On May 9, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease, reported financial results for the first quarter ended March 31, 2019 (Press release, Akebia, MAY 9, 2019, View Source [SID1234536069]). The company also announced full enrollment of its global Phase 3 INNO2VATE studies for vadadustat, that it has bolstered its commercial capabilities with the addition of Dell Faulkingham as Senior Vice President, Chief Commercial Officer, and appointed Steven K. Burke, M.D., as Senior Vice President, Chief Medical Officer.

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"The first quarter marked the achievement of another important milestone for Akebia with the announcement of positive top-line results from two Phase 3, active-controlled, pivotal studies evaluating vadadustat in Japanese patients with anemia due to chronic kidney disease (CKD)," stated John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "We are excited by these results as they increase our level of confidence in the hypoxia inducible factor (HIF) pathway and more specifically, the direction of our clinical program for vadadustat. These results are expected to serve as the basis for a New Drug Application in Japan (JNDA) by our collaboration partner, Mitsubishi Tanabe Pharma Corporation (MTPC), in 2019."

Butler continued, "We are also pleased to announce the completion of enrollment in our global Phase 3 INNO2VATE studies evaluating vadadustat for the treatment of anemia due to CKD in dialysis-dependent CKD subjects. With the addition of Dell Faulkingham to our executive team, we have strengthened our commercial capabilities and believe we are well positioned to execute on our revenue growth strategies for Auryxia. Lastly, we look forward to welcoming Dr. Steven Burke as our new Chief Medical Officer as we continue to execute on the multiple catalysts expected with vadadustat’s Phase 3 program over the next 12 to 18 months."

Auryxia Highlights

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Auryxia net product revenue for the first quarter of 2019 was $23.1 million, representing 12.1 percent growth over the first quarter of 2018.

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Total Auryxia prescriptions were 40,080, representing 22.5 percent growth over the first quarter of 2018.

Vadadustat Highlights

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Announced positive top-line results from two Phase 3, active-controlled, pivotal studies evaluating vadadustat in Japanese subjects with anemia due to CKD in March 2019. Data from these two pivotal studies as well as from two additional single-arm studies in peritoneal dialysis and hemodialysis subjects, also recently announced, are expected to serve as the basis for a JNDA submission by MTPC in 2019.

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Expanded license agreement with Vifor Pharma announced in April 2019 creates opportunity for accelerated introduction of vadadustat, if approved by the U.S. Food and Drug Administration (FDA), in up to 60 percent of U.S. dialysis patients.

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Enrollment in the global Phase 3 INNO2VATE studies evaluating the safety and efficacy of vadadustat in dialysis-dependent CKD subjects with anemia due to CKD, has been completed. Enrollment in the smaller of the two INNO2VATE studies (the "Correction Study"), was completed in April 2019, with a total of 369 subjects enrolled. Enrollment in the larger INNO2VATE study (the "Conversion Study") was completed in February 2019, with a total of 3,554 subjects enrolled. The company continues to expect to report top-line data from both INNO2VATE studies in the second quarter of 2020, subject to the accrual of major adverse cardiovascular events (MACE).

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The company expects enrollment in the global Phase 3 PRO2TECT studies evaluating the safety and efficacy of vadadustat in non-dialysis dependent CKD subjects with anemia due to CKD, to be completed in 2019, with up to approximately 3,700 subjects expected to be enrolled. The company continues to expect to report top-line results in mid-2020, subject to the accrual of MACE.

Financial Results

Total revenue for the first quarter of 2019 was $72.7 million, compared to $45.9 million in the first quarter of 2018.

Auryxia net product revenue for the first quarter of 2019 was $23.1 million, compared to $20.6 million, as reported by Keryx Biopharmaceuticals, Inc. ("Keryx") prior to its merger with the company, during the same period in 2018. This represents a 12.1 percent increase in net product revenue from the first quarter of 2018. Auryxia is the company’s FDA approved oral iron tablet to treat non-dialysis dependent adult CKD patients for iron deficiency anemia (IDA) and dialysis-dependent adult CKD patients for hyperphosphatemia.

