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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Pacira Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Pacira Pharmaceuticals, 2018, FEB 28, 2018, View Source [SID1234524217]).

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Can Fite Reports on the Progress of its Phase II NASH Study with Drug Candidate Namodenoson

On February 28, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address cancer, liver and inflammatory diseases, reported its Phase II clinical trial with drug candidate Namodenoson (CF102) in the treatment of NAFLD/NASH (Press release, Can-Fite BioPharma, FEB 28, 2018, View Source [SID1234524643]).

The current Phase II study is being conducted in three Israeli sites including Hadassah Medical Center, Jerusalem and the Rabin Medical Center, Petach Tikva. Patients who suffer from NAFLD/NASH with evidence of active inflammation are treated twice daily with 12.5 or 25 mg of oral Namodenoson vs. placebo. The primary end point of the Phase II study is the anti-inflammatory effect of the drug, as determined by ALT blood levels, and the secondary end points include percentage of liver fat, as measured by MRI-PDFF (proton density fat fraction). The company anticipates the completion of patient enrollment toward the end of 2018 and data release in the first half of 2019.

Recent safety data showed that Namodenoson has a favorable profile and lack of hepatotoxicity in patients. Preclinical data demonstrate robust anti-inflammatory, anti-fibrogenic and anti-steatotic effects, supporting its development for the NAFLD/NASH indication.

Can-Fite CEO Dr. Pnina Fishman commented, "We are pleased with the progress so far in our clinical trial with Namodenoson for the treatment of NAFLD/NASH, and we look forward to data release later in H1/2019."

There is currently no U.S. FDA approved drug for the treatment of NASH, which is an addressable pharmaceutical market estimated to reach $35-40 billion by 2025.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug

Pacira Reports Fourth Quarter and Full Year 2017 Financial Results and Provides Business Update

On February 28, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported financial results for the fourth quarter and full year of 2017 and its outlook for 2018 (Press release, Pacira Pharmaceuticals, FEB 28, 2018, View Source;p=RssLanding&cat=news&id=2335267 [SID1234524254]).

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"2017 was a year of solid progress and set the stage for an important year ahead," said Dave Stack, chairman and chief executive officer of Pacira. "EXPAREL has now been used in over 3.5 million patients across the United States and continues to grow. We remain steadfast in our mission to provide a non-opioid option to as many patients as possible, including defining the next steps for the expanded nerve block indication through our pending sNDA. Our strategic partnership with Johnson & Johnson continues to drive EXPAREL use within the orthopedic setting. In addition, we are advancing key collaborations to support best-practice opioid minimization strategies. Finally, our education and awareness campaigns are bearing fruit as more and more key stakeholders including patients, physicians, medical societies and advocacy organizations are recognizing and appreciating the benefits of non-opioid postsurgical pain control."

Highlights and Recent Events

Collaboration with The University of Tennessee Medical Center and CQ-Insights to minimize opioid use after hernia surgery. In February 2018, The University of Tennessee Medical Center and Pacira announced a continuous quality improvement (CQI) project designed to develop low-or no-opioid postsurgical pain management pathways for patients undergoing one of the most common surgical procedures, hernia surgery.

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee did not support approval of the EXPAREL sNDA for nerve block. In February 2018, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee’s (AADPAC) reviewed the company’s supplemental New Drug Application, or sNDA, seeking expansion of the EXPAREL label to include administration via nerve block for prolonged regional analgesia. The AADPAC voted six to four against approval of the expanded indication. The committee’s feedback will be considered for the FDA in its review of the sNDA. The FDA’s Prescription Drug User Fee Act goal date for completion of its review is April 6, 2018.

Partnership with WellStar Health Systems to minimize opioid use and standardize outcomes across surgical procedures. In January 2018, WellStar Health System, the largest health system in Georgia, and Pacira announced a joint commitment to address opioid use and dependence following surgery. Through a comprehensive opioid minimization strategy, the organizations will work together to educate hospital clinicians and administrators about the burden of postsurgical opioids; develop enhanced recovery protocols to reduce use in key surgical procedures; and standardize the rollout of these protocols across WellStar’s 11 hospitals.

Promotions of Scott Braunstein, MD, to Chief Operating Officer and Richard Scranton, MD, to Chief Scientific Officer. In December 2017, Scott Braunstein, MD, was named Chief Operating Officer and Richard Scranton, MD, was named Chief Scientific Officer. Dr. Braunstein is overseeing the company’s commercial and medical affairs functions while continuing to manage strategy and corporate development. As Chief Scientific Officer, Dr. Scranton is directing the company’s clinical research while continuing to lead scientific communications, market access, and health outcomes research and analytics for EXPAREL.

