Roche to present new data from its industry-leading oncology portfolio at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting

On May 8, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that new data from its early and late-stage clinical studies, on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from 1-5 June, in Chicago, IL, United States (Press release, Hoffmann-La Roche, MAY 8, 2018, View Source [SID1234526184]). More than 180 abstracts have been accepted across 13 cancer types, including two "late breakers" and 15 oral presentations.

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"New data to be presented from our industry-leading oncology portfolio, including our lung and haematology programmes, will demonstrate how our science-driven approach aims to improve outcomes for people living with cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "At ASCO (Free ASCO Whitepaper), we look forward to sharing our progress and commitment to build the future of personalised healthcare in oncology."

Further information on Roche’s contribution to the ASCO (Free ASCO Whitepaper) 2018 scientific programme, as well as Roche’s wider progress in cancer care, will be featured during the Roche Media Briefing from 09:00 – 10:45 CDT on Friday, 1 June at the Chicago Marriott Downtown Magnificent Mile, Chicago, IL, US. This event, independently organised by Roche, is open to journalists from outside the United States who have registered as media with the ASCO (Free ASCO Whitepaper) 2018 Annual Meeting. To register for the Roche Media Briefing, please follow this link: https://roche.cvent.com/d/6gq8k1/.

Follow Roche on Twitter via @Roche and keep up to date with ASCO (Free ASCO Whitepaper) 2018 congress news and updates by using the hashtag #ASCO18.

Key presentations in lung cancer
Key data to be presented at ASCO (Free ASCO Whitepaper) cover advances from Roche’s lung cancer programme, including a combination approach using the cancer immunotherapy, Tecentriq (atezolizumab) with targeted therapies and a range of different chemotherapies.

Updated OS data and new patient reported outcomes (PROs) data from the Phase III IMpower150 study of Tecentriq plus Avastin (bevacizumab) and chemotherapy (carboplatin and paclitaxel), in people with previously-untreated, advanced non-squamous non-small cell lung cancer (NSCLC), will be presented. The US Food and Drug Administration (FDA) recently granted Priority Review for this combination in the same patient population.

New PFS results from the Phase III IMpower131 study of Tecentriq plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) as an initial (first-line) treatment for people with advanced squamous NSCLC will also be shared and feature as part of ASCO (Free ASCO Whitepaper)’s official press programme on Saturday, 2 June.

Additional results in lung cancer include longer follow-up results from the Phase III ALEX study of Alecensa (alectinib) versus crizotinib in people with previously untreated anaplastic lymphoma kinase (ALK)-positive NSCLC. These data build on the primary results from the ALEX study, first presented at ASCO (Free ASCO Whitepaper) 2017, which demonstrated a significant reduction in the risk of disease progression or death versus crizotinib. New data that utilise the application of a real world endpoint to identify and characterise genetic profiles of people with a poor prognosis in advanced NSCLC will also be presented at the congress.

Additional presentations with cancer immunotherapy
Additional cancer immunotherapy data presentations of note include new Tecentriq plus Avastin PROs from the Phase III IMmotion151 study in advanced renal cell carcinoma (RCC), and Phase Ib data for the combination of Tecentriq plus Avastin in first-line hepatocellular carcinoma (HCC). These studies add to the growing body of evidence that support the use of Tecentriq plus Avastin across multiple tumour types.

New tumour mutational burden (TMB) data from two studies of Tecentriq will also be presented, including blood-based TMB data from the Phase II B-F1RST study in advanced NSCLC, and tissue-based TMB data across multiple tumour types including NSCLC, metastatic urothelial carcinoma and melanoma.

Key presentations in blood cancers
Data from pivotal studies in haematology will also be presented at ASCO (Free ASCO Whitepaper). Additional analyses on minimal residual disease (MRD) rates will be shared from the Phase III MURANO study evaluating Venclexta/Venclyxto (venetoclax) plus MabThera/Rituxan (rituximab), compared to bendamustine plus MabThera/Rituxan, in people with relapsed or refractory chronic lymphocytic leukaemia (CLL). A supplemental new drug application (sNDA) based on the MURANO data was granted Priority Review by the FDA, with an action date of 28 June 2018.

