AVEO Reports Third Quarter 2017 Financial Results and Provides Business Update

On November 7, 2017 AVEO Oncology (NASDAQ:AVEO) reported financial results for the third quarter ended September 30, 2017 and provided a business update (Press release, AVEO, NOV 7, 2017, View Source;p=RssLanding&cat=news&id=2314863 [SID1234521641]).

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"The third quarter was a transformative period for AVEO, with the achievement of significant milestones in each of the three pillars of our global strategy for tivozanib. Notably, with the European approval of tivozanib (FOTIVDA) in advanced RCC, we have transitioned from a development stage company to one with a commercially approved product, a watershed achievement for any emerging life sciences company," said Michael Bailey, president and chief executive officer of AVEO. "In addition, TIVO-3, our U.S. registration study, successfully passed the interim futility analysis with no changes to study protocol. Finally, we presented promising Phase 1 immunotherapy combination data from the Phase 1/2 TiNivo study of tivozanib and nivolumab (OPDIVO), and announced that EUSA Pharma, our European licensee for tivozanib, has opted into our combination development strategy."

Mr. Bailey continued, "In addition, we expect the imminent launch of tivozanib (FOTIVDA) in Europe, the anticipated readout of TIVO-3 in the first quarter of 2018 and Phase 2 data from TiNivo in the first half of 2018. Supporting these efforts, we have a balance sheet bolstered by recent milestone payments that could be extended by additional potential payments from EUSA related to reimbursement approval in EU5 countries, as well as double-digit royalty payments on net sales for tivozanib in Europe."

Recent Updates

Tivozanib (FOTIVDA) Approved in the European Union for the Treatment of Advanced Renal Cell Carcinoma (RCC). In August 2017, AVEO announced that the European Commission (EC) approved tivozanib (FOTIVDA) for the treatment of adult patients with RCC in the European Union plus Norway and Iceland. Tivozanib is indicated for the first line treatment of adult patients with advanced RCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.
Successfully Passed the TIVO-3 Futility Analysis with No Changes to Study Protocol. In October 2017, AVEO announced the completion of a pre-planned interim futility analysis of the Phase 3 TIVO-3 trial, the Company’s randomized, controlled, multi-center, open-label study to compare tivozanib (FOTIVDA) to sorafenib (NEXAVAR) in subjects with advanced RCC. Based on the results of the futility analysis, which were reviewed by an independent statistician, the study continued as planned without modification. The analysis did not allow for early stopping due to efficacy to assure adequate follow-up for the key secondary endpoint of overall survival. The Company continues to expect the TIVO-3 trial to read out in the first quarter of 2018. The TIVO-3 trial, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a potential regulatory approval of tivozanib in the U.S. as a first and third line treatment for RCC.
Phase 1 Results from the TiNivo Trial of Tivozanib and Nivolumab (OPDIVO) in RCC – Oral Presentation at the 16th International Kidney Cancer Symposium. On November 3, 2017 AVEO presented results from the Phase 1 portion of the Phase 1/2 TiNivo study at the 16th International Kidney Cancer Symposium. The oral presentation, titled "TiNivo: A Phase 1b Dose Escalation Trial of Tivozanib and Nivolumab in Renal Cell Carcinoma," was given by Laurence Albiges, M.D., Ph.D., Head, Genitourinary Unit, Institute Gustave Roussy, and a lead investigator of the study. The TiNivo trial is a Phase 1/2 multicenter trial of tivozanib (FOTIVDA) in combination with Bristol-Myers Squibb’s nivolumab (OPDIVO), an immune checkpoint, or PD-1, inhibitor, for the treatment of advanced renal cell carcinoma. The ongoing Phase 1 portion of the trial enrolled six patients, and demonstrated that the combination of tivozanib and nivolumab was well tolerated to the full dose and schedule of single agent tivozanib, with no dose limiting toxicities. The results also demonstrated promising early signs of potential efficacy, with 67% of patients demonstrating a partial response (PR), and a 100% disease control rate (PR + stable disease). Five out of six patients remain on study therapy. Enrollment of approximately 20 patients in the Phase 2 portion is ongoing. The trial is being led by the Institut Gustave Roussy in Paris under the direction of Bernard Escudier, MD, Chairman of the Genitourinary Oncology Committee.
TiNivo Combination Study Opt-in. In September 2017, AVEO announced that EUSA Pharma, under its multi-territory licensing agreement with AVEO for tivozanib (FOTIVDA), opted in to co-develop the Phase 1/2 TiNivo study and potential future combination studies in exchange for a research and development reimbursement payment totaling $2.0 million. Under terms of the agreement, EUSA will fund up to half of the Phase 1/2 TiNivo study, not to exceed $2.0 million, and may utilize data from study for regulatory or commercial purposes.
Receipt of Payments from EUSA Pharma and CANbridge. In September 2017, AVEO announced the receipt of a $4.0 million research and development reimbursement payment from EUSA Pharma related to the approval of tivozanib (FOTIVDA) for the treatment of adult patients with advanced RCC in Europe, and a $0.5 million milestone payment from CANbridge related to manufacturing development activities for AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate.
Third Quarter 2017 Financial Highlights

