On February 25, 2019 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of drugs to treat severe metabolic, oncologic and psychiatric disorders by modulating the effects of the stress hormone cortisol, reported its financial results for the quarter- and year-ended December 31, 2018 (Press release, Corcept Therapeutics, FEB 25, 2019, https://ir.corcept.com/news-releases/news-release-details/corcept-therapeutics-announces-fourth-quarter-and-full-year-1 [SID1234533647]).

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Financial Highlights

2018 revenue of $251.2 million, an increase of 58 percent from 2017
Fourth quarter revenue of $66.8 million, an increase of 25 percent from fourth quarter 2017
2018 GAAP net income of $0.60 per share, compared to $1.04 per share in 2017 (2017 includes one-time, non-cash tax benefit of $0.61 per share)
Fourth quarter GAAP net income of $0.18 per share, compared to $0.77 per share in fourth quarter 2017 (including $0.60 per share tax benefit)
Fourth quarter repurchases of 1.1 million shares of common stock; 2018 repurchases
totalling 1.8 million shares
Cash and investments at December 31, 2018 of $206.8 million, compared to $104.0 million
at December 31, 2017
Reiterated 2019 revenue guidance of $285 – 315 million
Relacorilant Phase 2 Trial Positive Top-Line Results

Relacorilant’s Phase 2 trial enrolled 35 patients, each of whom received a daily dose of relacorilant that was increased in 50 mg increments, as tolerable, every four weeks. The first 17 patients to enroll (the "low-dose cohort") started at 100 mg per day. The next 18 patients (the "high dose cohort") started at 250 mg per day.

Applying the endpoints for clinical benefit from relacorilant’s Phase 3 trial ("GRACE") to the high-dose cohort produces the following results:

Fifty percent of patients with hyperglycemia achieved improved glucose control, as shown by (i) a 0.5 percent or greater reduction in HbA1c or (ii) normalization of 2-hour oGTT glucose or decreased by at least 50 mg/dL or (iii) a 25 percent or greater decrease in antidiabetic medications
Sixty-four percent of patients with uncontrolled hypertension achieved a five millimeter or greater drop in either systolic or diastolic blood pressure, as measured by 24-hour ambulatory monitoring
No evidence of progesterone receptor affinity or hypokalemia
Plan to present data at the American Association of Clinical Endocrinologist ("AACE") Annual Scientific and Clinical Conference in Los Angeles, California, April 24-28th
Oncologic & Metabolic Disorders

Placebo-controlled, Phase 2 trial of relacorilant plus Abraxane in metastatic ovarian cancer underway, with planned enrollment of 180 patients in the United States and Europe
Data from dose-finding trial of relacorilant plus Abraxane to treat patients with metastatic, pancreatic cancer expected in second quarter
Dosing continues in Phase 1/2 trial of CORT125281 plus Xtandi to treat patients with metastatic castration-resistant prostate cancer
Placebo-controlled trial of CORT118335 for prevention of antipsychotic-induced weight gain to start second quarter; two trials in the reversal of antipsychotic-induced weight gain to start in second half of the year
Placebo-controlled, Phase 2 trial of CORT118335 to treat non-alcoholic steatohepatitis ("NASH") to start in second half of the year
Financial Results

Corcept’s 2018 revenue was $251.2 million, compared to $159.2 million in 2017. Fourth quarter revenue was $66.8 million, compared to $53.3 million in the fourth quarter of 2017. The company reiterated its 2019 revenue guidance of $285 – 315 million.

GAAP net income was $75.4 million for the year and $22.0 million in the fourth quarter of 2018, compared to $129.1 million for the year and $98.3 million in the fourth quarter of 2017. Fourth quarter 2017 net income included a one-time, non-cash gain of $76.4 million from the recognition of deferred tax assets.

Excluding non-cash tax benefits, non-cash expenses related to stock-based compensation, accreted interest on the company’s now-retired royalty financing obligation and related tax effects, non-GAAP net income was $30.4 in the fourth quarter, compared to $24.7 million in the fourth quarter of 2017. For the full-year, non-GAAP net income was $108.2 million, compared to $63.3 million in 2017. A reconciliation of GAAP to non-GAAP net income is included below.

