On May 8, 2018 Interim Report for the First Quarter of 2018(Press release, Genmab, MAY 8, 2018, View Source [SID1234526260]).

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Highlights

USD 432 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 310 million

U.S. FDA granted Priority Review to daratumumab in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma

Received USD 50 million from Novartis as payment for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-US markets

"During the first quarter of 2018, we saw regulatory progress with DARZALEX in multiple myeloma, continued to progress our innovative pipeline, and experienced good progress in a number of antibody programs run by our collaboration partners. We look forward to an exciting year ahead," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2018

Revenue was DKK 681 million in the first quarter of 2018 compared to DKK 251 million in the first quarter of 2017. The increase of DKK 430 million, or 171%, was mainly driven by the payment from Novartis of USD 50 million and higher DARZALEX royalties.
Operating expenses were DKK 357 million in the first quarter of 2018 compared to DKK 205 million in the first quarter of 2017. The increase of DKK 152 million, or 74%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating income was DKK 324 million in the first quarter of 2018 compared to DKK 46 million in the first quarter of 2017. The increase of DKK 278 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2018 today, Tuesday, May 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. The dial in numbers are:

+1 323 794 2094 (US participants) and ask for the Genmab conference call
+44 330 336 9411 (international participants) and ask for the Genmab conference call

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]

This interim report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab’s annual report, which is available on www.genmab.com and the "Significant Risks and Uncertainties" section in this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; the DuoBody logo; the HexaBody logo; HuMax; HuMax-CD20; DuoBody; HexaBody and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX is a trademark of Janssen Biotech, Inc.

Download the full Interim Report for the first quarter of 2018 on attachment or at www.genmab.com.

CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Highlights

USD 432 million in net sales of DARZALEX (daratumumab); resulting in royalty income of DKK 310 million
U.S. FDA granted Priority Review to daratumumab in combination with bortezomib, melphalan and prednisone in frontline multiple myeloma
Received USD 50 million from Novartis as payment for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-US markets
"During the first quarter of 2018, we saw regulatory progress with DARZALEX in multiple myeloma, continued to progress our innovative pipeline, and experienced good progress in a number of antibody programs run by our collaboration partners. We look forward to an exciting year ahead," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2018

Revenue was DKK 681 million in the first quarter of 2018 compared to DKK 251 million in the first quarter of 2017. The increase of DKK 430 million, or 171%, was mainly driven by the payment from Novartis of USD 50 million and higher DARZALEX royalties.
Operating expenses were DKK 357 million in the first quarter of 2018 compared to DKK 205 million in the first quarter of 2017. The increase of DKK 152 million, or 74%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
Operating income was DKK 324 million in the first quarter of 2018 compared to DKK 46 million in the first quarter of 2017. The increase of DKK 278 million was driven by higher revenue, which was partly offset by increased operating expenses.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.

Conference Call
Genmab will hold a conference call in English to discuss the results for the first quarter of 2018 today, Tuesday, May 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. The dial in numbers are:

+1 323 794 2094 (US participants) and ask for the Genmab conference call
+44 330 336 9411 (international participants) and ask for the Genmab conference call

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]

This interim report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab’s annual report, which is available on www.genmab.com and the "Significant Risks and Uncertainties" section in this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; the DuoBody logo; the HexaBody logo; HuMax; HuMax-CD20; DuoBody; HexaBody and UniBody. Arzerra is a trademark of Novartis AG or its affiliates. DARZALEX is a trademark of Janssen Biotech, Inc.

Download the full Interim Report for the first quarter of 2018 on attachment or at www.genmab.com.

CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

On May 8, 2018 Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta therapeutics to treat serious and rare diseases, today provided a corporate update and reported financial results for the first quarter ended March 31, 2018 (Press release, Acceleron Pharma, AUG 8, 2018, View Source [SID1234526277]).

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"2018 is an important year for our Company, as we prepare for the upcoming top-line results from our MEDALIST and BELIEVE Phase 3 trials with luspatercept expected mid-year. We and Celgene continue to invest heavily in the overall luspatercept opportunity by targeting myelodysplastic syndromes, beta-thalassemia, and myelofibrosis," said Habib Dable, Chief Executive Officer of Acceleron. "The joint collaboration teams recently kicked off strategic preparations for the anticipated regulatory and commercial activities planned to follow the luspatercept Phase 3 results."