"As we previously discussed, the Centers for Medicare & Medicaid Services’ (CMS) new prior authorization requirement for Auryxia caused delays in approvals of prescriptions and negatively impacted Auryxia product revenue for the first quarter. We believe our efforts to help patients and prescribers navigate this process are working and we’re encouraged with the growth in weekly prescriptions that we are now seeing. In fact, the prescription demand we’ve seen in the first four weeks of the second quarter exceeded the first four weeks of any quarter since Auryxia was launched," stated Butler. "Looking ahead, we believe continued execution on our growth strategy and underlying market demand, will drive increased revenue for Auryxia in the second quarter and across the year."

Collaboration revenue for the first quarter of 2019 was $49.6 million, compared with $45.9 million in the first quarter of 2018. The increase was primarily due to increased collaboration revenue in the first quarter of 2019 from the company’s cost sharing arrangement under its Otsuka collaboration agreements. The company expects Otsuka to begin funding 80 percent of its development costs for vadadustat in the second quarter of 2019.

Cost of goods sold was $31.3 million for the first quarter of 2019, consisting of $7.6 million of costs associated with the manufacture of Auryxia and $23.7 million related to the application of purchase accounting as a result of the merger with Keryx, including $14.6 million of inventory step-up and $9.1 million of amortization of intangibles.

Research and development expenses were $82.4 million for the first quarter of 2019 compared to $61.4 million for the first quarter of 2018. The increase was primarily attributable to an increase in external costs related to the continued advancement of the PRO2TECT and INNO2VATE Phase 3 studies.

Selling, general and administrative expenses were $34.3 million for the first quarter of 2019 compared to $9.0 million for the first quarter of 2018. The increase in selling, general and administrative expenses was primarily attributable to commercialization costs associated with Auryxia, as there were no comparable commercialization costs in the first quarter of 2018.

The company reported a net loss for the first quarter of 2019 of $72.4 million, or ($0.62) per share, as compared to a net loss of $23.4 million, or ($0.48) per share, for the first quarter of 2018. The company’s net loss for the first quarter of 2019 includes the impact of merger-related accounting charges totaling $23.7 million, offset by a $2.8 million deferred tax benefit.

The company ended the quarter with cash, cash equivalents and available-for-sale securities of $168.0 million. The decrease from the fourth quarter of 2018 was primarily related to the timing of cash flows between quarters, including reimbursement amounts from the company’s collaboration partners and payments related to its Phase 3 program for vadadustat, including $13.0 million of advanced purchases of comparator drug inventory in anticipation of Brexit. Additionally, cash was impacted by one-time payments of certain previously accrued, merger-related liabilities totaling $30.0 million. The company continues to expect its cash resources, including the prepaid quarterly committed cost-share funding from its collaboration partners, to fund its current operating plan into the third quarter of 2020.

Leadership Team Additions

Steven K. Burke, M.D. will succeed Rita Jain, M.D., who informed the company of her plans to step down from her position as Senior Vice President, Chief Medical Officer effective June 17, 2019 to pursue other opportunities. Dr. Jain has been a valued member of the company’s leadership team, and during her tenure made important contributions to the vadadustat development program and enhanced the development organization. She has advised the company that she is committed to supporting the company during a transitional period and ensuring a seamless and successful transition to her successor, Dr. Burke.

Dr. Burke will join the company from Proteon Therapeutics, Inc., where he has been Senior Vice President and Chief Medical Officer since 2006. Prior to joining Proteon, Dr. Burke served as Senior Vice President of Medical and Regulatory Affairs at Genzyme Corporation, where he worked from 2001 to 2006. From 1994 to 2001, Dr. Burke held roles at GelTex Pharmaceuticals, Inc. including Vice President of Clinical Research and Medical Director, and before that he held positions at Glaxo, Inc.. Dr. Burke received an A.B. from Harvard College and an M.D. from Cornell University Medical College. He completed a medical residency and fellowship at Brigham and Women’s Hospital and is certified by the American Board of Internal Medicine.

