On August 4, 2015 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune diseases, asthma and allergic diseases, and cancer, reported financial results for the second quarter ended June 30, 2015 and provided a review of its business highlights (Filing, 8-K, Xencor, AUG 10, 2015, View Source [SID:1234507195]).

"Currently eight XmAb antibody candidates are in clinical testing, six with partners and two internal. The accelerating momentum of this pipeline of antibodies is a direct result of the breadth of immune biology that our proprietary XmAb platform addresses. We recently unveiled updates on our development plans for our internally-led programs XmAb5871 in the rare autoimmune disorder IgG4-Related Disease (IgG4-RD) and XmAb7195 for the treatment of asthma, and we also announced the selection of our second oncology bispecific antibody, XmAb13676, which will enter clinical testing for B-cell malignancies in 2016," said Bassil Dahiyat, Ph.D., president and chief executive officer of Xencor. "With the recent expansion of our executive management team to include industry veterans in regulatory affairs and clinical oncology, we have built a team to advance this pipeline through key clinical inflection points. We look forward to advancing each of our lead antibodies and expanding our oncology bispecific antibody pipeline."

Recent Business Highlights

XmAb5871: A first-in-class monoclonal antibody that targets CD19 with its variable domain and that uses Xencor’s proprietary XmAb immune inhibitory Fc domain to target FcγRIIb, a receptor that inhibits B-cell function.

· Xencor plans to initiate an open-label, pilot study of XmAb5871 in IgG4-Related Disease (IgG4-RD) in 2015. The trial, designed to assess control of disease activity, will enroll approximately 15 subjects for up to 24 weeks and will utilize the IgG4-RD Responder Index to measure treatment activity (Carruthers 2012, International Journal of Rheumatology).

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· At the European League Against Rheumatism (EULAR) 2015 Annual Meeting in June 2015, Xencor reported complete data results from a Phase 1b/2a clinical trial for XmAb5871 in patients with rheumatoid arthritis (RA). XmAb5871 was generally well tolerated and showed trends in improvement in RA disease activity by multiple disease activity measures and across multiple dose groups. In the Phase 2a portion of the trial, Xencor reported that 33.3% of patients (5 of 15) who received six biweekly doses of XmAb5871 achieved DAS28-CRP remission (13.3%) or low disease activity (20%) versus zero on placebo. ACR responses were also enhanced in XmAb5871 treated patients, with 86.7%, 40.0% and 20.0% of patients achieving an ACR20, ACR50 and ACR70 response, respectively, compared to 62.5%, 12.5% and 0% for the placebo group. The trials’ primary objective was characterizing safety and tolerability, and XmAb5871 was generally well tolerated, with the most common treatment-related adverse events (AEs) observed being predominately mild-to-moderate gastrointestinal toxicities (nausea, vomiting, diarrhea) occurring during the first infusion of XmAb5871. These gastrointestinal AEs did not typically recur on subsequent infusions and no infusions were discontinued due to these AEs. Treatment related serious adverse events (SAEs) occurred in two patients who received XmAb5871: infusion-related reaction and venous thrombosis. Two patients in the placebo-treated group also reported SAEs.

XmAb7195: A first in class monoclonal antibody that targets IgE with its variable domain and uses Xencor’s XmAb immune inhibitor Fc domain to target FcγRIIb, resulting in three distinct mechanisms of action for reducing IgE levels.

· In June 2015, Xencor announced commencement of an expansion of the Phase 1a trial of XmAb7195, in which subjects will receive two doses of XmAb7195. This new part of the trial will allow Xencor to examine IgE reduction and the safety of XmAb7195 after a second infusion. Complete XmAb7195 Phase 1a study results are expected in the first half of 2016.
· Also in June 2015, Xencor announced that a Phase 1 trial with a subcutaneous formulation of XmAb7195 is planned for 2016.

Bispecific Oncology Pipeline: Xencor’s initial bispecific programs are tumor-targeted antibodies that contain both a tumor antigen binding domain and a cytotoxic T-cell binding domain (CD3). These bispecific antibodies activate T-cells for highly potent and targeted killing of malignant cells. Their XmAb Fc domains confer long circulating half-lives, stability and ease of manufacture.

