On May 9, 2019 BioTime, Inc. (NYSE American and TASE: BTX), a clinical-stage biotechnology company developing cellular therapies for unmet medical needs, reported financial and operating results for the first quarter ended March 31, 2019 (Press release, BioTime, MAY 9, 2019, View Source;p=RssLanding&cat=news&id=2398106 [SID1234536039]). BioTime management will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss its first quarter 2019 financial results and to provide a business update.

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"We have been transforming BioTime into what we believe is one of the foremost cell therapy companies, with a pipeline which now consists of three innovative and promising clinical-stage product candidates, each with the potential to significantly and positively impact serious diseases or degenerative conditions," stated Brian M. Culley, Chief Executive Officer of BioTime. "We will remain focused on progressing our clinical programs in a thoughtful and cost-effective manner throughout 2019. As of March 31, 2019, the value of our cash, marketable securities, equity positions in our affiliate companies, and the balance of the promissory note due to us in August 2020 was more than $100 million, and we believe we are well-positioned to advance our programs. Our goal is to build awareness and support for our reinvigorated and repositioned company with the investment, medical, and patient communities, and advance our objective of bringing cell therapies to patients who can most benefit from their extraordinary potential."

Recent Highlights

Presented positive results from the Company’s ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-age-related macular degeneration (AMD) with geographic atrophy (GA), at the 2019 Association for Research in Vision and Ophthalmology Annual Meeting. Data from the study demonstrate that treatment with OpRegen continues to be well tolerated and in some patients, signs of structural improvement in the treated areas of the retina have been observed. Of note, early data from Cohort 4 patients with earlier-stage dry-AMD and smaller areas of GA remain encouraging, with indications of the continued presence of the transplanted OpRegen cells and improvements in visual acuity.
Presented SCiStar Clinical Study Top-Line Results at the 26th Annual American Society for Neural Therapy and Repair Annual Conference. The primary goals of the SCiStar Clinical Study, which were to observe the safety of OPC1 in cervical spinal cord injury patients and other important metrics related to the optimal timing of OPC1 injection, the tolerability of the immunosuppression regimen, the engraftment of OPC1 cells, and rates of motor recovery observed among different study subpopulations, were all achieved.
Announced the issuance of a patent from the United States Patent and Trademark Office for a method of reducing spinal cord injury (SCI)-induced parenchymal cavitation in patients who suffered an acute SCI. The issued patent would have a term that expires no earlier than 2036.
Announced exclusive agreement with Orbit Biomedical Ltd. (Orbit) under which BioTime and Orbit will collaborate on the use of Orbit’s proprietary U.S. Food and Drug Administration 510(k) approved injection technology to enhance the sub-retinal delivery of OpRegen RPE cells for the treatment of dry-AMD in BioTime’s ongoing Phase I/IIa clinical study.
The ongoing transfer of assets acquired in the Asterias merger to BioTime’s existing GMP manufacturing facility in Jerusalem in preparation for the hand off of Asterias’s Fremont facility to Novo Nordisk in the third quarter of 2019. These actions are expected to lead to significant cost savings via headcount and facility reductions, as well as support BioTime’s innovative and diversified clinical-stage pipeline.
BioTime affiliate OncoCyte Corporation (NYSE American: OCX) recently reported successful completion of its Analytical Validation study and the commencement of a CLIA Validation study of DetermaVu, its non-invasive liquid biopsy test intended to facilitate clinical decision making in lung cancer diagnosis. BioTime owns approximately 28% of OncoCyte’s common stock, or 14.7 million shares, as of May 8, 2019. As of that same date, the value of BioTime’s OncoCyte share position was approximately $65.7 million, based on the closing price of OncoCyte’s common stock on that date.
Plans for 2019

