On August 7, 2018 Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK), a clinical-stage oncology company focused on biomarker-defined cancers, reported its second quarter 2018 financial results for the period ended June 30, 2018 (Press release, Merrimack, AUG 7, 2018, View Source [SID1234528764]).

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"A cornerstone of Merrimack’s approach to drug development is our commitment to test targeted therapies in biomarker-enriched patient populations, resulting in smaller, shorter and more personalized studies that lower development costs and accelerate the timeframe to clinically meaningful data. This quarter, we have continued to demonstrate prudent adherence to this clinical strategy," said Richard Peters, M.D., Ph.D., President and Chief Executive Officer. "Additionally, we are pleased to have strengthened our financial position with non-dilutive sources of capital, including an $18 million milestone announced today and the $15 million debt facility we closed in July, which we believe extend our cash runway into at least the first quarter of 2020 and position us to deliver on our corporate goals. Looking ahead, we anticipate significant progress across our pipeline, with two clinical readouts expected in the second half of 2018 from MM-121 in non-small cell lung cancer and MM-310 in solid tumors."

Key events from the second quarter and more recently include:

Receipt of $18 million milestone payment from Shire, resulting from the sale of ONIVYDE in two additional major European countries;

Closing in July of $25 million debt facility with Hercules Capital, $15 million of which was funded at closing, with eligibility for up to an additional aggregate of $10 million;

Announcement of top-line results from the CARRIE study, a randomized Phase 2 trial of MM-141 in front-line metastatic pancreatic cancer, in which MM-141 was added to standard-of-care chemotherapy treatments and evaluated in patients screened for high serum levels of the insulin-like growth factor-1 (IGF-1). As MM-141 did not demonstrate a clinical benefit in the study, Merrimack will cease all of its development activities for MM-141; and

Presentation of two posters at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, held June 1-5, 2018 in Chicago, IL:

Clinical data from MM-121 (seribantumab) in a poster titled, "Evaluation of fixed-dose regimens of seribantumab in patients with solid tumors," containing an analysis of pharmacokinetic and safety data comparing different dosing regimens from previous Phase 1 and Phase 2 studies of MM-121 in solid tumors. Data presented support use of the dosing regimen currently being evaluated in Merrimack’s two ongoing randomized Phase 2 studies of MM-121, SHERLOC in non-small cell lung cancer (NSCLC) and SHERBOC in HR+/HER2- metastatic breast cancer; and

A Trials-in-Progress poster for MM-310, Merrimack’s antibody-directed nanotherapeutic (ADN) targeting the EphA2 receptor, titled, "A Phase 1 study evaluating the safety, pharmacology and preliminary activity of MM-310 in patients with solid tumors."

Upcoming Clinical Milestones

Merrimack anticipates the following upcoming clinical milestones:

Top-line results in 2018 from the SHERLOC study, a randomized Phase 2 clinical trial evaluating MM-121, a fully human monoclonal antibody targeting the HER3 receptor, added to standard of care in patients with heregulin positive non-small cell lung cancer; and

Safety data and maximum tolerated dose in 2018 from the Phase 1 clinical trial of MM-310, an antibody-directed nanotherapeutic targeting the EphA2 receptor, in patients with solid tumors.

Second Quarter 2018 Financial Results

The following summarizes Merrimack’s financial results for the quarter ended June 30, 2018:

Research and development expenses for the second quarter ended June 30, 2018 were $13.7 million, compared to $19.8 million for the comparable period of 2017. Research and development spending for the second quarter of 2018 was lower versus the comparable period in 2017 primarily due to Merrimack’s refocused clinical and preclinical pipeline;

General and administrative expenses for the second quarter ended June 30, 2018 were $3.5 million, compared to $14.8 million for the comparable period of 2017. General and administrative spending for the second quarter of 2018 was lower versus the comparable period in 2017 primarily due to a decrease in corporate expenses related to headcount levels following the asset sale to Ipsen;

Net loss for the second quarter ended June 30, 2018 was $17.8 million, or $1.33 per share, compared to a net loss of $28.9 million, or $2.18 per share, for the comparable period of 2017; and

As of June 30, 2018, Merrimack had 13.3 million shares of common stock, $0.01 par value per share, outstanding.

