On February 28, 2019 Nektar Therapeutics (Nasdaq: NKTR) reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Nektar Therapeutics, FEB 28, 2019, View Source [SID1234533843]).

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Cash and investments in marketable securities at December 31, 2018 were $1.9 billion as compared to $353.2 million at December 31, 2017.

"2018 was a remarkable year for Nektar accentuated by new collaborations with leading pharmaceutical companies that validate the depth and innovation of our pipeline," said Howard W. Robin, President and Chief Executive Officer of Nektar. "We entered 2019 in an exceptionally strong financial position. We are working closely with the FDA during the ongoing review of our NDA for NKTR-181 while simultaneously preparing for a potential commercial launch later this year. We continue to design and execute on our broad registrational program for NKTR-214 (bempegaldesleukin1) with our partner Bristol-Myers Squibb. NKTR-358 is advancing in the ongoing clinical study in lupus patients and two new studies in additional auto-immune conditions are planned to start in 2019.NKTR-262, our TLR agonist is being evaluated in a Phase 1/2 study and finally, NKTR-255, our next I-O candidate is slated to move into the clinic first in patients with multiple myeloma and then in combination with CAR-T therapy."

Summary of Financial Results

Revenue for the fourth quarter of 2018 was $39.8 million as compared to $95.5 million in the fourth quarter of 2017. Revenue in the fourth quarter of 2017 included a total of $60.0 million of non-recurring revenue related to a new sublicense agreement, a contract settlement agreement and the recognition of deferred revenue from several collaboration agreements. Revenue for the year ended December 31, 2018 was $1.2 billion as compared to $307.7 million in 2017 and included the recognition of $1.06 billion of license revenue from the Bristol-Myers Squibb collaboration agreement.

Total operating costs and expenses in the fourth quarter of 2018 were $140.1 million as compared to $119.5 million in the fourth quarter of 2017. Total operating costs and expenses for 2018 were $505.4 million as compared to $367.4 million in 2017. Total operating costs and expenses increased primarily as a result of increased research and development (R&D) expense.

R&D expense in the fourth quarter of 2018 was $108.9 million as compared to $81.4 million for the fourth quarter of 2017. R&D expense for the year ended December 31, 2018 was $399.5 million as compared to $268.5 million in 2017. R&D expense was higher in the fourth quarter and full year 2018 as compared to the same periods in 2017 primarily because of expenses for our pipeline programs, including the continued development of bempegaldesleukin in Phase 2 and registrational studies and related manufacturing costs, costs related to the NKTR-181 New Drug Application and NKTR-181 pre-commercial manufacturing, Phase 1 clinical studies of NKTR-358, the Phase 1 study of NKTR-262 in combination with bempegaldesleukin and IND-enabling activities for NKTR-255.

General and administrative (G&A) expense was $23.8 million in the fourth quarter of 2018 as compared to $12.3 million in the fourth quarter of 2017. G&A expense for 2018 was $81.4 million as compared to $52.4 million in 2017. G&A expense was higher in the fourth quarter and full year 2018 as compared to the same periods in 2017 primarily due to an increase in non-cash stock-based compensation expense.

Net loss for the fourth quarter of 2018 was $98.2 million or $0.57 basic and diluted loss per share as compared to a net loss of $33.8 million or $0.21 basic and diluted loss per share in the fourth quarter of 2017. Net income for the year ended December 31, 2018 was $681.3 million or $3.78 diluted earnings per share as compared to a net loss of $96.7 million or $0.62 basic and diluted loss per share in 2017.

