On August 5, 2021 TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage cell therapy company with a pipeline of novel T cell therapies for patients suffering from cancer, reported financial results for the second quarter ended June 30, 2021 and provided a corporate update (Press release, TCR2 Therapeutics, AUG 5, 2021, View Source [SID1234585908]).

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"As we enter the second half of the year, we are approaching the conclusion of the Phase 1 portion of our gavo-cel clinical trial and selection of an RP2D. We look forward to presenting safety, efficacy and translational data from at least 17 patients, up to dose level 5, in an oral presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on September 17," said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. "We believe that gavo-cel has the potential to significantly improve the standard of care for patients with treatment refractory mesothelin-expressing solid tumors. We are focused on identifying the RP2D before the end of 2021 to advance this program into Phase 2 where we can more definitively evaluate efficacy, including retreatment with gavo-cel and combinations with checkpoint inhibitors. We also remain committed to advancing our broad emerging pipeline, including new enhancements, allogeneic TRuC-T cells and new targets and look forward to showcasing these programs at our upcoming virtual R&D Day."

Recent Developments

Gavo-cel:

TCR2 announced today the Company plans to present new clinical data from the dose escalation portion of the Phase 1/2 clinical trial of gavo-cel in patients with treatment refractory mesothelin-expressing solid tumors as part of an oral presentation on September 17 at 14:20 CEST (8:20am EST) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 being held in-person from September 16-21, 2021. The presentation will include long-term follow-up from initial and new patients from the Phase 1 dose escalation, with data from additional non-mesothelioma patients, and will focus on safety, efficacy and translational data at dose levels 3 (1×108 cells/m2 with lymphodepletion), 4 (5×108 cells/m2 without lymphodepletion) and 5 (5×108 cells/m2 with lymphodepletion).
Corporate:

TCR2 announced today that it will host a virtual R&D Day on Wednesday, October 20, 2021 to showcase the broad emerging pipeline focusing on its enhancements, allogeneic strategies and new targets.
TCR2 announced the appointment of Peter Olagunju as its first Chief Technical Officer where he will oversee process development, manufacturing, quality control and technical operations for the Company’s TRuC-T cell programs and emerging pipeline. Previously, Mr. Olagunju was Senior Vice President of Technical Operations at FerGene, Inc. Before that, Mr. Olagunju was Vice President of Global Patient Operations at bluebird bio, Inc., where he held several roles of increasing responsibility and was the program lead and functional head of manufacturing supporting the European approval for ZYNTEGLO, a transformational gene therapy for Transfusion dependent Thalassemia.
Anticipated Milestones

TCR2 to highlight interim progress from the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial for patients with mesothelin-expressing solid tumors in an abstract at the 2021 World Conference on Lung Cancer.
TCR2 to highlight additional safety, efficacy and translational data from all patients receiving therapy up to dose level 5 (second and third gavo-cel doses) in the Phase 1 portion of the gavo-cel Phase 1/2 clinical trial focused on mesothelin-expressing solid tumors in an oral presentation at the ESMO (Free ESMO Whitepaper) Congress 2021.
TCR2 to present an interim update from the Phase 1 portion of the TC-110 Phase 1/2 clinical trial for patients with CD19+ non-Hodgkin lymphoma or adult acute lymphoblastic leukemia in the second half of 2021.
TCR2 plans to file an IND for TC-510, the first enhanced TRuC-T cell (targeting mesothelin with a PD-1:CD28 switch), in the second half of 2021.
TCR2 plans to select a development candidate for its allogeneic program in the second half of 2021.
TCR2 to present preclinical data on its IL-15 enhancements program in the fourth quarter of 2021.
TCR2 to host virtual R&D Day focused on the broad emerging pipeline on October 20, 2021.
TCR2 anticipates production of clinical trial material from ElevateBio LLC and its manufacturing facility in Stevenage, UK, both in anticipation of demand from the Phase 2 expansion trial of gavo-cel, in 2022.
Financial Highlights

Cash Position: TCR2 ended the second quarter of 2021 with $317.3 million in cash, cash equivalents, and investments compared to $228.0 million as of December 31, 2020. Net cash used in operations was $15.0 million for the second quarter of 2021 compared to $16.0 million for the second quarter of 2020. TCR2 projects net cash use of $100-110 million for 2021, which includes tenant improvements to the Rockville facility. We expect cash on hand to support operations through 2023.

