Conatus 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, Conatus Pharmaceuticals, 2018, MAR 8, 2018, View Source [SID1234524552]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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On March 8, 2018 Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that fourth quarter and year-end 2017 financial and operating results after the close of the U.S. financial markets on Monday, March 12, 2018. Management will host a conference call and live audio webcast to discuss these results and provide a corporate update at 4:30 p.m. ET (Press release, Iovance Biotherapeutics, MAR 8, 2018, View Source;p=RssLanding&cat=news&id=2337036 [SID1234524541]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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In order to participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 1497629. The live webcast can be accessed under "News & Events" in the "Investors" section of the Company’s website at View Source or you may use the link: View Source

A replay of the call will be available from March 12, 2018 at 7:30 p.m. ET to April 18, 2018 at 8:30 p.m. ET. To access the replay, please dial 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and reference the access code 1497629. The archived webcast will be available for thirty days in the Investors section of Iovance Biotherapeutics’ website at View Source.

On March 8, 2018 Navidea Biopharmaceuticals, Inc. (NYSE American: NAVB) ("Navidea" or the "Company"), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported its financial results for the fourth quarter of 2017 (Press release, Navidea Biopharmaceuticals, MAR 8, 2018, View Source [SID1234524565]). Navidea reported total revenues for the quarter of $395,000. Net loss attributable to common stockholders for the quarter was $4.1 million. Total revenues for 2017 were $1.8 million, and net income attributable to common stockholders was $74.9 million.

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"It’s been quite a transition year for Navidea going from a commercial operation, with its own dedicated sales force, to a development-focused company leveraging its best-in-class activated macrophage targeting system," said Michael Goldberg, M.D., Navidea’s President and Chief Executive Officer.

Dr. Goldberg continued, "I am more excited today than I have ever been as we push forward on the three key pillars of our business; CD206 biomarker identification, diagnostic imaging and therapeutics. I expect that the coming year will be characterized by the release of data that confirms our strategy that focusing on the targeting of activated macrophages with our proprietary imaging agents in humans and our proprietary therapeutics in animals has the potential to generate significant commercial opportunities for Navidea in the short term."

Fourth Quarter 2017 Highlights and Subsequent Events

Selected as 1 of 25 from 1100 applicants to present a late-breaking poster at the American College of Rheumatology Annual Meeting detailing the results of an intravenous ("IV")-administered study in rheumatoid arthritis ("RA") patients;
Completed the Phase 2 IV RA study;
Commenced dosing and imaging in the 12-subject nonalcoholic steatohepatitis ("NASH") diagnostic study at Kettering Medical Center in Ohio;
Commenced dosing and imaging in the 24-subject visceral Kaposi’s Sarcoma ("KS") diagnostic study at the University of California, San Francisco;
Commenced dosing and imaging in the 24-subject HIV+ Cardiovascular trial at Massachusetts General Hospital-Harvard University under the direction of Dr. Steven Grinspoon;
Commenced dosing and imaging in the 12-subject colorectal cancer trial with synchronous liver metastases at the University of Alabama at Birmingham;
Submitted an extensive grant to support broad expansion of both Navidea’s and the Massachusetts General Hospital’s work in Cardiovascular imaging;
The National Cancer Institute awarded Navidea a Fast Track Small Business Innovation Research ("SBIR") grant that will provide up to $1.8 million to fund preclinical and subsequent clinical studies examining the safety and efficacy of IV Tc 99m tilmanocept to identify and quantify both skin- and organ-associated KS lesions;
Completed regulatory strategies for imaging and inflammation for Phase 3 trials (pending meeting with the U.S. Food & Drug Administration); and
Appointed Claudine Bruck, Ph.D. as a member of the board of directors of the Company effective March 5, 2018.
Financial Results

Our consolidated balance sheets and statements of operations have been reclassified, as required by current accounting standards, for all periods presented to reflect the line of business sold to Cardinal Health 414, LLC ("Cardinal Health 414") on March 3, 2017 as a discontinued operation. Accordingly, this discussion focuses on describing results of our operations as if we had not operated the discontinued operation during the periods being disclosed.