Added Mr. Dable: "Our team continues to make meaningful progress in the advancement of our wholly-owned clinical programs. In neuromuscular disease, we presented preliminary results from our Phase 2 trial of ACE-083 in FSHD for the first time and recently initiated Part 2 of the trial. In pulmonary, we expect to initiate our first Phase 2 trial with sotatercept in pulmonary arterial hypertension in the second quarter."

Development Program Highlights

Hematology

Luspatercept:

Myelodysplastic Syndromes (MDS), Beta-Thalassemia, and Myelofibrosis (MF)

Luspatercept is a first-in-class erythroid maturation agent (EMA) designed to treat the late-stage red blood cell (RBC) maturation defect that results in chronic anemia and the need for regular RBC transfusions in adults with rare blood disorders. Luspatercept is being developed as part of the global collaboration between Acceleron and Celgene.

Top-line results from the MEDALIST and BELIEVE Phase 3 trials in MDS and beta-thalassemia, respectively, are expected in mid-2018.
The initiation of the COMMANDS Phase 3 trial in first-line, lower-risk MDS patients is planned for the first half of 2018.
Enrollment and treatment are ongoing in the BEYOND Phase 2 trial in non-transfusion-dependent beta-thalassemia and the Phase 2 trial in MF.
The Company expects to provide updates from the ongoing long-term Phase 2 extension trials in MDS and beta-thalassemia at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and 23rdCongress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June.
Neuromuscular Disease

ACE-083:

Facioscapulohumeral Muscular Dystrophy (FSHD) and Charcot-Marie-Tooth (CMT) Disease

ACE-083 is a locally-acting therapeutic designed to have a concentrated effect on muscle mass and strength in target muscles for diseases that cause focal muscle weakness. ACE-083 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta ligands.

Preliminary results from dose cohorts 1 and 2 in Part 1 of the ACE-083 Phase 2 trial in patients with FSHD were highlighted in a "Best of Neuromuscular Disease" clinical session at the American Academy of Neurology (AAN) 70th Annual Meeting on April 26, 2018.
The Company plans to present additional preliminary results from all Part 1 dose cohorts during the second half of 2018.
Part 2 of the Phase 2 trial was recently initiated and preliminary results are expected in the second half of 2019.
ACE-083 received FDA Fast Track designation in FSHD.
Enrollment and treatment are ongoing in Part 1 of the Phase 2 trial in patients with CMT disease.
The Company plans to present preliminary Part 1 results in the second half of 2018 and to initiate Part 2 of the Phase 2 trial by the end of 2018.
ACE-2494:

ACE-2494 is designed to have a systemic effect on muscle mass and strength for diseases that cause muscle weakness throughout the body. ACE-2494 utilizes the "Myostatin+" approach to inhibit multiple TGF-beta ligands.

Enrollment and treatment are ongoing in the Phase 1 healthy volunteer trial.
Preliminary results from the Phase 1 trial are expected in the first half of 2019.
Pulmonary Disease

Sotatercept:

Pulmonary Arterial Hypertension (PAH)

Sotatercept is a ligand trap for members in the TGF-beta superfamily involved in remodeling a variety of different tissues, including the vasculature and fibrosis. In multiple preclinical studies in PAH, sotatercept decreased vessel muscularization, improved pulmonary arterial pressures, and decreased indicators of right heart failure.