Cash and investments increased by $10.1 million in the fourth quarter, to $206.8 million. This increase was after the expenditure of $14.8 million to acquire 1.1 million shares of the company’s common stock pursuant to its stock repurchase program. Under the program’s current terms, $76.3 million remains available for the repurchase of shares.

"2018 saw increased use of Korlym by patients with Cushing’s syndrome in every region of the country," said Joseph K. Belanoff, MD, Corcept’s Chief Executive Officer. "In the fourth quarter, 583 physicians were treating patients with the medication – a number that we expect to grow. Increased Korlym uptake fueled our strong financial results: revenue increased by $92.0 million, non-GAAP net income increased by $45.0 million. Cash and investments nearly doubled to $206.8 million. In addition, we repurchased 1.8 million shares of our common stock.

"We continue to protect and extend our Cushing’s syndrome franchise. On February 5th, for example, we were issued a patent (U.S. Pat. No. 10,195,214) covering the co-administration of Korlym and strong CYP3A4 inhibitors – a class of drugs that includes powerful antiviral, antibiotic, antifungal and antidepressant medications. The scientific discoveries that gave rise to this patent constituted an important advance in the safe treatment of patients taking Korlym, which is why corresponding instructions to prescribers are included in Korlym’s label.

"In 2018, we also made important clinical advances in our Cushing’s syndrome program. Data from the Phase 2 trial of our candidate to succeed Korlym – the proprietary, selective cortisol modulator, relacorilant – were strongly positive, with many patients exhibiting meaningful clinical benefit. Just as important, there were no instances of the two off-target effects – progesterone receptor affinity and increased cortisol levels – that cause Korlym’s most common and serious adverse events – termination of pregnancy, endometrial thickening, vaginal bleeding and low potassium (hypokalemia). We immediately began relacorilant’s Phase 3 trial."

Relacorilant Phase 2 Data

Applying the endpoints for clinical benefit from relacorilant’s Phase 3 trial, 50 percent of patients with hyperglycemia in the high-dose cohort achieved improved glucose control (see Figure 1). The response rate in patients with hypertension was 64 percent (see Figure 2). These response rates are comparable to those exhibited by patients at 16 weeks and a dose of 1200 mg in Korlym’s pivotal trial ("SEISMIC").

Patients in the high-dose group also met a wide range of secondary endpoints, including statistically significant improvements in hypercoagulopathy, liver function, insulin resistance, cognition and mood.

Figure 1 Figure 2.
Figure 1. Patients achieving clinically meaningful reductions in HbA1c, 2-hour oGTT or use of antidiabetic medications. Figure 2. Patients achieving clinically meaningful improvements in hypertension.
Relacorilant was well-tolerated. The most commonly reported adverse events were backpain, peripheral edema, headache and nausea – adverse events that are frequently seen when excess cortisol activity is reduced and that tend to be transitory.

Relacorilant’s Phase 3 GRACE trial is underway. It is expected to enroll 130 patients at 60 sites in the United States, Canada, Europe and Israel.

Oncology & Metabolic Disease

"We expect our oncology and metabolic disease programs to take important steps forward in 2019," said Dr. Belanoff. "Following encouraging data from our Phase 1/2 dose-finding study, we have begun a 180 patient, controlled Phase 2 trial of relacorilant plus Abraxane to treat patients with metastatic ovarian cancer, a disease with few good treatment options. We continue to gather data in metastatic pancreatic cancer and plan to release our results and clinical development plan at the time of the ASCO (Free ASCO Whitepaper) meeting this June. We expect to select the optimal dose of CORT125281 plus Xtandi to treat patients with metastatic castration-resistant prostate cancer this year."