We recorded a $89.2 million net gain on the line of business sold to Cardinal Health 414 for the year ended December 31, 2017, including $16.5 million in guaranteed consideration, which was discounted to the present value of future cash flows. The proceeds were offset by $3.3 million in estimated fair value of warrants issued to Cardinal Health 414, $2.0 million in legal and other fees related to the sale, $800,000 in net balance sheet dispositions and write-offs, and $4.1 million in estimated taxes.
Total revenues for the fourth quarter of 2017 were $395,000, compared to $1.0 million in the fourth quarter of 2016. Revenues for the full year of 2017 were $1.8 million, compared to $5.0 million in 2016. Revenues were primarily related to grants and licenses, and do not include the guaranteed earnout payments received from Cardinal Health 414 during 2017.
Research and development ("R&D") expenses for the fourth quarter of 2017 were $1.7 million, compared to $2.1 million in the fourth quarter of 2016. R&D expenses for the full year of 2017 were $4.5 million, compared to $7.1 million in 2016. The net decrease was primarily a result of decreases in Tc99m tilmanocept, NAV4694 and NAV5001 development costs coupled with decreased net compensation costs, offset by increases in Manocept platform development costs.
Selling, general and administrative ("SG&A") expenses for the fourth quarter of 2017 were $2.2 million, compared to $2.1 million in the fourth quarter of 2016. SG&A expenses for the full year of 2017 were $11.2 million, compared to $7.9 million in 2016. The net increase was primarily due to several non-recurring charges, including a $2.0 increase in legal expenses due to CRG and other concluded legal matters, $949,000 of other items including the FTI settlement, the Cardinal deal completion bonuses, severance payouts and asset disposal costs.
Navidea’s net loss attributable to common stockholders for the quarter ended December 31, 2017 was $4.1 million, or $0.03 per share (basic), compared to a net loss of $3.9 million, or $0.02 per share (basic), for the same period in 2016. Navidea’s net income attributable to common stockholders for the year ended December 31, 2017 was $74.9 million, or $0.47 per share (basic), compared to a net loss of $14.3 million, or $0.09 per share (basic), for the same period in 2016.
Navidea ended the quarter with $4.6 million in cash and investments.
Full Year 2017 Highlights and Subsequent Events

On March 3, 2017, Navidea completed the sale of the North American rights to Lymphoseek to Cardinal Health 414, receiving approximately $82 million at closing;
Presented two papers at the Society of Nuclear Medicine and Molecular Imaging Annual Meeting detailing initial results from the SC-administered study in RA;
Initiated Biomarker Qualification with FDA biomarker division;
Selected by NIH/NIAMS as one of 24 from 1200 awardees to present business development and RA clinical results at the International Biotechnology Innovation Organization 2017 meeting in June, 2017;
Initiated series of regular investor-focused Q&A conference calls to strengthen investor relations;
Presented a late-breaking poster presented at the American College of Rheumatology Annual Meeting detailing the results of an IV-administered study in RA patients;
Transferred three clinical trials in sentinel node biopsy to Cardinal Health 414, including cervical, anal/rectal and pediatric trials;
Completed filings or disclosures on multiple new intellectual property constructs and usages; and
Completed preclinical testing of therapeutic constructs in Zika, Dengue, leishmaniosis, KS, tumor models and NASH model systems.
Conference Call Details

Investors and the public are invited to access the live audio webcast through the link below. Participants who would like to ask questions during the question and answer session must participate by telephone. Participants are encouraged to log-in and/or dial-in fifteen minutes before the conference call begins.

Event: Q4 and Full Year 2017 Earnings and Business Update Conference Call
Date: Thursday, March 8, 2018
Time: 4:30 p.m. (Eastern Time)
U.S. & Canada Dial-in: 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.

On March 8, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the fourth quarter and year ended December 31, 2017 and provided recent company developments along with a business outlook for 2018 (Press release, TG Therapeutics, MAR 8, 2018, View Source [SID1234524542]).

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Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "2017 was a truly pivotal year for our company with the presentation of positive results from our first Phase 3 trial, the GENUINE trial, the completion of enrollment in our second Phase 3 trial, the UNITY-CLL trial, and the launch of our Phase 3 ULTIMATE trials in Multiple Sclerosis. These major milestones along with strong enrollment in our UNITY-NHL registration directed program sets the stage for an even more impactful 2018 and 2019." Mr. Weiss continued, "We are extremely pleased to enter 2018 with a healthy balance sheet and look forward to multiple value creating milestones this year, including presenting topline ORR data from our Phase 3 UNITY-CLL trial and, ideally, filing our first BLA and/or NDA later in the year."