· XmAb14045 (CD123xCD3 bispecific antibody): Xencor plans to initiate clinical trials of XmAb14045 targeting CD123, a target on tumor cells in acute myeloid leukemia, and CD3 in 2016.

· XmAb13676 (CD20xCD3 bispecific antibody): In June 2015, Xencor announced the selection of XmAb13676, its second bispecific oncology candidate for development. XmAb13676 targets CD20 on malignant B cells and CD3. The Company expects XmAb13676 to begin clinical trials for B-cell malignancies in 2016.

Corporate

· In May 2015, Xencor announced the appointment of Mark Lotz, R.Ph. as vice president of regulatory affairs and Wayne Saville, M.D., as vice president of clinical oncology. Previously, Mr. Lotz served as a regulatory and quality consultant and as a representative to regulatory agencies, and he has more than 35 years of biotechnology and pharmaceutical experience in regulatory affairs. Dr. Saville joins Xencor from Tocagen Inc., where he served as vice president of clinical development oncology, and has more than 25 years of clinical affairs and medical research experience.

· In July 2015, Xencor announced the appointment of Yujiro S. Hata to its board of directors. Mr. Hata joins the board with more than 20 years of industry-related experience. Currently, Mr. Hata serves as chief operating officer at immuno-oncology company FLX Bio where he oversees all business operations, mergers and acquisitions, and licensing.

Second Quarter and Six Months Ended June 30, 2015 Financial Results

Cash equivalents and marketable securities totaled $159.2 million as of June 30, 2015, compared to $54.7 million on December 31, 2014. The increase reflects the net proceeds of $115.0 million received from the completion of Xencor’s follow-on offering in the first quarter of 2015.

Revenues for the second quarter ended June 30, 2015 were $1.0 million, compared to $0.8 million for the same period of 2014. Revenues for the six months ended June 30, 2015 were $2.5 million, compared to $3.0 million for the same period in 2014. Revenues in the three and six month period ended June 30, 2015 were earned primarily from the Company’s Novo Nordisk and Alexion collaborations, compared to revenue for the same periods in 2014, which was primarily earned from Xencor’s Amgen collaboration that was terminated in the fourth quarter of 2014.

Research and development expenditures for the second quarter ended June 30, 2015 were $7.5 million, compared to $4.3 million for the same period in 2014. Total research and development expenses for the six month period ended June 30, 2015 were $12.7 million compared to $8.5 million for the same period in 2014. The increased research and development spending for the three and six months ended June 30, 2015 is primarily due to increased spending on Xencor’s bispecific technology and development candidates, including its initial bispecific oncology clinical candidates, XmAb14045 and XmAb13676.

General and administrative expenses in the second quarter ended June 30, 2015 were $2.5 million, compared to $1.6 million for the same period in 2014. Total general and administrative expenses for the first six months of 2015 were $5.3 million compared to $3.3 million in the first six months of 2014. Increased spending in the general and administration area reflects increased staffing in Xencor’s legal and accounting departments and additional spending in professional fees.

Non-cash, share-based compensation expense for the first six months of 2015 was $2.3 million, compared to $640,000 in the first six months of 2014.

Net loss for the second quarter ended June 30, 2015 was $8.9 million, or $(0.22) on a fully diluted per share basis, compared to a net loss of $5.0 million, or $(0.16) on a fully diluted per share basis, for the same period in 2014. For the six months ended June 30, 2015, net loss was $15.3 million, or $(0.41) on a fully diluted per share basis, compared to a net loss of $8.8 million, or $(0.28) on a fully diluted per share basis, for the same period in 2014. The increased loss for the three and six months ended June 30, 2015 is due to increased spending in both the research and development and general and administration areas and the increase in stock based compensation charges.

The total shares outstanding as of June 30, 2015 was 40,460,091, which reflects the additional 8,625,000 shares issued in the Company’s follow on financing in the first quarter of 2015.

Financial Guidance

Based on current operating plans, Xencor expects to have sufficient cash to fund research and development programs and operations through 2019.

(Filing, 10-Q, SciClone Pharmaceuticals, AUG 10, 2015, View Source [SID:1234507180])

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On August 10, 2015 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported financial results for the second quarter 2015 and commented on recent accomplishments and clinical development plans for selinexor, its lead product candidate (Filing, 8-K, Karyopharm, AUG 10, 2015, View Source [SID:1234507152]).