Dell Faulkingham joins the company with more than 20 years of commercial experience across a broad range of specialty pharmaceutical categories. His experience includes commercial leadership roles with Biogen Inc., where he held multiple positions of increasing responsibility, most recently serving as Senior Vice President and Head, U.S. Multiple Sclerosis (MS) Franchise. Mr. Faulkingham also recently served as Vice President, Head of U.S. MS Marketing and Field Operations at Biogen. Prior to joining Biogen, Mr. Faulkingham held several roles with Takeda Pharmaceuticals. Mr. Faulkingham began his career in sales at Forest Pharmaceuticals, Inc. and received a B.S. in biology from the University of Georgia.

Conference Call:

Akebia will host a conference call today, Thursday, May 9, 2019, at 9:00 a.m. Eastern Time to discuss its first quarter financial results. To listen to the conference call, please dial (877) 458-0977 (domestic) or (484) 653-6724 (international) using conference ID number 4271217. The call will also be webcast LIVE and can be accessed via the Investors section of the company’s website at View Source

A replay of the conference call will be available two hours after the completion of the call through May 15, 2019. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 4271217. An online archive of the conference call can be accessed via the Investors section of the company’s website at View Source

On May 9, 2019 Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that it will report its first quarter 2019 financial results on Tuesday, May 14, 2019 (Press release, Gossamer Bio, MAY 9, 2019, View Source [SID1234536086]).

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In connection with the earnings release, Gossamer’s management team will host a live conference call and webcast at 8:30 a.m. ET on Tuesday, May 14, 2019, to discuss the Company’s financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source Alternatively, the conference call may be accessed through the following:

Conference ID: 7791474
Domestic Dial-in Number: (866) 221-1654
International Dial-in Number: (470) 495-9466
Live Webcast: View Source

A replay of the audio webcast will be available for 30 days on the Investors section of the Company’s website, www.gossamerbio.com.

On May 9, 2019 Inovio Pharmaceuticals, Inc. (NASDAQ: INO), an innovative biotechnology company focused on the discovery, development and commercialization of its synthetic nucleic technology targeted against cancers and infectious diseases, reported financial results for the first quarter ended March 31, 2019 (Press release, Inovio, MAY 9, 2019, View Source [SID1234536135]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss financial results and provide a general business update.

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Inovio Highlights

VGX-3100/INO-3106; HPV-related Pre-cancers
Inovio’s Phase 3 trials for VGX-3100, REVEAL 1 and REVEAL 2, are both up and running and are executing on track. REVEAL 2 began recruitment in March while REVEAL 1 is anticipated to be fully enrolled with 198 patients by mid-2019. Additionally, Inovio expects interim data from its two Phase 2 trials with VGX-3100 in patients with vulvar and anal dysplasia later this year.

Inovio recently announced that VGX-3100 has been granted an Advanced Therapy Medicinal Product certificate by the European Medicines Agency’s (EMA) Committee for Advanced Therapies following an extensive evaluation of its chemistry, manufacturing and controls (CMC) data and nonclinical results. Since the inception of the program in 2009, only 11 ATMP Certifications have been awarded by the EMA. This certificate is an important developmental milestone for VGX-3100 as it will facilitate the preparation, filing, and review of a future European market application for VGX-3100.

In April, VGX-3100 was selected at the World Vaccine Congress as the 2019 "Best Therapeutic Vaccine."

