On August 7, 2018 Myovant Sciences (NYSE: MYOV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for the treatment of women’s health and endocrine diseases, reported corporate updates and reported financial results for the first fiscal quarter ended June 30, 2018 (Press release, Myovant Sciences, AUG 7, 2018, View Source [SID1234528486]).

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"We are off to an excellent start to the year, highlighted by the completion of patient screening for our Phase 3 LIBERTY 1 trial evaluating relugolix in women with heavy menstrual bleeding associated with uterine fibroids, and screening in the replicate LIBERTY 2 trial expected to be completed this quarter," said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. "We are at an exciting stage in the evolution of the Company, with top-line safety and efficacy data expected for relugolix in 2019 in three distinct indications, each with large markets and wholly owned North American and European rights."

Recent Business Highlights and Upcoming Milestones

On July 10, 2018, Myovant announced completion of patient screening for its LIBERTY 1 trial, the first of two Phase 3 replicate trials evaluating relugolix in women with heavy menstrual bleeding associated with uterine fibroids. Top-line safety and efficacy data from this trial are expected in the second quarter of 2019.
Screening for the LIBERTY 2 trial is anticipated to be completed this quarter.
Completion of enrollment and top-line safety and efficacy data from the two Phase 3 SPIRIT trials of relugolix in women with endometriosis-associated pain are expected in 2019.
Enrollment is expected to be completed in 2018 for the Phase 3 HERO trial of relugolix in men with advanced prostate cancer, and top-line safety and efficacy data are expected in 2019.
Myovant raised aggregate net proceeds of approximately $150.0 million during fiscal 2018 from the issuance and sale of 3,333,334 common shares in an underwritten public offering in July 2018, 1,110,015 common shares in a private placement to the Company’s controlling shareholder, Roivant Sciences, Ltd. in April 2018, and 2,767,129 common shares in an "at-the-market" equity offering program in April 2018.
On May 30, 2018, Myovant entered into a Commercial Manufacturing and Supply Agreement with Takeda Pharmaceutical Company Ltd. pursuant to which Takeda will manufacture and supply Myovant with relugolix drug substance to support the commercial launch of relugolix, if marketing authorization is granted. Takeda has also agreed to assist with the transfer of technology and manufacturing know-how to a second contract manufacturing organization of Myovant.
In May 2018, following the completion of a Phase 1 study, Myovant initiated a Phase 2a clinical trial in healthy female volunteers to characterize the dose-response curve in the controlled ovarian stimulation setting prior to studying MVT-602 in infertile woman seeking pregnancy.
On April 20, 2018, Myovant announced a partnership with PERIOD, Inc., a youth-led non-profit organization focused on menstrual equity, to elevate the conversation around period health, including an Ask Me About Periods campaign on college campuses around the country.
First Fiscal Quarter 2018 Financial Summary

Research and development (R&D) expenses for the quarter ended June 30, 2018, were $51.3 million compared to $17.7 million for the comparable period in 2017. The increase for the quarter primarily reflects the progress of Myovant’s ongoing Phase 3 clinical trials of relugolix, which were initiated in 2017, and additional personnel-related expenses.

General and administrative (G&A) expenses for the quarter ended June 30, 2018, were $8.7 million compared to $4.2 million for the comparable period in 2017. The increase for the quarter primarily reflects increases in personnel-related expenses, professional service fees, and other administrative expenses to support Myovant’s headcount growth and expanding operations.

Interest expense for the quarter ended June 30, 2018, was $1.6 million compared to no interest expense in the comparable prior year period. Interest expense for the quarter consisted of interest expense related to financing agreements with NovaQuest Pharma Opportunities Fund IV L.P. and Hercules Capital, Inc., as well as the associated non-cash amortization of debt discount and issuance costs.

Net loss for the quarter ended June 30, 2018, was $62.1 million, compared to $23.3 million for the comparable period in 2017. On a per common share basis, net loss was $0.98 and $0.39 for the quarters ended June 30, 2018, and 2017, respectively. The increases in the net loss and net loss per common share for the quarter were driven primarily by the increase in costs associated with Myovant’s ongoing Phase 3 clinical trials, which were initiated in 2017, as well as increased personnel-related expenses.

