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TCR2 Therapeutics Reports Second Quarter 2019 Financial Results and Provides Corporate Update

On August 8, 2019 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, TCR2 Therapeutics, AUG 8, 2019, View Source [SID1234538445]).

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"In the second quarter of 2019, we made significant progress with our two lead programs TC-210 and TC-110," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We began patient dosing in a Phase 1/2 clinical trial with TC-210 and partnered with the National Cancer Institute, an institution integral in the validation of targeting mesothelin, to further understand how our unique TRuC-T cells impact mesothelin-positive solid tumors. Additionally, we accelerated our ability to move programs toward and through the clinic by expanding our leadership team with experts that deepen our core competencies – manufacturing, IND enablement and innovation. We remain in a strong financial position with a cash runway into 2022 and look forward to providing updates on TC-210 as we progress through the clinic."

Recent Developments

TCR2 has begun dosing in its Phase 1/2 clinical trial of TC-210 to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma or cholangiocarcinoma.

TCR2 announced that it entered into a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute (NCI) to collaborate on the use of TCR2’s proprietary TRuC-T cells as a cancer therapeutic agent against mesothelin in the Company’s ongoing Phase 1/2 trial of TC-210.

TCR2 expanded its manufacturing and immuno-oncology expertise by hiring Vice Presidents Nigel Williams, Robert Tighe and Dario Gutierrez, Ph.D. The expansion of the leadership team strengthens the Company’s core competencies of manufacturing, IND enablement and innovation as it advances a broad portfolio of next generation TRuC-T cells.

The United States Patent and Trademark Office issued patents with claims covering TCR2’s T cell receptor (TCR) Fusion Construct T cells (TRuCTM-T cells) that express anti-B-cell maturation antigen (BCMA) and anti-CD19 TCR fusion proteins, including TC-110.

TC-210 Clinical Trial Design

The Phase 1/2 clinical trial (NCT03907852) is evaluating the safety and efficacy of TC-210, TCR2’s T-cell receptor fusion construct against mesothelin at Sarah Cannon Research Institute, MD Anderson Cancer Center and the NCI. The trial is enrolling patients with mesothelin expressing non-small cell lung cancer (NSCLC), ovarian cancer, cholangiocarcinoma or malignant pleural/peritoneal mesothelioma.

The Phase 1 portion of the clinical trial utilizes a 3+3 design with four escalating dose levels for TC-210. At each dose level, TC-210 is first administered without lymphodepletion and then following lymphodepleting chemotherapy. The primary objective for the study is patient safety with a key secondary objective to determine the recommended Phase 2 dose (RP2D). In addition to standard measures of safety and efficacy, translational work includes the assessment of TC-210 T cells for expansion, trafficking, persistence and phenotypic changes.

Under the terms of the CRADA, NCI will conduct translational studies, measuring potential biomarkers in patients treated with TCR2 Therapeutics’ proprietary mesothelin-specific T cell-based therapy to better understand the pharmacodynamics of TC-210.

In the Phase 2 portion of the clinical trial, approximately 50 patients are initially planned to receive TC-210 at the RP2D in four distinct cohorts according to their cancer diagnosis: NSCLC, ovarian cancer, malignant pleural/peritoneal mesothelioma and cholangiocarcinoma. Each cohort includes ten patients, except the NSCLC cohort which includes 20 patients with eight patients to receive TC-210 as single agent and 12 to receive TC-210 in combination with a programmed cell death 1 (PD-1) blocking antibody.

Financial Highlights

Cash Position: TCR2 ended the second quarter of 2019 with $180.7 million in cash, cash equivalents, and investments compared to $123.2 million as of December 31, 2018. Net cash used in operations was $21.0 million in the first half of 2019 compared to $7.7 million in the first half of 2018.