2018 and Year-to-Date Business Highlights

● In February 2019, Nektar presented clinical data from first-line Stage IV urothelial carcinoma patients enrolled in the PIVOT-02 study of bempegaldesleukin with nivolumab at the 2019 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
● In December 2018, Nektar and Gilead entered into a research collaboration to explore the potential of NKTR-255, an IL-15 agonist, in virology. The collaboration will evaluate NKTR-255 in combination with antiretroviral therapies in Gilead’s portfolio.
● In December 2018, Nektar and Bristol-Myers Squibb initiated PIVOT-10, a potential registrational study evaluating bempegaldesleukin with nivolumab in cisplatin-ineligible urothelial carcinoma patients whose tumors express PD-L1 (Combined Positive Score < 10).
● In December 2018, Nektar and Bristol-Myers Squibb initiated PIVOT-09, a Phase 3 study of bempegaldesleukin with nivolumab versus tyrosine kinase inhibitor (TKI) monotherapy in patients with advanced metastatic renal cell carcinoma.
● In November 2018, Nektar presented data for first-line Stage IV melanoma patients from the ongoing PIVOT-02 study at the 2018 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
● In November 2018, Nektar entered into a new clinical collaboration with Pfizer Inc. to evaluate several combination regimens in multiple cancer settings including metastatic castration-resistant prostate cancer (mCRPC) and squamous cell carcinoma of the head and neck (SCCHN). Under the collaboration, Pfizer will initiate a Phase 1b/2 clinical trial to evaluate the anti-cancer activity of the combined agents, avelumab, talazoparib and bempegaldesleukin and separately avelumab, enzalutamide and bempegaldesleukin.
● In September 2018, Nektar and Bristol-Myers Squibb initiated the Phase 3 study of bempegaldesleukin with nivolumab as compared to nivolumab monotherapy in participants with previously untreated unresectable or metastatic melanoma.
● In July 2018, the U.S. Food and Drug Administration filed and accepted a New Drug Application (NDA) for NKTR-181, a first-in-class opioid analgesic, to treat chronic low back pain in adult patients new to opioid therapy. In February 2019, Nektar received notification from the FDA that the review period for NKTR-181 has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is now August 29, 2019. The FDA extended the action date to allow time to review data from two additional preclinical studies that Nektar conducted which were requested by the FDA early on in our review process. The new preclinical data are supportive of the company’s abuse liability package included in the NDA filing for NKTR-181.
● In June 2018, Nektar presented data from the ongoing PIVOT study for bempegaldesleukin with nivolumab at the 2018 ASCO (Free ASCO Whitepaper) Meeting. Pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer.
● In May 2018, Nektar began dosing patients with systemic lupus erythematosus in a new Phase 1b multiple ascending dose study of NKTR-358, an IL-2 regulatory T cell stimulator, designed to correct the underlying immune system dysfunction found in patients with immune disorders.
● In April 2018, Nektar announced a new clinical collaboration agreement with Takeda to evaluate bempegaldesleukin with TAK-659, a dual SYK and FLT-3 inhibitor in liquid and solid tumors. The first of these studies, a Phase 1b study in patients with Non-Hodgkin Lymphoma, was initiated in January of 2019.
● In April 2018, Nektar presented preclinical data for its immuno-oncology pipeline at the 2018 AACR (Free AACR Whitepaper) Annual Meeting. Preclinical data presented by Nektar researchers and collaborators demonstrated that bempegaldesleukin combines with multiple modalities including TLR agonism and adoptive cell therapy.
● In April 2018, Nektar began dosing patients in the REVEAL Phase 1/2 study, which will evaluate NKTR-262, Nektar’s wholly-owned novel toll-like receptor 7/8 agonist, in combination with bempegaldesleukin. The dose-escalation phase of the study is continuing.
● In February 2018, Nektar and Bristol-Myers Squibb entered into a global development and commercialization agreement to evaluate the full potential of bempegaldesleukin with nivolumab in more than 20 indications in 9 tumor types.

The company also announced upcoming presentations and speaking engagements at the following scientific congresses during the first half of 2019:

ASCO-SITC Clinical Immuno-Oncology Symposium, San Francisco, CA

● Oral presentation (Abstract #28): "Phase Ib: Preliminary clinical activity and immune activation for NKTR-262 (TLR 7/8 agonist) plus NKTR-214 (CD122-biased agonist) in patients (pts) with locally advanced or metastatic solid tumors (REVEAL Phase Ib/II Trial)"
o Presenter: Dr. Adi Diab, MD Anderson Cancer Center
o Session: Oral Abstract Session B
o Session Date & Time: March 1, 2019, 1:00 p.m.-2:15 p.m. Pacific Time
26th International Molecular Medicine Tri-Conference, San Francisco, CA

● Presentation Title: "Advanced Cytokine Engineering for Immunotherapy"
o Presenter: Steven Doberstein, Ph.D., Nektar Therapeutics
o Session: Emerging Immuno-Oncology Targets Session
o Session Date & Time: March 12, 2019, at 11:25 a.m. Pacific Time
Keystone Symposia Cancer Immunotherapy: Mechanistic Insights to Improve Clinical Benefit, Whistler, BC, Canada