AVEO ended Q3 2017 with $37.4 million in cash, cash equivalents and marketable securities as compared with $23.3 million at December 31, 2016.
Total collaboration revenue was approximately $4.6 million in Q3 2017 compared with $1.0 million for Q3 2016.
Research and development expense was $4.7 million in Q3 2017 compared with $4.4 million for Q3 2016.
General and administrative expense was $2.1 million in Q3 2017 compared with $2.1 million for Q3 2016.
Net loss for Q3 2017 was $26.4 million, or a loss of $0.22 per basic and diluted share, compared with a net loss of $5.0 million, or a loss of $0.07 per basic and diluted share for Q3 2016. Approximately $23.5 million of the net loss was a non-cash loss attributable to the increase in the fair value of the warrant liability that was recorded in Q3 2017 that principally resulted from the increase in the stock price that occurred within the quarter. In Q3 2016, the non-cash gain attributable to fair value of the warrant liability was $1.2 million.
Updated Financial Guidance

We believe that our $37.4 million in cash resources would allow us to fund our planned operations into the fourth quarter of 2018. This estimate assumes no receipt of additional milestone or royalty payments from our partners or related payment of potential licensing milestones to third parties, no additional funding from new partnership agreements, no additional equity financings, no debt financings and no further sales of equity under our Sales Agreement with FBR or through the exercise of our outstanding PIPE Warrants. This estimate also assumes no acceleration in repayment of the term loan by Hercules in the event of non-compliance with the $10.0 million financial covenant.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). Tivozanib (FOTIVDA) is approved by the European Commission for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. For more information, please visit the company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words "anticipate," "believe," "expect," "intend," "may," "plan," "potential," "could," "should," "would," "seek," "look forward," "advance," "goal," "strategy," or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: clinical, regulatory and commercial plans of AVEO and its partner EUSA Pharma with respect to tivozanib (FOTIVDA); the expected timeline for reporting data from TIVO-3 and TiNivo; the role and expected benefits of tivozanib and other TKIs on a stand-alone basis, or in combination with or following immunotherapy; the expected enrollment of the TiNivo trial; expectations about the potential for additional payments by EUSA Pharma; the value of AVEO’s partnerships in advancing its pipeline; and AVEO’s strategy, prospects, plans and objectives, including as they pertain specifically to tivozanib. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to AVEO’s ability to enter into and maintain its third party collaboration agreements, and its ability, and the ability of its licensees and other partners, to achieve development and commercialization objectives under these arrangements; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including tivozanib. AVEO faces other risks relating to its business as well, including risks relating to its ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled "Risk Factors" and "Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources" included in AVEO’s Annual Report on Form 10-K for the year ended December 31, 2016, its quarterly reports on Form 10-Q and in other filings that AVEO may make with the SEC in the future. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date other than the date of this press release.

Myriad Genetics Reports Fiscal First-Quarter 2018 Financial Results

On November 7, 2017 Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal first-quarter 2018, provided an update on recent business highlights, maintained its fiscal year 2018 financial guidance, and issued fiscal second-quarter 2018 financial guidance (Press release, Myriad Genetics, NOV 7, 2017, View Source [SID1234521682]).

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"The first quarter exceeded our expectations and represented an excellent start to the fiscal year as a result of strong hereditary cancer and GeneSight test demand," said Mark C. Capone, president and CEO, Myriad Genetics. "Perhaps more importantly we had a number of significant reimbursement catalysts that strengthen our ability to deliver on our long-term financial goals."