The Company expects to initiate the PULSAR Phase 2 trial during the second quarter of 2018.
Preliminary results from the PULSAR Phase 2 trial are expected in the first half of 2020.
Financial Results

Cash position – Cash, cash equivalents and investments as of March 31, 2018 were $353.3 million. As of December 31, 2017, the Company had cash, cash equivalents and investments of $372.9 million. The Company believes that existing cash, cash equivalents and investments will be sufficient to fund projected operating requirements into 2021.
Revenue – Collaboration revenue for the first quarter was $3.2 million. The revenue is all from Acceleron’s partnership with Celgene and is primarily related to expenses incurred by the Company in support of luspatercept.
Costs and expenses – Total costs and expenses for the first quarter were $30.8 million. This includes R&D expenses of $23.4 million and G&A expenses of $7.4 million.
Net loss – The Company’s net loss for the first quarter ended March 31, 2018 was $26.2 million.
Conference Call and Webcast

The Company will host a webcast and conference call to discuss its first quarter financial results for 2018 and provide an update on recent corporate activities on May 8, 2018, at 5:00 p.m. EDT.

The webcast will be accessible under "Events & Presentations" in the Investors/Media page of the Company’s website at www.acceleronpharma.com. Individuals can participate in the conference call by dialing 877-312-5848 (domestic) or 253-237-1155 (international) and referring to the "Acceleron First Quarter 2018 Earnings Call."

The archived webcast will be available for replay on the Acceleron website approximately two hours after the event.

On May 7, 2018 Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, reported its financial results and corporate update for the quarter ended March 31, 2018 (Press release, Ultragenyx Pharmaceutical, MAY 7, 2018, View Source [SID1234526172]).

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"With the recent approvals and launches of Crysvita in the United States and Europe, we have transformed into a commercial stage company with two medicines now available for patients," said Emil D. Kakkis, M.D., Ph.D., Chief Executive Officer and President of Ultragenyx. "We continue to advance our clinical and preclinical programs and expect significant progress across our two clinical-stage gene therapy programs as well as our small molecule and biologics programs this year."

First Quarter 2018 Financial Results

For the first quarter of 2018, Ultragenyx reported net income of $30.3 million, or $0.63 per basic share and $0.62 per diluted share, compared with a net loss for the first quarter of 2017 of $68.3 million, or $1.63 per share, basic and diluted. The income for the first quarter of 2018 includes the $130 million gain from the sale of the priority review voucher (PRV). The net income for the first quarter of 2018 reflected cash used in operations of $89.5 million compared to $61.2 million reflected in the net loss for the same period in 2017.

For the first quarter of 2018, Ultragenyx reported $10.7 million in total revenue, which includes $1.3 million in product revenue from Mepsevii (vestronidase alfa) and UX007, and $9.4 million in collaboration and license revenue, primarily from our research agreement with Bayer. Total operating expenses for the first quarter of 2018 were $107.2 million compared with $70.0 million for the same period in 2017, including non-cash stock-based compensation of $18.8 million and $14.5 million in the first quarter of 2018 and 2017, respectively. The increase in total operating expenses is due to the increase in development, commercial, and general and administrative costs as the company commercializes, grows and advances its pipeline.

Cash, cash equivalents, and investments were $571.3 million as of March 31, 2018.

Recent Highlights

Crysvita (burosumab) in X-Linked Hypophosphatemia (XLH)

In the U.S., Crysvita was approved on April 17, 2018 and is now commercially available to adults and children with X-linked hypophosphatemia (XLH). In April, the U.S. Food and Drug Administration (FDA) approved Crysvita for the treatment of XLH in adult and pediatric patients one year of age and older. The first patient has now received commercial treatment with Crysvita.

In Europe, burosumab received conditional marketing authorization for the treatment of XLH with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.
DTX301 Gene Therapy in ornithine transcarbamylase (OTC) Deficiency

Data from Phase 1/2 study of DTX301, our AAV8 vector in patients with OTC, showed positive topline results including normalization of ureagenesis in one patient in the first, lowest-dose cohort. The first patient’s rate of ureagenesis was normalized, maintained and then substantially increased over 24 weeks. The second and third patients did not show a clinically meaningful change in rate of ureagenesis over 20 weeks and 12 weeks, respectively. There have been no infusion-related adverse events and no serious adverse events reported. All adverse events have been Grade 1 or 2 and have resolved. Two patients have been enrolled in the higher dose Cohort 2 portion of the study, and data from the second cohort are expected in the second half of 2018.
DTX401 Gene Therapy in glycogen storage disease type Ia (GSDIa)

The U.S. FDA cleared the Investigational New Drug (IND) application for DTX401 for the treatment of patients with GSDIa. Enrollment in the Phase 1/2 study is expected to begin in the first half of 2018, with data from the first cohort in the second half of 2018.
Corporate

PRV sold for $130 million: In January 2018, we completed the sale of the PRV that we received at the time of the approval of Mepsevii.

