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 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended June 30, 2018 (Press release, Vical, AUG 7, 2018, View Source [SID1234528485]). Net loss for the second quarter of 2018 was $4.9 million, or $0.22 per share, compared with a net loss of $3.3 million, or $0.30 per share, for the second quarter of 2017. Revenues for the second quarter of 2018 were $0.7 million, compared with revenues of $3.4 million for the second quarter of 2017, reflecting a decline in revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements.

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Vical recently announced plans to explore a range of strategic options to enhance shareholder value. The company retained MTS Health Partners, L.P. to assist in the strategic review process. There is no set timetable for the review process and there can be no assurance that the process will result in a transaction.

Vical had cash and investments of $54.3 million at June 30, 2018. The Company’s cash burn for the second quarter of 2018 was $4.0 million, which was consistent with the Company’s full year 2018 guidance of between $20 million and $24 million. The Company anticipates ending 2018 with a minimum of $40 million, which, in the absence of a strategic transaction, Vical believes to be sufficient to fund operations through the announcement of top-line data from its Phase 2 clinical trial of VL-2397, expected in 2020.

Program updates include:

VL-2397 Antifungal Candidate

The multinational Phase 2 registration trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant is ongoing (ClinicalTrials.gov Identifier: NCT03327727). Vical expects to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals.
VR-CHB01 Hepatitis B Virus (HBV) Therapeutic Candidate

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. The Company expects to complete the initial stage of preclinical development in the fourth quarter of 2018.

On August 7, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes reported financial results for the quarter ended June 30, 2018 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 7, 2018, View Source [SID1234528484]).

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"The second half of 2018 promises to be an important time for Syros," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Over the next several months, we plan to report initial clinical data from our Phase 2 trial evaluating the safety and efficacy of SY-1425 in combination with standard-of-care and targeted agents in genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome. We plan to open expansion cohorts in the ongoing Phase 1 trial of SY-1365 in multiple patient populations with ovarian and breast cancers, as well as report data from the dose-escalation portion of the trial. Notably, we expect this to be the first-ever reported human clinical data on a selective inhibitor of CDK7, which is gaining increased recognition as an important new drug target in oncology. Together, we believe these clinical results will provide important insights into these programs and hopefully bring us closer to our vision of translating our leadership in gene control into medicines that provide profound benefit for patients."

Upcoming Milestones

Syros plans to report initial clinical data in the fourth quarter of 2018 from cohorts in its Phase 2 trial evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive patients with relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS).
Syros plans to open expansion cohorts in the fall of 2018 in its Phase 1 trial of SY-1365. These expansion cohorts will evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple patient populations with ovarian and breast cancers.
Syros plans to report clinical data in the fourth quarter of 2018 from the dose escalation portion of its Phase 1 trial of SY-1365 in patients with advanced solid tumors.
Syros plans to select a new development candidate from its preclinical pipeline by the end of 2018.
Recent Pipeline Highlights

In July 2018, the European Medicines Agency (EMA) granted SY-1425 orphan drug designation for the treatment of AML. The EMA orphan drug designation is granted to medicines being developed for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition with a prevalence of not more than five in 10,000 people in the European Community. EMA orphan drug designation benefits include protocol assistance, access to the EU centralized authorization procedure, reduced EU regulatory filing fees and 10 years of market exclusivity.
In June 2018, Syros presented on the design of its Phase 1 clinical trial of SY-1365 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Based on preclinical data, which showed robust anti-tumor activity in ovarian and breast cancers, Syros designed the expansion phase of its trial to initially focus on these tumors. Expansion cohorts will evaluate the safety, tolerability and preliminary clinical activity of SY-1365 in:
Three ovarian cancer patient populations in earlier- and later-stages of disease, as either a single agent or in combination with carboplatin;
Hormone receptor-positive, CDK4/6 inhibitor-resistant breast cancer patients, in combination with fulvestrant;
Patients with solid tumors of any histology to evaluate pharmacodynamic endpoints and measures of biological activity in paired tumor biopsies.
Recent Corporate Highlights

In June 2018, Syros announced the appointment of Michael W. Bonney, Chief Executive Officer of Kaleido Biosciences, to its Board of Directors.
Second Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2018 were $124.4 million, compared with $72 million on December 31, 2017. During the second quarter, Syros sold $16.6 million in common stock under its at-the-market sales facility.

For the second quarter 2018, Syros reported a net loss of $14 million, or $0.43 per share, compared to a net loss of $13.4 million, or $0.52 per share, for the same period in 2017.