Pursuant to an exclusive collaboration with Orbit, initiate dosing of the first patient with the Orbit device and a new thaw and inject formulation in the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD, anticipated in the second quarter of 2019.
Announce decision on BioTime’s CE Mark application for Renevia, an investigational medical device being developed as an alternative for whole adipose tissue transfer procedures, now expected in the second quarter of 2019.
Continue advancement of the OPC1 program and meet with the U.S. Food and Drug Administration (FDA) to discuss plans for next steps in the clinical development of the program, anticipated by year end 2019.
Strengthen and expand existing partnerships with the California Institute for Regenerative Medicine and Cancer Research UK for the ongoing support of the development of the OPC1 and VAC2 programs.
Complete patient enrollment in the ongoing Phase I/IIa clinical study of OpRegen for the treatment of dry-AMD, anticipated by year end 2019.
Evaluate the development of OPC1 as a candidate for the potential treatment of multiple sclerosis (MS) and ischemic stroke through ongoing research collaborations with major universities.
Increase presence and engagement within the patient, physician, and advocacy communities.
Balance Sheet Highlights

Cash, cash equivalents and marketable securities totaled $27.1 million as of March 31, 2019.

BioTime’s investment in OncoCyte was valued at $58.0 million as of March 31, 2019 and at $65.7 million as of May 8, 2019, under the equity method of accounting, and based on the closing stock price of OncoCyte as of such dates.

Intangible assets, net increased during the first quarter of 2019 due to the Asterias merger and the acquisition of OPC1 (fair value of $31.7 million) and VAC2 (fair value of $14.8 million).

BioTime’s promissory note due from Juvenescence Limited had an outstanding balance (principal plus accrued interest) of $22.5 million as of March 31, 2019. Unless earlier converted into Juvenescence common shares, the promissory note is payable in cash, plus accrued interest at 7% per year, at maturity in August 2020. If Juvenescence completes an initial public offering (IPO) resulting in gross proceeds of not less than $50.0 million, the promissory note automatically converts into the Juvenescence securities issued in the IPO based on the per-share price to the public in the IPO, subject to an upward adjustment in the number of shares that would be issued to BioTime upon such conversion if the 20-day volume-weighted average trading price of one share of common stock of AgeX Therapeutics, Inc. (AgeX) before the IPO is priced above $3.00. If the promissory note is converted, the Juvenescence ordinary shares will be a marketable security that BioTime may use to supplement its liquidity, as needed and as market conditions allow.

First Quarter Operating Results

Revenues: BioTime’s revenue is generated primarily from research grants, licensing fees and royalties. Total revenues for the three months ended March 31, 2019 were $0.9 million, an increase of $0.2 million, compared to $0.7 million for the same period in 2018. The increase was primarily related to a $0.4 million increase in grant revenues, offset by a $0.2 million decrease in subscriptions and advertisement revenues attributable to the deconsolidation of AgeX. AgeX was deconsolidated from BioTime on August 30, 2018, and beginning on that date, AgeX’s revenues are not included in BioTime revenues.

Operating Expenses: Operating expenses are comprised of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Total operating expenses for the three months ended March 31, 2019 were $13.6 million, as reported, and $7.9 million, as adjusted. AgeX was deconsolidated from BioTime on August 30, 2018, and beginning on that date, AgeX’s operating expenses are not included in BioTime’s operating expenses.

As adjusted operating expenses is a non-generally accepted accounting principles (non-GAAP) financial measure. The reconciliation between operating expenses determined in accordance with GAAP and non-GAAP operating expenses, by entity, is provided in the financial tables included at the end of this press release.

R&D Expenses: Beginning on August 30, 2018, BioTime ceased recognizing R&D expenses related to AgeX and its programs due to the AgeX deconsolidation on that date.

R&D expenses for the three months ended March 31, 2019 were $5.0 million, a decrease of $0.9 million, compared to $5.9 million for the same period in 2018. The decrease was primarily related to a $1.6 million decrease from the AgeX deconsolidation and the absence of AgeX R&D expenses incurred after August 30, 2018, offset by a net increase of $0.6 million in BioTime programs primarily related to: (1) an increase of $0.8 million in OpRegen related expenses, (2) an increase of $0.6 million in OPC1 and VAC2 expenses (these programs were acquired in the Asterias merger) offset by (3) decreases of $0.8 million in Renevia and HyStem related expenses.

G&A Expenses: Beginning on August 30, 2018, BioTime ceased recognizing G&A expenses related to AgeX and its subsidiaries due to the AgeX deconsolidation on that date.