● Presentation Title: "Intratumoral expansion of CD8+ T cells and depletion of Tregs after treatment with NKTR-214, a first-in-class, CD122-preferential IL-2 pathway agonist"
o Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
o Session: Immune Checkpoints: Basic Mechanisms and Novel Targets
o Session Date & Time: March 13, 2019, 8:00 a.m.-11:00 a.m. Pacific Time
CHI’s Fourth Annual Immuno-Oncology Summit Europe, London, UK

● Presentation Title: "Exploratory Studies up to IND with NKTR-255, a Memory T-Cell Stimulating Cytokine"
o Presenter: Saul Kivimae, Ph.D., Nektar Therapeutics
o Session: Importance of Cytokines/Innovative Approaches with Clinical Benefit
o Session Date and Time: March 19, 2019, at 16:45 Greenwich Mean Time
ICI-IO Combinations Summit, Boston, MA

● Presentation Title: "Supercharging the Tumor Microenvironment: Lessons from NKTR-214 and OPDIVO"
o Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
o Session Date and Time: March 20, 2019, at 11:30 a.m. Eastern Time
American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019, Atlanta, GA

● Abstract 2256/Poster Board 15: "Combination of neoantigen DNA plasmid vaccine VB10.NEO and NKTR-214, a CD122-biased immunostimulatory cytokine, induces strong neoantigen-specific T cell responses and sustained tumor regression in pre-clinical models," Granum, S., et al.
o Session: Clinical Research – Combination Immunotherapies 1
o Session Date and Time: April 1, 2019, 1:00 p.m.-5:00 p.m. Eastern Time
o Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 19

● Abstract 3210/Poster Board 20: "A potential immunotherapeutic approach for the treatment of osteosarcoma," Wahba, A., et al.
o Session: Immunology – Combination Immunotherapies 2
o Session Date & Time: Tuesday, April 2, 2019, 8:00 a.m.-12:00 p.m. Eastern Time
o Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 2

● Abstract 3265/Poster Board 15: "NKTR-255, a polymer-conjugated IL-15 enhances anti-tumor NK cell responses and synergizes with monoclonal antibodies to provide long-term survival in human lymphoma model," Miyazaki, T., et al.
o Session: Immunology – Novel Immunomodulatory Agents
o Session Date and Time: April 2, 2019, 8:00 a.m.-12:00 p.m. Eastern Time
o Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25
15th Annual PEGS Boston Summit, Boston, MA

● Keynote: "Harnessing Potent Cytokine Agonist Pathways by Polymer Engineering to Develop Novel Immune Therapeutic Agents"
o Presenter: Loui Madakamutil, Ph.D., Nektar Therapeutics
o Session: Latest Developments in Agonist Immunotherapy – Cytokines and OX40 Targets
o Presentation Date and Time: Thursday, April 11, 2019 1:50 p.m. Eastern Time
6th Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference (ITOC6), Vienna, Austria

● Poster P2.12: "Mechanism of Action of NKTR-214, a first-in-class, CD122-preferential IL-2 pathway agonist"
o Presenter: Willem Overwijk, Ph.D., Nektar Therapeutics
o Session: Emerging Concepts/Novel Agents
o Session Dates and Times: April 11, 2019, at 18.20 Central European Time and April 12, 2019, from 14.00-14.30 Central European Time

Conference Call to Discuss Fourth Quarter and Year-End 2018 Financial Results
Nektar management will host a conference call to review the results beginning at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time today, Thursday, February 28, 2019. This press release and a live audio-only webcast of the conference call can be accessed through a link that is posted on the home page and Investors section of the Nektar website: View Source The web broadcast of the conference call will be available for replay through Thursday, March 28, 2019.

To access the conference call, follow these instructions:

Dial: (877) 881-2183 (U.S.); (970) 315-0453 (international)
Passcode: 4988768 (Nektar Therapeutics is the host)

In the event that any non-GAAP financial measure is discussed on the conference call that is not described in the press release, or explained on the conference call, related information will be made available on the Investors page at the Nektar website as soon as practical after the conclusion of the conference call.

On February 28, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on using the body’s immune system to fight cancer, reported that it will present data in an oral minisymposium presentation from its study utilizing Anixa’s artificial intelligence (AI) driven early cancer detection technology (Press release, Anixa Biosciences, FEB 28, 2019, View Source [SID1234533867]). The presentation will be made at the 2019 annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Atlanta, Georgia. The meeting will be held March 29–April 3, 2019 and will be attended by world leading experts across the field of cancer research. All abstracts are currently available to view by registered attendees on the online itinerary planner.