R&D Expenses: Research and development expenses were $8.8 million for the second quarter of 2019 compared to $5.2 million for the second quarter of 2018. The increase in R&D expenses is primarily related to increase in headcount and activities related to the start of the Phase 1/2 clinical trial of the Company’s lead solid tumor product candidate, TC-210.

G&A Expenses: General and administrative expenses were $3.3 million for the second quarter of 2019 compared to $1.6 million for the second quarter of 2018. The increase in general and administrative expenses was primarily due to an increase in personnel costs and cost associated with operations as a public company.

Net loss: Net loss was $11.1 million for the second quarter of 2019 compared to $6.2 million for the second quarter of 2018, driven predominantly by increased R&D expense in the quarter.

Upcoming Events

TCR2 Therapeutics management are scheduled to participate at the following upcoming conferences.

BTIG Biotechnology Conference 2019: Ian Somaiya, Chief Financial Officer of TCR2 Therapeutics, will be available for one-on-one meetings on Monday, August 12, 2019 in New York, NY.

2019 Wedbush PacGrow Healthcare Conference: Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics, will present on Tuesday, August 13, 2019 at 8:00am ET in New York, NY.

Synlogic to Present at the 2019 Wedbush PacGrow Healthcare Conference

On August 8, 2019 Synlogic, Inc. (NASDAQ: SYBX) reported that Scott Plevy, M.D., Synlogic’s chief scientific officer, will provide a corporate update at the 2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13 at 9:45 am ET, in New York City (Press release, Synlogic, AUG 8, 2019, View Source [SID1234538444]).

A live webcast of the presentation can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. An archived copy of the webcast will be available on the Synlogic website for approximately 30 days after the event.

Synlogic Reports Second Quarter 2019 Financial Results and Provides Program Updates

On August 8, 2019 Synlogic, Inc. (NASDAQ:SYBX), a clinical stage company applying synthetic biology to beneficial microbes to develop novel, living medicines, reported its financial results for the second quarter ended June 30, 2019 and provided an update on its programs (Press release, Synlogic, AUG 8, 2019, View Source [SID1234538443]).

"In the first half of the year we made significant advances in our Synthetic Biotic programs while strengthening our platform capabilities and our balance sheet," said Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer. "We look forward to an equally productive second half of the year as we continue to advance our novel Synthetic Biotic medicines to provide potential therapeutic solutions for patients with unmet medical needs."

Recent Highlights and Updates

Positive topline clinical data from phenylketonuria (PKU) patient cohorts in Phase 1/2a clinical trial enable next stage of clinical development of new solid formulation of SYNB1618. In July, Synlogic announced positive top-line clinical data demonstrating safety and tolerability of a liquid formulation of SYNB1618 in patients with PKU. Importantly, the data also demonstrated that production of biomarkers related to SYNB1618’s engineered ability to consume phenylalanine (Phe) was equivalent in patients and healthy volunteers. Synlogic has initiated a bridging study in healthy volunteers to evaluate the activity and maximum tolerated dose of a solid oral formulation of SYNB1618 manufactured by the company using an improved fermentation process. Full data and a description of the model will be presented at the annual symposium of the Society for the Study of Inborn Errors of Metabolism (SSIEM) in Rotterdam, September 3-6, 2019.
Expanded collaboration with Ginkgo Bioworks provides expanded synthetic biology capabilities and strengthens Synlogic balance sheet. In June, Synlogic and Ginkgo entered into a long-term strategic platform collaboration. Under the agreement Ginkgo invested $80.0 million in Synlogic at a premium to market. Synlogic will use Ginkgo’s cell programming platform for building and testing thousands of microbial strains to accelerate progression of early preclinical leads to drug candidates optimized for further clinical development. Synlogic paid $30.0 million to Ginkgo for synthetic biology services to be provided over an initial period of five years which can be extended. Synlogic has exclusive rights to any Synthetic Biotic medicines that it develops as part of the collaboration and to intellectual property covering such products.
Establishment of clinical collaboration with Roche will enable evaluation of SYNB1891, engineered to express a STING agonist, in combination with PD-L1-blocking checkpoint inhibitor (CPI) atezolizumab (Tecentriq) in patients with advanced solid tumors. Synlogic remains on track to file an Investigational New Drug application with the U.S. Federal Drug Administration in the second half of 2019 for SYNB1891 to enable the company to initiate an open-label Phase 1 clinical trial to evaluate the candidate as a monotherapy and a combination treatment with atezolizumab.
Appointment of Scott Plevy, M.D., as Chief Scientific Officer to lead Synlogic’s research organization. Dr. Plevy is a gastroenterologist who most recently served as Vice President, Gastroenterology Disease Area Leader and IL-23 Pathway Leader at Janssen Research & Development, LLC, after a successful career in academia. He has a wealth of experience in early-phase clinical trials and performed translational research to advance the understanding of novel immunologic interventions in inflammatory bowel disease, other inflammatory conditions, and microbiome-related diseases.
Second Quarter 2019 Financial Results
As of June 30, 2019, Synlogic had cash, cash equivalents and short and long-term investments of $149.1 million.