G&A expenses for the three months ended March 31, 2019 were $8.7 million, an increase of $2.7 million, compared to $6.0 million for the same period in 2018. The increase was primarily attributable to a $3.5 million increase in severance, legal, accounting and other expenses related to the Asterias merger and a $0.5 million increase in stock-based compensation, offset by a $1.3 million decrease in AgeX related G&A expenses.

Other Income/(Expenses), Net: Other income/(expenses), net for the three months ended March 31, 2019 reflected other income, net of $47.7 million, compared to other expense, net of ($51.5) million for the same period in 2018. The variance was primarily related to changes in the value of equity investments in OncoCyte and Asterias for the applicable periods.

Net income/(loss) attributable to BioTime: The net income/(loss) attributable to BioTime for the three months ended March 31, 2019 was net income of $39.3 million, or $0.30 per share (basic and diluted), compared to a net loss attributable to BioTime of ($63.5) million, or ($0.50) per share (basic and diluted), for the same period in 2018.

Conference Call and Webcast

BioTime will host a conference call and webcast today, at 1:30pm PT/4:30pm ET to discuss its first quarter 2019 financial results and to provide a business update. Interested parties may access the conference call by dialing (866) 888-8633 from the U.S. and Canada and (636) 812-6629 from outside the U.S. and Canada and should request the "BioTime Inc. Call". A live webcast of the conference call will be available online in the Investors section of BioTime’s website. A replay of the webcast will be available on BioTime’s website for 30 days and a telephone replay will be available through May 16th, 2019, by dialing (855) 859-2056 from the U.S. and Canada and (404) 537-3406 from outside the U.S. and Canada and entering conference ID number 9155549.

On May 9, 2019 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported a corporate and financial update for the first quarter ended March 31, 2019 (Press release, G1 Therapeutics, MAY 9, 2019, View Source [SID1234536038]).

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"Following meetings with regulatory authorities, we have clarity on a path to submitting marketing applications in the U.S. and Europe for trilaciclib based on existing data from our three trials in small cell lung cancer patients," said Mark Velleca, M.D., Ph.D., Chief Executive Officer. "Our goal is to make trilaciclib available to patients across the globe as quickly as possible and we are encouraged with regulators’ understanding of this new approach to protecting patients from the damaging effects of chemotherapy."

Raj Malik, M.D., Chief Medical Officer added, "Trilaciclib is the first in a deep pipeline of clinical-stage programs with near-term data readouts expected. We anticipate presenting new data on our next two programs – lerociclib and G1T48 – later this year. Based on promising early results in our Phase 1 clinical trial of G1T48 in ER+ breast cancer, we plan to present proof-of-concept data in the third quarter."

Clinical, Operational and Executive Team Updates

Plan to submit U.S. and European regulatory filings for trilaciclib: The company announced plans to submit marketing applications in the U.S. and Europe for trilaciclib for myelopreservation in small cell lung cancer (SCLC) based on written feedback from its end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and discussions with European regulatory authorities. G1 intends to file a New Drug Application (NDA) with the FDA in 2020 and submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) subsequent to an NDA filing. Full press release available here.

Executive team change: Jennifer Moses, who has been with the company for four years and most recently served as Vice President, Finance, has been appointed Chief Financial Officer. Barclay "Buck" Phillips, who had served as CFO and Senior Vice President, Corporate Development since 2017, departed the company to pursue other interests and opportunities.

First investor day presentation: The G1 management team provided a comprehensive overview of the company’s three clinical development programs and outlined the commercialization strategy for trilaciclib. External experts Jeffrey Crawford, M.D., Co-director, Solid Tumor Therapeutics Program, Duke Cancer Institute and Lowell Hart, M.D., Scientific Director of Research, Florida Cancer Specialists and trilaciclib clinical trial investigator,

discussed chemotherapy-induced myelosuppression and trilaciclib’s potential to protect the bone marrow from damage by chemotherapy and improve patient outcomes. The webcast is available on the G1 website here.

First Quarter 2019 Financial Highlights

Cash Position: Cash, cash equivalents and short-term investments totaled $347.8 million as of March 31, 2019, compared to $369.3 million as of December 31, 2018.

