On February 27, 2018 Integra LifeSciences Holdings Corporation (NASDAQ:IART) today reported financial results for the fourth quarter and full-year ended December 31, 2017 (Press release, IsoTis, FEB 27, 2018, View Source [SID1234524240]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Highlights:

The Company completed the acquisition of Codman Neurosurgery, the largest in its history, on October 2, 2017;

Reported revenue for the full-year 2017 was $1,188.2 million, an increase of 19.8%, or $196.2 million over the prior year; acquisitions contributed $162.1 million to the full year, while organic sales were higher by 4.6% over the prior year;

Fourth quarter revenue was $368.6 million, an increase of 44.2%, or $112.9 million over the prior year quarter; acquisitions contributed $103.3 million to the fourth quarter, while organic sales were higher by 5.8% over the prior year quarter;

Fourth quarter GAAP earnings per diluted share amounted to $0.56, a 60% increase over the prior year period, and includes a net tax benefit of $37.9 million, or $0.47 per diluted share, associated with the U.S. Tax Cuts and Jobs Act;

Fourth quarter adjusted earnings per diluted share amounted to $0.64, a 23% increase over the prior year period;

Full-year 2017 GAAP earnings per diluted share amounted to $0.82, a 12.8% decrease over the prior year; Full-year adjusted earnings per diluted share amounted to $1.94, a 10.2% increase over the prior year, which represents the fourth consecutive year of double-digit adjusted earnings per diluted share growth; and

The Company now expects to be at the high-end of its previously provided full-year 2018 revenue guidance range of $1.46 billion to $1.48 billion, largely due to favorable foreign currency exchange rates. The Company expects full-year GAAP earnings per diluted share to be in a range of $0.60 to $0.70, and also expects full-year adjusted earnings per diluted share to be at the high-end of its previously provided range of $2.25 to $2.35, due to a lower expected tax rate associated with the U.S. Tax Cuts and Jobs Act.

Total revenues for the full year 2017 were $1,188.2 million, an increase of $196.2 million, or 19.8%, over the prior year. Total revenues for the fourth quarter were $368.6 million, an increase of $112.9 million, or 44.2%, over the fourth quarter of 2016.

Organic revenues for the full year 2017, as set forth in the attached reconciliation, increased 4.6% over the prior year, while fourth quarter organic revenues were higher by 5.8% over the fourth quarter of 2016.

"2017 was a transformative year for Integra. We closed the two largest acquisitions in the Company’s history, expanded our regenerative portfolio with new, innovative products and successfully executed the global launch of CUSA Clarity, a significant upgrade to our tissue ablation platform," said Peter Arduini, Integra’s President and Chief Executive Officer. "We look forward to 2018 and another year of strong revenue growth, margin expansion and improving profitability."

The Company reported GAAP net income of $64.7 million, or $0.82 per diluted share, for the full year 2017, compared to GAAP net income of $74.6 million, or $0.94 per diluted share, in 2016.

The Company reported GAAP net income of $44.4 million, or $0.56 per diluted share, in the fourth quarter of 2017, compared to GAAP net income of $28.2 million, or $0.35 per diluted share, in the fourth quarter of 2016.

In 2017, the U.S. Tax Cuts and Jobs Act resulted in the Company recognizing a net income tax benefit of $37.9 million. This includes a $43.4 million benefit from the re-measurement of deferred taxes as a result of the reduction in U.S. corporate tax rates from 35% to 21%, offset by a one-time toll charge of $5.5 million imposed on deemed repatriation of foreign untaxed earnings.

Adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.

Adjusted EBITDA for the full year 2017 was $269.5 million, an increase of $37.8 million, over the prior year. For the full year 2017, adjusted EBITDA as a percentage of revenue declined from 23.4% in 2016 to 22.7% in 2017, largely resulting from the dilution of the Derma Sciences acquisition and higher sales channel investments.

Adjusted EBITDA for the fourth quarter of 2017 was $88.7 million, an increase from $66.5 million in the fourth quarter of the prior year. For the fourth quarter of 2017, adjusted EBITDA as a percentage of revenue was 24.1%, compared to 26.0% in the prior year period.