Extending its portfolio into additional HPV-related diseases, Inovio announced its novel therapy, INO-3106, against the human papilloma virus type 6 (HPV 6) demonstrated clinical efficacy in a pilot clinical study of two patients with recurrent respiratory papillomatosis (RRP), a rare orphan disease. Results presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) demonstrated that following both patient’s last dose of INO-3106, the patients have been surgery-free, due to lack of tumor recurrence. One patient has not needed surgery for over two years; the other has been surgery-free for over one year. A complete study report is being prepared for publication in a medical journal, and Inovio plans to further develop INO-3106 as a novel, non-invasive immunotherapy for the treatment of RRP, for both adult and pediatric populations.
MEDI0457 (VGX-3100 + IL-12; licensed to AstraZeneca)
Inovio achieved a third cancer indication milestone under its collaboration with AstraZeneca, triggered by AstraZeneca dosing a patient in a Phase 2 combination trial evaluating MEDI0457 (formerly called INO-3112) in combination with durvalumab, an anti-PD-L1 immune checkpoint inhibitor, targeting cervical, anal, penile, and vulvar cancers associated with human papilloma virus (HPV). AstraZeneca continues to evaluate MEDI0457 in combination with durvalumab in multiple Phase 2 trials in patients with HPV-related cancers.

In January, Inovio announced that two patients with HPV-related head and neck cancer, who were treated with MEDI0457 in a Phase 1 trial, achieved a sustained complete response (full remission) following subsequent treatment with a PD-1 checkpoint inhibitor.
INO-5401 – Cancer Combination Trials
Inovio completed enrollment of its Phase 1/2 immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM). The enrollment of 52 patients was achieved three months ahead of schedule. The trial is designed to evaluate Inovio’s INO-5401 T cell activating immunotherapy encoding multiple antigens expressed by GBM and INO-9012, an immune activator encoding IL-12, in combination with cemiplimab-rwlc (also known as Libtayo or REGN2810), a PD-1 inhibitor developed by Regeneron Pharmaceuticals in collaboration with Sanofi. Interim results evaluating safety, immunological impact, progression-free survival and overall survival from this study are expected before the end of this year.
DNA-Encoded Bi-specific T Cell Engagers (dBTEs)
Inovio presented pre-clinical results at a major cancer conference (AACR) (Free AACR Whitepaper) on the company’s novel DNA-encoded Bi-specific T Cell Engagers (dBTE) technology. Inovio, with its collaborators at The Wistar Institute, developed a novel dBTE targeting the HER2 molecule which was tested in therapeutic models for the treatment of ovarian and breast cancers. Importantly, just a single dose of Inovio’s HER2 dBTE resulted in high levels of corresponding BiTE in mice for four months, far exceeding what is typically displayed with conventional BiTE’s short half-life of only a few hours. The HER2 dBTE effectively killed HER2-expressing tumor cells resulting in a near-complete tumor clearance. Also presented was Inovio’s CD19 dBTE which can kill B cell cancers by targeting B cell specific marker CD19.

These results were subsequently published in a JCI Insight journal article entitled, "DNA-encoded bi-specific T cell engagers and antibodies present long-term antitumor activity."
DNA-Encoded Monoclonal Antibody (dMAb)
In February, the company dosed a subject in the first-ever human study of Inovio’s DNA-encoded monoclonal antibody (dMAb) technology evaluating the ability of our technology to express Zika virus-specific mAbs. This study is being fully funded by The Bill and Melinda Gates Foundation. While the trial’s focus is on evaluating the dMAb for Zika infection, the clinical results are intended to help advance Inovio’s dMAb and dBTE programs in infectious diseases and cancer.
Infectious Diseases
Phase 1 data for INO-4201, the company’s Ebola vaccine, was published in The Journal of Infectious Diseases, further supporting the advancement of the intradermal delivery platform for vaccines. Significantly, the study demonstrated that intradermal (skin) administration with Inovio’s CELLECTRA efficacy enhancing device resulted in 100% of evaluable subjects generating antigen-specific antibody responses that persisted for more than one year in most subjects and generated robust T cell responses. The published data further validates the safety, potency, and product stability advantages of Inovio’s immunotherapy platform.
Geneos Therapeutics, Inc.
In February, Inovio’s personalized cancer vaccine subsidiary Geneos, secured a Series A financing round with potential proceeds of up to $10.5 million. With this funding, Geneos is fully operational as a standalone entity in its efforts to develop the next generation of neoantigen-targeting cancer immunotherapies. Geneos has an exclusive license to Inovio’s immunotherapy platform in the area of personalized cancer immunotherapy; Inovio holds majority equity position in Geneos and continue to develop and commercialize all global population-based (non-personalized) cancer immunotherapies based on its proprietary SynCon design. Geneos is now focused on initiating its first clinical study in 2019.
Management and Board Updates
During the first quarter, Inovio announced the appointment of Jacqueline E. Shea, PhD, as Inovio’s Chief Operating Officer (COO) and Executive Vice President. Dr. Shea will be responsible for Inovio’s manufacturing, commercial, business development, and alliance management operations as well as serving as a key member of the executive team along with the CFO and CSO in formulating and implementing overall corporate strategy.

