On August 1, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $102.9 million and completed approximately 215,000 Cologuard tests during the quarter ended June 30, 2018 (Press release, Exact Sciences, AUG 1, 2018, View Source [SID1234528655]). Second-quarter 2018 revenue and Cologuard test volume grew by 78 percent and 59 percent, respectively, from the same period of 2017.

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"We are excited about the continued growth of our physician ordering base, as well as their increasing Cologuard utilization, which led to a record quarter for revenue, volume and gross profit," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are optimistic about the company’s future, including the opportunity to expand Cologuard’s label to reach even more people in the 45 to 49 age group, given the American Cancer Society’s recent guideline update."

Second-Quarter 2018 Financial Results

For the three-month period ended June 30, 2018, as compared to the same period of 2017 (where applicable):

· Revenue was $102.9 million, an increase of 78 percent, and test volume was 215,000, an increase of 59 percent

· Average recognized revenue per test was $479, an improvement of 12 percent

· Average cost per test was $125, an improvement of 6 percent

· Gross margin was 74 percent, an increase of 510 basis points

· Operating expenses were $108.7 million, an increase of 53 percent

· Net loss was $36.4 million or $0.30 per share, compared to $30.8 million or $0.27 per share

· Non-cash interest expense related to convertible debt was $6.7 million, or $0.05 per share

· Cash utilization was $45.3 million, compared to $43.9 million

· Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter

· More than 10,000 healthcare providers ordered their first Cologuard test during the second quarter, and nearly 121,000 have ordered since the test was launched

2018 Outlook

· The company continues to anticipate revenue of $420-$430 million for 2018

The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

Second-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Wednesday, Aug. 1, 2018, at 5 p.m. ET to discuss second-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4260268. The webcast, conference call and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy.

Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On August 1, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported financial and operating results for the second quarter ended June 30, 2018 and provided a business update (Press release, Ophthotech, AUG 1, 2018, View Source [SID1234528287]).

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"During the first half of the year, we continued implementing our strategy to broaden and advance our ophthalmic portfolio as we enter the emerging field of gene therapy by securing collaborations with three leading academic institutions, and continued advancing our therapeutic portfolio with Zimura," stated Glenn P. Sblendorio, Chief Executive Officer and President of Ophthotech. "Looking ahead to the remainder of 2018, we expect to report data for our Phase 2a clinical trial for Zimura combination therapy with anti-VEGF in wet-age related macular degeneration (AMD), complete recruitment for our Phase 2b clinical trial for Zimura monotherapy in geographic atrophy secondary to dry AMD and potentially enter into new opportunities to further expand our portfolio in both therapeutics and gene therapies for retinal diseases."

First Half 2018: Key Highlights

Zimura Complement Factor C5 Inhibitor Program

In April 2018, the Company completed patient recruitment in its randomized, dose-ranging, open-label, uncontrolled, multi-center Phase 2a clinical trial of Zimura (avacincaptad pegol) in combination with the anti-vascular endothelial growth factor (anti-VEGF) agent Lucentis (ranibizumab) in patients with wet age-related macular degeneration (AMD) who have not been previously treated with anti-VEGF therapies. This trial is designed to assess the safety of Zimura combination therapy at different dosages and to detect a potential efficacy signal. Data will be evaluated at month six and initial top-line data is expected to be available by the end of 2018.
Patient recruitment for the Company’s ongoing randomized, double-masked, sham controlled, multi-center Phase 2b clinical trial of Zimura for the treatment of geographic atrophy secondary to dry AMD is on track. The Company expects to complete recruitment in the third quarter of this year with initial top-line data expected to be available during the second half of 2019.
In January 2018, the Company started enrolling patients in a Phase 2b randomized, double-masked, sham-controlled, multi-center clinical trial assessing the efficacy and safety of Zimura in patients with autosomal recessive Stargardt disease (STGD1). Initial top-line data is expected to be available in 2020.
Gene Therapy Programs

