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OncoSec Expands Relationship with Merck, Announces Clinical Collaboration to Evaluate Combination of ImmunoPulse® IL-12 and KEYTRUDA® (pembrolizumab) for Triple Negative Breast Cancer

On May 8, 2018 OncoSec Medical Incorporated (OncoSec) (NASDAQ:ONCS), a company developing intratumoral cancer immunotherapies, has entered a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of OncoSec’s ImmunoPulse IL-12 with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) in a Phase II clinical trial (Press release, OncoSec Medical, MAY 8, 2018, View Source [SID1234526258]). The planned clinical trial will evaluate the safety and efficacy of the combination in patients with inoperable locally advanced or metastatic triple negative breast cancer (TNBC) who have previously failed at least one systemic chemotherapy or immunotherapy.

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"We are pleased to initiate a second clinical trial collaboration with Merck – one of the world’s leading immuno-oncology companies – in late stage TNBC, a disease which has few treatment options," said Daniel J. O’Connor, Chief Executive Officer of OncoSec. "This collaboration is another example of OncoSec’s strategy to work with innovative immuno-oncology leaders, combining our ImmunoPulse IL-12 program with checkpoint inhibitor therapies to advance the care of patients."

Eligible patients for this Phase II study will be those with TNBC who have inoperable locally advanced or metastatic disease and progressed on at least one previous treatment of systemic chemotherapy or immunotherapy. Under the collaboration agreement, OncoSec will sponsor and fund the study and Merck will provide KEYTRUDA. Additional details of the collaboration were not disclosed.

Proposed Acquisition of Shire plc by Takeda

On May 8, 2018 Takeda Pharmaceutical Company Limited (TSE: 4502) ("Takeda") and Shire plc (LON: SHP) ("Shire") reported that they have reached agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire (Press release, Takeda, AUG 8, 2018, View Source [SID1234526257]). Under the terms of the acquisition, each Shire shareholder will be entitled to receive $30.33 in cash for each Shire share and either 0.839 new Takeda shares or 1.678 Takeda ADSs. The transaction has been approved by both companies’ boards of directors, and is expected to close in the first half of calendar year 2019. Upon the closing of the transaction, Takeda shareholders will own approximately 50 percent of the combined group.

With leading market positions in prioritized therapeutic areas, an attractive geographic footprint, greater scale and efficiencies, and an even more productive R&D engine, the combined group will be better positioned to deliver highly-innovative medicines and transformative care providing better health and a brighter future for patients around the world.

"Since its inception, Takeda has transformed into an agile, R&D-driven global pharmaceutical company that is well-positioned to deliver innovative and transformative care to patients around the world," said Christophe Weber, president and chief executive officer of Takeda. "Shire’s highly complementary product portfolio and pipeline, as well as experienced employees, will accelerate our transformation for a stronger Takeda. Together, we will be a leader in providing targeted treatments in gastroenterology, neuroscience, oncology, rare diseases and plasma-derived therapies. We are looking forward to the benefits this combination will bring to patients worldwide, the opportunities it will bring for our employees and the returns it will deliver for our shareholders."

Susan Kilsby, chairman of Shire, said, "Over the last 30 years, Shire has become the global leader in treating rare diseases, delivering innovative products that transform patients’ lives. With this combination, Shire helps create an even stronger biopharmaceutical company, with a robust R&D pipeline and expanded global footprint. We are proud of what Shire has become and are grateful to all Shire employees for their contributions. We firmly believe that this combination recognizes the strong growth potential of our leading products and innovative pipeline and is in the best interests of our shareholders, our patients and the communities we serve."

Flemming Ornskov, chief executive officer of Shire, said, "I would like to thank the entire Shire team for all that we have accomplished over the last five years to transform Shire into a leading rare disease biotech company and a tenacious champion for patients in need. I am confident that this relentless focus will enable us to continue delivering against our priorities throughout this process. With a truly innovative portfolio and pipeline, I believe that the combination of the two companies is in the best interests of shareholders and offers an opportunity to improve the lives of even more patients globally with rare and highly specialized conditions."

