PDL BioPharma Announces Fourth Quarter and Year End 2017 Financial Results

On March 8, 2018 PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) reported financial results for the fourth quarter and year ended December 31, 2017 including (Press release, PDL BioPharma, MAR 8, 2018, View Source [SID1234524568]):

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Total revenues of $68.0 million and $320.1 million for the three and twelve months ended December 31, 2017, respectively.
GAAP diluted EPS of $0.15 and $0.71 for the three and twelve months ended December 31, 2017, respectively.
GAAP net income attributable to PDL’s shareholders of $22.3 million and $110.7 million for the three and twelve months ended December 31, 2017, respectively.
Non-GAAP net income attributable to PDL’s shareholders of $24.8 million and $100.7 million for the three and twelve months ended December 31, 2017. A full reconciliation of all components of the GAAP to non-GAAP financial results can be found in Table 3 at the end of the release.
"2017 was a great year for us and one where we experienced a 31 percent increase in revenue from the previous year," stated John P. McLaughlin, chief executive officer of PDL. "Since 2012, we have built a rich portfolio of income generating assets and products to replace revenues from our expired Queen et al patents. We expect the revenues from these assets, whose net book value is $5.54 per share, to fuel the building of our specialty pharma business. It’s important to note that $264 million, or 83 percent of our 2017 revenues, came from sources other than the Queen et al patents. In 2018, we need to continue to execute successfully on our business model as well as close the gap between our share price and our book value per share."

Revenue Highlights

Total revenues of $68.0 million for the three months ended December 31, 2017 included:
Royalties from PDL’s licensees to the Queen et al. patents of $4.5 million, which consisted of royalties earned on sales of Tysabri;
Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $30.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to Depomed, Inc. (Depomed) royalty asset;
Interest revenue from note receivable investment to CareView Communications of $0.8 million; and
Product revenues of $32.6 million, which consisted of $25.1 million from sales of Tekturna and Tekturna HCT in the United States, Rasilez and Rasilez HCT in the rest of the world (collectively, the Noden Products) and $7.5 million for product sales of the LENSAR Laser System.
Total revenues increased by 2 percent for the three months ended December 31, 2017, when compared to the same period in 2016.
Royalties from PDL’s licensees to the Queen et al. patents were lower due to reduced sales of Tysabri that was manufactured prior to the patent expiry date;
PDL received $32.8 million in net cash royalties from its royalty rights in the fourth quarter of 2017, compared to $25.3 million for the same period of 2016. The increase in cash royalties is mainly due to a one-time settlement payment from Valeant related to the royalty audit of Glumetza and the launch of the authorized generic for Glumetza sold by Valeant Pharmaceuticals International, Inc. PDL received royalties on the authorized generic equivalents under the same terms as the branded Glumetza;
The decrease in interest revenues was primarily due to the sale of the kaléo, Inc. note receivable in September 2017; and
The increase in product revenues were derived from the sale of the LENSAR Laser System, which PDL did not begin to recognize until May 2017.
Total revenues increased by 31 percent for the year ended December 31, 2017, when compared to the year ended December 31, 2016.
The decrease in royalties from PDL’s licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc. and reduced royalties on Tysabri.
The increase in royalty rights – change in fair value was primarily due to the year-to-date increase in fair value of the Depomed royalty asset by $134.1 million.
PDL received $107.3 million in net cash royalties, including a one-time settlement payment from Valeant related to the royalty audit of Glumetza, from its royalty rights in the year ended December 31, 2017, compared to $72.6 million for the same period of 2016.
The decrease in interest revenues was primarily due to the early repayment of the Paradigm Spine, LLC note receivable and the sale of the kaléo, Inc. note receivable.
Product revenue increased due to sales of the Noden Products, which PDL did not begin to recognize until the third quarter of 2016, and sales of the LENSAR Laser System, which PDL did not begin to recognize until May 2017.
License and other revenue increased by $19.6 million primarily due to a one-time $19.5 million payment from Merck as part of the previously announced settlement agreement to resolve the patent infringement lawsuit related to Keytruda.
Operating Expense Highlights

