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 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 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported it has entered into an exclusive licensing and research collaboration with the University of California San Francisco (UCSF) aimed at advancing novel engineered T Cell Receptor (TCR) therapies for rare and currently incurable pediatric conditions with high mortality rates (Press release, Tmunity Therapeutics, MAY 1, 2019, View Source [SID1234535501]). Initially, research will focus on Diffuse Intrinsic Pontine Glioma (DIPG), a rare and highly aggressive brain stem tumor.

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As part of the research collaboration, Tmunity will work with one of the world’s leading experts in the field of neuro-oncology gene therapy, Hideho Okada, MD, PhD, a physician-scientist and professor of neurological surgery at UCSF who studies immunotherapeutic strategies aimed at malignant brain tumors. Dr. Okada has discovered and engineered a TCR that binds to and is selective for the H3.3K27M neoantigen. Recent studies have shown that the K27M mutation in the H3.3 histone is observed in more than 70 percent of DIPGs, and that gliomas harboring this mutation are associated with a poor prognosis and survival rate. In animal studies, Dr. Okada found that T cells transfected with the engineered TCR and infused into a mouse model of H3.3K27M-positive glioma harboring the K27M mutation in H3.3 had anti-tumor activity and limited toxicity in treated animals.

"This collaboration with UCSF embodies our commitment to advance novel T cell therapies into the clinic faster. Sadly, children who are diagnosed with DIPG currently have very few therapeutic options and there has been little progress in improving treatments and overall survival rates for DIPG over the last few decades," said Usman "Oz" Azam, MD, President, Chief Executive Officer and Chairperson of the Board of Tmunity. "We look forward to working with Dr. Okada and his research team to help advance this exciting discovery of a novel TCR therapy that could be a potential breakthrough in the treatment of this devastating pediatric disease, and perhaps other gliomas."

Approximately 300 children in the U.S. are diagnosed with DIPG each year, with most diagnoses occurring between five and nine years of age. Children with DIPG have a median overall survival of nine to 10 months using currently available treatments that mainly manage symptoms and complications associated with the disease.

"We are excited to join forces with Tmunity to further study the potential of our TCR T cell as a therapy for DIPG," said Dr. Okada. "The expertise Tmunity brings in clinical development, regulatory and manufacturing is invaluable as our pre-clinical research suggests that our discovery may show promise as a therapeutic approach in pediatric patients with DIPG."

The exclusive collaboration between Tmunity and UCSF brings together leading technologies and expertise from both groups to accelerate the clinical development of this novel T cell therapy. Under the terms of the agreement, Tmunity will work closely with Dr. Okada’s laboratory with the intention of moving quickly into IND-enabling studies and into the clinic. Tmunity will be responsible for leading the development, manufacturing and commercialization of the H3.3K27M TCR T cell therapy. The negotiations were led by the Technology Management team in the UCSF Innovation Ventures office, which leads the university’s business development, technology licensing, and efforts to translate cutting-edge science into therapies and products that directly benefit patients worldwide.

On May 1, 2019 Flex Pharma, Inc. (NASDAQ: FLKS), reported its financial results for the three months ended March 31, 2019 (Press release, Flex Pharma, MAY 1, 2019, View Source [SID1234535500]).

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On January 3, 2019, Flex Pharma (the "Company") and Salarius Pharmaceuticals, LLC ("Salarius") entered into an Agreement and Plan of Merger (the "Merger Agreement") pursuant to which, among other things, Falcon Acquisition Sub, LLC, a wholly owned subsidiary of the Company, will merge with and into Salarius, with Salarius continuing as a wholly owned subsidiary of the Company and the surviving company. The Company has filed a registration statement on Form S-4 with the Securities and Exchange Commission (the "SEC") that provides additional information related to the merger. The Company is holding a special meeting of its stockholders on June 14, 2019, in order to obtain the necessary stockholder approvals to complete the merger and related matters. The merger is expected to close in the first half of 2019. The Company continues to sell HOTSHOT, its consumer product that helps to prevent and treat exercise associated muscle cramps.

The Merger Agreement (i) values Flex Pharma at $10.5 million, subject to adjustment, on a dollar-for-dollar basis, based on Flex Pharma’s net cash balance at the closing of the merger compared to a target net cash of $3.3 million, and (ii) values Salarius at $36.6 million, subject to adjustment, on a dollar-for-dollar basis, based on the sale of Series A Preferred Units pursuant to subscription agreements that Salarius entered into prior to the Merger Agreement compared to the target sale of $7.0 million of Series A Preferred Units.

Under the Merger Agreement, immediately following the effective time of the merger, Flex Pharma’s current stockholders will own approximately 19.9% of the combined company, on a partially-diluted basis, and Salarius’ current members will own approximately 80.1% of the combined company, on a partially-diluted basis.

