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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

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 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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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 Apollomics, Inc. (the "Company"), an innovative biopharmaceutical company committed to the discovery and development of oncology combination therapies, reported that Fabio M. Benedetti, M.D. has joined the senior leadership team as Chief Medical Officer (CMO), effective (Press release, Apollomics, MAY 1, 2019, View Source [SID1234535654]). Dr. Benedetti will lead the Company’s global clinical development programs including clinical strategy, clinical development, and regulatory affairs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Fabio’s global development expertise and insights into the oncology treatment landscape are a tremendous addition to our team at Apollomics," said Guo-Liang Yu, Ph.D., Chief Executive Officer. "Fabio is a proven leader with extensive knowledge in clinical and regulatory strategy, portfolio management, and all aspects of clinical development. In collaboration with our partners, we now have over ten clinical trials ongoing, and we look forward to his guidance as we advance these programs and our global partnerships."

Fabio Benedetti, M.D., added, "I am excited to join the Apollomics team and believe their combination therapy and focused biomarker-driven trials approach may offer significant benefits to patients with cancer. I hope to leverage my prior experience and responsibilities in global portfolio management and prioritization, as well as clinical development, to accelerate their clinical programs through all stages of development."

Dr. Benedetti has over 20 years industry experience in oncology clinical development and medical affairs. Prior to joining Apollomics, Dr. Benedetti was Global Chief Medical Officer at Taiho Pharmaceutical Company, Ltd. in Tokyo, Japan where he ran a global portfolio management and prioritization strategy group including strategic, clinical and commercial evaluation of global internal portfolio assets and business development opportunities. Before his promotion to Global CMO, Dr. Benedetti was Senior Vice President and Chief Medical Officer for Taiho Oncology, Inc. in Princeton, New Jersey, where he was a member of the Executive Leadership Committee and was responsible for ex-Asian clinical development and operations of the company’s oncology pipeline which included the development and US/EU approvals of LONSURF (trifluridine and tipiracil) tablets in refractory metastatic colorectal cancer. Previously, he held the positions of Senior Vice President, Clinical Oncology and Chief Medical Officer at Geron Corporation. Dr. Benedetti also has extensive experience in Medical Affairs having held Vice-President positions at Onyx Pharmaceuticals and Millennium Pharmaceuticals. Dr. Benedetti’s industry career also included Medical Director positions at Roche Laboratories as well as Bristol-Myers Squibb.

Dr. Benedetti is a trained medical oncologist who worked as an Attending Physician, Clinical Assistant, Department of Medicine, Division of Gastrointestinal Oncology at Memorial Sloan-Kettering Cancer Center in New York, NY prior to entering industry. He completed his fellowship in Oncology/Hematology at Memorial Sloan Kettering Cancer Center, and his residency in internal medicine at Strong Memorial Hospital at the University of Rochester. Dr. Benedetti earned both his Medical and Bachelor of Arts degrees from Brown University in Providence, RI.

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"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.

On May 1, 2019 KIYATEC, Inc. reported the initial $3 million closing of the company’s series B2 financing round. The round was led by VentureSouth and included LabCorp (NYSE: LH) (Press release, KIYATEC, MAY 1, 2019, View Source [SID1234535505]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"This validation and confidence by our investors, coupled with the exciting progress of our clinical trials, puts us on the path toward the next phase of growth and development," said Matthew Gevaert, CEO of KIYATEC. "We are particularly excited to welcome LabCorp as a new investor because of the depth and breadth of their expertise in oncology. With the preclinical and clinical development strengths of LabCorp’s Covance Drug Development business, and their corporate position as a world leader in clinical testing, there is great potential synergy across the many ways KIYATEC’s technology can be used to improve cancer care."

Proceeds from the financing will go toward KIYATEC’s ongoing clinical study, 3D-PREDICT, to validate KIYATEC’s proprietary assay as a patient-specific predictor of response to cancer therapies for solid tumors. The test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically relevant 3D microenvironment, to determine whether those cells respond to guideline-recommended cancer drugs. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors.

The company has gained significant momentum in 2019. Recently, at the 110th Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), KIYATEC demonstrated leading capabilities in modeling and predicting response to immuno-oncology therapies including checkpoint inhibitors. On April 10, KIYATEC was one of 20 companies recognized nationally on Capitol Hill as part of the 2019 University Innovation & Entrepreneurship Showcase. In the first quarter of 2019, KIYATEC added three clinical sites to its 3D-PREDICT study and expects to continue its momentum by adding additional sites in the second and third quarters.