On May 10, 2018 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company applying synthetic biology to probiotics to develop novel, living medicines, reported that Aoife Brennan, M.B., B.Ch., has accepted the position of Interim President and Chief Executive Officer of Synlogic, effective immediately (Press release, Synlogic, MAY 10, 2018, View Source [SID1234526495]).

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This appointment follows the resignation of Jose Carlos Gutiérrez-Ramos, Ph.D., as Synlogic’s President and Chief Executive Officer and a member of its board of directors. Dr. Gutiérrez-Ramos will serve in an advisory capacity as needed.

"On behalf of the entire board I would like to thank JC for his contributions to Synlogic, particularly in transitioning the Company from a research organization to a publicly traded, clinical-stage company, and we wish him well in his future endeavors," said Peter Barrett, chairman of Synlogic’s board of directors. "Aoife has done a remarkable job advancing our development efforts, and our board has complete confidence in her ability to lead the company on an interim basis as we conduct our search for a permanent CEO to drive the next stage of Synlogic’s growth. To aid in this transition, I will assume the role of Executive Chairman of the Board and will support Aoife as we continue to execute on Synlogic’s strategic priorities and advance the Company’s research, preclinical activities and ongoing clinical trials, which remain on track per the Company’s prior guidance."

"JC leaves us with a strong, well-funded organization, compelling science and clinical programs, and a world-class team. We greatly appreciate his efforts to bring Synlogic from discovery to a clinical development company and his guidance as a mentor and leader," said Dr. Brennan. "I look forward to working with the leadership team and our board to continue to advance our mission to develop novel living medicines that will change the lives of patients with serious and life-threatening diseases."

On May 10, 2018 Aduro Biotech, Inc. (NASDAQ:ADRO) reported that Stephen T. Isaacs, chairman, president and chief executive officer of Aduro, will present at the Bank of America Merrill Lynch 2018 Health Care Conference in Las Vegas, NV on Thursday, May 17, 2018, at 9:35 am Pacific Time (Press release, Aduro Biotech, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348537 [SID1234526462]).

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To access the live webcast and subsequent archived recording of this and other company presentations, please visit Aduro’s website at www.aduro.com

On May 10, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported financial and operating results for the first quarter ended March 31, 2018 (Press release, Genocea Biosciences, MAY 10, 2018, View Source [SID1234526480]).

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"2018 has been an exciting year for Genocea," said Chip Clark, president and chief executive officer of the company. "Following our January financing, we are funded to advance our lead neoantigen cancer vaccine candidate GEN-009 into clinical trials later this year, and to continue to generate and present scientific data further elaborating on the ability of our ATLAS platform to identify and characterize neoantigens for use in cancer vaccines."

Recent Milestones & Events

January 2018: Genocea announced completion of a financing resulting in net proceeds of $51.7 million, including significant investments by New Enterprise Associates (NEA) and Vivo Capital. (Vivo).
January 2018: The U.S. Patent and Trademark Office issued an allowance on United States Patent 9,873,870, further strengthening the Company’s intellectual property position on its ATLAS platform for the identification and characterization of neoantigens and tumor-associated antigens.
January 2018: Genocea and Oncovir, Inc. entered into a license and supply agreement for Oncovir’s Hiltonol (poly-ICLC) adjuvant, a key component of Genocea’s personalized cancer vaccine candidate, GEN-009.
February and March 2018: Genocea strengthened its leadership through the election of NEA partner Ali Behbahani, M.D., to its Board of Directors, and the appointment of industry veteran Narinder Singh as senior vice president of pharmaceutical sciences and manufacturing.
April 2018: Genocea scientists presented data at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) further highlighting the advantages of its ATLAS platform over in silico methods in neoantigen identification and detailing the development of a novel model to study the mechanism of inhibitory antigens identified by ATLAS.
April 2018: Genocea filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin clinical development of GEN-009. Genocea plans to initiate a Phase 1/2a clinical trial for GEN-009 in patients with a variety of tumor types in the second half of 2018 and to report top-line immune response data from this trial in the first half of 2019.
First Quarter 2018 Financial Results

Cash Position: As of March 31, 2018, cash and cash equivalents were $51.2 million compared to $12.3 million as of December 31, 2017.
Research and Development (R&D) Expenses: R&D expenses were $7.3 million for the quarter ended March 31, 2018, compared to $9.7 million for the same period in 2017. The decrease was largely due to reduced headcount, consulting and professional service costs, and decreased clinical costs.
General and Administrative (G&A) Expenses: G&A expenses were $3.1 million for the quarter ended March 31, 2018, compared to $3.6 million for the same period in 2017. The decrease was primarily due to reduced compensation, consulting, and professional services.
Net Loss: Net loss was $15.3 million for the quarter ended March 31, 2018, compared to a net loss of $13.7 million for quarter ended March 31, 2017. The increase in net loss is principally due to the change in fair value of warrants during the first quarter of 2018, related to the January 2018 public offering.
Financial Guidance
Genocea expects that its existing cash and cash equivalents are sufficient to support its operating expenses and capital expenditure requirements into the fourth quarter of 2019, having recently refinanced its debt facility with Hercules Capital.

Subsequent to the close of the first quarter ended March 31, 2018 and under its existing at-the-market equity offering program (ATM), Genocea sold an aggregate of 3.6 million shares of its common stock, receiving approximately $3.1 million in net proceeds after deducting commissions.