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"Important data describing the clinical benefit of selinexor across multiple solid and hematologic malignancies was presented during the quarter, including single agent anti-tumor activity and durable disease control in patients with recurrent glioblastoma, advanced sarcomas, ovarian and endometrial cancers. We also presented survival data in patients with relapsed/refractory diffuse large B-cell lymphoma treated with selinexor, along with combination data of selinexor with chemotherapy in patients with heavily pretreated acute myeloid leukemia," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "In addition, we continue to execute against the selinexor clinical development plan with the initiation of a Phase 2 study in patients with quad-refractory multiple myeloma and make steady progress enrolling patients in our other on-going later phase clinical trials in acute myeloid leukemia, diffuse large B cell lymphoma and Richter’s transformation. Furthermore, we made some important changes to certain trials based on our growing experience with selinexor. Finally, we recently met with FDA and now have a path forward for a phase 2/3 study in liposarcoma. In the second half of 2016, we look forward to reporting preliminary top-line data from our later phase clinical trials in AML, DLBCL and Richter’s transformation, as well as data from the first 80 patients in our later phase clinical trial in multiple myeloma in the middle of 2016."

Conference Call Information:
To access the conference call, please dial (855) 437-4406 (US) or (484) 756-4292 (international) at least five minutes prior to the start time and refer to conference ID 98056569. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of Karyopharm’s website, View Source, approximately two hours after the event.

Scientific Presentations and Publications:

• Presented positive clinical data with single-agent, oral selinexor in on-going Phase 2 and Phase 1b clinical studies across multiple solid tumors at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting including anti-tumor activity and disease control in patients with recurrent glioblastoma, advanced sarcomas, heavily pre-treated gynecological cancers and across multiple malignancies in Asian patients, including:

• anti-tumor activity, including brain penetration at clinically relevant drug levels, with a 13% overall response rate (ORR) and a 38% disease control rate (DCR) in patients with recurrent glioblastoma in an ongoing Phase 2 clinical trial;

• durable activity, including longer progression free survival (PFS) than last prior regimen, in an ongoing Phase 1b clinical study in patients with advanced sarcomas, including liposarcoma;

Targeting Disease at the Nuclear Pore

• promising anti-tumor activity or disease control across ovarian, endometrial and cervical cancers with disease control rates (DCR) of up to 62% and several patients remaining on study for up to 12 months in an ongoing Phase 2 clinical trial in patients with heavily pre-treated, progressive gynecological cancers;

• anti-tumor activity across a variety of malignancies in a Phase 1 clinical trial evaluating the activity of selinexor in Asian patients with advanced malignancies.

• Presented clinical data with oral selinexor, both as single agent and in combination with chemotherapy, in a number of hematologic malignancies including diffuse large B-cell lymphoma (DLBCL) and acute myeloid leukemia (AML) at the 20th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) 2015 Annual Meeting, including:

• updated survival data from an ongoing Phase 1b clinical trial of single-agent selinexor in heavily pre-treated patients with DLBCL in which patients with a response to selinexor (N=12) demonstrated a median overall survival (OS) of greater than 10 months (median not reached) and PFS was 24 months, significantly longer than those without a response (N=27; OS 3.5 months, PFS 1.2 months);

• preliminary Phase 2 results from an ongoing clinical trial of selinexor in combination with chemotherapy (idarubicin/Ara-C) in 18 evaluable patients with relapsed or refractory AML demonstrated a 56% ORR, including nine patients with complete remission (CR/CRi) and one patient with a partial remission (PR).

• Presented clinical and preclinical data with single agent, oral selinexor at the 13th International Conference on Malignant Lymphoma (ICML) in DLBCL patients with MYC, BCL2 and/or BCL6 translocations, so called "Double Hit and Triple Hit" Lymphomas — areas of significant unmet medical need associated with poor prognosis and limited standard-of-care treatment options:

• In an ongoing Phase 1 clinical trial in 14 relapsed, refractory DLBCL patients with triple, double or single hit MYC, BCL2 and/or BCL6 translocations, selinexor demonstrated clinically meaningful activity with a 43% ORR (PR or better) including two CRs, four PRs and two additional patients achieving stable disease (SD).