Financial Outlook

Merrimack believes that its cash, cash equivalents and marketable securities of $60.0 million as of June 30, 2018, in addition to $14.7 million in net borrowings from its July 2, 2018 loan and security agreement with Hercules Capital and the $18 million ONIVYDE milestone received from Shire, will be sufficient to fund its planned operations into at least the first quarter of 2020.

Merrimack remains eligible to receive additional milestone payments from Shire and Ipsen, resulting from the Company’s asset sale to Ipsen in 2017:

Merrimack is entitled to receive up to an additional $15 million in milestone payments from Shire, which are excluded from the Company’s cash runway guidance until achieved, consisting of:

$5.0 million related to the sale of ONIVYDE in the first major non-European, non-Asian country; and

$10.0 million for the first patient dosed in a pivotal clinical trial in an indication other than pancreatic cancer.

Merrimack is also entitled to receive up to an aggregate of $450 million in regulatory-based milestone payments from Ipsen, which Merrimack has said it expects to pass through to stockholders, net of any taxes owed and subject to there being sufficient surplus at that time, consisting of:

$225.0 million upon approval by the FDA of ONIVYDE for the first-line treatment of metastatic adenocarcinoma of the pancreas, subject to certain conditions;

$150.0 million upon approval by the FDA of ONIVYDE for the treatment of small cell lung cancer after failure of first-line chemotherapy; and

$75.0 million upon approval by the FDA of ONIVYDE for an additional indication unrelated to those described above.

Conference Call and Webcast

Merrimack will host a live conference call and webcast today, Tuesday, August 7, 2018 at 8:30 am ET, to provide an update on its operational progress and a summary of these financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 6476538. A listen-only webcast of the call can be accessed in the Investors section of Merrimack’s website, investors.merrimack.com, and a replay of the call will be archived there for six weeks following the call.

Upcoming Investor Conferences

Merrimack is scheduled to present at the 2018 Baird Global Healthcare Conference on Thursday, September 6, 2018, at 8:30 am ET in New York. A live webcast of the presentation can be accessed under "Events and Presentations" in the Investors section of the Company’s website at www.merrimack.com. A replay of the webcast will be archived there for approximately 30 days following the presentation.

On August 7, 2018 PRA Health Sciences, Inc. (the "Company") (NASDAQ: PRAH) reported the pricing of the previously announced secondary offering of shares of its common stock (Press release, PRA Health Sciences, AUG 7, 2018, View Source;p=RssLanding&cat=news&id=2362392 [SID1234528947]). An affiliate of, or a fund sponsored by, Kohlberg Kravis Roberts & Co. (the "Selling Stockholder"), has agreed to sell an aggregate of 6,500,000 shares of the Company’s common stock in an underwritten public offering at a price of $101.50 per share. The offering is expected to close on August 9, 2018, subject to customary closing conditions.

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Morgan Stanley and Goldman Sachs & Co. LLC acted as the underwriters for the offering.

The Company has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement, as well as the prospectus supplement related to this offering and other documents the Company has filed with the SEC for more complete information about the Company and this offering. You may obtain these documents for free by visiting EDGAR on the SEC Web site at: www.sec.gov. Alternatively, copies of the prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from:

Morgan Stanley & Co. LLC
Attention: Prospectus Department
180 Varick Street, 2nd Floor
New York, NY 10014

Goldman Sachs & Co. LLC
Attention: Prospectus Department
200 West Street
New York, NY 10282
Telephone: 866-471-2526
Facsimile: 212-902-9316
[email protected]
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Contact:

PRA Health Sciences, Inc.
Christine Rogers
919-786-8463
[email protected]

Mike Bonello
Chief Financial Officer
919-786-8270
[email protected]