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Oral Minisymposium Presentation:

Abstract Control Number: 598
Title: Using machine learning to predict the risk of either having an aggressive form of prostate cancer (PCa) or lower grade PCa/benign prostatic hyperplasia (BPH) based upon the flow cytometry immunophenotyping of myeloid-derived suppressor cells (MDSCs) and lymphocyte cell populations
Presenter: George A. Dominguez, PhD – Senior Clinical Research Scientist
Session Title: Biomarkers for Early Detection and Biologic Assessment of Cancer
Session Start: Sunday March 31, 2019 3:00 PM ET
Session End: Sunday March 31, 2019 5:00 PM ET

The presentation will focus on the continuing research progress of Anixa’s AI technology that combines the fields of flow cytometry with artificial intelligence featuring new data and insights into its application for early prostate cancer detection.

"We are pleased to be giving an oral presentation at this AACR (Free AACR Whitepaper) symposium focusing on early detection of cancer," stated Dr. Amit Kumar, President and CEO of Anixa Biosciences.

American Association for Cancer Research (AACR) (Free AACR Whitepaper)
The American Association for Cancer Research (AACR) (Free AACR Whitepaper) (www.aacr.org) is a 501(c)(3) public charity headquartered in Philadelphia, PA. The mission of the AACR (Free AACR Whitepaper) is to prevent and cure cancer through research, education, communication and collaboration. Through its programs and services, the AACR (Free AACR Whitepaper) fosters cancer research and related biomedical science; accelerates the dissemination of new research findings among scientists and others dedicated to the conquest of cancer; promotes science education and training; and advances the understanding of cancer causes, prevention, diagnosis and treatment throughout the world.

On February 28, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing neoantigen cancer immunotherapies, reported its operating and financial results for the fourth quarter and fiscal year ended December 31, 2018 (Press release, Genocea Biosciences, FEB 28, 2019, View Source [SID1234533787]). The company also announced the appointment of a new Chief Financial Officer, Diantha Duvall, a seasoned life science industry professional. Ms. Duvall will join the company on March 5th.

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"We are very pleased to welcome Diantha to Genocea," said Chip Clark, president & CEO of Genocea. "She joins us at a truly exciting time. With our recently completed equity financing and advancing pipeline, we look forward to an eventful 2019. We foresee important near-term milestones in two programs, each driven by our unique ATLAS neoantigen identification platform: first, our Phase 1/2a clinical program for our neoantigen cancer vaccine candidate, GEN-009, from which we expect to see the first immunogenicity data in mid-2019, and second, our GEN-011 program, a neoantigen adoptive T cell therapy, for which we plan to file an IND in the first half of 2020."

Ms. Duvall joins Genocea from Bioverativ, Inc., where she served as Vice President, Controller and Chief Accounting Officer since the company’s spin out from Biogen, where she had served as U.S. and then Global Commercial Controller. Prior to Biogen, Ms. Duvall held a variety of financial and accounting positions at Merck and Co. and PricewaterhouseCoopers.

Recent Operational Highlights

Strengthened senior management team, adding Thomas Davis, M.D., as Chief Medical Officer and Derek Meisner, J.D., as General Counsel in the Fall of 2018, Girish Aakalu, Ph.D. as Chief Business Officer in December 2018, and, as announced today, Diantha Duvall as CFO.
Completed a private placement financing in mid-February, the first closing of which resulted in aggregate gross proceeds of $15.0 million (before deducting fees to the placement agents and other expenses).
Announced a major clinical milestone in early January, dosing the first patients and completing enrollment in Part A of its Phase 1/2a clinical trial for GEN-009. The first immunogenicity data from this study are expected in mid-2019.
Presented additional ATLAS data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) meeting in November 2018. The posters further highlighted the advantages of Genocea’s ATLAS platform over in silico methods in identifying both neoantigens for vaccine inclusion and "inhibitory" neoantigens for exclusion, and presented, for the first time, data in a mouse model providing evidence that these neoantigen-specific inhibitory responses could be tumor-promoting.
Fourth-Quarter 2018 Financial Results