Additional data will also be presented from the Phase Ib M14-358 study of Venclexta/Venclyxto plus azacitidine or decitabine in people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Venclexta/Venclyxto is being developed by AbbVie and Roche.

Data from the randomised Phase II study evaluating polatuzumab vedotin in combination with bendamustine chemotherapy and MabThera/Rituxan in people with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) will also be presented at the meeting.

Key presentations in breast cancer
Updates from two investigational medicines in breast cancer will be presented at ASCO (Free ASCO Whitepaper). Data includes results from the Phase III SANDPIPER study of taselisib (GDC-0332) and fulvestrant, compared to fulvestrant alone, in estrogen receptor (ER)-positive, PIK3CA-mutant, locally advanced or metastatic breast cancer, and updated OS data from the LOTUS trial of ipatasertib (GDC-0068, RG7440) and paclitaxel for previously untreated, locally advanced or metastatic, triple-negative breast cancer. The SANDPIPER data will be featured as part of ASCO (Free ASCO Whitepaper)’s official press programme on Saturday, 2 June.

Overview of key presentations featuring Roche medicines at ASCO (Free ASCO Whitepaper) 2018

About Roche in Oncology
Roche has been working to transform cancer care for more than 50 years, bringing the first specifically designed anti-cancer chemotherapy drug, fluorouracil, to patients in 1962. Roche’s commitment to developing innovative medicines and diagnostics for cancers remains steadfast.

The Roche Group’s portfolio of innovative cancer medicines includes: Alecensa (alectinib); Avastin (bevacizumab); Cotellic (cobimetinib); Erivedge (vismodegib); Gazyva/Gazyvaro (obinutuzumab); Herceptin (trastuzumab); Kadcyla (trastuzumab emtansine); MabThera/Rituxan (rituximab); Perjeta (pertuzumab); Tarceva (erlotinib); Tecentriq (atezolizumab); Venclexta/Venclyxto (venetoclax); Xeloda (capecitabine); Zelboraf (vemurafenib). Furthermore, the Roche Group has a robust investigational oncology pipeline focusing on new therapeutic targets and novel combination strategies.

For more information on Roche’s approach to cancer, visit Roche.com.

Abeona Therapeutics Announces Upcoming Presentations

On May 8, 2018 Abeona Therapeutics Inc. (NASDAQ:ABEO), a leading clinical- stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases, reported upcoming presentations during two conferences, both to take place May 16 – 19, 2018; the 21st annual American Society of Gene and Cell Therapy 2018 conference being held in Chicago, IL, and the International Investigative Dermatology conference being held in Orlando, FL (Press release, Abeona Therapeutics, MAY 8, 2018, View Source;p=RssLanding&cat=news&id=2347659 [SID1234526221]).

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American Society of Gene and Cell Therapy
View Source

Oral Presentations:

Phase 1/2 Clinical Trial for Recessive Dystrophic Epidermolysis Bullosa Using EB-101 (COL7A1 Gene-Corrected Autologous Keratinocytes)
Presenter: Jean Yuh Tang, M.D., Ph.D., Stanford University
Thursday, May 17, 2018
Time: 8:20 AM Central Time

Update on Phase 1/2 Gene Transfer Clinical Trial of Systemic Gene Transfer of scAAV9.U1a.hSGSH for MPSIIIA (Sanfilippo Syndrome)
Presenter: Kevin Flanigan, M.D., Nationwide Children’s Hospital
Friday, May 18, 2018
Time: 8:30 AM Central Time

A Phase 1/2 Clinical Trial of Systemic Gene Transfer of rAAV9.CMV.hNAGLU for MPS IIIB: Safety, Tolerability, and Preliminary Evidence of Biopotency
Presenter: Kevin Flanigan, M.D., Nationwide Children’s Hospital
Friday, May 18, 2018
Time: 4:30 PM Central Time

Symposium and Forum:

Assessing Neurodevelopment in Neurodegenerative Disease: The Use and Interpretation of Cognitive Scales
Presenter: Maria Escolar, M.D., Children’s Hospital of Pittsburgh of UPMC
Moderator: Barry Byrne, M.D., Ph.D., University of Florida
Thursday, May 17, 2018
Time: 7:00 AM Central Time

Tools and Technologies Forum
Co-Chair: S. Kaye Spratt, Ph.D., Abeona Therapeutics Inc.
Friday, May 18, 2018
Time: 5:45 PM – 7:45 PM Central Time