Operating Expenses: Operating expenses were $25.9 million for the first quarter of 2019, compared to $20.7 million for the first quarter of 2018. GAAP operating expenses include stock-based compensation expense of $3.8 million for the first quarter of 2019, compared to $1.6 million for the first quarter of 2018.

Research and Development Expenses: Research and development (R&D) expenses for the first quarter of 2019 were $18.1 million, compared to $17.3 million for the first quarter of 2018. The increase in expense was primarily due to an increase in clinical program costs and personnel costs due to additional headcount.

General and Administrative Expenses: General and administrative (G&A) expenses for the first quarter of 2019 were $7.8 million, compared to $3.4 million for the first quarter of 2018. The increase in expense was largely due to an increase in compensation due to headcount increase, increase in pre-commercialization activities, and an increase in professional fees and other administrative costs necessary to support our operations as a public company.

Net Loss: G1 reported a net loss of $24.0 million for the first quarter of 2019, compared to $20.4 million for the first quarter of 2018.

Anticipated Milestones for 2019

Expect to complete pre-NDA meeting with the FDA.

Report additional data from all four randomized Phase 2 trilaciclib clinical trials.

Present proof-of-concept data from the Phase 1 clinical trial of G1T48, an oral selective estrogen receptor degrader (SERD), in ER+ breast cancer in 3Q19.

Present preliminary dose-escalation data from the Phase 1b clinical trial of lerociclib/Tagrisso (osimertinib) in non-small cell lung cancer in 3Q19.

Present additional data from the Phase 1b clinical trial of lerociclib/Faslodex (fulvestrant) in ER+, HER2- breast cancer in 4Q19.

Webcast and Conference Call

The management team will host a webcast and conference call at 4:30 p.m. ET today to provide a corporate and financial update for the first quarter 2019 ended March 31, 2019. The live call may be accessed by dialing 866-763-6020 (domestic) or 210-874-7713 (international) and entering the conference code:7988598. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

On May 9, 2019 bluebird bio, Inc. (Nasdaq: BLUE) reported that it will host an Analyst Day in New York that will highlight significant progress in the company’s emerging immuno-oncology and severe genetic disease pipeline, provide updates on launch expectations for its first gene therapy product and share key aspects of its long-term growth strategy (Press release, bluebird bio, MAY 9, 2019, View Source [SID1234536037]). The company also is announcing a new research collaboration with Seattle Children’s Research Institute in Acute Myeloid Leukemia (AML), a Phase 1/2 study planned in Merkel Cell Carcinoma (MCC) with the Fred Hutchinson Cancer Research Center and programs in Diffuse Large B-cell Lymphoma (DLBCL) and MAGE-A4 positive solid tumors.

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"bluebird is at a significant inflection point, with the potential approval and launch of our first gene therapy product this year and submissions for regulatory approval for potentially three additional products through 2022," said Nick Leschly, chief bluebird. "We have the opportunity to leverage our gene and cell therapy expertise across our platform and enable a steep innovation curve for next-generation products. We are fueled by what is just the beginning of our efforts to recode the science, systems and status quo to reach new innovation frontiers and make a significant impact on patients’ lives."

Further strengthening its leadership position in developing transformative first-in-class and best-in-class gene and cell therapies, bluebird bio will discuss several key milestones and collaboration updates across its research pipeline, which is focused on next-generation, disruptive solutions for devastating diseases. In addition to the two clinic-ready programs planned for 2019, the company is on track to submit 1-2 investigational new drug applications in 2020 and beyond.

"Relentless innovation is in our DNA at bluebird. Our 1-to-Many research strategy rapidly integrates and iterates our tools and technologies across our core platforms of gene editing, gene addition and cellular immunotherapy, to develop the next generation of gene and cell therapies with the potential to improve patients’ lives," said Philip Gregory, D. Phil., chief scientific officer, bluebird bio. "Our research engine, in partnership with our network of academic and industry collaborations, is designed to take on big problems that, if successful, will disrupt our field."