Highly Compelling Strategic and Financial Rationale

Brings together complementary positions in GI and neuroscience; provides leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines

The acquisition of Shire will accelerate Takeda’s transformation by bringing together Takeda and Shire’s complementary positions in GI and neuroscience. It will also provide the combined group with leading positions in rare diseases and plasma-derived therapies to complement strength in oncology and focused efforts in vaccines. Takeda will continue to focus on the acceleration of its oncology business, following its recent acquisition of ARIAD Pharmaceuticals. In addition, Takeda’s vaccine business will continue to address the world’s most pressing public health needs.

Creates a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, with an attractive geographic footprint and provides the scale to drive future development

The acquisition will build on Takeda’s long Japanese heritage and values-based culture to create a global biopharmaceutical leader, driven by innovative and world-class R&D. The combined group will have an attractive geographic footprint, with significantly increased exposure in the United States (U.S.), an important and growing market. In addition, Shire’s portfolio will benefit from Takeda’s strong international presence in emerging markets and Japan. The integrated company will continue to be headquartered in Japan, expand its R&D presence in the Boston area and have major regional locations in Japan, Singapore, Switzerland and the U.S. Together, the combined group will have leading positions in two of the largest drug markets globally: the U.S. and Japan. The acquisition is expected to result in Takeda being the only pharmaceutical company listed on both the Tokyo Stock Exchange in Japan, where it will continue to have its primary listing, and the NYSE in the U.S., enabling it to access two of the world’s largest capital markets.

Creates a highly complementary, robust, modality-diverse pipeline and a strengthened R&D engine focused on breakthrough innovation

Takeda and Shire have highly complementary pipelines. Shire has strong expertise in rare diseases, an attractive modality-diverse mid- and late-stage pipeline, enriched with large-molecule programs, as well as cutting-edge technologies in gene therapy and recombinant proteins. Combining this with Takeda’s early development and research-oriented R&D program will result in a highly complementary, robust, modality-diverse pipeline and a strengthened R&D engine focused on breakthrough innovation. The combined group will build on existing partnerships, including Takeda’s more than 180 active partnerships with academia, biotechnology companies and startups, to further enrich the pipeline.

Enhances Takeda’s cash flow profile, with management committed to delivering substantial annual cost synergies and generating attractive returns for shareholders

The acquisition of Shire will provide compelling financial benefits for the combined group. It will be significantly accretive to underlying earnings per share from the first full fiscal year following completion, and will produce strong combined cash flows. The transaction is also expected to result in attractive returns for shareholders, with the return on invested capital (ROIC) expected to exceed Takeda’s cost of capital within the first full fiscal year following completion. The substantial cash flow generation expected to result from the acquisition will enable the combined group to de-lever quickly following completion. Takeda intends to maintain its investment grade credit rating, with a target net debt to EBITDA ratio of 2.0x or less in the medium term.

Takeda is confident that the acquisition will create an opportunity to recognize significant recurring cost synergies, with potential for additional revenue synergies from the combination of Shire and Takeda’s combined infrastructure, market presence and development capabilities. Takeda expects recurring pre-tax cost synergies for the combined group to reach a run-rate of at least $1.4 billion per annum by the end of the third fiscal year following completion of the acquisition.

The acquisition will accelerate Takeda’s strategic transformation toward Vision 2025, and strong combined cash flows will enable continued investment in R&D. Takeda’s well-established dividend policy will remain a key component of future shareholder returns.

Execution

Takeda’s experienced management team has a proven track record of executing complex business integrations and large-scale transformations, and is well-positioned to successfully integrate Shire and maximize the value of the combination. The integration will be supported by the companies’ highly complementary organizational structures in geographic areas, including hubs in the Boston area, Switzerland and Singapore, as well as similar therapeutic area focus and complementary approaches to R&D. Takeda is dedicated to carrying out integration efforts in a manner consistent with the company’s core values of integrity, fairness, honesty and perseverance, building on the expertise of employees of both companies.

Transaction Terms

Under the terms of the acquisition, Shire shareholders will be entitled to receive, for each Shire share, $30.33 in cash and either 0.839 new Takeda shares or 1.678 Takeda ADSs.