"We are excited to advance CORT118335 as a potential treatment for antipsychotic-induced weight gain and NASH," added Dr. Belanoff. "We plan three placebo-controlled trials in antipsychotic-induced weight gain: the first will investigate CORT118335’s ability to prevent weight gain in healthy subjects given olanzapine (Eli Lily’s Zyprexa). We plan to start this trial in the second quarter. The second two trials will be in patients taking antipsychotic medications – one to study the reversal of recently-established weight gain and the other to study the reversal of long-standing weight gain. They are planned to start in the second half of the year. Our placebo-controlled, Phase 2 trial of CORT118335 as a treatment for NASH is also planned for the second half of 2019."

Conference Call

We will hold a conference call on February 25, 2019, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time). To participate, dial 1-888-220-8451 from the United States or 1-323-794-2588 internationally approximately 10 minutes before the start of the call. The passcode is 6598298. A replay will be available through March 11, 2019 at 1-888-203-1112 from the United States and 1-719-457-0820 internationally. The passcode will be 6598298.

Hypercortisolism

Hypercortisolism, often referred to as Cushing’s syndrome, is caused by excessive activity of the stress hormone cortisol. Endogenous Cushing’s syndrome is an orphan disease that most often affects adults aged 20-50. In the United States, an estimated 20,000 patients have Cushing’s syndrome, with about 3,000 new patients being diagnosed each year. Symptoms vary, but most people experience one or more of the following manifestations: high blood sugar, diabetes, high blood pressure, upper-body obesity, rounded face, increased fat around the neck, thinning arms and legs, severe fatigue and weak muscles. Irritability, anxiety, cognitive disturbances and depression are also common. Cushing’s syndrome can affect every organ system in the body and can be lethal if not treated effectively.

On February 25, 2019 Abbott (NYSE: ABT) reported that it will present at the Barclays Global Healthcare Conference on Wednesday, March 13, 2019 (Press release, Abbott, FEB 25, 2019, View Source [SID1234533630]). Brian Yoor, executive vice president of finance and chief financial officer, will present at 1:05 p.m. Central time.

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A live audio webcast will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com.

On February 25, 2019 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported its financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Alder Biopharmaceuticals, FEB 25, 2019, View Source [SID1234533649]). Alder also noted that it announced the completion of its Biologics License Application (BLA) submission for eptinezumab, the company’s investigational monoclonal antibody (mAb) for migraine prevention targeting the calcitonin gene-related peptide and lead commercial candidate, with the Food and Drug Administration (FDA) on February 22, 2019.

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r Alder, capped by the completion of eptinezumab’s BLA submission to the FDA last week," said Bob Azelby, president and chief executive officer of Alder. "We achieved all of the significant milestones we targeted for the year including positive top-line data from our PROMISE 2 Phase 3 clinical trial and positive PROMISE 1 and PROMISE 2 Phase 3 data demonstrating sustained or increased migraine prevention following subsequent infusions, as well as positive results from a pharmacokinetic study, to name a few. The achievement of these milestones further demonstrates eptinezumab’s differentiated profile, which we believe will allow Alder to compete in the highly impacted migraine patient segment."

Mr. Azelby added, "As we look ahead to 2019, we continue to make substantial progress advancing our supply chain, building commercial inventory, expanding our commercial and operational infrastructure, and executing on key pre-launch initiatives to enable a successful commercial launch of eptinezumab in the first quarter of 2020, if approved. Additionally, consistent with our commitment to forever change migraine treatment and give patients their lives back, we are focused on advancing our pre-clinical candidate, ALD1910. The totality of our pre-clinical data to date gives us confidence that we will be positioned to initiate a first in-human clinical trial by the end of 2019."

2019 Highlights and Upcoming Milestones

On February 22, Alder announced it completed its BLA submission for eptinezumab with the FDA. The BLA submission was supported by positive results from Alder’s two positive Phase 3 trials of eptinezumab, positive results from an open-label safety study and a pharmacokinetic (PK) comparability study, and chemistry, manufacturing, and controls (CMC) data packages.

Alder remains on track for the potential commercial launch of eptinezumab in the first quarter of 2020, and continues to advance its manufacturing and commercial readiness activities in anticipation of launch. Currently, Alder is advancing its supply chain, building commercial inventory, continuing to build out its commercial and operational infrastructure, and executing against other key pre-launch initiatives.

