Foamix Reports Fiscal Year 2017 Financial Results and Provides Corporate Update

On February 28, 2018 Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX) ("Foamix Pharmaceuticals" or the "Company"), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical foams to address unmet needs in dermatology, reported financial results for the fiscal year ended December 31, 2017 (Press release, Foamix, FEB 28, 2018, View Source [SID1234524231]).

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Clinical and Corporate Update:

FMX101, the Company’s minocycline foam 4% is currently being evaluated in a third Phase 3 study (Study 22) in patients with moderate-to severe acne.
Top-line results are expected in the third quarter of 2018.
The expected timing of an NDA filing for FMX101 is planned for the end of 2018.
FMX103, 1.5% minocycline foam, is currently being evaluated in two Phase 3 studies (Studies 11 and 12) in patients with moderate-to severe papulopustular rosacea. Long term safety is concurrently being evaluated in the open label Study 13.
Top-line results are expected in late third quarter or early fourth quarter of 2018.
Enrollment in the open-label long term safety study (Study 13) continues to progress as scheduled. A significant number of patients have enrolled into this study and we continue to observe low discontinuation rates.
The expected timing of an NDA filing for FMX103 is planned for 2019.
In January and February 2018, Bayer and Foamix filed joint complaints against each of Teva and Perrigo, respectively, alleging patent infringement under U.S. patent laws arising out of the submissions by Teva and Perrigo of ANDAs seeking approval to manufacture and sell generic versions of Bayer’s Finacea Foam. We are committed to defending our own intellectual property rights globally, including patents we have licensed to other pharmaceutical companies as part of our collaboration efforts.
In January 2018, as part of the orderly transition in management, CEO David Domzalski was appointed to the Board of Directors to replace former CEO and co-founder Dr. Dov Tamarkin.
In January 2018, the Company changed its filing status with the SEC and Nasdaq from a "Foreign Private Issuer" to a U. S. Domestic filer.

FMX101 Open Label Safety Study Results

A total of 657 patients were enrolled in the open-label safety extension after an initial 12 weeks of double-blinded therapy in Phase 3 studies 04 and 05. Of these, 291 completed an additional 40-weeks for a total of 52 weeks on FMX101 therapy. The primary endpoint was safety.
As previously communicated, no serious drug-related adverse events were reported during the open-label safety extension, validating earlier data demonstrating that FMX101 appears to be well tolerated with an acceptable safety profile. Specific findings included:
Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portion of Studies 04 and 05, with the most frequently reported treatment-emergent adverse event being nasopharyngitis (common cold).
Application-site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment. Four patients discontinued the study for an application-site adverse event.
In the assessment of facial dermal tolerability at week 52, more than 95% of patients had "none" or "mild" scoring of erythema, dryness, hyperpigmentation, peeling, and itching. No severe local tolerability scores were recorded.

Efficacy Results at 52 weeks:

Efficacy was also measured as a secondary endpoint in the open-label study for FMX101. During the study, patients were allowed to discontinue therapy with FMX101 if they believed their acne had sufficiently improved. Patients could re-start therapy as needed and were also allowed to use other acne medications concomitantly.
The following summarizes efficacy results for subjects who had been assigned FMX101 therapy for 52 weeks:
At week 52, 37.7% of patients from Study 04 had an Investigator’s Global Assessment (IGA) score of 0 (clear) or 1 (almost clear); 50.3% of subjects from Study 05 had an IGA score of 0 or 1.
At week 52, patients from Study 04 had a 64.3% reduction in inflammatory lesions; patients from Study 05 had a 78% reduction in inflammatory lesions.
At week 52, patients from Study 04 had a 52.5% reduction in non-inflammatory lesions; patients from Study 05 had a 59.6% reduction in non-inflammatory lesions.

Details on the open-label study results for FMX101 are contained within the most recent Investor Presentation, available on the Company’s website at View Source

Financial Results for the Year Ended December 31, 2017

Revenues
Revenues for the year ended December 31, 2017 were $3.7 million, compared with $5.5 million for the same period in 2016. The decrease is mainly due to a decrease of $2.5 million in contingent payments from Bayer, that were payable for 2016 due to Bayer’s achievement of certain sale targets during that year, offset by an increase in royalty payments in the amount of $565,000 from Bayer for the sales of Finacea Foam.