In June 2019, Synlogic issued to Ginkgo 6,340,771 shares of common stock at a purchase price per share of $9.00, and pre-funded warrants to purchase an aggregate of 2,548,117 shares of common stock at an exercise price of $9.00 per share, with $8.99 of such exercise price paid at the closing of the offering. The net proceeds to Synlogic were approximately $79.9 million.

For the three months ended June 30, 2019, Synlogic reported a consolidated net loss of $12.3 million, or $0.45 per share, compared to a consolidated net loss of $14.6 million, or $0.59 per share, for the corresponding period in 2018.

Research and development expenses were $9.7 million for the three months ended June 30, 2019 compared to $10.9 million for the corresponding period in 2018. The decrease was primarily due to decreased clinical development costs for its SYNB1618 program and a decrease in nonclinical development costs for its programs, partially offset by increased research and development support costs.

General and administrative expenses for the three months ended June 30, 2019 were $3.7 million compared to $4.7 million for the corresponding period in 2018. The decrease was primarily due to a decrease in compensation costs and other employee-related expenses.

Revenues were $0.4 million for the three months ended June 30, 2019, compared to $0.3 million for the corresponding period in 2018. Revenue for both periods was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of irritable bowel disease.

Six-months Results
For the six months ended June 30, 2019, the consolidated net loss was $25.3 million, or $0.96 per share, compared to a consolidated net loss of $25.8 million, or $1.14 per share, for the corresponding period in 2018.

Total operating expenses were $27.5 million for the six months ended June 30, 2019, compared to $27.6 million for the corresponding period in 2018.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast at 5:00 pm ET today, Thursday, August 8, 2019. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Alternatively, investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 6968273. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors and Media section of the Synlogic website.

Sierra Oncology Reports Second Quarter 2019 Results

On August 8, 2019 Sierra Oncology, Inc. (SRRA), a late-stage drug development company focused on advancing targeted therapeutics for the treatment of patients with significant unmet needs in hematology and oncology, reported its financial and operational results for the second quarter ended June 30, 2019 (Press release, Sierra Oncology, AUG 8, 2019, View Source [SID1234538442]).

"During the second quarter, we achieved major milestones in the development programs for our drug candidates. We reported Phase 3 regulatory clarity and the granting of Fast Track designation by the U.S. Food and Drug Administration (FDA) for our lead asset, momelotinib, and we reported proof-of-concept clinical data for our Chk1 inhibitor, SRA737, at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting, suggesting that this drug candidate has a defined clinical path forward toward potential initial registration," said Dr. Nick Glover, President and CEO of Sierra Oncology. "Our current focus is on preparing for the launch of the MOMENTUM Phase 3 clinical trial, expected in the fourth quarter of 2019, designed to support potential registration of momelotinib on a global basis. We also continue to develop the assets in our DDR portfolio, SRA737 and SRA141, and have previously announced we are conducting a campaign intended to seek non-dilutive strategic options to support their further advancement."