Also in the first quarter, the Company announced that Mr. Simon X. Benito, former Merck Vaccines executive, was appointed Chairman of Inovio’s Board of Directors. In addition, the Company appointed Ms. Lota Zoth, former CFO of MedImmune, and Dr. Ann C. Miller, former commercial executive with Merck, Amgen, Eisai and Sanofi, to its Board of Directors.
Cash Position
As of March 31, 2019, cash and cash equivalents and short-term investments were $128.0 million compared to $81.2 million as of December 31, 2018. In the first quarter 2019, the Company completed a private placement of $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024, or the Notes. The Notes were sold in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Net proceeds from the offering were approximately $75.7 million, after deducting the initial purchasers’ discount and offering expenses payable by the Company.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "The last several months have been extremely productive for Inovio by validating the company’s versatile technology platform. We ended the first quarter by featuring positive data from our Phase 1 Ebola study in a prestigious publication. Inovio further highlighted its capabilities in treating HPV-associated disease after presenting positive data from patients diagnosed with RRP, where we demonstrated a clinical benefit for these patients. Additionally, we initiated the first ever clinical study for our dMAb platform during the first quarter and unveiled an exciting new component within our platform involving our novel dBTE technology, which we’re working towards rapidly advancing the first product into clinical testing. Inovio enters the second quarter well-financed following the February raise, placing us in a prime position to continue to deliver on our game-changing clinical programs."

First Quarter 2019 Financial Results

Total revenue was $2.8 million for the three months ended March 31, 2019, compared to $1.5 million for the same period in 2018. Total operating expenses were $31.4 million compared to $34.3 million for the same period in 2018.

Inovio’s net loss for the quarter ended March 31, 2019 was $29.2 million, or $0.30 per basic and diluted share, compared to $32.4 million, or $0.36 per basic and diluted share, for the quarter ended March 31, 2018.

Revenue

The year over year increase in revenue under collaborative research and development arrangements was primarily due to the milestone payment recognized in the first quarter 2019 from AstraZeneca.

Operating Expenses

Research and development (R&D) expenses for the three months ended March 31, 2019 were $24.4 million compared to $24.6 million for the same period in 2018. The decrease in R&D expenses was primarily related to a sub-license expense of $1.9 million recorded in 2018 related to the ApolloBio collaboration, partially offset by an increase of $1.2 million related to Inovio’s VGX-3100 Phase 3 clinical trials, among other variances.

General and administrative (G&A) expenses were $7.0 million for the three months ended March 31, 2019 versus $9.7 million for the same period in 2018. The decrease in G&A expenses was primarily related to the foreign non-income taxes and advisory fees incurred in connection with the ApolloBio upfront payment Inovio received in 2018.