Capital resources: Cash and committed funding totaled $235.6 million at June 30, 2018, consisting of $143.6 million in cash and $92.0 million in remaining financing commitments available from NovaQuest under the NovaQuest Securities Purchase Agreement and the NovaQuest Equity Purchase Agreement. In the second quarter of fiscal year 2018, Myovant further strengthened its balance sheet, raising net proceeds of approximately $70.2 million from the issuance and sale of 3,333,334 common shares in an underwritten public offering. An additional $40.6 million of capacity remains available under the "at-the-market" equity offering program that Myovant initiated in April 2018.

About Relugolix

Relugolix is an oral, once-daily, small molecule that acts as a gonadotropin-releasing hormone, or GnRH, receptor antagonist that has been evaluated in approximately 1,600 study participants in Phase 1, Phase 2 and Phase 3 clinical trials. In these trials, relugolix has been shown to be generally well tolerated and to suppress estrogen and progesterone levels in women and testosterone levels in men. Common side effects observed were consistent with suppression of these hormones. In the ongoing Phase 3 LIBERTY clinical trials in women with heavy menstrual bleeding associated with uterine fibroids and the ongoing Phase 3 SPIRIT clinical trials in women with endometriosis-associated pain, relugolix is undergoing evaluation alone as monotherapy and in combination with estradiol and norethindrone acetate, a progestin. Myovant is studying whether the combination decreases estradiol levels to the range required to treat signs and symptoms of endometriosis and uterine fibroids while minimizing the side effects such as bone mineral density loss and hot flashes, associated with low estrogen levels. The ongoing Phase 3 HERO study is evaluating relugolix alone in men with advanced prostate cancer.

On August 7, 2018 Inovio Pharmaceuticals, Inc. (NASDAQ:INO), a late-stage biotechnology company focused on the development and commercialization of DNA immunotherapies targeted against cancers and infectious diseases,reported financial results for the second quarter ended June 30, 2018, along with a general business update (Press release, Inovio, AUG 7, 2018, View Source [SID1234528502]). Inovio’s management will host a live conference call and webcast at 4:30 p.m. Eastern Time today to discuss Inovio’s financial results and provide a general business update.

