On May 1, 2019 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the Company will release its first quarter 2019 financial results after the market closes on Wednesday, May 8, 2019 (Press release, Sangamo Therapeutics, MAY 1, 2019, View Source [SID1234535517]). The press release will be followed by a conference call at 5:00 p.m. ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a business update.

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The conference call dial-in numbers are (877) 377-7553 for domestic callers and (678) 894-3968 for international callers. The conference ID number for the call is 7577586. Participants may access the live webcast via a link on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations. A conference call replay will be available for one week following the conference call. The conference call replay numbers for domestic and international callers are (855) 859-2056 and (404) 537-3406, respectively. The conference ID number for the replay is 7577586.

On May 1, 2019 Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported that Sheila Gujrathi, M.D., Chief Executive Officer and Co-Founder, will participate in a fireside chat at the Bank of America Merrill Lynch Health Care Conference on Tuesday, May 14 at 1:00 p.m. PT (Press release, Gossamer Bio, MAY 1, 2019, View Source [SID1234535502]).

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A live webcast of the fireside chat will be available on the "Events and Presentations" page in the "Investors" section of the company’s website at View Source A replay of the webcast will be archived on the company’s website for 90 days following the presentation.

On May 1, 2019 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) today reported financial results for the three months ended March 31, 2019 (Press release, PRA Health Sciences, MAY 1, 2019, View Source [SID1234535618]).

"The year is off to a solid start and I am delighted to report that our first quarter results were in line with our expectations" said Colin Shannon, PRA’s Chief Executive Officer. "Our key financial metrics continue to improve, as we continue to see strong book-to-bill ratios and expanding margins. The entire team continues to focus on our commitment to client delivery and we look forward to delivering strong results for the remainder of 2019."

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Net new business for our Clinical Research segment for the three months ended March 31, 2019 was $664.6 million, representing a net book-to-bill ratio of 1.27 for the period. This net new business contributed to an ending backlog of $4.4 billion at March 31, 2019.

For the three months ended March 31, 2019, revenue was $722.0 million, which represents growth of 2.9%, or $20.2 million, compared to the three months ended March 31, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $30.8 million, an increase of 4.4% compared to the first quarter of 2018. By segment, the Clinical Research segment generated revenues of $666.6 million, while the Data Solutions segment generated revenues of $55.4 million.

Direct costs, exclusive of depreciation and amortization, were $377.9 million during the three months ended March 31, 2019 compared to $381.4 million for the three months ended March 31, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased $11.2 million compared to the first quarter of 2018. The increase in direct costs was primarily driven by an increase in labor-related costs in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels. Direct costs were 52.3% of revenue during the first quarter of 2019 compared to 54.3% of revenue during the first quarter of 2018.

Selling, general and administrative expenses were $97.1 million during the three months ended March 31, 2019 compared to $91.7 million for the three months ended March 31, 2018. Selling, general and administrative costs were 13.4% of revenue during the first quarter of 2019 compared to 13.1% of revenue during the first quarter of 2018. The increase in selling, general and administrative expenses as a percentage of revenue is primarily related to increased stock-based compensation during the current year.

GAAP net income was $44.1 million for the three months ended March 31, 2019, or $0.66 per share on a diluted basis, compared to GAAP net income of $39.0 million for the three months ended March 31, 2018, or $0.59 per share on a diluted basis.

EBITDA was $112.2 million for the three months ended March 31, 2019, representing an increase of 13.6% compared to the three months ended March 31, 2018. Adjusted EBITDA was $117.1 million for the three months ended March 31, 2019, representing growth of 22.4% compared to the three months ended March 31, 2018.

Adjusted net income was $73.3 million for the three months ended March 31, 2019, representing growth of 30.3% compared to the three months ended March 31, 2018. Adjusted net income per diluted share was $1.10 for the three months ended March 31, 2019, representing growth of 29.4% compared to the three months ended March 31, 2018.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2019 guidance, to the corresponding GAAP measures is included in this press release.

Guidance

The Company is reaffirming its 2019 revenue guidance of between $3.09 billion and $3.20 billion, representing as reported and constant currency growth of 8% to 11%. We are reaffirming our GAAP net income per diluted share of between $3.65 and $3.80 and Adjusted Net Income per diluted share of between $4.93 and $5.08, representing growth of 15% to 19%. We continue to estimate our annual effective income tax rate at approximately 24%. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in guidance from regulatory agencies related to interpretation, analysis and guidance of the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.15 and a GBP rate of 1.35. All other foreign currency exchange rates are as of January 31, 2019.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on May 2, 2019, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 1876878. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investors.prahs.com. A replay of the conference call will be available online at investors.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 1876878.