Equity financing of approximately $271.0 million: In January 2018, we completed an underwritten public offering, with net proceeds of approximately $271.0 million.
Upcoming Key Milestones

Crysvita (burosumab) in XLH

Data from the Phase 3 study in pediatric patients expected in the second half of 2018. The ongoing Phase 3 randomized open-label clinical study is comparing the efficacy and safety of burosumab to oral phosphate and active vitamin D therapy in pediatric patients with XLH. This study will serve as a confirmatory study in Europe.
Crysvita (burosumab) in tumor-induced osteomalacia (TIO)

Data from all patients in Phase 2 study in TIO expected in mid-2018. This is an open label Phase 2 study evaluating the safety and efficacy of burosumab in 17 adult patients with TIO.
Mepsevii (vestronidase alfa) in mucopolysaccharidosis VII (MPS VII)

In Europe, an opinion from the Committee for Medicinal Products for Human Use (CHMP) is expected in mid-2018.
UX007 in long-chain fatty acid oxidation disorders (FAOD) and glucose transporter type-1 deficiency syndrome (Glut1 DS)

Completing study design of Phase 3 study in patients with FAOD; providing additional data to FDA for consideration of early filing based on Phase 2 data. Following an end-of-phase 2 meeting, we are providing additional information to submit to FDA for consideration of an early filing based on the results from the Phase 2 study. While the FDA still prefers that a randomized controlled trial be completed before filing, it left open the possibility of filing on the current data. We are simultaneously completing the design of a Phase 3 study that could be used for registration or confirmatory purposes. We expect that a decision on a potential filing for approval based on Phase 2 data will be made in mid-2018.

Data from the Phase 3 movement disorder study in patients with Glut1 DS. Enrollment is complete and data are expected in the second half of 2018.
Conference Call & Webcast Information

Ultragenyx will host a conference call today, Monday, May 7, 2018 at 5pm ET to discuss first quarter 2018 financial results and to provide a corporate update. The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial 855-797-6910 (USA) or 262-912-6260 (international) and enter the passcode 3748439. The replay of the call will be available for one year.

On May 7, 2018 National Cancer Center (Tokyo Japan, President: Hitoshi Nakagama) and Carna Biosciences, Inc (Kobe Japan, President and CEO: Kohichiro Yoshino) reported that they have entered into a research
collaboration agreement to discover novel therapeutic interventions in cancers (Press release, Carna Biosciences, MAY 7, 2018, View Source [SID1234526520]).

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Under the agreement, National Cancer Center and Carna Biosciences will collaborate on drug discovery research to develop a novel anticancer drug with new mechanisms of action that have been discovered by Dr. Kenkichi Masutomi, Chief, Division of Cancer Stem Cell at National Cancer Center Research Institute.

During the research term, both parties will leverage their respective expertise, including Carna’s extensive expertise in small molecule drug discovery with its powerful drug discovery engine and National Cancer Center’s profound knowledge of cancer research.

National Cancer Center and Carna Biosciences have been working together successfully under a research collaboration since 2008 to research and develop new drugs targeting WNT signal. This new collaboration agreement will further strengthen the relationship between both parties, which enables to accelerate the development of novel anti-cancer drugs to bring innovative treatment to cancer patients.

On May 7, 2018 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of autoimmune disease, asthma and allergic diseases, and cancer, reported financial results for the first quarter ended March 31, 2018 and provided a review of recent business and clinical highlights (Press release, Xencor, MAY 7, 2018, View Source [SID1234526173]).