2017 Highlights

● Orphan Drug Designation: Orphan drug designation was granted for the combination of ublituximab (TG-1101) and umbralisib (TGR-1202) for the treatment of Chronic Lymphocytic Leukemia (CLL) and Diffuse Large B-Cell Lymphoma (DLBCL).
● Ublituximab Publication: Data from the Phase 1/2 trial of ublituximab was published in the British Journal of Haematology.
● GENUINE Phase 3 Data: Positive data from the Phase 3 GENUINE trial of ublituximab in combination with ibrutinib in patients with high risk CLL was presented at the ASCO (Free ASCO Whitepaper) annual meeting and Lugano Lymphoma Conference.
● ULTIMATE Phase 3 Trials in MS: Received a Special Protocol Assessment (SPA) for the Phase 3 ULTIMATE I and II studies in relapsing forms of multiple sclerosis, commenced enrollment into the global studies and presented clinical and MRI data from the supportive Phase 2 trial of ublituximab in RMS at various conferences throughout the year.
● UNITY-CLL Phase 3 Enrollment: Full enrollment in the UNITY-CLL Phase 3 Trial was completed in October 2017
● Umbralisib Grant: Umbralisib was selected for a grant by the National Multiple Sclerosis Society to support the development of umbralisib as an oral B-Cell targeted treatment option in progressive Multiple Sclerosis (PMS).
● Anti-PD-L1 Entered the Clinic: The Company advanced its anti-PD-L1 monoclonal antibody into clinical development, with the first patient being dosed in a Phase I clinical trial.

Key Objectives for 2018

● UNITY-CLL Phase 3 Trial: We plan to present top-line overall response rate results from our UNITY-CLL Phase 3 trial in both front line and relapsed or refractory CLL and also prepare a BLA/NDA filing for accelerated approval.
● GENUINE Phase 3 BLA Filing: A Biologics Licensing Application (BLA) filing will be prepared for ublituximab plus ibrutinib for potential accelerated approval based on the results from GENUINE.
● UNITY-NHL: Aggressively enroll into all cohorts of the UNITY-NHL clinical trial with the goal of completing enrollment into all cohorts.
● ULTIMATE Phase 3 Trials: Aggressively recruit to our Phase 3 MS trials.
● Data Presentations: Present new and updated data from ongoing trials at various scientific meetings throughout the year.

Financial Results for the Fourth Quarter and Full Year 2017

● Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $84.8 million as of December 31, 2017. Pro-forma cash, cash equivalents, investment securities, and interest receivable as of December 31, 2017 (excluding our first quarter 2018 operations) are approximately $114.6 million, after giving effect to $29.8 million of net proceeds from the utilization of the Company’s at-the-market ("ATM") sales facility during the first quarter of 2018.

● R&D Expenses: Research and development (R&D) expenses were $26.0 million and $102.5 million for the three and twelve months ended December 31, 2017, respectively, compared to $22.3 million and $69.2 million for the three and twelve months ended December 31, 2016, respectively. Included in research and development expenses for the three and twelve months ended December 31, 2017, in addition to our other clinical expenses, are $6.1 million and $26.6 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. The increase in R&D expenses for both the three and twelve months ended December 31, 2017, is primarily due to the ongoing clinical development programs and related manufacturing costs for TG-1101 and TGR-1202.

● G&A Expenses: General and administrative (G&A) expenses were $5.1 million and $16.3 million for the three and twelve months ended December 31, 2017, respectively, as compared to $1.8 million and $9.9 million for the three and twelve months ended December 31, 2016, respectively. The increase in G&A expenses for the three and twelve months ended December 31, 2017 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during 2017.

● Net Loss: Net loss was $30.9 million and $118.5 million for the three and twelve months ended December 31, 2017, respectively, compared to a net loss of $23.7 million and $78.3 million for the three and twelve months ended December 31, 2016, respectively.

● Financial Guidance: The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of December 31, 2017, inclusive of the proceeds raised subsequent to the year-end will be sufficient to fund the Company’s planned operations through mid-2019.

Conference Call Information

The Company will host an investor conference call today, Thursday, March 8, 2018 at 8:30am ET, to discuss the Company’s 2017 financial results and provide a business outlook for 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Year-End 2017 Earnings Call. A live audio webcast of this conference call will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call

On March 8, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported fourth quarter and full year 2017 financial results (Press release, OncoMed, MAR 8, 2018, View Source [SID1234524566]).

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"As we look ahead into 2018, OncoMed’s focus is on developing our novel anti-cancer therapeutic candidates through key value inflection points. OncoMed’s two most advanced immuno-oncology programs, anti-TIGIT and GITRL-Fc, are progressing well, and the Company is encouraged by the robust pace of enrollment in both programs. In the near-term, OncoMed will initiate the Phase 1b portion of anti-TIGIT in combination with an anti-PD1 agent, and it is the company’s current plan to present data from the on-going Phase 1a study in the 4th quarter of 2018," stated John Lewicki, Ph.D., President of OncoMed. "Additionally, OncoMed expects to present data from an on-going Phase 1b study of navicixizumab in the 2nd half of 2018."