Additional Information

A financial supplement with results for the three months ended March 31, 2019, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q1 2019 Earnings Presentation."

On May 1, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended March 31, 2019 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAY 1, 2019, View Source [SID1234535503]).

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"Our first quarter accomplishments mark important progress against our strategic priorities for 2019," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We refined our clinical development strategies for SY-1425 and SY-1365 with the aim of achieving proof-of-concept as soon as 2020 in three patient populations with high unmet needs that we believe offer opportunities for accelerated development. We presented new preclinical data supporting our mechanistic rationale for the ongoing development of SY-1365 in ovarian and breast cancers and highlighted the potency, selectivity and anti-tumor activity of SY-5609, our oral CDK7 inhibitor, further demonstrating our leadership in CDK7 inhibition. Following our successful financing in April, we believe we have sufficient funds to advance our clinical programs beyond potential proof-of-concept readouts, while continuing to execute on our long-term vision of building a fully integrated company with medicines that provide a profound benefit for patients."

Upcoming Milestones:

SY-1425

Syros plans to open an additional cohort in the ongoing Phase 2 trial in the third quarter of 2019 evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA or IRF8 biomarker-positive patients with relapsed or refractory acute myeloid leukemia (AML). Syros expects to report potential proof-of-concept data from this cohort in 2020 that, if positive, could enable a decision to move toward a registration study.
Syros plans to complete enrollment in mid-2019 in the ongoing Phase 2 trial cohort evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA or IRF8 biomarker-positive patients with newly diagnosed AML who are not suitable candidates for standard chemotherapy.
Syros plans to report updated data on SY-1425 in combination with azacitidine in the second half of 2019 in newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
SY-1365

Syros plans to report initial clinical data in the fourth quarter of 2019 from the expansion portion of its ongoing Phase 1 trial, including initial efficacy and safety assessments from the cohort evaluating SY-1365 as a single agent in high-grade serous ovarian cancer patients who have had three or more prior lines of therapy; initial safety and pharmacokinetic data from the cohort evaluating SY-1365 in combination with carboplatin in high-grade serous ovarian cancer patients who have had one or more prior lines of therapy; and initial safety, efficacy and mechanistic data from the cohort evaluating SY-1365 as a single agent in patients with advanced solid tumors accessible for biopsy.
Syros expects to report additional data from these cohorts, including potential proof-of-concept data from the ongoing cohort in high-grade serous ovarian cancer patients who have had one or more prior lines of therapy, in 2020. Syros also expects to report potential proof-of-concept data from an ongoing cohort evaluating SY-1365 as a single agent in patients with relapsed ovarian clear cell cancer and initial data from an ongoing cohort in hormone receptor (HR)-positive CDK4/6 inhibitor-resistant breast cancer patients in 2020.
SY-5609

Syros plans to complete investigational new drug-enabling studies of SY-5609 in 2019 to support the initiation of a Phase 1 oncology trial in early 2020.
Recent Pipeline Highlights:

In March 2019, Syros opened for enrollment the Phase 1 trial cohort evaluating SY-1365 in patients with relapsed ovarian clear cell cancer.
In April 2019, Syros presented new preclinical data on SY-1365 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The data showed that 90 percent of high-grade ovarian cancer patient-derived xenograft models with prospectively defined RB pathway alterations responded to treatment with SY-1365. These data support the ongoing development of SY-1365 in ovarian and breast cancer patient populations that are enriched for RB pathway alterations, as well as the evaluation of these alterations as potential biomarkers of response to SY-1365.
Also at AACR (Free AACR Whitepaper), Syros presented new preclinical data on SY-5609, demonstrating the potency, selectivity and anti-tumor activity in preclinical models of triple-negative breast cancer and ovarian cancer.
Recent Corporate Highlights:

In April 2019, Syros announced the closing of two concurrent underwritten public offerings, which together resulted in aggregate gross proceeds from the offerings of approximately $70 million, before deducting underwriting discounts and commissions and offering expenses of approximately $4.6 million. The offerings consisted of (i) 8,667,333 shares of Syros common stock and accompanying Class A warrants to purchase up to 1,951,844 shares of its common stock, at a combined price to the public of $7.50 per common share and accompanying Class A warrant and (ii) 666 shares of its Series A convertible preferred stock, which are convertible into 666,000 shares of its common stock, and accompanying Class A warrants to purchase up to 166,500 shares of its common stock, at a combined price to the public of $7,500 per Series A share and accompanying Class A warrant. Each Class A warrant has an exercise price of $8.625 per share and expires on October 10, 2022.
First Quarter 2019 Financial Results:

Syros had cash, cash equivalents and marketable securities of $75.9 million as of March 31, 2019, as compared with $99.7 million on December 31, 2018. Cash and cash equivalents as of March 31, 2019 do not include the net proceeds of approximately $65.4 million from the Company’s April 2019 financing.