The Company has initiated an innovative gene therapy program focused on applying novel gene therapy technology to discover and develop new therapies for ocular diseases.
In June 2018, the Company entered into an exclusive global license agreement with the University of Florida Research Foundation, Incorporated and the Trustees of the University of Pennsylvania (Penn) for rights to develop and commercialize a novel adeno-associated virus gene therapy product candidate for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (RHO-adRP), an orphan monogenic disease. The construct for the RHO-adRP product candidate combines a transgene expressing a highly efficient novel short hairpin RNA (shRNA) designed to target and knock-down endogenous rhodopsin (RHO) in a mutation-independent manner with a human RHO replacement transgene made resistant to RNA interference, in a single adeno-associated viral (AAV 2/5) vector. Ophthotech and Penn have also entered into a master sponsored research agreement, facilitated by the Penn Center for Innovation, pursuant to which Ophthotech and Penn plan to conduct natural history studies in RHO-adRP patients and additional preclinical studies. In parallel with the sponsored research, Ophthotech plans to commence IND-enabling activities. Based on current timelines and subject to regulatory review, Ophthotech expects to initiate a Phase 1/2 clinical trial in RHO-adRP in 2020.
In February 2018, the Company entered into a series of sponsored research agreements with the University of Massachusetts Medical School (UMMS) and its Horae Gene Therapy Center to utilize their next generation "minigene" therapy approach for the potential treatment of orphan degenerative retinal diseases such as Leber Congenital Amaurosis (LCA) type 10 due to CEP290 mutations (the most common type of LCA), and autosomal recessive Stargardt disease (STGD1) due to ABCA4 mutations. Further, the Company and UMMS are also evaluating novel gene delivery methods to target retinal diseases. UMMS has granted Ophthotech an option to obtain an exclusive license to any patent or patent applications that result from this research.
2018 Operational Update

As of June 30, 2018, the Company had $146 million in cash and cash equivalents. The Company estimates that its year end 2018 cash and cash equivalents will range between $112 million and $117 million based on its current 2018 business plan and planned capital expenditures. This estimate includes continuation of the Company’s development programs for Zimura and RHO-adRP gene therapy product candidate and the continuation of the Company’s collaborative gene therapy research programs as currently planned.

This estimate does not reflect any additional expenditures resulting from the potential in-licensing or acquisition of additional product candidates or technologies or associated development that the Company may pursue.

2018 Financial Highlights

Revenues: The Company did not have any collaboration revenue for the quarter and six months ended June 30, 2018, compared to $1.7 million and $3.3 million for the same periods in 2017. Collaboration revenue decreased due to the completion of the Company’s deliverables under its previous licensing and commercialization agreement with Novartis Pharma AG and the recognition of all associated deferred revenue during the third quarter of 2017.
R&D Expenses: Research and development expenses were $8.5 million for the quarter ended June 30, 2018, compared to $15.7 million for the same period in 2017. For the six months ended June 30, 2018, research and development expenses were $16.2 million compared to $47.6 million for 2017. As the Company pursues its ongoing and planned Zimura and gene therapy development programs, research and development expenses decreased primarily due to decreases in expenses related to the discontinuation of the Company’s FovistaPhase 3 clinical program and decreases in costs associated with the Company’s 2017 reduction in personnel program.
G&A Expenses: General and administrative expenses were $6.3 million for the quarter ended June 30, 2018, compared to $8.6 million for the same period in 2017. For the six months ended June 30, 2018, general and administrative expenses were $12.0 million compared to $21.7 million for 2017. General and administrative expenses decreased primarily due to decreases in costs to support the Company’s operations and infrastructure and decreases in costs associated with its 2017 reduction in personnel program, which includes facilities lease termination expenses incurred during the first quarter of 2017.
Net Loss: The Company reported a net loss for the quarter ended June 30, 2018 of $13.2 million, or ($0.37) per diluted share, compared to a net loss of $22.2 million, or ($0.62) per diluted share, for the same period in 2017. For the six months ended June 30, 2018, the Company reported a net loss of $26.3 million, or ($0.73) per diluted share, compared to a net loss of $65.3 million, or ($1.82) per diluted share, for the same period in 2017.
Conference Call/Web Cast Information

Ophthotech will host a conference call/webcast to discuss the Company’s financial and operating results and provide a business update. The call is scheduled for August 1, 2018 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2597 (International), passcode 3698278. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 3698278.

