a simple blood test for multiple cancers.
Volition is using these tools to expand diagnostic developments that focus on circulating DNA fragment analysis, to a broader and potentially more powerful investigation of the epigenetic status of a patient’s circulating chromosome fragments, in addition to its ongoing work with its assay-based format in a range of cancers.

Organization

Our laboratory team expanded appreciably to include, among others, the appointment of an Assay Validation Expert who has been instrumental in taking our assays forward.
We added two new operating subsidiaries with the formation of Volition Veterinary Diagnostics in June 2019 and the acquisition of our epigenetics reagents subsidiary, Octamer Gmbh, in the early part of 2020.
In connection with the formation of Volition Veterinary Diagnostics, we welcomed Nathan Dewsbury as its Chief Executive Officer and, Dr. Heather Wilson-Robles DVM, as its Chief Medical Officer.
In connection with the acquisition of Octamer we expanded our Scientific Advisory Board to include Dr. Adrian Schomburg, one of the world’s leading experts on Nucleosomes and founder and CEO of Octamer.
We also welcomed Dr. Phillip Barnes to our Board of Directors.
Upcoming Milestones

We expect to achieve the following milestones during 2020 :

Release a range of clinical data with our new optimised bead-based assays in colorectal, lung and other cancers.
Advance our previously announced large-scale colorectal and lung cancer trials in Europe, Asia and the U.S.
Advance the development of Nu.Q(TM) Capture by determining the level of discrimination of tumor associated nucleosomes using mass spectrometry and/or sequencing.
Announce patient data demonstrating the wide utility of Volition’s epigenetic toolbox.
Complete pre-analytical and clinical studies for Nu.Q(TM) Vet with the aim of launching our first product in 2020.
Publish several abstracts and peer reviewed articles with clinical results as well as showing the robustness and utility of our Nu.Q(TM) platform.
Mr. Reynolds concluded, "We are extremely proud of the accomplishments we have achieved thus far. I thank the dedicated Volition team for their tireless efforts. I, along with the rest of the Board and indeed the whole company, look forward to sharing the results of key studies over the coming year."

For further details please contact [email protected]

VolitionRx Limited Fourth Quarter & Full Year 2019 Earnings and Business Update Conference Call

Date: Friday, February 21, 2020
Time: 8:30 a.m. Eastern time
U.S. & Canada Dial-in: 1-877-407-9716 (toll free)
U.K. Dial-in: 0 800 756 3429 (toll free)
Toll/International: 1-201-493-6779
Conference ID: 13699351

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with David Vanston, Chief Financial Officer and Scott Powell, Executive Vice President, Investor Relations.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until March 6, 2020. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13699351.

On February 20, 2020 Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company leveraging the microbiome to develop therapeutics designed to prevent and treat gastrointestinal (GI) diseases in areas of high unmet need, provided a clinical programs update and reported financial results for the year ended December 31, 2019 (Press release, Synthetic Biologics, FEB 20, 2020, View Source [SID1234554579]).

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"2019 was a highly eventful period marked by significant progress as we continued to execute our strategy to advance and demonstrate the significant value of our portfolio of GI and microbiome-focused clinical programs," stated Steven A. Shallcross, Chief Executive and Financial Officer. "Following the announcement of our clinical trial collaboration with the Washington University School of Medicine in St. Louis ("Washington University") to advance SYN-004 in allogeneic hematopoietic cell transplant (HCT) patients, we held an extremely productive Type-C meeting with the U.S. Food and Drug Administration ("FDA") to finalize the clinical program parameters of a Phase 1b/2a clinical trial expected to begin next quarter. Allogeneic HCT recipients who receive broad-spectrum IV beta-lactam antibiotics at onset of fever following conditioning chemotherapy are at high risk for Clostridioides difficile infection (CDI), colonization by vancomycin-resistant Enterococci (VRE) and acute graft-versus-host-disease (aGVHD). We believe SYN-004’s unique mechanism of action designed to degrade IV beta-lactam antibiotics and prevent dysbiosis of the gut microbiome has the potential to significantly improve outcomes for patients who undergo allogeneic HCT, an area of significant unmet need."

Mr. Shallcross continued, "Enrollment in our investigator-sponsored Phase 2b clinical study for SYN-010 in breath-methane positive irritable bowel syndrome with constipation (IBS-C) patients remains ongoing. We anticipate a data readout sometime during the first half of 2020 which we believe will further fortify the established clinical data set for SYN-010 and support regulatory discussions to potentially simplify future registration studies. Preclinical activities and toxicology studies are ongoing and remain on track to support a near-term Investigational New Drug Application (IND) filing for our SYN-020 Intestinal Alkaline Phosphatase (IAP) program. We look forward to sharing important updates and progress for this and all our GI and microbiome-focused clinical programs."