Forward Looking Statements

This press release contains forward-looking statements that reflect, among other things, the Company’s current expectations and anticipated results of operations, all of which are subject to known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements, market trends or industry results to differ materially from those expressed or implied by such forward-looking statements. For this purpose, any statements contained herein that are not statements of historical fact may constitute forward-looking statements. Without limiting the foregoing, words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "should," "targets," "will" and the negative thereof and similar words and expressions are intended to identify forward-looking statements. Actual results may differ materially from the Company’s expectations due to a number of factors, including, that most of the Company’s contracts may be terminated on short notice, and that the Company may be unable to maintain large customer contracts or to enter into new contracts; the Company may underprice contracts, overrun its cost estimates or fail to receive approval or experience delays in documenting change orders; the historical indications of the relationship of backlog to revenues may not be indicative of their future relationship; if the Company is unable to achieve operating efficiencies or grow revenues faster than expenses, operating margins will be adversely affected; if the Company is unable to attract investigators and patients for its clinical trials, its clinical development business may suffer; the Company could be subject to employment liability with its embedded and functional outsourcing solutions as it places employees at the physical workplaces of its clients; the Company may be unable to recruit experienced personnel; changes in accounting standards may adversely affect the Company’s financial statements; the Company’s effective income tax rate may fluctuate which may adversely affect its operations, earnings, and earnings per share; the Company may be unable to maintain information systems or effectively update them; customer or therapeutic concentration could harm the Company’s business; the Company’s business is subject to risks associated with international operations, including economic, political and other risks, such as compliance with a myriad of laws and regulations, complications from conducting clinical trials in multiple countries simultaneously and changes in exchange rates; due to the global nature of its business, the Company may be exposed to liabilities under the Foreign Corrupt Practices Act and other similar non-U.S. laws; the Company may be unable to successfully develop and market new services or enter new markets; the Company’s failure to perform services in accordance with contractual requirements, regulatory standards and ethical considerations may subject it to significant costs or liability, damage its reputation and cause it to lose existing business or not receive new business; government regulators or customers may limit the scope of prescription or withdraw products from the market; government regulators may impose new regulations affecting the biopharmaceutical industry and the Company’s business; the Company’s services are related to treatment of human patients, and it could face liability if a patient is harmed; the Company’s insurance may not cover all of its indemnification obligations and other liabilities; the Company is subject to a number of additional risks associated with doing business outside of the United States, including foreign currency exchange fluctuations and restrictive regulations, as well as the risks and uncertainties associated with the United Kingdom’s expected withdrawal from the European Union; if the Company does not keep pace with rapid technological changes, its services may become less competitive or obsolete; the Company’s relationships with existing or potential clients who are in competition with each other may adversely impact the degree to which other clients or potential clients use its services; the Company may be unable to successfully identify, acquire and integrate businesses, services and technologies; the Company’s balance sheet includes a significant amount of goodwill and intangible assets and its results of operations may be adversely affected if the Company fails to realize the full value of its goodwill and intangible assets; the Company’s ability to utilize its net operating loss carryforwards and certain other tax attributes may be limited; if the Company is unable to manage its growth effectively, its business could be harmed; the Company’s reliance on third parties for data, products, services and intellectual property licenses could lead to an inability to access certain data or provide certain services; the biopharmaceutical services industry is fragmented and highly competitive; biopharmaceutical industry outsourcing trends could change and adversely affect the Company’s operations and growth rate; current and proposed laws and regulations regarding the protection of personal data could result in increased risks of liability or increased cost or could limit the Company’s service offerings; patent and other intellectual property litigation could be time consuming and costly; circumstances beyond the Company’s control could cause industry-wide reduction in demand for its services; the Company has substantial indebtedness and may incur additional indebtedness in the future, which could adversely affect the Company’s financial condition; and other factors that are set forth in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K filed with the SEC on February 22, 2018. The Company undertakes no obligation to update any forward-looking statement after the date of this release, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

On August 7, 2018 OPKO Health, Inc.(NASDAQ:OPK) reported its financial results and business highlights for the three months ended June 30, 2018 (Press release, Opko Health, AUG 7, 2018, View Source [SID1234528499]).

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Financial Highlights

Net loss for the quarter decreased by 63% to $6.2 million or $0.01 a share on revenues of $263.7 million during the three months ended June 30, 2018, compared to net loss of $16.9 million or $0.03 per share on revenues of $292.6 million for the comparable period of 2017.

Revenues from products during the three months ended June 30, 2018 include $4.8 million from RAYALDEE and revenues from services were $216.1 million for the 2018 period compared with $233.9 million for the corresponding 2017 period.