Revenues were $0.4 million for the second quarter of 2018, which relate entirely to Syros’ collaboration with Incyte. Syros did not record revenues in the second quarter of 2017.
Research and development (R&D) expenses were $11.1 million for the second quarter of 2018, as compared to $10 million for the same period in 2017. This increase was primarily attributable to an increase in costs associated with Syros’ Phase 1 clinical trial of SY-1365 and increased headcount.
General and administrative (G&A) expenses were $3.8 million for the second quarter of 2018, as compared to $3.5 million for the same period in 2017. This increase was primarily attributable to an increase in employee-related costs.
Financial Guidance

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2020.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing (866) 595-4538 for domestic callers or (636) 812-6496 for international callers and referencing conference ID number: 8675009. A live webcast of the conference call will be available online on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 90 days.

On August 7, 2018 TG Therapeutics, Inc. (NASDAQ: TGTX) reported its financial results for the second quarter ended June 30, 2018 and recent company developments (Press release, Manhattan Pharmaceuticals, AUG 7, 2018, View Source [SID1234528482]).

Michael S. Weiss, the Company’s Executive Chairman and Chief Executive Officer, stated, "We are extremely pleased with the progress made in the first half of 2018 and believe we have many value creating milestones achievable in the near future. This morning’s announcement of complete target enrollment in the ULTIMATE I & II Phase 3 trials in MS well ahead of our projections, similar to the rapid enrollment we had seen in our UNITY-CLL Phase 3 trial, reinforces our belief in the great need for our product candidates." Mr. Weiss continued, "We believe TG has never been better positioned for success and look forward to an impactful remainder of the year, and importantly the announcement of topline overall response rate data from the UNITY-CLL Phase 3 trial before the end of the summer."

Recent Developments and Highlights

ULTIMATE I & II: Completed target enrollment into the ULTIMATE I & II Phase 3 trials in Multiple Sclerosis (MS).
Anti-CD47/CD19 License: Entered into an exclusive global license agreement with Novimmune SA to collaborate on the development and commercialization of Novimmune’s novel first-in-class anti-CD47/anti-CD19 bispecific antibody known as TG-1801 (previously NI-1701).
Ublituximab Data in Multiple Sclerosis: Presented updated clinical data from the Phase 2 trial of ublituximab in RMS at the 4th Congress of European Academy of Neurology Meeting.
TG-1701 Preclinical Data: Presented the first preclinical data presentation of TG-1701, the Company’s orally available and covalently-bound BTK inhibitor, at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).
Umbralisib Data in CLL Patients Intolerant to Prior BTK/PI3K: Presented clinical data from the Phase 2 trial of umbralisib in CLL Patients Intolerant to Prior BTK or PI3K Delta Inhibitor Therapy at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and at the 23rd Congress of the EHA (Free EHA Whitepaper).
Umbralisib plus Ruxolitinib Data in Patients with Myelofibrosis: Presented updated clinical data from its ongoing Phase I study evaluating umbralisib with ruxolitinib, the JAK 1/2 inhibitor, in ruxolitinib experienced patients with myelofibrosis at the 23rd Annual EHA (Free EHA Whitepaper) Congress.
Umbralisib Safety Data: Presented an integrated analysis of long term safety data of umbralisib, either dosed as a single agent and in combination, in patients with relapsed or refractory lymphoid malignancies at the 23rd Annual EHA (Free EHA Whitepaper) Congress.
Chief Commercial Officer: Announced the hiring of Adam Waldman, former Celgene executive, as our Chief Commercial Officer.

Key Remaining 2018 Milestones

Present top-line overall response rate results from our UNITY-CLL Phase 3 trial in front line and relapsed or refractory Chronic Lymphocytic Leukemia (CLL).
Prepare and potentially file the Company’s first BLA and/or NDA.
Complete enrollment in the current arms of the UNITY-NHL trial, including the Follicular Lymphoma, Marginal Zone Lymphoma, and Diffuse Large B-Cell Lymphoma cohorts.
Present updated clinical data from ongoing oncology trials and final results from the Phase 2 trial of ublituximab in Multiple Sclerosis (MS) at major medical meetings during 2018.

Financial Results for the Second Quarter 2018

Cash Position: Cash, cash equivalents, investment securities, and interest receivable were $126.3 million as of June 30, 2018.