Operating Expenses
Research and Development Expenses
Research and development expenses for the year were $57.8 million, compared to $25.9 million in 2016. The increase in research and development expenses resulted primarily from an increase of $28.0 million in costs relating predominantly to FMX101 and FMX103 clinical trials and an increase of $3.0 million in payroll and payroll related expenses primarily due to an increase in headcount.

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the year were $11.5 million, compared to $9.2 million in 2016. The increase in selling, general and administrative expenses resulted primarily from an increase of $1.9 million in payroll and other payroll-related expenses mostly due to an increase in headcount and salary raises.

Net Loss
For the year ended December 31, 2017, the Company recorded a net loss of $65.7 million, or $1.76 per share, basic and diluted, compared with a loss of $29.3 million or $0.91 per share, basic and diluted, for the year ended December 31, 2016.

Cash & Cash Equivalents
At December 31, 2017, the Company had $76.4 million in cash and investments compared to $131 million at the end of December 2016. The Company believes, based on its current business plan, that its existing cash, cash equivalents and marketable securities will fund operating expenses and capital expenditure requirements throughout the completion of its third pivotal Phase 3 clinical trial for its lead product candidate FMX101 and its two pivotal Phase 3 clinical trials for FMX103.

Conference Call & Webcast
Wednesday, February 28 @ 8:30am Eastern Time
Toll Free: 800-289-0438
International: 323-794-2423
Conference ID: 2903389
Webcast: View Source

Replays, Available through March 14:
Toll-Free: 844-512-2921
International: 412-317-6671
Conference ID: 2903389

Nordic Nanovector ASA – Results for the Fourth Quarter and Full Year 2017: Solid performance through 2017, moving forward with pivotal trial

On February 27, 2018 Nordic Nanovector ASA (OSE: NANO) reported results for the fourth quarter and full year 2017 (Press release, Nordic Nanovector, FEB 27, 2018, View Source [SID1234553510]). A presentation by the company’s team will take place today in Oslo at 08:30 CET, see details below.

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Nordic Nanovector made significant progress during 2017, continuing the strong positive momentum started in 2016. The company has advanced the clinical development programme for Betalutin into its pivotal PARADIGME trial and expanded the knowledge base from which it intends to develop a successful commercialisation strategy for the candidate. The company also advanced its partnered early stage programmes aimed at creating a pipeline of novel targeted therapies for haematological cancers.

Updated clinical data from the Phase 1/2a LYMRIT 37-01 trial presented at ASH (Free ASH Whitepaper) in December continue to highlight Betalutin’s strong clinical profile as a single agent for treating patients with relapsed/refractory follicular lymphoma (R/R FL). Nordic Nanovector initiated its pivotal PARADIGME trial with Betalutin in the fourth quarter as planned and the study is currently open for patient enrolment. PARADIGME is a global randomized Phase 2b study comparing two Betalutin dosing regimens in third line (3L) FL patients who are refractory to standard-of-care anti-CD20-based therapy (including rituximab). Nordic Nanovector is targeting initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.

The final design for ARCHER-1 was completed and the trial will open for enrolment once regulatory approval has been received. The trial will be the first to combine Betalutin with rituximab in second line (2L) FL patients, based on promising preclinical data showing strong synergy between the two agents.

Recruitment into the Phase 1 study in diffuse large B-Cell lymphoma (DLBCL) remains on track, and a Phase 1 trial of Humalutin is ready to start with the first patient expected to be dosed in the second half of 2018.

Luigi Costa, CEO of Nordic Nanovector, comments: "In 2017 we continued with a strong momentum and have delivered on several important milestones. We continue to show strong clinical data that consistently reinforce Betalutin’s potential as one of the most promising new treatments for indolent non-Hodgkin Lymphoma (iNHL). We have transitioned the company to the next phase by starting PARADIGME, the pivotal Phase 2b study with the intent to generate the data for regulatory submission in 3L FL. I am very pleased with the good progress towards the first trial of Betalutin in combination with standard of care anti-CD20 therapy (rituximab) in 2L FL (ARCHER-1). Our focus during 2018 will be to drive recruitment into our leading clinical studies with the objective of taking Betalutin to patients as fast as possible while we progress in development of our commercial strategy."