On August 1, 2018 AVEO Oncology (NASDAQ: AVEO) reported that Michael Bailey, president and chief executive officer, will present at the Canaccord Genuity 38th Annual Growth Conference in Boston on Wednesday, August 8, 2018 at 4:30 p.m. Eastern Time (Press release, AVEO, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361232 [SID1234528350]).

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A live webcast of the presentation can be accessed by visiting the investors section of the Company’s website at www.aveooncology.com. A replay of the webcast will be archived for 30 days following the presentation date.

On August 1, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to quizartinib, an investigational FLT3 inhibitor, for the treatment of adult patients with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML) (Press release, Daiichi Sankyo, AUG 1, 2018, View Source [SID1234528390]).

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"There have been limited advances over the past several decades for the treatment of relapsed/refractory FLT3-ITD AML, a very aggressive form of the disease associated with poor prognosis. Quizartinib is the first FLT3 inhibitor to significantly improve overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory AML with FLT3-ITD, an underlying driver of this subtype of AML," said Arnaud Lesegretain, Vice President, Oncology Research and Development and Head, AML Franchise, Daiichi Sankyo. "We are excited that quizartinib has received Breakthrough Therapy designation and we look forward to working closely with the FDA to bring this potential new treatment option to patients as quickly as possible."

Breakthrough Therapy designation is designed to expedite the development and regulatory review of medicines that may demonstrate substantial benefit over currently approved treatments, in order to more quickly bring new treatment options to patients with serious diseases. Significant unmet medical need exists in relapsed/refractory AML, as available treatment options are limited and there are no approved targeted therapies for patients with relapsed/refractory FLT3-ITD AML.

The designation was granted based on the results of the pivotal phase 3 QuANTUM-R study of quizartinib, which were presented during the plenary program at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) in June 2018. QuANTUM-R is the first randomized phase 3 study to show that a FLT3 inhibitor, quizartinib, prolongs overall survival as an oral, single agent compared to chemotherapy in patients with relapsed/refractory FLT3-ITD AML.

The safety profile observed in QuANTUM-R appears consistent with that observed at similar doses in the quizartinib clinical development program. Incidence of treatment-emergent adverse events was comparable between patients who received single agent quizartinib (n=241) and those who received salvage chemotherapy (n=94). The most common adverse events (>30 percent, any Grade) in patients treated with quizartinib included nausea, thrombocytopenia, fatigue, musculoskeletal pain, pyrexia, anemia, neutropenia, febrile neutropenia, vomiting and hypokalemia.

About Quizartinib
Quizartinib, the lead investigational agent in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, is an oral selective FLT3 inhibitor currently in phase 3 development for relapsed/refractory (QuANTUM-R) and newly-diagnosed (QuANTUM-First) FLT3-ITD AML in the U.S., EU and Japan, and phase 2 development for relapsed/refractory FLT3-ITD AML in Japan.

In addition to Breakthrough Therapy designation, quizartinib has been granted Fast Track designation by the FDA for the treatment of relapsed/refractory AML. Quizartinib also has been granted Orphan Drug designation by both the FDA and the European Medicines Agency (EMA) for the treatment of AML. Quizartinib is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About FLT3-ITD Acute Myeloid Leukemia
AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.1 In the U.S. this year, it is estimated that there will be more than 19,000 new diagnoses of AML and more than 10,000 deaths from AML.2 The five-year survival rate of AML reported from 2005 to 2011 was approximately 26 percent, which was the lowest of all leukemias.1

FLT3 gene mutations are one of the most common genetic abnormalities in AML.3 FLT3-ITD is the most common FLT3 mutation, affecting approximately one in four patients with AML.4,5,6,7 Patients with FLT3-ITD AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse and a higher likelihood of relapse following hematopoietic stem cell transplantation as compared to those without this mutation.8,9

On August 1, 2018 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it will host a second quarter 2018 investor call on Thursday, August 9, 2018 at 8:00 AM (EDT) to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, AUG 1, 2018, View Source [SID1234528288]).

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To access the call, participants may dial 877-407-8920 (US & Canada) or 412-902-1010 (International) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing 877-660-6853 (Toll Free US & Canada) or 201-612-7415 (International) and providing the Conference ID #13661472.