Genocea continues to explore strategic alternatives for GEN-003, its Phase 3-ready investigational immunotherapy for the treatment of genital herpes.

Conference Call
Genocea will host a conference call and webcast today at 9:00 a.m. ET. The conference call may be accessed by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and refer to conference ID number 3866939. A live webcast of the conference call will be available online from the investor relations section of the Company’s website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 30 days.

On May 10, 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 March 31, 2018 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAY 10, 2018, View Source [SID1234526496]).

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"Our priorities for 2018 are advancing our first-in-class drug candidates SY-1425 and SY-1365, leveraging our leading gene control platform to continue fueling our pipeline, and building on our strong financial position and company fundamentals," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We have made terrific progress on all three fronts this year, presenting preclinical data that support the planned expansion of our Phase 1 trial of SY-1365 into ovarian cancer, entering into a collaboration with Incyte that applies our platform to diseases beyond our current areas of focus, and fortifying our financial position with a successful public offering. We continue to build momentum as we prepare for our planned data readouts in the fourth quarter of this year for both SY-1425 and SY-1365, and we remain focused on executing with excellence as we strive to build a great and enduring company with medicines that make a profound difference for currently underserved patients."

Upcoming Milestones

Syros plans to report initial clinical data in the fourth quarter of 2018 from cohorts in its Phase 2 trial evaluating SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive newly diagnosed acute myeloid leukemia (AML) patients who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS) patients. The primary objective of the trial is to evaluate the safety and efficacy of these combinations in biomarker-positive AML and higher-risk MDS patients. The Company announced today that it plans to add approximately 25 biomarker-negative newly diagnosed AML patients who are not suitable candidates for standard chemotherapy to its ongoing Phase 2 trial in order to support the development of a commercial companion diagnostic test for SY-1425. These patients will be treated with SY-1425 in combination with azacitidine.
Syros plans to open expansion cohorts in mid-2018 in its ongoing Phase 1 trial of SY-1365 in multiple patient populations with ovarian and breast cancer to evaluate SY-1365 as a single agent and in combination with standard-of-care therapies.
Syros plans to report clinical data in the fourth quarter of 2018 from the dose escalation portion of its ongoing Phase 1 trial of SY-1365 in advanced solid tumor patients.
Syros plans to select a new development candidate from its preclinical pipeline by the end of 2018.
Recent Platform and Pipeline Highlights

In April 2018, Syros and its collaborators at the Dana-Farber Cancer Institute presented new preclinical data on SY-1365 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago. SY-1365 demonstrated potent anti-tumor activity in multiple models of heavily pretreated ovarian cancer, inhibiting tumor growth in 10 of the 17 patient-derived xenograft models studied, including inducing complete regressions. These responses were observed irrespective of BRCA status or sensitivity to a PARP inhibitor. Preclinical studies also pointed to potential biomarkers of response to SY-1365.
First Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities as of March 31, 2018 were $121.7 million, compared with $72.0 million on December 31, 2017. This increase in cash reflects aggregate gross proceeds of approximately $46.0 million from Syros’ underwritten public offering of common stock that closed in February 2018, $1.4 million in proceeds from a private placement of stock to Incyte Corporation concurrent with this public offering, and a $10.0 million upfront payment and $10.0 million in proceeds from the sale of Syros common stock received in January 2018 in connection with Syros’ entry into its collaboration with Incyte.

For the first quarter 2018, Syros reported a net loss of $14.5 million, or $0.48 per share, compared to a net loss of $11.5 million, or $0.49 per share, for the same period in 2017. Stock-based compensation included in the net loss was $1.7 million for the first quarter 2018, compared to $0.9 million for the same period in 2017.

Revenues were $0.4 million for the first quarter of 2018, as compared to $1.1 million for the same period in 2017. Revenues in the first quarter of 2018 were earned under Syros’ collaboration with Incyte, compared to revenues in the first quarter of 2017, which were earned from a research agreement with a multinational pharmaceutical company.
Research and development (R&D) expenses were $11.1 million for the first quarter of 2018, as compared to $9.6 million for the same period in 2017. This increase was primarily attributable to increased external research and development costs associated with Syros’ ongoing clinical trials. Stock-based compensation included in R&D expenses was $0.6 million for the first quarter 2018, compared to $0.3 million for the same period in 2017.
General and administrative (G&A) expenses were $4.1 million for the first quarter of 2018, as compared to $3.1 million for the same period in 2017. This increase was primarily attributable to an increase in employee-related costs, including salary, benefits and stock-based compensation, as well as legal and professional fees associated with entry into Syros’ collaboration with Incyte. Stock-based compensation included in G&A expenses was $1.1 million for the first quarter 2018, compared to $0.6 million for the same period in 2017.
Financial Guidance

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to enable it 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 first 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: 2967666. 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 May 10, 2018 Alkermes plc (NASDAQ: ALKS) reported that its corporate presentation will be webcast live at the Bank of America Merrill Lynch Health Care Conference on Wednesday, May 16, 2018 at 11:20 a.m. PT (2:20 p.m. ET/7:20 p.m. BST) from Las Vegas (Press release, Alkermes, MAY 10, 2018, View Source;p=RssLanding&cat=news&id=2348542 [SID1234526463]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
Jennifer Zibuda
Corporate Communications
+1 781 609 6129