Alder continues to advance its pre-clinical candidate, ALD1910, a monoclonal antibody targeting PACAP-38 (pituitary adenylate cyclase-activating peptide-38). ALD1910 is currently undergoing Investigational New Drug (IND)-enabling preclinical studies and Alder expects to initiate its first in-human clinical study by the end of 2019.

In January, Alder announced the appointment of Dr. Paul Streck as Chief Medical Officer. He brings more than 25 years of experience in drug development, regulatory and medical affairs leadership across both large and small publicly traded biopharmaceutical companies. Dr. Streck previously served as Chief Medical Officer at Insmed Incorporated, where he played an instrumental role as a member of the executive leadership team and successfully led the Arikayce regulatory filing, approval and launch.

2018 Company Milestones

In December, Alder announced the appointment of Carlos Campoy as Chief Financial Officer. He brings nearly 30 years of financial leadership and expertise across global publicly-traded companies, including more than 20 years in the biopharmaceutical and healthcare sectors. Mr. Campoy previously served as Vice President of Finance, International at Allergan plc, where he had financial responsibility for $3B in sales and drove significant growth across all product divisions, including Neurosciences and BOTOXÒ.

In October, Alder announced positive results from a comparative PK study that supported the comparability evaluation of the clinical supply for eptinezumab and its planned commercial supply. Both the primary and key secondary PK results met the standard pre-specified acceptance criteria for drug product comparability.

In June, new data from Alder’s PROMISE 1 and PROMISE 2 Phase 3 clinical trials for eptinezumab in episodic and chronic migraine patients, respectively, were presented at the American Headache Society Meeting. The new data highlighted the strength of eptinezumab’s efficacy data by showing sustained or increased efficacy following subsequent quarterly administrations of eptinezumab.

In April, new data from Alder’s PROMISE 1 Phase 3 clinical trial for eptinezumab in episodic migraine patients were presented at the 70th Annual AAN Meeting. The new data demonstrated long-term and sustained or further increased efficacy in episodic migraine following the third and fourth quarterly infusion, as well as increased migraine-free intervals and improved quality of life outcomes.

Also in the second quarter of 2018, Alder completed a one-year safety study of eptinezumab, which generated favorable safety and tolerability data and demonstrated a favorable safety profile consistent with previous eptinezumab studies.

In January, Alder announced eptinezumab significantly reduced migraine risk and met the primary and all key secondary endpoints in its pivotal PROMISE 2 Phase 3 clinical trial for chronic migraine prevention.

Also in January 2018, Alder entered into a settlement and global license agreement with Teva Pharmaceuticals International GmbH, which provided clarity regarding Alder’s freedom to develop, manufacture and commercialize eptinezumab in the U.S. and globally.

Fourth Quarter and Year-End 2018 Financial Results

As of December 31, 2018, Alder had $412.4 million in cash and cash equivalents, short-term investments and restricted cash, compared to $484.7 million as of Sept. 30, 2018 and compared to $286.2 million as of December 31, 2017.

Research and development expenses for the fourth quarter ended December 31, 2018 totaled $64.4 million, compared to $44.7 million for the same period in 2017. For the full year 2018, research and development expenses totaled $239.1 million, compared to $252.9 million for the full year 2017. The year-over-year decrease was primarily due to lower clinical trial costs in 2018 as a result of the completion of several clinical trials.

General and administrative expenses for the fourth quarter ended December 31, 2018 totaled $13.0 million, compared to $10.3 million for the same period in 2017. For the full year 2018, general and administrative expenses totaled $47.5 million, compared to $38.1 million for the full year 2017. The year-over-year increases reflect Alder’s continued commitment to advance the eptinezumab program and position Alder for commercialization.

Net loss applicable to common stockholders for the fourth quarter ended December 31, 2018 totaled $81.5 million, or $1.19 per share, compared to net loss of $54.4 million, or $0.80 per share on a fully-diluted basis, for the same period in 2017. For the full year 2018, net loss applicable to common stockholders totaled $331.9 million, or $4.87 per share on a fully-diluted basis, compared to net loss of $288.9 million, or $4.95 per share, for the full year 2017.