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"With our XmAb platform of engineered antibody Fc domains, we can create antibody drug candidates with the potential for dramatically improved potency, half-life and stability over existing therapeutic options," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Recent accomplishments across both our internal pipeline and partnered programs demonstrate the potential and breadth of this approach. We are encouraged by the continued productivity of our own drug discovery engine, including the addition of XmAb24306, our IL15/IL15Rα-Fc program for T-cell expansion, and by the positive clinical trial results reported by our partners Alexion and MorphoSys. We look forward to advancing our internal XmAb product candidates as we progress through 2018, initiating our Phase 3 trial of XmAb5871 in IgG4-RD and reading out initial data from two ongoing clinical trials, including our first bispecific oncology candidate. With $582.5 million in cash, cash equivalents and marketable securities, we have sufficient resources to advance our novel portfolio into 2023, while also preparing for our next stage of growth."

Recent Business Highlights and Upcoming Clinical Plans

XmAb5871: XmAb5871 is a first-in-class monoclonal antibody that targets CD19 with its variable domain and uses Xencor’s XmAb immune inhibitor Fc domain to target FcyRIIb, a receptor that inhibits B-cell function. Xencor presented final data from a Phase 2 trial in IgG4-RD in November 2017, in which all 12 patients who completed the study achieved the primary endpoint of at least a two-point reduction in the IgG4-RD Responder Index and eight patients achieved disease remission. XmAb5871 is currently being evaluated in a Phase 2 trial in Systemic Lupus Erythematosus (SLE).

Initiation of Phase 3 trial in IgG4-RD expected in 2H18.
Topline data from Phase 2 trial in SLE expected in 4Q18.
Bispecific Oncology Pipeline: 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. Their XmAb Fc domains confer long circulating half-lives, stability and ease of manufacture.

Initial data from Phase 1 study of XmAb14045 for the treatment of AML and other CD123-expressing hematologic malignancies expected in 2018, pending alignment on timing with Novartis.
Initial data from Phase 1 study of XmAb13676 for the treatment of B-cell malignancies expected in 2019, pending alignment on timing with Novartis.
Initial data from Phase 1 study of XmAb18087 for the treatment of neuroendocrine tumors (NET) and gastrointestinal stromal tumors (GIST) expected in 2019.
Xencor’s bispecific pipeline also includes a suite of tumor microenvironment activators that engage multiple targets, such as T-cell checkpoints or agonists:

Initiation of Phase 1 trial evaluating XmAb20717, a PD-1 x CTLA-4 dual checkpoint inhibitor for the treatment of multiple oncology indications, expected in 2018.
Investigational New Drug (IND) filing for XmAb23104, a PD-1 x ICOS bispecific antibody for the treatment of multiple oncology indications, expected in 2018 and initiation of Phase 1 trial expected in 2019.
IND filing for XmAb22841, a CTLA-4 x LAG-3 dual checkpoint inhibitor for the treatment of multiple oncology indications, expected in 2018 and initiation of Phase 1 trial expected in 2019.
IND filing for XmAb24306, an IL15/IL15Rα-Fc bispecific antibody for the treatment of multiple oncology indications, expected in 2019.
At the AACR (Free AACR Whitepaper) Annual Meeting in April 2018, Xencor introduced its XmAb IL15 bispecific platform and presented preclinical data for XmAb24306. XmAb24306 is the first of a new suite of tumor microenvironment activators that use Xencor’s IL15 bispecific platform to provide a more druggable version of IL15 with superior tolerability, slower receptor-mediated clearance and a prolonged half-life. Data presented at AACR (Free AACR Whitepaper) show that the engineered IL15/IL15Rα-Fc complex enhances the duration and magnitude of T and NK cell proliferation in vitro and in vivo. Primate data also showed that treatment with XmAb24306 induces a steady, tolerable and sustained increase in T-cells. Also at AACR (Free AACR Whitepaper), Xencor announced that it is developing a broader suite of IL15 bispecific candidates, including a PD-1 x IL15 candidate to promote selective expansion and activation of exhausted T cells and additional targeted IL15/IL15Rα candidates.

XmAb7195: XmAb7195 is a first-in-class monoclonal antibody that targets IgE with its variable domain and uses Xencor’s XmAb immune inhibitor Fc domain to target FcyRIIb, resulting in three distinct mechanisms of action for reducing IgE. Data from Xencor’s Phase 1b study of subcutaneously-administered XmAb7195 were announced in November 2017 and showed potent IgE reduction with improved tolerability. Xencor is currently seeking a development partner for XmAb7195.