R&D Expenses: Research and development expenses were $18.6 million for the second quarter of 2021 compared to $12.9 million for the second quarter of 2020. The increase in R&D expenses was primarily due to an increase in headcount, additional lab facilities, and manufacturing facilities.

G&A Expenses: General and administrative expenses were $5.7 million for the second quarter of 2021 compared to $3.8 million for the second quarter of 2020. The increase in general and administrative expenses was primarily due to an increase in personnel costs and external professional fees.

Net Loss: Net loss was $24.3 million for the second quarter of 2021 compared to $16.2 million for the second quarter of 2020.
Adoption of New Lease Standard

During the second quarter of 2021, TCR2 adopted the new lease standard ASC 842 effective January 1, 2021. The lease standard requires companies to record right-of-use assets and lease liabilities for all leases. With the adoption of the new lease standard, the Company removed its facility in Rockville, MD as an asset under a built-to-suit lease in the amount of $41 million and removed the associated liabilities of $37 million. As of June 30, 2021, the Company’s right-of-use assets under operating leases, including the Rockville facility, were $30.6 million and operating lease liabilities were $27.6 million.

Upcoming Events

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

2021 Wedbush PacGrow Healthcare Conference: Robert Hofmeister, Ph.D., Chief Scientific Officer of TCR2 Therapeutics, will participate in a panel using a virtual platform on Tuesday, August 10, 2021 at 9:45am ET

On August 5, 2021 Exicure, Inc. (NASDAQ: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) technology, reported that it is providing an update on the Phase 1b/2 clinical trial of cavrotolimod (AST-008) (NCT03684785) (Press release, Exicure, AUG 5, 2021, View Source [SID1234585941]). The Phase 2 stage of the trial is evaluating cavrotolimod in combination with pembrolizumab (KEYTRUDA) or cemiplimab (LIBTAYO) in patients with locally advanced or metastatic solid tumors refractory to anti-PD-(L)1 therapy in two primary dose-expansion cohorts, one in MCC and one in cutaneous squamous cell carcinoma (CSCC), and three exploratory cohorts.

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Interim data highlights from the Phase 2 expansion stage

As of the data cut-off date of July 1, 2021, 26 patients, all with documented progression on anti-PD-(L)1 therapy, have been dosed in the Phase 2 stage, of whom 17 patients were evaluable.
Nine of the 17 evaluable patients were in the MCC cohort and, per RECIST v1.1, best overall response was a complete response (CR) in one MCC patient and stable disease in one MCC patient.
Injected and non-injected tumor lesions completely resolved in the MCC patient with a CR, supporting systemic (abscopal) effects.
The CR in one MCC patient met the pre-specified Phase 2 stage threshold to continue advancing patient enrollment in the MCC dose-expansion cohort.
The remaining 8 evaluable patients were enrolled in either the CSCC dose-expansion cohort, in which enrollment and data accrual is continuing, or in the exploratory cohorts.
The majority (93%) of treatment-related adverse events (TRAEs) were grade 1 or grade 2. The most common TRAEs were injection-site reactions and flu-like symptoms.
Two patients experienced serious adverse events assessed as related to cavrotolimod by clinical trial investigators. Treatment-related hypotension and flu-like symptoms were reported in one melanoma patient and a treatment-related injection reaction was reported in one MCC patient.
The confirmed ORR in all evaluable MCC patients enrolled in total in the Phase 1b/2 trial was 21% (three of 14) as of the July 1, 2021 data cutoff date.

The three patients were comprised of two CRs and one partial response (PR).
Biopsy of individual tumor lesions of the MCC patient assessed as PR by RECIST v1.1 revealed no evidence of residual tumor.
As of August 4, 2021, total trial enrollment for the Phase 1b/2 trial including primary and exploratory cohorts was 51 patients.