For the first quarter of 2019, Syros reported a net loss of $16.5 million, or $0.49 per share, compared to a net loss of $14.5 million, or $0.48 per share, for the same period in 2018.

Revenues were $0.5 million for the first quarter of 2019, as compared to $0.4 million for the same period in 2018. Revenues in both the first quarter of 2019 and first quarter of 2018 were earned under Syros’ collaboration with Incyte Corporation.
Research and development (R&D) expenses were $12.6 million for the first quarter of 2019, as compared to $11.1 million for the same period in 2018. This increase was primarily attributable to continued advancement of the Company’s existing clinical trials and advancement of its preclinical programs, including the advancement of SY-5609 into investigational new drug application (IND)-enabling studies.
General and administrative (G&A) expenses were $4.9 million for the first quarter of 2019, as compared to $4.1 million for the same period in 2018. This increase was primarily attributable to an increase in employee-related expenses.
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 to the end of the first quarter of 2021.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these first quarter 2019 financial results and provide a corporate update.

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 5435957. A webcast of the call will also be available on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 30 days following the presentation.

On May 1, 2019 Repare Therapeutics, a precision oncology company pioneering synthetic lethality to develop novel therapeutics that target specific vulnerabilities of tumors in genetically defined patient populations, reported that it has made three key additions to its leadership team and Board of Directors (Press release, Repare Therapeutics, MAY 1, 2019, View Source [SID1234535504]). Maria Koehler, MD, PhD, is joining May 1st as Executive Vice President and Chief Medical Officer and will lead Repare’s transition to a clinical-stage company . Katina Dorton has joined as Executive Vice President and Chief Financial Officer and will lead financial, capital markets and administrative operations. Carol Schafer has been appointed to the Board of Directors as an independent director.

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"We are pleased to make these important additions to our executive and governance leadership as Repare embarks on a clinically-driven path to bring important new cancer medicines to the patients who need them," said Lloyd M. Segal, President and Chief Executive Officer of Repare Therapeutics. Dr. Koehler and Ms. Dorton will be based in Repare’s offices in Cambridge, MA.

Maria Koehler

Dr. Koehler is a hematologist/oncologist with 20 years in pharmaceutical and biotechnology companies. She has experience in both early drug development and bringing new drugs to global markets, having developed strategies for all stages of cancer drug development and medical affairs. Prior to joining Repare, Dr. Koehler was Chief Medical Officer at Bicycle Therapeutics. Prior to Bicycle she was VP, Strategy and Innovation for Pfizer Oncology, spearheading major acquisitions and strategic oncology portfolio decisions. Dr. Koehler also served as Oncology Integrated Development Leader at Pfizer, where she led the clinical development of Pfizer’s first-in-class breast cancer medicine, Ibrance (palbociclib), first approved in 2015 and with sales of more than $4 billion in 2018.

Dr. Koehler received her MD and PhD from the Silesian Medical School in Poland and has co-authored over 150 publications, book chapters and patents.

Katina Dorton

Prior to joining Repare, Ms. Dorton was Chief Financial Officer of Avrobio (Nasdaq: AVRO), a clinical-stage gene therapy company. At Avro, Katina led the raise of $175M in equity capital, including the Company’s $114M IPO. Prior to Avro, Katina was Chief Financial Officer of Immatics Biotechnologies, a T-cell-based immuno-oncology company. Katina has more than 15 years of investment banking experience advising corporate clients and their boards on capital markets, fund raising, mergers and acquisitions, and other strategic transactions. She was a Managing Director at Morgan Stanley and a Managing Director at Needham & Co. She practiced law as an M&A and securities law attorney at Sullivan & Cromwell prior to her investment banking career. Katina currently serves as Lead Director at US Ecology (Nasdaq: ECOL), an environmental services company.

Katina holds a J.D. from the University of Virginia School of Law, an M.B.A. from George Washington University, and a B.A. from Duke University.

Carol Schafer

Ms. Schafer is a seasoned financial professional with more than 25 years of experience in investment banking, equity capital markets, corporate finance and business development. She most recently served as Vice Chair, Equity Capital Markets at Wells Fargo Securities. Prior to Wells Fargo, Ms. Schafer served as Vice President of Finance and Business Development at Lexicon Pharmaceuticals. Earlier in her career, she was a Managing Director and equity capital markets sector head at J.P. Morgan. She currently sits on the Board of Directors of Idera Pharmaceuticals, Inc. (Nasdaq: IDRA). Ms. Schafer received a B.A. from Boston College and an M.B.A from New York University.