Partnered XmAb Programs: Eight pharmaceutical companies and the National Institutes of Health are advancing novel drug candidates either discovered at Xencor or that rely on Xencor’s proprietary XmAb technology. Five such programs are currently undergoing clinical testing, including two in Phase 3 studies.

In March and April 2018, Alexion announced clinical data for its two Phase 3 trials comparing its Soliris product to ALXN1210, which uses Xencor’s XmAb Xtend technology to prolong duration of action. The data indicated that ALXN1210 was not inferior to Soliris for primary and secondary endpoints. Alexion indicated that it plans to submit regulatory filings for ALXN1210 in 2018 in the U.S., Europe and Japan, and it expects to have approval in 2019.
In March 2018, MorphoSys announced updated data from its Phase 2 L-MIND trial of MOR208 (XmAb5574) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). MOR208 has Breakthrough Therapy Designation in this indication and MorphoSys has indicated that it is discussing potential expedited approval with the FDA. Initial data from MorphoSys’s B-MIND trial comparing MOR208 plus bendamustine to bendamustine plus rituximab in r/r DLBCL patients are expected in 4Q19.
Corporate:

In March 2018, Xencor priced an underwritten public offering of 8,395,000 shares of its common stock at a public offering price of $31.00 per share. The Company received net proceeds from the offering of $245.5 million, after deducting underwriting discounts and commissions and offering expenses.
First Quarter Ended March 31, 2018 Financial Results:

Effective January 1, 2018 the Company adopted the new revenue recognition accounting standard, Accounting Standard Codification 606 (ASC606). In addition to adopting the standard for 2018, revenue reported for the prior period including March 31, 2017 has been revised to reflect the new standard.

Cash, cash equivalents and marketable securities totaled $582.5 million as of March 31, 2018, compared to $363.3 million on December 31, 2017. The increase reflects net proceeds of $245.5 million from Xencor’s sale of additional stock in March 2018, partially offset by cash used to fund operating activities in the first quarter of 2018.

No revenue was recognized for the first quarter ended March 31, 2018, compared to $3.5 million for the same period in 2017. Revenue reported for both periods was affected by the adoption of the new revenue recognition standard. Under historic revenue recognition methods, the Company would have recognized $6.8 million and $4.3 million of revenue for the periods ended March 31, 2018 and March 31, 2017, respectively. The adoption of the new revenue recognition standard shifted the period that revenue is being recognized under Xencor’sAmgen and Novartis arrangements to earlier periods.

Research and development expenditures for the first quarter ended March 31, 2018 were $26.1 million, compared to $15.0 million for the same period in 2017. Increased research and development spending for the first quarter of 2018 over the same period in 2017 reflects additional spending on Xencor’s bispecific clinical and preclinical candidates.

General and administrative expenses for the first quarter ended March 31, 2018 were $4.6 million, compared to $4.8 million in the same period in 2017. Decreased spending on general and administration for the first quarter of 2018 over the same period in 2017 reflects lower compliance costs associated with Xencor’sSEC filings.

Non-cash, share based compensation expense for the first quarter ended March 31, 2018 was $4.5 million, compared to $3.2 million for same period in 2017.

Net loss for the first quarter ended March 31, 2018 was $29.5 million, or $(0.62) on a fully diluted per share basis, compared to a net loss of $15.5 million, or $(0.33) on a fully diluted per share basis, for the same period in 2017. The increased loss for the first quarter of 2018 over the same period in 2017 is primarily due to additional spending on research and development activities for the three months ended March 31, 2018.

The total shares outstanding was 55,616,875 as of March 31, 2018, compared to 46,689,447 as of March 31, 2017. The additional shares outstanding at March 31, 2018 reflect the 8,395,000 shares sold in Xencor’s March financing.

Financial Guidance:

Based on current operating plans, Xencor expects to have cash to fund research and development programs and operations into 2023. Xencor expects to end 2018 with approximately $500 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 2018 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 5056978. 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. (Press release, Xencor, MAY 7, 2018, View Source [SID1234526173])