Poster Presentations:

Poster 547: Development of a Multi-Domain Responder Index for Clinical Trials with Multi-Domain Diseases
Presenter: Magdalena Tyrpien, Abeona Therapeutics Inc.
Thursday, May 17, 2018
Time: 5:15 PM Central Time

Poster 399: Identification of Novel AAV Capsids for Enhanced CNS Gene Transfer
Presenter: Daphne Chen, University of North Carolina, Chapel Hill
Thursday, May 17, 2018
Time: 5:15 PM Central Time

International Investigative Dermatology

View Source

Poster Presentation:

Poster 328: 50% Wound Healing Correlates with RDEB Patient Reported Outcomes in Pain, Itch, and Skin Durability
Friday, May 18, 2018
Time: 12:00 PM Eastern Time

Kura Oncology Reports First Quarter 2018 Financial Results and Provides Corporate Update

On May 8, 2018 Kura Oncology, Inc., (Nasdaq: KURA) a clinical-stage biopharmaceutical company focused on the development of precision medicines for oncology, reported first quarter 2018 financial results and provided a corporate update (Press release, Kura Oncology, MAY 8, 2018, View Source [SID1234526237]).

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"I am very pleased with the progress we made over the past quarter, highlighted by a successful end of Phase 2 meeting with the FDA," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "We are working diligently to initiate AIM-HN, our registration-directed trial of tipifarnib in HRAS mutant HNSCC, as well as SEQ-HN, our concurrent screening and outcomes study. We believe that tipifarnib has the potential to become an important treatment option for patients with HRAS mutant HNSCC, and we are committed to executing the clinical and regulatory strategy that best positions it for success."

"We are also excited about the potential to expand the clinical utility of tipifarnib to other solid tumor and hematologic indications," continued Dr. Wilson. "We are evaluating tipifarnib in multiple biomarker-guided Phase 2 clinical trials, and our goal is to generate proof-of-concept data in one or more of these additional indications by year end. We believe we have the cash runway to advance tipifarnib and our emerging pipeline of drug candidates through a series of upcoming potential data catalysts, and we look forward to providing further updates on our progress in the months ahead."

Corporate Update

Registration-directed trial of tipifarnib in HRAS mutant HNSCC – Following a positive Phase 2 trial in HRAS mutant HNSCC and a successful end of Phase 2 meeting with the FDA, Kura is planning to conduct a global, registration-directed trial of its lead drug candidate tipifarnib in at least 59 recurrent or metastatic patients with HRAS mutant HNSCC. The primary endpoint of the trial will be objective response rate. Based on feedback from the FDA, Kura believes that the single-arm trial, if positive, could support an application for accelerated approval. Kura anticipates that the trial, called AIM-HN, will require fewer than 100 clinical sites worldwide and take approximately two years to enroll. Kura expects to initiate the AIM-HN trial in the second half of 2018.

Screening and outcomes study in HRAS mutant HNSCC – Concurrent with the AIM-HN trial, Kura is also planning to conduct a non-interventional, case-control study in HNSCC, called SEQ-HN. The study is expected to facilitate the identification of patients with HRAS mutations for potential enrollment into the AIM-HN trial. In addition, SEQ-HN is designed to characterize the natural history of patients with HRAS mutant HNSCC, which may support any future discussions with regulatory agencies concerning the appropriateness and nature of a potential approval.

Tipifarnib in HRAS mutant lung squamous cell carcinoma (LSCC) – Kura recently presented new preclinical data showing that tipifarnib is highly active in HRAS mutant LSCC tumor models. The data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2018, illustrate the potential for tipifarnib in the treatment of HRAS mutant LSCC. Kura is collaborating with the Spanish Lung Cancer Group, a cooperative group consisting of more than 150 public and private oncology centers in Spain, on a proof-of-concept trial of tipifarnib in HRAS mutant LSCC. Kura anticipates this investigator-sponsored trial to initiate later this year.