• In preclinical models, selinexor demonstrated potency in double hit DLBCL cell lines in vitro and in an aggressive derived xenograft (PDX) model of triple hit DLBCL, with 84% tumor growth inhibition.
Regulatory and Intellectual Property Updates:

• Karyopharm met with the FDA in July and plans to initiate a Phase 2/3 clinical trial of selinexor versus placebo to treat liposarcoma in the second half of 2015. Accrual to Karyopharm’s Phase 1b clinical trial in sarcomas, including liposarcoma, is nearly complete.

• Granted U.S. patent for KPT-350, an oral SINE compound being developed for the treatment of inflammatory and autoimmune diseases. This patent, which will expire in 2033 absent any patent term extensions, covers the composition of matter for KPT-350, as well as certain other compositions and related methods.

• Granted U.S. patent covering method of treatment using certain SINE compounds, including selinexor and verdinexor. This patent will expire in 2032 absent any patent term extensions, and the covered methods of treatment include methods for treating viral infections, inflammatory disorders and cancer.

Targeting Disease at the Nuclear Pore

Clinical Development Plans:

• Karyopharm initiated a single-arm trial in multiple myeloma called STORM, for Selinexor Treatment of Refractory Myeloma, which will initially include 80 patients. If the data from the initial 80 patients is promising, the study may be expanded to potentially support accelerated approval. Preliminary top-line data from this study are anticipated in mid-2016.

• Karyopharm is actively enrolling patients in three later-stage clinical studies evaluating selinexor: one in older patients with relapsed/refractory AML (SOPRA study), the second in patients with relapsed/refractory DLBCL (SADAL study) and the third in patients with Richter’s transformation (SIRRT study). Preliminary top-line data from all three studies are anticipated in the fourth quarter of 2016.

• Following evaluation of over 1,000 patients treated with selinexor to date, Karyopharm has determined that the recommended phase 2 dose (RP2D) for patients with the majority solid tumors and selected hematologic malignancies is 60 mg fixed dose, twice weekly; the maximum tolerated dose is ~120 mg. The recommended dose in multiple myeloma is 80 mg selinexor + 20 mg of dexamethasone together, twice weekly. Doses of up to 100 mg twice weekly will continue to be evaluated in certain indications.

• In July 2015, Karyopharm amended the SOPRA study, a Phase 2 randomized clinical trial of single-agent, oral selinexor in older patients with acute myeloid leukemia, or AML, to reduce the dose from 55mg/m2 to a fixed dose of 60mg, which corresponds to approximately 35 mg/m2. Dosing will remain twice weekly. This change was implemented based on ongoing safety and tolerability evaluations in the SOPRA study, as well as maturing data from AML patients in the Phase 1 first-in-human clinical trial of selinexor. The SOPRA study uses a two-to-one randomization of AML patients to selinexor or physician’s choice and, therefore, approximately twice as many cases of sepsis would be expected on the selinexor arm compared with the physician’s choice arm. As of the end of July 2015, there have been eight reports of sepsis in seven patients receiving selinexor 55 mg/m2 on the SOPRA study, as compared with two reports of sepsis in two patients receiving physician’s choice on that study. Therefore, although the numbers are small, and sepsis is often observed in patients with AML, the incidence of sepsis appears to be higher in the patients receiving selinexor. In addition, as our data are maturing, an apparent increase in the incidence of sepsis in patients with relapsed or refractory AML receiving high doses of selinexor twice weekly was noted in Karyopharm’s Phase 1 clinical trial in hematologic malignancies. Importantly, doses of 60mg twice weekly do not appear to be associated with any increase in sepsis or other infection-related events in patients with hematologic malignancies or solid tumors. In addition, the majority of the patients with AML in the Phase 1 study who showed a response to selinexor treatment, including patients with complete remissions, received selinexor at doses of approximately 60mg or below. As a result of the change in dose, the SOPRA study will now have an interim assessment in mid-2016 with topline data expected in the fourth quarter of 2016.