Adjusted net income for the full year 2017 was $153.4 million, or $1.94 per diluted share, compared to $135.3 million, or $1.76 per diluted share, in 2016. Adjusted net income for the fourth quarter of 2017 was $51.0 million, or $0.64 per diluted share, compared to adjusted net income of $40.7 million, or $0.52 per diluted share, in the fourth quarter of 2016.

For the year ended December 31, 2017, cash flows from operations totaled $114.5 million. Capital expenditures were $43.5 million. Adjusted free cash flow conversion for the trailing twelve months ended December 31, 2017 was 46.3% versus 82.7% for the twelve months ended December 31, 2016, due to significant one-time cash outlays associated with the acquisition integrations. In the fourth quarter of 2017, the Company generated $11.6 million of cash flows from operations, and incurred capital expenditures of $13.7 million.

Outlook for 2018

The Company is reiterating its full-year 2018 revenue guidance in the range of $1.46 billion to $1.48 billion, and now expects to be at the high end of the range due primarily to more favorable foreign currency rates.

The Company expects GAAP earnings per diluted share for the full year to be between $0.60 and $0.70, and adjusted earnings per diluted share to be at the high end of its previously provided range of $2.25 to 2.35, due primarily to a lower expected tax rate from the U.S. Tax Cuts and Jobs Act.

"Given our strong close to the year, the momentum in our businesses, and the benefit of a lower tax rate, we remain confident that we will deliver 5% organic growth and adjusted earnings per share at the high-end of our range," said Glenn Coleman, Chief Financial Officer. "Consistent with previous guidance, we expect first quarter organic growth to be in the low single-digits as we work through the sales channel integration in both of our segments, which we believe will result in higher organic growth in the second half of 2018."

In the future, the Company may record, or expects to record, certain additional revenues, gains, expenses or charges as described in the Discussion of Adjusted Financial Measures below that it will exclude in the calculation of organic revenue growth, adjusted EBITDA and adjusted EPS for historical periods and in providing adjusted EPS guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET today, Tuesday, February 27, 2018 to discuss fourth quarter and full-year 2017 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.

On February 27, 2018 FibroGen, Inc. (NASDAQ:FGEN), a science-based biopharmaceutical company, reported financial results for the fourth quarter and full year 2017 and provided an update on the company’s recent developments (Press release, FibroGen, FEB 27, 2018, View Source;p=RssLanding&cat=news&id=2335086 [SID1234524229]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In 2017, we continued to make significant progress on key clinical and regulatory milestones. Our first NDA submission for roxadustat was accepted for review by the China Food and Drug Administration. With our partners, we are advancing the roxadustat Phase 3 CKD anemia programs to completion with plans to file for market approvals in the U.S., Europe, and Japan. In our fibrosis program, pamrevlumab has demonstrated tremendous potential in multiple indications. In a randomized double-blind, placebo-controlled Phase 2b study in IPF, pamrevlumab was well-tolerated and achieved statistical significance in the primary endpoint of FVC % predicted, in FVC, and in the secondary endpoints of quantitative changes of lung fibrosis, disease progression, and patient-reported outcomes," said Thomas B. Neff, FibroGen’s Chief Executive Officer. "We are intensely focused on the execution of critical activities for our CKD anemia, idiopathic pulmonary fibrosis, and pancreatic cancer programs as these approach important new milestones in 2018."

Recent Developments and Highlights
Roxadustat for CKD Anemia in U.S./ROW

With our partner AstraZeneca, we have agreed to a timeline for Phase 3 enrollment completion in the second quarter of 2018 and data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019
DSMB recommended Phase 3 clinical studies to continue under current protocols with no changes

Roxadustat for CKD Anemia in China

Positive efficacy and safety results reported from two Phase 3 trials
New Drug Application accepted for filing by the CFDA

Roxadustat for CKD Anemia in Japan

Our partner Astellas has completed three of six Phase 3 trials
Topline positive Phase 3 results reported in peritoneal dialysis study

Roxadustat for MDS Anemia

Enrollment commenced in our first U.S./Europe Phase 3 study for the treatment of anemia in myelodysplastic syndromes (MDS)

Pamrevlumab for Idiopathic Pulmonary Fibrosis (IPF)

Statistically significant high-resolution computed tomography (HRCT) results achieved in our randomized double-blind, placebo-controlled Phase 2b study
Positive Phase 2b study results presented at European Respiratory Society (ERS) International Congress 2017