R&D Expenses: Research and development (R&D) expenses were $38.7 million and $73.7 million for the three and six months ended June 30, 2018, respectively, compared to $26.7 million and $49.4 million for the three and six months ended June 30, 2017. The increase in R&D expense is primarily attributable to an increase in clinical trial expenses of $10.0 million and $15.7 million, respectively during the three and six months ended June 30, 2018, as compared to prior periods. In addition, included in R&D expenses for the three and six months ended June 30, 2018 are $1.8 million and $11.4 million, respectively, of manufacturing and CMC expenses for Phase 3 clinical trials and potential commercialization. Also included in R&D expense for the six months ended June 30, 2018 was $4 million ($3 million of which was recorded in the three months ended June 30, 2018) of non-cash stock expense recorded in conjunction with the licenses to the BTK and CD47/CD19 programs.

G&A Expenses: General and administrative (G&A) expenses were $5.7 million and $12.3 million for the three and six months ended June 30, 2018, respectively, as compared to $1.8 million and $6.8 million for the three and six months ended June 30, 2017. The increase in G&A expenses for the three and six months ended June 30, 2018 relates primarily to non-cash compensation expenses related to equity incentive expense recognized during the three and six months ended June 30, 2018.

Net Loss: Net loss was $44.1 million and $85.7 million for the three and six months ended June 30, 2018, respectively, compared to a net loss of $28.4 million and $56.1 million for the three and six months ended June 30, 2017, respectively. Excluding non-cash items, the net loss for the three and six months ended June 30, 2018 was approximately $36.9 million and $70.1 million.

Financial Guidance: Net cash utilized for operating activities during the six months ended 2018 was approximately $62.2 million. The Company believes its cash, cash equivalents, investment securities, and interest receivable on hand as of June 30, 2018 will be sufficient to fund the Company’s planned operations into the second half of 2019.

Conference Call Information

The Company will host an investor conference call today, August 7, 2018, at 4:30pm ET, to discuss the Company’s second quarter 2018 financial results and provide a business outlook for the remainder of 2018.

In order to participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics Second Quarter 2018 Earnings Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.

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On August 7, 2018 AVEO Oncology (NASDAQ: AVEO) reported financial results for the second quarter ended June 30, 2018 and provided a business update (Press release, AVEO, AUG 7, 2018, View Source [SID1234528477]).

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"Our U.S. registration strategy remains a key focus for AVEO, with topline readout of the Phase 3 TIVO-3 study expected in the fourth quarter of this year," said Michael Bailey, president and chief executive officer of AVEO. "TIVO-3 is the first randomized Phase 3 study in advanced kidney cancer to stratify for prior immunotherapy and, as a result, it has the potential to serve as a benchmark study for the sequencing of therapies in advanced disease."

Mr. Bailey added: "The next two pillars of our tivozanib strategy also continue to make progress. The recent launch of FOTIVDA in Scotland adds to ongoing commercial efforts in Germany, the U.K., and Austria by our partner EUSA Pharma. We anticipate additional potential reimbursement approvals for France, Germany, Italy, and Spain in the coming months, triggering up to $8 million in milestone payments due to AVEO in addition to double-digit royalty payments on net sales of FOTIVDA in Europe. EUSA has the option to access TIVO-3 data in the event of a positive outcome in exchange for a $20 million R&D reimbursement payment to AVEO. Finally, we look forward to presenting additional data at the ESMO (Free ESMO Whitepaper) meeting in October from the Phase 2 portion of the TiNivo study of tivozanib and nivolumab (OPDIVO) in aRCC, a study which to date has demonstrated promising activity and a favorable safety profile."

Tivozanib TIVO-3 Study North America Update

Topline Data from Phase 3 TIVO-3 Study Anticipated in the Fourth Quarter of 2018. As previously announced, the Company expects to report topline results from the TIVO-3 study, AVEO’s Phase 3 trial of tivozanib as a third-line treatment for advanced renal cell carcinoma (aRCC), in the fourth quarter of 2018, approximately 6-8 weeks after the trial records 255 progression free survival (PFS) events. AVEO plans to announce when 255 PFS events have occurred and the topline data analysis for the trial has been initiated. Together with the TIVO-1 study, TIVO-3 is designed to serve as the basis for a potential U.S. approval of tivozanib (FOTIVDA) as a first- and third-line treatment for aRCC.

Tivozanib (FOTIVDA) European Union Updates

Tivozanib (FOTIVDA) Launched in Scotland for the Treatment of aRCC. In July 2018, FOTIVDA was launched in Scotland for the first-line treatment of adult patients with aRCC after the Scottish Medicines Consortium approved its use. FOTIVDA is now available in Germany, Scotland, the U.K., and Austria. FOTIVDA was granted European

Medicines Association approval in August 2017 for the treatment of adult patients with aRCC in the European Union plus Norway and Iceland.