Collaboration with Illinois Surgical Quality Improvement Collaborative to minimize opioid exposure for postsurgical patients. In December 2017, the Illinois Surgical Quality Improvement Collaborative, a nationally recognized partnership of 56 Illinois hospitals, and Pacira announced an initiative to jointly develop programs and resources that will support best practice pain management prescribing for surgical patients throughout the state of Illinois. The focus of the initiative is to develop and provide intensive, interactive educational tools for hospitals in order to improve adherence to evidence-based best practices for perioperative pain management.

Collaboration with Cancer Treatment Centers of America to educate physicians and patients about responsible opioid use. In November 2017, Cancer Treatment Centers of America, a national network of five hospitals and Pacira announced a new collaboration dedicated to reducing the risk of opioid dependence among cancer patients. The goal of the Opioid Risk Reduction Initiative—an education effort focused on responsible use and increased awareness of opioid alternatives—is to improve the cancer patient experience through expanded pain management options.

Fourth Quarter 2017 Financial Results

EXPAREL net product sales were $78.7 million in the fourth quarter of 2017, a 10% increase over the $71.4 million reported for the fourth quarter of 2016.

Total revenues were $79.1 million in the fourth quarter of 2017, an 8% increase over the $72.9 million reported for the fourth quarter of 2016.

Total operating expenses were $70.6 million in the fourth quarter of 2017, compared to $75.4 million in the fourth quarter of 2016.

GAAP net income was $4.6 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2017, compared to a GAAP net loss of $4.0 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2016.

Non-GAAP net income was $16.0 million, or $0.39 per share (basic) and $0.38 per share (diluted), in the fourth quarter of 2017, compared to non-GAAP net income of $3.6 million, or $0.10 per share (basic) and $0.09 per share (diluted), in the fourth quarter of 2016.

Pacira had 40.6 million basic weighted average shares of common stock outstanding in the fourth quarter of 2017.

Pacira had 41.6 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2017.

Full-Year 2017 Financial Results

EXPAREL net product sales were $282.9 million in 2017, a 6% increase over the $265.8 million reported in 2016.

Total revenues were $286.6 million in 2017, a 4% increase over the $276.4 million reported in 2016.

Total operating expenses were $311.6 million in 2017, compared to $308.4 million in 2016.

GAAP net loss was $42.6 million, or $1.07 per share (basic and diluted) in 2017, compared to a GAAP net loss of $37.9 million, or $1.02 per share (basic and diluted) in 2016.

Non-GAAP net income was $8.6 million, or $0.22 per share (basic) and $0.21 per share (diluted), in 2017, compared to non-GAAP net income of $25.2 million, or $0.68 per share (basic) and $0.62 per share (diluted), in 2016.

Pacira ended 2017 with cash, cash equivalents, short-term and long-term investments ("cash") of $371.4 million.

Pacira had 39.8 million basic weighted average shares of common stock outstanding in 2017.

For non-GAAP measures, Pacira had 41.4 million diluted weighted average shares of common stock outstanding in 2017.

2018 Outlook

Pacira announces its full year 2018 financial guidance as follows. Pacira expects:

EXPAREL net product sales of $300 million to $310 million.

Non-GAAP gross margins of 70% to 72%.

Non-GAAP research and development (R&D) expense of $50 million to $60 million.

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.

See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, February 28, 2018, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 5198726.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 5198726. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude stock-based compensation, amortization of debt discount, loss on early extinguishment of debt, a contract termination fee with CrossLink BioScience, LLC, or CrossLink, exit costs related to the discontinuation of DepoCyt(e) production and inventory and related reserves from 2016.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2018 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2018 financial guidance for gross margins, R&D expense and SG&A expense.

Navidea Biopharmaceuticals Schedules Fourth Quarter and Full Year 2017 Earnings Conference Call and Business Update

On February 28, 2018 Navidea Biopharmaceuticals (NYSE MKT: NAVB) ("Navidea" or "the Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported it will host a conference call on March 8, 2018 at 4:30pm E.T. to discuss its financial results for the fourth quarter and full year 2017, in conjunction with the filing of its annual report on Form 10-K for the fourth quarter and full year results ended December 31, 2017 (Press release, Navidea Biopharmaceuticals, FEB 28, 2018, View Source [SID1234524252]).

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Michael Goldberg, President and Chief Executive Officer, and Jed Latkin, Chief Financial and Operating Officer of Navidea, will host the call and provide an update on recent developments and clinical progress. Management will be answering questions live immediately following the earnings announcement part of the call.

To participate in the call, please dial +1 646-828-8143 (toll-free) in the U.S. and Canada. The conference ID number is 1826783.