Pamrevlumab for Pancreatic Cancer

Reported positive interim Phase 2 open-label results at 2017 ASCO (Free ASCO Whitepaper)-GI conference showing a majority of pamrevlumab-treated patients converted from unresectable to resectable cancer; all resection evaluations complete and results continue to be favorable for pamrevlumab

Corporate and Financial

Net loss for the fourth quarter of 2017 was $22.1 million, or $0.27 per share, compared to $34.0 million, or $0.54 per share one year ago
Net loss for the year ended December 31, 2017, was $126.2 million, or $1.73 per share, compared to $61.7 million, or $0.98 per share one year ago
At December 31, 2017, FibroGen had $762.2 million in cash, restricted time deposits, cash equivalents, investments, and receivables
Received a $15.0 million milestone payment from AstraZeneca in the fourth quarter of 2017 upon roxadustat NDA submission to CFDA
Completed financings in April 2017 and in August 2017 with net proceeds of $115.1 million and $356.2 million, respectively

2018 Outlook

U.S. Phase 3 CKD anemia enrollment completion in the second quarter of 2018
U.S. Phase 3 CKD anemia data readout in the fourth quarter of 2018 to support U.S. regulatory submission in the first half of 2019
NDA approval decision expected in China for CKD anemia by the end of 2018
Expect to confirm plans with our partner Astellas for regulatory submissions in Europe and Japan
Anticipate data readout from two Japan Phase 3 hemodialysis studies, a long-term conversion study and a correction (ESA-naïve) study, in the first quarter of 2018
Anticipate initiation of roxadustat Phase 2/3 clinical study in China for anemia associated with MDS in first half of 2018
Expect to present HRCT and health-related quality-of-life results from the IPF Phase 2b trial at an upcoming scientific conference
Design pivotal trials for IPF and locally advanced pancreatic cancer

Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, February 27, 2018, at 5:00 p.m. Eastern (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (888) 771-4371 (U.S. and Canada) or 1 (847) 585-4405 (international), reference the FibroGen fourth quarter and full year 2017 financial results conference call, and use passcode 46307822#. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (888) 843-7419 (domestic) or (630) 652-3042 (international), and use passcode 46307822#.

On February 27, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, reported that the Company will host a conference call and live audio webcast on Monday, March 5, 2018 at 5:00 p.m. ET to report its fourth quarter and full year 2017 financial results and provide a corporate update (Press release, Fate Therapeutics, FEB 27, 2018, http://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-fourth-3 [SID1234524228]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 7589759. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website beginning approximately two hours after the event.

On February 27, 2018 Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics, reported a corporate update and financial results for the fourth quarter and full year ending December 31, 2017 (Press release, Five Prime Therapeutics, FEB 27, 2018, View Source [SID1234524230]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"2017 was a year of continued progress across our pipeline," said Aron Knickerbocker, chief executive officer of Five Prime Therapeutics. "Notably, positive and important data in microsatellite stable pancreatic cancer are driving further development of the cabiralizumab/Opdivo combination in this cancer type, which is associated with tremendous unmet need, and in which no response to immunotherapy has been demonstrated. We also presented data in 2017 showing clinical benefit with cabiralizumab in patients with PVNS, and with bemarituzumab in patients with gastric cancer. In 2018, our clinical pipeline is on track to more than double to five products, and we will initiate our first global registrational clinical trial. Our unique discovery platform is proving to be an IND engine, and more programs are forthcoming. Additionally, our strategic alliances and strong balance sheet position us well to further advance our multiple assets."

2017 Business Highlights and Recent Developments

Clinical Pipeline:

Cabiralizumab (FPA008): an antibody that inhibits CSF1R and has been shown to block the activation and survival of monocytes and macrophages.

• Completed enrollment of the ongoing Phase 1a/1b trial of cabiralizumab/Opdivo (nivolumab) and Five Prime continues to treat patients who remain in the study.

- Five Prime completed enrollment in the trial, including patients with pancreatic cancer who were added to the trial after encouraging data were observed in the initial Phase 1b cohort of 31 patients with late-line pancreatic cancer.