Cash position: As of December 31, 2018, cash and cash equivalents were $26.4 million compared to $12.3 million, as of December 31, 2017; this does not include approximately $15.0 million in aggregate gross proceeds (before deducting fees to the placement agents and other expenses) from the company’s recently closed private placement.
Research and Development (R&D) expenses: R&D expenses were $6.3 million for the quarter ended December 31, 2018, compared to $7.9 million for the same period in 2017.
General and Administrative (G&A) expenses: G&A expenses were $2.6 million for the quarter ended December 31, 2018, compared to $2.5 million for the same period in 2017.
Net income/loss: Net income was $0.4 million for the quarter ended December 31, 2018, compared to a net loss of $1.7 million for quarter ended December 31, 2017.
Full-Year 2018 Financial Results

Research and Development (R&D) expenses: R&D expenses were $25.2 million for the year ended December 31, 2018, compared to $39.2 million for the year ended December 31, 2017.
General and Administrative (G&A) expenses: G&A expenses were $14.3 million for the year ended December 31, 2018, compared to $13.4 million for the year ended December 31, 2017.
Net loss: Net loss was $27.8 million for the year ended December 31, 2018, compared to a net loss of $56.7 million for year ended December 31, 2017.
Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operations into the first quarter of 2020.

Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes.

Genocea’s Board of Directors has adopted a resolution approving and recommending that stockholders support a proposal in the company’s upcoming proxy statement to effect a reverse stock split of the company’s issued and outstanding common stock, if necessary, to maintain the company’s NASDAQ Capital Market listing.

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 6953999. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On February 28, 2019 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 Tuesday, March 5, 2019 at 5:00 p.m. ET to report its fourth quarter and full year 2018 financial results and provide a corporate update (Press release, Fate Therapeutics, FEB 28, 2019, https://ir.fatetherapeutics.com/news-releases/news-release-details/fate-therapeutics-webcast-conference-call-reporting-fourth-4 [SID1234533844]).

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In order to participate in the conference call, please dial 877-303-6235 (domestic) or 631-291-4837 (international) and refer to conference ID 3374407. 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, 2019 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading genome editing company focused on developing curative therapeutics using CRISPR/Cas9 technology in both in vivo and ex vivo applications, reported operational highlights and financial results for the fourth quarter and year ended December 31, 2018 (Press release, Intellia Therapeutics, FEB 27, 2019, View Source [SID1234533717]). In addition, Intellia highlighted select corporate milestones for 2019 and upcoming events for the first quarter of 2019.

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"We are delivering on our full-spectrum strategy, and we expect to have two candidates in development in 2019. Our in vivo transthyretin amyloidosis program is on track for IND filing in 2020, and by the end of this year we anticipate having our first engineered cell therapy development candidate targeting acute myeloid leukemia," said Intellia President and Chief Executive Officer John Leonard, M.D. "We have shown that a single lipid nanoparticle administration can produce very substantial transthyretin protein reduction in non-human primates, reaching levels that we believe hold great therapeutic promise for patients. We also look forward to sharing additional data on our acute myeloid leukemia program this year. We believe our TCR-based, CRISPR-engineered cell therapy will provide a much-needed option for patients."