Second Quarter 2019 Highlights:

Momelotinib (targeting JAK1/JAK2/ACVR1):

During the second quarter, Sierra obtained regulatory clarity with the FDA concerning the design of a Phase 3 clinical trial for momelotinib intended to support its potential registration.
Sierra also announced the design of the MOMENTUM Phase 3 clinical trial, planned for launch in the fourth quarter of 2019. The randomized double-blind trial is designed to enroll 180 myelofibrosis patients who are symptomatic, anemic and have been treated previously with a JAK inhibitor. The Primary Endpoint of the trial is the Total Symptom Score (TSS) response rate of momelotinib compared to danazol at Week 24 (99% power; p-value < 0.05). Dr. Srdan Verstovsek, MD, PhD, Chief, Section for Myeloproliferative Neoplasms, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, has been named Chief Investigator of the MOMENTUM trial.
Sierra also reported that the FDA has granted Fast Track designation to momelotinib for the treatment of patients with intermediate/high-risk myelofibrosis who have previously received a JAK inhibitor.
DNA Damage Response (DDR) portfolio (SRA737 and SRA141):

At the 2019 ASCO (Free ASCO Whitepaper) Annual meeting, Sierra reported preliminary efficacy and safety data from two ongoing clinical trials evaluating SRA737 across multiple indications, as monotherapy and when potentiated by non-cytotoxic low-dose gemcitabine (LDG). SRA737 demonstrated notable anti-cancer activity in multiple indications including a 30% Overall Response Rate in evaluable patients with anogenital cancer treated with SRA737+LDG, an indication for which the second line metastatic setting represents a significant unmet medical need with no approved therapies and very poor life expectancy. Additionally, evaluable RAS wild-type subjects whose tumors harbored FA/BRCA gene network mutations displayed favorable outcomes across multiple indications, with an Overall Response Rate of 25%.
During the second quarter, Sierra announced plans to prioritize its resources on the development of momelotinib and that it has launched a campaign exploring non-dilutive strategic options to support the future continued development of its portfolio of DDR assets.
Second Quarter 2019 Financial Results (all amounts reported in U.S. currency)

Research and development expenses were $11.7 million for the three months ended June 30, 2019, compared to $8.8 million for the three months ended June 30, 2018. The increase was primarily due to momelotinib related costs, including a $3.1 million increase in clinical trial and development related costs and a $1.2 million increase in third-party manufacturing costs, and a $1.1 million increase in personnel-related and allocated overhead costs. These increases were partially offset by decreases in SRA737 and SRA141 costs, including a $1.3 million decrease in third-party manufacturing costs, a $0.7 million decrease in clinical trial costs primarily related to SRA737, and a $0.5 million decrease in research and preclinical costs. Research and development expenses included non-cash stock-based compensation of $1.2 million for the three months ended June 30, 2019 and 2018.

Research and development expenses were $21.9 million for the six months ended June 30, 2019, compared to $17.1 million for the six months ended June 30, 2018. The increase was primarily due to momelotinib related costs, including a $4.4 million increase in clinical trial and development costs and a $1.3 million increase in third-party manufacturing costs, and a $2.4 million increase in personnel-related and allocated overhead costs. These increases were partially offset by decreases in SRA737 and SRA141 costs, including a $2.2 million decrease in third-party manufacturing costs and a $1.2 million decrease in research and preclinical costs. Research and development expenses included non-cash stock-based compensation of $2.4 million and $2.2 million for the six months ended June 30, 2019 and 2018, respectively.

General and administrative expenses were $3.5 million for the three months ended June 30, 2019, compared to $4.2 million for the three months ended June 30, 2018. This decrease was primarily due to decreases in professional fees of $0.4 million and personnel-related and allocated overhead costs of $0.3 million. General and administrative expenses included non-cash stock-based compensation of $0.5 million and $0.6 million for the three months ended June 30, 2019 and 2018, respectively.