- Five Prime and Bristol-Myers Squibb Company (BMS) are evaluating the safety, tolerability and preliminary efficacy of the immunotherapy combination of cabiralizumab with the PD-1 immune checkpoint inhibitor Opdivo (nivolumab) in advanced solid tumors, including non-small cell lung cancer, squamous cell carcinoma of the head and neck, pancreatic cancer, glioblastoma, renal cell carcinoma and ovarian cancer.

• BMS initiated randomized Phase 2 clinical trial in patients with locally advanced or metastatic pancreatic cancer.

- In January 2018, BMS initiated a randomized Phase 2 clinical trial (NCT03336216), evaluating cabiralizumab and Opdivo (nivolumab) with and without chemotherapy compared to chemotherapy alone in patients with advanced pancreatic cancer. The Phase 2 trial is expected to enroll approximately 160 patients with locally advanced or metastatic pancreatic cancer that has progressed during or after one line of chemotherapy.

- The advancement of the cabira/ Opdivo (nivolumab) combination into Phase 2 development triggered a $25 million payment to Five Prime.

- Five Prime and others have previously demonstrated evidence of synergy by combining CSF-1R and PD-1 antibodies with chemotherapy in preclinical models of pancreatic cancer.

• Presented initial Phase 1a/1b data demonstrating early efficacy signal in heavily pre-treated patients with advanced pancreatic cancer with microsatellite stable (MSS) disease.

- In November 2017, Five Prime and BMS presented initial clinical safety data from all cohorts in the Phase 1a/1b clinical trial of cabiralizumab and Opdivo (nivolumab), and efficacy data from the Phase 1b pancreatic cancer cohort. In this Phase 1b cohort of heavily pre-treated patients with advanced pancreatic cancer (n=31 evaluable patients), durable clinical benefit was observed in five patients (16%), including confirmed objective responses in four patients with microsatellite stable (MSS) disease (objective response rate of 13%, confirmed by blinded independent review committee), a patient population in which no prior responses to immunotherapy have been demonstrated.

- Preliminary results show that the safety profile of cabiralizumab plus Opdivo (nivolumab) was generally consistent with that of monotherapy of the two drugs.

• Advanced the ongoing Phase 1/2 trial of cabiralizumab in patients with pigmented villonodular synovitis (PVNS).

- Five Prime reported initial trial data at the ASCO (Free ASCO Whitepaper) Annual Meeting in June 2017, showing that cabiralizumab demonstrated clinical benefit in patients with PVNS.

- The company is enrolling up to 30 additional patients in the Phase 2 portion of the trial to refine the dosing schedule to optimize the therapeutic index of cabiralizumab in this chronic disease setting. Data from these additional patients are intended to enable a go/no go decision by the end of 2018 on whether to advance cabiralizumab in PVNS into a pivotal trial.

- Five Prime estimates the combined prevalence of diffuse PVNS is approximately 67,500 patients in the U.S., EU5 and Japan.

Bemarituzumab (FPA144): an isoform-selective antibody with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) in development as a targeted immuno-therapy for tumors that overexpress FGFR2b.

• Initiated Phase 1 portion (NCT03343301) of the FGFR2b Inhibition in Gastric Cancer Treatment (FIGHT) Phase 1/3 clinical trial, a global registrational study.

- The FIGHT trial will evaluate bemarituzumab in combination with the modified FOLFOX6 regimen (mFOLFOX6) versus placebo plus mFOLFOX6 in approximately 550 patients with advanced gastric or gastroesophageal junction cancer whose tumors overexpress FGFR2b or have FGFR2 gene amplification.

- In January 2018, Five Prime initiated patient dosing in the Phase 1 portion of the FIGHT trial. This safety lead-in portion of the study is designed to identify a recommended dose of bemarituzumab and to support the Phase 3 portion of the trial.

- The Phase 3 portion of the FIGHT trial is expected to begin in 2018 and will include sites in the U.S., Europe and Asia, including China, South Korea and Japan, where the incidence of gastric cancer is high.

- Five Prime will use immunohistochemistry (IHC) and circulating tumor DNA (ctDNA) tests to identify the estimated 10% of patients with gastric cancer who would be eligible for the trial.