Financial Outlook

Alder expects full-year 2019 net cash used in operating activities and purchases of property and equipment will be in the range of $285 to $315 million dollars. The majority of the spend is focused on ensuring that Alder is prepared for the potential launch of eptinezumab in the first quarter of 2020, including advancing eptinezumab’s supply chain, building commercial inventory, continuing to build out Alder’s commercial footprint and other pre-launch market readiness activities.

Alder believes its available cash, cash equivalents, short-term investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020 and the anticipated launch of eptinezumab.

Conference Call and Webcast

Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers and providing conference ID number 7655239. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for at least 30 days.

On February 25, 2019 Horizon Pharma plc (Nasdaq: HZNP), reported that the company will participate in the following conference in March (Press release, Horizon Biopharm, FEB 25, 2019, View Source [SID1234533631]):

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Cowen and Company 39th Annual Health Care Conference

Date: March 11, 2019
Presentation Time: 12 p.m. ET
Location: Boston
The conference presentation will be webcast live and may be accessed by visiting Horizon’s website at View Source A replay of the webcast will be available for the event.

On February 25, 2019 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, CRISPR Therapeutics, FEB 25, 2019, View Source [SID1234533633]).

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"This past year was truly transformational for CRISPR Therapeutics as we achieved milestones across our key programs in β-thalassemia, sickle cell disease and immuno-oncology. We’re pleased with the progress we’ve made in 2018, especially in clinical execution and the expansion of our development pipeline. We also strengthened our team with key new hires, positioning us well as we advance to the next stage of development. This progress brings us closer to realizing our mission of bringing transformative therapies to patients with serious diseases," said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics.

Dr. Kulkarni added: "Over the next two years, we expect to generate data from clinical trials across multiple indications as we bring CRISPR technology to patients. In addition, we are making deliberate steps to scale the Company as we advance programs across a number of therapeutic areas while continuing to bolster our proprietary CRISPR platform."

Recent Highlights and Outlook

Hemoglobinopathies

° β-thalassemia
CRISPR Therapeutics, together with its partner, Vertex, announced that the first patient has been treated with CTX001 in a Phase 1/2 clinical study of patients with transfusion-dependent beta thalassemia (TDT), marking the first company-sponsored use of a CRISPR/Cas9 therapy in a clinical trial. The Phase 1/2 open-label trial is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with TDT, non-beta zero/beta zero subtypes. The first two patients in the trial will be treated sequentially and, pending data from these initial two patients, the trial will open for broader concurrent enrollment. The companies plan to target presentations of data at scientific conferences once there is sufficient data on multiple patients.

° Sickle Cell Disease
CRISPR Therapeutics, together with its partner, Vertex, are also investigating CTX001 for the treatment of severe sickle cell disease (SCD) and announced that the first patient has been enrolled in a Phase 1/2 clinical study of CTX001 in severe SCD in the U.S. and is expected to be infused with CTX001 in mid-2019. The Phase 1/2 open-label trial is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with severe SCD. Similar to the trial in beta thalassemia, the first two patients in the trial will be treated sequentially prior to broader concurrent enrollment. The companies plan to target presentations of data at scientific conferences once there is sufficient data on multiple patients. CTX001 was recently granted Fast Track Designation by the U.S. Food and Drug Administration for the treatment of SCD.
Immuno-Oncology

° CRISPR Therapeutics is on track to initiate a clinical trial for CTX110, its wholly-owned allogeneic CAR-T cell therapy targeting CD19+ malignancies, in the first half of 2019. CRISPR/Cas9 has the potential to create the next-generation of CAR-T cell therapies that may have a superior product profile compared to current autologous therapies and allow accessibility to broader patient populations. The Company continues to advance two additional allogeneic CAR-T candidates; CTX120, targeting B-cell maturation antigen (BCMA) for the treatment of multiple myeloma; and CTX130, targeted towards CD70 for the treatment of both solid tumors and hematologic malignancies. In November, the Company presented a poster at the Society for Immunotherapy in Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting related to multiplex editing and production of allogeneic CAR-T therapies. Additionally, the Company presented a poster at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2018 Annual Meeting in December, highlighting further development and preclinical data for CTX120. The study showed maintained cytotoxic capacity over multiple in vitro re-challenges, demonstrating durable potency and reduced susceptibility to exhaustion.
Other Programs