Pipeline Highlights

Anti-TIGIT (OMP-313M32)

OncoMed plans to initiate the Phase 1b portion of its anti-TIGIT trial to study anti-TIGIT in combination with anti-PD1 in the first half of 2018. The Phase 1b portion of the anti-TIGIT trial is designed to assess safety and tolerability of escalating doses of the combination treatment.
OncoMed continues enrollment in the Phase 1a single agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses. Pharmacodynamic biomarkers will be assessed in this study which includes a dose expansion cohort. The company’s current plan is to present data from the on-going Phase 1a study in the 4th quarter of 2018.
GITRL-Fc (OMP-336B11)

Enrollment continues in the Phase 1a single agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to directly activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses. The presentation of data from this Phase 1 study is currently planned for 2019.
Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer. To date, OncoMed has enrolled over 90 patients across the Phase 1a and Phase 1b trials. In the 2nd half of 2018, we expect to publish the Phase 1a data and report interim data from the Phase 1b ovarian cancer study.
Fourth Quarter and Full Year 2017 Financial Results

Cash, cash equivalents and short-term investments totaled $103.1 million as of December 31, 2017, compared to $184.6 million as of December 31, 2016.

Revenues were $38.2 million for the full year of 2017, an increase of $13.0 million, compared to $25.2 million in 2016. The increase in revenue was primarily due to an increase in amortization of upfront fees from our partnership with Celgene as a result of revision of estimated period of performance. Revenues were $20.6 million during the fourth quarter of 2017, an increase of $14.4 million, compared to $6.2 million for the same quarter in 2016.

Research and development (R&D) expenses were $59.8 million for the full year of 2017, a decrease of $49.9 million, compared to $109.7 million in 2016. The decrease was primarily due to lower external research and development costs resulting from the discontinuation of dosing of all patients in our demcizumab and tarextumab programs and a decrease in internal costs due to reduced headcount following the restructuring actions in April 2017. R&D expenses were $8.6 million for the fourth quarter of 2017, a decrease of $15.6 million, compared to $24.2 million for the same quarter in 2016.

General and administrative (G&A) expenses were $16.8 million for the full year of 2017, a decrease of $2.0 million, compared to $18.8 million in 2016. The decrease was primarily attributable to a decrease in personnel costs, including stock-based compensation expenses, as a result of our reduced headcount following the restructuring actions in April 2017. G&A expenses were $3.8 million for the fourth quarter of 2017, a decrease of $0.6 million, compared to $4.4 million for the same quarter in 2016.

Net loss for the year ended December 31, 2017 was $39.1 million ($1.04 per share), compared to $103.1 million ($3.14 per share) in 2016. The change in year-over-year net loss was primarily due to higher collaboration revenue and lower operating expenses. Net income for the fourth quarter of 2017 was $9.5 million ($0.25 per share, basic and diluted), compared to a net loss of $22.3 million ($0.60 per share, basic and diluted) for the same quarter in 2016.

2018 Financial Guidance

OncoMed’s current cash is estimated to be sufficient to fund operations through at least the third quarter of 2019, without taking into account future potential milestone payments from its partners. OncoMed estimates 2018 operating cash burn to be approximately $55 million, before considering potential milestones/opt-ins.

Corporate Update

As announced in January, the Board of Directors has retained an executive search firm and initiated a search for a Chief Executive Officer. The company also announced in January that Executive Vice President and Chief Financial Officer Sunil Patel has resigned effective March 9, 2018. As a result of these executive changes, OncoMed named Perry Karsen as Executive Chairman of the Board of Directors and John Lewicki as President of OncoMed. The company plans to provide an update on the CEO search once a final decision has been made.

"We are very grateful for Sunil’s nine years of leadership, and wish him the best in all of his future endeavors. Sunil has played an instrumental role in OncoMed’s growth, and his contributions to our patients and shareholders will be carried forward in the continued advancement of our clinical programs," commented Perry Karsen, Executive Chairman of OncoMed.

Conference Call Today

OncoMed management will host a conference call today beginning at 4:30 p.m. ET / 1:30 p.m. PT to review fourth quarter and full year 2017 financial results and corporate updates.

Analysts and investors can participate in the conference call by dialing (855) 420-0692 (domestic) and (484) 756-4194 (international) using the conference ID# 4997704. The webcast of the conference call can be accessed live on the Investor Relations section of the OncoMed website, View Source

An audio replay of the conference call can be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) utilizing the conference ID number listed above. The web broadcast of the conference call will be available for replay through the OncoMed website.