General and administrative expenses were $6.8 million for the six months ended June 30, 2019, compared to $7.6 million for the six months ended June 30, 2018. This decrease was primarily due to decreases in professional fees of $0.5 million and personnel-related and allocated overhead costs of $0.3 million. General and administrative expenses included non-cash stock-based compensation of $1.0 million and $1.1 million for the six months ended June 30, 2019 and 2018.

For the three months ended June 30, 2019, Sierra incurred a net loss of $14.9 million compared to a net loss of $12.0 million for the three months ended June 30, 2018. For the six months ended June 30, 2019, Sierra incurred a net loss of $27.9 million compared to a net loss of $23.5 million for the six months ended June 30, 2018.

Cash and cash equivalents totaled $78.8 million as of June 30, 2019, compared to $106.0 million as of December 31, 2018. At June 30, 2019, there were 74,688,283 shares of common stock issued and outstanding, an additional 13,335,583 issuable upon exercise of stock options and warrants, and a term loan of $5.0 million.

Equity Inducement Plan

On August 5, 2019, the Compensation Committee of Sierra Oncology’s Board of Directors granted non-qualified stock options to purchase an aggregate of 112,000 shares of its common stock to two new employees under Sierra Oncology’s 2018 Equity Inducement Plan.

The 2018 Equity Inducement Plan is used exclusively for the grant of equity award to individuals who were not previously an employee or non-employee director of Sierra (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Sierra, pursuant to Rule 5635(c)(4) of the NASDAQ Listing Rules.

The options have an exercise price of $0.49 per share, which is equal to the closing price of Sierra’s common stock on the date of grant. Each option will vest and become exercisable as to 25% of the shares on the first anniversary of the recipient’s start date, and then will vest and become exercisable as to the remaining 75% of the shares in 36 equal monthly installments following the first anniversary, in each case, subject to each such employee’s continued employment with Sierra on such vesting dates. The options are subject to the terms and conditions of Sierra’s 2018 Equity Inducement Plan, and the terms and conditions of the stock option agreement covering the grant.

Selecta Biosciences Reports Second Quarter 2019 Financial Results and Provides Corporate Update

On August 8, 2019 Selecta Biosciences, Inc. (NASDAQ: SELB), a clinical-stage biotechnology company focused on unlocking the full potential of biologic therapies based on its immune tolerance platform technology, ImmTOR, reported financial results for the second quarter ended June 30, 2019 and provided a corporate update (Press release, Selecta Biosciences, AUG 8, 2019, View Source [SID1234538441]).

"Our gene therapy program has gained a lot of momentum, most notably with our new strategic partnership with AskBio, which will combine our ImmTOR platform technology with AskBio’s AAV technology and know-how. We believe this partnership will allow us to develop a robust pipeline of products that can potentially be re-dosed and offer patients a new treatment paradigm in areas of high unmet need," said Carsten Brunn, Ph.D., President and CEO of Selecta. "We are also pleased that the COMPARE trial continues to actively enroll patients, and we look forward to differentiating SEL-212 compared to the current FDA-approved uricase therapy in adult patients with chronic refractory gout. We believe the clinical profile of SEL-212, along with its more convenient monthly dosing, makes it a compelling product for patients and their providers and represents a very large market opportunity of over $1.0 billion."