Revenue and net loss for the three months ended June 30, 2017 benefited from a non-recurring $10 million milestone payment for VARUBI while net loss for the three months ended June 30, 2018 benefited from the reduction of contingent consideration expense of $15.4 million attributable to changes in assumptions regarding the timing of milestone payments.

During the three months ended June 30, 2018, costs of revenue and selling, general and administrative expenses decreased by approximately 9%, or $26.0 million, compared to the 2017 period. Research and Development expenses were $29.2 million compared to $33.1 million for the corresponding 2017 period.
Business Highlights

RAYALDEE total prescriptions reported by IMS for Q2 2018 increased 467% compared with Q2 2017 and 36% compared with Q1 2018: As of August 1, 2018, more than 83% of patients have access to RAYALDEE under their insurance plans. Fresenius Medical Care Renal Pharma (Vifor Fresenius) received approval from Health Canada to market RAYALDEE in Canada for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

4Kscore utilization in Q2 2018 increased 10% compared with Q2 2017. Utilization of the 4Kscore continues to improve with nearly 20,500 4Kscore tests performed during the three months ended June 30, 2018 compared to 18,600 tests performed during the second quarter of 2017.

Geoff Monk Appointed as General Manager, BioReference Laboratories: Mr. Monk has more than 20 years of management experience in the diagnostic laboratory business and was previously Managing Director of the New York and New Jersey unit of Quest Diagnostics.

Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment is ongoing in this dose ranging study for our orally administered SARM. This medicine is expected to improve symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease body fat. BPH affects approximately 50 million men in the U.S.

Completed the enrollment of a Global Phase 3 study of somatrogon (hGH-CTP) in Growth Hormone Deficient Children: The somatrogon Phase 3 trial is a randomized, open-label, active-controlled study taking place in over 30 countries. This study enrolled approximately 225 treatment naïve children with growth hormone deficiency (GHD) who were randomized 1:1 into two arms: once-weekly somatrogon vs once-daily Genotropin. The primary endpoint of the trial is height velocity at 52 weeks. Secondary endpoints are safety and pharmacodynamic endpoints.

Japanese Phase 3 registration trial of somatrogon in growth hormone deficient children continues to enroll patients: The global and Japanese pediatric studies utilize the multiple dose pen device that will be launched commercially upon approval.

Completed the enrollment of a Phase 2b clinical trial for our once-weekly oxyntomodulin dual GLP1-Glucagon agonist to treat type 2 diabetes and obesity: In a previous Phase 2 trial in 420 overweight patients with type 2 diabetes, the drug was shown to be safe and effective. The current trial is to study a new dosing schedule to achieve even greater weight loss.
Premarket Approval (PMA) application for Claros point-of-care PSA test under review by FDA: OPKO has submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product utilizing the Claros platform to measure testosterone is advancing toward a 510(k) submission to the FDA.
Initiation of two additional Phase 2 clinical trials anticipated in 2018:

RAYALDEE in dialysis patients with SHPT: Together with our partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 CKD patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial during Q3 of this year.

OPKO’s NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and a single-dose Phase 2a trial is commencing. Pruritus is often a problem for renal dialysis patients.
Conference Call & Webcast Information

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

WHEN:
DOMESTIC DIAL-IN:
INTERNATIONAL DIAL-IN:
PASSCODE:
WEBCAST:
Tuesday, August 7, 2018 at 4:30 p.m. Eastern time.
(866) 634-2258
(330) 863-3454
9243717
investor.opko.com/events
For those unable to participate in the live conference call or webcast, a replay will be available beginning August 7, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 9243717. The replay can be accessed for a period of time on OPKO’s website at View Source

On August 7, 2018 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported that it will release its financial results for the second quarter ended June 30, 2018 on Tuesday, August 14, 2018 during pre-market hours (Press release, Cancer Genetics, AUG 7, 2018, View Source [SID1234528566]). The Company will hold a conference call at 8:30 a.m. Eastern on Tuesday, August 14, 2018 to discuss the financial results and provide an update on its strategic direction and key organizational improvements being made by the Company.

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CONFERENCE CALL & WEBCAST
Tuesday, August 14, 2018, 8:30 a.m. Eastern Time
Domestic: 800-289-0438
International: 323-794-2423
Conference ID: 1766530
Webcast: View Source
Replay – Available through August 28, 2018
Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 1766530

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.