• Entered into strategic development collaboration and exclusive license agreement in Greater China for bemarituzumab with Zai Lab in December 2017. Five Prime’s collaboration with Zai Lab will increase the speed of the FIGHT trial and lower Five Prime’s global development costs for the FIGHT trial. Five Prime earned a $5 million upfront payment and is eligible to receive up to $39 million in development and regulatory milestone payments. Five Prime is also eligible to receive from Zai Lab a royalty percentage on net sales of bemarituzumab in Greater China ranging from the high teens to the low twenties.

• In December 2017, Five Prime filed a clinical trial application (CTA) for bemarituzumab in China. With its collaborators at Zai Lab, Five Prime is aiming to initiate clinical trial sites in China for the FIGHT trial by the end of 2018.

• Enrolling patients in Phase 1 safety trial of bemarituzumab monotherapy in unselected patients with gastric cancer in Japan, where the incidence of gastric cancer is high. Completion of this Phase 1 trial is intended to enable the inclusion of Japanese patients in the Phase 3 portion of the FIGHT trial.

• Advanced the Phase 1 monotherapy cohort testing bemarituzumab in patients with metastatic bladder cancer. The company continues to enroll patients in the Phase 1 clinical trial cohort testing bemarituzumab as a treatment for patients with metastatic bladder cancer whose tumors overexpress FGFR2b.

FPA150 (anti-B7-H4): An antibody designed for two mechanisms of action: to block an inhibitory T cell checkpoint pathway and to enhance killing of B7-H4-expressing tumors by ADCC. B7-H4 is frequently overexpressed in breast, ovarian, endometrial and bladder cancers.

• Investigational New Drug (IND) application submitted December 2017.

- Five Prime anticipates initiating the Phase 1 trial in the first half of 2018.

• Data featured in an oral poster discussion during the ESMO (Free ESMO Whitepaper) 2017 Congress.

- Data presented suggest that FPA150, which possesses T cell checkpoint and ADCC activity, has the potential to be an effective therapeutic by improving anti-tumor immune responses in patients with cancer.

BMS TIM-3 Antibody: Achieved a $5 million milestone payment for the first IND filing by BMS for a therapeutic candidate under the immuno-oncology research collaboration with Five Prime.

• In January 2018, BMS filed an IND for the first clinical candidate from the immuno-oncology research collaboration with Five Prime. The candidate is a fully-human monoclonal antibody targeting TIM-3 (T-cell immunoglobulin and mucin domain-3), an immune checkpoint receptor that is known to limit the duration and magnitude of T-cell responses.

• In December 2017, BMS extended the research term an additional year to March 2019. This is the second extension to the original research term under the agreement that was established in March 2014.

Preclinical Research and Development:

FPT155 (CD80-Fc): A CD80 fusion protein that uses the binding interactions of soluble CD80 to (i) block CTLA-4 from competing for endogenous CD80, allowing CD28 signaling to prevail in T cell activation in the tumor microenvironment and (ii) directly engage CD28 to further enhance its co-stimulatory T-cell activation activity without inducing super agonism.

• Preclinical data on FPT155 were featured in a poster presentation at the 2017 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October. Work done in preclinical models with FPT155 suggests that it has the potential to be a potent T-cell co-stimulator with strong monotherapy antitumor activity, and it may have a synergistic effect when combined with anti-PD1 therapy.

• Five Prime anticipates filing an IND application or a foreign equivalent in mid-2018.

Target discovered by Five Prime in its respiratory disease collaboration exclusively licensed by partner GSK.

• In August 2017, GSK exercised its right to license exclusively a drug target discovered by Five Prime in the respiratory disease collaboration between the companies. This resulted in a $500,000 payment to Five Prime.

• This is the second respiratory target that GSK exclusively licensed from Five Prime under the respiratory disease collaboration.

Summary of Financial Results and Guidance:

• Cash Position. Cash, cash equivalents and marketable securities totaled $292.7 million on December 31, 2017 compared to $421.7 million on December 31, 2016. The decrease in year-end cash in 2017 was primarily attributable to net cash used in operations to advance the company’s clinical and preclinical pipeline. On January 29, 2018, Five Prime completed a public offering resulting in estimated net proceeds of approximately $108 million.