"Merkel cell carcinoma is an aggressive skin cancer with a high probability of metastasis. Observing a patient with metastatic MCC who had been previously progressing on pembrolizumab monotherapy and radiation, achieve a complete response, is highly encouraging," said Dr. Sunandana Chandra, M.D., Assistant Professor at Northwestern University Feinberg School of Medicine and principal investigator in the Phase 1b/2 clinical trial of cavrotolimod.

Trial results and further response details are summarized in the company’s updated corporate presentation on the Company’s website.

About Cavrotolimod (AST-008)

Cavrotolimod (AST-008) is an SNA consisting of toll-like receptor 9 agonists designed for immuno-oncology applications. Cavrotolimod is in a Phase 1b/2 clinical trial in patients with advanced solid tumors. In December 2019, Exicure announced preliminary results from the Phase 1b stage of the clinical trial including potential signs of anti-tumor activity with cavrotolimod in combination with pembrolizumab in cancer patients. In the second quarter of 2020, Exicure initiated the Phase 2 stage of the clinical trial with dose-expansion cohorts of intratumoral cavrotolimod in combination with approved checkpoint inhibitors to treat two cohorts of patients with locally advanced or metastatic MCC or CSCC. Additional information regarding the Phase 1b/2 study can be found here: View Source Cavrotolimod in combination with anti-PD-1 therapy was granted Fast Track and Orphan Drug designations for locally advanced or metastatic MCC refractory to anti-PD-(L)1 therapy and Fast Track designation for locally advanced or metastatic CSCC refractory to anti-PD-1 therapy.

On August 5, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the second quarter ended June 30, 2021 (Press release, ViewRay, AUG 5, 2021, View Source [SID1234586033]).

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Second Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $37.9 million, compared to four new orders totaling $24.6 million in the second quarter of 2020.
Total backlog increased to $278.4 million as of June 30, 2021, compared to $232.2 million as of June 30, 2020.
Total revenue of $15.0 million primarily from two revenue units, compared to $14.2 million primarily from two revenue units in the second quarter of 2020.
Cash usage in the second quarter of 2021 was approximately $15 million compared to approximately $11 million in the second quarter of 2020.
Cash and cash equivalents were $166.9 million as of June 30, 2021.
"Our second quarter performance is a solid step forward and reflects progress on our commercial, innovation, and clinical pipelines. Our team has executed very well in an environment that continues to be challenging," said Scott Drake, President and CEO. "We are well positioned to drive further growth, therapy adoption, and extend our innovation lead."

Three Months Ended June 30, 2021 Financial Results

Total revenue for the three months ended June 30, 2021 was $15.0 million compared to $14.2 million for the same period last year.

Total gross profit (loss) for the three months ended June 30, 2021 was ($1.7) million, compared to ($1.0) million for the same period last year.

Total operating expenses for the three months ended June 30, 2021 were $24.8 million, compared to $24.5 million for the same period last year.

Net loss for the three months ended June 30, 2021 was $31.0 million, or $0.19 per share, compared to $26.2 million, or $0.18 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $166.9 million at June 30, 2021.

Six Months Ended June 30, 2020 Financial Results:

Total revenue for the six months ended June 30, 2021 was $30.6 million compared to $28.5 million for the same period last year.

Total gross profit (loss) for the six months ended June 30, 2021 was $(1.4) million, compared to $(3.1) million for the same period last year.

Total operating expenses for the six months ended June 30, 2021 were $49.8 million, compared to $52.5 million for the same period last year.

Net loss for the six months ended June 30, 2021 was $57.7 million, or $0.36 per share, compared to $53.7 million, or $0.36 per share, for the same period last year.

Financial Guidance
For the full year 2021, ViewRay anticipates total revenue to be in the range of $63 million to $73 million, and total cash usage to be in the range of $58 million to $68 million.

Conference Call and Webcast
ViewRay will hold a conference call to discuss results on Thursday, August 5, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (844) 277-1426 for domestic callers and (336) 525-7129 for international callers. The confirmation number is 8473598. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available for seven days after the call. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8473598.