The acquisition terms imply an equivalent value of:

£48.17 per Shire share based on the closing price of ¥4,535 per Takeda share on May 2, 2018, and the exchange rates of £:¥ of 1:147.61 and £:$ of 1:1.3546 on May 4, 2018 (being the latest practicable date prior to this announcement); and
£49.01 per Shire share based on the closing price of ¥4,923 per Takeda Share and the exchange rates of £:¥ of 1:151.51 and £:$ of 1:1.3945 on April 23, 2018 (being the day prior to the announcement that the Shire board would, in principle, be willing to recommend the consideration).

The equivalent value of £49.01 per Shire share values the entire issued and to be issued ordinary share capital of Shire at approximately £46 billion.

Immediately following completion of the transaction, Takeda shareholders will hold approximately 50 percent of the combined group.

The transaction has been approved by the boards of both companies, and is subject to the approval of Shire and Takeda shareholders and certain customary closing conditions, including regulatory approvals.

The acquisition is expected to close in the first half of calendar year 2019. Upon completion, the new Takeda shares will be listed on the Tokyo Stock Exchange, and local Japanese stock exchanges. In addition, Takeda will apply for its ADSs (each representing 0.5 Takeda shares) to be listed on the NYSE effective on or shortly after the effective date.

Financing

Takeda has entered into a bridge facility agreement of $30.85 billion with, among others, J.P. Morgan Chase Bank N.A., Sumitomo Mitsui Banking Corporation and MUFG Bank, Ltd., part of the proceeds of which will be used to fund the cash consideration payable to Shire shareholders in connection with the acquisition. It is currently contemplated that, prior to completion, the commitments under the bridge facility agreement will be reduced or refinanced with a combination of long-term debt, hybrid capital and available cash resources.

Rule 2.7 Announcement

Agreement on Commencement of a Friendly Acquisition Procedure to Make Shire plc a Wholly-owned Subsidiary

Conference Call Webcast Information
Agreement on Commencement of a Friendly Acquisition Procedure to Make Shire plc a Wholly-owned Subsidiary

Takeda will host a transaction conference call at 4.15pm – 5pm JST / 8.15am – 9am BST / 3.15am – 4am EST on May 8, 2018 to discuss the transaction.

Investors and analysts can dial in to the conference call using the numbers below:

Standard International Access: +44 (0) 20 3003 2666; Japan Toll Free: 006633132499; UK Toll Free: 0808 109 0700; USA Toll Free: 1 866 966 5335; Tokyo Toll Free: +81 (0) 3 5050 5366; and Passcode: 161017

A presentation for the call will be available at:

View Source

Takeda will host an additional audio webcast at 10.00 p.m. JST / 2.00 p.m. BST / 9.00 a.m. ET on May 8, 2018 with Japanese translation, to discuss the transaction. The webcast can be accessed at the following link:

View Source

Replays of the conference calls will be available within 24 hours.

For more information, the full Rule 2.7 announcement setting out full details of the offer to Shire shareholders is available at: View Source

RXi Pharmaceuticals Bolsters Strength of Dermatology Intellectual Property Estate Following Granting of Patent From USPTO

On May 8, 2018 RXi Pharmaceuticals Corporation (NASDAQ: RXII) a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (sd-rxRNA) therapeutic platform, reported that it was granted a patent from the United States Patent and Trademark Office (USPTO) for the methods of use of sd-rxRNAs targeting Connective Tissue Growth Factor (CTGF) for the treatment or prevention of fibrotic disorders, including skin fibrosis (USPTO Patent #: 9,963,702 B2) (Press release, RXi Pharmaceuticals, MAY 8, 2018, View Source [SID1234526255]). This patent includes RXI-109 and its use in dermal scarring, for which the safety and efficacy was shown in a recent Phase 2 clinical trial with statistically significant outcomes for improved visual appearance for RXI-109 treated scar over control. The patent is set to expire in 2031.

"Robust clinical data and strong IP are key elements to successful pharmaceutical development and commercialization," said Dr. Gerrit Dispersyn, Chief Development Officer of RXi Pharmaceuticals. He added that, "Additional data on the results of our recent clinical study with RXI-109 in dermal scarring will be presented next week at the International Investigative Dermatology Conference. These data, in combination with the granting of this patent, supports RXi’s ongoing discussions with potential partners for our Dermatology Franchise, including RXI-109."