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Inovio Highlights

VGX-3100 – HPV-related Precancers
REVEAL 1 Phase 3 trial enrollment on track. Opened a total of 70 sites across 16 countries and are actively recruiting for REVEAL 1, Inovio’s Phase 3 clinical trial for treating cervical dysplasia (CIN) caused by the human papillomavirus (HPV); the company anticipates opening approximately 90 sites globally by the end of August 2018. Also commenced during the quarter a Phase 2 clinical trial in its third indication to evaluate the efficacy of VGX-3100 in approximately 24 patients, adult men and women, with HPV-related anal dysplasia. This expansion increases the overall commercial value potential of our lead product, VGX-3100.
INO-5401 – Cancer
Dosed first patient in June as part of its Phase 1/2 immuno-oncology trial in patients with newly diagnosed glioblastoma (GBM); open-label, multi-center trial evaluating INO-5401 and INO-9012 in combination with cemiplimab in 50 newly diagnosed GBM patients with primary endpoint of safety and tolerability; the study will also evaluate immunological impact, progression-free survival and overall survival (see www.clinicaltrials.gov, identifier NCT03491683).
INO-5150 – Cancer
Presented prostate cancer data at ASCO (Free ASCO Whitepaper) 2018 where analyses showed clinically meaningful PSA stabilization post-administration of INO-5150 in patients with no documented disease progression during the study; of the 61 evaluable patients, 77% (47/61) demonstrated T cell immunogenicity; additional immunology data past week 27 is expected to be presented at a major oncology conference in the third quarter of 2018.
PENNVAX-GP – HIV
Presented data in May from a Phase 1 clinical trial in which Inovio’s HIV vaccine maintained durable and robust immune responses at month 12, a full 6 months after the last dose; 96% (26 of 27) of participants receiving PENNVAX-GP and IL-12 via IM delivery demonstrated a CD4+ T cell response, while the same percentage (96%, 27 of 28) of participants receiving the vaccine formulation via ID delivery also displayed anti-HIV CD4+ T cell responses; this data was presented at the 2018 HVTN Full Group Meeting in May.
INO-4700 (GLS-5300) – MERS
Reported positive Phase 1 results of Inovio’s collaborative vaccine study with INO-4700 (GLS-5300) against the MERS virus (Middle East Respiratory Syndrome); results showed that the vaccine was well-tolerated and approximately 95% of treated patients achieved overall high levels of antibody responses and approximately 90% of subjects also generated robust T cell responses. The new data was presented in June at the WHO-IVI Joint Symposium for MERS-CoV Vaccine Development.
Established partnership with CEPI
Signed a partnership agreement with the Coalition for Epidemic Preparedness Innovations (CEPI) under which CEPI will directly fund up to $56 million to support Inovio’s pre-clinical and clinical advancement through Phase 2 of INO-4500, its Lassa fever vaccine, and INO-4700, its MERS vaccine, over a five-year period. Additional revenue is possible with vaccine stockpile post-Phase 2 testing.
Recognized revenue from ApolloBio Partnership
Received an upfront payment of $23 million (approximately $19.4 million after payment of required taxes) in March 2018 from ApolloBio, which gained the rights to develop, manufacture and commercialize VGX-3100 to treat precancers caused by HPV, within Greater China. This amount was recognized in Inovio’s reported revenue for the second quarter of 2018.
Cash Position
As of June 30, 2018, cash and cash equivalents and short-term investments were $95.6 million compared to $112.8 million as of March 31, 2018.
Dr. J. Joseph Kim, Inovio’s President & CEO said, "The second quarter included important strategic accomplishments for Inovio, while also providing shareholders with much to look forward to over the next 12 months. From presenting expanded data from our HIV developmental vaccine, PENNVAX-GP, to dosing our first patient with INO-5401 in our GBM trial, Inovio continues to showcase the versatility of our technology in both immunotherapy and infectious diseases. We continue to work diligently with our newly established partners ApolloBio, CEPI and the Parker Institute, while maintaining focus on opening sites and enrolling patients globally for our lead asset, VGX-3100, for treating patients with cervical dysplasia as well as capturing the overall commercial value potential of VGX-3100 through the expansion of our immunotherapeutic solution capabilities in HPV-related vulvar and anal precancers."

Second Quarter 2018 Financial Results

Total revenue was $24.4 million for the three months ended June 30, 2018, compared to $20.4 million for the same period in 2017. Total operating expenses were $29.7 million compared to $30.0 million for the same period in 2017.

As a result of the adoption of Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, beginning on January 1, 2018, all contributions received from current grant agreements have been recorded as a contra-expense as opposed to revenue on the consolidated statement of operations. For the three months ended June 30, 2018, $1.9 million was recorded as contra-research and development expense, which amount would have been classified as grant revenue in the prior year. Had this change in presentation not occurred, total revenue would have been $26.3 million for the three months ended June 30, 2018, compared to $20.4 million for the same period in 2017. Total operating expenses would have been $31.6 million compared to $30.0 million for the same period in 2017.

Inovio’s net loss for the quarter ended June 30, 2018 was $6.6 million, or $0.07 per basic and $0.08 per diluted share, compared to $9.5 million, or $0.13 per basic and diluted share, for the quarter ended June 30, 2017.

Revenue

The increase in comparable revenue and grant agreement recognition for the second quarter of 2018 compared to 2017 was primarily due to the recognition of the gross up-front payment from ApolloBio of $23.0 million during the period (approximately $19.4 million after payment of required taxes). This increase was partially offset by $12.8 million in lower revenues recognized under Inovio’s collaborative research and development agreement with MedImmune, as previously deferred revenue totaling $13.8 million in the aggregate was recognized in June 2017 upon MedImmune’s selection of the first cancer research collaboration product candidate. Inovio also had a decrease in grant funding recognized from its DARPA Ebola grant of $2.2 million and a decrease in revenue of $2.1 million under its prior collaboration with Roche, as all remaining deferred revenue was recognized upon termination of that collaboration agreement in 2017, among other variances.