Financial Highlights
The following table summarizes the financial results for the fiscal first-quarter 2018:

Revenue
Fiscal First-Quarter
($ in millions) 2018
2017
%
Change
Molecular diagnostic testing revenue

Hereditary cancer testing revenue $ 126.7 $ 139.3 (9 %)

GeneSight testing revenue 28.8 7.2 300 %

Vectra DA testing revenue 16.0 11.6 38 %

Prolaris testing revenue 2.9 2.9 0 %

EndoPredict testing revenue 1.9 1.7 12 %

Other testing revenue 2.5 2.4 4 %

Total molecular diagnostic testing revenue 178.8 165.1 8 %

Pharmaceutical and clinical service revenue 11.4 12.4 (8 %)

Total Revenue $ 190.2 $ 177.5 7 %

Income Statement
Fiscal First-Quarter
($ in millions) 2018
2017
%
Change
Total Revenue $ 190.2 $ 177.5 7 %

Gross Profit 147.2 137.5 7 %
Gross Margin 77.4 % 77.5 %

Operating Expenses 59.8 131.8 (55 %)

Operating Income 87.4 5.7 1433 %
Operating Margin 46.0 % 3.2 %

Adjusted Operating Income 24.7 21.6 14 %
Adjusted Operating Margin 13.0 % 12.2 %

Net Income 81.1 (1.2 ) NM

Diluted EPS 1.15 (0.02 ) NM

Adjusted EPS $ 0.26 $ 0.23 13 %

Business Highlights

• Hereditary Cancer

Exceeded three percent hereditary cancer volume target in the first quarter, and achieved the third straight quarter of volume growth with pricing in-line with expectations.
Launched riskScore, a new clinically validated personalized medicine tool to enhance the myRisk Hereditary Cancer test. riskScore quantifies a woman’s risk of developing breast cancer by combining genetic markers throughout the genome with her family and clinical history and represents a major new epoch in hereditary cancer testing.
Presented data at the National Society of Genetic Counselors demonstrating that in a cohort of 17,205 women, the riskScore single nucleotide polymorphism (SNP) panel was highly predictive of breast cancer risk with a p- value of less than 10-50.
The National Comprehensive Cancer Network (NCCN) updated their professional guidelines to include a recommendation that all metastatic prostate cancer patients receive hereditary cancer testing. There are approximately 26,000 men in the United States every year who develop metastatic prostate cancer.
• GeneSight

Achieved statistically significant improvement in the gold-standard outcomes of response and remission in 1,200 patient prospective randomized controlled trial.
Presented data from the IMPACT study at the World Congress of Psychiatric Genetics demonstrating that GeneSight statistically significantly improved anxiety symptom severity in 210 patients with generalized anxiety disorder. Anxiety symptoms based on the GAD-7 scale, improved 45 percent in patients receiving congruent therapy versus 26 percent for patients receiving non-congruent therapy. The result was statistically significant with a p-value of 0.03.
Presented MEDCO health economic data showing patients with generalized anxiety disorder who used GeneSight saved on average $6,747 in prescription costs with congruent versus non-congruent therapy selection.
• Vectra DA

Presented data at the American College of Rheumatology (ACR) meeting demonstrating that Vectra DA was four times better at predicting radiographic progression compared to DAS28 and other conventional measures of disease activity.
Presented new clinical utility data from 60,596 patients demonstrating that physicians use Vectra DA scores to change treatment decisions appropriately. The study found that in patients who were naive to biologics, rheumatologists were 118 percent more likely to recommend a biologic for patients with a high Vectra DA score when compared to patients with a low Vectra DA score. For patients already on a biologic, rheumatologists were 158 percent more likely to change therapy on patients with high Vectra DA scores compared to those with low Vectra DA scores.
Signed coverage with evidence development agreement with CareFirst BlueCross BlueShield, the 18th largest commercial payer in the United States.
• EndoPredict

Presented new data at the World Congress on Controversies in Breast Cancer. In a study of 387 women determined to be at intermediate risk by the Nottingham Prognostic Index, EndoPredict markedly outperformed the first generation test with two times the prognostic power. Additionally, in this patient cohort EndoPredict was the only test that was statistically significant for predicting late stage recurrence (5-10 years).
• Companion Diagnostics

Submitted a supplemental PMA for BRACAnalysis CDx in conjunction with AstraZeneca’s Lynparza submission for HER2- metastatic breast cancer with approval expected in the fiscal third quarter.
UnitedHealthcare recently updated its hereditary breast and ovarian cancer coverage policy to include coverage for all metastatic breast cancer patients based upon the need to evaluate these patients for PARP inhibitor therapy.
• International