Capital Resources

As of March 31, 2019, cash and cash equivalents and short-term investments were $128.0 million compared to $81.2 million as of December 31, 2018. As of March 31, 2019, the Company had 97.9 million common shares outstanding and 125.3 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, restricted stock units, convertible preferred stock and convertible notes.

In the first quarter 2019, the Company completed a private placement of $78.5 million aggregate principal amount of 6.50% convertible senior notes due 2024. Net proceeds from the offering were approximately $75.7 million.

Inovio’s condensed consolidated balance sheet and statement of operations are provided below. Additional information is included in Inovio’s quarterly report on Form 10-Q for the quarter ended March 31, 2019, which can be accessed at: View Source

Conference Call / Webcast Information

Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10131163.

On May 9, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported financial results for the first quarter ended March 31, 2019 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 9, 2019, View Source [SID1234536036]).

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"At Xencor, we continue to leverage our protein engineering expertise to rapidly generate a range of drug candidates with enhanced biologic functionality or new therapeutic mechanisms. Our development focus is on the growing set of opportunities provided by our XmAb bispecific Fc domains, which provide a core scaffold to create stable therapeutic proteins with easily substituted antigen binding domains," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "In the first quarter we entered into two collaborations that complement our development strategy, demonstrate the broad applicability of our bispecific Fc platform and provide us additional resources for advancing our oncology pipeline. Looking ahead, we remain on track to present initial clinical data from three Phase 1 bispecific antibody programs in the second half of 2019."

Recent Business and Clinical Highlights and Anticipated Upcoming Milestones

CD3 Bispecific Antibodies: Xencor’s initial bispecific antibody 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.

XmAb14045 (CD123 x CD3) is being evaluated through a Phase 1 study in patients with relapsed or refractory acute myeloid leukemia and other CD123-expressing hematologic malignancies. In April 2019, the FDA lifted the partial clinical hold that had been placed on this study in February 2019 due to safety issues of cytokine release syndrome and pulmonary toxicities. The FDA’s decision followed discussion and agreement on amendments to the study protocol, including guidance on the monitoring and clinical management of cytokine release syndrome, and the Company is working with investigational sites to resume enrollment based on the amended protocol.
Initial data from the Phase 1 studies of XmAb13676 (CD20 x CD3) in patients with B-cell malignancies and XmAb18087 (SSTR2 x CD3) in patients with neuroendocrine tumors or gastrointestinal stromal tumors are expected in the second half of 2019.
Tumor Microenvironment (TME) Activating Bispecific Antibodies:Xencor’s bispecific pipeline includes a suite of TME activators that engage multiple, different targets, such as T-cell checkpoint or agonist receptors. Xencor’s TME activators are designed to promote tumor-selective T-cell activation.

In May 2019, the first patient was dosed in DUET-3, a Phase 1, first-in-human clinical study to evaluate the safety and tolerability of XmAb23104 (PD-1 x ICOS), for the treatment of patients with advanced solid tumors.
Initiation of a Phase 1 study of XmAb22841 (CTLA-4 x LAG-3) as a monotherapy and in combination with pembrolizumab in patients with select advanced solid tumors is expected in the second quarter of 2019.
Initial data from DUET-2, a Phase 1 study of XmAb20717 (PD-1 x CTLA-4) in patients with advanced solid tumors, are expected in the second half of 2019.
Cytokines:Xencor uses its bispecific Fc domain and Xtend technology to engineer cytokines, which are immune signaling proteins, that have potency tuned to improve therapeutic index and have longer half-life.