About RXi’s Dermatology Franchise

RXi announced in January 2018 that it would exclusively focus on developing the next generation of immuno-oncology therapeutics based on its self-delivering RNAi therapeutic platform. As such, it is actively seeking to partner or out-license both its Dermatology and Ophthalmology Franchises.

Each of these Franchises is comprised of a number of preclinical and clinical-stage assets broadly covered by a robust intellectual property estate. To obtain more information about these assets, contact RXi’s Director of Business Development, Dr. James Cardia at [email protected]

Bellicum Pharmaceuticals Reports First Quarter 2018 Financial Results

On May 8, 2018 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers and orphan inherited blood disorders,reported financial results for the first quarter ended March 31, 2018, and provided an update on recent developments(Press release, Bellicum Pharmaceuticals, MAY 8, 2018, View Source [SID1234526254]).

"We remain very encouraged with interim results from our BPX-501 program in malignant and nonmalignant pediatric patients, and remain on track for filing of MAAs in the European Union in 2019," said Bellicum’s President & CEO Rick Fair. "We are also working to expand the BPX-501 opportunity into the U.S. and into the adult stem cell transplant population with the planned initiation of two new clinical trials later this year. In our BPX-601 GoCAR-T program, we reported early promising first-in-human data on CAR-T cell expansion with the use of our iMC activation switch. We look forward to sharing data readouts on all our clinical programs during 2018, and providing further guidance on our plans to advance two new dual-switch controllable CAR-T candidates into clinical studies."

PROGRAM HIGHLIGHTS AND CURRENT UPDATES

Clinical Hold Lifted by FDA on U.S. Studies of BPX-501
The Company is now working with U.S. clinical sites to resume patient recruitment based on amended study protocols, including guidance on monitoring and management of neurologic adverse events. The FDA clinical hold did not affect the BP-004 registration trial in Europe.

BPX-501 E.U. Registration Trial Enrollment Complete
Enrollment was recently completed in the treatment arm of the BP-004 E.U. registration trial in malignant and nonmalignant pediatric patients undergoing haploidentical hematopoietic stem cell transplant (haplo-HSCT). The Company expects to have topline data at the end of 2018, followed by a readout of comparative data from its ongoing C-004 observational study in children receiving a matched unrelated donor (MUD) transplant without BPX-501. Bellicum expects to file for E.U. approvals of BPX-501 and rimiducid in 2019.

BPX-501 Interim Survival Results Reported
In March, the Company announced favorable interim results in pediatric patients with acute myeloid leukemia (AML), with overall survival of 97.3% in patients with a median follow-up of over one year. The Company also reported new updated interim data in pediatric patients with primary immunodeficiencies (PIDs) undergoing a curative haplo-HSCT with BPX-501. Abstracts providing more comprehensive interim data on these patients have been accepted for presentation at the 23rd Annual Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Stockholm in June.

CAR-T and TCR Phase 1 Studies Enrolling
Bellicum and its collaborators are currently enrolling Phase 1 clinical trials of three CAR-T and TCR programs featuring its industry-leading cellular control technology: BPX-601, BPX-701, and an academic collaborator’s CaspaCIDe-enabled CD19 CAR-T. The Company expects to report preliminary findings from all three studies at medical meetings later this year. BPX-601, the Company’s first GoCAR-T product candidate—differentiated by the inclusion of its proprietary iMC activation switch—is the first controllable CAR-T to enter clinical trials and is being studied in adults with nonresectable pancreatic cancer who test positive for prostate stem cell antigen (PSCA). The Company recently reported that the first patient dosed with rimiducid in the BPX-601 trial showed a robust expansion of circulating BPX-601 cells following a single dose of rimiducid, providing initial clinical proof of concept of the iMC activation switch. As enrollment continues, the Company is preparing to amend the trial to include additional PSCA-expressing tumors. In the Phase 1 study with BPX-701, Bellicum is working to add clinical sites to accelerate enrollment.