Operating expenses were $38.2 million for the three months ended December 31, 2017, compared to $74.2 million for the same period of 2016. The decrease in operating expenses for the three months ended December 31, 2017, as compared to the same period in 2016, was primarily a result of the prior year period loss on extinguishment of Direct Flow Medical notes receivable, partially offset by the increase in operating expenses related to the acquisitions and operations of Noden and LENSAR, contributing an additional $13.8 million of cost of product revenue and $6.0 million in sales and marketing expenses due to an increase in Noden’s sales force.
Operating expenses were $126.3 million for the year ended December 31, 2017, compared to $114.9 million for the year ended December 31, 2016. The increase in operating expenses in 2017 was a result of the acquisitions and operations of Noden and LENSAR, contributing an additional $26.5 million of cost of product revenue, $12.7 million of intangible asset amortizations, $17.1 million in sales and marketing expenses, and $3.6 million in research and development costs for the completion of a pediatric trial for Tekturna. General administrative expenses increased by $5.9 million of which $7.5 million was related to Noden and $3.2 million was related to LENSAR, partially offset by a decrease of $51.1 million from the loss on extinguishment for the Direct Flow Medical notes receivable in 2016.
Recent Developments

On February 1, 2018, PDL completed the retirement of the remaining $126.4 million of aggregate principal of its 4.0% Convertible Senior Notes due 2018 at their stated maturity by making a payment to the noteholders of $126.4 million, plus $2.6 million of accrued interest.
In February 2018, we entered into a modification agreement with CareView whereby we agreed, effective as of December 28, 2017, to modify the credit agreement before remedies could otherwise have become available to us under the credit agreement in relation to certain obligations of CareView that would potentially not be met, including the requirement to make principal payments. Under the modification agreement we agreed that (i) a lower liquidity covenant would be applicable and (ii) principal repayment would be delayed for a period of up to December 31, 2018. In exchange for agreeing to these modifications, among other things, the exercise price of our warrants to purchase 4.4 million shares of common stock of CareView was reduced and, subject to the occurrence of certain events, CareView agreed to grant us additional equity interests.
Other Financial Highlights

PDL had cash, cash equivalents, short-term investments and other investments of $532.1 million at December 31, 2017, compared to $242.1 million at December 31, 2016.
Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results at 4:30 p.m. Eastern Time today, March 8, 2018.

To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 internationally. The conference ID is 9384627. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through one week following the call, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 9384627.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at View Source and go to the Investor Relations section and select "Events & Presentations." Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

8-K – Current report

On March 8, 2018 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel small molecule drug candidates to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported a corporate update and financial results for the full year ended December 31, 2017 (Press release, Onconova, MAR 8, 2018, View Source [SID1234524567]).

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"The recently completed year was a pivotal period for rigosertib development programs in MDS. We achieved important goals across our full pipeline, highlighted by the recently announced promising interim analysis and the advancement of the INSPIRE pivotal trial for rigosertib, our lead Phase 3 clinical candidate. With no FDA approved therapies available for patients with higher-risk MDS who are refractory to hypomethylating agents, Onconova has taken a leadership position in this indication. Looking ahead, we now expect topline analysis to be concurrent with enrollment completion, which can be achieved in the first half of 2019," said Dr. Ramesh Kumar, President and Chief Executive Officer.

"We also announced three important collaborations in recent months. Regional licensing of our pre-IND stage next generation CDK 4/6 inhibitor for Greater China which we believe advnaces this program on the IND track and towards clinical data in 2019. Our collaboration with the National Cancer Institute for clinical development of rigosertib in children suffering from incurable inherited diseases (RASopathies) could provide Onconova with the opportunity to establish a rare disease development program. Finally, our licensing agreement for rigosertib in Latin America further expands the global commercial footprint of rigosertib, and is in addition to our existing partnership in Japan and Korea. Execution of these transactions we believe indicates the ability to leverage our late stage and pipeline assets to finance multiple programs. Based on the progress achieved in our oral rigosertib-azacitidine combination Phase 2 program in front-line MDS indications, we expect to secure additional collaborations and regional partnerships to help support a pivotal Phase 3 trial for oral rigosertib."

INSPIRE Trial of IV Rigosertib in 2nd Line Higher-risk (HR) MDS

Interim Analysis (IA)

· On January 17, 2018, Onconova announced that it is moving forward with its Phase 3 INSPIRE pivotal trial following the interim analysis and the Data Monitoring Committee’s (DMC) recommendation, together with unanimous approval by the Executive Committee overseeing this trial. The DMC recommended continuation of the trial with a one-time expansion in enrollment, using a pre-planned sample size re-estimation, consistent with the Statistical Analysis Plan.

· The expanded INSPIRE study will increase enrollment by adding 135 patients to the original target to reach a total enrollment of 360 patients.

· At the topline analysis of the INSPIRE trial, the primary endpoint of overall survival will be analyzed in both the ITT population and the Very High Risk (VHR) subgroup.

· In the INSPIRE trial enrollment so far, the predefined subgroup of VHR patients constitutes greater than 70% of patients enrolled to date.

·The Company remains blinded to the interim analysis results.

Trial Progress

· The INSPIRE study is open in more than 170 sites in 22 countries across four continents.