XmAb24306, an IL15/IL15Rα-Fc fusion protein, is currently in IND-enabling studies, and the Company will support Genentech’s efforts to submit an IND application for this candidate in the second half of 2019.
Corporate:

In April 2019, Xencor announced a research and license agreement with Astellas Pharma Inc. in which the companies are collaborating to generate bispecific antibodies directed toward an undisclosed anti-tumor target for the potential treatment of patients with cancer. Astellas will have an exclusive worldwide license to develop and commercialize novel drug candidates. Xencor received an upfront payment of $15 million and will be eligible to receive development, regulatory and sales milestone payments up to $240 million and high-single digit to low-double digit percentage royalties on net sales.
First Quarter Ended March 31, 2019 Financial Results

Cash, cash equivalents, marketable securities and receivables totaled $650.5 million at March 31, 2019, compared to $540.7 million at December 31, 2018. The increase reflects upfront proceeds of $135 million from our Genentech and Astellas collaborations, which were reported as receivables at March 31, 2019 and were received in April, net of cash used to fund operating activities in the first quarter of 2019.

Total revenue for the first quarter ended March 31, 2019 was $111.9 million which reflects revenue recognized from our research and licensing collaboration with Genentech. No revenue was reported for the same period in 2018.

Research and development expenditures for the first quarter ended March 31, 2019 were $28.2 million, compared to $26.1 million for the same period in 2018. Spending on research and development expenses for the first quarter of 2019 is primarily on our bispecific technologies and pipeline including the cytokine candidate, XmAb24306.

General and administrative expenses for the first quarter ended March 31, 2019 were $5.5 million, compared to $4.6 million in the same period in 2018. The increased spending on general and administrative expenses for the first quarter of 2019 reflects additional spending on professional fees related to licensing and intellectual property.

Non-cash, stock-based compensation expense for the first quarter ended March 31, 2019 was $5.9 million, compared to $4.5 million for same period in 2018.

Net income for the first quarter ended March 31, 2019 was $80.0 million, or $1.38 on a fully diluted per share basis, compared to a net loss of $29.5 million, or $(0.62) on a fully diluted per share basis, for the same period in 2018. The net income reported for first quarter of 2019 over the loss for the same period in 2018 is primarily due to revenue recognized from our Genentech collaboration.

The total shares outstanding were 56,349,389 as of March 31, 2019, compared to 55,616,875 as of March 31, 2018.

Financial Guidance

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations beyond 2024. Xencor expects to end 2019 with between $550 million to $575 million in cash, cash equivalents and marketable securities.

Conference Call and Webcast

Xencor will host a conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss these first quarter 2019 financial results and provide a corporate update. The live call may be accessed by dialing (877) 359-9508 for domestic callers or (224) 357-2393 for international callers and referencing conference ID number 8597541. A live webcast of the conference call will be available online from the Investors section of the Company’s website at www.xencor.com. The webcast will be archived on the company’s website for 90 days.

On May 9, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported financial results for the first quarter ended March 31, 2019 and provided an update on clinical and corporate developments (Press release, Deciphera Pharmaceuticals, MAY 9, 2019, View Source [SID1234536053]).

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"Our team made significant progress during the first quarter of 2019 advancing our portfolio of novel drug candidates from our proprietary kinase switch control inhibitor platform," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "We expect top-line data from our INVICTUS pivotal Phase 3 study of ripretinib for the treatment of fourth-line and fourth-line plus GIST patients in mid-2019 and pending favorable results from this study, we look forward to our first NDA submission and laying the groundwork for our first potential launch in the United States. In addition, we continue to advance key clinical trials of DCC-3014 and rebastinib and we expect to announce the initiation of IND-enabling preclinical studies for a new clinical candidate later this year."