• In July 2015, Karyopharm amended the protocol of SIRRT, a Phase 2 clinical study of single-agent, oral selinexor in patients with Richter’s transformation, an aggressive form of lymphoma, to include patients with newly diagnosed Richter’s transformation. There is no standard of care for patients with Richter’s transformation and these patients have an extremely poor prognosis. As a result of these factors, and in order to improve patient accrual, in consultation with key opinion leaders in the area, Karyopharm determined that there was a compelling rationale to amend the SIRRT protocol to include patients who had not yet received chemotherapy to treat Richter’s transformation. Karyopharm is now implementing the revised protocol across SIRRT study sites in the United States and Europe.

• Karyopharm expects to commence the STOMP ("Selinexor and Backbone Treatments of Multiple Myeloma Patients") study in the third quarter with support from Myeloma Canada. In this multi-arm clinical study, Karyopharm plans to evaluate the combination of selinexor and low dose dexamethasone with backbone therapies including bortezomib, pomalidomide or lenalidomide in patients with multiple myeloma. Selinexor and low dose dexamethasone is already being combined with Kyprolis in an Investigator Sponsored Trial, where promising preliminary data were presented at ASH (Free ASH Whitepaper) 2014.

Targeting Disease at the Nuclear Pore

• Karyopharm is currently conducting company-sponsored trials of single-agent selinexor in four solid tumor indications. At ASCO (Free ASCO Whitepaper) 2015, Karyopharm reported responses and disease control in patients with heavily pretreated gynecologic malignancies (SIGN study) and in recurrent glioblastoma multiforme (KING study); accrual to these studies is continuing. Karyopharm is also continuing to accrue patients to the SHIP study, a phase 2 study of selinexor in previously treated, hormone-refractory prostate cancer. The fourth phase 2 solid tumor study, the STARRS study, involves patients with relapsed or refractory squamous cell tumors. Enrollment to the head and neck cohort of this study has been completed and, due to very slow accrual in the lung and esophageal squamous carcinoma cohorts, Karyopharm is terminating further enrollment to these arms and finalizing the study. Additional trials with selinexor in combination with various chemotherapies are ongoing and may include patients with squamous cell carcinomas.

• In addition, a number of investigator-sponsored (ISTs) or company-sponsored clinical studies evaluating the potential of selinexor in combination with either chemotherapy or targeted agents are currently ongoing or planned.

Second Quarter June 30, 2015 Financial Results
Cash, cash equivalents and investments as of June 30, 2015, including restricted cash, totaled $256.0 million, compared to $285.3 million as of March 31, 2015.

For the quarter ended June 30, 2015, research and development expense was $27.0 million compared to $13.2 million for the quarter ended June 30, 2014. For the quarter ended June 30, 2015, general and administrative expense was $6.2 million compared to $3.3 million for the quarter ended June 30, 2014. The increase in research and development expenses resulted primarily from the increase in expenses related to the continued clinical development of selinexor. The increase in general and administrative expense resulted primarily from the costs of being a public company and an increase in stock-based compensation.
Karyopharm reported a net loss of $32.7 million, or $0.92 per share, for the quarter ended June 30, 2015, compared to a net loss of $16.4 million, or $0.55 per share, for the quarter ended June 30, 2014. Net loss includes stock-based compensation expense of $4.5 million and $3.9 million for the quarters ended June 30, 2015 and June 30, 2014, respectively.

Financial Outlook
Based on current operating plans, Karyopharm expects that its existing cash and cash equivalents will fund its research and development programs and operations into 2018, including moving the four later-stage clinical studies to their next data inflection points. Karyopharm expects to end 2015 with greater than $200 million in cash, cash equivalents and investments.
"Karyopharm continues to maintain a very strong balance sheet, with approximately $256M in cash as of the end of the second quarter of 2015," said Justin Renz, Executive Vice President, Chief Financial Officer & Treasurer. "As for financial guidance this year, we remain on track to end 2015 with greater than $200M in cash."

On August 10, 2015 Kite Pharma, Inc. (Kite) (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT) products for the treatment of cancer, reported financial results for the quarter ended June 30, 2015 (Press release, Kite Pharma, AUG 10, 2015, View Source [SID:1234507155]).