Patent protection for tipifarnib in hematologic malignancies – Kura recently announced the issuance of U.S. patent 9,956,215, "Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors." The newly issued patent includes multiple claims directed to the use of tipifarnib as a method of treating patients with CXCL12-expressing peripheral T-cell lymphoma (PTCL) and acute myeloid leukemia (AML) and has an expiration date of November 2037, excluding any possible patent term extension. This patent comes less than one year after the U.S. Patent and Trademark Office issued a similar patent for tipifarnib in HRAS mutant HNSCC, reinforcing the potential of Kura’s broader strategy to generate intellectual property related to its drug candidates and their use in treating genetically defined patient populations.

Potential biomarker for KO-947 in squamous cell carcinomas – At the AACR (Free AACR Whitepaper) Annual Meeting in April 2018, Kura presented new preclinical data for its ERK inhibitor, KO-947, including the identification of 11q13 amplification as a potential biomarker of activity in squamous cell carcinomas. Amplification of chromosomal region 11q13 is a common genetic alteration in squamous cell carcinomas, comprising approximately 20% of HNSCC and 50% of esophageal squamous cell carcinoma.

Upcoming Milestones

Initiation of AIM-HN, a registration-directed trial of tipifarnib in HRAS mutant HNSCC, and SEQ-HN, a non-interventional, case-control study in HRAS mutant HNSCC, in the second half of 2018

Additional data from RUN-HN, an ongoing Phase 2 trial of tipifarnib in HRAS mutant HNSCC, in the second half of 2018

Biomarker-enriched data from ongoing Phase 2 trials of tipifarnib in hematologic malignancies in the second half of 2018

Initiation of a proof-of-concept study of tipifarnib in HRAS mutant LSCC sponsored by the Spanish Lung Cancer Group in 2018

Data from a Phase 1 dose-escalation trial of KO-947 in solid tumors in the second half of 2018

Submission of an investigational new drug application for KO-539, a potent and selective inhibitor of the menin-MLL interaction, in late 2018 or early 2019

Financial Results

Research and development expenses for the first quarter of 2018 were $11.6 million, compared to $5.5 million for the first quarter of 2017.

General and administrative expenses for the first quarter of 2018 were $3.4 million, compared to $2.1 million for the first quarter of 2017.

Net loss for the first quarter of 2018 was $14.6 million, compared to $7.5 million for the first quarter of 2017.

Cash, cash equivalents and short-term investments totaled $138.2 million as of March 31, 2018, which included $57.7 million in net proceeds under an ATM facility in January 2018, compared with $93.1 million as of December 31, 2017.

Management expects that current cash, cash equivalents and short-term investments will be sufficient to fund its current operations into the first half of 2020.

Conference Call and Webcast

Kura’s management will host a webcast and conference call today at 4:30 p.m. ET / 1:30 p.m. PT today, May 8, 2018, to discuss the financial results for the first quarter of 2018 and provide a corporate update. The live call may be accessed by dialing (877)

516-3514 for domestic callers and (281) 973-6129 for international callers and using conference ID #7199738. A live webcast of the call will be available from the Investors and Media section of the company website at www.kuraoncology.com, and will be archived there for 30 days.

8-K – Current report

On May 8, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ: OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported first quarter 2018 financial results and provided a corporate update (Press release, OncoMed, MAY 8, 2018, View Source [SID1234526253]). As of March 31, 2018, cash, cash equivalents, and short-term investments totaled $88.4 million.

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"The Company is encouraged by ongoing clinical progress on its two most advanced immuno-oncology programs, anti-TIGIT and GITRL-Fc, and preclinical data on these programs were recently highlighted in multiple poster presentations at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. We also continue to dose patients in two Phase 1b studies of navicixizumab, our anti-DLL4/VEGF bispecific antibody. We look forward to delivering on numerous near-term catalysts, including the initiation of the Phase 1b portion of the anti-TIGIT study in combination with anti-PD1 in the second quarter of this year, the publication of the navicixizumab Phase 1a manuscript and the presentation of the navicixizumab Phase 1b ovarian cancer data in the second half of 2018, and the planned presentation of the anti-TIGIT Phase 1a data in the fourth quarter of 2018," stated John Lewicki, Ph.D., President and CEO of OncoMed.