Event: FY+ 2017 Earnings and Business Update Conference Call
Date: Thursday, March 8th, 2018
Time: 4:30pm E.T.
U.S. & Canada Dial-in: +1 646-828-8143 (toll free)
Conference ID: 1826783

A live audio webcast of the conference call will also be available on the investor relations page of Navidea’s corporate website at www.navidea.com. In addition, the recorded conference call can be replayed and will be available for 90 days following the call on Navidea’s website.

TRACON Pharmaceuticals Reports Fourth Quarter and Year-End 2017 Financial Results and Provides Corporate Update

On february 28, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age‐related macular degeneration, reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Tracon Pharmaceuticals, FEB 28, 2018, View Source [SID1234524975]).

Fourth Quarter 2017 and Recent Corporate Highlights

In February, TRACON’s partner, Santen Pharmaceutical Co. Ltd. (Santen), reported Phase I/II data for DE‑122 (carotuximab) in patients with refractory wet age-related macular degeneration (AMD) at the 15th Annual Angiogenesis, Exudation, and Degeneration meeting organized by Bascom Palmer Eye Institute. The study assessed the safety, tolerability and bioactivity of a single intravitreal injection of DE-122 at four dose levels in 12 subjects with wet AMD refractory to vascular endothelial growth factor (VEGF) inhibitors. Improvement was observed in mean change in central retinal subfield thickness (CST) based on the spectral domain optical coherence tomography (SD-OCT) suggesting bioactivity of DE-122 in these refractory wet AMD patients. No serious adverse events were reported. Based on these results, Santen previously advanced DE-122 into a Phase 2a randomized controlled trial assessing the efficacy and safety of intravitreal injections in combination with Lucentis (ranibizumab) compared to Lucentis monotherapy in patients with wet AMD that continues to enroll subjects, and which resulted in TRACON receiving a $7.0 million milestone payment.

In January, initial data from the ongoing open-label, non-randomized Phase 1b/2 study of TRC105 and Nexavar (sorafenib) in patients with advanced hepatocellular carcinoma (HCC) were presented by Dr. Kanwal Raghav from the University of Texas MD Anderson Cancer Center at the 2018 ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium. Partial responses by RECIST 1.1 occurred in 25% (2 of 8) of evaluable patients and a reduction of 50% or greater in alpha fetoprotein (AFP) concentration occurred in 38% (3 of 8) of evaluable patients, including both partial responses. Reduction in AFP, a tumor marker expressed in patients with HCC, in early treatment may help identify a favorable response to treatment. Adverse events typical of each drug were observed but did not increase in frequency or severity when the drugs were administered concurrently. The 25% response rate seen in this trial is consistent with the 25% (5 of 20) response rate reported in a Phase 1/2 trial of TRC105 and Nexavar conducted by the National Cancer Institute and published in Clinical Cancer Research in 2017. The response rates observed in both trials compare favorably with the 2% and 3% response rates in HCC patients reported for single agent Nexavar in its pivotal studies. The trial is currently ongoing, and we expect to complete the enrollment of approximately 33 patients by the end of 2018.

In December, TRACON licensed development and commercialization rights outside of ophthalmology indications to TRC105 in China, Hong Kong, Macau, and Taiwan to Ambrx. Deal terms included a $3.0 million upfront payment to TRACON, up to $140.5 million in development and commercial milestones and potential high single digit to low teen royalties from net sales of TRC105 in the Ambrx territories. Ambrx is expected to file an IND later this year and to subsequently begin clinical development of TRC105 in China.

In December, Brian Daniels, M.D., was appointed to TRACON’s Scientific Advisory Board. Dr. Daniels was Senior Vice President at Bristol-Myers Squibb until 2014, where he chaired the development investment committee and oversaw the development of Sprycel (dasatinib), Ixempra (ixabepilone), Yervoy (ipilumumab), Empliciti (elotuzumab), and Opdivo (nivolumab). He is currently a venture partner at 5AM Ventures, and previously held senior level development-related positions at Merck and Genentech. In addition, Dr. Daniels previously served in multiple academic roles in the Department of Medicine at the University of California, San Francisco.

In November, the first patient was dosed in a Phase 1b clinical trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer. The Phase 1b clinical trial is an open-label, dose-escalation and expansion cohort study of TRC105 and Opdivo in patients with non-small cell lung cancer that have received prior chemotherapy. The primary objectives of the Phase 1b study are to assess the safety of TRC105 when dosed with Opdivo, determine its recommended Phase 2 dose and evaluate the response rate. The trial incorporates tumor biopsy testing to determine if there is a correlation of tumor myeloid cell infiltration with response, in order to allow for potential biomarker-directed therapy in lung cancer patients.