Recent Operational Highlights

ATTR Program: During the fourth quarter, Intellia completed confirmatory non-human primate (NHP) studies, previewed in October, using its lead candidate for the treatment of transthyretin amyloidosis (ATTR). Fifty-one days post infusion, these NHP studies verified a favorable tolerability profile across various dose levels, and a near-complete (average of >95 percent) reduction in circulating transthyretin (TTR) protein in the liver. The improvements in TTR protein reduction were the result of certain modifications made to the lipid nanoparticle (LNP) cargo components of the therapy, and these modifications have been incorporated into the ongoing, dose-range finding studies and scale-up activities. These modifications will also have application in subsequent programs. The ATTR program is being co-developed with Regeneron Pharmaceuticals, Inc. (Regeneron) with Intellia being the lead party. Intellia confirmed that it is on track for submitting an Investigational New Drug (IND) application in 2020 for ATTR.
In Vivo Insertion: In October, Intellia demonstrated in vivo CRISPR-mediated, targeted transgene insertion in mouse liver. Data shared at the Annual Congress of the European Society of Gene and Cell Therapy highlighted the use of Intellia’s bi-directional DNA template, delivered in a proprietary hybrid LNP/adeno-associated viral (AAV) template delivery system. Insertion of the human F9 gene, the gene encoding the protein deficient in hemophilia B, yielded Factor IX protein levels in mice at or above therapeutic targets in patients. This work was done in collaboration with Regeneron. Additionally, the Company demonstrated the versatility of the hybrid LNP/AAV approach by successfully inserting a functional human SERPINA1 gene (encoding alpha-1 antitrypsin) into the same locus. These experiments in mice yielded human protein expression levels consistent with those of normal individuals without alpha-1 antitrypsin deficiency.
Engineered Cell Therapies: As part of the broad engineered cell therapy platform that the Company is developing, Intellia and its partner, Ospedale San Raffaele, isolated novel active T cell receptors (TCRs) recognizing an epitope of the Wilms’ Tumor 1 (WT1) protein. This protein is overexpressed in many blood cancers, as well as in solid tumors. T cells modified with these TCRs successfully killed acute myeloid leukemia (AML) blasts in an in vitro model. This work will be the foundation for the Company’s first wholly owned ex vivo development candidate for the treatment of AML.
Novartis: In December, Intellia announced an expansion of the existing cell therapy collaboration with Novartis Institutes for Biomedical Research, Inc. (Novartis) to include ocular stem cells. The Company received a $10 million payment from Novartis in relation to the inclusion of this cell type. Regarding its proprietary LNP delivery system and improvements, Intellia also obtained expanded access to Novartis’ LNP library, including the rights to use these lipids for in vivo or ex vivo applications in any genome editing technology.
Board of Directors: In January of 2019, Intellia appointed Fred Cohen, M.D., D.Phil, F.A.C.P., to its board of directors, adding both biotechnology drug development experience and extensive medical expertise to the current knowledge base of the Company’s board.
Upcoming Milestones

The Company has set forth the following for 2019 pipeline progression:

ATTR: Complete dose-range finding studies, initiate IND-enabling toxicology studies and commence manufacturing of lipid and CRISPR/Cas9 cargo
Engineered Cell Therapy: Nominate first engineered cell therapy development candidate for acute myeloid leukemia by the end of 2019
Present additional in vivo NHP insertion data and ATTR formulation improvement data at upcoming scientific conferences
Upcoming Events

The Company will participate in the following investor events:

Leerink Healthcare Conference, February 28, New York City
Barclays Global Healthcare Conference, March 12, Miami
Fourth Quarter and Full Year 2018 Financial Results

Cash Position: Cash, cash equivalents and marketable securities were $314.1 million as of December 31, 2018, compared to $340.7 million as of December 31, 2017. The decrease was driven by cash used to fund operations of approximately $96 million, which was offset in part by $28.5 million of net equity proceeds raised from the Company’s "At the Market" (ATM) agreement, $11.7 million in proceeds from employee-based stock plans, $10.4 million of ATTR cost reimbursements made by Regeneron, and $19.0 million of funding received under the Novartis collaboration. The Novartis funding received included a $10.0 million upfront payment related to the expansion of the existing collaboration in the fourth quarter of 2018.
Collaboration Revenue: Collaboration revenue increased by $1.2 million to $7.9 million during the fourth quarter of 2018, compared to $6.7 million during the fourth quarter of 2017. The increase in collaboration revenue in 2018 was primarily driven by amounts recognized from the expansion of the existing collaboration with Novartis, as well as by amounts recognized under the Company’s ATTR Co/Co agreement with Regeneron. As previously disclosed, Regeneron is obligated to fund approximately 50 percent of the development costs for the ATTR program.
R&D Expenses: Research and development expenses decreased by $1.3 million to $19.9 million during the fourth quarter of 2018, compared to $21.2 million during the fourth quarter of 2017. This decrease was driven primarily by lower consumable costs, as well as the timing of general R&D expenses.
G&A Expenses: General and administrative expenses decreased by $1.5 million to $8.7 million during the fourth quarter of 2018, compared to $10.2 million during the fourth quarter of 2017. This decrease was driven primarily by a decrease in stock-based compensation.
Net Loss: The Company’s net loss was $19.1 million for the fourth quarter of 2018, compared to $24.0 million during the fourth quarter of 2017.

Financial Guidance

Intellia expects that its cash, cash equivalents and marketable securities as of December 31, 2018, as well as technology access and funding from Novartis and Regeneron, will enable Intellia to fund its anticipated operating expenses and capital expenditure requirements into the first half of 2021. This expectation excludes any potential milestone payments or extension fees that could be earned and distributed under the collaboration agreements with Novartis and Regeneron or any strategic use of capital not currently in the base-case planning assumptions.