Recent Highlights and Anticipated Upcoming Milestones

Chronic Refractory Gout Program:

COMPARE Clinical Trial of SEL-212 vs. Krystexxa Enrolling Patients: In March 2019, Selecta initiated a six-month head-to-head clinical trial (COMPARE) designed to evaluate the superiority of its lead product candidate, SEL-212 (ImmTOR + Pegadricase), compared to Krystexxa, the current U.S. Food and Drug Administration (FDA)-approved uricase therapy, in adult patients with chronic refractory gout. The COMPARE trial, which is currently enrolling patients, is expected to enroll 150 patients, and the primary endpoint is the maintenance of serum uric acid (sUA) levels of <6mg/dL at six months. An interim data analysis is expected in the fourth quarter of 2019 with a full statistical superiority analysis expected in the second quarter of 2020.
AAV Gene Therapy Program:

New Strategic Partnership with Gene Therapy Leader AskBio: In August 2019, Selecta announced a strategic partnership with Asklepios BioPharmaceutical, Inc. (AskBio), to jointly develop, manufacture and commercialize a broad portfolio of life-changing, next-generation adeno-associated virus (AAV) gene therapies. This partnership will leverage the unique proprietary technology platforms of both companies with a human proof of concept trial to validate this portfolio of products and their potential for re-dosing in patients.
Advancing Collaboration with CureCN Consortium: Under a collaboration with the European consortium, CureCN, for an ImmTOR+AAV gene therapy combination product candidate in Crigler-Najjar Syndrome, Selecta expects CureCN to obtain scientific advice from the German drug regulatory authority in the second half of 2019.
Corporate Updates:

Strengthened Management Team: Selecta announced the appointment of Alison Schecter, M.D., as Chief Medical Officer in July 2019. Dr. Schecter has over 20 years of combined drug development, strategic management and practical clinical experience in academia and industry and joins Selecta from Sanofi, where she was the Global Project Head, Rare Diseases, and was responsible for leading the Niemann-Pick Disease (ASMD) project.
Expanded Board of Directors: Selecta announced the addition of Scott D. Myers to its Board of Directors, in June 2019. Mr. Myers has more than 20 years of leadership experience in the biopharmaceutical industry and currently serves as Chief Executive Officer and Chairman of the Board of Rainier Therapeutics.
Second Quarter 2019 Financial Results:

Revenue: For the second quarter ended June 30, 2019, the company recognized less than $0.1 million of revenue under its collaboration agreement with Spark.

Research and Development Expenses: Research and development expenses for the second quarter ended June 30, 2019 were $12.1 million, which compares with $14.4 million for the second quarter of 2018. Research and development expenses decreased by $2.3 million, or 16%, as compared to the same period in 2018. The decrease reflects the reduced salaries and benefits as a result of the company’s headcount reduction at the beginning of fiscal 2019. There were further cost reductions related to discontinued programs. These cost reductions were offset by the timing of costs incurred for both the company’s Phase 2 and Phase 3 clinical programs for SEL-212.

General and Administrative Expenses: General and administrative expenses for the second quarter ended June 30, 2019 were $4.1 million, which compares with $4.4 million for the second quarter of 2018. General and administrative expenses decreased by $0.3 million, or 6%, as compared to the same period in 2018. The reduction in costs was primarily the result of reduced legal fees, offset by an increase in professional fees.

Net Loss: For the second quarter ended June 30, 2019, Selecta reported a net loss of $16.4 million, or $0.37 per share, compared to a net loss of $18.8 million, or $0.84 per share, for the same period in 2018.

Cash Position: Selecta had $42.0 million in cash, cash equivalents, restricted cash and short-term investments as of June 30, 2019, which compares to cash, cash equivalents, restricted cash and short-term investments of $48.7 million as of March 31, 2019.
Financial Outlook:

Selecta believes its available cash, cash equivalents and restricted cash will be sufficient to meet its operating requirements into the first quarter of 2020.

Conference Call and Webcast Reminder
Selecta management will host a conference call at 8:30 a.m. ET today to provide a corporate update and review the company’s second quarter 2019 financial results. Investors and the public can access a live and archived webcast of this call via the Investors & Media section of the company’s website, View Source Individuals may also participate in the live call via telephone by dialing (844) 845-4170 (domestic) or (412) 717-9621 (international) and may access a teleconference replay for one week by dialing (877) 344-7529 (domestic) or (412) 317-0088 (international) and using confirmation code 10127459.