Signed the company’s first payer demonstration study with GeneSight in Canada with Sun Life Financial, the largest private health insurer in Canada. The study will evaluate the ability of GeneSight to improve both clinical and health economic outcomes in patients with anxiety and depression.
Submitted BRACAnalysis CDx in Japan for review by the Pharmaceutical Medical Devices Agency (PMDA) and marketing approval by Ministry of Health, Labor and Welfare as a companion diagnostic to olaparib for use in HER2- metastatic breast cancer patients.
Fiscal Year 2018 and Fiscal Second-Quarter 2018 Financial Guidance
Below is a table summarizing Myriad’s fiscal year 2018 and fiscal second-quarter 2018 financial guidance:


Revenue GAAP Diluted
Earnings Per
Share Adjusted
Earnings Per
Share
Fiscal Year 2018 $750-$770
million $1.41-$1.46 $1.00-$1.05

Fiscal Second-Quarter 2018 $187-$189
million $0.08-$0.10 $0.22-$0.24

These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The Company will provide further details on its business outlook during the conference call today to discuss the fiscal first-quarter financial results, fiscal year 2018 financial guidance, and fiscal second-quarter 2018 financial guidance.

Conference Call and Webcast
A conference call will be held today, Tuesday, November 7, 2017, at 4:30 p.m. EST to discuss Myriad’s financial results for the fiscal first-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-701-6414. International callers may dial 1-303-223-4376. All callers will be asked to reference reservation number 21859999. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.

DelMar Pharmaceuticals Appoints Saiid Zarrabian as Interim Chief Executive Officer

On November 7, 2017 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" and "the Company"), a biopharmaceutical company focused on the development of new cancer therapies, reported the appointment of Mr. Saiid Zarrabian as interim Chief Executive Officer (Press release, DelMar Pharmaceuticals, NOV 7, 2017, View Source [SID1234521675]).

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"DelMar is pleased to welcome Mr. Zarrabian as interim CEO at an important time for our company," said Dr. Erich Mohr, DelMar’s Chairman of the Board. "Saiid’s experience in overseeing the growth of multiple companies will augment DelMar’s management as we continue to transition to a late-stage development company and seek additional opportunities to maximize shareholder value."

Jeffrey Bacha, cofounder of DelMar, will continue in his senior management role as President and in the newly created position of Chief Operating Officer (COO). Both Mr. Zarrabian and Mr. Bacha will continue to serve on the Company’s Board of Directors.

"I am delighted to accept the position of interim CEO and to work with Jeffrey and the DelMar team as well as with Erich and the Board with the goal of creating value for our shareholders, said Mr. Zarrabian. "DelMar has successfully advanced VAL-083 into a pivotal clinical trial and has established several additional opportunities that we believe can create significant value in the treatment of multiple cancer indications. I look forward to leading the company at this critical time and to contributing to the success of DelMar."

Saiid Zarrabian joined the DelMar Board of Directors in July, 2017. Mr. Zarrabian is a highly successful industry veteran. He is currently serving as an advisor to Redline Capital Partners, S.A., a Luxemburg-based investment firm. Mr. Zarrabian has previously served as Chairman and member of the board of directors of La Jolla Pharmaceutical Company during the company’s transition from an OTC listed company to a NASDAQ listed company. He also served as President of the Protein Production Division of Intrexon Corporation, a synthetic biology company. Prior to that, he served as Chief Executive Officer and a member of the board of directors of Cyntellect, Inc., a stem cell processing and visualization Instrumentation company until it’s sale in 2012. He has previously served as President and Chief Operating Officer of Senomyx, Inc., a company focused on discovery and commercialization of new flavor ingredients, and as Chief Operating Officer of Pharmacopeia, Inc., a former publicly-traded provider of combinatorial chemistry discovery services and compounds, where he also served as President and Chief Operating Officer of its MSI Division. In addition, Mr. Zarrabian has served on numerous private and public company boards, including at Immune Therapeutics, Inc.; Exemplar Pharma, LLC; Ambit Biosciences Corporation; eMolecules, Inc.; and Penwest Pharmaceuticals CO.

10-Q – Quarterly report [Sections 13 or 15(d)]

Alnylam has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Alnylam, 2017, NOV 7, 2017, View Source [SID1234521660]).

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10-Q – Quarterly report [Sections 13 or 15(d)]

Nektar Therapeutics has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Nektar Therapeutics, 2017, NOV 7, 2017, View Source [SID1234521728]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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