· More than half of the expanded study is now enrolled.

The Company is planning to add sites in Europe and new territories, including in Latin America, in concert with our new partner Pint Pharma ("Pint").

·The INSPIRE trial was designed with stringent selection criteria so as to identify a more homogenous MDS patient population. Accordingly, extensive eligibility verification and trial site education are integral to the Company’s plan.

Oral Rigosertib in Combination with Azacitidine for 1st-line HR-MDS

Pivotal Phase 3 Trial Protocol

·phase 2 Expansion Trial is expected be fully enrolled this month with the addition of more than 40 patients.

· Onconova plans to present initial data from this study at a scientific conference in 2018, highlighting the results of dose selection and optimization of the combination regimen.

On March 2, 2018, Onconova presented data relating to the mechanism of action of rigosertib in combination with azacitidine at the AACR (Free AACR Whitepaper) Special Conference. The results suggested potential novel clinical strategies to improve outcomes for patients with higher-risk MDS and reversal of resistance to treatment with epigenetic therapies.

Progress in Business Development around Rigosertib and Pipeline Products

Onconova and Pint Pharmaceutical Announce Licensing Agreement for Rigosertib in Latin America

On March 5, 2018, Onconova and Pint announced that they had entered into a Latin American licensing agreement for rigosertib. Pint is a private, European-based pharmaceutical company focused on the development, registration and commercialization of specialty-based treatments for the Latin American market.
Under the terms of the agreement, Pint will make an investment in Onconova totaling up to $2.5 million by purchasing shares at a premium to market. In addition, Pint will make potential additional regulatory, development and sales-based milestone payments to Onconova of up to $42.75 million and pay double digit tiered royalties on net sales in Latin America.

Rigosertib Collaboration for Pediatric RASopathies

On January 4, 2018, Onconova announced that it had entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI), part of the National Institutes of Health. Under the terms of the CRADA, the NCI will conduct research, including preclinical laboratory studies and a clinical trial, on rigosertib in pediatric cancer associated RASopathies. The RASopathies are a group of rare diseases which share a well-defined molecular basis in expression or defects involving Ras Effector Pathways.

License and Collaborative Development Agreement with HanX Biopharmaceuticals for ON 123300

·On December 19, 2017, Onconova announced the signing of a license and collaboration agreement with HanX Biopharmaceuticals, Inc., a company focused on development of novel oncology products, for the further development, registration and commercialization of ON 123300 in China. ON 123300 is a first-in-class dual inhibitor of CDK4/6 + ARK5, which is currently in advanced pre-clinical development. This compound has the potential to overcome the limitations of current generation CDK 4/6 inhibitors.

Under the terms of the agreement, Onconova will receive an upfront payment, and is eligible to receive potential regulatory and commercial milestone payments, as well as royalties on Chinese sales. HanX will provide all funding required for Chinese IND enabling studies performed for Chinese Food and Drug Administration IND approval. The Companies also intend for these studies to comply with US Food and Drug Administration (FDA) standards. Accordingly, such studies may be used by Onconova for an IND filing with the FDA. Onconova will maintain global rights outside of China.

Pre-clinical Stage CDK4/6 + ARK5 Inhibitor Program

Following signing of the collaboration agreement with HanX, Onconova initiated a pre-IND process with the U.S. Food and Drug Administration (FDA).

Presentations of Data

Rigosertib in MDS at the ASH (Free ASH Whitepaper) 2017 Meeting

Onconova delivered two poster presentations highlighting drug activity and the mechanism of action of rigosertib in MDS during the 59th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in Atlanta in December, 2017.

· Among the highlights of the presentation were: Oral rigosertib as a single agent demonstrated activity in a Phase 2 trial for lower-risk MDS; 32% of 62 evaluable patients, and 44% of patients receiving optimal dosing, achieved transfusion independence; and new data on the molecular basis of the combination therapy with rigosertib and azacitidine in epigenetic studies in patient derived stem cells.

Full Year 2017 Financial Results:

Cash and cash equivalents as of December 31, 2017, totaled $4.0 million, compared to $21.4 million as of December 31, 2016. Subsequently, on February 12, 2018, Onconova announced the closing of a $10 million underwritten public offering of 9,947,500 shares of common stock or common stock equivalents and warrants to purchase an aggregate of 994,750 shares of Onconova’s Series A convertible preferred stock, including the exercise in full of the underwriter’s option to purchase additional securities, at the public offering price of $1.01 per share and accompanying Preferred Stock Warrant. Onconova also issued to the underwriter a preferred stock warrant to purchase 49,737.5 shares of Series A convertible preferred stock. Based on the Company’s cash burn for 2017 and its current projections, Onconova expects that cash and cash equivalents will be sufficient to fund ongoing trials and operations into the third quarter of 2018.