Operating Expenses

Research and development (R&D) expenses for the three months ended June 30, 2018 were $22.5 million compared to $23.9 million for the same period in 2017. The decrease in R&D expenses was primarily due to the $1.9 million contra-research and development expense recorded from grant agreements as discussed above, as well as a decrease of $2.1 million in expenses related to the DARPA Ebola grant. These decreases were slightly offset by an increase in employee headcount to support clinical trials and partnerships and an increase in expenses related to Inovio’s VGX-3100 clinical trials and its collaboration with MedImmune, among other variances.

General and administrative (G&A) expenses were $7.2 million for the three months ended June 30, 2018 versus $6.2 million for the same period in 2017.

Capital Resources

As of June 30, 2018, cash and cash equivalents and short-term investments were $95.6 million compared to $112.8 million as of March 31, 2018. As of June 30, 2018, the Company had 91.5 million common shares outstanding and 102.8 million common shares outstanding on a fully diluted basis, after giving effect to outstanding options, warrants, restricted stock units and convertible preferred stock.

Inovio’s balance sheet and statement of operations are provided below. Form 10-Q for the quarter ended June 30, 2018 providing the complete 2018 second quarter financial report can be found at: View Source

Conference Call / Webcast Information

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

The live webcast and a replay may be accessed by visiting the Company’s website at View Source Telephone replay will be available approximately two hours after the call at 877-481-4010 (domestic) or 919-882-2331 (international) using replay ID 33743.

On August 7, 2018 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported financial results for the quarter ended June 30, 2018 (Press release, Sunesis, AUG 7, 2018, View Source [SID1234528528]). Loss from operations for the three and six months ended June 30, 2018 was $6.6 million and $13.7 million. As of June 30, 2018, cash, cash equivalents and marketable securities totaled $20.4 million. This capital is expected to fund the company into the first quarter of 2019.

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"During the second quarter, we continued to focus on advancing our Phase 1b/2 trial evaluating our lead program, the non-covalent BTK inhibitor vecabrutinib, to help patients who have developed resistance to covalent BTK inhibitors such as ibrutinib," said Dayton Misfeldt, Interim Chief Executive Officer of Sunesis. "Specifically, we have added clinical sites, including the recent additions of Memorial Sloan Kettering Cancer Center and Moffitt Cancer Center, and strengthened our development team. We also entered into a financing facility with Aspire Capital to provide us with another flexible financing tool to support our development programs. We expect to present an update on our ongoing vecabrutinib trial at the annual American Society of Hematology (ASH) (Free ASH Whitepaper) meeting."

Recent Highlights

Strengthened Senior Management Team. In July 2018, the Company announced three key new management appointments as part of its expanded development team. Deepali Suri, a former Executive Director at Pharmacyclics (an AbbVie Company), was appointed Vice President, Clinical Operations and Sean Gharpurey joined as Executive Director, Project Management. Stephen Nava was promoted to Vice President, Quality Assurance, Compliance and Regulatory Affairs.

Entered into $15.5 Million Common Stock Purchase Agreement with Aspire Capital Fund, LLC. In June 2018, Sunesis entered into a Common Stock Purchase Agreement (CSPA) of up to $15.5 million with Aspire Capital. Under the terms of the Agreement, Aspire made an initial investment via purchase of $500,000 worth of SNSS common shares at a price of $2.19 per common share. In addition, Aspire committed to purchasing up to an additional $15 million of common shares of Sunesis at Sunesis’ request from time to time during a 24-month period, at prices based on the market price at the time of each sale. As consideration for Aspire’s obligations under the CSPA, Sunesis also issued 212,329 shares of common stock to Aspire as a commitment fee.

Presented Pre-clinical Data Demonstrating Activity of Vecabrutinib at EHA (Free EHA Whitepaper) Annual Meeting. In June, the laboratory of Professor Gilles Salles at the Université Claude Bernard de Lyon presented preclinical validation of vecabrutinib activity at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in Stockholm, Sweden. The data demonstrated the activity of Sunesis’ non-covalent BTK inhibitor vecabrutinib in BTK-dependent lymphomas, including lymphoma cell lines overexpressing mutated BTK C481S. In addition, a Sunesis-supported study led by Professor Paolo Ghia for the European Research Initiative on CLL (ERIC) assessed the

real-world prevalence of BTK C481 and PLCγ2 mutations in CLL patients relapsing under ibrutinib. Approximately half of the relapsed patients had BTK C481S mutations.