In November, TRACON presented updated data from the Phase 1b/2 study of TRC105 and Votrient (pazopanib) in patients with soft tissue sarcoma, including angiosarcoma, at the Connective Tissue Oncology Society (CTOS) annual meeting. Median progression-free survival (PFS) was 7.8 months in 13 VEGF inhibitor naïve angiosarcoma patients treated with the combination of TRC105 and Votrient using either 10 mg/kg weekly dosing or the hybrid dosing schedule of TRC105. The reported median PFS compares favorably to the median PFS of 3 months reported in a retrospective study of single agent Votrient in patients with angiosarcoma. In the 17 patients who received prior treatment for metastatic disease, treatment duration on TRC105 and Votrient exceeded the duration of the most recent prior therapy in 7 of 12 VEGF naïve angiosarcoma patients and 2 of 5 patients who received a VEGF inhibitor as part of their most recent prior therapy. Treatment with the combination of TRC105 and Votrient continued to be well-tolerated and allowed for dosing of the combination for more than two years in the two patients who experienced complete responses to treatment.

Enrollment continues in the Phase 1/2 trial of TRC253, TRACON’s product candidate for treating prostate cancer that was in-licensed from Janssen. The Phase 1/2 trial is designed to assess the safety, determine a recommended Phase 2 dose and assess response by prostate-specific antigen (PSA) levels. If Janssen opts to reacquire TRC253 prior to or following completion of the Phase 1/2 trial, TRACON is entitled to receive a $45.0 million opt-in payment, up to $137.5 million in potential milestone payments and a low single digit royalty.
"We achieved important progress across our pipeline and continued to position the Company well for long-term success during the fourth quarter and throughout 2017," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Most importantly, our pivotal Phase 3 TAPPAS trial of TRC105 in angiosarcoma continues to enroll well across sites in the U.S. and now Europe, with the key interim analysis projected for later this year. Moreover, our recent partnership with Ambrx expands the development and potential commercial opportunity of TRC105 into China."

Expected Additional 2018 Milestones

Completion of the dose escalation portion of the Phase 1/2 trial of TRC253 in patients with prostate cancer is expected in mid-2018.

Announcement of top-line data from the randomized Phase 2 TRAXAR trial of TRC105 in combination with Inlyta for patients with advanced or metastatic renal cell carcinoma is expected in mid-2018.

Announcement of the results of the interim analysis from the Phase 3 pivotal TAPPAS trial of TRC105 in angiosarcoma is expected in the second half of 2018.

Presentation of data from the Phase 1b trial of TRC105 in combination with Opdivo in patients with non-small cell lung cancer is expected in the second half of 2018.
Fourth Quarter 2017 Financial Results

Cash, cash equivalents and short-term investments were $34.5 million at December 31, 2017, compared to $44.4 million at December 31, 2016.

There was no collaboration revenue for the fourth quarter of 2017 compared to $0.6 million for the fourth quarter of 2016.

Research and development expenses for the fourth quarter of 2017 were $4.6 million compared to $4.8 million for the fourth quarter of 2016.

General and administrative expenses for the fourth quarter of 2017 were $1.7 million compared to $1.9 million for the fourth quarter of 2016.

Net loss for the fourth quarter of 2017 was $6.6 million compared to a net loss of $6.3 million for the fourth quarter of 2016.
Investor Conference Call

The Company will hold a conference call today at 4:30 p.m. EST / 1:30 p.m. PST to provide an update on corporate activities and to discuss the financial results of its fourth quarter of 2017. The dial-in numbers are (855) 779‑9066 for domestic callers and (631) 485-4859 for international callers. Please use passcode 1894785. A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Carotuximab (TRC105)

TRC105 is a novel, clinical stage antibody to endoglin, a protein overexpressed on proliferating endothelial cells that is essential for angiogenesis, the process of new blood vessel formation. TRC105 is currently being studied in a pivotal Phase 3 trial in angiosarcoma and multiple Phase 2 clinical trials, in combination with VEGF inhibitors. TRC105 has received orphan designation for the treatment of soft tissue sarcoma in both the U.S. and EU. The ophthalmic formulation of TRC105, DE-122, is currently in a randomized Phase 2 trial for patients with wet AMD. For more information about the clinical trials, please visit TRACON’s website at www.traconpharma.com/clinical_trials.php.

About TRC253

TRC253 is a novel, orally bioavailable small molecule that is a potent, high affinity competitive inhibitor of the androgen receptor (AR) and AR mutations, including the F876L (also known as F877L) mutation. The AR F876L mutation results in an alteration in the AR ligand binding domain that confers resistance to therapies for prostate cancer. Activation of the AR is crucial for the growth of prostate cancer at all stages of the disease. Therapies targeting the AR have demonstrated clinical efficacy by extending time to disease progression, and in some cases, the survival of patients with metastatic castration-resistant prostate cancer. However, resistance to these agents is often observed and several molecular mechanisms of resistance have been identified, including gene amplification, overexpression, alternative splicing, and point mutation of the AR.