Recent Clinical Updates

Ripretinib (DCC-2618)
Deciphera expects to report top-line data from the INVICTUS pivotal Phase 3 clinical study evaluating the safety and efficacy of ripretinib, the Company’s investigational broad-spectrum KIT and PDGFRα inhibitor, in fourth-line and fourth-line plus gastrointestinal stromal tumor (GIST) patients in mid-2019. The Company is building its commercial and medical affairs capabilities to support the planned launch of ripretinib in the United States, if approved.
Deciphera is actively enrolling patients in the INTRIGUE Phase 3 clinical study comparing ripretinib to sunitinib for the treatment of second-line GIST patients who have previously received imatinib.
Rebastinib
Deciphera announced the initiation of an open-label, multicenter, Phase 1b/2 combination study of rebastinib, the Company’s investigational small molecule switch control inhibitor of TIE2 kinase, with carboplatin in patients with advanced or metastatic solid tumors.
Deciphera completed enrollment of 40 patients in Part 1 of the Phase 1b/2 combination study of rebastinib with paclitaxel. In April 2019, Deciphera selected a 100 mg BID dose of rebastinib in combination with a weekly dose of 80 mg/m2 of paclitaxel as the recommended Phase 2 dose for Part 2 of the study, which is expected to begin enrollment later this quarter. The Company expects to report initial data from Part 1 of this study in the second half of 2019.
DCC-3014
Deciphera announced positive, preliminary top-line data from the ongoing dose escalation portion of the Phase 1 clinical study of DCC-3014, the Company’s investigational small molecule switch control inhibitor of CSF1R, in patients with advanced malignancies. The Company plans to present a review of further data from this Phase 1 study in the second half of 2019.
The Company is currently enrolling patients diagnosed with tenosynovial giant cell tumors (TGCT) in its expanded Phase 1 study evaluating DCC-3014.
Corporate Update

Deciphera announced the appointment of Steve Hoerter as President & Chief Executive Officer, effective March 18, 2019. Mr. Hoerter has served as a member of the Deciphera Board of Directors since May 2018. He joined the Company from Agios, where he was Chief Commercial Officer. He succeeded Michael D. Taylor, Ph.D., who retired as President & Chief Executive Officer of the Company. Dr. Taylor remains as senior advisor to the Company and a member of the Company’s Board of Directors.
First Quarter 2019 Financial Results

Cash Position: As of March 31, 2019, cash, cash equivalents and marketable securities were $262.3 million, compared to cash and cash equivalents of $293.8 million as of December 31, 2018. Deciphera expects its current cash, cash equivalents and marketable securities will enable the Company to fund its operating, capital expenditures and debt service payments into the second half of 2020.
R&D Expenses: Research and development expenses for the first quarter of 2019 were $35.8 million, compared to $16.9 million for the same period in 2018. The increase was primarily due to an increase in spending on the ripretinib program of $10.7 million as a result of clinical trial costs related to the Phase 3 INTRIGUE study in second-line GIST, which the Company initiated in December 2018, and includes $5.3 million for comparator drug to be used in this trial. Expenses related to the rebastinib program increased $3.2 million, primarily due to the Phase 1b/2 study of rebastinib in combination with paclitaxel, which the Company initiated in October 2018, and the second Phase 1b/2 clinical trial of rebastinib in combination with carboplatin, which the Company initiated in January 2019. Personnel-related costs increased $3.7 million due primarily to increased headcount and stock-based compensation expense in research and development functions. Personnel-related costs for the first quarters of 2019 and 2018 included non-cash stock-based compensation expense of $1.7 million and $1.0 million, respectively. Facility-related and other costs included in unallocated expenses increased $1.7 million primarily due to increased costs incurred in connection with early-stage drug discovery programs and increased consulting fees.
G&A Expenses: General and administrative expenses for the first quarter of 2019 were $13.2 million, compared to $5.0 million for the same period in 2018. The increase was primarily a result of increases in stock-based compensation expense and headcount in general and administrative functions. Non-cash stock-based compensation was $4.5 million and $1.1 million for the first quarters of 2019 and 2018, respectively. The increase in stock-based compensation expense was primarily related to the modification of stock options pursuant to the transition agreement with the Company’s former President and Chief Executive Officer and additional employee stock options. In addition, professional and consultant fees increased due to various advisory fees, including those related to commercialization preparedness.
Net Loss: For the first quarter of 2019, Deciphera reported a net loss of $47.4 million, or $1.25 per share, compared with a net loss of $21.4 million, or $0.66 per share, for the same period in 2018.