Financial Highlights

Cash, cash equivalents, and marketable securities totaled $20.4 million as of June 30, 2018, as compared to $31.8 million as of December 31, 2017. This capital is expected to fund the company into the first quarter of 2019. The 6-month decrease of $11.4 million was primarily due to $12.4 million of net cash used in operating activities, partially offset by $1.1 million in net cash flows from financing activities.

Net cash flows from financing activities comprised $0.8 million in proceeds from the issuance of common stock and $0.3 million in proceeds from stock option exercises and ESPP stock purchases.

Subsequent to June 30, 2018, the Company raised an additional $2.6 million in net cash proceeds from a combination of the Aspire CSPA and the Cantor Fitzgerald Controlled Equity Offering facility.

Research and development expense was $3.8 million and $7.7 million for the three and six months ended June 30, 2018, as compared to $4.9 million and $11.1 million for the same periods in 2017, primarily relating to the vecabrutinib and the vosaroxin development program in each period. The decreases of $1.1 million and $3.4 million between the comparable periods from last year was primarily due to decreases in salary and personnel expenses due to lower headcount, and decrease in professional services and clinical trials expenses related to higher expenses incurred in the second quarter of 2017 due to the MAA with the EMA.

General and administrative expense was $2.8 million and $6.2 million for the three and six months ended June 30, 2018, as compared to $3.7 million and $7.6 million for the same periods in 2017. The decreases of $0.9 million and $1.4 million between the comparable periods in 2017 were primarily due to reduced personnel and commercial expenses.

Interest expense was $0.3 million and $0.6 million for the three and six months ended June 30, 2018, as compared to $0.3 million and $0.8 million for the same periods in 2017. The decreases were primarily due to the decrease in the outstanding notes payable.

Cash used in operating activities was $12.4 million for the six months ended June 30, 2018, as compared to $20.5 million for the same period in 2017. Net cash used in the 2018 period resulted primarily from the net loss of $14.1 million, partly offset by net adjustments for non-cash items of $1.6 million and changes in operating assets and liabilities of $0.1 million. Net cash used in the six months ended June 30, 2017, resulted primarily from the net loss of $18.7 million and changes in operating assets and liabilities of $3.9 million, partly offset by net adjustments for non-cash items of $2.1 million.

Sunesis reported loss from operations of $6.6 million and $13.7 million for the three and six months ended June 30, 2018, as compared to $8.6 million and $18.0 million for the same periods in 2017. Net loss was $6.8 million and $14.1 million for the three and six months ended June 30, 2018, as compared to $8.8 million and $18.7 million for the same periods in 2017.

Conference Call Information

Sunesis will host a conference today at 4:30 p.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 5198125. To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

On August 7, 2018 genomiQa, one of Australia’s leading genomic analytics companies, reported that Colin Albert has been appointed as the company’s new CEO (Press release, QIMR Berghofer Medical Research Institute, AUG 7, 2018, View Source [SID1234528570]).

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Mr Albert has more than 20 years’ commercial experience in start-ups and large pharmaceutical companies both in Australia and globally.

Most recently, he held the roles of Commercial Head of the Asia Pacific region for Roche Pharmaceuticals and Regional General Manager of the Asia Pacific region for Roche Foundation Medicine based in Singapore. Prior to that, he was the Vice President, Business Effectiveness and Strategy with Shanghai Roche Pharmaceuticals Ltd based in Shanghai.

Mr Albert completed a Bachelor of Arts, majoring in Economics and Politics, at the University of Queensland before pursuing other post-graduate study and business qualifications. He is a graduate of the Australian Institute of Company Directors.

genomiQa’s strength is the analysis of the whole genome, particularly the use of bioinformatics, to provide guidance for clinicians on decisions about treatment.