Progressing Next-Generation Dual-Switch Preclinical Programs
Leveraging its innovative technology platform, Bellicum has created next-generation controllable CAR-Ts that incorporate both activation and safety switches in the same T cell. At the AACR (Free AACR Whitepaper) Annual Meeting in April, the Company presented promising preclinical results highlighting the ability to manage expansion, persistence and safety of tumor antigen-specific CAR-T cells, potentially allowing for more aggressive anti-tumor therapies. The Company has nominated two new dual-switch CAR-Ts for clinical trials next year, and will provide additional details on these programs later this year.

Underwritten Public Offering of Common Stock
In April, Bellicum completed a public offering of 9.2 million shares, including 1.2 million shares sold under the underwriters’ option to purchase additional shares, at $7.50 per share. The aggregate offering size was $69.0 million before deducting the underwriting discounts and commissions and other offering expenses.

First Quarter 2018 Financial Results

Cash Position and Guidance: Bellicum ended the quarter on March 31, 2018 with cash, restricted cash and investments totaling $88.0 million, compared to $106.5 million at December 31, 2017. Based on current operating plans, Bellicum expects that current cash resources, including proceeds from its April 2018 public offering, will be sufficient to meet operating requirements through the end of 2019.

R&D Expenses: Research and development expenses were $16.5 million for the quarter ended March 31, 2018, compared to $15.3 million for the comparable period in 2017. The increase of approximately $1.2 million is primarily due to increased general research and development and collaboration costs of $1.9 million and increased costs related to BPX-701 of $0.2 million, partially offset by reduced costs related to BPX-501 of $0.9 million. Costs related to BPX-601 were comparable in each of the three-month periods.

G&A Expenses: General and administrative expenses were $5.7 million for the first quarter ended March 31, 2018, compared to $5.9 million during the comparable period in 2017. The decrease in G&A expenses in 2018 is primarily due to severance costs related to former executive officers incurred in the three months ended March 31, 2017.

Net Loss: Bellicum reported a net loss of $22.8 million during the first quarter of 2018 and $22.0 million during the comparable period in 2017. The results include non-cash, share-based compensation charges and depreciation of $5.0 million and $4.1 million in the first quarters of 2018 and 2017, respectively.

Shares Outstanding:

Bellicum had 34,288,556 and 42,873,045 shares of common stock outstanding as of March 31, 2018 and April 30, 2018, respectively. The increase in the number of outstanding shares was primarily attributable to the public offering of 9.2 million shares in April.

About BPX-501
BPX-501 is an adjunct T-cell therapy administered after allogeneic HSCT, comprising genetically modified donor T cells incorporating Bellicum’s CaspaCIDe safety switch. It is designed to provide a safety net to eliminate alloreactive BPX-501 T cells (via administration of activator agent rimiducid) should uncontrollable GvHD or other T-cell mediated transplant complications occur. This may enable physicians to more safely perform stem cell transplants by administering BPX-501 engineered T cells to speed immune reconstitution, provide control over viral infections, and enhance graft-versus-leukemic activity while minimizing GvHD side effects.

About BPX-601
BPX-601 is a GoCAR-T product candidate containing Bellicum’s proprietary inducible MyD88/CD40, or iMC, activation switch, designed to treat solid tumors expressing prostate stem cell antigen, or PSCA. Preclinical data show enhanced T cell proliferation, persistence and in vivo anti-tumor activity compared to traditional CAR-T therapies. In addition to pancreatic cancer, PSCA is expressed in several other solid tumor indications, including: gastric, esophageal, cholangiocarcinoma, glioblastoma, prostate and bladder cancers. The Company plans to expand the clinical development of BPX-601 to include additional PSCA expressing cancer types.

About BPX-701
BPX-701 is a high affinity T cell receptor product candidate designed with the CaspaCIDe safety switch. In preclinical studies, PRAME-specific clones showed high reactivity against a panel of PRAME positive tumor cell lines, metastatic melanoma, sarcomas and neuroblastoma tissues. In vitro study data showed that BPX-701 demonstrated strong affinity to panels of cancer cells presenting PRAME peptides and low affinity to non-tumor cells, as well as complete elimination of BPX-701 cells in response to rimiducid.

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.

"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.