On August 5, 2021 Merus N.V. (Nasdaq: MRUS) ("Merus", the "Company," "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported financial results for the second quarter that ended June 30, 2021 and provided a business update (Press release, Merus, AUG 5, 2021, View Source [SID1234586049]).

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"We are encouraged by the interim results on Zeno in patients with NRG1 fusion cancers that we reported in the second quarter and remain focused on successful execution of our Zeno program and our other clinical trials," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "We are planning to provide a clinical update on MCLA-145 and MCLA-158 later this year."

Clinical Programs

Zenocutuzumab (Zeno or MCLA-128: HER3 x HER2 Biclonics)

Phase 2 part of the phase 1/2 trial continues: update planned by the first half of 2022

We shared interim clinical data of our zenocutuzumab (Zeno) program in patients with NRG1 fusion (NRG1+) cancers at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting. The highlights from the presentation included:

As of the April 13, 2021, efficacy data cutoff, 61 patients with NRG1+ cancer were enrolled, including 45 patients evaluable for response.
Encouraging early clinical activity was observed, with confirmed partial responses by investigator review (RECIST v1.1) in 42% (5 of 12) patients with pancreatic cancer and in 29% (13 of 45) patients across all NRG1+ tumor types treated.
One additional partial response was confirmed after the data cutoff date, which if included in the interim efficacy analysis, would increase the percentage of confirmed partial responses across all NRG1+ tumor types treated to 31% (14 of 45 patients).
More than three quarters (34 of 45) of evaluable patients showed tumor reduction. In addition, 40% (19 of 47) of all patients remained on therapy as of the data cutoff date.
Zeno continues to be well tolerated with a favorable safety profile.
As of June 4, 2021, more than 70 patients had been treated in the eNRGy trial and Early Access Program (EAP). We continue to be encouraged by the ongoing trial, rate of enrollment, observed clinical activity and safety profile, and plan to provide a clinical and regulatory program update by the first half of 2022.

In the second quarter of 2021, we entered into collaborations with several companies and medical organizations in Israel, Italy and Spain with the goal of raising awareness of the eNRGy trial and providing access to molecular screening opportunities for eligible patients with cancers that may have NRG1 fusions. Merus is now working with more than ten different industry and academic collaborators across Asia, North America and Europe aimed to enhance testing for NRG1 fusions, to raise awareness of and support enrollment into the eNRGy trial.

Details of the eNRGy trial can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com, or by calling 1-833-NRG-1234.

MCLA-158 (Lgr5 x EGFR Biclonics): Solid Tumors

Phase 1 trial continues with dose expansion cohorts: update planned for Q4’21

The phase 1, open-label, multicenter clinical trial of MCLA-158 is ongoing in the dose expansion phase. Enrollment of patients with gastro-esophageal and head-and-neck cancers continues, and preliminary evidence of antitumor activity has been observed. We plan to provide an update at a medical conference in the fourth quarter of 2021.

MCLA-145 (CD137 x PD-L1 Biclonics): Solid Tumors

Phase 1 trial continues: update planned for Q4’21

The phase 1, open-label, single-agent clinical trial of MCLA-145 is ongoing and consists of a dose escalation phase, to be followed by a planned dose expansion phase. MCLA-145 is the first drug candidate co-developed under Merus’ global collaboration and license agreement with Incyte Corporation ("Incyte"), which permits the development and commercialization of up to 11 bispecific and monospecific antibodies from the Biclonics platform. Merus retains full rights to develop and commercialize MCLA-145, if approved, in the United States; and Incyte holds full rights to develop and commercialize MCLA-145 outside the United States. We plan to provide an update at a medical conference in the fourth quarter of 2021.

We published a report in Nature Communications in July titled "A human CD137×PD-L1 bispecific antibody promotes anti-tumor immunity via context dependent T cell costimulation and checkpoint blockade" demonstrating in preclinical models that MCLA-145 potently activates T cells, even in the presence of suppressive conditions, as well as enhances T cell priming and promotes long-term T cell immunity. In addition, the antitumor activity of MCLA-145 in in vivo models was superior to those of the current standard immune checkpoint inhibitor comparators and associated with recruitment and intratumoral expansion of CD8+ T cells.