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"This past quarter has been marked by a number of significant milestones. Most notably, we launched the first Company-sponsored clinical trial of our lead product candidate, KTE-C19," said Arie Belldegrun, M.D., FACS, Chairman, President and Chief Executive Officer. "We also entered into multiple collaborations, and expanded our manufacturing capabilities. In addition, we were very pleased to convene our first investor day on June 23rd, which allowed us to unveil new initiatives and highlight the progress of both our chimeric antigen receptor (CAR) and T cell receptor (TCR) programs."

Highlights of Developments in Second Quarter 2015

Commenced Kite’s Phase 1/2 clinical trial of KTE-C19, an anti-CD19 CAR T-cell therapy, for treatment of refractory, aggressive Non-Hodgkin’s Lymphoma (NHL).

Presented clinical biomarker results at the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which demonstrated that conditioning chemotherapy was associated with a significant rise in homeostatic cytokines and chemokines, which could favor expansion, activation, and trafficking of CAR T cells.

Announced our first TCR product candidate, targeting HPV-16 E6, that we plan to advance to a company-sponsored clinical trial.
Entered into an exclusive worldwide collaboration with bluebird bio to advance second generation TCR products to treat HPV-associated cancers.

Partnered with The Leukemia & Lymphoma Society to enhance the development of KTE-C19 in refractory, aggressive NHL and to launch CAR T-cell therapy educational programs.

Completed construction of our clinical supply manufacturing facility in Santa Monica, California.
Began construction on our manufacturing facility in El Segundo, California to support our commercial plans.
Hosted our first Investor Day, which focused on our future research, clinical, and manufacturing plans.

Second Quarter 2015 Financial Results

Cash Position: As of June 30, 2015, Kite had $392.9 million in cash, cash equivalents, and marketable securities, compared to $367.0 million as of December 31, 2014.

Cash Burn: The net increase of $25.9 million in the first half of 2015 was primarily due to $26.7 million in proceeds from the underwriters’ exercise of the over-allotment option from the follow-on public offering and the $60.0 million upfront payment from the Amgen collaboration. This increase was partially offset by cash outflows related to the acquisition of TCF, license obligations, and funding of ongoing operations, including for the advancement of the KTE-C19 program.

Net Loss: GAAP net loss attributable to common stockholders was $20.9 million, or $0.48 per share, for the second quarter of 2015, compared to $17.9 million, or $2.27 per share, for the second quarter of 2014. Non-GAAP net loss attributable to common stockholders for the second quarter of 2015 was $11.5 million, or $0.26 per share. Non-GAAP net loss for the second quarter of 2015 excludes non-cash stock-based compensation expense of $9.4 million. Please see "Note Regarding Use of Non-GAAP Financial Measures" for a reconciliation of GAAP net loss to non-GAAP net loss.

Revenue: Collaboration revenue was $4.4 million for the second quarter of 2015 compared to $0 for the second quarter of 2014. The increase was primarily comprised of the amortization of deferred revenue related to the $60.0 million upfront payment received from Amgen in the first quarter of 2015.

Total Operating Expenses: Total GAAP operating expenses for the second quarter of 2015 were $26.4 million compared to $11.1 million for the second quarter of 2014.

R&D Expenses: GAAP research and development (R&D) expenses were $16.6 million for the second quarter of 2015, compared to $7.4 million for the second quarter of 2014. The increase of $9.2 million was primarily due to costs associated with the ongoing KTE-C19 Phase 1/2 clinical trial in DLBCL, preparing for the additional trials in acute lymphoblastic leukemia (ALL), mantle cell lymphoma (MCL), and chronic lymphocytic leukemia (CLL) later this year, as well as increased personnel expense, including non-cash stock-based compensation, and costs related to growing the Company’s operations in the US and EU.

G&A Expenses: GAAP general and administrative (G&A) expenses were $9.8 million for the second quarter of 2015, compared to $3.7 million for the second quarter of 2014. The increase of $6.1 million was primarily due to increased personnel expense, including non-cash stock-based compensation, and other professional expenses to support growing the Company’s operations, as well as license obligations.

2015 Financial Guidance: Kite’s guidance remains unchanged. Kite expects to burn between $100 million and $125 million in cash for the full year 2015, which includes both operating expenses and capital expenditures. This guidance does not include cash inflows or outflows for business development activities.

(Filing, 10-Q, Intrexon, AUG 10, 2015, View Source [SID:1234507151])

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