Pipeline Highlights

Anti-TIGIT (OMP-313M32)

OncoMed plans to initiate dosing of the Phase 1b portion of its Phase 1a/b anti-TIGIT (OMP-313M32) trial, in combination with anti-PD1, in the second quarter of 2018. The Phase 1b portion of the open-label clinical trial is designed to assess the safety, tolerability, preliminary efficacy, and pharmacodynamic biomarkers of escalating doses of OMP-313M32 in combination with anti-PD1 for the treatment of patients with solid tumors who have progressed after prior treatment with anti-PD1 or anti-PD-L1.

OncoMed continues enrollment in the Phase 1a single-agent study of anti-TIGIT in patients with advanced or metastatic solid tumors. The Phase 1a study is designed to assess safety and tolerability of escalating doses of anti-TIGIT. Biomarkers will be assessed in this study which includes a single-agent dose expansion cohort.

The company currently expects to present data from the Phase 1a portion of the Phase 1a/b study in the fourth quarter of 2018.

Navicixizumab (anti-DLL4/VEGF bispecific; OMP-305B83)

Enrollment continues in two Phase 1b multi-center, open-label, dose escalation and expansion studies of OncoMed’s anti-DLL4/VEGF bispecific antibody in combination with standard-of-care chemotherapies: one in patients with platinum-resistant ovarian cancer who have failed more than two prior therapies or prior bevacizumab and a second in patients with 2nd line metastatic colorectal cancer.

To date, OncoMed has enrolled approximately 100 patients across the Phase 1a and Phase 1b trials of navicixizumab.

The Phase 1a data are expected to be published in the second half of 2018, and interim data from the ongoing Phase 1b ovarian cancer study are also expected to be reported in the second half of 2018.

GITRL-Fc (OMP-336B11)

Robust enrollment continues in the Phase 1a single-agent study of its wholly-owned GITRL-Fc in patients with advanced or metastatic solid tumors. GITRL-Fc is a fusion protein with an Fc-linked fully human trimer ligand and is designed to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptor-related protein) to enhance T-cell modulated immune responses. The Phase 1a study is designed to assess safety and tolerability of escalating doses.

The Phase 1a data are expected to be presented in 2019.

New product discovery

OncoMed continues to make strong progress in its pursuit of novel immune-oncology agents, including emerging opportunities from the TNF superfamily of ligands, using the company’s proprietary linkerless fully human trimer technology.

First Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments totaled $88.4 million as of March 31, 2018, compared to $103.1 million as of December 31, 2017.

Revenues were $7.8 million for the first quarter of 2018, an increase of $1.6 million, compared to $6.2 million for the same period in 2017. The change in revenue was due to the effect of the adoption of the new revenue recognition standard in the first quarter of 2018. For further discussion regarding our adoption of the new revenue recognition standard and its effects, see page 12 of our Quarterly Report on Form 10-Q for the first quarter ended March 31, 2018, filed with the Securities and Exchange Commission on May 8, 2018.

Research and development (R&D) expenses were $8.4 million for the first quarter of 2018, a decrease of $15.6 million, compared to $24.0 million for the same period in 2017. The decrease in R&D expenses was due to decreases in clinical development costs and reduced headcount following the restructuring actions in April 2017.

General and administrative (G&A) expenses were $5.4 million for the first quarter of 2018, an increase of $0.4 million, compared to $5.0 million for the same period in 2017. The increase in G&A expenses was primarily due to an increase in personnel cost, including retention bonus and severance expenses in the first quarter of 2018, offset by a decrease in headcount as a result of restructuring actions in April 2017.

Net loss for the first quarter of 2018 was $5.6 million ($0.15 per share), compared to $22.6 million ($0.61 per share) for the same period of 2017. The change in year-over-year net loss was primarily due to lower operating expenses in the first quarter of 2018.

2018 Financial Guidance

OncoMed’s current cash is estimated to be sufficient to fund operations through at least the third quarter of 2019, without taking into account future potential milestone or opt-in payments from its partners. OncoMed estimates 2018 operating cash burn to be approximately $55 million, before considering potential milestone or opt-in payments.

SANGAMO THERAPEUTICS REPORTS FIRST QUARTER 2018 FINANCIAL RESULTS

On May 8, 2018 Sangamo Therapeutics, Inc. (NASDAQ: SGMO) reported first quarter 2018 financial results and recent accomplishments (Press release, Sangamo Therapeutics, MAY 8, 2018, View Source [SID1234526271]).