Operational Highlights Q4’17

• Updated results from LYMRIT 37-01 Phase 1/2a trial presented at ASH (Free ASH Whitepaper) show Betalutin’s strong clinical profile in patients with R/R iNHL

o Significant anti-tumour activity observed: 90% of patients (n=59) had a reduction in tumour size

o ORR of 60% and CR of 24% for all evaluable iNHL patients

o Highly active in target population of FL patients with two or more prior therapies (3L FL) with 66% ORR and 25% CR

o Median duration of response of 13.3 months for FL patients receiving 40 mg lilotomab pre-dosing followed by 15 MBq/kg Betalutin (n=17); median duration of response of 22.9 months for patients with a CR (n=7)

o Promising early data from second dosing regimen (Arm 4 – 100 mg/m2 lilotomab/20 MBq/kg Betalutin)

o Well tolerated with predictable and manageable safety profile

• Phase 1/2a study LYMRIT 37-01 recruitment completed with 74 patients enrolled

• Pivotal Phase 2b PARADIGME trial initiated to investigate Betalutin in patients with 3L R/R FL

o Study opened for patient enrolment

o Two promising dosing regimens to be evaluated (40mg lilotomab/15 MBq/kg Betalutin and 100 mg/m2 lilotomab/20 MBq/kg Betalutin)

• Finalised design for ARCHER-1, trial aims to investigate Betalutin in combination with rituximab in 2L FL

o Trial will open for patient enrolment once regulatory approvals has been received

• Results from extensive research aimed at supporting market strategy for Betalutin demonstrate clear commercial opportunities

• Rosemarie Corrigan appointed to the Executive management team as Chief Quality Officer

Events after Q4’17

• Malene Brondberg appointed as Vice President, IR and Corporate Communications

Financial Highlights Q4 and FY’17

(Figures in brackets = same period 2016 unless otherwise stated)

• Revenues for the fourth quarter amounted to NOK 0.1 million (NOK 0.1 million). Revenues for the full year 2017 were NOK 0.3 million (NOK 0.3 million).

• Total operating expenses for the fourth quarter were NOK 102.0 million (NOK 65.4 million). Total operating expenses for the full year 2017 amounted to NOK 316.8 million (NOK 216.7 million).

• Comprehensive loss for the fourth quarter amounted to NOK 87.6 million (loss of NOK 59.3 million). Comprehensive loss for the full year 2017 was NOK 295.6 million (NOK 235.8 million).

• Cash and cash equivalents amounted to NOK 756.6 million at the end of December 2017 (NOK 1 018.2 million).

Outlook

Nordic Nanovector aspires to become a leader in the field of Precision Therapies for haematological cancers by developing, manufacturing and commercialising innovative therapies to address major unmet medical needs and advance cancer care.

Betalutin, the company’s most advanced product candidate, is developing a well differentiated, competitive, clinical profile for R/R FL, based on the promising preliminary results from the LYMRIT 37-01 Phase 1/2a clinical study. The company’s pivotal Phase 2b PARADIGME trial with Betalutin in 3L R/R FL is underway with the goal to have the initial data read-outs from the study and subsequent filing in the second half of 2019 for marketing approval.

Nordic Nanovector intends to maximize the value of Betalutin across other stages of FL, NHL and other haematological cancer indications. A further element of the company’s strategy is to selectively extend its pipeline of novel targeted biopharmaceutical candidates to support future growth.

Management will continue to focus its efforts on the efficient execution of its plans and to meet clinical and pre-commercialisation milestones. The company is confident that Betalutin could become an attractive and convenient therapeutic option, which, based on detailed market research, has the potential to be commercially successful.

Current cash resources are expected to be sufficient until first regulatory filing of Betalutin in 3L R/R FL and to advance other key programmes

Presentation and webcast – Fourth Quarter and Full Year 2017 results

A presentation by Nordic Nanovector’s senior management team will take place today at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2017 from 7:00 am CET today.

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

Clovis Oncology 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, Clovis Oncology, 2018, FEB 27, 2018, View Source [SID1234524211]).

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Coherus BioSciences to Report Fourth Quarter and Full Year 2017 Financial Results on March 8th

On February 27, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS), reported that its fourth quarter and full year 2017 financial results will be released after market close on Thursday, March 8, 2018. At 4:30 p.m. Eastern Time, Coherus’ management will host a conference call to discuss the financial results and provide a general business update.

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After releasing fourth quarter and full year 2017 financial results, we will post them on the Coherus BioSciences website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information
When: Thursday, March 8, 2018 at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 7098068
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

Five Prime Announces Fourth Quarter and Full Year 2017 Financial Results

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]).

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"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.