MCLA-129 (EGFR x c-MET Biclonics): Solid Tumors

The phase 1/2, open-label, single-agent clinical trial of MCLA-129 is ongoing and consists of a dose escalation phase, to be followed by planned expansion cohorts evaluating MCLA-129 for the treatment of patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. MCLA-129 is a Biclonics, which binds to EGFR and c-MET and is being investigated for the treatment of solid tumors. EGFR is an important oncogenic driver in many cancers, and upregulation of c-MET signaling has been associated with resistance to EGFR inhibition.

Second Quarter 2021 Financial Results

We ended the second quarter with cash, cash equivalents and marketable securities of $352.8 million compared to $207.8 million at December 31, 2020. The increase was primarily the result of net proceeds from our follow-on offering and proceeds from the collaboration with and equity investment by Eli Lilly and Company ("Lilly"), net of cash used in operations and other items. Based on the Company’s current operating plan, we expect that our existing cash and cash equivalents and marketable securities of $352.8 million as of June 30, 2021, will fund the Company’s operations into the second half of 2024.

Collaboration revenue for the three months ended June 30, 2021 increased by $6.3 million as compared to the three months ended June 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $4.6 million that commenced in the first quarter of 2021, and a $1.4 million increase primarily in reimbursement revenues related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the three months ended June 30, 2021 increased by $10.9 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the three months ended June 30, 2021 increased by $2.6 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in stock-based compensation and other personnel related expenses as well as facilities and professional fees, partially offset by decreases in legal and IP related costs.

Collaboration revenue for the six months ended June 30, 2021 increased by $8.4 million as compared to the six months ended June 30, 2020, primarily as a result of an increase from a Lilly upfront payment amortization and reimbursement revenues of $6.0 million that commenced in the first quarter of 2021, and a $2.2 million increase primarily in reimbursement revenues related to Incyte reflecting activities in the period for MCLA-145. The change in exchange rates did not significantly impact collaboration revenue.

Research and development expense for the six months ended June 30, 2021 increased by $14.7 million as compared to the six months ended June 30, 2020, primarily as a result of an increase in clinical and manufacturing costs related to our programs and stock-based compensation.

General and administrative expense for the six months ended June 30, 2021 increased by $3.0 million as compared to the three months ended June 30, 2020, primarily as a result of an increase in stock-based compensation and other personnel related expenses as well as facilities and professional fees, partially offset by decreases in legal and IP related costs and travel expenses.

Other income (loss), net consists of interest earned and fees paid on our cash and cash equivalents held on account, accretion of investment earnings and net foreign exchange (losses) gains on our foreign denominated cash, cash equivalents and marketable securities. Other gains or losses relate to the issuance and settlement of financial instruments.

On August 5, 2021 IntelGenx Technologies Corp. (the "Company") reported that closed an offering by way of private placement in the United States (the "Private Placement") of unsecured convertible notes (the "Notes"). Each Note bears interest at a rate of 8% (payable quarterly, in arrears, with the first payment being due on September 1, 2021), matures on July 31, 2025 and is convertible, after a six-month holding period from the Initial Closing Date, into common stock of the Company (the "Common Shares") at a conversion price of $0.40 per share (the "Conversion Price") (Filing, 8-K, IntelGenx, AUG 5, 2021, View Source [SID1234586309]). The Notes issued on the Closing Date pursuant to the Private Placement were issued for gross proceeds of approximately $2.1 million.

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The Company intends to use the proceeds from the Private Placement for its Montelukast study, working capital and the Company’s expenses of the Offering.

Cantone Research, Inc. ("Cantone") acted as placement agent in respect of the Private Placement.

In connection with the Private Placement, Cantone is entitled to a cash commission of approximately $199,525 and non-transferable warrants entitling Cantone to purchase 613,000 Common Shares (the "Placement Agent Warrants"). The Placement Agent Warrants are exercisable into Common Shares at the Conversion Price and will expire in two years from the Closing Date.