"Based on the high-quality genomic pipeline developed by genomiQa’s founders, Dr Nic Waddell and John Pearson, the company is poised to become a world leader in whole-genome analytics, and further, establish a role for whole genome analysis in routine clinical practice," Mr Albert said

"I am delighted to join a world-recognised team that is dedicated to commercialising research that will make a difference to patients’ lives, and to support Australia’s biopharmaceutical industry in developing breakthrough, innovative products to treat cancer and other diseases."

The Chairman of the genomiQa board and Director and CEO of QIMR Berghofer Medical Research Institute, Professor Frank Gannon, said Mr Albert brought a rich and diverse set of skills, knowledge and business experience to the role.

"I am delighted to welcome Colin Albert as we enter a new and ambitious phase of the company," Professor Gannon said.

"Under his leadership, genomiQa will reach its goal of becoming a global leader in whole-genome data analysis, both in Australia and abroad.

"genomiQa has ambitious plans to expand into China in the next 12 months and to launch genomiQa:CapeXLTM – which will provide whole genome analysis for cancer patients – and genomiQa:NGSCheckTM – a quality check for the output from next generation sequencing machines – onto the global market.

"Mr Albert brings a great combination of skills, experience and business acumen, which will ensure that these goals are reached."

On August 7, 2018 XOMA Corporation (Nasdaq: XOMA), a pioneer in the discovery, development and licensing of therapeutic antibodies, reported its second quarter 2018 financial results (Press release, Xoma, AUG 7, 2018, View Source [SID1234528769]).

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"We continue to focus our efforts on expanding our portfolio of partner-funded programs through both acquisition and out-license activities," said Jim Neal, Chief Executive Officer at XOMA. "We believe we are well-positioned to execute on our royalty-aggregator strategy to create near- and long-term value for shareholders."

Financial Results
XOMA recorded total revenues of $2.3 million for the second quarter of 2018, $1.8 million of which was recognized under XOMA’s license agreement and common stock purchase agreement with Rezolute. In the second quarter of 2017, XOMA reported $10.9 million in revenue, $10.0 million of which was milestone revenue earned under one of the Company’s license agreements with Novartis.

Research and development (R&D) expenses were $0.4 million for the second quarter of 2018, compared to $2.9 million for the second quarter of 2017. The decrease in R&D expenses was due primarily to reductions of $1.0 million in clinical trial costs, $0.4 million in consulting costs, $0.4 million in the allocation of facilities costs, $0.4 million in external manufacturing activities, and $0.1 million in stock-based compensation. The significant reduction in R&D spending is a result of the discontinuation of clinical trial activities and the execution of the Company’s royalty-aggregator business model.

General and administrative (G&A) expenses were $4.4 million for the second quarter of 2018, compared to $5.2 million for the second quarter of 2017. The decrease in G&A expenses was due primarily to reductions of $0.9 million in stock-based compensation, $0.2 million in legal and accounting fees, and $0.1 million in information technology costs, partially offset by increases of $0.2 million in consulting services and $0.4 million in the allocation of facilities costs due to a greater proportion of G&A personnel after the Company’s restructuring activities.

The Company recorded a lease-related restructuring charge of $0.5 million in the second quarter of 2018, compared with $1.5 million for personnel-related restructuring expenses in the same period of 2017.

Total other income, net was $1.2 million for the second quarter of 2018, compared to other expense of $0.7 million for the second quarter of 2017. During the second quarter of 2018, we recorded $1.0 million in income from Ology Bioservices related to the disposition of our biodefense business in March 2016. Separately, we received long-term equity securities that consisted of an investment in Rezolute Inc.’s common stock under the terms of a licensing agreement. As of June 30, 2018, the fair value of the long-term equity securities had decreased, and we recognized a loss of $0.4 million.

Net loss for the second quarter of 2018 was $1.9 million, compared to net income of $0.3 million for the second quarter of 2017.

On June 30, 2018, XOMA had cash and cash equivalents of $38.7 million. The Company ended December 31, 2017, with cash and cash equivalents of $43.5 million. The Company’s current cash and cash equivalents are expected to be sufficient to fund its operations for multiple years.