Net loss was $24.1 million for the year ended December 31, 2017, compared to $19.7 million for the year ended December 31, 2016, primarily due to the lack of collaboration cost sharing revenue in the 2017 period and a smaller change in fair value of warrant liability in the 2017 period.

Research and development expenses were $19.1 million for the year ended December 31, 2017, and $20.1 million for the comparable period in 2016.

General and administrative expenses were $7.4 million for the year ended December 31, 2017, and $9.2 million for comparable period in 2016.

The Company will host a conference call on March 8th at 9:00 a.m. Eastern Time to provide a corporate update and discuss fourth quarter and full-year financial results. Interested parties may access the call by dialing toll-free (855) 428-5741 from the US, or (210) 229-8823 internationally and using conference ID: 2947108.

The call will also be webcast live. Please click here to access the webcast.

A replay will be available at this link until June 29, 2018

OncoMed Announces Fourth Quarter and Full Year 2017 Financial Results and Operational Highlights

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.

Navidea Biopharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results

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.

MIRATI THERAPEUTICS REPORTS FOURTH QUARTER AND FULL-YEAR 2017 FINANCIAL RESULTS

On March 8, 2018 Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, reported financial results for the fourth quarter and full-year ended December 31, 2017 (Press release, Mirati, MAR 8, 2018, View Source [SID1234524564]).

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"We made significant progress in our key programs in 2017," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. "Promising data from the sitravatinib and KRAS programs encouraged us to pursue a more aggressive approach to accelerate development, supported by the successful financing we completed in November. In early 2018, we initiated a strategic regional partnership with BeiGene Ltd. that we anticipate will rapidly expand the development of sitravatinib in multiple tumor types. We expect to report multiple key catalysts in 2018, including a mid-year clinical update for our sitravatinib program. Our KRAS inhibitor program, an important yet elusive target, is growing and we remain on track for an IND filing in the fourth quarter of 2018."

Recent Corporate Highlights

Sitravatinib clinical data presented at 2017 IASLC World Conference on Lung Cancer

Combination of sitravatinib and nivolumab in non-small cell lung cancer (NSCLC) patients with documented progression following checkpoint inhibitor therapy demonstrated 3 confirmed Partial Responses in first 11 evaluable patients

First evaluable NSCLC patient with CBL inactivating mutation treated with single agent sitravatinib demonstrated confirmed Partial Response with 77% tumor reduction

KRAS G12C lead candidates selected and advanced into IND-enabling development activities

Significant achievement in development of a direct inhibitor of KRAS, a well-known but previously undruggable cancer mutation

A potentially transformational, first-in-class treatment for 14% of NSCLC and 5% of colorectal cancer patients

Program is on track to advance to IND filing in the fourth quarter of 2018

Exclusive license agreement initiated with BeiGene Ltd. for the development, manufacture and commercialization of sitravatinib in Asia (excluding Japan), Australia and New Zealand

Expected to accelerate development of sitravatinib in NSCLC as well as other key indications including bladder, renal and hepatocellular cancer

$86.7M public offering completed in November 2017; $150.8M of cash, cash equivalents and short-term investments as of December 31, 2017

Fourth Quarter and Full Year Financial Results
Cash, cash equivalents, and short-term investments were $150.8 million on December 31, 2017, as compared to $56.7 million on December 31, 2016.

Research and development expenses for the fourth quarter of 2017 were $15.2 million, compared to $16.0 million for the same period in 2016. Research and development expenses for the year ended December 31, 2017 were $58.1 million, compared to $68.5 million for the same period in 2016. The decrease in research and development expenses for both periods is primarily due to a reduction in glesatinib expenses and a reduction in share-based compensation expense. These decreases are partially offset by increases in expenses associated with our ongoing sitravatinib clinical trials.

General and administrative expenses for the fourth quarter of 2017 were $3.0 million, compared to $3.9 million for the same period in 2016. General and administrative expenses for the year ended December 31, 2017 were $13.5 million, compared to $15.3 million for the same period in 2016. The decrease in general and administrative expense for both periods is primarily due to a decrease in share-based compensation expense.

Net loss for the fourth quarter of 2017 was $17.9 million, or $0.67 per share basic and diluted, compared to net loss of $19.7 million, or $0.99 per share basic and diluted for the same period in 2016. Net loss for the year ended December 31, 2017 was $70.4 million, or $2.78 per share basic and diluted, compared to net loss of $83.1 million, or $4.20 per share basic and diluted for the same period in 2016.