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"This is an exciting time for Sangamo; we expect potential clinical data readouts from 7 studies in 2018 and 2019, beginning in late summer of this year with anticipated data from our hemophilia A gene therapy and MPS II genome editing programs," said Sandy Macrae, CEO of Sangamo. "In order to realize the potential of our platform technologies, we recently raised additional capital to strengthen our balance sheet. This funding will allow us to retain and invest in valuable programs for development and potential commercialization, particularly in select therapeutic areas including inherited metabolic diseases, rare CNS disorders, and immunology."

Recent Highlights

Corporate

Strengthened balance sheet with public offering of common stock raising net proceeds of approximately $216 million

Established global collaboration and license agreement with Kite, a Gilead Company, for the development of next-generation cell therapies for oncology

Clinical

Treated the fourth patient in the SB-525 Phase 1/2 Alta Study for hemophilia A

Treated the fourth patient in the SB-913 Phase 1/2 CHAMPIONS Study for MPS II

Received Clinical Trial Authorization (CTA) from the MHRA of the U.K. for enrollment of subjects in the ongoing Phase 1/2 clinical trial of SB-FIX for hemophilia B. The CTA allows enrollment of adolescent patients, ages 12-17, once preliminary safety and efficacy have been demonstrated in adults

Awarded an $8 million grant from the California Institute of Regenerative Medicine (CIRM) to evaluate ST-400, a gene-edited cell therapy candidate, for the treatment of transfusion-dependent beta-thalassemia. ST-400 is being developed in collaboration with Bioverativ, a Sanofi Company

After demonstrating safety at the first dose cohort in the SB-913 MPS II clinical trial, amended Phase 1/2 study protocol for SB-318 MPS I trial to begin enrolling patients directly into the second dose cohort

Research

Publication of preclinical murine study data from MPS II in vivo genome editing program in the April 2018 issue of Molecular Therapy

Sangamo scientists or collaborators will deliver three oral and four poster presentations during the 21st Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) being held in Chicago, IL from May 16-19, 2018

First Quarter 2018 Financial Results

For the first quarter ended March 31, 2018, Sangamo reported a consolidated net loss of $20.2 million, or $0.23 per share, compared to a net loss of $16.6 million, or $0.23 per share, for the same period in 2017. As of March 31, 2018, the Company had cash, cash equivalents, marketable securities and interest receivable of $234.9 million. This balance does not include the $150 million upfront payment from the collaboration agreement with Kite, effective April 5th, or the approximately $216 million in net proceeds from the recent public offering of Sangamo’s common stock, which closed on April 30th.

Revenues for the first quarter ended March 31, 2018 were $12.6 million, compared to $3.4 million for the same period in 2017. The increase in revenues was primarily related to the hemophilia A collaboration and license agreement with Pfizer. First quarter 2018 revenues were primarily generated from Sangamo’s collaboration agreements with Pfizer and Bioverativ.

Total operating expenses for the first quarter ended March 31, 2018 were $33.6 million, compared to $20.2 million for the same period in 2017. Research and development expenses were $23.5 million for the first quarter of 2018, compared to $12.9 million for the same period in 2017. The increase was primarily due to clinical and manufacturing expenses in support of current clinical studies and investment in dedicated manufacturing capacity. General and administrative expenses were $10.1 million for the first quarter ended March 31, 2018, compared to $7.3 million for the same period in 2017. The increase was primarily due to salaries and related costs and other professional fees in support of overall Company growth.

Financial Guidance for 2018

The Company updates guidance as follows:

Operating Expenses: Sangamo expects that operating expenses will be in the range of $140 million to $150 million for year-end 2018, including non-cash stock-based compensation expense.

Cash and Investments: Sangamo expects a year-end 2018 balance of cash, cash equivalents, marketable securities and interest receivable of at least $485 million. This anticipated cash balance is inclusive of research funding from existing collaborators and recent financings, but exclusive of funds arising from any additional new collaborations or partnerships or other sources of capital.

Conference Call

Sangamo will host a conference call today, May 8, 2018, at 8:00 a.m. ET, which will be open to the public. The call will also be webcast live and can be accessed via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 1194369. For those unable to listen in at the designated time, a conference call replay will be available for one week following the conference call, from approximately 11:00 a.m. ET on May 8, 2018 to 11:00 a.m. ET on May 15, 2018. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 1194369.