° In September, CRISPR Therapeutics and ViaCyte, Inc. announced a collaboration focused on the discovery, development, and commercialization of gene-edited allogeneic stem cell derived islet cell progenitors which may offer curative benefit to patients with insulin-requiring diabetes. The combination of ViaCyte’s stem cell capabilities and CRISPR Therapeutics’ gene editing capabilities has the potential to enable a beta-cell replacement product that may deliver durable benefit to patients without the need for immune suppression.

° Earlier this year, CRISPR Therapeutics announced strategic collaborations with StrideBio, Inc. and ProBioGen. The Company’s collaboration with StrideBio expands upon an existing agreement to generate engineered AAV capsids with improved properties for in vivo gene editing programs and now includes additional undisclosed applications. CRISPR Therapeutics and ProBioGen announced a collaboration focused on the development of novel in vivo delivery modalities for CRISPR/Cas9 leveraging ProBioGen’s existing technology and expertise.

° In November, CRISPR Therapeutics and MaxCyte announced the expansion of an existing collaboration by entering into a non-exclusive commercial license agreement allowing CRISPR Therapeutics to deploy MaxCyte’s Flow Electroporation Technology to develop CRISPR/Cas9-based therapies in immuno-oncology. The collaboration builds on an existing agreement which allowed for the development of commercial therapeutics for hemoglobin-related diseases.
Company Building

° CRISPR Therapeutics continued to expand core capabilities in critical areas with the addition of key new talent across several functions.

° In February, CRISPR Therapeutics proposed to elect John T. Greene and Katherine A. High, M.D. to its Board of Directors at the Company’s upcoming annual general meeting to be held later this year. Together, they will bring significant strategic and operational experience to CRISPR Therapeutics.
Fourth Quarter and Full Year 2018 Financial Results

Cash Position: Cash and cash equivalents as of December 31, 2018 were $456.6 million, compared to $239.8 million as of December 31, 2017, an increase of $216.8 million, which was primarily driven by the net proceeds of $307.1 million from the sale of shares in follow-on financing rounds executed in January and September of 2018, offset by the Company’s use of $96.2 million for operating activities.

Revenue: Total collaboration revenue was $0.1 million for the fourth quarter of 2018 compared to $32.3 million for fourth quarter of 2017, and $3.1 million for the year ended December 31, 2018, compared to $41.0 million for the year ended December 31, 2017. The decrease in annual revenue is primarily attributable to deferred revenue recognized in 2017 in conjunction with the execution of the Company’s collaboration agreement with Vertex. During 2018 and going forward, Vertex funding of hemoglobinopathies programs are categorized as a contra-expense as opposed to revenue.

R&D Expenses: R&D expenses were $28.8 million for the fourth quarter of 2018 compared to $20.0 million for the fourth quarter of 2017, and $113.8 million for the year ended December 31, 2018 compared to $69.8 million for the year ended December 31, 2017. The increase in expense for the year was driven by greater investment in CRISPR’s lead hemoglobinopathies program partnered with Vertex, one-time expense associated with beginning our ViaCyte collaboration and expenses from the Company’s wholly owned immuno-oncology and in vivo programs.

G&A Expenses: General and administrative expenses were $16.5 million for the fourth quarter of 2018 compared to $11.3 million for the fourth quarter of 2017, and $48.3 million for the year ended December 31, 2018 compared to $35.8 million for the year ended December 31, 2017. The increase in general and administrative expenses for the year was driven by increased professional services and employee-related costs associated with our growing organization.

Net Income/Loss: Net loss was $47.6 million for the fourth quarter of 2018 compared to income of $0.1 million for the fourth quarter of 2017, and net loss was $165.0 million for the year ended December 31, 2018 compared to a loss of $68.4 million for the year ended December 31, 2017.