In addition, at or prior to the closing of the merger, Flex Pharma will pay a dividend of or distribute one right per share of the Company’s common stock to its stockholders of record as of a date and time determined by the Company’s board of directors. Each right will entitle such stockholders to receive a warrant to purchase shares of Flex Pharma’s common stock ("Warrant") six months and one day following the closing date of the merger.

The aggregate value of all of the Warrants to be issued to Flex Pharma’s stockholders generally represents the difference between (i) Flex Pharma’s value per the Merger Agreement and (ii) the value of Flex Pharma’s common stock that Flex Pharma’s current stockholders will have in the combined company.

"We continue to believe that a merger with Salarius is the best opportunity for significant near- and long-term value creation for Flex stockholders. Salarius’ lead compound, Seclidemstat, is currently enrolling patients in an open-label Phase 1 dose escalation/dose expansion study in Ewing sarcoma and Salarius is also preparing to initiate additional studies in advanced solid tumors, including prostate, breast and ovarian cancers. We believe that Salarius could be poised to address significant unmet needs in oncology and we look forward to completing the merger with Salarius," stated William McVicar, Ph.D., Flex Pharma’s President and Chief Executive Officer.

First Quarter 2019 Financial Results

Cash Position: As of March 31, 2019, Flex Pharma had cash and cash equivalents of $7.3 million. The Company held no marketable securities at March 31, 2019. During the three months ended March 31, 2019, cash and cash equivalents decreased by $2.5 million.
Total Revenue: Total revenue for the three months ended March 31, 2019 was approximately $105,000.
Cost of Product Revenue: Cost of product revenue for the three months ended March 31, 2019 was approximately $47,000. There were no inventory write-offs during the three months ended March 31, 2019.
R&D Expense: Research and development expense for the three months ended March 31, 2019 was approximately $2,000.
SG&A Expense: Selling, general and administrative expense for the three months ended March 31, 2019 was $2.3 million, including merger related costs of $1.2 million. Selling, general and administrative expense for this period also included personnel costs (including salaries and stock-based compensation costs), fulfillment costs related to HOTSHOT, legal and professional costs, and external consultant costs.
Net Loss and Cash Flow: Net loss for the three months ended March 31, 2019 was ($2.2) million, or ($0.12) per share and included $0.2 million of stock-based compensation expense. As of March 31, 2019, Flex Pharma had 18,068,017 shares of common stock outstanding. The net loss for the first quarter of 2019, was primarily driven by the Company’s operating expenses related to its merger related costs, costs associated with HOTSHOT, and general and administrative costs.

On May 1, 2019 Triumvira Immunologics Inc. (Triumvira), a privately held biopharmaceutical company developing a novel platform for engineering T cells to attack cancers, has reported simultaneously submitted an IND to the U.S. Food and Drug Administration and a CTA to Health Canada to initiate a Phase 1/2, first-in-human trial of TAC01-CD19, a TAC-T cell therapy product engineered to target CD-19 in patients with Relapsed/Refractory Large B-Cell Lymphoma (TACTIC-19) (Press release, Triumvira Immunologics, MAY 1, 2019, View Source [SID1234535499]).

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"TAC01-CD19 has the potential to be a next generation solution for cell therapy for patients with different types of cancer," commented Paul Lammers, MD, MSc., President and CEO of Triumvira. "This filing is the result of an intensive preclinical development effort by the Triumvira team including the completion of the necessary IND-enabling studies as well as simultaneously preparing IND and CTA filings. We look forward to opening our first of five prominent clinical trial sites in the early summer of 2019."

Despite transformational efficacy with existing approved Chimeric Antigen Receptor T Cells (CAR-T), a significant unmet need remains due to substantial CAR-T toxicities and limited tumor types where CAR-T is effective. Triumvira is developing a proprietary T Cell Antigen Coupler (TAC) technology platform which is biologically distinct from CAR-T and has the potential to be a next generation solution to these challenges. TAC technology is a novel way to genetically modify T cells and redirect these T cells to target cancer antigens by co-opting the natural T cell receptor (TCR) to eradicate the tumor cells. TAC01-CD19 is the lead program in Triumvira’s pipeline of several TAC programs for both solid tumors and hematological malignancies.

About TAC01-CD19

TAC-01CD19 is a novel genetically engineered T cell therapy product targeting CD19 for use in B-cell malignancies. The product comprises autologous T cells that have been genetically engineered via lentiviral transduction to express the CD19 T cell Antigen Coupler (TAC). Preclinical data suggest that TAC01-CD19 has the potential for being highly efficacious with minimal side effects.

About CD19 and DLBCL

CD19 is a B cell marker and is expressed on the surface of B cell malignancies such as Diffuse Large B Cell Lymphoma (DLBCL). DLBCL is a subtype of Non-Hodgkin Lymphomas (NHLs). DLBCL is expected to impact approximately 26,000 patients in the U.S. in 2018. Even though significant improvements in therapies have occurred in the past years, about 45% of patients with DLBCL die of either their disease or of non-cancerous causes (1).