Clinical Development and Operational Update

Received official meeting minutes from FDA following a Type-C meeting held on December 2, 2018 at the Company’s request to discuss the development of a Phase 1b/2a clinical trial of SYN-004 (ribaxamase) in allogeneic HCT recipients. Based on the final meeting minutes,
Enrollment is expected to begin during the second quarter of 2020 contingent upon approval of the clinical trial protocol by the Washington University School of Medicine’s Institutional Review Board (IRB) and the FDA,
The Phase 1b/2a clinical trial will comprise a single center, randomized, double-blind, placebo-controlled clinical trial of oral SYN-004 (ribaxamase) in up to 36 evaluable adult allogeneic HCT recipients,
The goal of this clinical trial is to evaluate the safety, tolerability and potential absorption into the systemic circulation (if any) of 150 mg oral SYN-004 (ribaxamase) administered to allogeneic HCT recipients who receive an IV beta-lactam antibiotic to treat fever,
Clinical trial participants will be enrolled into three sequential cohorts and administered a different study-assigned IV beta-lactam antibiotic. Eight participants in each cohort will receive SYN-004 (ribaxamase) and four will receive placebo,
Safety and pharmacokinetic data for each cohort will be reviewed by an independent Data and Safety Monitoring Committee, which will make a recommendation on whether to proceed to the next IV beta-lactam antibiotic;
Enrollment is ongoing in the Phase 2b investigator-sponsored clinical study of SYN-010 for the treatment of IBS-C
The Phase 2b clinical trial is being conducted by the Medically Associated Science and Technology (MAST) Program at Cedars-Sinai Medical Center and is a 12-week, placebo-controlled, double-blind, randomized clinical trial evaluating two dose strengths of oral SYN-010 (21 mg and 42 mg) in up to 150 patients diagnosed with IBS-C,
The primary objective for the study will be to determine the efficacy of SYN-010, measured as an improvement from baseline in the weekly average number of complete spontaneous bowel movements (CSBMs) during the 12-week treatment period for SYN-010 21 mg and 42 mg daily doses relative to placebo,
Secondary efficacy endpoints for both dose strengths of SYN-010 will measure changes from baseline in abdominal pain, bloating, stool frequency as well as the use of rescue medication relative to placebo,
A data readout is anticipated in 1H 2020,
Cedars-Sinai Medical Center and Synthetic Biologics are co-funding the study. The patent rights covering the use of SYN-010 are owned by Cedars-Sinai Medical Center and are exclusively licensed by Cedars-Sinai Medical Center to Synthetic Biologics;
Completed Pre-IND meeting with FDA to discuss advancement of SYN-020 (intestinal alkaline phosphatase) into clinical trials targeting areas of significant unmet medical need, including enterocolitis associated with radiation therapy for cancer
Anticipate filing a US IND in Q2 2020;
Continued to exercise prudent cash management and financial stewardship to maintain cash runway through at least the fourth quarter of 2020.
Year Ended December 31, 2019 Financial Results

General and administrative expenses decreased to $4.6 million for the year ended December 31, 2019, from $5.7 million for the year ended December 31, 2018. This decrease of 19% is due to decreased stock-based compensation expense related to forfeitures and decreased option grants, along with the reduction of investor relations, consulting, registration, and legal costs. The charge relating to stock-based compensation expense was $0.3 million for the year ended December 31, 2019, compared to $1.0 million for the year ended December 31, 2018.

Research and development expenses decreased to $11.1 million for the year ended December 31, 2019, from $11.8 million for the year ended December 31, 2018. This decrease of 6% is primarily the result of lower SYN-004 (ribaxamase) indirect program costs for the year ended December 31, 2019, including salary and related expense reductions resulting from the 2018 restructuring, and the fact that no clinical trial activity for SYN-004 (ribaxamase) was ongoing during the year ended December 31, 2019, offset by an increase in manufacturing and pre IND-enabling toxicology study costs for SYN-020. Research and development expenses also include a charge relating to non-cash stock-based compensation expense of $75,000 for the year ended December 31, 2019, compared to $1.1 million for the year ended December 31, 2018.

Total other income was $283,000 for the year ended December 31, 2019, compared to other income of $4.2 million for the year ended December 31, 2018. Total other income for the year ended December 31, 2019 is primarily comprised of interest income while total other income for the year ended December 31, 2018 is comprised of non-cash income of $4.1 million from the change in fair value of warrants. The decrease in the fair value of warrants was due to the decrease in our stock price from December 31, 2017 to December 31, 2018.

Cash and cash equivalents on December 31, 2019 were $15.0 million, a decrease of $13.9 million from December 31, 2018.

Conference Call

Synthetic Biologics will hold a conference call today, Thursday, February 20, 2020, at 4:30 p.m. (EST). The dial-in information for the call is as follows, U.S. toll free: 1-888-347-5280 or International: +1 412-902-4280. Participants are asked to dial in 15 minutes before the start of the call to register. The call will also be webcast over the Internet at View Source." target="_blank" title="View Source." rel="nofollow">View Source An archive of the call will be available for replay at the same URL, View Source, for 90 days after the call.