Tivozanib (FOTIVDA) Expanded Access Program Launched in Italy. In July 2018, The Program of Therapeutic Use Tivozanib (Expanded Access Program) for renal cell carcinoma (RCC) was initiated, allowing patients in Italy to have access to tivozanib as front-line therapy. In addition, EUSA pharma is effecting the reimbursement procedure with the Italian Drug Agency (AIFA), a process which is expected to be finalized in the coming months.

Additional Tivozanib Updates

Updated Phase 2 Results from the TiNivo Trial of Tivozanib and Nivolumab (OPDIVO) in aRCC to be Presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting. Updated Phase 2 data from the Phase 1b/2 TiNivo study of tivozanib in combination with nivolumab (OPDIVO, Bristol-Myers Squibb), an immune checkpoint, or PD-1, inhibitor, will be presented at the 2018 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Munich. The data will be presented during a poster presentation titled, "TiNivo: Tivozanib combined with nivolumab: safety and efficacy in patients with metastatic renal cell carcinoma (mRCC)" (Presentation Number 878P). Previously presented results support the potential advantages of a combination therapy using a high-specificity VEGF inhibitor TKI in connection with an immune checkpoint therapy in renal cancer.

Ficlatuzumab Update

Trials in Progress Poster for Phase 2 Study of Ficlatuzumab in Combination with Cetuximab in HNSCC to be Presented at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting. Data from an ongoing, investigator-sponsored Phase 2 trial of ficlatuzumab and cetuximab (ERBITUX), an EGFR-targeted antibody, in patients with cetuximab-resistant, metastatic head and neck squamous cell carcinoma (HNSCC) will be presented as a trials in progress poster at the 2018 ESMO (Free ESMO Whitepaper) Annual Meeting (Presentation Number 1124TiP). This randomized multi-center study, which is being conducted under the direction of Julie E. Bauman, MD, MPH, Professor of Medicine, Chief, Division of Hematology/Oncology, Associate Director of Translational Research, University of Arizona Cancer Center, is expected to enroll approximately 60 patients randomized to receive either ficlatuzumab alone or ficlatuzumab and cetuximab.

Trials in Progress Poster for Phase 1b Study of Ficlatuzumab in Combination with Gemcitabine and Nab-paclitaxel in Pancreatic Cancer Presented at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting. Data from an ongoing, investigator-sponsored Phase 1b study to test the safety and tolerability of ficlatuzumab when combined with nab-paclitaxel and gemcitabine in previously untreated metastatic pancreatic ductal cancer (PDAC) was presented as a trials in progress poster (Poster Board: #330b, Abstract TPS4152) at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL in June 2018. The study, which is being conducted under the direction of Kimberly Perez,

MD at the Dana-Farber Cancer Institute, is currently enrolling, with an expected total enrollment of approximately 30 patients.

Corporate Update

Added to the Russell 2000, Russell 3000, and Russell Microcap Indexes. In June 2018, AVEO announced that it had been added to the Russell 2000, Russell 3000, and Russell Microcap Indexes as part of FTSE’s annual reconstitution. Russell U.S. Indexes are widely used by investment managers and institutional investors as the basis for index funds and as benchmarks for active investment strategies. Approximately $9 trillion in assets are benchmarked against Russell U.S. Indexes.

Second Quarter 2018 Financial Highlights

AVEO ended Q2 2018 with $18.1 million in cash, cash equivalents and marketable securities as compared with $33.5 million at December 31, 2017.

Total revenue for Q2 2018 was approximately $0.4 million compared with $0.4 million for Q2 2017.

Research and development expense for Q2 2018 was $4.9 million compared with $6.9 million for Q2 2017.

General and administrative expense for Q2 2018 was $2.8 million compared with $2.3 million for Q2 2017.

Net income for Q2 2018 was $4.0 million, or income of $0.03 per basic share and a loss of $0.06 per diluted share, compared with net loss of $33.3 million for Q2 2017, or a loss of $0.30 per basic and diluted share. Approximately $11.1 million of Q2 2018 net income was a non-cash gain attributable to the decrease in the fair value of the 2016 private placement warrant liability that principally resulted from the decrease in the stock price that occurred within the quarter. In Q2 2017, the non-cash loss attributable to the increase in the fair value of such warrant liability was $23.9 million.

Financial Guidance

We believe that our $18.1 million in cash resources would allow us to fund our planned operations into the first quarter of 2019. This estimate assumes no receipt of additional milestones from our partners, no additional funding from new partnership agreements, no additional equity or debt financings, and no sales of equity through the exercise of our outstanding warrants issued in connection with our 2016 private placement or outstanding warrants issued in connection with the recent settlement of our securities class action litigation.