• Revenue. Collaboration and license revenue for the fourth quarter of 2017 increased by $4.9 million, or 59%, to $13.2 million from $8.3 million for the fourth quarter of 2016. Five Prime earned a $5 million milestone payment from BMS in the fourth quarter of 2017 for the first IND application by BMS for a therapeutic candidate under the immune checkpoint pathway discovery collaboration. Collaboration and license revenue for the full year 2017 increased by $8.8 million, or 29%, to $39.5 million from $30.7 million for the full year 2016. This difference was primarily from increases in revenue from the cabiralizumab collaboration agreement with BMS and the immune checkpoint pathway discovery collaboration with BMS.

•

R&D Expenses. Research and development expenses for the fourth quarter of 2017 increased by $3.6 million, or 12%, to $32.7 million from $29.1 million in the

fourth quarter of 2016. Full year 2017 research and development expenses increased by $56.8 million, or 60%, to $150.9 million from $94.1 million in 2016. These increases were primarily related to advancing the bemarituzumab program in a Phase 1 clinical trial, advancing the cabiralizumab program in immuno-oncology and PVNS, advancing the FPA150 program to an IND application, and advancing our internal immuno-oncology preclinical and research activities.

• G&A Expenses. General and administrative expenses for both the fourth quarters of 2017 and 2016 was $10.5 million. Full year 2017 general and administrative expenses were $40.0 million, an increase of $4.2 million, or 12%, from $35.8 million in 2016. This increase was primarily due to greater facilities expenses related to our new corporate office and personnel related expenses, including stock-based compensation.

• Net Income (Loss). Net loss for the fourth quarter of 2017 was $29.2 million, or $1.04 per basic share and diluted share, compared to a net loss of $20.1 million, or $0.73 per basic and diluted share, for the fourth quarter of 2016. Full year 2017 net loss was $150.2 million, or $5.38 per basic share and diluted share, compared to a net loss of $65.7 million, or $2.44 per basic share and diluted share for the full year 2016. These increases in net loss were primarily related to advancing the clinical pipeline and preclinical research and development.

Cash Guidance. Five Prime expects full-year 2018 net cash used in operating activities to be less than $135 million, which includes the previously mentioned milestone payments earned by Five Prime. The company estimates ending 2018 with approximately $250 million in cash, cash equivalents and marketable securities.

Conference Call Information

Five Prime will host a conference call and live audio webcast today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial results and provide a corporate update. To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID 7184787. To access the live webcast please visit the "Events & Presentations" page under the "Investors" tab on Five Prime’s website at www.fiveprime.com. An archived copy of the webcast will be available on Five Prime’s website beginning approximately two hours after the conference call. Five Prime will maintain an archived replay of the webcast on its website for at least 30 days after the conference call.

On February 27, 2018 GlycoMimetics, Inc. (Nasdaq: GLYC) reported that it will host a conference call and webcast to provide an update on development plans for GMI-1271 in acute myeloid leukemia (AML) as well as to report its fourth quarter and fiscal year 2017 financial results on Tuesday, March 6, 2018, at 8:30 a.m. ET (Press release, GlycoMimetics, FEB 27, 2018, View Source [SID1234524233]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The dial-in number for the conference call is (844) 413-7154 for domestic participants and (216) 562-0466 for international participants, with participant code 1453008. A webcast replay will be available via the "Investors" tab on the GlycoMimetics website for 30 days following the call. A dial-in phone replay will be available for 24 hours after the close of the call by dialing (855) 859-2056 for domestic participants and (404) 537-3406 for international participants, participant code 1453008.

About GMI-1271

GlycoMimetics plans to initiate in mid-2018 a Phase 3 clinical trial evaluating GMI-1271 in relapsed/refractory AML patients. In the recently completed Phase 1/2 clinical trial, GMI-1271 was evaluated in both newly diagnosed elderly and relapsed/refractory patients with acute myeloid leukemia (AML). In both populations, patients treated with GMI-1271 together with standard chemotherapy achieved better than expected remission rates and overall survival compared to historical controls, as well as lower than expected induction-related mortality rates. Importantly, treatment in this patient population was well tolerated with minimal adverse effects. The candidate drug is designed to block E-selectin (an adhesion molecule on cells in the bone marrow) from binding with blood cancer cells as a targeted approach to disrupting well-established mechanisms of leukemic cell resistance within the bone marrow microenvironment.