Research highlights include:

AML Research Collaboration with Seattle Children’s Research Institute: The research collaboration is intended to address two challenges of tackling AML, specifically the heterogeneity of the disease as well as the salvage of normal tissues with the potential for on-target/off-tumor targeting. Our T cell immunotherapy approach is expected to leverage technology that enables T cells to target multiple antigens on the surface of cancer cells as well as bluebird’s proprietary Dimerizing Agent Regulated Immunoreceptor Complex (DARIC) platform. By utilizing the DARIC platform in potential product candidates, we expect to be able to exert pharmacologic control of CAR T cell activity in vivo, allowing the investigator to switch on and switch off the activity of the engineered T cells in the patient as needed by administering a small molecule drug. Combined with Seattle Children’s world-class bench-to-bedside expertise in the arena of oncology cell therapies, the research collaboration’s goal is to rapidly accelerate development of potential new therapies for patients with AML.
Phase 1/2 Trial for Merkel Cell Carcinoma: An academic, proof-of-concept phase 1/2 single-arm study evaluating Merkel Cell Polyomavirus (MCPyV) TCR-engineered autologous T cells in combination with avelumab (anti-PDL1) is FDA-approved and in the final initiation stages of trial approval at the Fred Hutchinson Cancer Research Center for the treatment of MCC, a rare neuroendocrine cancer. Exploratory clinical data generated by researchers at the Fred Hutchinson Cancer Research Center exploring patient derived MCPyV reactive T cells in combination with PD1 axis blockade has shown promising depth and durability of response. Results from the academic phase 1/2 single-arm study are expected to inform next-generation T cell approaches including TCR engineering and checkpoint inhibition.
MAGE-A4: Through its collaboration with Medigene, bluebird has developed a next-generation MAGE-A4 TCR expected to enter the clinic for solid tumors in 2020. This co-receptor-independent TCR candidate has shown robust anti-tumor activity controlling tumors in a subcutaneous melanoma xenograft model as a single agent. Moreover, this highly active TCR can be combined with bluebird’s chimeric TGF-β receptor signal converter technology to "flip" the immunosuppressive signals present in the tumor microenvironment toward T cell stimulation and proliferation. This is the first collaboration target with Medigene of a potential six TCR products that the companies have agreed to work on together.
Diffuse Large B-cell Lymphoma Candidate: Our DLBCL preclinical program builds on the knowledge gained from the current generation of CD19-targeting cell therapies by incorporating multiple next-generation technologies to potentially address both the depth and durability of response. Specifically, our potential DLBCL product candidate combines (i) dual-targeting directed to two novel antigens; (ii) within a unique CAR construction that is designed to enhance T cell activation; and (iii) gene editing for potential potency and durability enhancements, all in a single product candidate.
Mucopolysaccharidosis (MPSI): Our MPSI program is focused on the severe form of MPSI, an ultra-rare metabolic condition that causes severe neurologic impairment and organ damage, also referred to as Hurler Syndrome. In our academic collaboration with the University of Minnesota, we expect to leverage key learnings from our hematopoietic stem cell lentiviral vector (HSC LVV) platform technology to deliver gene-modified cells that can potentially cross the blood-brain barrier and express high and sustained levels of therapeutic enzyme. Preclinical data in the MPS1 mouse model demonstrates full molecular correction of the disease across all critical organs impacted by the disease, including the brain, following administration of an HSC LVV-gene-modified stem cell product. These robust preclinical data support the potential clinical application of this product candidate.
Webcast

To access the live webcast of bluebird bio’s Analyst Day presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source A replay of the webcast will be available on the bluebird bio website for 90 days following the meeting.

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 Allergan plc (NYSE: AGN) reported that Chief Financial Officer Matthew Walsh will participate in a fireside chat at the Bank of America Merrill Lynch 2019 Health Care Conference in Las Vegas, Nevada (Press release, Allergan, MAY 9, 2019, View Source(2) [SID1234536035]). The presentation will begin at 10:40 a.m. Pacific Time (1:40 p.m. Eastern Time) on Tuesday, May 14, 2019.

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The presentation will be webcast live and can be accessed on Allergan’s Investor Relations website at View Source;. The webcast can also be accessed through the following URL: https://www.veracast.com/webca…

An archived version will be available following the live presentation and can be accessed at the same location for 90 days.